Year Ahead In IP, Biotech, Biodiversity: A Trio Fuelling Debates, Opportunities In 2013

The coming year promises to be very interesting at the intersection of intellectual property with biotechnology and biodiversity. Patentability of human genes in the United States, of conventionally bred plants in Europe, plant breeders’ rights and the management of regulatory authorisations when patents on genetic traits expire, the future of genetically modified organisms in developing countries, and the usual resistance they are meeting from civil society and famers’ groups are some of the issues that will continue to feed debates – and potentially create opportunities – in 2013.

One of the questions that will keep legislators and lawyers busy this year is that of patentability. In the United States, the patentability of human genes is still in question with the Association for Molecular v. Myriad Genetics. At the heart of the matter are two genes, BRCA1 and BRCA2, in which mutations can increase the risk of breast and ovarian cancers (IPW, Public Health, 21 December 2012).

The case should be heard by the Supreme Court sometime in the course of the summer, according to Robert Cook-Deegan, director of the Center for Genome Ethics, Law & Policy at Duke University. The Supreme Court will address the patentability of human genes. The last documents from Myriad are due on 7 March, Cook-Deegan said.

“As a practical matter, the decision probably does not have huge implications for biotech patents,” he told Intellectual Property Watch, but the matter will be different if the Supreme Court finds a difference between discoveries and inventions. “That would require a body of jurisprudence to develop, and would reverse the stream of increasingly broad subject matter interpretation for the past several decades,” he said.

Patent law in the field of biotechnology continues to be discussed in the European Union. In particular, the European Commission has decided to set up an expert group to examine the implications of patent law in the field of biotechnology and genetic engineering, according to a November decision [pdf]. This working group is expected to provide “high-quality legal and technical expertise” to the Commission “with its reporting obligations under the Biotechnology Directive,” according to the decision.

The group is expected to be composed of a maximum of 15 experts to be chosen from a roster of candidates having responded to an open call for applications that ended on 12 December. The information about the experts and the work plan of the expert group is expected to be posted on the DG MARKT web page.

At the European Patent Office, a decision should be made by the Enlarged Board of Appeal concerning the long standing so-called “tomato case II” (IPW, Briefs, 13 June 2013). The questions put to the Enlarged Board of Appeal refer to the exceptions to patentability. A number of amicus curiae briefs have been submitted by stakeholders. A decision could have consequences on future patent applications on plants bred by an essentially biological process.

According to an EPO official, there is currently no indication when the decision will be taken by the Enlarged Board of Appeal. “This will certainly also be of importance for all other cases pending in that same area, notably the parallel ‘broccoli case’,” he told Intellectual Property Watch. The broccoli case is about a patent awarded on a breeding method for conventional broccoli, increasing the level of a “potentially anticarcinogenic” substance in broccoli plants, according to the EPO.

In the tomato case, the large-scale agriculture industry holds the view that “patents should be allowed on products obtained from essentially biological processes,” Denise Dewar, executive director of plant biotech for CropLife International, told Intellectual Property Watch. “Patent protection for plants obtained from essentially biological processes should continue and be assessed on their own merit.”

Key in the United States is the so-called Bowman case pending before the US Supreme Court, which is expected to take a stance on when IP rights are exhausted. In the case of Bowman v. Monsanto Co, the issue is the use by a farmer of second generation of soybeans on which Monsanto has a patent (IPW, Education/R&D/Innovation, 11 January 2013).

Dewar said that CropLife “strongly believes that the US Supreme Court must confirm the judgment of the Federal Circuit which balances the right of the patentee to preserve the exclusivity conferred by a patent versus the right of a consumer to freely enjoy the use of a patented article that is the subject of an authorised sale.”

Expiring GMO patents are raising regulatory issues as a number of patents on GMOs will expire in the coming years and the question of the maintenance of regulatory obligations will have to be addressed if the products are to be kept on the market.

In the US, the Biotechnology Industry Organization (BIO), along with the American Seed Trade Association (ASTA), developed a framework called “the Accord” which aims to provide for the transition of global regulatory responsibilities and authorisations for patented traits after the patents expire.

The framework is articulated around two initiatives, one called the Generic Event Marketability and Access Agreement (GEEMA), and the other the Data Use and Compensation Agreement (DUCA), which is expected to open for signature in 2013 (IPW, Biodiversity/Genetic Resources/Biotech, 5 February 2013). Members of the GEEMA are currently BASF Plant Science, Bayer CropScience, Dow AgroSciences, Dupont Pioneer, and Monsanto.

