Patenting Lives

Access to Research - The Seeds of Thought, the Wisdom of Tradition

2009-08-28T20:20:00.006Z

Access to patented seed for research and development has been very much in the news of late. Of course, it is not the patent necessarily rendering a product inaccessible for research, but the agreements licensing the seed.

27 representatives of the research community and industry met in Ames, Iowa, 30 June 2009, to consider the issues surrounding access to research in the seed industry. The meeting generated discussion on a set of principles to support public sector research on commercial, patented seed products. The final version of these principles will be presented to the major industry bodies for approval in September (going to the Biotechnology Industry Organization (BIO) 10 September, and to the American Seed Trade Association (ASTA) Executive Committee of the Board of Directors, 17 September). Their implementation by the industry will be of interest.

Although agricultural biotechnology is a significant commercial and innovative bonus to the seed industry, its promise for food security in the developing world is less certain and more socio-political. Wilhelmina Quaye argues that agricultural biotechnology is a socio-cultural issue. Writing in Business Daily, Quaye says in order to improve the use of biotechnology for food security and advancement in developing countries, the communities themselves must be involved in its implementation and development: "it must improve their capacity rather than create ties of dependency." Quaye also notes in Africa in particular the fear over losing traditional ways of farming: "The bottom line is that anyone developing biotechnologies must respond effectively to the intended users' needs and aspirations ... To do this, biotech agendas must consider the socio-cultural realities in Africa."

In the United States, the real significance of traditional agricultural knowledge and practices is starting to be recognised. The US Department of Agriculture (USDA) recently released the 2007 Agricultural Census, which is the first to count all individual Native American farmers on reservations across the country. Native Americans in Arizona, for instance, have been found to operate more than half that State's farms and ranches. And the numbers are expected to be even higher. Despite efforts to publicise the Census widely, including meeting with tribal leaders to discuss the process, individuals were inevitably missed. Farms are generally smaller than the national average, but nearly the entirety of the Dine reservation is under cultivation or grazing. One Hopi farmer, Richard Kuwunvana (pictured at right), says, "Our family has farmed this land forever. We're part of the corn, and it's part of us."

Going to Seed - More Corporate Drama in the Fields

2009-08-20T10:45:00.015Z

Following on from the story in "Seeded Players" (18 August 2009), Monsanto is again in the news over alleged anti-competitive behaviour. The New York Times reports today that DuPont and Monsanto are locked in a battle, with DuPont accusing Monsanto of anti-competitive practices, while Monsanto has retaliated saying DuPont has committed a "serious breach of business ethics."

In a letter obtained by Reuters, Monsanto chief executive, Hugh Grant (pictured at right), requests DuPont chairman, Charles O. Holliday Jr. (pictured below left), to establish a special committee of DuPont's independent directors to investigate the matter. Meanwhile, Monsanto has released a statement in response to the increased negative press. The claims of corporate misconduct include allegations that DuPont provided financial support to critics of Monsanto and forged documents. But DuPont has stood fast saying that Monsanto has conducted itself anti-competitively to the detriment of farmers and others.

And in May this year, Monsanto sued DuPont for patent infringement; in June DuPont retaliated with a countersuit in antitrust: "This case involves a scheme by Monsanto to monopolize agricultural biotech traits in corn and soybeans, and emerging combinations of such traits." Trait-stacking is where more than one trait (such as herbicide and insect resistance) is transferred to a crop, and so more than one gene. Cross-breeding of GM plants can achieve this as well as genetic engineering. The litigation follows a breakdown in a licensing arrangement between the two companies. DuPont claims it was entitled to combine the traits from Optimum GAT (DuPont) and Roundup Ready (Monsanto) under the terms of its licence. However, Monsanto argues that this is infringement of its patent and that "DuPont’s unauthorized use of our technology and patents is simply unacceptable."

However, the US Department of Justice Antitrust Division appears to have a different position. Indeed, investigations into several recent mergers in the industry have required significant divestitures, including that required of Monsanto and Delta & Pine Land, where a significant seed company and other assets had to be divested before the companies could proceed with their merger. The companies were also required to amend licensing agreements to respond to concerns with trait-stacking. Philip J Weiser, the Deputy Assistant Attorney-General, explains, "because DPL had had a license allowing it to "stack" a rival's trait with a Monsanto trait, Monsanto was also required to amend certain terms in its current trait license agreements with other cottonseed companies to allow them, without penalty, to stack non-Monsanto traits with Monsanto traits. As a result, producers of genetically modified traits gained greater ability to work with these seed companies."

Notably, the US Department of Agriculture and the US Department of Justice has announced that they will investigate antitrust concerns in the seed industry through a series of public workshops in 2010. In an address to the Organization for Competitive Markets two weeks ago, Weiser said, "Over the last twenty years, changes in technology and the marketplace have revolutionized agriculture markets, producing some substantial efficiencies as well as concerns about concentration. Notably, farmers today increasingly turn to patented biotechnology ... At the same time, this technological revolution and accompanying market developments have facilitated the emergence of large firms that produce these products, along with challenges for new firms to enter the market."

A lawyer for DuPont, Donald L Flexner, spoke to Reuters, "This is not just a DuPont problem. This is a competition problem. They've gained illegal monopoly power."

Seeded Players - Corporate Control in Agricultural Research

2009-08-18T10:31:00.018Z

Genetic modification is not infrequently referred to as the future for food security and agricultural sustainability in developing countries. This alone is perhaps a controversial statement and many would take issue - for instance, questions of environmental security and loss of agricultural biodiversity are just some of the major questions raised.

But rather crucially, apart from debates over the nature of the technology, there must be access to that technology, not only for its immediate application but also for its ongoing development and improvement. This is a major issue raised in a recent editorial in Scientific American. Agritech companies like Monsanto and Syngenta are regularly requiring those purchasing their seed to contract out of any research or experimental use exemption that might be provided in patent law and other areas of intellectual property law. Such an exemption (often referred to as the experimental-use defence) allows for research on a patented invention in order to continue to the cycle of innovation. In other words, research conducted upon a patented invention is exempted from infringement. Indeed, this is perhaps one of the fundamental and historical premises of patent law - that is, to disclose an invention in order to acquire a monopoly. It may be argued by some that this is a legitimate exploitation of the monopoly, however such contractual restrictions may persist well beyond the life of a patent, thus compromising the supposed calculation of time needed to balance the costs of research and development and the public benefit of access to innovation. Thus, if such an agreement can override exceptions for research and become a genuine and explicit obstacle to independent research, then the notion of "user rights" sometimes applied to exceptions in patent law and other areas of intellectual property becomes somewhat problematic, if not specious. But what of the rights of purchasers of seed?

Thus, it is not an issue with patent law per se, but an issue of contract law. If the exception is not to be compromised, the relevant legislation must preclude a contractual condition having effect. But this is an issue that is not necessarily addressed in the applicable legislation, not only in the US but also in the UK and elsewhere in Europe. Similarly, many developing countries have introduced patent regimes that neglect this protection. Nevertheless, in Europe the rights of the user with respect to research conducted upon seeds may indeed be less ambiguous. For instance, in relation to plant variety rights, Switzerland has implemented recently a separate defence to prevent the practice of contracting out of the research exception (Article 8), restricted of course to plant variety aspects. Many have recommended that this sort of protection should be harmonised throughout Europe (and indeed internationally).

According to Scientific American, the agreements deployed by Monsanto and others "have explicitly forbidden the use of the seeds for any independent research. Under the threat of litigation, scientists cannot test a seed to explore the different conditions under which it thrives or fails ... And perhaps most important, they cannot examine whether the genetically modified crops lead to unintended environmental side effects." As the article explains, research is still published, but only that research approved by the company itself, completely disabling the intellectual freedom of scientific research and perhaps also the objectivity upon which scientific knowledge bases its import.

Access to Knowledge for Patent Offices

2009-08-17T15:18:00.005Z

Under the Access to Research for Development and Innovation (aRDi) scheme, Patent offices in developing countries will be given greater access to 150 online scientific journals by the end of the year. The scheme was launched in July by the World Intellectual Property Organisation (WIPO) in partnership with major scientific publishers, including Elsevier, Oxford University Press, Springer Science+Business Media, and Taylor & Francis, and linked to one of the key recommendations of the WIPO Development Agenda. Recommendation 8 of Cluster A (Technical Assistance and Capacity Building) of the 45 Adopted Recommendations under the WIPO Development Agenda, calls for WIPO "to develop agreements with research institutions and with private enterprises with a view to facilitating the national offices of developing countries, especially LDCs, as well as their regional and sub-regional intellectual property organizations to access specialized databases for the purposes of patent searches." According to the Science and Development Network, the scheme will facilitate the process of patent examination in developing countries, with 50 least-developed countries being provided with free subscriptions and 57 developing countries offered low-cost subscriptions.

Monsanto strikes back - Company takes action against the ban of its transgenic maize by the German government

2009-04-23T13:20:00.007Z

After last week´s sowing ban of MON 180, a genetically modified maize strain by the German Federal Minister of Agriculture, Ilse Aigner ("Patenting lives" reported), the patent holder Monsanto launched a legal action against this decision yesterday. A representative of Monsanto stated that the ban was contradictory and not in accordance with EU-rules. Hence, along with filing an action at the administrative court of Braunschweig, Monsanto is also seeking injunctive relief by the court. The haste in which these steps are taken is grounded on the fact that maize would need to be sown in May. According to Monasanto´s speaker the company is expecting a decision by the court by mid May.

MON 180 is genetically modified strain of maize which includes a gene from the bacillus thuringiensis and produces a poison which repels the parasitic larvae of the European Corn borer, a butterfly. By declaring the sowing ban, Ms Aigner applied the Safeguard Clause by which the competent authority may suspend the permission to dispose genetically altered organisms if new or additional information becomes available which may lead to a new risk assessment. The Minister based her decision on new studies which apparently have provided reasonable evidence that the genetically modified strain of maize would present a hazard to the environment - specifically for butterflies, lady birds and creature od the water.

Meanwhile, evidence is given that the German Federal Government has not yet reached a common consensus on its position on green genetical engineering. The Federal Minister of Education and Research, Annette Schavan, is critizising her colleague´s decision to mandate a sowing ban on MON 180. Ms. Schavan refers to green genetic engineering as one of the technologies of the future. Additionally she announced that fundings for such technologies will be expanded.

The Minister has announced that she is scheduling a roundtable in Berlin for the 20th of May on genetical engineering. Hereby all stakeholders would be invited. This would include associations, companies, scientists, non-governmental organisations as well as churches.

The outcome of this roundtable might shed some light on what direction green genetical engineering might be heading to in Germany. This will most certainly have an impact on the wider, namely the European scale.

"Pig patent" and ban of genetically modified crops - The week on biotech patents in Germany

2009-04-20T18:36:00.000Z

Last week has been a noteworthy one in Germany for biotechnological patents for agricultural applications and has received wide interest, nationally as well as internationally.

Hundreds of farmers, environmentalists and others gathered outside of Munich´s Erhardtstrasse 27, the principal seat of the European Patent Office (EPO) last Wednesday to protest against the so-called „Pig patent“ EP 1651777 B1 (above; 30 pigs "accompanied" the protests). The protesters used this opportunity to file a notice of opposition backed by more than 5000 individuals and more than 50 associations against the patent at the EPO which was granted on the 16th of July 2008 to Newsham Choice Genetics.

The protesters criticized the practice of patenting biological processes since “they have nothing to do with inventions”, as Hubert Weiger, the head of the “Bund Naturschutz Bayern”, an environmental group in Bavaria, stated. The farmers were specifically concerned that the continuing patenting of life stock would seriously aggravate their work by being threatened to pay excessive royalty fees to patentees which usually are multinational corporations in this area.

Initially the patent application contained 30 claims, from which some were related to animals as such, DNA sequences and the test kit. However the examination of the EPO has limited the claims to the screening method, whereas the claims to animals (pigs), the gene sequences and the test kit were rejected. The patent now solely relates to a “breeding method whereby a genetic analysis is carried out to screen for a variation (polymorphism) occurring naturally in some pigs, with a view to identifying those animals suitable for improving pork production and to selection appropriate breeding pairs” (see the press release of the EPO).

The main motto of the protest however was: “Stoppt das Patent auf die arme Sau” which stands for “No patents on the poor pig” and hereby – deliberately or negligently - wishes to render the patent as granted to a patent on pigs as such and hence being misleading. This may be excused due to the fact that this slogan is in its German meaning quite catchy and therefore serves the purpose of the protests. The press release of the EPO however clearly highlights that no patent on animals or gene sequences has been granted. The claims as they were initially filed may have lead to the realisation of such fears as expressed by the protesters but the examiners at the EPO did their job well in applying the rules of the European Patent Convention (EPC).

However, the protests and the hereby created public interest actually do highlight a major deficiency in the IP system and its public perception. It has not been achieved to thoroughly inform society as a whole what IP, and specifically patents is all about, how it operates and where its limitations are. IP has lately had a bad press whereas its benefits are often overseen. This needs to be addressed, bearing in mind its possible negative effects as well as to further explore how these may be overcome.

The press release by the EPO has highlighted in its last paragraph another rather more legal deficiency, which remains a hot topic and warrants determined action by policy makers. The EPO ceases to have jurisdiction totally 9 months after grant and the patent then falls within the jurisdiction of the nominated Member States. Post grant “quality control” by litigation on what should be patented is therefore seriously being hampered. In case of the “pig patent” (18 of the 35 Member States of the European Patent Organisation have been nominated for patent protection) this could mean multiple - and therefore expensive - litigation in all nominated jurisdictions.

Earlier this week the German Federal Minister of Agriculture, Ilse Aigner, has proclaimed a ban on the use of the genetically modified maize strain MON 810, which has been patented by Monsanto. The Minister was not hesitant to state that the decision was not a political one but was solely based on the facts of the case. Therefore, the decision should not be regarded as a fundamental verdict on the use of genetically modified crops in Germany, as Ms. Aigner affirmed. However, the political pressure is constantly growing. The Minister of Environment of the Federal State of Bavaria, Marcus Söder, has expressed the wish to make Germany a „genecrop-free zone“ and has reaffirmed this goal in a speech at Wednesdays´ protests against the “pig patent”. He joins the Ministry of Environment of the Federal State of Hessen, which is about to launch a legislative initiative in the „Bundesrat“, the 2nd chamber of parliament in Germany which consists of representatives from the 16 federal governments, to ban the patenting of newly bred animals and plants. By doing this, the Ministry wishes to call upon the German Federal Government to lobby the European Council and the European Commission to tighten Directive 98/44/EC on the legal protection of biotechnological inventions.

It now remains to be seen what impact the incidents of last week in Germany will have on the patenting of biotechnology. Mon 810 is currently banned in 6 countries of the European Union, including Germany. And it appears that the European Commission is willing to reconsider certain issues on patenting biotechnology.

Wikipedia for Agriculture

2009-01-24T18:30:00.000Z

Scientists in India have launched Agropedia, an "agricultural Wikipedia."

The project was first devised around 3 years ago by project lead, T V Prabhakar. Prabhakar, of the Indian Institute of Technology in Kanpur, saw a need for the equivalent of Wikipedia to be created for global agriculture. The project was revised to focus on information specific to India.

The 85 million rupee project will be implemented over 30 months to provide on-line access to agricultural information and knowledge throughout the country. Funded by the Indian government (the National Agriculture Innovation Project (NAIP)) and World Bank, resources will include information on crops and practices, regional knowledge and relevant research. Its primary objective is to provide an effective dissemination mechanism not only for researchers and students, but also farmers and agricultural extension workers.

The website launched with information on 9 crops - rice, wheat, sugarcane, lychee, groundnut, sorghum, chickpea, vegetable pea and pigeon pea - but the objective is to expand the resource so as to include all information related to agriculture and agricultural practice.

In true wiki-style, Agropedia is a dynamic resource to which content is constantly added and reviewed. Agricultural researchers are invited to validate information through the "open source" wiki model, but additional review will no doubt emerge through user feedback and contributions. Blogs and user forum facilities enhance and broaden the kind of knowledge provided and exchanged through the project.

The 7 consortium partners in the project include the International Crop Research Institute for the Semi-Arid Tropics (ICRISAT); Indian Institute of Technology, Kanpur (IITK); Indian Institute of Technology, Bombay (IITB); G B Pant University of Agriculture and Technology (GBPUAT); Indian Institute of Information Technology and Management, Kerala (IIITM-K); National Academy of Agricultural Research Management (NAARM); and the University of Agricultural Sciences, Dharwad (UASD).

The first stage of the project involved refining the mechanism to manage the knowledge, with the next phase to concentrate on dissemination, with trials to commence in 6 locations around the country.

Dissemination is not a straightforward exercise. While access to the necessary communication technology may be difficult for some, the resource will nevertheless improve the infrastructure to deliver information to all farmers. With the cooperation of agricultural extension workers and the establishment of around 12000 information technology-enabled rural information centres, the introduction of Agropedia should improve the accessibility of agricultural information whether directly or through farming networks. Innovative approaches to innovation are therefore very important. For example, V Balaji, head of knowledgment management and sharing at ICRISAT, has suggested that Agropedia resources might be used in various ways to disseminate information, including radio plays.

As one of the agricultural centres of the world and in a region rich with traditional agricultural practices and knowledge, India possesses unique resources for its ongoing development. This kind of enterprise has the potential to provide a significant facility for detailing and sustaining that development.

GM Wars

2008-10-13T09:32:00.015Z

Last week's announcement that UK Minister for the Environment, Jeff Rooker, was leaving government and Hilary Benn was appointed Secretary of State for Environment, Food and Rural Affairs led many to consider this a strong shift in the politics of GM food in the UK.

At a fringe meeting of the Labour Party Conference in Manchester, the then Minister (pictured at right) was credited with describing opponents of GM as being "... on a messianic mission. It is almost a religion where there isn’t any science base to it." However, a Jay Rayner writing in Sunday's Observer disagrees: "Benn has hardly been a friend of those who have been calling for an end to all GM experiments."

As the April report of the International Assessment of Agricultural Knowledge, Science and Technology for Development (IAASTD) explains there are new liability concerns for farmers with the advent of GM: "Farmers face new liabilities: GM farmers may become liable for adventitious presence if it causes loss of market certification and income to neighboring organic farmers, and conventional farmers may become liable to GM seed producers if transgenes are detected in their crops." In other words, the revolutionary changes in farming include not only influences upon traditional methods but also a revolution in the way in which farmers interact with their resources as patented materials.

As Rayner's article explains, the debate over GM is a debate not only in science, but also in politics and indeed commercial law. As a consumer issue, it is also a competition issue when intellectual property rights might interfere with access not only for consumers but for the farmers themselves. Noting Monsanto's practices of conscientious pursuit of litigation and the creation of seed "technology packages," the article raises the links between competition and intellectual property. Such packages (or bundling) as discussed earlier in Patenting Lives, are considered by the article to "force farms into a dependence on the company." It is this constraint upon ordinary farming practice that is credited with a breakdown in trust, not only for the technology but also for the commercial re-structuring of traditional farming practices.

Don't steal the steelpan

2008-08-23T12:51:00.006Z

The United States Patent and Trademark Office (USPTO) has revoked a patent for the "Cycle of Fifths Steel Pan" after an inter partes request for re-examination filed by the Government of Trinidad and Tobago.

The request led to re-examination of the patent granted to Trevor King (Jamaica, NY):

US Patent 6 750 386 -"Cycle of Fifths Steel Pan"

as well as the patent granted to George Whitmyre et al:

US Patent 6 212 772 - "Production of a Caribbean Steel Pan"

The third patent of interest, granted to Wheeler Matthews, was US Patent 5 973 247, "Portable Steel Drums and Carrier." However, this patent had lapsed due to non-payment of fees.

In the "Cycle of Fifths Steel Pan" patent, the Government of Trinidad and Tobago challenged the claim for inventiveness pertaining to an arrangement of notes on the surface of the steelpan, the technical solution offered being that this made the playing of the steelpan easier. This claim was challenged for novelty and inventiveness - it was shown to be well-known and anticipated in the published local work of pannist, Anthony Williams (pictured at right).

The USPTO Inter Partes Re-examination Certificate will identify which claims can be confirmed as patentable, which have not been examined and which are to be cancelled, disclaimed. In response to this request, the Inter Partes Re-examination Certificate cancelled all claims effectively invalidating the patent.

The "Production of a Caribbean Steel Pan" patent, which claimed a hydroforming production method for a mass production of steelpans, was confirmed. Perhaps this second patent raises questions not of "industrial application" but of misappropriation of a traditional industry and knowledge. The steelpan itself emerged from the history and circumstances of slavery and linguistic and cultural displacement in the region. It was such an important means of communication and cohesion between slaves that it was prohibited by the colonisers in the late 19th century. The question of mass production appears to under-estimate the greater significance of the production itself.

