The Year Ahead In Biotechnology And Intellectual Property

The year 2016 promises to be rich in debates on plant patenting, protection of genetic resources and traditional knowledge, and biopharmaceuticals. Here are some key issues and dates to watch for.

In Europe, a number of patents on conventional plants are expected to be challenged, mainly by competitors, according to the European Patent Office. Meanwhile, the International Plant Treaty will continue the quest for a sustainable funding scheme, and discussions will resume on genetic resources and traditional knowledge at the World Intellectual Property Organization.

Under attack by several stakeholders about the unaffordability of new drugs, the biotechnology industry issued new principles on values of biopharmaceuticals at the beginning of the year. The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits, whose reach is growing, raised questions at the World Health Organization on pathogens in January, and the International Union on the Protection of New Varieties of Plants (UPOV) will be working on easier ways for breeders to deposit applications in member countries.

EPO: Challenges to Patents on Conventional Plants

According to a European Patent Office official, 2016 should see challenges to a number of patents on conventional plants, much like the patent held by Monsanto on virus-resistant melons, which was revoked by the EPO in January (IPW, Biodiversity/Genetic Resources/Biotech, 22 January 2016).

“There was a sort of blocking of the cases in waiting for the decision on of the Supreme Judiciary, on whether or not to grant claims on essentially biological methods,” Rainer Osterwalder, EPO spokesperson told Intellectual Property Watch. He was referring to the decision taken in April 2015 on cases involving tomatoes and broccoli (IPW, Biodiversity/Genetic Resources/Biotech, 1 April 2015).

Over 300 cases are currently in the pipeline on which no decision has been taken yet, he added. A lot of patents in biotech granted in 2003 and 2004 are under opposition now, mainly by competitors, and it is still uncertain how many will remain standing, he said.

On 17 December, the European Parliament took a non-legislative resolution saying that “a ban on the patenting of products obtained by conventional breeding techniques, such as crossing, is essential to sustain innovation, food security and small businesses,” according to a EU Parliament press release.

The Parliament resolution came after the decision on the tomato and broccoli cases. Members of Parliament called for the EU Commission “to clarify existing EU rules [and in particular the EU’s Biotech Directive 98/44/EC] as a matter of urgency and protect plant breeders’ access to biological material,” according to the release.

Osterwalder said the EPO is merely implementing the law that was handed down to them by their member states, particularly the EU Patent Convention.

“The ball is now in the hands of the [EU] member states, and also in the hands of the member states of the EPO,” he added. “Should they agree that the law needs to be changed and bring such change in the law….we will of course implement it.”

Osterwalder also mentioned the European Unitary Patent entering into force. “We have a situation where there is an exemption for breeders,” he said. “The legislator has already included an element that is softening the effect of patents.”

CBD, Nagoya Protocol Takes Ground, WHO Questions

According to a UN Convention on Biological Diversity (CBD) press release [pdf], the Nagoya Protocol is expected to reach “milestone 100 ratifications in 2016.” The ratification now stands at 70.

In 2016, the International Development Law Organization and the secretariat of the CBD are expected to hold capacity building courses “aimed at equipping national policy-makers and legislators to develop legal frameworks on Access and Benefit-Sharing (ABS).”

The courses “will introduce participants to the core requirements of the Nagoya Protocol, key considerations for the design and implementation of ABS frameworks, and the different approaches to ABS based on country experiences and best practices.”

The implementation of the Nagoya Protocol was recently brought to the attention of the WHO Executive Board by the United Kingdom and the Netherlands, and Board members asked WHO to look at how the implementation of the protocol could affect the sharing of pathogens samples around the world (IPW, WHO, 26 January 2016).

Discussions on Genetic Resources, TK, Resume at WIPO

After a one-year hiatus, the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) is resuming its work in 2016. The committee has been working for several years on a potential treaty or several treaties protecting genetic resources, traditional knowledge and traditional cultural expressions from misappropriation.

The revised schedule for 2016 is available here [pdf].

The 29th session of the IGC will take place from 15-19 February. This session is expected to focus on the protection of genetic resources, and the proposed theme to be tackled during this session are to undertake negotiations on genetic resources (GRs) “with a focus on addressing unresolved issues and considering options for a draft legal instrument,” and “elaborate an indicative list of outstanding/pending issues to be tackled/solved at the next session on GRs.”

The 30th session of the IGC, expected to take place from 30 May-3 June will also focus on generic resources and will be preceded by a seminar on Intellectual Property and Genetic Resources on 26-27 May.

