In 2012: Are Biotech, Ethics And Biodiversity Friends or Foes?

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With food demand and prices rising as the world crosses the threshold of 7 billion people, the need to find new medicines, concerns about the shrinking biodiversity and the effects of climate change may designate biotechnologies as the main response. Opinions differ on the way to address those issues, in particular about intellectual property rights attached to biotechnologies.

Legislative questions are being discussed on both sides of the Atlantic around the scope of patentability, and intellectual property rights on plants, seeds, molecules or methods, as well as exemptions that some think should be applied. The year ahead will see some decisions that might impact the biotechnology industry both in the United States and in Europe.

Innovation is hailed by most as necessary, but strong intellectual property protection – vehemently defended by industry – is sometimes denounced as hindering further research. Ethical questions are also being asked by civil society and some professionals about the patentability of living organisms, human genes, and the alleged growing weight of industry in multilateral discussions.

Food Sustainability, Climate Change, and Agricultural Innovation

According to Shakeel Bhatti, secretary of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) at the Food and Agriculture Organization of the United Nations (FAO), “one of the biggest challenge to food agriculture is the impact of climate change, in particular for food crops.” In that context, he told Intellectual Property Watch, “it is critical to start working immediately on climate-ready crops because breeding cycles take such a long time. Adaptation of our crops to climate stress is really urgent.”

“The benefit-sharing fund of the treaty is supporting such work,” he added.

Concerns have been voiced by civil society and the United Nations Special Rapporteur on the right to food, Olivier de Schutter, who advocates recourse to agroecology. Of concern are the IP rights attached to engineered crops, higher prices of seeds, farmer reliance on external inputs, and potential loss of biodiversity.

But Bhatti tempered those concerns. “Which technologies are used is a matter of application, or choice; different countries may have different uses,” he said, adding that “the International Seed Treaty has a distinct IP management model applicable to the global gene pool created under the Multilateral System of Access and Benefit-Sharing.”

“In order to enable innovation, which is critical to adaptation, we have to produce new varieties,” he said. The distinctive IP management of the International Seed Treaty does not seek to modify the IP system as such, Bhatti said, as the multilateral system recognises all forms of IP and existing IP practice. But it “sets a number of terms and conditions in which such rights can or cannot be acquired and exercises when it concerns genetic material in the global gene pool.”

“When a restriction for further research, breeding or training is imposed by an IP title, like a patent,” he said, “then there is a mandatory requirement for benefit sharing.”

For Denise Dewar, executive director of plant biotechnology at CropLife International, “innovation in agriculture will be crucial to meeting the needs of a growing world population.” Public funding for agricultural research has declined, she said, “leaving the weight to be carried by industry.”

“It has been essential for the private sector to continue its investment in innovation,” Dewar said. “The industry is committed to helping to develop new crop varieties which allow farmers to sustainably grow diverse, safe, and nutritional foods while preserving natural resources.”

In Europe, Legal Cases, Biotech Directive, Unitary Patent

Ongoing legal cases pertaining to the patentability of conventional plants, discussions about a unitary patent and plant breeders’ exemption are major focuses in biotech this year in Europe.

Still ongoing is what is known as “the tomato case” relating to a patent granted in November 2003 by the European Patent Office to the Israeli Ministry of Agriculture. The patent concerns a “method for breeding tomatoes with reduced water content and on products of that method,” according to the EPO. Unilever filed an opposition on the grounds that the patent did not fulfil certain patentability requirements, and relates to an essentially biological process for the production of plants.

The patent was maintained but without covering the breeding method. In 2006, the patent owner appealed the decision. On 8 November, the Board of Appeal decided to forward the case to the Enlarged Board of Appeal of the EPO. According to Rainer Osterwalder, deputy spokesman for the EPO, “the timing of the case is not clear at this moment.”

For the No Patents on Seeds coalition, in sending the case to the Enlarged Board of Appeal, “the EPO surprisingly followed calls by critics who fundamentally oppose patents on plants and animals. This decision questions the office’s current practice of granting patents on plants and animal derived through traditional breeding methods,” they said in a release.