Separately, the Food and Agriculture Organization of the United Nations (FAO) organised an e-conference from 5 November to 2 December on “GMOs in the pipeline.” According to contributions from participants, a considerable number of new GMOs are likely to be released in developing countries in the next five years. This is particularly the case in the crop sector but also in areas such as fish, insects and trees.

According to the summary of the e-conference, some countries have strong GMO programmes, such as Brazil, China, India and Iran, in which the public sector is playing a key role (IPW, Biodiversity/Genetic Resources/Biotech, 4 February 2013).

Patents or Plant Variety Protection

In January, biotech company Syngenta launched e-licensing platform TraitAbility to broaden availability to some of its patented traits and technologies for vegetables (IPW, Education/R&D/Innovation, 18 January 2013).

According to François Meienberg of the Berne Declaration, a Swiss NGO opposed to patents on life forms, “we see clearly two poles in the discussion about patents on seeds.”

On the one hand, the large seed and pesticide companies such as Monsanto, Syngenta, Bayer, and ASF, are lobbying for the patentability of plants derived from conventional breeding, he said. On the other hand, some breeders associations, farmers’ organisations, non-governmental organisations, and the European Parliament argue that there should be no patents on conventionally bred plants, Meienberg told Intellectual Property Watch.

With the new e-licensing platform from Syngenta, breeders will have a facilitated access to patented material but will still “have to pay licence fees based on highly disputed patents,” Meienberg said. The approach consisting of denying patents on conventional plants “is a much better way to secure access to genetic resources, the basis for further breeding,” he said.

Plant variety protection is “free, non-bureaucratic and it has proven to be a well-functioning system for innovation for the last 50 years,” he added.

According to CropLife, “since PVP rights only protect a new plant variety as a whole, but do not protect a specific trait or essential genetic element, CropLife International strongly believes an effective patent system is needed in addition to plant variety protection rights,” since they have different objectives, Dewar told Intellectual Property Watch.

In Europe, she said, “effective protection of biotech patents is provided by the Biotech Patent Directive,” which protects “genes and individual phenotypic traits of a plant, while PVP legislation protects the unique combination of genes expressed as a distinct, uniform and stable phenotype.”

According to Marcel Bruins, secretary general of the International Seed Federation, which adopted a new position paper [pdf] on IP in 2012, several initiatives, including the GEEMA and Syngenta’s TraitAbility, will unfold in 2013, and aim toward the same target to enable access to protect germplasm. This comes in response to growing concerns about access to patented traits in the past years in the seed industry, and the private sector “is taking its responsibility” in building initiatives to provide access, he told Intellectual Property Watch.

Others initiatives are being set up, he said, such as the European Seed Association (ESA) working on a database providing information on the patent status of plant varieties commercialised in Europe, according to ESA [pdf]. The ISF thinks both plant variety protection and patents are useful to the seed industry and is calling on governments to introduce a breeders’ exemption in their patent law, in order to ensure balance between access and protection.

Meanwhile, plant variety protection is meeting resistance in some developing countries. For example, in Africa and Latin America, discussions arose in 2012 that will lead to further developments in 2013 (IPW, Biodiversity/Genetic Resources/Biotech, 4 February 2013).

The African Regional Intellectual Property Organization (ARIPO) has proposed a draft regional harmonised policy and legal framework on plant variety protection based on the International Union for the Protection of New Varieties of Plants (UPOV) Convention of 1991, and has met resistance from a number of African civil society organisations.

They were concerned about potential adverse consequences for small-scale farmers, as well as for food security, agricultural biodiversity, and national sovereignty. ARIPO decided to hold national and regional consultations in 2013, opening the draft policy for further examination and revisions, according to Mariam Mayet, director of the African Centre for Biosafety.

In Colombia, the Constitutional Court declared [php in Spanish] unconstitutional UPOV 91 in December, according to a Colombian lawyer. In particular, the court found that indigenous and afro-Colombian peoples had not been consulted before the approval of Act 1518 of 2012. According to the source, the government is expected to start a process of consultation with indigenous and afro-Colombian peoples in 2013.

