In a move which appears to have been motivated by the desire for redress, countries possessing traditional knowledge (TK) and genetic resources (GR) proposed an internationally binding legal instrument for the protection of these. The countries were mainly developing countries. This occurred more than 20 years ago. An arduous process of negotiations and many IGC meetings at WIPO followed. Initially positive progress was made, at least in the field of understanding TK and GR’s better and the aspirations of the countries wanting protection for their TK and GR’s. In view of the complexities relating to TK and GR’s slow progress was made to coming to any agreement on the protection of TK’s and GR’s. At one stage it looked like the efforts at the IGC would come to nought. However, during covid, in a politically well executed manoeuvre, developing countries managed to secure a Diplomatic Conference to negotiate and agree on a treaty relating to TK and GR’s. This has resulted in the recently adopted WIPO Treaty On Intellectual Property, Genetic Resources And Associated Traditional Knowledge.
Seen at a high level, and with this background, the treaty represents a very much watered-down version of the initial aspirations. The objectives in Article 1 are stated as to (a) enhance the efficacy, transparency and quality of the patent system with regard to genetic resources and traditional knowledge associated with traditional knowledge, and (b) preventing patents from being granted erroneously that are not novel or inventive with regard to genetic resources and traditional knowledge. It essentially provides an obligation on patentees to disclose the source of TK or GR where the claimed invention is based on these. Provision is made for correcting disclosures where the information provided is incorrect and the consequences for mistakes thus not dire. Only in the case of fraud is the patent application liable to revocation.
The treaty is not retroactive and thus only needs to be considered going forward. It is, of course, only applicable to patent applications filed in contracting states, and it is to be expected that major jurisdictions such as the United States and Japan will not become contracting states.
In short, the terms of the treaty are not very onerous and are in line with FICPI resolutions on this issue.
The Treaty
Rowan Joseph attended the WIPO Diplomatic Conference on Genetic Resources and Associated Traditional Knowledge (DipCon) held in Geneva May 13-24, 2024 on behalf of FICPI.
This was a historic event in that it resulted in the WIPO Treaty On Intellectual Property, Genetic Resources And Associated Traditional Knowledge which represented the culmination of more than 20 years of negotiations.
The treaty itself is quite fair and the terms fall within Resolutions which FICPI passed in 2004 and 2023. The nub of the treaty is that an applicant for a patent must disclose the source of the GR or TK if the GR or TK forms part of the claimed invention (Art 3), to enhance the quality of patents and so that patents are not erroneously issued where they are based on TK or (known) GR (Art 1). The idea behind this appears to be that it will enable identification of the “ownership” of the GR or TK. This should be seen in the light of potential benefit sharing with Indigenous Peoples or local communities. This idea surfaced in previous meetings of the IGC but does not appear in the Treaty, probably because it is dealt with under the Nagoya Protocol.
A further aim of the Treaty is to be able to properly assess the patentability of the invention, particularly through databases of TK and GR.
What follows is a more detailed look at some of the important articles of the treaty.
The Trigger – Art 2
The Trigger
The so-called “trigger” to disclosure is to be found in the List of Terms (Art 2) read with Art 3. The Chair’s Text, on which negotiations were based, proposed disclosure in terms of Art 3 where “the claimed invention in a patent application is [materially/directly] based on GRs”.
Arts 3.1 and 3.2 were accepted to commence “Where the claimed invention in a patent application is based on genetic resources / traditional knowledge associated with genetic resources”.
In terms of Art 2, “Based on” means that “the genetic resources and/or traditional knowledge associated with genetic resources must have been necessary for the claimed invention, and that the claimed invention must depend on the specific properties of the genetic resources and/or on the traditional knowledge associated with genetic resources.”
The trigger appears clear and capable of practical application, especially by patent offices where this determination is invariably to be made.
“Genetic material” is also defined in Art 2 and interestingly does not specify digital sequence information (DSI).
Disclosure Requirement – Art 3
Disclosure is one of the key provisions and is dealt with in Art 3. GR and TK are dealt with individually but in the same manner.
For GR, an applicant for a patent which is based on GR is required to disclose:
(a) the country of origin of the GR; or
(b) the source of the GR if the country of origin is unknown to it.
Similarly, for TK an applicant for a patent which is based on TK is required to disclose:
(a) the Indigenous Peoples or local community which provided the TK; or
(b) the source of the TK if the Indigenous Peoples or local community is unknown to it.
