We have a new treaty! Report on the conclusion of the WIPO Diplomatic Conference on Genetic Resources and Traditional Knowledge

The second and final week of the WIPO Diplomatic Conference on Genetic Resources and Traditional Knowledge has come to an end with the adoption of a new international legal instrument, entitled the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge (available here). This is the first WIPO Treaty to include provisions specifically for Indigenous Peoples as well as local communities.

Image from Pixabay.

The crux of the Treaty is an international disclosure requirement related to genetic resources and traditional knowledge associated with genetic resources in patent applications. It is the first instrument to emerge from the 25 years of work of the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC), initiated in 1999 with a proposal by Colombia and then established in 2000.

The Negotiations

As this Kat reported last week (here), the negotiations began slowly but accelerated quickly into the second week. The pace improved after a change of modalities to use ad hoc contact groups, or what the President of Main Committee 1, Jodie McAlister, described as "epic huddles" (see photo). 

The days were very long as delegates requested more time from the President of the Conference to continue their positive and constructive discussions. On Wednesday evening, Jodie McAlister specifically acknowledged the "resilience of the Indigenous Caucus and Indigenous observers" for their constructive engagement, even where "processes have not been as accommodating as maybe we would like."

An "epic huddle" to negotiate a new WIPO treaty.
Photo courtesy of James Love.

There was a notable shift during the plenary session on Wednesday evening. The President of the Conference recognised that the delegates were dealing with complex issues with a diversity of views and approaches. In order to move things forward, Ambassador Patriota presented a "President's Proposal." This text sought to reflect the negotiators' agreements, while offering a compromise that would strike a balance on the outstanding issues, both in the substantive and administrative provisions. The President requested "quick reactions" that evening, then undertook consultations on Thursday.

The Outcome

In the early hours of this morning, the Diplomatic Conference met in plenary session to adopt the final text. The outcome was clearly a huge relief for the WIPO and Diplomatic Conference leadership, with joyful applause and hugs all around. After some rest, the delegates returned to the WIPO Headquarters later this morning for the closing ceremonies and declarations from the delegations and observers.

What does the final text say? Firstly, it should be noted that the term "genetic resources" is used in line with the Convention on Biological Diversity, which means that the Treaty is not intended to cover human genetic resources (footnote to Article 2). 

Article 3, as adopted, requires patent applicants to disclose the following:

1. Where the claimed invention is "based on genetic resources," the applicant shall disclose the country of origin, or if that is not known, the source of the genetic resources. The text clarifies that if there is more than one country of origin, the applicant shall disclose where the genetic resources were actually obtained.
2. Where the claimed invention is based on traditional knowledge, the applicant shall disclose the Indigenous Peoples or local community who provided the knowledge, or if that is not known, the source (such as scientific literature, publicly accessible databases, patent applications and patent publications). 

Where applicants do not know the origin of genetic resources or traditional knowledge, they must make a declaration that the disclosed information is "true and correct to the best knowledge" of the applicant (Article 3.3). Patent offices are expected to provide guidance on meeting the disclosure requirement and opportunities to rectify failures to disclose (Article 3.4), but there is no obligation for patent offices to verify the disclosed information (Article 3.5). The requirement is not retroactive (Article 4).

One of the "next steps" is to ensure that this treaty is implemented in a mutually supportive manner with other international agreements. To that end, the footnote to Article 7 indicates that the parties will request consideration of amendments to the Patent Cooperation Treaty (PCT), so that international applicants can comply with the formal requirements of national laws on disclosure of origin.

Ratification and Entry into Force

The Treaty will enter into force three months after 15 eligible parties have deposited their instruments of ratification or accession (Article 17). No reservations are permitted (Article 20). The signed original English, Arabic, Chinese, French, Russian, and Spanish versions of the text are equally authentic (Article 21). The final text includes specific provisions for the European Union to join the Treaty (Article 12.3).

R.I.P. the Patent Bargain?

The Treaty is a momentous achievement, but being brand new does not insulate the Treaty from criticism. One of the most controversial provisions eventually became Article 5 on sanctions and remedies. A key sacrifice that was made to ensure the adoption of the Treaty was the removal of consequences for validity of the patent if there has been a failure to disclose the origin of genetic resources or traditional knowledge.

Whilst the Treaty allows for post-grant sanctions or remedies where there has been fraudulent intent in regard to the disclosure requirement (Article 5.4), the Treaty otherwise prohibits parties from revoking, invalidating, or rendering unenforceable the patent rights due to a failure of disclosure (Article 5.3).

Patents are often justified as a quid pro quo that offers the exclusivity of patent rights in exchange for the disclosure of the invention to the public. On that basis, failures of disclosure usually have serious consequences; for instance, insufficiency of disclosure is grounds for revocation of a European patent (EPC Articles 83 and 138(1)(b)). Why should disclosure of origin be an exception to this principle?

The limited consequences for failures of disclosure might have been justified to reach consensus at WIPO, but it may pose a challenge for the countries who already have disclosure of origin requirements with "teeth." In order to ratify the Treaty, countries such as India, Ecuador, Cuba, South Africa, and Peru may need to wind back their national provisions that have consequences for the validity or enforceability of the patent. This Kat also wonders whether laws that impose fines for failures of disclosure of origin might be considered "appropriate, effective and proportionate legal, administrative, and/or policy measures to address a failure to provide the information" (Article 5.1).

An Exciting Day

Criticisms aside, the closing sessions of the Diplomatic Conference had a very positive mood. The delegates spoke of this landmark agreement as cause for pride and optimism about multilateralism and the future of the rights of Indigenous peoples and local communities in the intellectual property system. After 25 years of debate and negotiation, the conclusion of this Treaty certainly makes today a historic day!