In the meantime, the German Parliament is supposed to take a decision banning patents on conventionally bred plants, according to François Meienberg of the Berne Declaration. Osterwalder told Intellectual Property Watch that “a motion to that effect has indeed been tabled by an inter-fraction committee uniting MPs [Members of Parliament] of all parties but Die Linke.”

“A plenary vote on the motion could still take place before the summer break, and the government would then be asked to intervene in Brussels in the sense of the motion,” he added.

This decision by the German Parliament in correlation with the initiatives of Dutch, German, and French breeders as well as farmers’ organisations and non-governmental organisations (NGOs), might help to reopen discussion to amend the biotech directive, said Meienberg.

According to the Europa website, the European Parliament and Council Directive of 6 July 1998 on the legal protection of biotechnological invention seeks to clarify “what is patentable and what is not.” In particular, plant and animal varieties, the human body and the simple discovery of one of its elements, and essentially biological processes for the production of plants or animals, are excluded from patentability.

In the Netherlands, “discussions on the protection of IP in the plant breeding sector have been heated” for the past two years, Judith de Roos, legal counsel for Plantum, a prominent Dutch breeders’ association told Intellectual Property Watch. Plantum has been pushing for all commercial varieties to be freely available for further breeding. This is necessary to support continued innovation and secure healthy competition in the market, she said.

“The Dutch government has agreed to establish a limited breeder’s exemption in the national patent law as was done in Germany, France and Switzerland,” she said, and “to promote the inclusion of such exemption in the unitary patent system of the European Union.”

According to de Roos, a “wide range of member states” would support this exemption. A limited exemption, she said, “creates freedom for breeders to use any commercially available variety for further breeding, but licences are needed to commercialise the new varieties when patented components are present in these commercial products.”

The European Commission “recently informed about its intention to publish a new report provided for in Article 16c of the Directive 98/44 on the development and implications of patent law in the field of biotechnology and genetic engineering,” Osterwalder told Intellectual Property Watch, adding that “the Commission already published such a report twice in the past,” in 2002 and in 2005.

The objective of the report, he said, “would be to review important decisions in the field of biotechnology,” such as the Court of Justice of the European Union’s decision on Monsanto, the EPO Board and Enlarged Boards of Appeal decisions on the tomato and broccoli cases, and the patentability of human embryos (Case C-34/10 Oliver Brüstle v. Greenpeace). The report should be published over the summer.

The International Seed Federation (ISF) is “working on revising its position paper on intellectual property,” Marcel Bruins, secretary general of the International Seed Federation told Intellectual Property Watch. “We hope to get it finalised at the next ISF World Seed Congress, in June 2012.” According to Bruins, in the paper “there will be more attention for patents as this has become a more used practice over the last decade.”

The ISF is also working “to raise the bar at patent offices.” The ISF has visited the EPO, the United States Patent and Trademark Office and the Indian Plant Variety Protection Office “to exchange views on IP and the seed industry.” Bruins said the ISF “also feel that there should be rigorous application of the criteria for patentability and governments must provide necessary human resources and skills to patent offices and courts to allow for high quality, fast and cost efficient examination and opposition procedures.”

Also this year, discussions will be ongoing about a European unitary patent. According to the Council of the European Union, on 27 June 2011 [pdf], “the Competitiveness Council agreed on two proposals on the creation of a EU-wide patent title and its language regime.” This unitary patent protection is supposed to reduce costs and stimulate European innovation.

The unitary patent initiative has already provoked reaction from two member states. They have decided to opt out, the Council said (IPW, IP Live, 7 July 2011).

Most of the costs of patenting an invention in Europe come from translation costs and under the new regime “applications will only have to be translated in one of the three working languages – English, German or French – and for a transitional period of 12 months into another language chosen by the applicant.” The texts will have to be discussed and agreed with the European Parliament, the Council said.