European Commission Open Access Pilot

2008-08-20T21:05:00.005Z

The European Commission launched today a pilot project in open access research.

Pointing the the importance of access to research results as a driver of the knowledge-based economy, the Commission announced that it would use the pilot to disseminate EU 7th Research Framework Programme (FP7) project results as widely as possible. FP7 will fund more than 50 billion euros over 2007-2013 and the pilot will include results from projects in health, environment, social sciences, energy and information and communication technologies. Other EU projects relevant to the initiative include OAPEN (Open Access Publishing in European Networks) and e-SciDR (e-science digital repositories).

The project is part of the response of EU research ministers to examine the application of open access in FP7, as described in the February 2007 Communication on "Scientific information in the digital age: access, dissemination and preservation". It is complemented by the eContentplus programme, announced in 2005, which is committed to providing multi-lingual access to content.

The project is to give access to the EU-funded research results by placing them online for unrestricted access after an initial period of 6-12 months, making such results progressively much more widely available. The embargo period of 6-12 months is described as a limited period during which time publishers can get a return on their investment - a kind of management of the commons in the traditional sense.

The EU Commissioner for Science and Research, Janez Potocnik (pictured at left), said "This open access pilot is an important step towards achieving the 'fifth freedom', the free movement of knowledge amongst Member States, researchers, industry and the public at large."

The Prince and GM: A Potential Bundle of Problems

2008-08-13T18:39:00.009Z

Except when inundated with repeated stories about medal hauls, it would have been difficult to miss Prince Charles's comments on the GM agriculture debate in the news today.

In an interview with the Daily Telegraph, Prince Charles criticised the terms of the debate: "What we should be talking about is food security, not food production - that is what matters and that is what people will not understand."

Although branded a Luddite by Des Turner, Labour MP and member of the Commons science committee, can this statement really be dismissed out-of-hand? Des Turner stated in the same article: "In some developing countries, where for instance there is a problem with drought or salinity, if you can develop salt or drought-resistant crops there are great benefits." But is it really clear that the transfer of GM technology to this part of the world has really been this efficient or philanthropic? Or is this just the query of a troubled misanthrope?

Far be it from me, an Australian, to unpick a statement of the UK's leading republicanism campaign group, but Republic is reported by the BBC as saying "Prince Charles is quickly making his position as heir to the throne untenable with his meddling in politics." So it's accepted that GM is a political debate, not just one over the grocery trolley?

Perhaps providing greater insight into the issues of the UK debate are the farmers themselves. In an interview broadcast by the BBC today, Michael Hart of the Small and Family Farmers' Alliance set out the real terms of the problem. He explained that when purchasing GM seed, farmers must agree to purchase the "related" products as well, including pesticides, fertiliser and so on. And of course, contrary to 1000s of years in farming traditions around the world, farmers cannot ordinarily save seed from their crops because to do so would usually infringe any patent or plant variety right on the seed they have purchased (because it amounts to keeping a protected product outside the terms of the licence).

Apart from the obvious concern with the obstacles presented by intellectual property rights to traditional farming methods, what should also be considered are the competition concerns with what sounds like licences that are "bundling" products. Bundling is where a company, which is found to be in a dominant position in the market, sells two or more products together as a bundle, charging more for the bundle than for the component parts. Assuming that the seed is not incompatible with every other fertiliser and pesticide on the market, then if a seed company is shown to be dominant within the market, it may well be acting anti-competitively because it causes customers to purchase seeds and related products as a "bundle" from that company only. As Michael Hart put it, it's the "package deal" that is the problem.

The Luddites rioted against the changes of industrialisation when machines threatened their employment and owners could replace artisans with unskilled labour. Today, loss of traditional skills and diversity of knowledge in trades is being lamented. This is not to say that industrialisation was a negative and undesirable process, but the debate is far more complex than a mere comedy in technophobia. The technology perhaps requires some diversity and innovation from all participants and potential beneficiaries in the way in which it is introduced and managed.

In principle, were the Luddites really far wrong?

Poland to Commence Public Consultations on GM Foods

2008-08-06T21:34:00.004Z

Poland has remained one of the strongest opponents to the introduction of GM foods since the WTO Panel Decision on the approval and marketing of biotech products in the EU. The panel was assembled in response to complaints from the US, Canada and Argentina regarding the de facto moratorium on GM foods.

Nevertheless, opposition to GM persists throughout Europe and Poland in particular has continued to block approvals. In January this year, in the face of the deadline to comply with the Panel Decision, the Commission was expected to take legal action in the ECJ. In April this year, the Commission brought an action against Poland (C165/08) seeking a declaration that Poland was failing to comply with its obligations under Directive 2001/18/EC (on the deliberate release into the environment of genetically modified organisms) by introducing a ban on the movement of genetically-modified seed.

The case is yet to be heard, but meanwhile the Polish government will launch public consultations this week on the draft of new Polish Act on Genetically Modified Organisms, prepared by the Ministry of Environment. Among other things, the new Act introduces criminal penalties for unauthorised introductions and will give authorities the power to establish GMO-free areas, without necessarily imposing a blanket ban. Therefore, the new Act is proposed to take account of European obligations towards the introduction of GMO while at the same time inviting public consultations to take account of the widespread opposition in Poland to the introduction of GMO.

The consultation comes after an earlier survey, conducted for Gazeta Wyborcza by the PBS DGA market research company.

Poland is just one of several European countries opposed to GM, including the United Kingdom. The Environmental News Network reported this week that British opposition to genetically modified crops has increased with nearly all 54 trials over the last 8 years being attacked.

Global Science - Threat to Local Innovation?

2008-08-04T11:52:00.004Z

With all the row on press freedom and Internet access in China during the Olympics, it is interesting to note other obstacles to knowledge, including those threatening the dissemination of local knowledge and development.

In a recent article in Nature, 24 July, Lan Xue, Director of the China Institute for Science and Technology Policy, Tsinghua University, Beijing, raises issues with the globalisation and corporatisation of science and the possible threat to local innovation in China and other developing countries.

With participation and collaboration in global innovation, China's role in innovation is a marked development on its traditional manufacturing position in the market. However, participating as an innovator in the trade in global knowledge may actually limit China's ability to build capacity and development in various technical industries. Disseminating and repeating the knowledge is perhaps more critical to China's development than patent applications. Further, perceived obstructions to the flow of knowledge through intellectual property protection (whether through working that knowledge or accessing scientific publications) may also dictate research priorities other than those of immediate importance to China or other developing countries: "Research priorities in developing countries may be very different from those in developed nations, but as sicence becomes more globalized, so too do priorities. At the national level, developing countries' research prioirites increasingly resemble those of the developed nations."

Having access to knowledge for ongoing research and development, as distinct from realising the products of that knowledge in global trade, is of particular concern to researchers in China. As Lan Xue explains, "for a country in development, the application of knowledge in productive activities and the related social transformations are probably more important than the production of the knowledge itself."

Monsanto's Blooms and Booms

2008-01-17T19:03:00.000Z

In the current climate of recessions and dwindling sales figures, agricultural companies are enjoying a bumper crop.

According to yesterday's Financial Times, Monsanto is the top seller of corn seeds in US and Brazil, where there is huge demand for Roundup-Ready soybean in particular. The corollary of this is that there was a 25% increase in the volume of herbicide in Brazil last quarter. According to the FT, "High food prices are inspiring some farmers to plant extra acreage and drench valuable plants in even more Roundup than usual to avoid crop losses.

Concerns, from both farmers and from consumers, over the risks of contamination are well-known. Indeed, these risks are part of the background to Europe's stance on GM, the subject of a complaint to the WTO by the US, Canada and Argentina.

One problem for farmers is that classical patent protection of GM seeds can lead to costly infringement proceedings, either through drift or through the usual practices of saving and re-using seed. In other words, the business models of patented seed industries are contrary to established farming practices, as the recent case of Homan McFarling v Monsanto Co shows. On the question of saving seed, McFarling's lawyers argued that patent law does not allow Monsanto to control the natural products (future seeds) from the seeds legitimately purchased and planted by McFarling. But the Supreme Court denied the petition for writ of certiorari and let stand the lower court ruling that second-generation seeds were copies, the saving of which amounted to unlicensed use of the patented invention.

The intrusion of multinational corporations upon local farming practices and communities was the subject of a 25th anniversary Pesticide Action Network (PAN) meeting in Penang, Malaysia in December. At the meeting, food security campaigners raised concerns over the concentration of sales within a small number of MNCs, including Monsanto.

Anil Netto reports that vertical integration, where the corporatisation and propertisation of agriculture dominates all stages in the food production cycle: "from the development of proprietary strains of DN and the sales of seeds to farmers right down to the distribution and retail sales of food products in supermarkets and hypermarkets." Monsanto recently purchased Agroeste Sementes, a Brazilian corn seed company.

Javier Souza Casadinho, Centre for Studies on Appropriate Technologies in Argentina, has been raised concerns that such activity leads to a concentration of market control in those MNCs: "The transnational corporations are buying up companies that have the potential to create added value ... [and] entering into contracts with food producers that will determine what is produced, how it is produced, for whom it is produced and at what price and quality."

In the same article, Antonio A Tujan Jr, International Director of the Ibon Foundation Inc, describes vertical integration as turning the market into a sellers' market, compromising the choice for consumers. This is very similar to the concerns raised in the GM debate in Europe, where the risk of contamination is conceptualised as a serious risk to the conditions for consumer choice of organic, conventional or GM products.

What is at stake is not only the limits of the product but also the limits of the markets that preserve consumer choice. And in technologies in living organisms, those limits are sometimes difficult to define.

GM and Europe

2008-01-16T19:51:00.000Z

Last Friday the deadline by which the European Communities were to comply with the WTO Panel Decision on the approval and marketing of biotech products, including an end to national bans on GM products otherwise approved by the EU as a whole, came and went.

The de facto moratorium ended in 2004 and so this was not ultimately an issue in the final panel decision. However, with ongoing national bans, the original complainants (United States, Canada and Argentina) may request WTO sanctions for noncompliance.

France is one country in the European Communities that is considering a long term ban following the temporary measure put in place by President Sarkozy last October, which is due to expire next month. French activist and one of the 12 candidates for the French Presidency 2007, Jose Bove (pictured at left), was joined by 15 people on a hunger strike last year to campaign for the year long ban.

Other countries, including Germany, advocate a temporary halt to all authorisations until an effective mechanism is in place for such approvals. Minister of Agriculture, Horst Seehofer, has described the procedure as "questionable" for its failure to take adequate account of public opinion and concerns.

And the European Commission's environment minister, Stavros Dimas (pictured at right at the Climate Change Conference, Bali, December 2007), in plans to reject applications from Syngenta and Pioneer Hi-Bred International to grow GM maize, demonstrates the emphasis in Europe on the ability to exercise the fundamental precautionary principle, presuming the environmental will be damaged without adequate evidence to the contrary (rather than placing the burden on the decision not to introduce). Dimas's stance has attracted criticism as a political rather than a scientific decision. However, perhaps it is better science to demand the evidence that the environment will not be harmed (that is, that markets can be protected through containment), rather than trying to delimit a perhaps less well-defined risk that the environment will be harmed (where markets and consumer choice are perhaps more vulnerable). Or is it simply misunderstanding the consumer stakes to expect the possibility of the separation of science and politics?

Arguably such criticism should take account of not only the market in GM, but also the market in organic foods and the potential costs to organic farmers if contamination should occur. The question is whether certain standards in handling and the mechanisms and procedures for approval, are sufficient to protect these markets such that they may co-exist in a genuine way both for consumers and for farmers.

Inaugural QMIPRI Annual Conference

2008-01-08T20:12:00.000Z

The inaugural annual conference of the Queen Mary Intellectual Property Research Institute (QMIPRI) will take place in London, Monday 18 February 2008.

Intellectual Property Strategies explores the divergent perspectives strategies in use, innovation and access, reflected in the expert panels assembled on each of these concepts.

Speakers include Allan James (Intellectual Property Office), Guido von Scheffer (IP Bewertungs, patent value funds), Tim Hubbard (Sanger Institute) and Michelle Childs (Knowledge Ecology International).

The Conference will take place in the historic New Connaught Rooms, Great Queen St, London, WC2B 5DA. Further information and registration details are available at the Conference website.

Dates for the Diaries - Patenting Lives; EPO Patent Forum; EUPACO-2

2007-04-09T12:42:00.000Z

A few dates for your patents diaries ...

The Patenting Lives Project is presenting a free lunchtime seminar - "Patenting Lives: GMOs and (Cultural) Co-Existence in Europe" - at the University of Queensland this Friday 13th. Co-hosted by ACIPA and the TC Beirne School of Law, the seminar will run from 12-1pm, Forgan-Smith Building (Room 1-W341). If any of you are in Brisbane it would be great to see you there.

The European Patent Forum will be taking place in Munich, 18-19 April. The Patent Forum will consider the broader context in which the development of patent law takes place: "one of the first attempts to examine intellectual property as a whole, taking into account political, social, ethical, technological, environmental and historical factors". Johanna Gibson will be there following work on the Scenarios for the Future project and Patenting Lives.

Another important event in the discussion of patent policy is EUPACO-2. This next meeting in the series of EUPACO events will be held in Brussels, 15-16 May and the draft programme is now available. EUPACO (the European Patent Conference - "Towards a New Patent System") was conceived by the Foundation for Free Information Infrastructure (FFII), largely in response to the proposed software patents directive. But from this work, EUPACO has developed the debate towards sustainability in the patent system more broadly, with particular attention to the context and framework for policy development in the area of patents. Johanna Gibson was at the earlier meeting (24 January 2007), which was a very successful example of the diverse interests contributing to EUPACO, with a wide range of contributions from various stakeholders, including practitioners and academics, industry and civil society. The forthcoming 2 day meeting in May promises to be an equally stimulating event and a further example of genuine policy debate.

Patenting Lives On the Road!

2007-04-02T01:37:00.000Z

I will be in Queensland, Australia for the next couple of weeks presenting some free seminars on the Patenting Lives Project.

The first of these will be at Phillips Fox Lawyers (co-hosting the event with Griffith University Law School), Level 29 Waterfront Place, 1 Eagle Street Brisbane. The seminar, looking at patent protection and gene sequences, starts at 5.15pm followed by a drinks reception. Further details are available from Leanne Wiseman of Griffith University on l.wiseman@griffith.edu.au. I hope to see you there!

Can you repeat that? Genetic technology and IP

2007-01-30T13:16:00.000Z

The most striking thing about intellectual property frameworks and cloning is perhaps the way both appear to rely upon the ability to repeat the unrepeatable - the idea (?), the individual (?)

In an opinion piece in the New York Times, Denise Caruso says, "Someone (Other Than You) May Own Your Genes."

Caruso is responding to the recent approval by the US Food and Drug Administration (FDA) of food products derived from cloned animals, meaning that such products need not be labelled as such for consumers.

Caruso points to a survey by the Pew Initiative on Food and Biotechnology (Pew), which contradicts the often cited view that US citizens accept biotechnology in the food industry, and identifies similar concerns with industry and loss of consumer confidence that have been surveyed in Europe.

When it comes to biotechnology, the concerns raised by campaigners and researchers alike frequently refer to the specific character and base material of research in biotechnology, and a fundamental incompatibility with the patent system and its arguably greater suitability for "mechanical" innovation. Caruso quotes a comment from Tim Hubbard of the Human Genome Analysis Group at the Wellcome Trust Sanger Institute, "If you have a patent on a mousetrap, rivals can still make a better mousetrap. This isn't true in the case of genomics. If someone patents a gene, they have a real monopoly."

Under European patent law a patentable invention must be useful (industrial application), and the European Biotechnology Directive requires utility for patent protection to be available for genetic sequences (in other words, a use/purpose must be identified). Classical interpretation of patent protection might indeed mean that the identification of one use might result to protection over all uses - effectively, protection for a naturally-occurring substance. But, developments towards purpose-bound protection in Europe mean that this anomaly would be reconciled within the system. Similarly, in the US, efforts to patent isolated gene sequences in 1994 were defeated for lack of utility.

On the "property" aspects, Caruso considers the work of Stephen Hilgartner (pictured at right), Department of Science and Technology Studies (STS), Cornell University, who published a paper on these issues. "Acceptable Intellectual Property" is articulated upon the notion of "risk" and the conventional concept of "balance" in intellectual property protection, Hilgartner asks whether the protection of biotechnology fulfils that balance.

And indeed, strikingly, he suggests that theories of real property and the attending expectations and obligations might be more applicable for these technologies - that is, a certain reconciliation of the unrepeatable.

EUPACO - Brussels 24 January 2007

2007-01-22T15:42:00.000Z

The European Patent Conference (EUPACO) will be held in Brussels this week, Wednesday 24 January (programme).

The Conference is free and open to all, but registration is advised. Speakers from the US and across Europe (including myself) will present current research, policy, and proposals for reform of the EU patent system.

The EUPACO is an initiative of the Foundation for a Free Information Infrastructure (FFII), directed at assembling experts and stakeholders from a variety of perspectives for the examination and discussion of patent law in Europe.

FFII is a not-for-profit civil society organisation concerned particularly with information technology and market competition in this sector. In particular, the FFII has been very active in developments concerning the European Patent Litigation Agreement (EPLA). FFII has expressed concerns with these reforms, and has produced the FFII Analysis of the EPLA to set these out.

Although FFII is well known for its contribution to debates on the impact of patent frameworks in software development, the EUPACO will be examining patent frameworks in diverse fields of technology, with a view to comprehensive debate on future patent policy in Europe.

The Brussels meeting will be an opportunity opportunity for individuals from diverse perspectives - including researchers, practitioners, industry and civil society - to examine patent law reform in Europe.

Patenting Lives Free Public Workshop - London

2007-01-18T23:53:00.000Z

patentingLIVES The second free public workshop in the Patenting Lives series will be held in London, 12th February 2007.

The workshop will deal with the potential overlap of protection for signs as both trade marks and designs. This issue is particularly important because designs give broader protection, while trade marks are potentially protected indefinitely. Therefore, the overlap in rights has generated much concern.

The issue will be addressed by a distinguished panel:

Tibor Gold MBE, Partner, Kilburn & Strode
David Musker, Partner, RGC Jenkins & Co
Spyros Maniatis, Professor of Intellectual Property, Queen Mary CCLS

The discussion will be chaired by Simon Malynicz, Intellectual Property Barrister, Hogarth Chambers.

The workshop will be held at 6pm in the Intellectual Property Seminar Room, Charterhouse Square (#1 on the map), and will be followed by drinks.

The workshop is free but numbers are limited, so please register by email to Johanna Gibson. More details are available at Patenting Lives.

The Blots on the "Copy" Books - Copy Cats and Hokey Holsteins

2007-01-14T17:28:00.001Z

Best wishes for 2007 from Patenting Lives. I hope everyone enjoyed the holidays!

Intellectual property news has a strange propensity for the "copy" - not only in copyright but also in patents. However, what is of particular interest in recent news is where the copy itself becomes the item of enhanced value - the case of cloned animals. For biotechnology, the "copy" is the original value in itself. But the technology aside, the general "mis-trust" of the copy is an interesting aspect of debates, ranging from the welfare of pets to the safety of steak trays in the supermarket.

Copy Cat

In the recent news, the birth of kittens to the world's first cloned cat, CC (pictured at right), and the news of Dundee Paradise, born to the clone of a champion dairy cow, has generated substantial debate concerning food safety and animal welfare.

CC, short for reportedly both Copy Cat and Carbon Copy (not even copies are accurate?), was born 5 years ago in December 2001 at the Texas A&M University, being a copy of the calico domestic shorthair cat, Rainbow (pictured at left).

The CC was then born to and raised by Allie, the tabby surrogate mother (pictured at right) meeting with both acclaim and controversy.

And in fact, on the "inaccuracy" of cloning, CC grew up neither to look nor to act like her mother, showing that environmental and non-genetic factors continue to be significant in determining the ultimate phenotype. In fact, fur patterning might have more to do with Allie's womb. A predisposition, in other words, should not be made a pathology.

And now CC has had 3 kittens o f her own (pictured at left). However, CC achieved motherhood "old school" with Smokey, a male tabby bought as a partner for CC by Duane Kraemer (pictured at right), match-maker and professor of veterinary medicine at Texas A&M and member of the original cloning team. Mother and kittens are reportedly doing fine.

Hokey Holsteins

Before Christmas, the Holstein calf, Dundee Paradise, was born. Dundee Paradise is the daughter of a clone produced by US company Cyagra Clone, using cells from a champion Holstein cow (Holsteins are bred for their milk production).

