Finally, WIPO Adopts a Treaty on IP, Genetic Resources and Associated TK! But at What Cost?

25 years since Colombia first brought the issue of protection of IP rights of indigenous communities, and 14 years since the Text based negotiations on the agreement commenced, WIPO finally adopted a Treaty on IP, Genetic Resources (GR) and Associated Traditional Knowledge (TK) on May 24, 2024. Adopted in the recently concluded Diplomatic Conference on Genetic Resources and Associated Traditional Knowledge, 2024, the Treaty is the fruit of the WIPO’s special body’s (Intergovernmental Committee on IP and Genetic Resources, Traditional Knowledge and Folklore (IGC)) efforts of engaging in routine negotiations to come up with an instrument to protect the rights of indigenous people concerning GR and associated TK via an IP framework (see here). And the Treaty does so via the good old patent system. While the Treaty has been adopted by the WIPO, for it to come into force, it requires 15 members to deposit their instruments of ratification or accession with WIPO (Art. 17). 

As is evident, the Treaty is the result of hard fought negotiations over several years, and for those details, you can see here, here, and here. For those who haven’t been following this development, the Treaty is the first international agreement to mandate a disclosure requirement for inventions that utilize genetic resources and traditional knowledge in the inventions. As such, it is perhaps understandable that there seems to be much celebration regarding the text of the Treaty finally being agreed upon. However, as is not uncommon, the devil lies in the details. And in this case at least, despite the general celebratory notions around the Treaty, there are certain areas with cause for concern, such as signatory countries needing to agree not to enforce some patent quality safeguards that countries like India already mandate! Before we get into that, let’s first step back and quickly take a look at what the Treaty tries to achieve. 

Mandatory (?) Disclosure of Source/ Origin of GK and Associated TK

The Treaty mandates disclosure of the source of the GR or associated TK on two fronts:-

1) when a claimed invention is based on a GR, the applicant shall disclose the country of the GR.

2) when it’s based on an associated TK, it shall disclose the indigenous people or local community wherefrom the associated TK was obtained.

Providing some flexibility to the applicant, the Treaty states that in case both these sources are not available, the applicant gives any source of GRs or/ and associated TKs wherefrom they have obtained the relevant resource or knowledge (Art. 3.1(b) and 3.2(b) r/w Art. 2). And in case even this information is not available, the applicant can make a declaration stating so, along with an affirmation that the content of the declaration is true and correct to the “best knowledge” of the applicant. [Question that arose when Swaraj and I were discussing this: Does this include inventions based upon synthetic biology, where most of such inventions are likely to happen in the coming decades? It’s not clear. Any readers in the know could kindly comment].  In addition to this three-tier approach towards the disclosure requirement, the Treaty also mandates that the Contracting Parties shall provide guidance to the applicants on how to meet this requirement and should also afford them opportunity to rectify the disclosure in case it’s erroneous or incorrect.

Why Do We Need a System of Mandatory Disclosure of GRs and Associated TK?

Patents are granted by the virtue of a social bargain wherein the inventor is able to reap the benefits of exclusivity over its invention against undertaking an obligation to disclose the best mode of achieving it. In context of inventions based on GR and associated TKs, there is an additional layer of obligation (a phrase borrowed from Dr. Claudio Chiarolla and Burcu Kılıç’s report here) towards indigenous communities, on top of the general public, considering that these inventions are derived out of culturally sensitive materials.

Further, Prof. Sarnoff and Prof. Correa explain (albeit in the context of the Convention on Biological Diversity), mandatory disclosure requirement is necessary to prevent misappropriation of GR and the associated TK. They suggest that the obligation may be useful in improving substantive examinations and may also assist in identifying situations where the access to these resources were obtained unduly, without proper informed consent (See here on pages iv and v). These justifications apply squarely in the present situation too (See pages 18-21 here).

Provisions on Sanctions and Remedies: Toothless Tiger?

Considering the above logic, the present obligation for the disclosure requirement seems more like a mere formality for the patent offices. This understanding gets aggravated when we read this obligation along with the provision on sanctions prescribed for not disclosing the above information. The Treaty prescribes that a Contracting Party cannot revoke a patent if the obligation to share this information is not fulfilled, except in the cases where the applicant has not disclosed the origin owing to fraudulent intentions (Art. 5.3 r/w 5.4). This provision may require a complete overhaul of relevant laws in many countries like India that impose sanctions for non disclosure.

While the Treaty leaves it open for the Contracting States to decide post grant sanctions or remedies in case the application is found to be fraudulent, it mandates that the Contracting Parties shall not place an obligation on its offices to verify the authenticity of the disclosure (Article 3.5). This makes me wonder how can the office then determine whether the disclosure was made with a fraudulent intent or not? Won’t this render the remaining tooth under sanctions and remedies infructuous?  

What Does this Mean for India?

If India does sign on, these provisions will require us to dilute some of our crucial safeguards against bad patents. Presently under the Patent Act, a pre grant opposition can be filed against non disclosure of the source of origin (Section 25(1)(j)) and a granted patent could even be revoked for non disclosure of this information (Section 64 (1)(p)). As per Articles 3 and 5 of the current Treaty, these provisions would not be allowed, as their conjoint reading mandates that the applicant will be allowed to not disclose the source of origin (when the same is not known to it) and a patent cannot be rejected on the ground of such non disclosure, unless the non disclosure is fraudulent! With these provisions in place, consequently India may see a surge in the number of patent applications especially from applicants in countries with sophisticated synthetic biology and bioprospecting industries. However, it must be kept in mind that this surge will be at the cost of losing crucial levers to guard against meritless applications. One saving grace for India to completely avoid the conundrum of not agreeing to these obligations could have been to express a reservation against them i.e. declaring their non application to India. Unfortunately, this flexibility is not available to any contracting party since no reservations to the treaties are permitted under Art. 20.

The debate over mandatory disclosure requirement has been a long standing one and perhaps is as old as Colombia’s proposal to protect biological and genetic resources. As pointed out by Sreenath Namboodri here, and Prof. Biswajit Dhar and R. V Anuradha here, the Colombian Proposal’s suggestion to have a mandatory disclosure requirement was strongly opposed by a group of developed countries- USA, EU, and Japan. In fact, as discussed by Prof. Margo Bagley here, the US has consistently raised its so-called concerns against this requirement in other forums like the WTO too, arguing that this obligation imposed needless extra obligations on the applicants. The same arguments were raised by associations based in the US (American Intellectual Property Law Association (IPLA)) and other lobby organizations, like from International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) from Switzerland in the 2024 Diplomatic Conference too (see here for Prof. Chidi Oguamanam’s update on Linkedin). While the parties in favor of having this obligation are successful in getting these obligations in the Treaty, looking at the diluted state of this obligation, it seems like the ones opposing this obligation eventually had the last laugh.

Apart from the above issues, there are other alarming issues with the Treaty. For instance, just like the base document, the Treaty has not defined the meaning of “confidential information” (Art. 3.6) which as pointed out by Prof. Peter K. Yu may lead to constructive ambiguity. The Treaty has removed the provision on “exception and limitations” allowing parties to deviate from the obligations in light of public interest. These issues are extremely pressing and perhaps require detailed separate posts on their implications. Also, as many of our readers would know, India has a Traditional Knowledge Digital Library. How will this Treaty impact this institution? We have a guest post coming up discussing just that. [Edit: The guest post is available here.]

A big thanks to Swaraj for his inputs on the post. H/t to Jocelyn Bosse for highlighting the issues with provisions on mandatory disclosure in this post on the IPKat, and to Roshan John for sharing this development with me.