Report Sees Industry Pressure on International Negotiations

The ETC group, an international NGO based in Canada and working on sustainable development and supporting “socially responsible developments of technologies”, released a report [pdf] in January saying that “international agencies are having trouble with the ‘public/private’ boundaries.” The report, entitled “The Greed Revolution”, alleges the Food and Agriculture Organization and some centres of the Consultative Group on International Agricultural Research are “adopting private sector culture, under pressure from big foundations,” such as the Bill and Melinda Gates Foundation, and developed country governments.

Meanwhile, they said, trade association lobbyists and agribusinesses, such as Nestlé and Pepsi, “are hiring their own agronomists” to work with farmers in the South “to get the products the companies want and under conditions they dictate.” “They have a new interest in agricultural policy,” it said.

The report presents three cases where the ETC group found conflicts of interest, in particular that the FAO and the CGIAR are “looking the other way as the private sector overrides governments and farmers to commandeer agricultural policy and practice.” One case study is about the International Center for Agricultural Research in Dry Areas (ICARDA) in Syria, a research centre affiliated with the CGIAR. According to the report, in 2009 ICARDA signed a three-year contract with the Mexican beer industry to provide advanced lines of malting barley for assessment in Mexico. The report says that according to the contract, if the industry requests exclusive Mexican rights on any of the transferred barley, ICARDA agrees to withhold distribution of the barley material to any other party in Mexico. It seems that the transfer of barley materials under this agreement was not made under a standard material transfer agreement, which, in ETC’s view is a violation of the International Seed Treaty.

A source at the international treaty said that the treaty secretariat did not have all the facts other than the ones stated in the ETC report. It seemed to the source that if ETC writes to the treaty making a formal notification, an inquiry would be launched about a possible breach of the terms and conditions under the treaty.

The report also recommends that “as a matter of priority, FAO should strengthen the secretariat and financial resources available to the International Treaty on Plant Genetic Resources for Food and Agriculture … in order to promote the availability of genetic resources to address climate change.”

According to one source, “with that recommendation they are basically underlining that the scope of the international treaty governs all plant genetic resources for food and agriculture, and for that governance to be fair and equitable and serve both innovation and the public good, the treaty needs to be further strengthened.”

In the US, Patents on Methods and Genes Still Debated

Issues about the patentability of human genes and methods have been vividly discussed in the US over the last years with some pending legal cases. One of those cases is the Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., lawsuit, filed in May 2009. The last decision on the case was given in July 2011 (IPW, US Policy, 2 August 2011) by the US Court of Appeals for the Federal Circuit.

On 7 December, the Association for Molecular Biology filed a petition for a writ of certiorari [pdf] to the US Court of Appeals for the Federal Circuit in the hope that the case can be heard by the Supreme Court of the United States. The question here is whether or not isolated human genes are patentable

Following this petition, a number of parties supported it, including the National Women’s Health Network et al, Knowledge Ecology International, Kaiser Permanente, the Cancer Council Australia et al, and a group of academics in law, medicine, health policy and clinical genetics.

According to Hans Sauer, deputy general counsel for intellectual property at the US-based Biotechnology Industry Organization (BIO), the lawsuit started with a broad proposition but now the issues are relatively narrow. Myriad already lost its claim on the broadest method, he said. What is really left is on chemical claims, he added.

“A troubling fact is that no discussion about whether the patents would be infringed by genetic testing is happening and this deserves to be explored,” Sauer told Intellectual Property Watch. The so-called “gene patent claims” which are “patent claims on isolated or purified DNA molecules, are typically written to protect high-value commercial applications.”

For example, Sauer added, “in order to transfer a gene into a production cell line to make a recombinant natural protein in a bioreactor, one may need to use a full-length isolated gene. So that’s what’s claimed in the patent.” But, he said, “for a completely different application, such as a diagnostic test, it is not at all clear that one needs to use or make an isolated copy of the whole gene.”

There is a question whether these patents would even be infringed, he said, asserting that, “In actual practice it is not necessary to make a full length BRCA molecule to test patients.”

“This petition could affect all kind of patents on naturally sourced molecules, as the same reasoning could be applied to patents on antibiotic molecules from fungi, or on immunosuppressive molecules from snake venom, etcetera,” he said.