But copies are inherently valuable, Dundee Paradise is reported to have been sold for £14 700 (although elsewhere the figure is reported to be much higher) to Princess Noora bint Isa al-Khalifa, of the Bahrain royal family. It is reported that the calf is being raised at a farm in Wales.

Reports, including the Guardian and Food Production Daily, have described the urgent concerns for the UK Food Standards Agency (FSA). The FSA met with European Officials Friday to decide whether tests would be required before marketing milk and meat from cloned animals. The European Regulation EC No 258/97 sets out the rules for authorising novel foods and novel food ingredients for marketing and consumption. The review of this Regulation is underway, with an online Consultatio n launched in June 2006, with a legislative proposal to be prepared this year. The earlier evaluation report of 2004 recommended further work to determine whether food from cloned animals should be treated as novel. At present, there is no specific regulatory framework for dealing with food and food ingredients from cloned animals.

The US Food and Drug Administration (FDA) approved the sale of cloned meat in US supermarkets late last year. The Independent reports that the draft rule allows the sale of meat and milk without requirements to state the origin on the labels. According to The Times, is thought it will be in supermarkets within months. However, the Telegraph suggests that most of the cloned animals will be reserved for breeding, with the offspring going to market. While welcomed by some groups, including the Biotechnology Industry Organisation (BIO), the approval has provoked significant criticism from consumer groups as well as experts in food safety. Furthermore, concerns for the welfare of cloned animals have been raised since the heady days of Dolly the Sheep (Dolly, pictured at right with her foster mum).

It is notable that the debate focuses attention on the relevance of consumer confidence and choice. Peter Melchett (pictured at left, photo courtesy of the Soil Association), policy director of the Soil Association, was quoted in Daily Telegraph as saying that the lack of regulation was "inexcusable," and "will undermine trust in British farming and British food." Calling for a moratorium on cloned animals, he described the current situation as "irresponsible and bad for the industry."

The Guardian reports that the FDA's approval has not translated into consumer confidence, and notes that the FDA plans to continue public consultations until April this year. In particular, the absence of obligations to disclose the origin of the food product has generated objections among activists both in food safety and the environment.

In an article in Nature, 8 January, US and Japanese researchers claim that cloned meat should not be treated differently, and advocate somatic cell nuclear transfer (SCNT) as the only means by which ensure survival of the genetic characteristics of the highest value animal. However, the lessons from Copy Cat make clear that not all desirable traits are necessarily guaranteed by the duplication of genotype.

Further, the "economic" interests of high value animals captures neither the consumer interests identified by Melchett, nor the ethical concerns for the welfare of the animals involved. As the GM debate in Europe has shown, many developments in the organic market reflect specific cultural and social concerns of Europeans. Despite the WTO Panel Decision on the complaints by the US, Canada and Argentina concerning the so-called moratorium on GM food in Europe, Austria has been allowed to maintain its ban on genetically modified crops, Austria has recently retained its right to ban GM corn by relying on the Biosafety Protocol. The Protocol allows such a ban where there is a lack of scientific certainty over the safety of the crop. The US has not signed the Protocol, and Canada and Argentina, although signatories, have not ratified the Protocol (signatures and ratifications).

It is this dimension of the market for organic food that was missed by David Miliband, UK Secretary of State for Environment, Food and Rural Affairs, when he told the Sunday Times recently that organic produce is "no better." The outcry was such that Miliband responded with praise for the "entrepreneurship" of organic farming in his blog. But again, to characterise the success of the organic food industry this simplistically dismisses the activity of consumers as nothing more than a "lifestyle choice." With respect to the environment, consumers are acting as citizens rather than making choices simply from the perspective of cost or prestige. As The Independent points out, David Miliband is surely "playing to the gallery" of the many farmers not using organic methods: "Instead of mocking this trend as unscientific, or jeering at it as a 'lifestyle' choice, which makes it sound like a slightly silly, magazine fashion, Mr Miliband would do better to praise it."

(Guest consultant on feline aspects: Roman the Cat)

Review for Science and Innovation in the UK

2006-12-05T13:56:00.000Z

Hot on the heels (or indeed, breaking at the starting gates) of the Gowers Review of Intellectual Property (due to be published tomorrow), the UK Treasury has announced the Sainsbury Review, the Review of Science and Innovation Policies of Government.

The new Review, to be led by Lord Sainsbury (former Parliamentary Under Secretary for Science and Innovation, pictured at right), will consider various Government policy developments and interventions, in the context of globalisation. Lord Sainsbury's retirement from the Department of Trade and Industry was announced by 10 Downing Street, 10 November 2006, when mention of the proposed review was also made.

The Review will make particular reference to (from the terms of reference)

industry R & D and investment in innovation
publicly funded R & D (including government departments) and investment in innovation
knowledge exchange (universities and business), and progress since the Lambert Review
supply of skilled persons
supply of venture capital
patents, measurement system and standards; and
international science and technology collaboration.

The Review is due to report in time for the 2007 Comprehensive Spending Review, and it will do so to the Chancellor of the Exchequer and the Secretaries of State for Trade and Industry and Education and Skills.

The subject matter of the new Review appears to be strikingly similar to some issues just considered in the Gowers Review, which may lead one to ask why a new Review is commencing before the other is reported.

Criminal Enforcement Directive - A Review of the Rapporteur's Report - Too Late to Lock the Stable Door?

2006-11-17T18:05:00.000Z

The European Parliament's Committee on Legal Affairs is due to discuss at Monday's meeting the Rapporteur's draft report on the proposed Criminal Enforcement Directive.

Having just reviewed the English translation of the Rapporteur's Report, I would suggest that it narrows significantly the scope of the proposed Directive, but it remains a Trojan Horse for first pillar powers.

Definition for Intellectual Property - Whither a Patent?
In particular, the Rapporteur proposes a definition for intellectual property which excludes patents. The attempt to define intellectual property proved to be very controversial in the passage of the earlier Enforcement Directive, 2004/48/EC. This discord eventually led the Commission to propose its own list of intellectual property rights, 2005/295/EC. One of the reasons patents are excluded in the current report, according to the Rapporteur, is the European Parliament's rejection of the Directive on the Patentability of Computer-Implemented Inventions (Software Directive). The Rapporteur concludes that the Parliament considered it inappropriate to legislate on patents. Accordingly, he suggests that criminalising patent infringement would be "a dangerous foray into a very complex area."

The Rapporteur's report also proposes that the Directive be limited to intellectual property rights which are harmonised at the Community level, and does not include other national "intellectual property rights."

Other Definitions
The Rapporteur's report also proposes definitions for other key phrases, including that of infringement on a commercial scale. The idea of "commercial scale" previously proved problematic during the negotiation of the Enforcement Directive. In the Enforcement Directive, the problems of definition were to some extent remedied by Recital 14. However, the definition proposed in the current Rapporteur's Report on the proposed Criminal Enforcement Directive seems considerably broader.

Does the Punishment fit the "Crime"?
The Criminal Enforcement Directive is presented on the basis of being a response to serious organised crime, the potential threat to public safety, and to the "serious threat to national economies and governments." The Rapporteur also acknowledges that "serious" intellectual property crimes can be committed outside organised crime, and therefore extends high levels of punishment to all serious crimes, rather than limiting such punitive measures to those actions committed by large criminal organisations.

On a number of occasions, the Rapporteur points out the fact that there are domestic provisions on criminal infringement in the domestic laws of many Member States, and he discusses harmonisation in this context. One intriguing point which seems to be overlooked is that the sentence of a minimum maximum of 4 years imprisonment proposed by the Criminal Enforcement Directive ignores the various sentencing rules across the Member States. In the UK, for example, the practical effect of a 4 year sentence is that the person will be eligible for release after 2 years. Therefore, it is unclear how the Commission can rely on terms like 4 years imprisonment, in the context of a harmonised approach, when it is presumed that the time served may mean quite different things for different Member States.

Competence - Win the Horse or Lose the Saddle
Finally, on the issue of competence (see the earlier post, A Trojan Horse?), the Rapporteur's report indicates that the proposal falls within the Commission's "broad interpretation" (my emphasis) of its powers under the first pillar. The Commission has relied upon Case C176/03, Commission v Council (environmental law), to use first pillar powers to impose criminal sanctions. The Commission issued a Communication on the implications of that judgment on criminal law provisions under the first pillar. After that, there was a Resolution on 14 June 2006, where the European Parliament welcomed the ECJ's judgment, although had reservations about the Commission extending it further.

The Rapporteur takes the view that applying criminal penalties to patent rights does not seem particularly appropriate in itself, and does not follow previous actions of the European Parliament. He also concludes that there is no urgent need to intervene on criminal penalties for patent infringement. What is problematic about his position is that he doesn't come to any opinion on whether the Commission's position on broad interpretation is correct. But he does believe that the scope of the proposed Directive seems to be too broad.

It's unlikely that many Member States will find much solace on the competence issue within the Report of the Legal Affairs Committee. Although, in terms of the Directive as a whole, it provides many sensible limitations. But one can still question the necessity of the Directive at all.

The Criminal Enforcement Directive - A Trojan Horse?

2006-11-14T12:47:00.000Z

patentingLIVES

Last night the Patenting Lives network hosted its first in a series of workshops on current issues in patent law, policy and development.

The first in the series was concerned with the proposed Directive of the European Parliament and of the Council on criminal measures aimed at ensuring the enforcement of intellectual property rights (Criminal Enforcement Directive also known as IPRED2 in view of its amendment this year). One participant described the Directive as the possible "Trojan Horse" that may be used to expand EU competence in the area of criminal justice, moving towards first pillar matters.

Background
The present proposal for IPRED2 is being considered by the European Parliament and the Council at present, as the Directive must be adopted following the co-decision procedure.

In the European Parliament it is presently before the Legal Affairs Committee. The rapporteur, Nicola Zingaretti (an Italian MEP), will present a draft report on the proposed Directive at the next meeting of the Legal Affairs Committee, 20 November 2006. If and when the Committee approves the report, there will be a vote at a plenary session of the European Parliament for its first reading.

Meanwhile, Member States are continuing to negotiate the text before the Council. The most recent Council text includes a number of amendments to the original Commission proposal. But until both the Council and the Parliament have finished the first reading the Directive cannot progress any further. At present, it looks like it might be held up before the Council, even if the Parliament is making progress.

The European Union is structured as "three pillars," - the European Communities, common foreign and security policy, and cooperation in justice and home affairs. Some Member States have indicated that they believe that the measure is not within Community competence as a first pillar instrument. Instead, they suggest that it should be a Framework Decision under the third pillar. It is anticipated that the Court of Justice's ruling in Case C-440/05 Commission v Council (ship source pollution) will give a good indication of whether or not IPRED2 can go forward as a first pillar Directive or will need to revert to being a Framework Decision.

Workshop
Around 35 participants took part in the seminar, which included presentations from Gwilym Roberts, partner at Kilburn & Strode Patent Attorneys; Phillip Johnson, DTI and legal adviser to the UK Patent Office, but speaking in his personal capacity; and Julian Heathcote Hobbins, senior legal counsel for the Federation Against Software Theft (FAST).

All speakers had reservations about the proposed Directive, some stronger than others, including predictions that it would be "completely disastrous."

Gwilym Roberts (pictured at left) very importantly identified not only the way in which it might impact upon patent practice, but also the significant commercial effect of criminalising patent infringement, "changing the game theory of decision-making at the commercial level." Rather than being able to negotiate normal commercial risk, commercial entities would now be constrained in their daily commercial decisions by the threat of criminal sanctions.

As Gwilym explained, copying a CD in large-scale copyright piracy is quite a different concern from the very complicated questions to be considered when trying to determine whether a patent has been "copied." The application of criminal sanctions to all areas of intellectual property simply cannot be justified by the same arguments. He said that the patent system is not designed to implement public health policy (such as the arguments concerned with health risks and counterfeit medicines) and should not be expected to deliver such regulation. Gwilym predicted that the Directive would effect a "significant stifling of innovation."

Julian Heathcote Hobbins (pictured at left) gave a detailed introduction to the activities of FAST and its position in the debate. Julian also identified the problem with trying to polarise the activities of users and proprietors as two mutually exclusive groups. Often in patentable technologies, proprietors are in effect potential infringers because of the very nature of innovation; therefore, as the workshop discussion largely considered, criminalising patents would interfere with the nature of innovation because it would elevate the risk of potential infringement to a level that noone would want to try to negotiate.

Phillip Johnson (pictured at right), who practised as a criminal barrister before moving into IP, gave a detailed background to the Directive. He noted the significance of applying criminal measures to all areas of intellectual property rights and outlined the potential public interest concerns with this kind of approach. In particular, the nature of criminal prosecution was discussed, including the consequences for the taxpayer. The impact of possible moves toward jury trials was also discussed, with the workshop discussion raising concerns over the possibly adverse impact on subsequent law, causing damage to the patent system in the long term.

In discussion, the impact on small and medium enterprises was considered as a potentially negative rather than positive consequence. The threat of criminal prosecution was debated as a way in which bigger interests could throw their weight around, effectively changing the landscape of the industry, with SMEs discouraged from entry into the market. Interestingly, Gwilym noted that the threat of criminal sanctions would be a public relations bonus to right-holders, giving a problematic moral high ground. He noted that, in contrast to the current bad press, a somewhat worrying outcome might be that prosecution of patent infringement is now re-presented as a "protection of the public" argument. Some participants suggested that big pharma was "playing the public health card."

Future Workshops
More workshops are planned, including discussions on the forthcoming report of the Gowers Review, a workshop on biopharmaceuticals and biosimilars, and more. If you'd like further details, email me, Johanna Gibson, to be on the mailing list, or check this blog and Patenting Lives for more.

DR-CAFTA - Extension to Patent Term

2006-11-04T10:35:00.000Z

The Dominican Republic is considering an extension to patent protection in order to give effect to its free trade agreement with the US.

The DR-CAFTA was agreed back in December 2003 after only 12 months of negotiation involving the US, El Salvador, Guatemala, Honduras, Nicaragua, and Costa Rica. Costa Rica remained resilient in the negotiations until January 2004, generating ongoing oppositions that continue today. Just 10 days ago, Costa Ricans protested in a general strike challenging the DR-CAFTA and the moves of their President, Nobel Laureate Oscar Arias (pictured at right), to progress its conclusion. President Arias, who achieved his second term as President in the May elections this year after serving his original term 1986-1990, has been a strong supporter of the agreement, despite the opposition among his people.

The Dominican Republic negotiated a separate bilateral agreement with the US towards joining the CAFTA scheme, which it did in 2004. Despite this, the Dominican Republic remained on the Watch List in 2004, 2005, and 2006. As reported in the Dominican Today, a bill presented to the Congress for the implementation of the DR-CAFTA proposes amendments to the Industrial Property law 20-00 that will establish an extension to patent protection for a maximum of 3 years in addition to the 20 year term, through revisions of articles 27 and 30. The US has also called for periods of data exclusivity protection of 5 years for pharmaceuticals and 10 years for agricultural chemicals, leading to strong criticism from Dominican pharma.

The DR-CAFTA has been criticised as sustaining colonial tensions. Noam Chomsk y (pictured at right) has said that the agreement will maintain Central America as a region under US control.

Chomsky was in Santo Domingo in March this year giving several talks and public lectures. During this time he spoke in a free public lecture on "Latin American and US Foreign Policy" to a huge audience at the Foundation for Democracy and Development. In June this year, at a press conference in New York, Chomsky described "For the first time in its history, first time since the Spanish colonization, Latin America is moving towards a degree of independence and also a degree of integration ... And the United States is terrified."

US Rice Industry Adopts Plan to Save 2007 Crop

2006-11-03T08:30:00.000Z

The US rice industry has adopted a plan to eliminate the illegal Liberal Link strains from the 2007 crop.

Discovery of the two contaminating strains in US imports, LLRICE601 and LLRICE62, have led the EU to decide upon mandatory testing of all US rice coming into Europe, with significant implications for the US rice industry. Farmers in the US are taking Bayer, the proprietor of the strains, to court for damage to their markets (a full list of Patenting Lives posts on this issue is available here).

The USA Rice F ederation sought legal counsel following the August announcement of the contamination, and engaged King & Spalding in assessing its position. A USA Rice paper setting out the legal position of USA Rice suggests that the Federation does not have legal standing for a class action. However, it also indicates that "aggressive legal action" by individual and similarly situated members is not ruled out.

Earlier this month, the USA Rice Federation issued a press release in which Al Montna, Chairman of the USA Rice Federation and California rice producer, described the decision on mandatory testing as "an unfortunate overreaction."

The USA Rice Federation Daily, 1 Nov 2006, reports that representatives at the two-day USA Rice Federation Conference on GE Elimination adopted a plan to begin immediate work on ridding the 2007 crop of the contaminating strains. Strategies include plans to certify negative test results, suspending planting of the 2007 Cheniere variety, and a decision by mills to purchase rice grown only from negative seed (or farm-saved seed that has tested negative).

The draft plan will be submitted to the USA Rice Executive Committee to be adopted this week.

GM "Round-Up" - Rice, Romania, Rampura, and Regionalism

2006-11-02T16:27:00.000Z

Over the past few months there has been extensive press, including here at Patenting Lives (click here for all stories on GM rice), on the controversial GM contamination of US rice imports to Europe, first announced in August.

In September the UK Food Standards Agency (FSA) published a statement declaring there to be no health risk associated with the contamination. Now the FSA is preparing to face a legal challenge over its response to the contamination Friends of the Earth UK (FOE) has filed in the High Court an application for judicial review. In a press release last week, FOE stated that the FSA "failed to take necessary action to prevent UK consumers being exposed to illegal GM rice in their food." Back in September, the BBC reported that FOE first wrote to the FSA in an attempt to avoid legal action. In that same report, the FSA response was, "We haven't told retailers not to test, but haven't required them to test."

The application follows the decision of the Standing Committee on the Food Chain and Animal Health (SCFCAH) to back the Commission Decision on strict counter testing of all US rice imports. Speaking in a report by Andrew Bounds, in the Financial Times, Philip Tod, spokesperson for Markos Kyprianou (EU Commissioner for Health and Consumer Protection and pictured at right), said, "We can only be responsible for our own testing and controls ... It is incumbent on other countries to enforce theirs."

The US and Europe have yet to agree on a common testing regime. Floyd Gaibler, US Deputy Undersecretary for Farm and Foreign Agricultural Services, has been reported in Farm Futures as stating that the burden of mandatory testing will effectively end its rice trade with Europe: "it would just have the effect of not allowing trade to resume." European environment ministers are calling for international rules to improve the detection of contamination. This has been supported by EuropaBio, the European association for bioindustries. Simon Barber of EuropaBio told the FT, "Because we have a global trading system there is always the possiblity that minute trace levels of GMOs will turn up where they do not have legal approval. This is going to happen again and again." According to the Andrew Bounds, US GM proprietors "appear to have lost control of their technology."

Such "lost control" has prompted Greenpeace to demand immediate suspension of all US imports, asking for Bayer to be "held accountable for its negligence" by banning the company from conducting further trials. Greenpeace described Bayer as "clearly incapable of controlling contamination of rice with its genetically engineered varieties," after the discovery of a second illegal strain from Bayer in as many months. Meanwhile, US farmers are suing Bayer because of the commercial threat of contamination, closing markets and driving away consumers.

But a report in Thailand's The Nation describes the "burden" for the US as a "windfall" for Thai farmers. The report notes that the Thai government has remained committed to its non-GM policy. Open field trials were banned in 2001, but papaya farmers have had the ban lifted. But in light of the "windfall," Greenpeace has petitioned the Administrative Court to end open-field trials, as reported in the Bangkok Post. Greenpeace also filed a petition against the Department of Agriculture and its Director, Adisak Sreesunpagit, for negligence in preventing a leak of GM papaya seeds during a controlled field trial by Khon Kaen Horticultural Research Station in 2004. According to Patwajee Srisuwan of Greenpeace, contamination continues despite the Department's decision to elminate all GM papaya at Khon Kaen. Earlier this week, the Bangkok Post Business reported that Thai authorities have re-assured importers that Thai rice is GM-free.

The EU mandatory testing has also led India's top rice exporters and farmers unions to warn against further field trials for GM rice. A report by the BBC states that farmers insist that any doubt in the GM-free status of their rice will threaten their trade. And the newspaper, The Hindu, reports that leading rice exporters are concerned that restrictions now imposed on the US could be extended to other countries, including India, if contamination is not prevented . Reuters has reported that farmers and importers are concerned that contamination during storage or transportation will undermine not only consumer confidence but also India's reputation. According to the director of Tilda Riceland, RS Seshardri, "Indian rice is GM-free and we want to keep it that way."

