Genetic resources and traditional knowledge can be used in various contexts, including inventions where patent protection is pursued. This page provides updates on the Government of Canada's efforts, particularly by the Canadian Intellectual Property Office (CIPO), to address the intersection of patent rights and the use of genetic resources and associated traditional knowledge.
On this page
- Background
- Patent examination in Canada
- Traditional knowledge as prior art
- Prior user rights and traditional knowledge
- Protesting the granting of a patent before it is granted
- International cooperation and engagement
- Education and outreach
- Current international discussions on genetic resources and traditional knowledge
- Resources
Background
A patent is a form of intellectual property (IP) granted by a government that confirms the exclusive right to an invention for a period of up to 20 years. An invention is a new, inventive and useful solution to a problem. It can be a novel device, process or product. A patent is only valid in the country where it is granted and there is no such thing as an international patent; patent rights must be sought in each desired country. For more background information about patents, visit our Learn about patents page.
Many countries and Indigenous peoples around the world are concerned about the undesired use of genetic resources originating from their territories and the misappropriation of traditional knowledge, including knowledge related to those genetic resources (e.g. traditional medicines).
There have been several developments worldwide in recent years in relation to the intersection of patent rights and the use of genetic resources and associated traditional knowledge by inventors, patent applicants and patent owners. Patents are available for inventions in many technology areas and, particularly in the biotechnology and chemistry fields, patents can relate to subject matter that is associated with genetic resources and/or associated traditional knowledge.
Genetic resources and traditional knowledge may be obtained and used in many contexts, one of which may be in relation to inventions where patent protection is pursued. In situations where patents are erroneously granted for inventions that are already known, for example the invention or parts thereof being known in traditional knowledge held by Indigenous peoples, there are several ways in which the patent rights can be challenged. For example, anyone can request that the Patent Office re-examine the patent on the basis that the invention was already known or was obvious. Positive protection, in the form of applying for a patent, may also be sought by individuals or Indigenous communities for inventions that use traditional knowledge or genetic resources in a new, non-obvious, and useful way. Protection through a patent may have limitations, as the patenting process would only provide exclusion protection for a limited period of time and it requires sufficient public disclosure, which could risk traditional knowledge being subject to further undesired use.
Patent examination in Canada
The Commissioner of Patents at CIPO is responsible for the granting of patents in Canada. CIPO's Patent Office receives patent applications from Canadians and from applicants around the world. These applications are examined when the applicant submits a request and pays the required fee.
The examination of a patent application is an integral component of the patenting process in Canada. Patent applications are reviewed by patent examiners to ensure conformance with the requirements in the Patent Act and Patent Rules. A patent must only be granted in Canada if it complies with all requirements.
The claims are a part of a patent application that defines the invention. One of the requirements for a patent to be granted is that the claimed invention must be new. For example, if the invention was made known to the public, anywhere around the world, before the filing date of the patent application, it would not be considered new and a patent could not be obtained. A crucial component of patent examination is the comprehensive search by examiners for publicly available information, known as the "prior art" search. Prior art refers to any publicly available information that existed before a patent application was filed.
Information about genetic resources and traditional knowledge can be prior art that could prevent a patent from being granted. To be citable by a patent examiner, to show that the invention is not new, this information must be publicly available prior to the filing date of the patent application. Canadian patent examiners search for this type of information and refer to it in examination reports in the same way as other forms of prior art (such as patents, scientific publications, trade show literature, etc.).
Indigenous knowledge that was already in use long before someone tried to patent it can serve as prior art. It could be cited by patent examiners to prevent a patent from being granted and it could cause the invalidation of claims in an erroneously granted patent.
CIPO has a certified quality management system in place and maintains access to hundreds of databases to ensure high-quality prior art searches and examination, which can help prevent the erroneous granting of patents.
Patent examiners have access to traditional knowledge databases that can be consulted, particularly when examining patent applications that appear to be related to genetic resources and associated traditional knowledge. For example, the following traditional knowledge databases represent some databases which are available to CIPO's patent examiners:
- Korean Traditional Knowledge Portal
- India's Traditional Knowledge Digital Library
In relation to genetic resources, patents are available in Canada for inventions related to genetic material such as bacteria, some fungi and algae, cell lines and hybridomas. Biotechnology processes are also patentable. Plants and animals are not patentable but cells from plants or animals could be patentable. In these scientific areas, patent applications are examined by patent examiners that are skilled in a variety of disciplines in the organic and general chemistries and biotechnology fields. They perform searches in specialized databases, including the STN search tool and GenomeQuest.
Traditional knowledge, including knowledge in relation to genetic resources, that was known and publicly available prior to the filing date of a patent application is not patentable.
Traditional knowledge as prior art
The Patent Office relies on dated, documented information to determine what is known as of the filing date of a patent application. This often takes the form of scientific papers, patents and other published documents. This information is typically available in publicly accessible databases that anyone can obtain access to.
There are few publicly accessible databases that relate to the traditional knowledge of Indigenous peoples. Indigenous peoples have expressed concerns about documenting traditional knowledge in databases as once documented it can be difficult to control access to the information and to obtain prior consent for its use. Further, traditional knowledge is often orally transmitted, partially secret, or not documented in ways that can be readily accessible to patent examiners. As a result, patent examiners may fail to discover the traditional knowledge that could prevent the granting of patents.
