The New Treaty
The new World Intellectual Property Organization ("WIPO") Treaty (the "Treaty"), titled The Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, was recently approved following a negotiation period which spanned over two decades. This landmark Treaty is the first from the WIPO to address the convergence of intellectual property, genetic resources, and traditional knowledge, and is also the first to deliberately include measures for Indigenous Peoples alongside local communities. Canada's role in drafting this Treaty was limited, but as a member nation of WIPO the Canadian Delegation present cast a vote in favour of the Treaty. Two Canadian experts were called by WIPO directly to share their expertise on the matter. Canada has yet to adopt the Treaty, to take steps to ratify it, or to start implementing legislation.
At a high level, the purpose of the Treaty is to achieve two objectives: first, to enhance the efficacy, transparency and quality of the patent system with regard to genetic resources and traditional knowledge associated with genetic resources; and, second, to prevent patents from being granted erroneously for inventions that are not novel or inventive with regard to genetic resources and traditional knowledge associated with genetic resources.
What are Genetic Resources and Traditional Knowledge?
Genetic resources, for the purposes of the Treaty, has a two-tiered definition. Genetic materials are first defined as any material of plant, animal, microbial or other origin containing functional units of heredity. In turn, genetic resources are genetic material(s) of actual or potential value. Examples of genetic resources include: gene sequences, enzymes from microorganisms, animal breeds, biopolymers, and CRISPR-Cas systems amongst other things.
Traditional Knowledge generally refers to an intergenerational body of knowledge, practices, beliefs, and teachings of Indigenous peoples embedded in their ancestral experiences, and ecological stewardship, culture, medicine, language, and education. Some examples of traditional knowledge relating to genetic resources include nutritional knowledge, climate resilience, fermentation processes, medicinal plant use and herbal remedies, and crop cultivation, amongst many more applications and information. For more information on Indigenous traditional knowledge in Canada, see the Government of Canada's resource page.
Under this Treaty, claimed inventions in a patent application that are based on traditional knowledge associated with genetic resources will be subject to disclosure requirements.
The Treaty Framework
Article 3 of the Treaty introduces disclosure requirements for patent applications based on genetic resources, or traditional knowledge associated with genetic resources. These disclosure requirements include the country of origin of the genetic resource, or in cases where a country of origin does not apply, the source of the genetic resource. Likewise, for patent applications based on traditional knowledge associated with genetic resources, the applicants would be required to disclose: the Indigenous Peoples or local community who provided the traditional knowledge, or where this information is not known to the applicant or there is no specific Peoples to disclose, the source of the traditional knowledge.
Article 3.4 makes clear that Contracting Parties of the Treaty will be required to provide guidance to patent applicants on how to meet these disclosure requirements. The Treaty generally encourages the establishment of databases, to be built in collaboration with Indigenous Peoples and local communities, which would further facilitate the disclosure requirements – see Article 6.
Until further steps are taken by Canada, and until the Treaty is ratified, there are no further details as to what form this guidance will take in Canada. However, the framework makes clear that patent applicants who fail to meet the disclosure requirements will generally be able to rectify the mistake and correct erroneous disclosures. However, fraudulent intent may attract stricter application of the frameworks sanctions and remedies, and could potentially deny an applicant the opportunity to correct the inaccurate disclosure.
The sanctions and remedies outlined in Article 5 of the Treaty are quite obscure, having purposely been left to each Contracting Party to implement "effective and appropriate legal, administrative, and/or policy measures to address a failure to provide information required in Article 3 of the Treaty".
Implications for Canada – Having it on Your Radar
As the Government of Canada continues its reconciliation efforts with First Nations, Inuit, and Métis peoples, there is some momentum toward incorporation of the Treaty's framework into the Canadian patent law framework. Notably, the Treaty's preamble acknowledges the UN Declaration on the Rights of Indigenous Peoples, which Canada is already progressively integrating into its national laws. This commitment to integration demonstrates that the two pieces of international law will likely eventually become part of Canada's reconciliation commitment to Indigenous Peoples.
In terms of assessing current practices, the framework is going to be non-retroactive, meaning the disclosure requirements will not be applied to previously issued patents or applications.
Naturally, bio-prospective research and development may face increased regulation and reporting scrutiny with respect to patent applications. The extent of this change is difficult to predict this early into the framework's implementation, however, some preliminary changes could include: increased costs to patent applications, changing time frames for patent applications as it relates to sourcing the information required for disclosure, and increased due diligence and compliance costs.
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