WIPO IGC30: Questions remain on protection of genetic resources as hard decisions postponed until 2017

By Sophia Simon

Friday, 3 June 2016 marked the end of the 30th session of the Intergovernmental Committee (IGC) on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (GRTKF). In the heart of the World Intellectual Property Organization (WIPO) in Geneva, delegates deliberated for five days on a potential draft of a legally binding international instrument to protect Genetic Resources (GRs). Following the work which began in 29th session of the IGC (February/March 2016) in which member states also focused on GRs, during IGC 30, the Committee agreed to transmit the consolidated working document on genetic resource to IGC 34 (June/July 2017) after which it will be presented to the 2017 WIPO General Assembly. However, the submitted working text remains heavily disputed and a is a long way from being adopted as an international treaty.

The first day of the conference, members discussed key definitions and concepts in the working document (WIPO/GRTKF/IC/30/4). The main issue at hand was whether or not mandatory disclosure of GRs should be required in patent applications, and if so, the form it would take. A proposed alternative to mandatory disclosure, seen by many members as complementary, is the use of databases and other preventive measures to reduce the granting of erroneous patents. Other issues which were touched upon included mandatory disclosure requirements, defensive measures, the instrument’s subject matter, “derivatives” of GRs, sanctions, and how these could apply to inventions using GRs.

Informal deliberations took place the second and third days, and on Wednesday evening, the committee reconvened in plenary, during which Margo Bagley (Mozambique), a facilitator, introduced the first revision of the consolidated text. After reviewing two hundred pages of transcript, the facilitators endeavored their best to account for all member states’ interventions, while simultaneously aiming to simplify and clarify the text by “narrowing existing gaps” among members.

Although the list of terms included in the working document is not part of the substantive text, it was one of the week’s hottest debate topics. Explicit and comprehensive terms are vital as they define what an instrument may or may not apply to. In the first revision, changes to the terms list included the deletion of “Associated Traditional Knowledge” and “Internationally Recognized Certificate of Compliance,” along with the insertion of “Directly Based Upon,” “Unauthorized Use,” “Source of Associated Traditional Knowledge,” and “Protected Genetic Resources.” Another significant change was the inclusion of a comprehensive alternative to Articles 3, 4, and 5, a “No New Disclosure Requirement.” Other sections of the text continued to be highly bracketed, demonstrating the divergence of opinions.

Despite the efforts of the facilitators, many members expressed disappointment with the first revision. Bolivia, Peru, Chile, Brazil, Colombia, and Nigeria argued that some of the supplementary text had not been sufficiently discussed before being incorporated. Additionally, some member states noted that the text was more complex than the previous version (Brazil, Nigeria, India) while the EU took a contradictory stance, thanking the facilitators for their clarity.

Regardless of the already highly contested nature of the consolidated text, the US proposed to bracket all of the facilitators’ new language and interventions, along with all of articles 1 and 5, while the EU suggested bracketing all policy objectives. Other member states also added brackets, giving facilitators an even greater burden before the second revision.

Emilia Hernandez (Mexico), another facilitator, presented the second revised text on Friday, 3 June 2016. The policy objectives and subject matter were considerably shortened, reflecting the goals to simplify the text, while an alternative objective was provided courtesy of the EU. The most disputed issues related to objectives and subject matter included whether or not to keep the term “derivatives” in the text, along with the phrase “misappropriation of GRs.” No consensus was reached on these terms, so the decision remains in the air. The most significant change in the second revision was an alternative to Articles 1, 2, 3, 4, and 5, copied below, which would not require patent applicants to disclose use of Genetic Resources (GRs):

[ALTERNATIVES TO ARTICLES 1, 2, 3, 4 & 5
NO NEW DISCLOSURE REQUIREMENT]

[ARTICLE 1]
[OBJECTIVE]

1 [The objective of this instrument is to prevent the grant of patent rights on inventions that are not novel, non-obvious, and industrially applicable.]

ALT
[ARTICLE 2]
[SUBJECT MATTER]
2 [This instrument shall/should apply to patent applications for inventions directly based on genetic resources, and traditional knowledge associated with genetic resources.]

ALT
[ARTICLE 3]
[NO NEW DISCLOSURE REQUIREMENT
3.1 [IP] [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, [their derivatives] and [traditional knowledge associated with genetic resources], for reasons other than those related to novelty, inventive step, industrial applicability or enablement.]

