WIPO’S International Legal Instrument on Genetic Resources and Associated Traditional Knowledge-An Overview vis-a-vis its application in Nigeria
On May 24, 2024, the WIPO Diplomatic Conference to conclude an International Legal Instrument Relating to Intellectual Property, Genetic Resources and Traditional Knowledge Associated with Genetic Resources, approved the WIPO Treaty on Intellectual Property (IP), Genetic Resources (GR), and Traditional Knowledge associated with Genetic Resources (ATK).
The legal instrument represents a significant effort to incorporate TK into the WIPO framework, like how the Convention on Biological Diversity (CBD) operates.
It is the most developed outcome of the WIPO Intergovernmental Committee's discussions on Intellectual Property and Genetic Resources, Traditional Knowledge, and Folklore.
Following the Diplomatic Conference on GR and TK, negotiations are anticipated to continue regarding the remaining aspects of the committee's mandate, specifically Traditional Knowledge and Folklore (alternatively termed Traditional Cultural Expressions or TCEs).
Key components of the Treaty
The Treaty aims to enhance the efficacy, transparency and quality of the patent system regarding GR and ATK; and to prevent patents from being erroneously granted for inventions that are not novel or inventive vis-a-vis GR and ATK.
These objectives are crucial for addressing biopiracy occasioned by the misappropriation and misuse of GRs and TK, including instances of patent grants based on inventions sourced from GRs or ATKs. Several cases have been observed where patent offices, such as the European Patent Office and the United States Patent and Trademarks Office have erroneously issued patents for GRs, TK associated with GRs or TK-based inventions that do not meet the standards of novelty and inventiveness, as seen with the Hoodia and Neem plants.
This is because the patent examination process often fails to recognize previously known TK as prior art, making it challenging and expensive to contest patents after they are granted. Moreover, indigenous peoples and local communities, unfamiliar with the IP system, face hurdles in seeking redress for these issues.
To this end, the Treaty provides for the following-
Mandatory patent disclosure requirement
The Treaty establishes a mandatory patent disclosure requirement. This mandatory disclosure requirement mandates patent applicants to disclose the origin and/or source of inventions that are materially or directly based on GRs and/or ATKs sourced from indigenous peoples or local communities.
However, if this information is not known, the patent applicant would be required to make a declaration to that effect.
Patent offices are not obligated to verify the authenticity of this disclosure. However, they can provide guidance to patent applicants on how to meet the disclosure requirement as well as provide an opportunity for applicants to rectify a failure to include the minimum information or correct any disclosures that are erroneous or incorrect. Thereafter, patent offices are required to make the information disclosed available to the public.
This disclosure aims to ensure transparency within the patent system, aiding patent examiners in examining prior art. Additionally, it could aid TK holders and GRs providers in contesting the validity of questionable patent applications. Understandably, the objective of the Treaty is to empower TK holders and GRs providers to collaborate and reap the benefits derived from innovations associated with their knowledge and resources, preventing their exclusion from such opportunities. This is an extension of access and benefit sharing.
The mandatory disclosure aims to prevent the misappropriation of GRs and ATK through the misuse of patents, vis-a-vis anti-biopiracy. While the term ‘biopiracy’ is not explicitly mentioned in the Treaty, the mandatory disclosure requirement clearly reflects the concerns of GRs and ATK provider countries.
In addition, mandatory disclosure would significantly improve Access and Benefit Sharing (ABS) ensuring that local communities receive fair benefits from innovations utilizing their resources and knowledge.
Country of origin
The mandatory disclosure requirement encompass the disclosure of the country of origin of the GRs and/or the indigenous peoples or local community who provided the ATKs.
The ‘country of origin’ means the country which possesses those GR in situ conditions. ‘In situ conditions’ refers to where the GR exists within ecosystems and natural habitats, and, in the case of domesticated or cultivated species, in the surroundings where they have developed their distinctive properties.
In situations where the GRs is from more than one country of origin, the applicant must disclose the country from which the GR were obtained.