And farmers are certainly taking action to keep it that way. The Bharatiya Kisan Union (BKU), a farmers union in India, recently destroyed a GM rice trial in Haryana. According to a report in the India Express, around 400 farmers, many from the Rampura village in the Karnal district of Haryana, met at the site of the trial, calling for its destruction for fear of GM contamination. The group then torched the trial in what the Indian Express described as a "serious setback" for GM field trials.

One of the protestors, Paramjit Singh, was in fact the farmer on whose land Mahyco-Monsanto was conducting the trial. A report in the Business Standard says that Mr Singh had not been informed that the trial was a GM trial. But nevertheless, the burning was described as "unwarranted" by the Department of Biotechnology (DBT) Review Committee on Genetic Manipulation (RCGM). Member Secretary of the RCGM, Dr TV Ramanaiah, appeared to dismiss the obligation to inform was apparently dismissed by Member Secretary, saying to the Business Standard, "Mahyco which grew the crop for contained field trial had our approval. So it was a legal activity. As for informing farmers, how do you expect every farmer to be told about the various experiments that are being done." How indeed. The Business Standard report states "Activists of BKU pointed out that neither the farmer nor the panchayat president were told of the trials, as is required under the regulations." The farmer had leased the land for contract farming at Rs 15 000.

Meanwhile, Mahyco has come under other "fire" recently, after the publication of the findings of an investigation by the Centre for Sustainable Agriculture (CSA) into Bt Okra trials in the Gulbarga district of Karnataka. The report notes also that the DBT Guidelines are not always being followed, leading to similar problems with information. The state government of Karnataka was unable to respond adequately to applications for information, admitting that it had no information on where GM trials were being undertaken in the region.

The Supreme Court of India banned new field trials of GM crops earlier this year, following a public interest petition filed in May 2005. The petition claimed inadequate biosafety protocols, including allowing field childs to commence prior to biosafety testing, were a serious threat to both public health and the environment. The Supreme Court ban is to allow for an examination of these approval mechanisms.

And recently, Iran's Department of Environment (DoE) has decided against issuing an official approval to commence cultivation of GM rice. According to reports, the DoE did not receive sufficient documentation to be convinced that the benefits outweighed the potential risks.

Back in Europe, resistance to GM among consumers remains high. A recent AFP report says that very little GM food ends up on the plates of European consumers. And the preferences of EU citizens have relevant and significant effects on the markets for EU member states, particularly those for organic products. Efforts to achieve meaningful co-existence measures for traditional, organic, and GM crops, are repeatedly undermined by contaminations.

The UK Department for Environment, Food and Rural Affairs (DEFRA) has recently received strong criticism for its coexistence proposals. According to a report in Farmers Weekly, a joint response by FOE, the Soil Association, and GM Freeze, to the government's coexistence consultation claimed that some of the proposals breached European law. In an FoE pr ess release, Pete Riley, Director of GM Freeze, and Peter Melchett, Policy Director of the Soil Association, both condemn the proposals as removing the rights of consumers and farmers to choose. Clare Oxborrow, of FoE, said that "The proposals are a thinly veiled attempt to introduce GM crops through the back door." She said further, "Allowing routine, unlabelled, GM contamination of conventional and organic crops is not only unacceptable to the public, it is legally flawed too." The consultation closed Friday, 20 October.

Elsewhere in Europe, contamination continues to undermine arguments that coexistence can been meaningfully achieved. Planet Ark recently reported that organic farmers in Spain have been forced to abandon maize crops after detecting traces of GM strains. And farmers in Greece are taking action against Syngenta, Pioneer, and the Greek Government for GM maize contamination in 2004. The General Confederation of Greek Agrarian Association (GESASE).

Meanwhile, GM crops threaten to defeat Romania's ability to meet the deadline for banning GM "Roundup Ready" soybean crops. The deadline, an effort to meet EU environmental rules, is set at 1 January 2007, the same day Romania is to join the EU. Unlike many citizens in the EU, however, Romanians are reported as being less concerned about the regulation of GM. The Balkan Insight reports that "A poor level of compliance reflects the lack of interest in the subject felt by Romanian consumers." Whether this also reflects levels of awareness, information, or engagement in the debate is unclear.

And the push towards bilateral negotiations adds to these concerns. A report, Bila teral Biosafety Bullies, by GRAIN and the African Centre for Biosafety identifies a relationship between bilateral trade channels and an associated weakening in biotech regulations, in favour of opening markets for GM crops. This kind of regionalism threatens to undermine genuine multilateral negotiation. "The push to regulate - or rather, prevent the regulation of - GM food through bilateral instruments is not happening in isolation. It is part of a much larger trend in international relations."

But European consumers will continue to work to buck the trend.

Patents - Merit or Menace for the Knowledge Economy?

2006-10-31T19:02:00.000Z

The October issue of Chemistry World has a "Head to Head" on patents and innovation, building on the current debates over patents and incentives. Many thanks to Jim Roche, Lecturer in the School of Science, Athlone Institute of Technology (AIT), Ireland, for pointing it out.

Barry Treves (pictured at left), President of the Chartered Institute of Patent Attorneys UK (CIPA), takes on the "for," while Terence Kealey (pictured at right), Vice-chancellor of the University of Buckingham UK, and clinical biochemist, handles the "against."

Mr Treves highlights the social benefit of obligations to disclose the full details of the patent, arguing that this characteristic of the patent framework "adds enormously to the wealth of scientific and technical knowledge available." He also argues that without the confidence created by the greater "certainty" in the market conferred by the patent monopoly, the entrepreneurial activity in research and development would be compromised. Although Dr Kealey proclaims "Patents are a Menace," he surprisingly seems to agree on one point with his opponent, conceding "Only in the pharmaceutical industry are patents justifiable." Head to head or tete a tete?

The article also comes at a very busy time for the European Patent Office (EPO). At the beginning of this month, Alain Pompidou, President of the EPO, said to the EPO's Online Services Conference in Lisbon, "If Europe really wants to become the world's leading knowledge economy by 2010, the patent network urgently needs to be developed." He supported ratification of the London Protocol and the opportunity to reduce costs of patenting, and advocated the European Patent Litigation Agreement (EPLA) as an important step towards harmonising patent law in the EU, with patents as a kind of "protection" for a competitive research market. But as discussed here earlier this month, the European Parliament voted to postpone membership of EPLA, with many expressing concerns for ongoing democratic control over patents.

Next week, 6-8 November, the EPO will be conducting the Patent Information Conference in Cyprus. A status report on the action list, from the 2005 conference in Budapest, has now been prepared and made available. 6-10 November, EPO Munich will be conducting a public seminar on IP for government officials and information administrators.

13-17 November, the EPO is staging IP Enforcement Week at the EPO Munich.

21 November, there will be a conference in London, Putting the right value on your patents, co-organised by the EPO, the UK Patent Office, and the Organisation for Economic Co-operation and Development (OECD). Taking place at the British Library Conference Centre, the meeting will concentrate on the commercialisation of patents, the management of portfolios, and other concerns of the market, business, and industry.

Free Public Workshop - London, 13 November 2006

2006-10-26T09:54:00.001Z

Criminal Enforcement Directive

Let the Punishment Fit the Crime?

The Patenting Lives network will be conducting a free public workshop on the proposed European Directive on criminal measures aimed at ensuring the enforcement of intellectual property rights (Criminal Enforcement Directive).

The workshop will commence with a discussion by a panel of experts, looking at the possible implications of the Directive for patentable technologies and patent practice.

Expert Panellists

Gwilym Roberts, Partner, Kilburn & Strode Patent Attorneys

Julian Heathcote Hobbins, Senior Legal Counsel, FAST (Federation Against Software Theft)

Phillip Johnson, Barrister, DTI Legal Services, Legal Adviser to the UK Patent Office

(Chair Johanna Gibson)

The event will commence at 6pm, 13 November 2006, and will be held at the Centre for Commercial Law Studies (CCLS) in the QMIPRI Seminar Room, John Vane Science Centre, Charterhouse Square, Queen Mary University of London (map).

The workshop is FREE but numbers are limited, so please register by email to Johanna Gibson.

This is the first in a series of Patenting Lives public workshops on current issues in patent law. Stay tuned for more to come.

For more details on the Patenting Lives project and network, please visit patenting lives or of course, here, the patenting lives blog

Indonesian Farmers Prosecuted for Seed

2006-10-25T22:46:00.000Z

Indonesian farmers in Kediri regency have been punished for the breeding and stealing of seeds.

According to a report by asianfarmers.org, since 2003 around 10 peasant farmers have been sued or jailed after accusations by seed company PT BISI (Benih Inti Subur Intani) of illegal breeding and theft of seed. Other reports put the figure much higher.

The Aliansi Petani Indonesia (API) has been documenting the cases of its peasant members, whose case was recently presented during the workshop of the Asian Farmers' Association for Sustainable Rural Development (AFA) in Indonesia last month. Presented to the workshop by East Java Research and Development Coordinator Dawud, the cases show the serious problems associated with corporate monopolies over seed in regional and traditional farming communities.

According to the Case Documentation by Hira Jhamtani (Third World Network, TWN) and Dey Patria (researcher), farmers were issued with a warning early last year: "Do not be too creative, do not breed your own seed, or you will be prosecuted." The authors follow the experiences of Tukirin, a farmer who was given a suspended prison sentence and prohibited from planting his own corn seeds for one year. Further detail on Tukirin's case and the cases of others is provided in an additional Case Documentation, which provides information on incarcerations of several farmers as well as detailing costs for farmers producing seeds.

GM Rice in Europe - New Strains and New Tests

2006-10-23T20:05:00.000Z

Today, the European Commission tabled a Decision imposing mandatory testing for US long grain rice.

The Decision (2006/601/EC) was tabled at today's meeting of the Standing Committee on the Food Chain and Animal Health (SCFCAH), section for genetically modified food and feed and environmental risk. A press release last week stated that discussions between the US and European Commission had not been able to achieve a consensus on a protocol for sampling and testing. Further, it was confirmed that certification requirements will continue to be imposed, in keeping with those announced in August and reported in Patenting Lives. The draft Decision is to introduce sampling and testing for all consignments of US long-grain rice at the point of entry to the EU, with costs to be incurred by the operators.

The Decision follows the controversial contamination of US imports of long grain rice by the unauthorised variety LLRICE601, back in August this year. Subsequently, Chinese rice imports were also found to be contaminated with unauthorised GM strains, prompting Friends of the Earth Europe (FOEE) to call for an immediate ban.

In September, Bayer released a subsequent statement declaring that the variety was safe according to the US Department of Agriculture (USDA) and the Food and Drug Administration (FDA), as well as authorities elsewhere in the world, including the UK's Food Standard Agency (FSA) as well as the European Food Safety Authority (EFSA).

Since then, a second variety of Bayer GM rice has been detected according to Philip Tod, the Commission's spokesperson for health and consumer issues, speaking to Dow Jones Newswires Friday (courtesy of Indymedia). The second strain, LLRICE62 was found in France by authorities and was notified under the European rapid alert system for food and feed (RASFF). The strain is authorised for marketing in the US but to date has not been commercialised there, as confirmed by Anette Josten, speaking on behalf of Bayer and quoted in the Dow Jones Newswire piece. The recent finding of the unauthorised LLRICE62 was noted in the press release announcing the tabling of the Decision, with counter tests confirmed as able to detect this strain as well as the original contaminating strain, LLRICE601.

Consumers in Europe remain concerned about GM technology in food products, despite confidence in other areas of technology. Today, Planet Ark reported on research showing that 75% of Italians continue to view GM food as a health risk. Civil society and environmental organisations have maintained strong support for robust testing and certification procedures, with Greenpeace last week calling for strategies to prevent further contamination by other GMOs, and FOEE welcoming proposals for testing. Last week, FOEE released a list of episodes of GM rice contamination in Europe, noted a "growing number of cases." Adrian Bebb, of FOEE, said, "This is absolutely necessary since there have now been almost eighty cases of contamination across Europe in the past six weeks."

According to EurActiv, officials at the US mission to the EU declined to comment.

Public-Private Biotechnology in India

2006-10-22T10:20:00.000Z

The Indian government is encouraging the establishment of biotechnology parks, in a move to facilitate research under a public-private partnership scheme.

Private institutions can participate under the Department of Biotechnology's (DBT) Small Business Innovation Research Initiative (SBIRI). The DBT has invited propo sals for product related pre-proof-of-concept, product related research or development, and evaluation under the initiative. Late last month, in India's Business Line newspaper, it was reported that the Government has granted permission to a private entity, TCG Urban Infrastructure Holdings, in order set up a "Biotech Special Economic Zone" (SEZ) in Kalamassery. The SEZ Approval Committee has now granted 26 formal clearances and 8 in-principle approvals, as reported in Business Line. The approvals include a multi-product SEZ in Chhattisgarh of around 2000 hectares, leading to concerns from some that the SEZ scheme is simply "a legal land-grab scheme." A potential problem Vandana Shiva has identified for some time, including her contribution to the New Scientist Greenpeace Debates in 2002.

In an article in The Hindu earlier this month, R Ramabhadran Pillai reported that the DBT had signed a Memorandum of Understanding with the Australian Department of Education, Science and Training (DEST) for cooperation in the field of biotechnology. The Australia-India Strategic Research Fund (AISRF) aims to assist and build upon cooperation between Australia and India and establishing strategic alliances between researchers in the two countries.

The recent Guidelines for Intellectual Property Management and Technology Transfer/Commercialization, produced by the Indian Council of Agricultural Research (ICAR), are particularly concerned with public-private partnerships. In the accompanying letter, Dr Mangala Rai, Secretary and Director-General of ICAR, says that technology transfer through public-private partnerships will necessarily be facilitated by intellectual property rights and commercial routes, as much as they are enabled through the public system.

Public-private partnerships were also the theme of this year's Open Days event in Brussels, "Investing in Europe’s Regions and Cities – Public and Private Partnership for Growth and Jobs," hosted by the Committee of the Regions. 134 offices of regions and cities in Brussels were selected as official partners, with over 100 seminars and workshops focusing on public and private initiatives as means by which to improve growth and employment at the local and regional level.

Rice Patents - An Obstacle to Research

2006-10-18T10:36:00.000Z

At the 2nd International Rice Congress 2006, held in Delhi last week, delegates considered whether patent protection presents a major obstacle to research and innovation.

The international event attracted scientists from around the world concerne d with research and development contributing to food security, alleviating poverty, and enhancing economic and social development.

Areas of interest included genetic enhancement and development of seeds compatible with environmental conditions in developing countries, as well as technologies in production and storage and sustainability. In addition, the Congress also addressed related commercial and research industry concerns, including creating markets for rice, use of information and communication technologies (ICT), and public-private partnerships.

At the recent meeting, farm ministers from China, India, Indonesia, Laos, Nepal, Pakistan, the Philippines, Sri Lanka, and Vietnam, signed an accord for multilateral cooperation on these issues.

However, patent monopolies remain on the agenda as a significant obstacle to research and to the achievement these aims. Reporting on the Congress, Ashok Sharma notes in the Indian newspaper, the Financial Express, "rice scientists are likely to face major hurdles in moving towards their goal." The report notes the monopoly control of Syngenta in this area of agricultural production, and criticises the company's action in "seeking global patent rights over thousands of gene sequences." The article suggests that this is comparable to ownership of "the world's most important staple crop." Although strictly speaking, such patentability is tied to the identification of the gene sequence's function, this nevertheless raises the issue of classical interpretation leading to the consequences of a gene sequence in effect being subject to a monopoly. And indeed, this is what Sharma is suggesting, in arguing that Syngenta is attempting to extend monopolies over all uses on the basis of one use - thus, in effect, achieving a monopoly.

Also speaking at the Congress was Robert S Zeigler (pictured at right), of the International Rice Research Institute (IRRI) as well as a member of the International Advisory Board of Biotec. Biotec is one fo the centres of the National Science and Technology Agency (NSTDA), Thailand. Zeigler argued against the patenting of germplasm, maintaining that, while final products could be patentable, basic research tools should not be. Although Sharma expresses concern that this might not be possible, if a purpose-bound approach is pursued, the potential for relevant patent protection in gene technologies is available.

On this issue, the European Commission recently adopted a second report to the European Parliament on the Biotechnology Directive. The report is concerned with the implications of patent law in biotechnology and genetic engineering, including patents relating to gene sequences and stem cells. In particular, the report considers the "scope of protection" and the need or otherwise for a more limited "purpose-bound" approach to protection. Although not taking a position in the report, the issue nevertheless remains relevant to the Commission not only in a legal context, but also in an economic one, in that Member States have taken varying approaches to the interpretation of so-called gene patents. France and Germany both rely on purpose to limit the interpretation of patents in some technologies this area.

Also considered at the Congress was the impact of GM on international markets and the complexity of trade, as reported in another article in the Financial Express. Issues relating to food safety and certification were significant to the discussions, particularly in the light of the recent US GM rice contamination (see recent Patenting Lives posts, US Farmers to Sue Bayer, European Standing Committee Considers Rice Contamination, More Trouble for US Rice Industry, Japan Lifts Rice Ban, and Russia Suspends US Ric e). And the fall-out from this contamination continues. In a press release from GE Free NZ, activists are urging the Ombudsman to become involved in New Zealand, in response to a rejection by the New Zealand authorities of calls to test for the contaminating strain, LLRICE601.

The International Food Policy Research Institute (IFPRI) will be hosting a Policy Seminar, "Distributional Effects of WTO Agricultural Reforms in Rich and Poor Countries," which will be considering some of these issues in food security and market concerns. The seminar will be held at the offices of IFPRI, Washington DC, 2 November.

Pew Workshop Report on Co-Existence

2006-10-14T18:02:00.000Z

The Pew Initiative on Food and Biotechnology (Pew) has published a report on co-existence in agriculture.

The Report, "Peaceful Coexistence Aong Growers Of: Genetically Engineered, Conventional and Organic Crops," is the output of a Workshop held in March this year. The workshop was the second of three sponsored by Pew together with NASDA (National Association of State Departments of Agriculture).

Coexistence remains a critical issue in Europe, with consumers continuing to be concerned about the introduction of GM crops in Europe. Despite the recent WTO Panel Decision, countries in Europe continue to impose a ban on GM crops, including Italy, where the organic market remains one of the strongest in Europe.

Meanwhile, the controversy over the GM rice contamination of US exports (with bans in the European Union, Japan, and Russia, among others) has raised major concerns about not only the potential environmental risks but also the tangible damage to the commercial assets of organic and traditional farmers, leading to large compensation payments from governments.

In a recent BBC viewpoint, Sue Mayer has described GM crops as looking like "more of a liability than an asset." And in Australia, the Western Australian Agriculture Minister, Kim Chance, has criticised strongly the Australian Federal Government's premature call for all states to lift their moratorium on GM crops. The call, from the Hon Peter McGauran, Federal Minister for Agriculture, Fisheries and Forestry (DAFF), responds to the DAFF report, Creating Our Future: Agriculture and Food Policy for the Next Generation (Corish Report).

While governments and trade disputes remained entrenched in a debate over scientific evidence, the distraction from the real problem of product credibility and consumer confidence is potentially marginalised.

DIME Papers Online

2006-10-13T19:18:00.000Z

The papers and presentations from the DIME Conference staged in London 14-15 September are now online.

Papers include Frederic M Scherer's "The Political Economy of Patent Policy Reform in the United States," David Paul's "Using IPR to Expand the Research Common for Science," Fiona Macmillan's "Cultural Diversity in an Era of Corporate Dominance," and my own, "The Discovery of Invention."

Dynamics of Institutions and Market Economics (DIME) is a network of excellence of social scientists, including specialists in law, economics, and politics, as introduced in an earlier post. DIME is sponsored by the 6th Framework Programme (FP6) of the European Union.

European Parliament Votes to Postpone Membership of EPLA

2006-10-13T14:33:00.000Z

Yesterday, members of the European Parliament voted at the Brussels plenary session to approve a resolution postponing EU membership of the European Patent Litigation Agreement (EPLA). In a vote of 494 against 109, with 18 abstentions, the result was largely due to major concerns with the text of the EPLA. One motion for a resolution, submitted by Sharon Bowles (ALDE Group) and others, described the need for "significant improvements" to the text.

The Working Party on Litigation was established at the Paris Intergovernmental Conference of 1999, and mandated, among other things, to produce a draft text for a common European patent system. The sub-group of the Working Party produced the first draft of EPLA in 2004, with a revised draft submitted to the Working Party in December 2005 (to take account of the Enforcement Directive, 2004/48/EC).

