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

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.

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.

Rice Patents - An Obstacle to Research

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 concerned 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 Rice). 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.