Biotech Industry Fights Disclosure In Patents On Three IP Policy Fronts

For the coming months, key biotechnology industry organisations are focusing their efforts on blocking the addition of disclosure of origin requirements in international patent applications on three fronts.

The issue is being debated in three international fora: the World Trade Organization, the World Intellectual Property Organization and the Convention on Biological Diversity.

Industry is mustering resources to convince governments in each of these bodies not to support proposals to force them to disclose the origin of genetic resources in their patent applications, according to Jacques Gorlin, president of the recently formed American BioIndustry Alliance.

The ABIA is based in Washington, DC, but is active in Geneva, home of the WTO and WIPO. The ABIA is set up as a non-profit, non-governmental organisation advocating for biotechnology patenting and against any amendment of WTO rules to create mandatory disclosure requirements. The group is working to “counter the unprecedented global threat to biotechnology patents in the WTO,” it states. It is the only industry group solely focused on the intellectual property issues facing the biotech industry, according to Gorlin.

Member companies of the ABIA include: Bristol Myers-Squibb, Eli Lilly, Hana Biosciences, General Electric, Merck, Pfizer, Procter & Gamble and Tethys Research.

Gorlin, who is president of the Gorlin Group (a Washington, DC consulting firm), played a key role in the drafting of the 1994 WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as documented in the 2003 book, Private Power, Public Law, by George Washington University professor Susan Sell.

Gorlin was in Geneva to attend a portion of the WIPO open forum on the draft Substantive Patent Law Treaty, which would improve harmonisation of national patent laws. He also met informally with US and other officials while at the WIPO event, as well as with clients in London earlier in the week, and at the International Chamber of Commerce in Paris on Thursday.

At the WTO, the issue of disclosure is being considered in the Doha negotiating round, driven by India and kept alive at the WTO Hong Kong ministerial in December. Disclosure is discussed under the topic of the relationship between WTO rules and the CBD, and is considered an “implementation” issue. The ministerial declaration called for more consultations on the issue, and they are being held until a 31 July deadline.

The next WTO TRIPS Council meeting will be held on 14-15 March, and will address implementation issues including disclosure. On the evening of the 14th, ABIA and the Biotechnology Industry Organisation (BIO) will hold an event for key delegations following the issue in the TRIPS Council, Gorlin said. At the event, business representatives will discuss their concerns and views on intellectual property and biotech, and try to drive home why additional disclosure would be not help developing countries address the problems they are seeking to fix. Developing countries generally are seeking greater benefits for the use of their genetic resources.

“We think industry’s comparative advantage is telling a story,” he said. The message will be: “We are the people who you are depending on to generate commercial benefits. If you do it through the disclosure system, it ain’t gonna happen.”

The problem, he said, is that countries tell industry to patent their products and ideas, but then can take it away, which leads to uncertainty. “Industry is able to plan for good certainty and plan for bad certainty but it cannot plan for uncertainty,” he said.

At WIPO, the issue is discussed in the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC). The European Union and Switzerland have proposals there that industry opposes, and which Gorlin argues would not satisfy India and others who want benefit-sharing schemes linked to patents. The next IGC meeting is 24-28 April.

Europe is considering moving its WIPO proposal to the WTO, according to a source. At the WTO, Europe is looking for ways to move its proposal on the protection of geographical indications, which are products like certain foods named after places.

At the CBD, the disclosure issue made surprising progress at a recent meeting of the access and benefit sharing working group meeting in Granada, Spain, where it adopted three draft documents recommending a new international regime for the use of genetic resources (IPW, Biodiversity, 3 February). The recommendations will be taken up at the next CBD Conference of Parties meeting 20-31 March in Curitiba, Brazil.

Gorlin predicted that the Conference of Parties is likely to continue the mandate of the access and benefit sharing group and have it report back at the next conference in two years. Industry also has been working to win greater support from the CBD, and has been pleased with signs that the new CBD executive secretary is reaching out to industry.

Plan: Work with Friends, India

According to Gorlin, the lobbying strategy for the coming months then becomes bi-level: Maintain the support of friendly countries such as Australia, Canada, Korea, Japan, New Zealand and the United States, and work to soften India’s stance.

“The country that remains an enigma is India,” said Gorlin, because it has a billion-dollar biotechnology industry and yet continues to push for disclosure requirements. “India is not hearing its biotech industry.” The plan is to begin a dialogue with Indian industry, he said.