Yesterday's decision postpones moves towards a European patent court, but does not mean a complete rejection of the Agreement. One of the particular sticking points was a perceived lack of democratic control over the granting of patents. During the debate held 28 Septe mber, Richard Corbett (MEP) expressed "grave doubts about the proposals for a system of patent courts that would be at arm's length both from democratic institutions and from proper judicial review." He continued, "The draft resolution of on the European Patent Litigation Agreement could, if implemented, place patent disputes in the hands of those who have a vested interest in a very wide use of patents."

Nevertheless, Members remain committed to the Community Patent as part of what Charlie McCreevy suggests is a "better, cheaper, more reliable patent system." And in a recent briefing produced by the London School of Economics and Political Science (LSE), Centre for Economic Performance (CEP), the greater productivity of the US was attributed in part to Europe's ongoing failure to create a Community patent. The CEP briefing notes that registering a patent in the EU costs 5 times more than in the US. The debate concerning patent protection in Europe continues in the context of the revitalised Lisbon Agenda and concerns for Europe's competitiveness and innovation in a global market.

Civil society groups such as the Foundation for a Free Information Infrastructure (FFII) have expressed ongoing cynicism regarding the cost and efficiency promises of the EPLA. In a press release in September, Pieter Hintjens, president of FFII said, "The EPLA means higher costs for small businesses, and increased litigation risks. More US-style litigation is not the solution. We just need a better patent office."

FFII board member, Jonas Maebe, has said "We're 80% happy with the result."

European Study on Scientific Publication

2006-10-11T21:46:00.000Z

The European Commission has published a synthesis report on a public consultation on the scientific publication system in Europe.

In January this year, the comprehensive "Study on the economic and technical evolution of the scientific publication markets in Europe" was published. Commissioned by DG-Research, the 108 page study was undertaken in the economic and policy context of debates concerning access to scientific research and results, the archiving of materials, and relevance of the publication market not only to dissemination but also to the certification of "quality."

A public consultation on the study was launched and undertaken 31 March to 15 June 2006, drawing substantial input from various stakeholders, which have now been distilled in a report on the public consultation.

A recommendation in the original report receiving substantial support in the consultation was to guarantee public access to publicly-funded research results shortly after publication. This is important in that it balances the "commercial" value of the research publication and the need to dissemination quality research as quickly and widely as possible. The use of "open access archives" for EC-funded research received support in a wide range of submissions, including the response from the Wellcome Trust. The Wellcome Trust is the lead partner in the UK PubMed Central Implementation Group (UKPMC), which is working towards establishing a UK version of PubMed Central (PMCI) system of networked digital archives. The Wellcome Trust has a noted commitment to effective open access publishing in biomedical research.

Nevertheless, some responses expressed concern over trends towards open access publishing, mostly those from publishers. In particular, the response from Wiley is strikingly similar in its concerns (and wording) as the response from the Association of American Publishers (AAP), both of which state that there is "no credible evidence" that open access publishing is more effective. AAP describes the system as an "author-pays" system. Both responses make exactlyh the same statement - that "no credible evidence is presented that such models are inherently better than the current ones employed or that they have the necessary long-term viability." At least the industry line is readily available.

The Commission will host a conference on scientific publication issues in Brussels next year, 15-16 February.

Patent Filings = Innovation? Audi's Advertising Agency Thinks So

2006-10-08T14:42:00.000Z

Not quite a life patent, but so interesting I could not resist blogging it. The latest Audi commercial features "patent filings" as a slogan. The campaign hinges on a link between filings (not even granted patents, but just filings) and prestige and innovation.

It's the latest campaign for the Audi A6, entitled "A6: Patent No VOR5PRU7NGDUR6CHT3CHN1K" (catchy, yes?). The advertisement features a man and his dog walking along a deserted country road in the middle of the night. He hears a sound in the sky and looks to the stars, a fast-moving object speeds through the sky, interspersed with quick images of patent specification documents. The advertisement reaches the climax slogan, "To date, NASA has filed 6509 patents. In development the A6, Audi filed 9621" ... as an A6, after orbiting the earth, plunges out of the sky and into the ocean.

Now that's compelling advertising.

Access to Research - FAO Agora

2006-10-08T12:10:00.000Z

The United Nations (UN) Food and Agriculture Organization (FAO) has launched the second phase of its Global Online Research in Agriculture (AGORA) initiative.

AGORA was introduced in 2003, contributing the UN Millenium Development Goals. A public-private partnership between the FAO and 37 international science publishers, together with the World Health Organization (WHO), Cornell University, and other key partners, the aim of AGORA is to provide access to 69 low-income countries. The second phase expands that access to include universities and other higher education institutions, as well as government ministries and non-governmental organizations in an additional 37 middle income countries.

Eligible institutions are invited to subscribe, which involves registering for a free 3 month trial and then paying an annual subscription of US$1000. All subscription income is then re-invested into local training initiatives.

In its press release, the FAO describes AGORA as "closing the knowledge gap." AGORA is a notable manifest response to the importance of information in economic development.

DG Trade and IPR Enforcement

2006-10-06T08:29:00.000Z

Yesterday, the European Commission published a survey of EU businesses and intellectual property enforcement. The results identify several countries "in the fight against counterfeiting," including China as a main priority, and Russia, the Ukraine, Chile and Turkey as secondary priorities.

Intellectual property enforcement is central to EU policy, and "goes to the heart of the EU's ability to compete in the global economy" with Europe's key competitive advantage coming from the so-called creative economy.

This week, the Commissioner for External Trade, Peter Mandelson, launched the Global Europe external competitiveness strategy, which identified the fight against counterfeiting as critical. In the Commission Staff Working Document, produced by the Directorate-General for Trade (DG Trade), trade policy was tied to better recognition and enforcement of intellectual property rights. In particular, international patent harmonisation is identified in the document as a possible mechanism by which to minimise redundancies and delays in the grant of patents.

International patent harmonisation is part of ongoing discussions in WIPO, considered in particular earlier this week at the 33rd General Assembly. At the General Assembly, Members agreed to submit proposals on the work programme of the Standing Committee on the Law of Patents (SCP) by December, with informal consultations towards a work plan to be held next year. The results of the consultations are to be considered in the 2007 General Assembly at which time a work plan for 2008 and 2009 will be established. WIPO will also be staging a number of informal colloquia on patent issues, including two planned for 11 October (Research Exemption) and 29 November (Standards and Patents) this year.

Importantly, the Commission working document states that work towards international patent harmonisation should keep in mind the potential relationship between intellectual property rights, public health, and sustainable development. Indeed, openness and market access are not necessarily the key to economic development according to the Secretary-General of the UN Conference on Trade and Development (UNCTAD), Supachai Panitchpakdi. The Secretary-General explained at a recent Geneva meeting, "UNCTAD, development, and the way forward," that without technical assistance and the development of regional capacity, least developed and developing countries will not benefit from globalization. In an UNCTAD press release, he states, "In fact, some have argued that trade liberalization has in some cases resulted in de-industrialization and even greater poverty."

The EU announcement of its recent survey maintains that although the EU does not exclude the possibility of WTO action against intellectual property infringement, it is also "looking to focus technical assistance and cooperation in the joint fight against piracy."

USPTO to Reexamine Stem Cell Patents

2006-10-05T10:41:00.000Z

(Also posted on IPmed)

A request to the United States Patent and Trademark Office (USPTO) to reexamine 3 patents relating to stem cell technology has been granted.

The requests came from California-based consumer group, Foundation Taxpayer and Consumer Rights (FCTR), and were filed in July on the Foundation's behalf by the Public Patent Foundation (P UBPAT).

The patents are owned by the Wisconsin Alumni Research Foundation (WARF) whose researchers include James Thomson (pictured at left), who led the team which, in 1998, made the first successful isolation of human embryonic stem cells. Thomson later founded Cellular Dynamics International (CDI), a private biotechnology company based in Madison, Wisconsin. Last year, the State of Wisconsin granted CDI a US$1M Technology Development Grant and a US$1M Technology Development Loan.

The 3 patents in question are US Patent 5,843,780 (780 communication); 6, 200, 806 (806 communication); and 7, 029, 913 (communication forthcoming). The requests from FCTR were accompanied by the declaration of Jeanne F Loring, Adjunct Associate Professor at the Burnham Institute, and include references to prior art not considered at the time the patent was granted. This raises a "substantial new question" (SNQ) of patentability and grounds for a complete reexamination of the patent claims on the basis of prior art.

The requests also included reference to public harm, but the USPTO communication is clear that this is beyond the scope of reexamination. Nevertheless, John M Simpson, Stem Cell Project Director of FTCR, has welcomed the announcement and condemned WARF's patent policy, described in the press release as "WARF's aggressive assertion of patents." Simpson claims that WARF has "a history of putting profits before public benefit." An earlier press release quotes the Juvenile Diabetes Research Association (JDRF) as saying that WARF patents pose a "major inhibition to productive scientific research."

Should WARF really have a monopoly on the toolbox?

Russia Suspends US Rice

2006-10-04T18:43:00.000Z

Rosselkhoznadzor, Russia's Federal Agency of Veterinary and Phytosanitary Surveillance, has announced that it has stopped issuing quarantine permits for US rice imports, following the GM rice contamination revealed in August this year.

LLRICE601 has not been passed for human consumption, however, as reported in an earlier post, Bayer CropScience are seeking an extension on the basis that it is not significantly different from deregulated GM varieties.

Meanwhile, Reuters reports that two bargeloads that had previously been certified for import into the EU, have subsequently tested positive for the GM strain.

PUBPAT Challenges Monsanto Patents

2006-10-03T20:52:00.000Z

"It appears as though Monsanto wants to control all of America's farmland and - unfortunately - the patent system is providing them the perfect means."

The Public Patent Foundation (PUBPAT) has filed formal request with the United States Patent and Trademark Office (USPTO) to revoke four Monsanto patents.

In a press release, Monsanto is described as using the patents "to harass, intimidate, sue - and in many cases bankrupt - American farmers." Executive Director of PUBPAT, Dan Ravicher, says "Monsanto's aggressive assertion of its patents is not only obnoxious and offensive to the core fabric of American life and culture, it is also causing substantial public harm."

The Center for Food Safety (CFS) completed a study on these concerns, and recently released the Monsanto v US Farmers Report, looking into the extent to which US farmers are negatively affected by litigation of patented GM crops.

The filings have included the submission of prior art which PUBPAT says will show that the patents lack novelty, are therefore invalid, and should be revoked.

Japan Lifts Rice Ban

2006-10-03T11:00:00.000Z

Japan has lifted its ban on US long grain rice.

According to a report in Capital Press, Japan has now lifted its ban on US long grain rice after tests did not reveal any evidence of contamination.

Meanwhile, it is likely that rice farmers' legal action against Bayer will be heard in Arkansas in January. A report in the Economist suggests that the farmers are likely to prevail in their demands for stricter controls. But, as the Economist report says, "once genetically modified foods are out in the environment it is pretty hard to recall them, regardless of what politicians would like."

One of the most critical aspects for the GM industry is perhaps not a monopoly in seeds but the oversight necessary to generate consumer confidence in a market.

More Trouble for US Rice Industry

2006-10-02T09:42:00.000Z

The Guardian reported on the GM rice controversy this weekend, saying that the contamination of US rice has effectively blocked its import into the UK.

As reported in previous posts - Aug 30 and Sept 12 - the contamination of US rice with the GM strain, LLRICE601, has led to immediate bans on imports into the EU rice market, subject to strict testing for contamination. The European Commission announced shortly after the discovery of the contamination in August, that all US rice imports would now require certification before gaining entry to the EU.

The Guardian has reported that Spanish rice processing company, Ebro Puleva, the world's biggest importer of rice and controlling 30% of the EU rice market, has announced that it has ceased trading in US grown rice.

The contamination has been traced to crop trials conducted by Bayer CropScience, between 1998 and 2001. US rice farmers are taking action against Bayer for what they argue is serious damage to their valuble crops.

LLRICE601 has not been tested for human use. However, the US Department of Agriculture (USDA) is assisting Bayer to obtain fast track retroactive approval for human consumption, according to the Guardian.

Bayer CropScience made a petition application to the USDA and Animal Plant Health Inspection Service (APHIS), 22 August 2006, shortly after the contamination was announced, 18 August 2006. The petition requested the extension for LLRICE601 based on its similarity to previously deregulated rice lines, LLRICE62 and LLRICE06. The extension process is based on the rationale that many regulated articles that are developed will be similar to already reviewed articles that have been given nonregulated status, or differ from them only insignificantly. On this basis, that status would be extended to the regulated article (in this instance, LLRICE601).

In response to that petition, the USDA/APHIS published a Draft Environmental Assessment
which evaluates the comparison provided by Bayer CropScience in the petition. In that assessment, the USDA/APHIS concluded that LLRICE601 had undergone extensive field testing and charracterization and that the available evidence supported the conclusion that "LLRICE601 is likely to be as safe as LLRICE06, -62, and conventionally bred rice lines."

The USDA issued a notice, 8 September, which concluded that "rice line LLRICE601 is similar to the antecedent organisms ... and we have reached a preliminary decision that rice line LLRICE601 should no longer be regulated under the regulations in 7 CFR part 340." The regulations in 7 CFR part 40, "Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There is Reason to Believe Are Plant Pests," regulate the introduction of organisms or products into the environment. In the accompanying press release, the USDA seeks public comment on the petition, which may be submitted online.

The Guardian reports that Aldi and Morrison's supermarkets in the UK have recalled products that have tested positive for LLRICE601. Others have not acted, relying on assurances from the Food Standards Agency (FSA) that there is no health problem, based on the European Food Safety Authority (EFSA) opinion.

But what of the consumer, who wishes to make a choice? Is this really "putting the consumer first"?

The Center for Food Safety (CFS) has filed a petition with the USDA asking it to regulate the rice as a "plant pest" under the Plant Protection Act. In the accompanying press release, the CFS describes the process as "an after-the-fact USDA rubber stamp for the illegal rice." Friends of the Earth announced in a press release that it is mounting a legal challenge to compel the FSA to commence testing. Japan has already expanded testing of US rice, in response to what has been described as "a lack of proof from Washington" that exports are free from contamination. According to a recent Reuters report, Japan has a "zero-tolerance" policy on imports of unapproved GM crops.

WTO Panel Decision on EU Biotech Cases

2006-10-01T15:59:00.000Z

The WTO Panel has delivered its final report on the European Communities (EC) approval and marketing of biotech products.

In May 2003, the United States, Canada, and Argentina took their complaints to the WTO Dispute Settlement Body on EC approval and marketing of biotech products and, in particular, the moratorium on GM agricultural and food imports (introduced in the context of a need for effective regulation of co-existence of agricultural markets in Europe). The final report was published Friday afternoon, 29 September, and has concluded that the moratorium is inconsistent with obligations under the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement).

Although the Panel concluded that the moratorium had caused "undue delay" and so the EC had acted inconsistently with obligations under Annex C(1)(a) and thus Article 8 (Control, Inspection and Approval Procedures), the complainants had either failed to establish their position or the EC had not acted inconsistently in respect of the other obligations raised in the complaints.

Consumer groups have criticised the report, suggesting that alternative mechanisms must be available to rule on what are international environmental laws, not trade disputes as such. On this point, consumer groups have objected to the prohibition of public involvement.

Of particular interest, a Friends of the Earth Europe press release, suggested that it makes no difference to the rejection of GM products by European consumers. Earlier posts to Patenting Lives, including GM Food in Europe and Beyond: Consumer Trends, make similar observations.

Down on the Pharm

2006-09-20T18:22:00.000Z

So-called pharm animals are being described as "revolutionising" the pharmaceutical industry.

Pharming refers to the use of host animals (and also plants) to express certain qualities (for example, in their milk). Such animals have been described as "animal factories," and their use has attracted a great deal of criticism and debate. As well as concerns over safety (such as the Starlink controversy and the ProdiGene episode), such use of animals has raised ethical questions from various groups, including Animal Liberation (Australia) and the British Union for the Abolition of Vivisection (BUAV).

One such pharm animal is on its way to market. European regulators have recently approved a drug produced in the milk of genetically modified goats.

ATryn is a recombinant form of human antithrombin (ATIII), used in the treatment of hereditary antithrombin deficiency (HAD), where the individual is missing the gene responsible for making the protein, antithrombin. HAD can lead to various problems, including deep-vein thrombosis, because the blood clots too easily. ATryn is lauded as much safer to deliver the missing copy of the gene than other methods, such as through human blood plasma (which carries the risk of vCJD). Antithrombin is administered to HAD patients during times when the usual treatment by warfarin is too risky (such as during childbirth and surgery).

GTC Biotherapeutics, the company responsible for developing the drug, applied for European Market Authorization in January 2004, as discussed in an earlier post, Milking Medicines. However, in February this year, (see previous post, Crying over Spilt Milk), the European Medicines Agency (EMEA) refused the application to license ATryn, calling for more evidence on the benefits of the drug. After reversing this decision and deciding to issue the licence in June, as set out in its positiv e opinion, the EMEA Committee for Medicinal Products for Human Use (CMPH) has now given approval to the drug (as reported in The Times and a GTC press release).

Tom Newberry, spokesperson for GTC Biotherapeutics, claims the drug could be available in the UK and Europe from mid-2007. The company also has many more transgenic products in various stages of development.

The European approval of the transgenic drug is a boost to other drugs being developed, including the production of polyclonal antibodies in chicken eggs for the treatment of cancer (Origen Therapeutics); the production of high level proteins in insect larvae (Minos Biosystems); and several treatments being developed by Pharming and produced in the milk of transgenic animals. Pharming recently announced its application to the EMEA for marketing authorisation of Rhucin, a drug to be used in the treatment of hereditary angioedema, accepted for review by the EMEA. If approved, Rhucin will receive marketing authorisation in all 25 EU member states.

Consumer Rights and FTAs on the European Agenda

2006-09-19T18:49:00.000Z

The President of the European Commission, Jose Manuel Barroso, has announced that consumer rights must become central to the economic and social agenda for the EU.

In a letter to colleagues, Barroso stated, "We must treat the internal market and social realities as one ... The citizens must move to the centre of our activities." In an article published today, Anne-France White suggests that this is a notable change from the focus on industry that has previously dominated the commission, as presented by EU executives Gunther Verheugen, Vice-President and European Commissioner for Enterprise and Industry, and Charlie McCreevy, European Commissioner for the Internal Market and Services.

Some commentators have suggested that Barroso's agenda is linked to his desire to secure a second five year mandate. But it is almost certainly motivated by attempts to revitalise moves towards a European constitution.

It has been predicted that the push will be resisted by some members of the Commission, including Charlie McCreevy and Peter Mandelson, European Commission for Trade.

Mandelson has been in the press recently on the Global Europe Strategy Paper, emphasising trade and the use of bilateral Free Trade agreements (FTAs) with key growing markets. In a speech echoing sentiments of US approaches to "contractual law-making," Mandelson says, "We must keep the WTO as the fundamental platform on which to build global liberalisation. There will be no European retreat from multilateralism. But we should also go beyond the EU's existing bilateral free trade agreements, by setting out the case for new free trade agreements designed to deliver more open markets and fairer trading conditions in new areas of growth, particularly in Asia". In that same speech, Mandelson emphasises the enforcement of intellectual property rights as central to the EU's trade strategy in China.

UK Patent Office - "Rules of Public Engagement"

2006-09-13T13:03:00.000Z

Gareth Huw-Davies of the Sunday Times did an interesting story on the UK Patent Office this weekend, highlighting the significance of the public face of the Agency. Increasingly, intellectual property policy making has sought to engage the public in efforts to regain the legitimacy of intellectual property rights among the consumers of such products.

Ron Marchant, chief executive of the UK Patent Office, opened the third annual THINK k it awards this summer. The THINK kit awards, sponsored by the Patent Office, aim to promote innovation in school students. The awards are part of the contemporary public profile of the UK Patent Office, and its emphasis on the promotion of "intellectual property."

This is particularly significant in the context of the current climate of review and consultation in the UK, with publication of the Gowers Review of Intellectual Property, led by Andrew Gowers, expected later this year. It is anticipated that the document will emphasise the interaction between intellectual property laws and economic growth, particularly in the light of one of the key themes of the new Office of Science and Innovation - "levering the economic value from creativity." The Office of Science and Innovation, which includes the Patent Office and is within the Department of Trade and Industry (DTI), is a significant branding of this public face of innovation in the UK and the policy initiatives of the Patent Office.

The Sunday Times described the new role of the Patent Office as one which is "regularly on the road" at workshops and advising firms. Marchant was reported in the Sunday Times as saying, "When I started as a patent examiner we basically opened a file, examined the patent, closed the file and it went off to a warehouse. We really didn't feel we had much impact. Now we have a very active engagement with our customers. We talk all the time about how we can help them."