The 31th session of the IGC is scheduled for 19-23 September, with a focus on traditional knowledge, and the 32nd session is expected to take place from 28 November-2 December.

UPOV: Electronic Applications, Cooperation

The International Union for the Protection of New Varieties of Plants (UPOV) is working on separate initiatives to help its members to file applications in member countries. The organisation also has planned a seminar in October on propagating and harvested material in the context of the UPOV Convention, according to Peter Button, UPOV’s vice secretary-general.

The full calendar of UPOV events in 2016 is available here.

The October seminar is organised for information-sharing purposes, Button said. UPOV is also planning on improving the usability of its website, and on working on a project to develop an electronic application form for breeders, he said, to facilitate applications with different members.

UPOV will continue discussion about an international system of cooperation, he said, although members have not yet agreed to start work on exploring such a system.

Separately, the International Plant Treaty is expected to make a presentation to UPOV members in March 2016 on possible areas of interrelations between the two organisations, he said.

[Note: an IP-Watch in-depth look at UPOV priorities will follow shortly.]

Plant Treaty: Funding, Collaborations with Other UN Agencies

According to the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA)’s secretariat, three main areas of development are expected in 2016: the revision of the material transfer agreement for sharing of genetic material, farmers’ rights, and a global information system.

In particular, a dedicated working group is expected to provide for a subscription system and a draft revised standard material transfer agreement (SMTA) to answer to the chronic lack of funding of the treaty.

The funding of the system has been met by country contributions in the past.

On farmers’ rights, which are included in the treaty, the secretariat is planning for a Global Consultation on Farmers’ Rights in collaboration with Indonesia, which is expected to host it, and the support of Norway.

The Plant Treaty is also working on a Global Information System (GLIS).

[Note: An IP-Watch in-depth look at Plant Treaty priorities will follow shortly.]

FAO Focus Hunger, Climate Change, SDGs

FAO’s priorities for the coming years will include the eradication of hunger and addressing climate change, according to Silvano Sofia, partnerships & communications officer for the FAO Geneva office.

“For FAO, it will be crucial to ensure that agriculture, and food security and nutrition remain high on the global agenda, highlighting their key role in driving progress toward the SDGs [United Nations Sustainable Development Goals],” he said.

Five regional conferences are expected to take place in 2016, beginning with Mexico in February, Malaysia in March, Côte d’Ivoire and Lebanon in April and a regional conference for Europe in Turkey in May.

According to Sofia, the UN Standing Committee on Nutrition has been relocated from the WHO in Geneva to the FAO in Rome, “reaffirming the Organization’s leading role and focus on nutrition.”

On 27 January, the FAO launched the Global Nutrition Report 2015: Actions and accountability to advance nutrition and sustainable development in Geneva. At the launch, Corinna Hawkes, co-chair of the Global Nutrition Report and professor at London City University, said the role of the report is to hold multilateral institutions, governments, donors and businesses accountable for achieving the targets they have set and how they take action.

BIO’s New Principles on Values of Biopharmaceuticals

On 4 February, the Biotechnology Innovation Organization (BIO) released new Principles on the Value of Biopharmaceuticals. According to BIO’s press release, those voluntary principles “represent the first-ever systemic, industry-endorsed set of commitments by research-based biopharmaceutical companies to support comprehensive and sustainable solutions to improve patient access to and affordability of innovative medicines that are transforming how we treat and cure patients with once-devastating diseases.”

“Among other principles, BIO members are committed to open dialogue with patients, healthcare providers, and payers on the value of their biopharmaceutical innovations and to take these stakeholders’ views into account in the development and delivery of such cures and treatments,” said the release.

According to BIO, the organisation will work with stakeholders and policymakers “to explore a broad range of novel delivery approaches to maximize the value of these innovations for patients and the overall healthcare system, including by seeking to remove legal barriers that currently limit the ability to engage in value-based contracting and communications.”

Biopharmaceuticals are often considered to be the future of medicines, but their high prices has sparked a debate on accessibility, even in developed countries.

“As evidenced by these Principles, the research-based biopharmaceutical industry welcomes the vigorous public debate about the cost and value of our medical innovations,” BIO President and CEO Jim Greenwood said in the release.

BIO’s International Convention will take place on 6-9 June in San Francisco, and the 13th Annual World Congress on Industrial Biotechnology is scheduled to take place in San Diego on 17-20 April.

Separately, the International Seed Federation’s World Seed Congress is expected to take place in Punta del Este, Uruguay, on 15-18 May.