Other legal cases are of interest of the biotechnology industry, such as Mayo Collaborative Services v. Prometheus Laboratories (IPW, US Policy, 13 January 2012), which is more important than Myriad for the biotech industry because its scope is broader. In particular because it affects the use of biomarkers, a biochemical feature that is used to measure the progress of a given disease or the effects of a treatment, according to Sauer.

Two other cases are important for the biotech industry, involving “divided” infringement, where the infringement is brought about by several infringers. The two cases are Akamai Technologies v. Limelight Networks, and McKesson Technologies, Inc. v. Epic Systems Corp., both about method claims, where the court ruled that the defendants did not infringe the claims because the defendants did not perform all of the steps of the claimed method.

Those two cases are currently being considered by the full US Court of Appeals for the Federal Circuit, “which is expected to issue a rare en banc decision sometime in the spring,” according to Sauer. It seems that many observers are expecting these cases will go to the US Supreme Court “because of their great commercial importance to different industries,” including e-commerce.

America Invents Act, US Biotech’s International Efforts

One of the main issues this year for the biotech industry is how the proposed regulations included in the America Invents Act patent reform (IPW, US Policy, 6 December 2011) will be implemented, according to BIO. This implementation requires a lot of work, they said, including input from the user community, so it is likely to be a lengthy process. For example, included in this new legislation are new opposition proceedings that will be created under the America Invents Act, which will be closer to the European proceedings where the European Patent Office is the place where patents can be challenged.

BIO also intends to widen its international presence, according to Lila Feisee, vice president of international affairs. “BIO has received queries from many emerging and developing markets about how to cultivate a robust biotechnology sector,” she said, adding that the BIO International Convention is hosting over 65 countries every year.

“As part of our international advocacy this year, BIO will engage in efforts to explain and demonstrate the various forms of IP necessary to incentivize biotechnology innovation. BIO will explain the role that IP plays in generating investment upstream and the role it plays in protecting investments downstream,” she told Intellectual Property Watch.

“We will highlight the need for strong, consistent and predictable IP protections globally to enable collaborations of all types between key biotechnology stakeholders,” Feisee said. “In addition, we will continue our engagement in multilateral forums such as WIPO [World Intellectual Property Organization] and WHO [World Health Organization] as well as regional forums and discussions.”

Biodiversity, Genetic Resources at WIPO, Nagoya Protocol

According to Wend Wendland, director of the Traditional Knowledge Division at WIPO, in 2012 “IP intersects with biodiversity in at least two ways.” The first relates to “biodiversity-related traditional knowledge, which is currently regarded as ‘public domain’,” he told Intellectual Property Watch. “It is argued by many that the protection of TK would promote biodiversity conservation.”

In the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC), there are two main genetic resources issues, he said. “The first is the proposal that genetic resources should be defensively protected against erroneous patents.” One of the ways to achieve that result is to provide relevant information to patent examiners so that erroneous patents are avoided, Wendland added. An example of this approach is India’s Traditional Knowledge Digital Library (TKDL). Japan also proposes a “one-click” database which would allow examiners to search more efficiently for prior art and related traditional knowledge in the context of genetic resources.

The second IP issue is the broader synergy between the Convention on Biological Diversity (CBD) and intellectual property, and the issue of a proposed mandatory disclosure requirement in patent applications. Proposals currently on the table come from the European Union, Switzerland, the African Group, and a group of Like-Minded Countries.

All proposals will be discussed during the next session of the IGC, which will be devoted to genetic resources, over an eight day period, from 14-22 February. According to Wendland, former chair of the IGC Ambassador Philip Richard Owade of Kenya has prepared a summary of the issues [pdf].

The CBD announced [pdf] on 3 February that 92 countries had signed the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the CBD. The Nagoya Protocol was closed for signature on 1 February 2012, according to the press release.

The Nagoya Protocol will enter into force 90 days after 50 countries ratify it. So far, two countries have ratified the Protocol, according to the CBD.

Catherine Saez may be reached at info@ip-watch.ch.

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