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

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."

Seeded Players - Corporate Control in Agricultural Research

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

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's Blooms and Booms

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.

Can you repeat that? Genetic technology and IP

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.

DR-CAFTA - Extension to Patent Term

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 Chomsky (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."