WIPO norm-setting on IP and genetic resources: will impasse on mandatory disclosure and the nature of instrument be resolved?

It is crunch time for WIPO’s Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Folklore (IGC). The 26th session meets from 3-7 February 2014 in Geneva. This week’s session will focus on setting international norms for the protection of genetic resources against misappropriation and resolving two key areas of divergence: 1) the nature of the instrument and 2) the disclosure of origin requirement. Much of this week’s negotiations will take place in informal mode; WIPO observers can listen to the informal negotiations (the audio feed is piped in) but have been requested not to report on the informal proceedings.

The WIPO General Assembly in 2013 charged the Committee with continuing to “expedite its work with open and full engagement, on text-based negotiations with the objective of reaching an agreement on a text(s) of an international legal instrument(s) which will ensure the effective protection of GRs, TK and TCEs. (WIPO/GRTKF/IC/26/4). A cursory review of the negotiating text, Consolidated Document Relating to Intellectual Property and Genetic Resources, reveals a heavily bracketed text.

The Chair of IGC26, Ambassador Wayne McCook (Jamaica) has prepared an Informal Issues Paper on Genetic Resources (this is not a working document) which aims to serve as guide on the current state of play of WIPO discussions on a international instrument for the protection of genetic resources.

The Chair’s informal paper presents the WIPO negotiations on genetic resources (GRs) in the broader context of “relevant international frameworks for regulating access to and benefit sharing” in genetic resources with such instruments as 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 (Nagoya Protocol) and the Convention on Biological Diversity (CBD). The informal paper notes that genetic resources are

differentiated from the two other subjects being dealt with by the IGC: traditional knowledge (TK) and traditional cultural expressions (TCEs). TK and TCEs, which are developed by the human mind, can be considered “intellectual property” suitable for direct protection by an intellectual property (IP) instrument. By contrast, GRs as such are not produced by the human mind and the IP issues that they raise are distinct. However, it should be noted that TK is often (but not always) associated with a genetic resource and linked as “associated TK” (for example, traditional medical knowledge concerning the healing properties of a plant genetic resource).

With respect to the question of what are intellectual property issues associated with genetic resources, the non-paper said,

Inventions based on or developed using GRs may be patentable. Some members are concerned with patents being granted over inventions based on or developed using GRs (and associated TK) without fulfilling the existing patentability requirements of novelty and inventiveness. Some Member States of WIPO consider that defensive protection of GRs should also address applications for IP rights that do not evidence compliance with access and benefit-sharing (ABS) obligations, specifically those related to prior and informed consent (PIC), mutually agreed terms, fair and equitable benefit-sharing, and disclosure of origin.

The Chair singled out two “possible main objectives” in which to regulate the intersection between intellectual property and access and to benefit-sharing in GRs:

– To comply with International/National laws relating to ABS,
– To ensuring that IP offices have appropriate information on GRs and associated TK to make proper and informed decisions in granting IP rights.

The Chair laid out the following suite of options for the Committee to consider:

Databases and other information systems: it has been proposed to create and further develop databases and information systems related to GRs to help patent examiners find relevant prior art and avoid the granting of erroneous patents;

Disclosure requirements: one of the options is to develop disclosure requirements, in other words, provisions which require patent (and perhaps also other IP) applications to show the source or origin of GRs, as well as evidence of PIC and benefit-sharing; Contract: some believe that the issues can be dealt with through suitably drafted contracts, and guidelines for IP-related clauses for such contracts are proposed;

Guidelines or recommendations on defensive protection: for example, guidelines to help guide patent authorities when examining TK or GR-related applications, so as to decrease the likelihood of the grant of patents in respect of inventions that do not fulfill patentability requirements;

Improved classification, search and examination: to help patent examiners find relevant prior art and avoid the granting of erroneous patents, new subclasses were introduced several years ago into the International Patent Classification (the IPC) to facilitate the identification of relevant prior art when dealing with TK-related applications. Furthermore, certain TK journals were accepted as part of non-patent literature for patent examination purposes. These practical steps, taken early on in the life of the IGC, could be revisited and expanded upon.

The Chair highlighted the proposed disclosure requirement as the key challenge in untangling the Gordion knot of the genetic resources negotiations at WIPO:

It seems that the key normative issue is the proposal for a disclosure requirement. This is not to suggest that the other steps are not valuable or necessary: in fact, they may be necessary to complement and implement a disclosure requirement. However, they are practical initiatives that can be undertaken by States and others within existing international legal frameworks.

The Chair identified the following questions that need to be resolved with respect to creating an international norm for a disclosure requirement:

– Subject matter (GRs and associated TK?);
– Nature of the obligation to disclose (mandatory or voluntary? is the obligation ‘substantive’ or ‘formal’?);
– Information to be disclosed (origin/source, proof of legal access, PIC and benefit-sharing?);
– Trigger for disclosure (what relationship or ‘link’ between the GRs (and associated TK) and the claimed invention would trigger a required disclosure);
– Consequence of non-compliance (dismissal or no further processing of a pending application prior to the grant of the right, nullity or unenforceability of a granted patent, or administrative or criminal sanctions outside of the patent system without effect on any granted patent?);
– How would the requirement be implemented, verified and monitored? (for example, through
the PCT/PLT?);
– How would a claim to a right over a GR be attested? – Who would have standing to assert a claim or to initiate an action for non-compliance with a disclosure requirement?;
– How would overlapping claims by several claimants be addressed?;
– What burden would these requirements place on stakeholders and what harm might the requirement pose to stakeholders, if any?;
– Would any forms of compensation for any harm be required?

The Chair tabled the following questions for the IGC to consider in their text-based negotiations for a international instrument for the protection of genetic resources.

– Which issues and options may need to be addressed through international norms in an international legal instrument to be developed at WIPO?

– At what level of detail should these issues and options be regulated, in other words, how much room (policy space) should be left for implementing Member States?

– What working methodology(ies) should the IGC utilize to facilitate the achievement of agreement on these issues and options?

– Which of the proposed solutions that are more practical in nature should be developed and implemented further? How and by whom?