European Standing Committee Considers GM Rice Contamination

2006-09-12T18:29:00.000Z

The European Commission released a press release today on the meeting of the Standing Committee on the Food Chain and Animal Health (SCFCAH), reviewing the GM rice contamination.

As discussed in a earlier post, the contamination of US rice exports by the GM strain, LL601, led to immediate bans on imports in Europe and Japan, with the European Commission announcing that it would require certification to prevent further entry of GM rice.

The Federation of European Rice Millers (FERM), representing over 90% of the milling capacity in Europe, was in attendance at the meeting to report on the system of control of rice imports. Last month, FERM released a statement supporting the Commission's decision to introduce a system of testing and certification and at the SCFCAH meeting a detail report was provided of the controls and validated testing methods currently in place. FERM reported that 33 of the 162 samples tested had returned positive results for LL601. Indications at the SCFCAH meeting were that LL601 could be present on the European markets, but actual tests could not be confirmed for another 2 weeks at least. However, of the Member States already testing, no positive results for LL601 have been returned.

As mentioned in an earlier post, the Commission adopted a decision in August to require all rice to be certified free of LL601. Since then, no consignments without certification have entered the EU market.

A shipment of approximately 20000 tonnes of US rice was detained in Rotterdam, 26 August 2006. After testing the barges, 3 have been positive for LL601 while 20 have been negative and have since proceeded to market. The positive consignments are to be returned to the USA or destroyed. Shortly thereafter, evidence of GM rice in Chinese imports was reported by Greenpeace and Friends of the Earth. The Commission has requested the submission of information and samples to the competent authorities to confirm this and has also written to the Chinese authorities for further information.

The SCFCAH is one of several Regulatory Committees which assist the European Commission in the development of food safety measures at all stages of the food chain. Referred to as the “from the farm to the fork” approach, the Committee deals with food & feed safety, animal health, animal welfare and plant health.

DIME-EU Network of Excellence - Conference

2006-09-12T09:10:00.002Z

Dynamics of Institutions and Market Economics (DIME) is a network of excellence of social scientists, sponsored by the 6th Framework Programme (FP6) of the European Union.

The DIME network is concerned with the impact of global forces in the context of the knowledge economy and, in particular, the socio-economic factors associated with increasing globalisation.

This week, 14-15 September 2006, I will be speaking at DIME's international conference in intellectual property rights in London, in association with the Global Network on IPR Research. The conference will be held in the Clore Management Centre, Birkbeck College, University of London, located in Bloomsbury.

US Rice Farmers to Sue Bayer CropScience for GM Crop Contamination

2006-08-30T12:56:00.000Z

The German chemical and drugs company, Bayer, is to face claims by US rice farmers that Bayer CropScience's GM rice has contaminated valuable crops.

Although unavailable for comment earlier this week, Bayer has finally confirmed that US rice farmers have filed a lawsuit alleging that the company had failed to prevent its GM rice contaminating other crops, according to a report in The Times newspaper today. In a statement by the plaintiffs' law firm, Cohen, Milstein, Hausfeld & Toll, it was confirmed that the class action was filed this week (Monday) in the US District Court for the Eastern District of Arkansas in Little Rock. The firm's website provides a copy of the complaint.

The contamination of rice crops by the untested strain, LLRICE601, has greatly compromised the export value of the rice, a significant export crop with the US rice making up around 12% of the international market.

EU imports are subject to laws restricting GM crops and food including GM rice, for which no varieties are currently authorised for sale in the EU. The EU executive stated that the rice could be blocked after it was informed by US authorities earlier this month that the contamination had been detected. And indeed, last week, 23 August 2006, in a press release the Commission confirmed that certification would now be required for all US rice exports, in order to stop the entry of unauthorised GMO into the EU. As an emergency measure, the adopted decision took effect immediately. However, the decision has been submitted to Member State experts for review within 10 days, and the Standing Committee on the Food Chain and Animal Health conducted an urgent meeting last Friday.

Reu te r s and the BBC have also reported that Japan, the world's largest importer of US rice, had already suspended imports of US long-grain rice shortly after the contamination became public. According to an earlier report in the Environment New Service (ENS), the contaminating GM variety has not been approved for human consumption.

However, in the statement released by the Food and Drug Administration (FDA), the FDA concluded that "the presence of this bioengineered rice variety in the food and feed supply poses no food or feed safety concerns." Agriculture Secretary, Mike Johanns (pictured at right), was quoted by ENS as saying "The US Department of Agriculture and US Food and Drug Administration have been notified by Bayer CropScience that the company has detected trace amounts of regulated genetically engineered rice in samples taken from commercial long grain rice. Both have reviewed the available scientific data and concluded that there are no human health, food safety, or environmental concerns associated with this GE rice." Nevertheless, it seems that there are significant commercial concerns in the "diminished prices for US rice exports" in the farmers' complaint. Nevertheless, the ENS report states that the secretary acknowledged the potential impact on rice exports.

The lawsuit is a significant development in the context of current concerns over the liability of GM producers in organic and traditional markets. In a Friends of the Earth Europe (FoE) pres s release, campaigner Adrian Bebb stated, "The biotech industry has failed once again to control its experiments."

California State Assembly Votes for Control of GM Crops

2006-08-27T18:44:00.000Z

In an earlier post, "Pre-emptive Strikes," reported on the California Senate Bill 1056. Sponsored by Monsanto, the bill was introduced by Democrat Senator Dean Florez in February this year.

The bill has just been read for the third time and passed by the State Assembly, in the session of Thursday, 24th August. The bill passed with a bipartisan majority of Republicans and centre-right Democrats in a vote of 51 to 24, with 4 abstaining.

In the comments to the bill, it is stated that "This bill clarifies that no state law shall be more restrictive than federal law by providing that no ordinance or regulation of any political subdivision may prohibit, or in any way attempt to regulate, any matter relating to the registration, labeling, sale, storage, transportation, distribution, notification of use, or use of seeds or nursery stock."

As to existing county actions, if such actions have gained passage on or before July 1, 2006, the passage of the new Bill will not invalidate those actions. This means that the Counties of Marin (at left, Prince Charles and the Duchess of Cornwall visiting the organic markets in West Marin, last year), Mendocino, Trinity, and (most recently) Santa Cruz, will be exempt from the provisions of the bill if it passes into law. However, as Kimberly Geiger notes in an article in The San Francisco Chronicle, this still leaves 54 counties (including the Orange County) subject to the state when it comes to regulation of the industry, "even though the state does not have any regulation on the books."

Senate Bill 1056 must now go to the state's Senate and the Governor for approval before passing into law. The Governor must be given the opportunity to veto the law.

ICAR Transgenics to Market

2006-07-28T12:02:00.000Z

The Indian Council of Agricultural Research (ICAR) has announced that it will be able to commercialise its first transgenic crop varieties by 2008.

According to a report by Haris Damodaran in the Hindu Business Line, the ICAR has been under intense scutiny for "not doing enough" in the area of GM crops. But Dr Mangala Rai, Director-General of ICAR, told the Hindu Business Line, "There are seven GM varieties on which field trials have been completed under teh supervision of the Department of Biotechnology's Review Committee on Genetic Manipulation (RCGM) ." The RCGM, which is made up of representatives from the Department of Biotechnology, Indian Council of Medical Research (ICMR), ICAR, and the Council of Scientific and Industrial Research (CSIR), as well as other experts in their individual capacity, monitors safety related aspects of research projects and other activities involving GM organisms.

The RCGM stage of approvals has been passed for all seven transgenics, which include American bollworm-resistant cotton, yellow stem borer-resistant rice, fruit and shoot borer-resistant brinjual, leaf curl virus-resistant tomato, protein-enriched potato, and salinity/drought tolerant tomato and mustard.

The ICAR suggests that one of the most important aspects of increased momentum in the area of commercialisation of GM crops is competition, maintaining that such competition will benefit farmers in the long run. To this end, the Government has already approved 59 hybrids of Bt cotton for commercial release, with 52 of these based on Monsanto's Bollgard gene technology.

The ICAR will be making applications to Genetic Engineering Approval Committee (GEAC) this season. GEAC functions within the Department of Environment Forests and Wildlife for approval of large scale use of recombinants in research and industrial production in the context of potential environmental concerns, as well as the release of GMOs into the environment, such as in experimental field trials.

ICAR will be seeking the permission of GEAC to conduct large-scale trials and seed production, with a view to delivering the first transgenics to farmers' fields by 2008/9.

Environmental Censorship? Greenpeace Ordered to Remove GMO Map

2006-07-27T12:43:00.000Z

Yesterday, a French court ordered Greenpeace France to remove from its website Google Maps of genetically modified (GM) maize. Greenpeace has described the order as censorship, maintaining on its website that EU law obliges the government to make such information available to the public - an obligation which Greenpeace France believes is being neglected.

The order followed a complaint filed by two GM maize farmers. The farmers claimed that they feared their commercial fields may be attacked as a result of the publication, and that the publication was a violation of their privacy. The Paris court held that the farmers' privacy had indeed been violated and ordered the removal of the maps.

The maps (example at left) have been described by Greenpeace as complying with an obligation on member states to maintain public registers informing citizens of the locations of GM fields. However, this is the obligation of the Commission and competent authorities on request from individuals, and so the action by Greenpeace France was held to be a violation of the farmers' privacy. Under current French law, the obligation to the public is in relation to the location of open-field experiments only.

Today Greenpeace France opted to react with a "physical" map, carving a crop circle into one of the GM maize fields as an "X marks the spot." Arnaud Apoteker, of Greenpeace France, says "As we are now forbidden to publish these maps of GE maize on our webpage, we have gone into the fields and marked the field for real."

Stem Cell Compromise

2006-07-26T09:58:00.000Z

At Monday's meeting of the Competitiveness Council, agreement was finally reached on EU funding of stem cell research through what has been described as a "historic" compromise. Under the terms of the compromise, the part of the research process that requires the destruction of human embryos, to allow the harvesting of embryonic stem cells, will have to be funded by other means.

The positions of different member states over the direction of FP7 funding to stem cell research were outlined in "Heated Debates". In a campaign led by the German Federal Minister for Education and Research, Dr Annette Schavan, Germany has been strongly opposed to the use of EU funding for stem cell research, subsequently joined by a group of countries in opposition to the proposed expenditure. However, as mentioned in "Heated Debates" the movement of Slovenia towards the support for the research left the opposing countries unlikely to achieve a blocking minority.

And so, after a lengthy debate, Germany supported Monday's compromise which will allow individual member states to continue the funding of stem cell research with money from the EU's £37 billion science budget (around 50 billion euros). The bargain was the assurance from the European commission that no EU money would be directed to projects involving the destruction of human embryos. Annette Schavan, explained that the important point was "that there can be no financial incentives for the destruction of embryos."

Originally the divisions between for and against were described as divisons between Roman Catholic and non-Catholic countries. However, this characterisation has been shown to be too simplistic, with Portugal strongly in favour of stem cell research. According to Nicholas Watt's report in the Guardian newspaper, Portugal's Minister of Science, Technology and Higher Education, Dr Jose Mariano Gago, "turned on his opponents" and argued very emotively and personally, "I hope that none of the colleagues will ever need treatment which does not yet exist for dementia and Alzheimer's. These are treatments which could be made possible by research with stem cells. If you find yourself in such a position I hope you would be able to say you did not stand in the way of such research."

The decision reflects an emphasis on the sovereignty of individual members of the European Union, allowing individual states to decide whether to spend EU money in this way within its own borders.

Following US President Bush's veto last week of federal expenditure on stem cell research, a potential "US brain drain" has been described, with scientists heading to the EU to take advantage of the research funding compromise. As reported in the Guardian, Lord Sainsbury has described the US President's position as "a very negative position."

Earlier this week, Prof essor Stephen Hawking of the University of Cambridge warned the EU against taking the "reactionary lead" of the US. However, Professor Hawking has described the EU compromise as a "fudge," and has raised concerns that it mounts practical limits to the research.

Nevertheless, yesterday, just one day after the agreement, the University of Cambridge announced the new £10million Cambridge Stem Cell Inititiative, The Institute for Stem Cell Biology. The new centre will be dedicated to stem cell research, under the direction of Austin Smith, the former director of the Institute for Stem Cell Research (ISCR) at the University of Edinburgh. Funded primarily by the Wellcome Trust, the new centre will open in December.

Heated Debates - EU Stem Cell Research

2006-07-24T10:20:00.000Z

The temperatures in London might be soaring at the moment, but they're rivalled by the heat over stem cell research in Europe.

EU Ministers will meet today to consider ongoing obstacles to funding agreement, ahead of approving the EU's 7th Research Framework Programme (FP7). Framework Programmes are the main mechanism for the funding of research and development in the European Union, and have been implemented since 1984.

Each FP runs for a period of 5 years, with a one year overlap with the subsequent FP. However, it has been proposed that FP7 should run for 7 years, commencing 1 January 2007 and expiring in 2013. FP6 will run up until the end of this year, but FP7 is still yet to be approved.

Agreement on the Programme must be reached at today's meeting of the EU's Competitiveness Council. Stem cell research remains a significant obstacle, along with other debated areas including concerns over nuclear research and training activities, and the new European Research Council (ERC) initially proposed in 2002 and subsequently developed through public consultation and the work of the European Research Council Expert Group (ERCEG). But it is the controversy over the funding of stem cell research which threatens to prevent an agreement at today's meeting.

9 high level themes have been proposed for EU action in FP7, including health. Strict funding procedures would ensure that EU funds would not support research into the use of stem cells for reproductive cloning or the creation of human embryos. However, Monday's meeting is expected to vote in favour of opposing EU funding on embryonic stem cell research.

But the vote is in the balance. Although Germany, Poland, Austria, Slovakia, Lithuania, Malta, and Luxembourg are likely to vote against the funding of stem cell research, this vote will fail unless one other member state supports the group to create a blocking minority. Slovenia, once thought to be a possible waverer, defected from the blocking minority over the weekend. However, Italy and Ireland may yet join the Berlin-led group to vote against stem cell funding.

The EU heat follows that of last Wednesday, when US President Bush rejected legi slation passed by Congress that would have allowed federal expenditure on research into embryonic stem cells. President Bush claimed, "It crosses a moral boundary that our decent society needs to respect, so I vetoed it."

Civil Society - World Superpower

2006-06-30T16:55:00.000Z

The CIVICUS World Alliance for Citizen Participation held its 6th World Assembly last week in Glasgow, Scotland, with meeting documents published by Terraviva, an independent publication of the IPS-Inter Press Service news agency.

CIVICUS is an international alliance of around 1000 members across about 100 countries, advocating citizen action and civil society participation throughout the world. Emphasising participation and active citizenry as the foundation for development, CIVICUS aims to provide information and resources for civil society. Its global headquarters are in Johannesburg, South Africa, although CIVICUS was originally based in Washington DC.

The Assembly came at a time of increasing attention on civil society activity, not only in terms of international debate, but also in the form of growing economic influence, in the form of consumer boycotts, ethical consumerism, and so on.

Nevertheless, some remain less optimistic about the capacity of civil society in the context of international norm setting and public policy making. In an article in OneWorld South A sia, Tiberius Baraza, a researcher in the Governance and Development Department at the Institute of Policy Analysis, Nairobi, Kenya, describes civil society participation as "elementary." Similarly, Faith Kasiva, executive director of the Coalition on Violence Against Women, describes the "consultation" process as mere "rubberstamping."

Nevertheless, civil society is undoubtedly growing as a critical aspect of international policy and legal developments. Professor Graeme Dinwoodie, speaking at the Birkbeck AHRC Copyright Network Conference earlier this week, suggests that the nature of international legal development is much more complex than intergovernmental debates and agreements, noting a greater role for non-governmental organisations and civil society.

This capacity of civil society and its importance in development is emphasised in a recent article considering socio-economic and political circumstances in Morocco. An effective civil society is identified as critical to the facilitation of development. However, development planners have suggested that the lack of such organisation in Morocco has slowed efforts to improve citizens' circumstances. In particular, the 5 year National Initiative for Human Development (NIHD), launched by King Mohamed IV last year, has been somewhat weakened by the absence of a "robust" civil society. This has been the case despite the explicit identification of civil society's involvement as critical to the plan at the time of its launch.

Importantly, what is emerging is the significance of civil society in the economics of development. Professor Robert Innes recently published a paper in the Economic Journal of the Royal Economic Society, describing the increasing sophistication of civil society strategies and consumer boycotts, particularly in the context of ethical consumerism.

In collaborating internationally on the development dimension of intellectual property laws, diverse civil society organisations are working together to increase their policy influence and interact critically with political entities. This week, civil society and governments met in Geneva for the Second Session of the Provisional Committee on Proposals Related to a WIPO Development Agenda. However, as reported by IP-Watch, claims of a persistent bias in favour of countries against the development agenda suggest that the future of these discussions may be threatened.

Nevertheless, arguably the presence of a "robust" international civil society is somewhat of an assurance that the development agenda will continue to "irritate" those most against.

European Patent Office - Annual Report Now Available

2006-06-30T14:21:00.000Z

The European Patent Office (EPO) today published its Annual Report for 2005.

In his Foreword to the Report, Professor Alain Pompidou, President of the EPO, emphasises the quality of patents as a critical issue: "Quality is a key to the future of the European patent system."

As well as the quality debate, Professor Pompidou highlights the political, cultural, and ethical context in which technologies are patented. In this area, the Scenarios project is an important initiative of the EPO. In this project, the EPO has undertaken extensive interviews internationally with users, experts, and critics. I was interviewed as part of this project earlier this year.

The material arising from these interviews will be compiled and published in 2007, as the basis for future policy development in Europe for 2020. As Pompidou states, "By systematically examining and analysing the material it has gathered, the Office hopes to establish meaningful scenarios for the future development of the patent system."

The Annual Report is available on the website as well as in hard copy by emailing infowien@epo.org.

GM Food in Europe and Beyond - Consumer Trends

2006-06-26T21:44:00.000Z

In Brussels today, Friends of the Earth Europe (FoEEurope) urged EU Environment Ministers to introduce tougher safety rules on GM foods.

In today's press release, Adrian Bebb, GM Campaigner for FoEEurope, suggests that the European Food Safety Authority (EFSA) appears biased towards the biotech industry rather than the public, in defiance of public concerns about GM crops. The FoEEurope press release reports that the European Commission has also been critical of the EFSA. In April, the Commission criticis ed the EFSA, calling for greater transparency and scientific consistency on approvals on genetically modified organisms (GMO). Indeed, the Austrian Presidency suggested that the EFSA exercised GMO bias, approving GM products without proper research. The Austrian Presidency announced the re-opening of the debate over safety assessment in March this year. Austria remains one of the supporters of the de facto moratorium on GM crops in Europe. However, FoEEurope reports that the incoming Finnish Presidency has closed the doors of these discussions to environmental groups.

Previous posts, including the recent post on the Eurobarometer on biotechnology, have reported that European citizens remain concerned about the introduction of GM crops in Europe, despite an overall confidence in biotechnology as a whole. Tomorrow, in Luxembourg, environment ministers are to discuss new proposals to address the approval of GM products.

Co-existence of GM crops with traditional and organic systems of agriculture remains a critical issue in Europe, as reported here previously in Co-Existence and Co-existing: Disharmony? One of the important aspects of this debate in Europe is not only the cultural context for European agriculture, but also the commercial viability of organic markets.

However, increasingly, the commercial value of organic is being reported in other jurisdictions. US consumers are also becoming "greener," according to a report, by Brad Dorfman, from the Reuters Industry Summit in Consumer and Retail held last week. While GM continues to be associated with risks to the environment, such "greening" will arguably include similar choices with respect to GM food, as currently seen in Europe. Indeed, this comes at the same time as the recent decision in Santa Cruz County, California, to ban GM crops, as discussed in a previous post. It was suggested in a report in the San Francisco Chronicle online that the Santa Cruz County Supervisors were responding to Monsanto's purchase of Seminis, the world's largest vegetable and fruit seed company, prompting concern that the company would be extending GM technologies into crops traditionally grown in the Californian county.

And non-GM is said to be "booming" in the developing world as well, as reported by Reuters India. Indian soybean meal exports are expected to double, attributable to demand and competitive prices and because "Everywhere Indian meal was better accepted this year because it is non-genetically modified and of good quality," according to the Chairman of the Soybean Processor' Association of India (SOPA), Rajesh Agrawal.

In the United States again, the Foundation on Economic Trends (FOET), founded by economist, Jeremy Rif kin, released a white paper earlier this month, describing the "obsolescence" of GM and the growth of technologies compatible with agroecological approaches, blurring the common claims of "technophobe" levelled against those resisting GM crops. The white paper outlines the importance of marker-assisted selection (MAS) as the "new" agricultural technology, "within the context of a broader, more holistic, agroecological approach to farming."

