WIPO Genetic Resources Text Compiles Differences, Heads To General Assembly

Despite spending a week in mostly closed, informal discussions, the World Intellectual Property Organization committee working on the protection of genetic resources, got little closer to breaching the opposing viewpoints. Members managed to produce a draft text – with signs of steps toward a middle ground – that they say can serve as a basis for further discussion on the development of an international instrument preventing wrongful patents.

On the last day of the 26th session of the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC), a second revision [pdf] of the document relating to intellectual property and genetic resources was issued. The IGC met from 3-7 February.

Draft decisions [pdf] of the session were issued and approved by member states at the close of the session. The second revision of the text will be sent to the annual WIPO General Assembly in September “subject to any agreed adjustments or modifications arising on cross-cutting issues” at the 28th session of the IGC in July 2014.

Experts from countries, working in small groups, helped by facilitators and a friend the chair, Ian Goss of Australia, had been trying to produce a text reflecting all points of view. A first revision of the original text was published on 5 February (IPW, WIPO, 6 February 2014).

The second revision shows substantial structural changes, mainly because paragraphs and articles have been rearranged, but also because of textual changes. The text contains tentative articles of a potential international instrument destined to protect genetic resources from misappropriation, in particular from wrongful patenting.

The text reflects elements that appear diametrically opposed, demonstrating that strong positions remain. A major dissenting point is whether or not patent applicants should be required to provide information about the origin of the generic material they have used or on which they are seeking claims. This mandatory disclosure requirement is, for a large proportion of developing countries, and some developed countries, a key in the process, and would prevent a number of biopiracy cases.

Some developed countries contend that this obligation might create disincentives for innovation, put an additional burden on patent offices, and might not be an effective tool to fight the erroneous granting of patents.

Misappropriation, Scope

The definition of misappropriation is also under debate. In the second revision of the document, an alternative definition was suggested by the United States, which includes a negative definition of the term. It states: “Use of genetic resources and associated traditional knowledge that has been acquired by lawful means, such as reading publications, purchase, independent discovery, reverse engineering, and inadvertent disclosure resulting from the holders of genetic resources and associated traditional knowledge failure to take reasonable protective measures, is not misappropriation.”

This definition is of concern to developing countries, and works contrary to the objectives of the work of the IGC, developing country sources said.

Article 2 (scope of instrument) is also substantially longer in the second revision of the text. It now states that the instrument is meant to “support the prevention of misappropriation” of genetic resources through the patent system but also “to prevent the patenting of genetic resources and associated traditional knowledge that were not invented by the patent applicant or patentee or do not have an inventive step over genetic resources and traditional knowledge associated with genetic resources.” This too is of concern to developing countries, according to sources.

To Disclose or Not to Disclose?

Article 3 (disclosure requirement) indicates dispositions to be applied for disclosure, and Article 5 lists sanctions and remedies. One of the post-grant sanctions proposed is the possible revocation of a patent, which is opposed by some developed countries. The European Union, for example, said on the final day that the revocation is a strong penalty and might run counter to the policy objective of the instrument being developed by the IGC. If a patent is revoked, the EU representative said, the invention will go into the public domain and the opportunities for benefit-sharing will be reduced.

The text also includes a section that has not been presented as articles. The section titled “no new disclosure requirement” is introduced by a paragraph which is now longer in the second version of the text and states that, “Patent applicants may only be required to state where the genetic resource can be obtained if that location is necessary for a person skilled in the art to carry out the invention. Therefore no disclosure requirements can be imposed upon patent applicants or patentees for patents related to genetic resources and associated traditional knowledge, for reasons other than those related to novelty, inventive step, industrial applicability or enablement.”

The section includes a set of defensive measures, in which language from two joint recommendations put forward by some developed countries has been inserted. The second version of the document collapsed some of those paragraphs which had duplicative content.

A footnote to the part on defensive measures indicates that some members consider defensive measures as an alternative option for disclosure. In plenary on the final day, several developing countries underlined that they view those defensive measures, such as databases, as complementary measures to mandatory disclosure.

The text is heavily bracketed, indicating differences on all sections of the document. Some brackets apply throughout the text, such as around “derivatives” of genetic resources. Derivatives are naturally occurring biochemical compounds resulting from the genetic expression or metabolism of biological or genetic resources, according to the list of terms of the document.

This issue was also heavily debated in the context of the adoption of 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 (IPW, United Nations, 26 October 2010).

France against Reference to Indigenous “Peoples”

A recurring issue has been raised by France about the use of “peoples” to refer to Indigenous Peoples in the text. The French Constitution, issued from the French Revolution, the French representative argued, says that all French people, without any distinction between their origin or their race, are considered to be French and are not defined by ethnicity, origins, or any other criteria. The delegate asked that the word peoples be bracketed.

A representative of Indigenous Peoples remarked that the recognition of the terms was agreed upon in several international instruments, such as the International Labour Organization Convention 169 “Indigenous and Tribal Peoples Convention” of 1989. The Convention has been ratified by 22 countries, not by France. The United Nations Declaration on the rights of indigenous peoples, he said, was voted by 143 countries, including France. He said collective rights of Indigenous Peoples are a vital subject to them. France did not respond to these remarks.

Industry against Mandatory Disclosure

A range of developed country industry groups that could be affected by the changes, including the Biotechnology Industry Organization, Intellectual Property Owners Association, International Federation of Pharmaceutical Manufacturers Association, and CropLife International, issued a joint statement against mandatory disclosure.

“New mandatory requirements for patent disclosure will introduce significant legal uncertainty into the patent system which impedes investment into research and development of innovative agricultural, biopharmaceutical and environmental products and technologies,” they said.

“As such developments are capable of generating benefits, these types of requirements would undermine benefit-sharing by disincentivising this innovation and would therefore run counter to the objectives of the CBD [Convention on Biological Diversity]. Furthermore, industry remains unconvinced that the patent system is the appropriate tool to achieve benefit-sharing,” said a representative for the group.

Industry, she said, is favourable to enhancing the ability of IP offices to prevent the erroneous grant of patents or other IP rights, and share the objective to ensure appropriate access to genetic resources and equitable benefit sharing.

A side event to the IGC this week presented a number of possible cases of biopiracy and the results of a study showing that three-quarters of international patent applicants do not disclose the origin of the genetic material they used (IPW, WIPO, 7 February 2014).

Facilitator Goss described the 26th session of the IGC as “the most cooperative and positive meeting … with much sharing of knowledge and ideas.” Several sources, however, considered that discussions were still in a deadlock over key aspects of the future instrument.

The next session of the IGC will take place from 24 March to 4 April, and will address traditional knowledge and traditional cultural expressions.