Trigger for Disclosure
According to the Treaty, the trigger for the mandatory disclosure is ‘materially/directly based on’ GRs and ATKs. However, the Treaty is silent on how this test will be applied and what it will constitute.
The nature and interpretation of the trigger language has implications for the scope of activities that come under the Treaty.
Dr. Chidi Oguamanam suggests that the logical approach to interpret this would be the ‘but-for’ test, that is, ‘but for’ the GRs/ATKs, the invention would not have been made. This is captured in Article 2 of the Treaty which describes the term, ‘based on’ to mean that the GR and/or ATKs must have been necessary for the claimed invention and the claimed invention must depend on the specific properties of the GR and/or ATKs. However, the trigger debate is more complex and will probably be determined by the national law of the country.
Exceptions and limitations
The Treaty provides that contracting parties may, in special cases, adopt justifiable exceptions and limitations (E & L) necessary to protect the public interest, provided that the E & L do not unduly prejudice the implementation of the Treaty.
Sanctions and remedies
Non-compliance with the mandatory patent disclosure requirement would be subject to sanctions and remedies vis-a-vis the national law. However, the Treaty does not impose any sanction for failure to disclose the source/origin of GRs and ATKs in patent applications. Revocation of patent is neither mentioned nor ruled out as a post-grant sanction. Revocation or declaration of unenforceability is only possible ‘where there has been fraudulent intent’ vis-a-vis the disclosure requirement. However, patent applicants would have the opportunity to rectify a failure to disclose the required information.
Consequently, save for cases of fraud, no contracting party shall revoke or render unenforceable a patent solely on the basis that an applicant failed to disclose the required information.
The Treaty also requires that the national laws provide adequate dispute mechanisms that allow parties concerned to reach timely and mutually satisfactory solutions. Thus, patent applicants are encouraged to use dispute settlement to resolve nondisclosure matters.
Non-retroactivity
The Treaty includes a non-retroactivity clause the effect of which is that the mandatory disclosure obligation will not be applicable in relation to patent applications filed prior to the ratification of or accession to the Treaty.
Information system
The Treaty contains provisions requiring contracting parties to voluntarily establish information systems such as databases of GRs and ATK, in consultation with indigenous person and local communities. This database would be open for access by patent offices for the search and examination of patent applications.
However, key aspects such as the involvement of Indigenous peoples, local communities, various stakeholders, WIPO, and intellectual property offices in setting up and running these systems, including issues surrounding consent, remain unresolved.
Review mechanism
The Treaty provides an in-built review mechanism to allow for certain issues to be reviewed no later than four years after its entry into force. Issues such as the possible extension of the disclosure requirement to other areas of IP and to derivatives, and other issues arising from new and emerging technologies that would be relevant to the application of the Treaty.
Implications of the Treaty for Nigeria
Nigeria’s Constitution recognizes the Nigerian Government’s mandate to protect and safeguard the forest and wildlife of Nigeria. To this end, the National Environmental (Access to Genetic Resources and Benefit Sharing) Regulations, 2009, provides for access and benefit sharing vis-a-vis GRs.
In Nigeria, an inventor who intends to access GR, is required to apply to the National Environmental Standards and Regulations Enforcement Agency (the ‘Agency’) for a permit to access the GR. The permit shall be accompanied by evidence of prior informed consent (PIC) from interested persons such as the local communities and other stakeholders as well as research clearance from relevant agencies.
The transfer of GR outside Nigeria is done by a Material Transfer Agreement and must provide for benefit sharing to ensure the active involvement of Nigerian citizens and institutions. The benefit sharing shall include negotiated monetary and non-monetary benefits arising from the right of access granted and the use of GR and TK in accordance with the terms of the MTA.
Importantly, the person accessing GR in Nigeria is expected to respect traditional and community rights over ownership and custody of GR, including the collective rights to benefits accruing from knowledge, innovations, discoveries, uses and practices acquired overtime and for the conservation and sustainable use of the GR.
Consequently, the Treaty can complement the provisions of the Regulation in ensuring mandatory disclosure of the use of GR and ATK, to reduce incidences of erroneous patent filings.