Banning Biopiracy at WIPO

The World Intellectual Property Organization held the 23rd session of Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, from 4-8 February. After an intense drafting exercise on protection of genetic resources, delegates produced a text that is expected to be sent to the General Assembly in autumn. Main issues remain open, such as the nature of the instrument(s), whether it will be legally binding or not, and whether or not it should include a mandatory disclosure of the source of genetic resources in patent applications (IPW, WIPO, 8 February 2013).

In April, the 24th session will focus on traditional knowledge, while the 25th session in July will meet for eight days, a longer session than usual. They will address traditional cultural expressions for five days and during the remaining three days, delegates will be expected to take stock of the progress made on the draft texts to make a recommendation to the General Assembly, which will take place from 23 September – 2 October.

The General Assembly will then decide on convening a diplomatic conference, out of which could presumably come one or more treaties, or lesser instruments. Developing countries are advocating for a diplomatic conference in 2014.

EU Resolution

Meanwhile, during a plenary session on development and cooperation on 15 January, members of the European Parliament adopted a resolution stating that the European Union “must combat ‘biopiracy’ of multinationals that exploit plants with medicinal properties and traditional remedies originating from developing countries but fail to share the profits with indigenous peoples,” according to a press release.

The resolution was adopted by a show of hands, said the release, which defined biopiracy as “the practice of patenting and marketing the use of traditional knowledge and genetic resources of indigenous peoples without authorization from source countries.” The resolution says biopiracy can “impede the economic progress of developing countries and runs counter to EU development policy goals.” The author of the resolution is Catherine Grèze, from the French Green Party.

“Existing intellectual property law can even have adverse effects, as it assesses traditional knowledge solely from a mercantile point of view,” said the MEPs, who advocated the disclosure of origin of genetic resources and traditional knowledge used in inventions in patent applications, according to the release. “The EU should not push developing countries into trade agreements that entail far-reaching intellectual property standards,” and should “help developing countries to build legal and institutional mechanisms and understand patent application systems.”

Nagoya Protocol

Separately, countries are ratifying the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (CBD). According to a 28 January press release, South Africa became the 12th country to ratify the Nagoya Protocol on 10 January. The country joins Ethiopia, Fiji, Gabon, India, Jordan, Lao, Mauritius, Mexico, Panama, Rwanda and the Seychelles. The protocol will enter into force on the 90th day after the 50th ratification. At the date of the closure of signature, on 1 February 2012, 92 parties had signed the protocol.

According to the release, Braulio Ferreira de Souza Dias, executive secretary to the CBD said, “We are firmly on track for entry into force in time for the Twelfth meeting of the Conference of the Parties to the Convention on Biological Diversity.” The meeting is scheduled to take place in South Korea in autumn 2014.

Other countries are working on the ratification of the protocol, such as the European Union, Switzerland, Denmark, Japan, and Norway.

A proposal [pdf] for a regulation of the European Parliament and of the Council to implement the Nagoya Protocol in the European Union and enable its ratification was issued in October 2012. According to Joe Hennon, spokesperson for Environment Commissioner Janez Potocnik at the European Commission, since October, both the Council and European Parliament have started examining the draft regulation in view of its adoption. “Several meetings had already taken place within the Council Working Party on Environment and several others are planned for the next few months,” he told Intellectual Property Watch.

The European Parliament is also working on the draft proposal with a view to obtain a first vote in the Committee on the Environment, Public Health and Food Safety (ENVI) in July 2013. “The Commission is aiming to get the Regulation adopted by June-July 2014,” he said.

Consultations were also carried out in May 2012 in Switzerland with the aim of ratifying the protocol.

In another development, the second Indian Biodiversity Congress, gathering scientists, conservationists, environmentalists, civil society groups and local communities, which took place in December in Bangalore, produced a list of recommendations, among which is a review and reform of the IP rights regime. In particular, the congress said, “Life, life forms, and the traditional knowledge and practices associated with biological diversity are kept totally out of its purview, and should not be subject to any IP rights.” According to the recommendations, this had been addressed by “a few amendments to the Patents Law,” but it needs to be explicitly enacted in all other IP rights policies and laws.

In addition, the congress advocated the mandatory disclosure of genetic resources and traditional knowledge in patent applications. The recommendations also ask that GM crops not be incorporated in India’s food security and farming system, and that “as a precautionary measure, there should be a ten year moratorium on Bt food crops.”