Info Service on Biodiversity and Traditional Knowledge (Feb14/06)
No consensus on disclosure requirement in genetic resources text
Geneva, 10 February (Alexandra Bhattacharya) – With no consensus on mandatory disclosure requirements, the revised text for a new genetic resources and associated traditional knowledge agreement will now be considered by the General Assembly of the World Intellectual Property (WIPO).
WIPO’s Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) just completed a week’s negotiations on 3-7 February in Geneva. The key normative issue, thus far unresolved, is the creation of a mandatory disclosure requirement to disclose the country of origin and the source of the genetic resource and associated traditional knowledge in intellectual property applications.
(The WIPO General Assembly in 2009 provided the mandate for text-based negotiations to conclude an international legal instrument, which was renewed twice in 2012 and 2013. The IGC’s 2014/2015 biennium authorizes the IGC to hold three sessions in 2014. It is to submit to the 2014 General Assembly the text(s) of the international legal instruments that will ensure the legal protection of genetic resources, traditional knowledge and traditional cultural expressions. The Fifty Second session of the Assembly in 2014 will take stock and consider the progress made on the text(s) and decide on convening a Diplomatic Conference. It will also consider the need for additional meetings, taking into account of the budgetary process.)
The 26th session of the WIPO IGC that finished on 7 February was devoted solely to genetic resources.
The second revision of the text “Consolidated Document Relating to Intellectual Property and Genetic Resources” (Rev. 2) was circulated at 4.30 pm on the last day. It had been prepared by the facilitator, Mr. Ian Goss (Australia) and co-facilitators Chandni Raina (India) and Emmanuel Sackey (Ghana) and was based on the inputs received by Member States during the expert group meetings. Following WIPO procedures, an expert group comprising a maximum of 6 representatives per region worked on the text through the week.
[The first revision of the text Rev.1 had been circulated late afternoon of 5 February. See TWN Info Service on Biodiversity and Traditional Knowledge (Feb14/05) http://www.twnside.org.sg/title2/biotk/2014/btk140205.htm]
The plenary resumed at 5.30 pm and the IGC Chair, Ambassador Wayne McCook (Jamaica) invited comments on the new text. He urged the members to keep their interventions strictly on the revised text and not make any new additional substantive comments at this late stage.
Amb. McCook said that the revised text (Rev.2) as corrected by the plenary interventions would be transmitted to the 2014 WIPO General Assembly which is expected to held in September 2014. There would however, be further discussion on “cross cutting” issues during the 28th session of the IGC which will be held in July 2014.
Facilitator Ian Goss provided an overview of the revised text, noting that that it was now refined to a point “where key positions were clear” but accepting that “we don’t have consensus”.
The key changes in the text (Rev.2), based on inputs received during the Expert Group Meetings, include: (i) a new alternate definition of misappropriation (proposed by the US) and patent offices; (ii) minor edits to preamble; (iii) changes to Policy Objectives including the preambular language; (iv) Article 2 (Scope of the Instrument) includes language on preventing the grant of erroneous patents; (v) changes to the text on the Disclosure Requirement including in 3.1, 3.2 (which introduced language that IP/Patent offices must provide sufficient effective guidance to applicants on how to meet disclosure requirements); (vi) 3.3 reintroduces language on notification procedures; (vii) “Exclusions” from the disclosure requirement has been made a separate article with the heading “Exceptions and Limitations”; (viii) “Relationship with PCT and PLT” and “Sanctions” have been made into separate articles (5 and 6 respectively).
The central issue of whether or not revocation of patents for failure to disclose the origin of genetic resources will be permitted as part of post grant sanctions is yet to be resolved. On (ix), Defensive Measures, Due Diligence has been located differently as a more standalone obligation ;(x) the prior text on the Prevention of the erroneous Grant of Patents and Voluntary Codes of Conduct has been reduced significantly; (xi) changes in Article 10 Relationship with International Agreements is now more focused on principles.
Consistent brackets also remain for options in the text, such as Intellectual Property versus Patent Offices; shall or should, and indigenous people or peoples.
The first intervention was made by Ghana who noted a “dramatically improved product”. It also made comments relating to points of law with regard to the definition of misappropriation. Ghana said that the current text centered on an approach based on utilization or acquisition and did not take in to account the notion of Nemo dat quod non habet which states that thieves do not acquire title to stolen property. Ghana also stated that the exclusion of genetic resources from areas beyond national jurisdiction in 4.1 (e) was redundant as the instrument did not have extra territorial application.
Switzerland requested for the bracketing of “country of origin” in Article 3.1 which related to the disclosure requirement. It also preferred the wording of “human genetic resources” as opposed to all genetic resources taken from humans (including human pathogens) which is found in 4.1(a).
The Tulalip Tribes, speaking for the Indigenous Caucus, referred to the discussion in the Expert Group meetings and noted that with regard to the inclusion of database search systems as part of Defensive Measures, there was need to further elaborate these safeguards. It added that one fundamental safeguard would be the recognition of the right of free prior informed consent. It also requested that the reference to “non secret” traditional knowledge associated with genetic resources be bracketed.
The Chair confirmed that there was a need to further discuss safeguards to the databases and that the view of the Tulalip Tribes would be recorded.
The United States said it would support the further elaboration of safeguards when defensive measures would be discussed again.
Brazil requested that the text consistently refer to “genetic resources [their derivatives] and associated traditional knowledge”. It specifically requested this inclusion in Article 9.1 (a). It said we have better, clearer text. It added that there was a need for a consistent and mutually supportive relationship between IP and the ABS system.
