Wipo Treaty: Promoting biopiracy

No procedure has been laid down on who, how or which technologies can be brought into its purview.
Wipo Treaty: Promoting biopiracy

On May 24, 2024, the World Intellectual Property Organization (WIPO) adopted a treaty regarding genetic resources and the associated traditional knowledge. This treaty brings in a new disclosure requirement for patent applicants whose inventions are based on genetic resources or associated traditional knowledge.

Broadly, where a claimed invention in a patent application is based on genetic resources, each contracting party shall require applicants to disclose the country of origin or source of the genetic resources. Where the claimed invention in a patent application is based on traditional knowledge associated with genetic resources, each contracting party shall require applicants to disclose the Indigenous Peoples or local community, as applicable, who provided the traditional knowledge. This is the first WIPO Treaty to link intellectual property, genetic resources and traditional knowledge. And, it is also the first WIPO Treaty to include provisions specifically for indigenous people.

The negotiation for this treaty began in 2001. It also specifies implementation of the treaty in a mutually supportive manner with other international agreements relevant to this treaty such as the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), the Kunming-Montreal Global Biodiversity Framework (GBF), etc.

The treaty was put in motion by the WHO as part of the under-negotiation World Pandemic treaty, through which it is trying to establish a Pathogen Access and Benefit Sharing System (PABS), under which all information of infection has to be shared within the system, by all the signatories. This treaty cannot be applied retroactively – past claims or research or usurpation of genetic resources most probably do not get covered under this treaty. There is no obligation for disclosure.

Controversy

On the downside, this WIPO treaty frees companies involved in using gene editing technologies on new products of vaccines, seeds or any genetic modification, from the obligation of providing information mandatorily to the countries from which the genetic material has been sourced. It also frees them from guilt, obligation and punishment.

Further, national patent laws have been subsumed by this treaty. In other words, countries that sign this treaty negate a process of national control over genetic material available within their boundaries.

In addition, the treaty does not have a mechanism to deal with failure to acknowledge or disclose the sources of origin. WIPO does not have a role in sanctions or remedies, which are anyway lax. It is left to the contracting party in the treaty, where a supposed infringement might have happened, to establish mechanisms and measures. Most countries do not have the technical expertise to establish the infringement defined under this treaty.

Further, countries do not have the power to punish if a company does not acknowledge the origin of the genetic resources. This treaty specifically prohibits the invalidation of patent rights even after the infringement has been established.

However, the contracting parties have the obligation to enable access to local information systems (such as databases) of genetic resources and traditional knowledge associated with genetic resources to patent offices. This means the companies or patent applicants can have access to local information systems. The treaty does not include any obligation on the patent applicants to share the genetic resources material used for their products, either at WIPO level or at the country level. The treaty also mandates the scope for expansion to relate itself to new and emerging technologies through a built-in review. No procedure has been laid down on who, how or which technologies can be brought into its purview.

India’s stand

Interestingly, after 10 days of deliberations from May 13 to 24, the basic proposal in toto became the treaty. India signing this treaty is surprising, given that it is in contradiction with the national patent law on two counts. The Indian Patents Act, under Section 10.4(D) mandates the disclosure of source and geographical origin of the biological material used. Failure to disclose or wrongful disclosure attracts revocation of patents under Section 64.1(p).

Way forward

This PABS has been flagged as a potential conduit for collection of all kinds of information on genetic resources, including viruses, microbiomes related to humans, animals and other forms of life, and not just the pathogens. This treaty has a potential application for all kinds of biotech, including medical biotech.

Progress on the new Pandemic Agreement apparently hinges on the possibility of agreement on a new mechanism to facilitate access to information on pathogens while also committing to share benefits. African countries want a robust PABS that imposes binding obligations on users of biological materials and genetic sequence data to make mandatory monetary contributions.

PABS is necessary but not sufficient to ensure equity. There is still important work to be done on intellectual property waivers and technology transfers. It was reported that the Africa Group and the Equity Group are unlikely to acquiesce to a treaty without a strong PABS system. At the same time, the pharma industry wants unconditional access to genetic resources without benefit sharing obligations.

(Dr Narasimha Reddy Donthi is a public policy expert.)

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