A declaration is required to be submitted where none of the information is known to the applicant. Also, an opportunity to correct erroneous or incorrect disclosures in patent applications must be provided.
As indicated, these requirements are clear and do not appear to be overly onerous.
Former Art 4, which provided for Contracting Parties to adopt exceptions and limitations to the disclosure requirements to protect public interest, was eventually deleted. This article had been viewed with suspicion by many of the States and Indigenous Peoples groups, and as a potential loophole to circumvent this Treaty.
Retroactivity – Art 4
FICPI’s 2024 Resolution encouraged non-retroactivity to be calculated from the date of a Contracting Party’s accession. Art 4 of the Treaty appears to be consistent with this. It provides that obligations shall not be imposed on patent applications filed before the “entry into force of this Treaty with regards to that Contracting Party”.
Art 17 provides that the Treaty “shall enter into force” three months after 15 eligible parties have deposited their instruments of ratification or accession, and Art 18 provides that the Treaty “shall bind other eligible parties” three months after depositing their instruments of ratification or accession (in terms of Art 13).
The language chosen for Art 4 thus appears somewhat inconsistent as the Treaty will in most cases “come into force” before a Contracting Party “becomes bound” by it (as it must be assumed that many states will only join later).
The Treaty may thus affect applications filed after Treaty comes into force but before a state becomes party to the Treaty.
Remedies – Art 5
In terms of FICPI’s resolutions, “failure to comply properly with the declaration requirements, and regulate that the consequence of any ultimate failure to meet such requirements shall not, in the absence of fraudulent intent, be invalidation or unenforceability of the patent.”
An opportunity to rectify a failure to disclose must be provided (Art 5.2) unless there has been “fraudulent conduct or intent” (Art 5.2(bis)). And a Contracting Party shall not “revoke, invalidate, or render unenforceable the conferred patent rights solely on the basis of an applicant’s failure to disclose” (Art 5.3) unless there has been “fraudulent intent” (Art 5.4).
The provisions of the Treaty are thus in line with FICPI’s stance and should not be overly onerous to patent applicants.
Information Systems – Art 6
Art 6 provides that “information systems (such as databases)” of GR and TK may be established.
Security of the information contained in these was a concern but not an easy topic to address in a Treaty such as this.
Art 6.2 provides that the information should be made available to patent offices for purposes of search and examination. What is not dealt with is how secret information could be made available to a patent office and used by the patent office to reject a patent application for lack of novelty or inventiveness. One would expect that the information would have to be made known to the applicant to enable it to formulate arguments against the patent office’s assessment.
Review and Revision – Arts 8 & 14
Art 8 provides for a broad ”review of the scope and contents” of the Treaty, “addressing issues such as the possible extension of the disclosure requirement in Article 3 to other areas of intellectual property and to derivatives and addressing other issues arising from new and emerging technologies that are relevant for the application of this Treaty”.
It is not clear what is meant by “derivatives”, and it is conceivable that it could include DSI and the like. The review is to be undertaken by an Assembly as contemplated in Art 10. The Assembly will be of Contracting States, rather than WIPO member states. Voting is provided for in the absence of consensus. A requirement for a two-thirds majority for amendments in the absence of consensus was sought by the North. It will be noted that no majority is specified in Art 10.3 and that the Assembly can make its own rules, including deciding a “required majority” (Art 10.5).
Art 14 makes provision for the revision of the treaty. This is the process through which the terms of the treaty may be changed, especially based on the review (Art 10.2(d)). The terms of this article are rather vague in that it is only specified that a Diplomatic Conference must be held and that the revision will be in accordance with the Vienna Convention on the Law of Treaties. It can be assumed that all WIPO member states will be invited and that each will have a vote, not only the Contracting States.
Conclusions
The terms of the treaty are not unusually onerous and should not represent a significant challenge to most of FICPI’s members and their clients. Systems will, however, have to be adapted for both. Clients will especially have to pay closer attention to the sourcing of genetic material used in their inventions. It will also be incumbent on FICPI members to provide proper training and advice to clients on identifying whether GR or TK was used in a claimed invention and equally as importantly where the provisions of the treaty do not apply.
Next steps
If you would like to become involved in this topic, please contact Robert Watson or Rowan Joseph.
Read Rowan's previous article on this topic at "The importance of the May 2024 Diplomatic Conference on Genetic Resources to FICPI members"
Images: Copyright: WIPO. Photo: Emmanuel Berrod. This work is licensed under a Creative Commons Attribution 4.0 International License.