This technology is being applied in research in Australia, in the case of wheat. In my homeland, research into non-GM wheat breeding technology is, according to an article by the Network of Concerned Farmers, leading the way. Research Director of the Cooperative Research Centre for Value Added Wheat, Dr Bill Rathmell, describes the importance of marker assisted selection in realising non-GM approaches to breeding technologies. The story also notes the "strong economic promise" of this research, as it was described in a recent study by the Australian Allen Consulting Group.

It seems that non-GM research is proving popular not only with consumers, but also with funders and research institutions, responding to what appear to be growing commercial advantages.

GRAIN Report: Sustainable Monoculture? No Thanks!

2006-06-26T21:28:00.000Z

A new report from GRAIN criticises corporate initiatives to promote sustainable monocultures.

Sustainable Monoculture? No, thanks! is strongly critical of not only the transparency of such initiatives but also the scientific validity of such claims. As the accompanying press release states, "It is flawed to think that a monoculture of one crop can be sustainable."

GRAIN is an international non-governmental organisation (NGO), established 16 years ago during arguably the early period of increased awareness of the loss of biological diversity and threats to food security. GRAIN is committed to the promotion of the sustainable use and management of agricultural biodiversity. Building upon local and community control over genetic resources and local and traditional knowledge, GRAIN maintains that genetic resources represent not only genetic diversity but also options for development for many communities and regions.

Pre-emptive Strikes - States and Counties Battle over GM Regulation

2006-06-25T15:26:00.000Z

In the United States, a recent factsheet suggests a rise in state bills supportive of agricultural biotechnology, to head off attempts by local and county authorities to regulate genetically modified (GM) crops.

The US-based Pew Initiative on Food and Biotechnology (Pew) was established in 2001. Its mission is "to be an independent and objective source of credible information on agricultural biotechnology for the public, media and policymakers." Importantly, the Initiative recognises the significance of consumer perspectives and attitudes not only to the technology, but also to the regulatory system itself. Indeed, as discussed here in a recent post on consumer attitudes to biotechnology in Europe, the latest Eurobarometer report suggests that resistance to GM food in Europe is not resistance to the technology as such, but rather, lack of confidence in the ability of regulatory mechanisms to mitigate perceived risks to the environment and to organic and traditional agricultural markets.

Pew's recent factsheet (accompanied by a legislation tracker) concludes that state legislatures are acting to stifle local and county attempts to limit GM crops. In a press release, Michael Fernandez, executive director of Pew, describes states as having "little choice but to address new policy issues, even before they emerge at the federal level." However, it is arguable that this approach of a futures market in policy might suggest a worrying trend for consumers and other groups seeking greater information and transparency in the way in which GM agriculture is introduced - especially in Europe.

The announcement by Pew follows an interesting event in California, where Santa Cruz County supervisors have recently banned the cultivation of GM crops, approving a moratorium on GM crops within County lines last week. The ban was imposed after the findings of a 9 month study of the laws and risks. According to an article by Genevieve Bookwalker, published in the Santa Cruz Sentinel, there was no opposition to the ban by those in attendance at the meeting, and all written comments showed support for the measure.

Santa Cruz is currently "GM-free," with no GM crops grown within County lines. This is largely attributable to the nature of agriculture in Santa Cruz. The dominant GM crops in the US (and indeed elsewhere) include corn, cotton, and soybeans; whereas the dominant crops in Santa Cruz are berries and lettuce. The moratorium comes as companies have commenced research into crops such as flowers, strawberries, and applies, traditionally grown north of the Pajaro River.

Pew's factsheet highlights an obstacle expected to be faced by Santa Cruz County as well, with the moratorium under threat if a State Bill passes that will remove the authority of local jurisdictions to regulate GM crops. Senate Bill 1056 is sponsored by Monsanto and has been introduced by Senator Dean Florez. The Bill was last amended 19 June, and has a hearing date of 28 June. Patenting Lives will be following its progress.

UK Patent Office Publishes National IP Enforcement Report

2006-06-23T15:25:00.000Z

The United Kingdom Patent Office has just released its National Intellectual Property (IP) Enforcement Report 2005.

The report is the second since Lord Sainsbury of Turville, Parliamentary Under Secretary of State for Science and Innovation, launched the National IP Crime Strategy (Strategy) in 2004 and plans for a National IP Crime Group (IPCG). The Strategy is described as bringing together industry, government, and enforcers, "widely seen as the way forward" and "already bearing fruit." Plans for further education of the general public is also advocated in the report, "to convince the public that counterfeiting and piracy is not a victimless crime."

The report includes an introduction to TellPatTM, the national IP crime intelligence database. Lord Sainsbury describes TellPatTM as "a crucial strand in our Strategy," with numerous entries concerning IP crime "and the criminals involved." The information, however, comes from not only enforcement agencies, but also industry. The press release accompanying the launch states that more than 500 000 intelligence reports have been received by the Patent Office in the last 9 months.

Members of the IPCG, trading standards officers, and police officers, will all undertake training in the database over the next 12 months as it is introduced into the UK.

Notably, the report continues to concentrate upon initiatives that are motivated by the relationship between industry, government, and enforcement agencies. In this way, such initiatives do not necessarily engage with the public other than through education in "IP crime." By continuing to concentrate on traditional models of property in IP, it might well be that the Strategy utilises a dynamic that threatens to continue the alienation of individual users from the "crime" arguments. On the other hand, genuine "industries" in counterfeiting probably won't attend the classes.

International Plant Genetic Resources Treaty - First Session

2006-06-23T00:31:00.000Z

The First Session of the Governing Body of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR) took place 12-16 June in Madrid. With attendance by representatives of parties to the Treaty, other governments, intergovernmental organisations, non-governmental or civil society organisations, and industry, the First Session was described by the Food and Agriculture Organization (FAO), as making "great progress." The Governing Body came to agreement on several issues before the international body before it, including the adoption of a standard Material Transfer Agreement (MTA), which sets out the conditions for access and benefit-sharing.

The ITPGR was adopted in November 2001, at the 31st Session of FAO Conference, after 7 years of negotiations. The Treaty then remained open for signature by all FAO members and any States that are not Member of the FAO, but are Members of the United Nations (UN) or any of its specialized agencies. There are 103 parties to the Treaty, which entered into force, 29 June 2004, 3 months after it reached the required number of instruments of ratification, acceptance, approval or accession, as per Article 28.

The Treaty's subject matter - plant genetic resources for food and agriculture - is defined in the Treaty as "any genetic material of plant origin of actual or potential value for food and agriculture" (Article 2). In harmony with the Convention on Biological Diversity (CB D), the Treaty is concerned with the conservation and sustainable use of such resources, and the fair and equitable sharing of benefits derived from their use (Art 3).

The First Session of the Governing Body agreed upon the text for a standard Material Transfer Agreement (MTA). The standard MTA has been in development since 2004. The MTA Expert Group met in October of that year to discuss various issues raised by the First Meeting of hte ITPGR Interim Committee (which met for the first time in 2002). At this time, the Expert Group recommended the establishment of an intersessional contact group to draft the standard MTA.

The first meeting of the MTA Contact Group took place in July 2005 and, at its second meeting in April this year, finalised the draft to be considered by the Governing Body at its First Session.

After extended debates at the First Session, the final MTA was adopted with amendments on Friday 16th. The most contentious issue was that of the rates and modalities of payment for benefit-sharing - this is the payment made by a recipient. A Friends of the Chair group was convened to finalise this issue, taking late into the Friday evening to reach agreement. The rate agreed was 1.1% of product sales for commercialisation where that product is not made available to others for further research and breeding. Where the product is sold with no restriction on further research and breeding, the discounted rate of 0.5% would apply.

A excellent summary of the First Session debates is provided by the Earth N egotiations Bulletin.

Seed Vault - Banking Crop Diversity

2006-06-22T11:41:00.000Z

With advances in agriculture and farming technologies, the common subject matter of those advances is the seeds themselves. What is sometimes not discussed, however, is the way in which crop diversity is influenced not only by the technologies deployed, but also by environmental catastrophes, cultural influences, and political events.

A new seed bank project in Norway is concerned with preserving the genetic diversity in the world's seeds. The Svalbard International Seed Vault, to be managed by the Global Crop Diversity Trust, is to be housed in the permafrost and rock of the remote Svalbard peninsula, about 620 miles from the North Pole. The Trust and the Norwegian government have been working towards a global seed bank since 2004.

The bank will be contained in a reinforced concrete tunnel to be drilled into the rock of a mountain. The natural environment means that there is no need for reliance on artificial refrigeration systems (which can fail). And for even more protection, it is thought that Svalbard's polar bears will act as ready-made guards.

Speaking in a report by the Guardian Newspaper, London, Cary Fowler (Executive Secretary of the Trust) explained that wars in Iraq and Afghanistan, as well as the 1994 genocide in Rwanda, decimate unique crops resulting in the irreversible loss of that genetic diversity: "You can use the word extinction in this case."

It has been suggested in some reports that the facility will run as a kind of bank, in an effort to mitigate concerns regarding national sovereignty over seeds stored in the vault.

Announced earlier this year, the 30 million kroner project was launched this week by the prime ministers of Norway, Sweden, Denmark, Finland and Iceland, and will start accepting "deposits" in 2007.

The "Eurobarometer" on Biotech

2006-06-21T20:43:00.000Z

European citizens have been characteristically reluctant about the entry of GM food into European agricultural markets. Previous posts have looked at efforts to achieve adequate co-existence regulations ahead of admitting GM food into Europe. However, many have continued to reject the possibility of genuine co-existence of organic, traditional, and GM agriculture in Europe, particularly given the very specific nature of European agricultural practices, where many farms are just a few hectares in size. Despite the efforts towards co-existence on the one hand, complaints of a de facto moratorium on approvals of biotech products in Europe have been brought to the World Trade Organization (WTO) by the United States, Canada and Argentina. The final report of the Dispute Settlement Panel is expected sometime in September this year.

However, this week, a report on the most recent "Eurobarometer" on public attitudes to biotechnology suggests a shift. Prepared for the European Commission's Research Directorate-General (DG Research), the report is based on a survey of 25 000 respondents, undertaken in 2005.

The report concludes that just over half of European citizens are optimistic about biotechnology. Nevertheless, the concerns about GM food remain, with most of those surveyed stating that GM food should not be encouraged. The summary of key findings notes that "resistance to GM food is the exception rather than the rule."

Notably, the increased optimism in biotechnology more widely is largely influenced by a growing confidence in the EU regulation of the technologies. However, the ongoing resistance to GM food suggests that this confidence in regulatory frameworks does not extend to confidence in this area: "The introduction of the new regulations on the commercialisation of GM crops and the labelling of GM food (2001/18/EC) appears to have done little to allay the European public's anxieties about agri-food biotechnology."

Arguably, the very specific nature of agricultural practices, including the important diversity of European agricultural communities and the cultural importance of food, suggests that efforts at co-existence do not seem to be generating confidence in European consumers. Importantly, that lack of confidence is not a sense of alienation from the technology, nor can it be dismissed as merely resistance to the technology and science as such. Indeed, this is borne out by the survey's results in other areas, there being "no evidence that opposition to GM food is a manifestation of a wider disenchantment with science and technology in general."

Rather, public attitudes to GM food in Europe embody very particular issues and concerns specific to farming and food cultures in Europe.

Agbiotech - Does Research Reach Marginalized Farmers?

2006-06-21T10:13:00.000Z

Research and development into agricultural biotechnology (agbiotech) is treated with both support - as an answer to poverty, economic growth, and food security - and suspicion - as a threat to organic and traditional agricultural practices, public health, and symptomatic of policies of denial of information (inadequate labelling, and so on).

However, what is important about a recent publication in AgBioForu m, is the analysis of whether or not the technology and knowledge arising from that research and development is genuinely accessible by and deliverable to marginalised farmers and farmers in developing countries.

The authors are all based at the International Food Policy Research Institute (IFPRI), a research centre of the Consultative Group on International Agricultural Research (CGIAR) concerned in particular with research into food security and agricultural solutions to economic development. David J Spielman (Addis Ababa, Ethiopia) Joel I Cohen (Science, Technology and Education Associates, Potomac, MD) and Patricia Zambrano (Washington DC) argue that public-private research collaboration will be critical in the effort to ensure that agbiotech research benefits developing countries. Of significance is their analysis of the way in which public institutions are isolated in the particular policy and economic context in which this research takes place. Arguably, increased participation of public research in agbiotech would also enhance public capacity in that research.

The importance of public collaboration in research was also recognised by the Union Minister of State for Commerce in India, Jairam Ramesh, in the keynote address at "Agri-biotech Day," Bangalore BIO 2006, earlier this month. Appealing to the industry to "undertake research in the public spirit," Ramesh's comments are of special significance here, highlighting the way in which research cultures can and do benefit from public "investment" in that research - in particular, motivating public interest and a sense of participation.

EU Presidencies Biotechnology Roundtable

2006-06-20T23:08:00.000Z

An EU Biotechnology Policy Roundtable was held in Helsinki today, ahead of the European mid-term review of the Biotech Strategy, expected later this year. Jointly organised by the 2006 EU Presidencies of Austria (outgoing, January-June 2006) and Finland (incoming, July-December 2006), the event follows a Competition Day (competition policy), organised yesterday in Vienna.

In a press release of the co-organisers of the Roundtable, biotechnology was described as a "core part" of the EU Lisbon strategy. Importantly, the Roundtable considered the need for improvements to the regulatory system for biotechnology, as a key factor for approximating predictability in what is a rapidly advancing and often "incomparable" technology and market. Similarly, greater translation of medical biotechnology developments into consumer benefits calls for "closer integration of user interests or the entire health care system into technology development," said Ms Paula Nybergh, Director General for Technology Policy of the Ministry of Trade and Industry in Finland.

Further information is available from:
Chief Counsellor Pekka Lindroos, Ministry of Trade and Industry, Finland, +358 1606 3597 or pekka.lindroos@ktm.fi

European Patent Troubles

2006-06-20T19:57:00.000Z

European innovation has been described as "at risk" in a recent article by Chris Jones, if delays to the introduction of the Community Patent continue.

Measuring "innovation" through patent applications, Europe is filing far fewer applications than the rest of the world. Arguably relevant here, however, is the very nature of European innovation cultures, including the existence of very small enterprises (of just a few people), and the possible lack of access on the part of such small players to the rather expensive investment of patent protection. Therefore, underpinning European policy and legal developments is the cost of the system itself and the need to ensure the diversity of players taking advantage of the system. Indeed, Professor Alain Pompidou, the President of the European Patent Office (EPO), is quoted in the Jones as saying, "The systematic use of patents to protect technical innovations is important if the EU's Lisbon strategy is to be a success. One aim of an effective innovation policy should therefore be to develop patent use among European companies, especially small and medium-sized firms." And in an interview at the end of last year, Pompidou stressed the importance of the patent system in this context: "The EPO has a clear role to play in the innovation process in Europe. By securing the transition from invention to innovation and facilitating access to the market-place, the patent system constitutes the key mechanism for such a transformation process."

Despite this support, the Community Patent has had quite a troubled history. Discussions have continued for other 30 years, and yet the Community Patent Convention (CPC) continues to stall. The most recent version, the Amended CPC (1989), is yet to come into force. On the other hand, the Community Trade Mark and Community Design have proceeded successfully.

In 2000 the European Commission revitalised discussion on the Community patent, on the basis that a European wide patent would be a tremendous advantage to European innovation, and published a proposal for a Council Regulation on the Community Patent. In 2003, the Common Political Approach was agreed, but to date this earlier enthusiasm has become somewhat distracted.

The European Patent Convention (EPC) sets out the legal framework for states to come to special agreements concerning translations, as well as the institution of a central court to enforce the Community patent.

In 2005, the EPO pushed the discussions in the direction of the implementation of the London Agreement, which would allow for EPO States to waive their right under Art 65 ("Translation of the Specification of the European Patent") of the EPC. Art 65 gives a State the right to require a full translation into one of that State's official languages. In other words, the patent must be filed in one of the EPO's official languages (French, English, or German). However, at present, the patent must also be translated into the official language of any State in which it is it be protected. Under the London Agreement, the patent would be protected without translation. Therefore, a patent could be filed in German, and nevertheless protected in France despite no French translation (although it may be that courts would require translation in proceedings).

The London Agreement was lauded as recently as yesterday, in a press release of the EPO, where its adoption was explicitly advocated towards saving European firms up to EUR 500 million each year. However, at this stage, the Agreement is yet to come into force. It will come into force only when 8 signatories - including France, UK, and Germany - have ratified the Agreement. Germany and the UK have ratified the Agreement (a consultation on the ratification process was undertaken by the UK Patent Office in 2004). But its progress is stalled until France does so - which by all accounts seems unlikely.

The European Patent Litigation Agreement (EPLA) is a similar exercise in efficiency, providing for the establishment of a European Patent Court and, thus, greater access to the enforcement process for small companies.

Earlier this year, the Commission launched a consultation on future patent policy in Europe, including the future of the Community Patent. Stakeholders and industry submitted their contributions in April and a public hearing is to be held 12 July 2006 when the results of the consultation will be considered.

Update on Monsanto-Mahyco in India

2006-06-20T09:47:00.000Z

In earlier posts (see June archives, 7 June), the battle between Andhra Pradesh and Monsanto-Mahyco Biotech Ltd (MBBL), the Indian arm of Monsanto, was reported. To re-cap, the government of Andhra Pradesh sought an order from the Monopolies and Restrictive Trade Practices Commission (MRTPC) to lower Monsanto-Mahyco's prices on GM Bt cotton seeds. The MRTPC ordered Monsanto to charge no more than 750 rupees for 450g. Monsanto-Mahyco has appealed to the Supreme Court arguing that the fixing of prices is beyond the powers of the Andhra Pradesh government. However, in an interim order a few weeks ago, the Supreme Court refused to grant a stay of the MRTPC order. A full hearing is to take place 5 July, which will be followed in this discussion here.

Further to this battle, the Andhra Pradesh government hosted a meeting in Hyderabad earlier this month. In attendance were officials from Andhra Pradesh, Madhya Pradesh, Gujarat, Karnataka, Maharashtra, Tamil Nadu, and West Bengal. This meeting produced a common memorandum of understanding to join all states as a party before the MRTPC and Supreme Court of India. The governments of Punjab and Haryana sent letters in their absence, in order to demonstrate their support for the united effort.

An update of events has been published in the Weekly Highlights for India, published by the United States Department of Agriculture (USDA) in a Global Agriculture Information Network (GAIN) report. In that report, it was noted that the state governments have also appealed to the federal government to speak on their behalf before the Supreme Court.

Monsanto is quoted in that report as arguing that prices should be market-driven. This is in response to the questions of Mahyco-Monsanto regarding the marked differences in pricing between India and China, prices being much lower in China. Monsanto has argued that different agricultural practices in China (18 times more seed per acre is required) are also relevant to the market and thus the pricing. According to the GAIN report, "any state intervention would go against the intersts of farmers."

On the other hand, it might also be argued that this kind of intervention is critical to the market. Competition law must be concerned not only with the competition between players, but also with the benefit to consumers and thus to the market itself - one into which new players can enter.

The 5 July hearing promises to be an important development in competition law in India.

BP Joins BIO

2006-06-19T23:10:00.000Z

In a recent press release, the Biotechnology Industry Organization (BIO), announced the new membership of BP (British Petroleum), becoming the first fully integrated energy company to join BIO.

President of BIO, former Republican Pennsylvania Congressman, Jim Greenwo o d, stated: "BP joins a growing list of forward-looking companies in BIO's Industrial and Environmental Section, all of whom recognize the key role industrial biotechnology will play in transforming how we produce fuels and consumer products in teh 21st century."

BIO was founded in 1993 through the merger of two Washington-based biotechnology trade organizations - the Industrial Biotechnology Association (IBA), which represently mostly larger companies before Congress and federal regulatory agencies, and the Association of Biotechnology Companies (ABC), which represented emerging enterprises and academic institutions.

According to its mission statement, BIO aims to be "the champion of biotechnology and the advocate for its member organizations - both large and small." Representing over 1100 biotechnology companies, centres, and other organizations, BIO is a strong lobbying group. BIO advocates strong intellectual property rights and patent protection, and is an accredited observer of the World Intellectual Property Organization (WIPO) attending discussions on various issues, including meetings of the Intergovernmental Committee on Genetic Resources and Intellectual Property, Traditional Knowledge and Folklore (GRTKF).

A full list of BIO members is available from BIO's website.

Biotechnology CEO Awarded MBE

2006-06-19T22:17:00.000Z

The Chief Executive of a biotechnology company specialising in anti-cancer drug development has been recognised in the Queen's Birthday Honours List. Glyn Edwards, Chief Executive of Antisoma, has been recognised as a Member of the Order of the British Empire (MBE), for services to the biotechnology industry.

