Industry Works To Allay Concerns On Patenting Of Genetic Resources

By William New
Addressing a mixed crowd of private-sector innovation champions and cautious keepers of traditional indigenous ways at the World Intellectual Property Organization (WIPO) last week, biotechnology industry representatives sought to overcome fears of intentional misappropriation.

“We support regimes for benefit sharing,” to ensure local communities receive fair recognition and compensation for their resources, Jacques Gorlin of the American BioIndustry Alliance (ABIA) told the audience. ABIA sponsored the 5 December event alongside the 30 November to 8 December meeting of the WIPO Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Folklore (IGC).

But Gorlin acknowledged that “there is a tension” between the needs of industry and those of governments and local communities, as communities do not always get the appropriate compensation for their resources.

Gorlin’s main message was that access and benefit sharing agreements create certainty for all involved, especially businesses. “Industry can plan for good certainty, it can plan for bad certainty, but it cannot plan for a lack of certainty,” he said.

Meanwhile, representatives from local communities attending the meeting questioned the industry proposals. “One of the biggest concerns indigenous people have is biopiracy, which happens because the intellectual property system is not adequate to protect traditional knowledge,” an indigenous group representative said.

“In particular,” he added, “the patent system is predatory on traditional knowledge.” He said there is a high degree of mistrust. “If we believe biopiracy is not going to stop, how are we going to get involved in access and benefit-sharing arrangements?” There is no case where such an arrangement has provided benefits to indigenous people, he said. Gorlin questioned the definition of biopiracy and the assertions that it happens, but developing countries have been working to get more help on this.

A key point made by community representatives is that their governments may not always have their local interests as the highest priority. “In countries where governments may not even recognise the rights of local communities, it is hard to see how we will benefit” from such arrangements. Therefore, communities hope for additional international protection. But Sauer shot back, “Do you think a treaty will create trust? I don’t know.”

In addition, the industry representatives were vague on the basis for defining benefits. “Sometimes we don’t know the value,” Gorlin said, so negotiations are held on the basis of progress that is achieved. He also said that if the other party lacks the authorisation or experience to negotiate, industry prefers to put someone in between.

Gorlin placed the focus on industry needs. He said that intellectual property is “often a biotech startup’s only asset” and that venture capitalists look at a company’s IP rights portfolio. He said that mandatory disclosure of origin in patent applications would create uncertainty, and that bio-prospecting already is a “roll of the dice.”

USTR Letter of Support for ABIA

ABIA has strongly opposed efforts by key developing countries including Brazil and India to amend the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to require disclosure of origin. Gorlin helped to draft the original TRIPS agreement in the 1990s.

ABIA sent a letter to US Trade Representative Susan Schwab [.pdf] in August applauding the trade office’s “steadfast opposition to developing country proposals that would weaken patent protection for biotechnology inventions” at the WTO, WIPO and the Convention on Biological Diversity.

Schwab replied in a letter [.pdf] dated 30 November, the first day of the IGC, thanking Gorlin. “Be assured that we share your concerns and will remain engaged,” the letter said.

“We have been working hard to counter the efforts of several developing countries, including Brazil and India, which if accepted, could undermine the intellectual property set forth in the TRIPS agreement,” USTR said. “The US has provided several written communications to the WTO laying out our objections to new patent disclosure requirements and describing the potential detrimental impact on the patent system.”

Schwab also said the United States has provided “potential solutions” to the concerns raised by Brazil, India and others. She added, “Despite the current suspension of the WTO Doha negotiations, the United States position on these issues has not changed.”

A Deal You Can Trust

Hans Sauer of the Biotechnology Industry Organization (BIO) said at the meeting that its member companies want a legally binding instrument on “material transfer agreements.” He said agreement-based access and benefit-sharing can provide “upstream” benefits as it will not be necessary to wait for a product to emerge. It also can provide trust in fair dealing by providing a longer-term relationship, and it presupposes that there was prior informed consent of the contracting parties, he added.

Other benefits are the certainty it provides for investors, clear definition of the subject matter being transferred, and affirmation of the autonomy of the provider and custodian of the resource, Sauer said. Furthermore, contracts can become business assets, as rights that may be sold or borrowed against.

BIO has developed voluntary “bioprospecting guidelines” agreed among its 1,300 members. The guidelines create trust for communities and lay the groundwork for exchanges of genetic resources, he said, adding that benefits can be doled out as gains are made in developing viable products with the resources. Compliance with the guidelines would include using the genetic materials only for the agreed purpose, keeping records on handling, arrangements on the involvement of third parties, and a dispute settlement mechanism.

But when pressed by an indigenous group representative in the meeting, Sauer said BIO does not enforce against members who do not abide by the guidelines. As punishment, “We pooh-pooh them,” he said.

Governments have sovereign rights over their resources, Sauer said, arguing that foreign companies unable to determine who has rights over resources should not be faulted. “We prefer to work with the local community, but if not then we will work with whomever has the legal right,” Sauer said.

Sauer said industry requires documents showing where materials come from, and is concerned that the appropriate party receives payment. “Our interest is not to have payments disappear into the [national] treasury but rather into the hands of the community,” he said.

Japan Seeks International Patent Database

Also on the panel, an official from the Japan Patent Office described his government’s efforts to create an international database system for patent examiners. This could reduce problems of erroneously granting patents for materials for which the prior art was not readily available but later became apparent. Nakaya said this could help in instances such as the commonly cited turmeric and neem cases where the patents were granted for traditional products and later cancelled when longstanding use was proven.

“The problem was the patent examiner could not access the prior art,” Nakaya said. “It is difficult to access all the relevant documents in the world,” adding that prior art is sometimes passed down orally.”

Japan favours a “one-stop” type of database system that would access all regional and national databases in one search, Nakaya said. Other improvements might be to make the database available to all examiners; overcome language barriers with brief summaries in every language; allow countries to assess and compile information; and create a glossary of common names of genetic resources, he said.

Nakaya argued against a requirement for the disclosure of origin of genetic material in patent applications, as sought by a number of countries, mostly developing nations, at the World Trade Organization. He said it would not help with erroneously granted patents.

Shakeel Bhatti of WIPO described efforts under the aegis of the IGC to establish an online database of access and benefit-sharing contracts, now on the WIPO website. WIPO also is compiling a survey of related laws expected to be ready any day.

William New may be reached at wnew@ip-watch.ch.