3.2 [Where the subject matter of an invention is made using genetic resources obtained from an entity having a legal right over the genetic resource [(including a patent owner)], that entity may in the permit agreement or license granting the applicant access to the genetic resource or the right to use the genetic resource, require a patent applicant to:

(a) include within the specification of a patent application and any patent issuing thereon a statement specifying that the invention was made using the genetic resource and other relevant information, and
(b) obtain consent for uses not encompassed within the permit agreement or license.]

3.3 [Patent offices shall/should publish the entire disclosure of the patent on the Internet, on the date of the patent grant and shall/should strive to make the contents of the patent application publicly accessible over the Internet as well.]

3.4 [Where access to a genetic resource or traditional knowledge associated with genetic resources is not necessary to make or use the invention, information regarding the source or origin of genetic resource or the traditional knowledge associated with the genetic resource[1] can be provided at any time after the filing date of the application.]

3.5 [Failure to examine a patent application in a timely manner shall/should result in an adjustment of the term of the granted patent to compensate the patentee for delays. Applicants shall/should be provided an opportunity to correct any incorrect or erroneous disclosures.]

Azerbaijan opened the discussion on the second revision, noting that the term “erroneous” is not a legal term and should be replaced by “patents that do not meet the requirements.”

The delegations of Chile, the EU (supported by Latvia on behalf of CEBS), Canada, and Bolivia pointed out missing brackets in different articles. Additionally, Chile remarked that the new preamble lacked clarity and proposed bracketing “protected GR,” a term which the US proposed.

The US delegation rejected moving the definition of “Protected GR” and “Source of Associated TK” into footnotes. Furthermore, the delegation highlighted discrepancies in subject matter and policy objectives from different pages of the text, which could be consolidated. They also reserved the right to reintroduce deleted text which may not have been agreed upon or discussed sufficiently by members, as did the EU.

Many points of confusion were isolated in the text. Bolivia indicated that the former text gave the impression of being a new proposal due to poor organization, while Peru highlighted ambiguity in Article 7.2 (c) regarding patent offices’ access of databases, which they commented should be filtered and safeguarded before any traditional knowledge can enter the public domain. The representative of the Tulalip Tribes reiterated the importance of safeguards in databases to ensure that information remains confidential. Furthermore, the Republic of Korea underscored the lack of clarity in the objectives contained in Article 1, questioning whether or not they are applicable to the articles on mandatory disclosure, defensive measures, or no new disclosure.

Even though they urged the importance of narrowing gaps in the articles on disclosure, the Indonesian delegation mentioned that the second revision provided a good basis to move forward. Guatemala, Egypt, Colombia, Latvia and Nigeria shared this view, expressing positive feedback on the text and welcoming it as a basis for further discussions.

The IGC culminated by adopting the agenda and the report of the twenty-ninth session, as well as accrediting 6 organizations as ad hoc observers. They also noted the reports from the seminars on intellectual property and GRs of May 26-27, and the documents encouraging members to contribute to the WIPO Voluntary Fund for Accredited Indigenous and Local Communities to increase indigenous and local community (ILC) representation. Regarding “Agenda Item 7: Genetic Resources,” which was the consolidated text subject to discussion, the IGC decided:

GENETIC RESOURCES

The Committee developed, on the basis of document WIPO/GRTKF/IC/30/4, a “Second Revision of the Consolidated Document Relating to Intellectual Property and Genetic Resources”. The Committee decided that this text, as at the close of the session on June 3, 2016, be transmitted to the Thirty-Fourth session of the Committee, in accordance with the Committee’s mandate for 2016-2017 and the work program for 2017, as contained in document WO/GA/47/19.”

It seems as though the IGC has delayed the ongoing debate regarding the adoption of any international instrument until their 34th session in the summer of 2017. One might perceive this as a setback in progress. Upon closer inspection, one might say the IGC has met their initial goal of “considering options for a draft legal instrument,” although it is doubtful whether the other objective of “narrowing existing gaps” has been reached. Even without reading the many alternative articles and phrases which were proposed, just one glance at the many brackets in the text make it clear that significant divisions remain.

One of the goals of IGC 34, when GRs will be next addressed, is to convene a stocktaking session and make a recommendation to the WIPO General Assembly. The General Assembly in 2017 will be tasked to “stock of and consider the text(s), progress made, and decide on whether to convene a diplomatic conference or continue negotiations.” Consequently, it remains to be seen whether further consensus will emerge by the time the WIPO General Assembly convenes in September 2017.

Decisions:
http://www.wipo.int/edocs/mdocs/tk/en/wipo_grtkf_ic_30/wipo_grtkf_ic_30_decisions.pdf

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