While at the helm, Glyn Edwards has steered Antisoma through a partnering with Roche. On the potential to risk to biotech through partnering with pharma and the subsequent loss of control, Edwards has suggested that the risk to biotech is mitigated by the investment in longer-term product development: "We think by having this wider, deeper, longer-term relationship covering multiple products we stand more chance of at least one of these products getting to market and being a great success."

The full list of honours is available from the BBC.

US-Malaysia Trade Talks

2006-06-15T09:35:00.000Z

Monday this week, Malaysia and the US began talks towards a new trade agreement, with hopes of concluding the agreement at the end of this year, before the expiration in mid-2007 of the Bush administration's fast-track authority for legislative approval of international deals. In particular, the US is calling for an effective response to intellectual property piracy in the region, particularly trade in unauthorised copies of DVDs and computer software.

In March, the Prime Minister of Malaysia, Abdullah Ahmad Badawi, launched his plans for Malaysia to become the first developed Muslim nation by 2020. However, according to a report in the Financial Times, the Prime Minister is already facing strong political criticism for his economic reforms, making the passage of the US trade talks somewhat resisted. Further, it has been suggested that a US-Malaysia trade agreement would compromise Bumiputra laws, part of Malaysia's policy of affirmative action for ethnic Malays (motivated in part by the 13 May 1969 Chinese-Malay race riots).

The Second Finance Minister, Nor Mohammed Yakcop, has stated that Malaysia will insist on an agreement beneficial to the country, and will not be pressured by the deadline of 2007: "The FTA is an instrument that if it's beneficial for Malaysia, the country would use it; but if it is no longer in its interest, then Malaysia would not agree."

Generic Omnitrope Approved

2006-06-13T10:13:00.000Z

Earlier this month the US Food and Drug Administration (FDA) authorised the recombinant DNA human growth hormone, Omnitrope, a generic competitor for Pfizer's Genitropin. Omnitrope is manufactured by the generic arm of Switzerland's Novartis, Sandoz.

This follows an earlier deferral of a decision on the drug by the FDA in 2004, at which time uncertainty regarding scientific and legal issues was cited although no deficiencies in the application were identified. However, at this same time, the drug was approved by the Australian Therapeutic Goods Administration (TGA). European regulators approved the drug earlier this year, when the European Medicines Agency (EMEA) concluded that the drug exhibited comparable quality, safety, and efficacy to that of the Pfizer reference drug, Genotropin. Sandoz filed a lawsuit against the FDA in late 2005 seeking a ruling on the drug.

The recent approval has been described in the Financial Times as a move closer towards generic competition in biological medicines, although in a article in The Boston Globe is less optimistic, suggesting that the relatively simple case of Omnitrope does not make the process clearer for manufacturers of recent blockbuster biotechnology drugs. In that article, Ken Kaitin, director of the Tufts Centre for the Study of Drug Development, suggests growing pressure upon regulators not only from the companies involved, but also from third-party payers. At the same time, however, pharmaceutical and biotechnology lobbyists are resisting the preparation of guidelines arguing that the complexity of biological drugs makes the approval of generics too complicated. Strong lobbying pressure is coming from the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Biotechnology Industry Organization (BIO).

However, interviewed in that same article, Kathleen Jaeger, Chief Executive of the Generic Pharmaceutical Association (GPhA), regards the ruling as showing that the science supports the development of a clear approval process. To this end, legislative changes by Congress are desirable to accelerate the process. The GPhA is working with various policy makers, including Henry Waxman and Orrin Hatch of the Hatch-Waxman Act, to push for legislation to facilitate the entry of cheaper generic drugs into the market.

Consumer Action Against Biotech Foods

2006-06-09T12:35:00.000Z

The US non-profit and public interest environmental advocacy organisation, the Center for Food Safety (CFS), filed a lawsuit in the US District Court for the District of Columbia this week to compel the US government to impose mandatory labelling and safety reviews of GM foods.

The CFS has been campaigning for testing and labelling requirements for some time. This action follows a history of campaigning on GM foods, including the filing of a legal petition with the Food and Drug Administration (FDA), together with more than 50 consumer and environmental groups, back in 2000. However, the CFS reported that this petition was ignored, as it stepped up its campaign this week. Maintaining that the government should take responsibility for safety tests on GM food, the CFS argues that the FDA should not rely "the very companies that have a financial interest in bringing these biotech crops to market" for an objective and reliable report on the safety of those crops. At present the US does not require independent testing or labelling of GM crops. However, CFS Legal Director, Joseph Mendelson, stated in a Reuters report that this much change: "We think the FDA should be the gatekeeper." He continued that what should be required is "a mandatory process that has rigorous science behind it and public involvement and an actual approval process."

With offices in Washington DC and San Francisco, California, the CFS was established in 1997 by the International Center for Technology Assessment (CTA), to concentrate on campaigns in food production technologies and sustainable alternatives.

The Competition for Science - Private Versus Public?

2006-06-08T10:38:00.000Z

An interesting exchange took place this week in The Times newspaper, in London. Terence Kealey, Vice-Chancellor of Buckingham University, (the only private university in the United Kingdom) argued that private enterprise is not just contributing to scientific innovation, it is essential for it. Referring to 1940 US government spending, he describes little investment in applied science and pure science, with the lion's share going on defence and agriculture. On the other hand, Kealey presents the private sector (and private money) as the only real means by which research and development in pure science was being undertaken.

However, what Kealey doesn't really consider is the innovation within funding and research cultures themselves. While drawing obvious parallels between wartime spending in the 1940s, and US spending priorities today, Kealey criticises the National Science Foundation model, developed by engineer, Vannevar Bush (who also developed the concept of memex, sometimes considered a predecessor of the World Wide Web), where federal funding is distributed to university scientists through competition for grants. In doing so, he refers to Vannevar Bush's warning "that federal money might not just supplement the private money but might, instead, 'drive it out' and end up reducing the total spent on research." To support this statement today, Kealey notes the 2003 Organisation for Economic Co-Operation and Development (OECD) survey to argue that "only private research powers economic growth." That report suggests that public funding of R&D "crowds out resources that could be alternatively used by the private sector, including private R&D."

This seems to be an extraordinary interpretation, suggesting that public funding is somehow rivalrous with the ventures of private interests in a race for "profitable" results. Using the Human Genome Project as his prime example, Kealey argues that this illustrates the point "that science is not the public good of Bush's book. Science is not a field of endeavour on which taxpayers' money need be spent."

In a letter to the newspaper, Dr AR Williamson identifies quite different issues. Indeed, he suggests that scientific research driven purely by private (and thus commercial) concerns might compromise the breadth of that research and the clarity with which it is communicated and disseminated. Also drawing upon the Human Genome Project, Dr Williamson rightly notes it was not merely a question of profitability that motivated greater public investment in the project, in the light of Celera's interests, but the fear that Celera would obtain patents without producing a complete reference sequence.

In other words, Celera would research to the limit of profitability. Public funding, on the other hand, will investigate to the limits of knowledge.

Monsanto Loses Appeal in India

2006-06-07T10:00:00.000Z

The Supreme Court of India, New Delhi, has rejected an appeal by Monsanto against an order by the Monopolies and Restrictive Trade Practices Commission (MRTPC). The Supreme Court upheld the order for Mahyco-Monsanto (Monsanto's division in India) to reduce the price of GM Bt Cotton seeds.

Last month, as reported in The Hindu, the MRTPC granted an injunction against Mahyco-Monsanto, ordering it to charge no more than 750 rupees for 45o g of cotton seeds, after the Andhra Pradesh government, supported by some of the Indian seed companies, argued before the Commission that 900 rupees was an unreasonable price and as such a "restrictive trade practice," where prices are fixed and the monopoly is cartel-like in operation. In fact, Nuziveedu Seeds Ltd, a sub-licensee, was prevented from selling the seed at 800 rupees, and was forced to sell the 450 g packets for more than double, at 1818 rupees. The MRTPC described the prices as "exhorbitant" and ordered Mahyco-Monsanto to fix a reasonable trait value as charged by the parent company, Monsanto, in China.

The Supreme Court decided to hear the petition of the Monsanto against the order, which included, among others, grounds that the MRTPC neglected to stay proceedings while a petition by an NGO was pending before the Andhra Pradesh High Court. The decision has been described as a victory against the "tight grip" of Monsanto on seed prices, while others, such as the Foundation for Biotechnology Awareness and Education (FBAE) see it not in terms of the very real problem of anti-competitive conduct, but rather, problematically dismiss the concerns as "anti-technology."

New Zealand Project on the "Costs" of GM

2006-06-06T10:34:00.000Z

A $4.6 million research project, funded by the Foundation for Research, Science and Technology, has just been announced in New Zealand, examining the environmental impact of new agricultural biotechnologies. According to a report in the New Zealand Herald, the project is responding to a "major knowledge gap" in New Zealand on the impact of GM plants and the like.

The project is proposed to run over 4 years and will benefit from the collaboration of AgResearch, HortResearch and the Institute of Environmental Science and Research. The research will work to mitigate the potential "costs" (financial, environmental, and otherwise) that might be associated with the release of GM plants and other new biotechnologies into the environment before obtaining adequate preparation and information on safety.

But in particular, the research is concerned with the costs of getting new products to market. According to the project head, Travis Glare (AgResearch), it is particularly expensive in New Zealand to get new products through to practical application: "So what we're trying to do is put some tools around that will make the process cheaper in coming up with answers."

Importantly, the project will produce significant outputs to be incorporated into a computer-based network, including a database on pasture and forest-based organisms that might be at risk. The studies will include microscopic ecosystems of microorganisms and invertebrates. According to Glare, the computer system will then allow modelling of potential impacts on the environment to facilitate the processes of applications for GE field trials and to provide information to community groups.

Public concern over GM remains strong in New Zealand, and groups such as GE Free NZ continue to campaign the technologies. At the Brazil meeting of the Conference of the Parties (COP8) to the Convention on Biological Diversity, New Zealand fully supported a consensus agreement on genetic use restriction technologies (GURTS), otherwise commonly known as terminator technology. However, others have criticised the government's public face on GM as disingenuous in the light of offical denial of the existence of the CBD de facto moratorium, in place since 2000 but under fire according to civil society reports.

A Farmer's Innovation: Esteeming Vegetables

2006-06-05T09:14:00.000Z

Described as a "senior citizen" in a report in the Chinese People's Daily Online, Jiang Jiyu is working on restoring productivity to areas of desertification in China. According to the report, the 65 year old former farmer in the port city of Dalian in Liaoning Province, has recently signed an agreement to supply Jerusalem artichokes to restore vegetation in the Inner Mongolia Autonomous Region.

Jiang has been working on Jerusalem artichokes for around 10 years after being shocked by the desertification he saw in a visit to Inner Mongolia. He had noticed that the artichokes could withstand tremendously dry conditions on the beach near his home, and so he proceeded to test the plants under various harsh conditions. In 1999, he returned to Inner Mongolia to plant the artichokes over 80 hectares of land. A subsequent drought killed the existing flowers in the area, but the artichokes survived and produced new tuberous roots. With the help of students, Jiang was able to plant a further 200 hectares.

According to the report, Jiang has had to rely on his own funds to support the research, resulting in serious debts. Nevertheless, he has continued to donate plants to local governments without the finances to purchase them.

An important innovation for desertification, based upon traditional farming practices in China, this case also draws attention to the quality of the reward for Jiang - one of esteem and recognition for his work. The comments of Sir John Sulston at the launch of the Adelphi Charter on Creativity, Innovation and Intellectual Property, are extremely relevant here. During discussion, Sir John remarked that one of the very important aspects of the "reward" for creators is "peer esteem, or indeed esteem in general by people." He went on to explain: "Now of course, scientists in the same way desperately want esteem, although we always pretend that we don't. And the way we get it is by people recognising that we have done something." This esteem is thus achieved through "openness" and dissemination of research - through publishing, through access to that publishing, and through the ongoing exchange of ideas: "the more you give away in a sense ... Then the more esteem you get."

Notwithstanding the critical problems with funding for Jiang, his dedication to the research and the dissemination of the benefits are illustrative of this kind of underlying principle of exchange. Jiang himself explains that it is esteem which is both reward and incentive for his research: "I'll never give up my choice no matter what difficulties occur again as people have recognized my efforts."

Putting Biodiversity in the Bank

2006-06-03T00:47:00.000Z

In an article published in Nature, 1 June, Rex Dalton has reported on a bioprospecting plan for Instituto Nacional de Biodiversidad (INBio), the national biodiversity institute of Costa Rica. The ambitious 5 year project is setting out to catalogue species that may be potential drug candidates, and is to be funded by the United States. The Fogarty International Center at the US National Institutes of Health (NIH) is providing $3.5 million for the new bioprospecting team. Any economic rewards are then to be shared with INBio, which has been facing a funding crisis. The funds are part of the International Cooperative Biodiversity Group (ICBG) projects, which fund projects concerning drug discovery, biodiversity conservation, and sustainable economic growth. The project includes researchers from the University of Michigan, the Broad Institute (Harvard and Massachusetts Institute of Technology) and the Novartis Institutes for Biomedical Research in Cambridge.

In 1989, INBio was established as a private centre for research and biodiversity management, with the ambitious effort to catalogue each and every species in Costa Rica, one of the most mega-biodiverse regions in the world, and to realise sustainable use of that biodiversity. INBio has continued to work as a non-governmental, non-profit, civil society organisation, cooperating with academic and government institutions, as well as industry and other private interests nationally and internationally. In October 2005, in a report in Science Erik Stokstad described the "flagship project" as being "in serious trouble," and that major grants were now simply running out. The report describes the termination of INBio researchers and technicians and the closure of an ecological mapping division, seriously threatening the ability to continue field collecting - a critical aspect of INBio's work.

The new deal with industry is being viewed as a possible answer to the vulnerability of this hugely significant institution. However, the current funding crisis is largely due to the drying up of industry grants offered in the early days of INBio. Merck, for instance, gave grants of more than US$4 000 000, but no major commercial products (or blockbuster drugs) were derived from this and other similar relationships, despite reports that Merck found around 200 substances in preliminary screening. In Dalton's report, one scientist is quoted as saying "I think they bought good public relations with the grants." Thus, the real need for INBio is clear government financial commitment to the centre and its considerable work. Realistically, however, there is a critical need for a substantial endowment - the aim being for US$500 million to preserve Costa Rica's biodiversity.

The significant difference proclaimed by the current project relationship is a commitment to openness about potential new drug candidates, as distinct from the previous partnerships where possibly useful compounds were developed "behind the proprietary walls of corporate science" after the initial access was obtained. In this way, the realisation of any economic value in the compounds was achieved outside the relationship with INBio and thus without any adequate benefit or knowledge sharing in the outcomes.

Notwithstanding the promise of "openness" in the current project, the concern of some INBio scientists is that the motivation to develop products in early trials might be compromised by commercial concerns. In earlier deals, according to Dalton's paper, Bristol-Myers Squibb reportedly identified some potentially useful compounds from insects, but did not pursue these - to INBio's economic detriment.

Nevertheless, despite these concerns and doubts, data from the new bioprospecting project will be made publicly available in a database, ChemBank. Information will include the origin of the compounds, their area and conditions of collection, and possibly also information on early screening tests, leading to what is hoped to be a comprehensive library of 5000-10 000 compounds. Significantly, the database will therefore include material that has been and would be considered proprietary, although its release will be after its research and development. After initial work, Novartis will have to negotiate agreements with INBio to advance material to drug stage, in what could promise to be a significant benefit-sharing consortium.

India's Second "Green Revolution"?

2006-06-02T13:56:00.000Z

Today, an international workshop in Hyderabad, India, will consider ways in which to maximise the contribution of biotechnology towards ensuring food security. The workshop, "Fostering Next Green Revolution - Role of Biotechnology in Advancing Indian Agriculture," will include presentations from US scientists as well as scientists researching in India, according to a report in the newspaper, The Hindu. As well as scientists, delegates are to include farm experts and various stakeholders.

The "Green Revolution" is the term commonly applied to the last 50 years of global agricultural history, gains in food security and reduction in hunger. As such, the term is highly emotive and the attachment of certain farming practices to this language is quite strategic. The Biotechnology industry and other stakeholders attribute much of the Green Revolution to the development of new seeds, fertiliser, and pesticides, as well as associated developments in farm machinery. Unfortunately, this positions much of the important activity in civil society and local and indigenous groups, questioning the gains and raising concerns about biosafety, at the margins. Indeed, such concerns have even been reported as "campaigning to limit advances," according to Borlaug and Carter, writing "Extending the Green Revolution" in the Wall Street Journal in October 2005 - that is, civil society is interpreted and constructed as campaigning against progress rather than campaigning in favour of examination, preparation, and information. Keya Acharya provides a useful report of the concerns in India. In particular, concerns have been raised about the driving of research and development by proprietary and commercial choices (such as the conduct of expensive genetic research on tomatoes rather than food grains), at the "expense" of socio-economic and cultural concerns. This is particularly serious in the number of farmer suicides, largely attributed by Vandana Shi va, Devinder Sharma and others to despair over the high costs (of seed and chemicals) associated with an increasingly commercial articulation of the local agricultural market and practice. In addition, perceived failures at the level of government policy appear to be exacerbating the crisis, and interfering directly with agricultural tradition (such as the support of cash crops like cotton), according to the Frontline Report, Seeds of Suicide. PHOTO: Vandana Shiva

The workshop follows the annoucement of Prime Minister Manmohan Singh at the International Conference on Agriculture for Food, Nutritional Security and Rural Growth to commemorate the birth centenary of Late Dr B P Pal, staged in New Delhi at the end of May. As reported in ZeeNews, the Prime Minister outlined a 7 point strategy for facilitating the second green revolution. Today's workshop is to be inaugurated by Finance Minister K. Rosaiah and chaired by Vice-Chancellor, Acharya N.G. Ranga Agricultural University, S. Raghuvardhan Reddy.

TRIPS and the CBD - Developing Country Proposal on Disclosure Obligations

2006-06-01T13:09:00.000Z

A communication (see WTO Documents, 31 May 2006), at the request of India and also on behalf of Brazil, Pakistan, Peru, Thailand and Tanzania, has been circulated to the WTO General Council and Trade Negotiations Committee, ahead of the June meeting of the WTO TRIPS Council. The Communication refers to discussions that have, to date, developed towards reform of patent law so as to introduce a mandatory requirement for the disclosure of origin of biological resources and traditional knowledge. This requirement would form a part of the procedure towards a grant of patent rights in an invention, based upon such resources.

This communication follows an earlier document, circulated at the request of Bolivia, Cuba, Ecuador, India, Sri Lanka and Thailand for the March 2006 meeting, in which revocation of patent rights was advocated where origin of materials was not adequately disclosed: "The disclosure of source and country of origin are critical tools in the determination of novelty and inventiveness." At the same time, the United States circulated a communication arguing against such disclosure requirements. In that document, the United States shifted the responsibility away from the TRIPS Agreement and what it described as "burdensome remedies" (in the form of possible reform), and placed that responsibility onto individual members and "the lack of clearly defined national systems." However, developing countries and indigenous groups have continued to advocate an international basis for such obligations (as for other obligations under international patent systems) as the only way to ensure cross-border enforcement in the context of otherwise disproportionately imbalanced contractual relationships.

This week's communication refers to the commitment to outstanding implementation issues, as part of the Doha Ministerial Declaration, and states that the relationship between the TRIPS Agreement and the Convention on Biological Diversity (CBD) remains an outstanding issue. In particular, Art 27.3(b) deals with optional exclusions from patentability (at the discretion of member states), "plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes." Art 27.3(b) goes on to provide that members must protect plant varieties "either by patents or by an effective sui generis system or by any combination thereof." Importantly, built into Art 27.3(b) is an obligation to review the provision four years after the date of entry into force of the TRIPS Agreement. To date, many have lamented the torpor of this review process.

The Communication presents a draft Art 29bis, for insertion into the TRIPS Agreement. Following Art 29bis, Disclosure of Origin of Biological Resrouces and/or Associated Traditional Knowledge, where the subject matter of a patent application has derived from or been developed with biological resources and/or associated traditional knowledge, disclosure of the country of origin of biological resources and traditional knowledge would be required as a condition of patentability. This would be in addition to compliance with the national requirements for access and benefit sharing, including prior informed consent and fair and equitable terms.

In interview with IP-Watch, a Thai official described as "sad" the fact that developing countries had to negotiate such a provision 10 years after the negotiation of the TRIPS Agreement, and that it was "unfortunate" that this had not taken place during the Uruguay Round.