Prior user rights and traditional knowledge
Indigenous peoples worldwide have reported experiencing situations where outsiders gain knowledge from them and then use that knowledge without their consent. This may include filing patent applications based on knowledge relating to the use of plants for medicinal purposes, cultural techniques, or other locally known practices. These actions can amount to an attempt to claim exclusive rights over knowledge that has been in Indigenous communities for generations.
Canada's patent law contains a defense to allegations of infringement known as "prior user rights". These rights help to ensure that someone is not deprived of their ability to use knowledge that they were using prior to that knowledge being claimed in a patent. Where a prior use is established, a person that was already using certain knowledge could be protected against patent infringement liability.
Documenting or carefully disclosing traditional knowledge, while respecting cultural constraints, can help show that the knowledge is not new or can serve as a defence to allegations of infringement.
Protesting the granting of a patent before it is granted
In Canada, patent applications are opened to public inspection at 18 months after the filing date, or 18 months after the priority date, if claimed. The Canadian Patents Database can be used to search for publicly available Canadian patent applications and patents. For example, a common search might be to identify patent applications containing particular keywords or ones that were filed by a particular person or company.
During the patent application phase, anyone can submit prior art to the Patent Office if they believe that the prior art has a bearing on the patentability of an invention. The patent examiner will consider this prior art during their examination of the patent application. To submit this type of information, one must write to the Patent Office and identify the patent application number, the details of the prior art, and how it is relevant to the claimed invention.
Anyone may also submit a protest against the granting of a patent in writing, on other grounds. For example, if you believe a patent application contains an invention that cannot be patented in Canada, this information can be brought to the attention of the Patent Office.
International cooperation and engagement
Patent examiners at CIPO as well as patent examiners at patent offices worldwide consult traditional knowledge databases and perform chemistry and biological sequence searches to find information on genetic material.
Many patent offices will publish prosecution histories and prior art results in publicly accessible databases. Our patent examiners regularly consult these foreign databases when examining patent application. By doing so, we leverage the specialized work and expertise of other patent offices, including those with significant experience in the treatment of traditional knowledge, leading to more comprehensive and reliable patent examination.
Canada also has memoranda of understanding with several foreign patent offices to enable the cooperation in the training of patent examiners, including in promoting the search and citation of traditional knowledge and traditional knowledge associated with genetic resources.
Education and outreach
CIPO offers a number of tools and resources on its Indigenous peoples and intellectual property page. Those include tailored training opportunities and one-on-one consultations in partnership with Indigenous organizations, government departments, businesses, academia and regional offices.
In May 2019, CIPO and the World Intellectual Property Organization (WIPO) co-hosted the Practical Workshop on Intellectual Property, Traditional Knowledge and Traditional Cultural Expressions for Countries from the Arctic Region, in Iqaluit.
The Indigenous Intellectual Property Program grant aims to make the IP system more inclusive of First Nations, Métis, and Inuit peoples. It promotes initiatives focused on education, awareness-raising and capacity-building, and provides opportunities for Indigenous peoples to advocate their interests through engagement activities, increase participation in domestic and international discussions on IP and traditional knowledge and indigenous cultural expressions, and explore ways to make the IP system more accessible to Indigenous peoples.
Current international discussions on genetic resources and traditional knowledge
New WIPO treaty on IP, genetic resources and associated traditional knowledge
For more than two decades, the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) has been studying issues related to these topics, including how the patent system could be improved to accomplish various goals. Canada is an active participant in discussions at the WIPO IGC. In 2024, more than two decades of negotiations culminated in a new WIPO treaty related to patents.
The WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge was adopted by the Member States of WIPO in May 2024. This is the first WIPO Treaty that addresses the interface between IP, genetic resources and associated traditional knowledge, and it includes provisions specifically for Indigenous peoples. The Treaty aims to enhance the efficacy, transparency and quality of the patent system with regard to genetic resources and traditional knowledge associated with genetic resources, and to prevent patents from being granted erroneously for inventions that are not novel or inventive with regard to genetic resources and associated traditional knowledge.
One of the key outcomes of the Treaty is a mandatory disclosure requirement if a claimed invention is "based on" genetic resources and/or associated traditional knowledge. The mandatory disclosure requirement requires patent applicants to disclose certain information to the Patent Office. This information includes the country of origin or source of the genetic resource and/or the Indigenous peoples or local community providing the associated traditional knowledge. If this information is unknown to the patent applicant, they would be required to declare that.
The Treaty is not yet in force and Canada has not yet made any decision in relation to signing or acceding to the Treaty.
The United Nations Declaration on the Rights of Indigenous Peoples Act
The United Nations Declaration on the Rights of Indigenous Peoples Act (UNDRIP) came into force in 2021 and provides Canada's framework for reconciliation, healing and peace, as well as harmonious and cooperative relations based on the principles of justice, democracy, respect for human rights, non-discrimination and good faith. For more information, consult the UNDRIP page and Action Plan.
Convention on Biological Diversity
Canada is party to the United Nations's Convention on Biological Diversity (CBD), which entered into force in 1993, with the objectives of the conservation and sustainable use of biological diversity, and the fair and equitable sharing of the benefits related to the use of genetic resources.
Resources
ISED, Intellectual Property Strategy, Indigenous peoples and intellectual property
WIPO publication, Intellectual Property and Genetic Resources