WIPO Members Agree New Text On IP And Genetic Resources; Move Talks Forward

World Intellectual Property Organization members negotiating for an instrument to protect against theft of genetic resources last week agreed on a new text with more options on legal terms, effectively moving the talks forward. In this round of talks, the African Group showed signs of moving off its position of revoking patents for violators, while the United States came out strongly against disclosure of origin at the expense of amiable relations with key allies.

The 30th session of the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) took place from 30 May – 3 June.

The IGC agreed on the draft decisions [pdf] on 3 June, allowing a text which is more representative of differences in goals for protecting genetic resources than consensus, to be moved forward for further discussion.

According to the IGC Chair Ian Goss, general manager of Continuous Improvement Projects at IP Australia, core issues remain: the scope of the instrument or the regime (in particular whether it should apply to patents or to other IP instruments); the utilisation of GR; the sanctions to be applied in case of non-compliance; and the mandatory disclosure requirement.

New Text: Clear Layout of Positions

The second revision [pdf] of the consolidated document on which delegates started to work at the beginning of the week was released on 3 June.

The new revision shows a variety of options on basic legal terms such as “traditional knowledge associated with genetic resources”, “biotechnology”, “Country of Origin” or “Country Providing Genetic Resources”, “Derivative”, “Directly Based On”, “Ex Situ Conservation”, “Genetic Material”, “Genetic Resources”, “In Situ Conditions”, “Misappropriation”, “Physical Access”, “Source”, “Unauthorized Use”, and “Utilization”.

The latest revision came after a first revision [pdf] issued on 1 June, which some delegations said they could not accept, in particular because the text as revised seemed to widen the gaps between country positions rather than reducing them, so did not meet the mandate of the IGC. It also was rejected because some delegations, such as the United States, introduced a number of textual proposals verbally, which were included without preliminary discussions with other members.

In the corridor, countries seemed resigned and some told Intellectual Property Watch that they would go along with the text because it reflected enough of their positions and they would take time to reflect upon it until it is next addressed by the committee. They said the week’s work helped clarify the differences in positions, by having clear options.

The first revision of the consolidated text did not meet the approval of some member states. The second text took into account all comments made by member states on the first revision, but was based on the consolidated text from which the delegates started working at the beginning of the week.

The new text clearly sets out alternatives on positions.

A number of changes can be noted in the new text, for example, in the list of terms, there are now two options to describe traditional knowledge associated with genetic resources.

One of them says TK associated with GR is a knowledge which is dynamic and evolving, generated in a traditional context, collectively preserved and transmitted from generation to generation.

The second option said it means substantive knowledge of the properties and uses of GRs which directly leads to a claimed invention and where, but for the TK, the invention would not have been made.

The second definition appears to imply that the instrument would only apply to GR in the case of an invention.

Both options carry a number of bracketed words, indicating the lack of consensus.

A new term is also being described: “Invention directly based on.” The text explains that the invention must make immediate use of the GR, and depend on the specific properties of the resource of which the inventor must have had physical access. There again, a number of brackets pepper the text.

An additional option has been added to the term “utilisation”. The first one describes utilisation of GRs while conducting research and development on GRs. The second option includes the notion of making a new product, or a new method of use or manufacturing of a product. The whole second option is bracketed.

In the first revision of the document, a definition of “protected genetic resources” had been added by the United States, stating that protected genetic resources means GRs that are protected either pursuant to an IP right or other legal right. Once IP rights in a GR expire, the GR should be in the public domain and not treated as a protected GR.

The second revision of the text does not include this paragraph, as underlined by the US, which requested that it be put back in the text.

The preamble of the potential treaty now has a number of new additions, in particular a mention that the instrument should contribute to the prevention of misappropriation of GR, their derivatives and TK associated with GR (with brackets), and also an alternative section which introduces several paragraphs. One of those paragraphs acknowledges “the important economic, scientific, cultural, and commercial value” of GR and TK associated with GR, and another reaffirms “the important contribution of the patent system to scientific research, scientific development, innovation and economic development.” Both additions were made on the request of the US.

The text has also been arranged according to a different frame, with general headings in addition to articles for more clarity, which was welcomed by delegates.

