GM and Europe

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.

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

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 of 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 Consultation 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)

TRIPS and the CBD - Developing Country Proposal on Disclosure Obligations

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.

TK on the Hong Kong Table

At the World Trade Organization (WTO) Ministerial Conference in Hong Kong, HE Mr Kamal Nath, Indian Minister of Commerce and Industry, delivered a significant Statement from India, emphasising the centrality of development to the Sixth Session.

The concern raised by some members and NGOs in various international arenas is that development has been rendered a marginal issue in many circumstances, rather than understood as integral to the international trading environment. For instance, many expressed disappointment at the dismantling of the Permanent Committee on Cooperation on Development relating to Intellectual Property (PCIPD) within WIPO, with discussions on development to occur through a provisional committee instead. This was interpreted as a lost opportunity to recognise and articulate the relationship between these questions and "core" developments.

India, in the Statement to the Ministerial Conference, critically set out development as inextricable from the global trading system itself. Furthermore, the Statement identified the asymmetry between the TRIPS perspective on intellectual activities (as articulated through private IPRs) and the intellectual heritage and traditional knowledge (TK) of communities, and the ongoing prlblems with biopiracy and the misappropriation of TK. Specifically, and in a very important and significant way, the Statement calls for the Hong Kong Ministerial to facilitate ongoing considerations of the relationship between intellectual property rights and biodiversity (through the relationship between TRIPS and the Convention on Biological Diversity, CBD). As India states, "A Development Round has no credibility in the absence of substantial benefits for the weakest members of the WTO ... if the content of this Round only perpetuates the inequities of global trade, then it will be no Round."

TRIPS Council Talks - Decision or Distraction?

Today, the WTO reconvened intellectual property talks ahead of the forthcoming December ministerial in Hong Kong. Of particular interest to the Patenting Lives project is that the talks considered the patentability of life forms and the review of the exception to optional patenting of plants and animals, found in Article 27.3(b) of the TRIPS Agreement. Related to the question of patents on life are proposals to require mandatory disclosure of origin in patent applications (particularly relevant to community autonomy with respect to its genetic resources, medicinal knowledge, and other forms of traditional knowledge) and the protection of traditional knowledge and folklore.

In today's discussions, a decision was reached on the extension of the transition period for least-developed countries (LDCs) for implementation of the TRIPS Agreement. This is significant with respect to patents, and the impact on local and traditional communities of patents incorporating traditional knowledge as well as the socio-cultural impact of life patents on diverse communities and indigenous groups. The members decided to grant an extension until 1 July 2013, with reference to trade marks, copyright, patents, and other forms of intellectual property covered by the TRIPS Agreement. The decision on paragraph 6 of Doha (with respect to patents for pharmaceutical products) is not affected and the extension until 2016 for LDCs remains in place.

This is a significant decision in that it extends the transition period by a further 7.5 years. However, in granting an extension, the immediate problems and questions regarding the broader implications of an ultimately global system remain under-examined and indeed are effectively deferred. It may even be suggested that an increasingly global coverage of bilateral trade agreements and "contractual" law-making will make the implementation by this deadline almost redundant. Indeed, the decision states that if LDCs voluntarily provide intellectual property protection (as, for example, in bilateral agreements), then TRIPS provisions on non-discrimination must be observed and the countries "have promised not to reduce or withdraw the current protection they give."