Canada said that it welcomed the new language based on the US proposal under the definition of misappropriation. It added that the last paragraph of the preamble, was it said was based on Article 15.1 of the Convention on Biological Diversity (CBD) should read “natural resources” rather than “biological resources”. It reiterated the view that the separation between ABS (access and benefit sharing) and IPR systems should be maintained. Canada welcomed the facilitators’ note on page 9 of the text which states that “Members should note that some members consider Defensive Measures as an alternative to Disclosure.” Canada was of the opinion that defensive protection in and of itself would provide adequate protection in the IP context. Canada also requested that every instance of “should” in the text be reflected as “should/shall”. This was seconded by the US.
The US also stated that currently paragraphs 7-10 (which deal with Defensive Measures) were not included as Articles. It added that although its preference was not to have Articles in order not to prejudge the outcome but for the sake of consistency Articles should be added before the paragraphs.
South Africa referred to the facilitators’ foot note on page 9 and noted that the word “complementary” should be added to “Members should note that some members consider Defensive Measures as an alternative to Disclosure” in order to fully reflect both sides of the discussion. (This point was also raised by Iran.)
South Africa also referred to the discussion in the Expert Group meeting, noting that there was agreement for a “high principled approach” regarding Database Search Systems (9.2) and WIPO Portal Site (9.3) which fall under Defensive Measures. It noted that during informal consultations four principles had been agreed upon and these had not been captured in the text.
Ian Goss, the facilitator in response said that after talking to the proponent of the texts including US and Japan, it was not possible to condense it completely, and there may still be some redundancy in the text. In particular, the proponents wanted to maintain a linkage between the text and to the Joint Recommendations.
[The two Joint Recommendations include (i) the Joint Recommendation on the Use of Databases for the Defensive Protection of Genetic Resources and Traditional Knowledge associated with Genetic Resources (wipo/grtkf/ic/26/6) by the delegations of Canada, Japan, the Republic of Korea and the US and also (ii) the Joint Recommendation on Genetic Resources and Associated Traditional Knowledge (wipo/grtkf/ic/26/5) by Canada, Japan, Norway, the Republic of Korea and the US.]
India referred to Canada’s intervention and said that the last paragraph of the preamble’s reference to “biological resources” stemmed from the preamble of the CBD and not from its Article 15 as Canada had stated, and therefore “biological resources” was in fact correct.
Iran said that the Definition of Patent Office should rather be titled IP /Patent Office and end with IP/ Patents. It also added that the reference to dispute resolution mechanisms under Sanctions and Remedies (Article 6.1) should not have been deleted. It also reiterated its view that the scope of the instrument should include and cover all forms of IP on all Genetic Resources, their parts and components derivatives and associated traditional knowledge. (“Parts and components” is language referencing the International Treaty on Plant Genetic Resources for Food and Agriculture.)
The EU at the outset said the word “peoples” be placed in brackets, in its entirety, as it relates to some of its members’ constitutional arrangements. It also expressed reservations with the term misappropriation, noting that there was still lack of clear definition. (France has on a number of occasions raised issues with the word “peoples” stating that this conflicted with the indivisibility and equality principle as reflected in the French Constitution.
The EU also requested that the term “associated TK” be bracketed, along with “TK associated with GR”. It also expressed the preference for disclosure requirement to be limited to patent applications.
With regard to the section on the disclosure requirement, the EU said that Article 3.1.b was unclear and asked for it to be bracketed. On para 3.4, the EU said that the practicality of the provision which calls for each party to make the information disclosed to be publicly available at the time of the publication was unclear and should be bracketed for further discussion. The EU did not support Bolivia’s proposal in para.3 .5 which states that genetic resources as found in nature and isolated therefrom shall not be considered as inventions as this extended to substantive patent law, it said.
With regard to sanctions and remedies, EU said that the pre grant sanction in 6.1 a (ii) withdrawal of applications must be in accordance with national law. It also stated that post grant sanction in 6.1(b) (ii) which calls for fines or adequate compensation was outside patent law and should be deleted. It reiterated the need for a ceiling for the instrument stated that “revocation” as found in 6.1(b)(iii) should be deleted as it was a severe penalty. It also said it was general supportive of exclusions, however a full discussion was pending.
Nigeria asked for an “s” in Disclosure Requirement (s) to be placed in brackets as found in the heading of Article 3.
An intervention on behalf of 4 Industry Associations (BIO, IP Owners Association, IFPM, and Croplife International) stated that countering misappropriation in areas of IP could be done with due diligence, not with a disclosure requirement. It added that it supported the CBD and the development of new technology. It noted that legal certainty was necessary for food security and new disclosure requirements would introduce uncertainty and impede R&D investment. This would also undermine benefit sharing.
Towards the end of the session, US noted wanted to discuss the document 26/7 “Proposal for the Terms of Reference for the Study by the WIPO Secretariat on Measures Related to the Avoidance of the Erroneous Grant of Patents and Compliance with Existing Access and Benefit-Sharing Systems”. This was submitted by Canada, Japan, the Republic of Korea, the Russian Federation and the US, with Norway coming on as a new co-sponsor following modifications to the draft TORs.
The US referred to the 2014/15 mandate of the IGC, which stated that members could request studies or provide examples. Referring to the document, it said that this was a resubmitted version of the Terms of Reference for a study on the impacts of disclosure requirements on national legislation which had been initially submitted during the 24th session of the IGC. The US mentioned that it would include this issue on the agenda of IGC 27.
The next session of the IGC (27th) is expected to be held from March 24 to April 4, 2014 where the focus of the negotiations will be on an instrument on Traditional Knowledge followed by Traditional Cultural Expressions. It will also include discussions of cross cutting issues for these two clusters.