The two facilitators, Margo Bagley of Mozambique and Emelia Hernandez of Mexico, tasked with collecting members’ comments and reflecting them in succeeding revisions of the text also provided in that second revision a full alternative to articles 1 to 5 (Objectives, Subject matter, Mandatory disclosure, Exceptions and limitations, and Sanctions and remedies) under the heading “no new disclosure requirement.”

They said this was to provide more clarity to the text and try and reduce gaps, and that it reflects the text provided by the US. For example, in this alternative, the objective of the instrument would be to prevent the grant of patent rights on inventions that are not novel, non-obvious, and industrially applicable.

Commenting the new text on 3 June, the US said that under this heading, some paragraphs of what now is an alternative to Article 3 did not belong with the no-disclosure requirement and should be placed back under the general Article 3 (Disclosure requirement). One of the paragraphs says that failure to examine a patent application in a timely manner should result in an adjustment of the term of the granted patent to compensate the patentee for delays, and applicants should be provided an opportunity to correct any incorrect or erroneous disclosures.

Earlier in the week, the facilitators had noted that this provision was not limited to delays caused by a disclosure requirement, but would require term extensions for all examination delays, and expand the scope of the agreement to address issues beyond the disclosure requirement. [corrected]

A number of countries said the text was acceptable for further discussion, would be analysed by experts in their capitals, and that they would come back with comments at a later stage.

Drawing Lines

Late in the week, the United States tabled a diplomatically questionable document that hypothetically applied Switzerland’s legislation on mandatory disclosure of origin of genetic resources in patent applications to a US patent on pharmaceuticals, showing a possible negative effect. This was admonished by Switzerland, which said it was not consulted on the matter and that it contained errors, supported by several countries. (See related story.)

Separately, last week’s decision on agenda item 7, which was added late to the draft decisions, reads as follows: “the Committee developed on the basis of document WIPO/GRTKF/IC/30/4 [pdf] a second revision of the consolidated document relating to intellectual property and genetic resources. The Committed decided that this text as of the close of the session on June 3rd 2016 be transmitted to the 34th session to the Committee, in accordance with the Committee’s mandate for 2016/2017 and the programme for work for 2017 as contained in document WIPO/GA/47/19.”

Positions have been quite clear for years at the IGC. Developing countries are pushing for an international binding instruments with strict compliance measures, including a mandatory disclosure of the origin of genetic resources in patent applications. Some developing countries would like the possibility of revoking patents in case of non-compliance, for example.

Some developed countries such as Switzerland, Australia, New Zealand and Norway have been supportive of an international solution to the issue of genetic resources misappropriation. Switzerland and Norway, for example, have legislation requesting disclosure of genetic resources.

Some other developed countries, such as Canada, the United States, Japan, and South Korea have been reluctant to agree to an international protection of genetic resources, in favour of lighter sanctions in case of non-compliance, and opposed the idea of a mandatory disclosure requirement. They have said in the past that an international instrument should not impede innovation and should not place an additional burden on patent applicants and patent offices.

Most developed countries oppose the revocation of patents in case of non-compliance of the international rules that would be developed by the IGC.

Indigenous peoples, who are the main holders of GRs and associated TK, have been asking that the protection of genetic resources be tailored to the particular nature of such knowledge and have said that the patent system might not answer to that particularity.

Shifting Positions

However, the sands seemed to be shifting last week. According to some developing sources, the African Group gave ground on issues, such as the revocation of patents when patent owners failed to disclose the origin of genetic resources used in the invention, much to the discontent of other developing countries, such as members of the Asia and Pacific Group.

According to a member of the African Group, the group is seeking a way out of years of fruitless discussion by recognising that some issues have very little chance of being resolved, such as the revocation of patents, which even IGC members favourable to mandatory disclosure would not be able to agree on, such as the European Union.

Prior to the IGC session, on 24-25 May, the African Group organised a roundtable [pdf] at WIPO titled, “Towards a Consensus Text on Intellectual Property, Genetic Resources, Traditional Knowledge and Traditional Cultural Expressions,” with the same aim at trying to narrow differences on several issues, according to a source (IPW, WIPO, 30 May 2016).