A good idea will be to look to South Africa and India’s examples in taking the initiative to address bio-prospecting issues and protecting biological resource-based TK. Example of cases where the grant of erroneous patents based on TK have been challenged include-
- The Turmeric case where two Indians were granted a US patent (NO 5401504A) for using turmeric as a medicine for healing wounds. On a re-examination application, the patent granted was challenged on the ground of ‘prior art’. In the application, it was stated that turmeric has been used for thousands of years in India for healing wounds and rashes and therefore its use as a medicine was not new. The US patent office, satisfied by the applicant’s assertions, ordered the revocation of the patent granted on the ground of lack of novelty.
- In the Neem case, a US company called W R Grace was granted a patent by the European Patent Office (EPO Patent No 436257) in 1994, for a method of controlling fungi on plants using extracted neem oil. However, in 1995, a group of international NGOs and representatives of Indian farmers filed a petition against the patent, claiming that it was prior knowledge and has been practiced in India for centuries to protect crops. The EPO accepted the claims and revoked the patent on the grounds of lack of novelty and inventive steps.
- In the Hoodia case, the Hoodia plant of the Kalahari Desert was used for thousands of years by the nomadic San people in southern Africa to help survive through hunger and thirst during their long expeditions in the desert. In 2016, the South African Council for Scientific and Industrial Research (CSIR) gained a government-funded patent for a new drug (P57) derived from the Hoodia plant for its appetite-suppressing qualities. The patented formula was sold Pfizer and Phytopharm as a miracle drug for weight loss. The representatives of the San people, backed by the global support, demanded restitution of their rights to their common intellectual property. After a long dispute, CSIR and the San people came to a confidential 'benefit-sharing' agreement where the San people were given royalties, knowledge exchange and creation of jobs from the industry.
- There have been arguments that PALF, might be a case of biopiracy. Piña cloth is a creation unique to the Philippines and used to weave the Barong Tagalog. With fibres collected from the leaves of pineapples, the weaving mechanism of piña is a complex and labour-intensive process. To extract pineapple leaf fibre (PALF), the women carefully remove the prickles, epidermis, and pulp from the sides of the leaf with a dull knife. This is followed by exposing the fibre and finely combing it to separate the strands. With the help of a bamboo device, the separated strands are then threaded and weaved together through a delicate process to create a continuous filament. After researching potential leather alternatives at the Royal College of Art in London, Dr. Carmen Hijosa, founder and chief creative innovation officer of Ananas Anam, claimed the rights to Piñatex, a leather alternative made from PALF. The patent on this technology (US20130149512A1; EP2576881) makes it nearly impossible for the indigenous people of the Philippines and indigenous people to gain credit for the fabric that greatly impacted the shape of their history and culture for generations. Piñatex recently partnered with Dole, promising scaled-up leather production with the waste product from their pineapple farms in the Philippines and has been expanding its market by collaborating with brands like Chanel, H&M, and Nike. The patent remains to this day.
These cases show that the ATK of local communities have long been unlawfully exploited and used as the basis for modern research and product development without benefit sharing. Nigeria is not left out.
In Nigeria, we have had instances of insider biopiracy, whereby Nigerian citizens working as scientists or researchers in mostly foreign universities, capitalize on their knowledge of GR and ATK. This is evident in the US Patent No. 6,713,098 issued to Dr Ernest Izevbigie in 2004 for anti-cancer medication. Also, US Patent No. 6,531,461 issued in 2003 to Dr. Nelson Oyibo for a method of treatment of hyperglycemia (diabetes) in mammals.
Both patents were for inventions based on the use of extracts of Vernonia amygdalina, popularly called Bitter leaf, a plant with a long history of traditional medicinal use in various parts of Africa. Its potential anti-cancer properties are intriguing, especially in the context of inhibiting the growth of human breast cancer cells and as treatment of diabetes.
The Way Forward for Nigeria
The Treaty marks a significant advancement in protecting indigenous knowledge and genetic resources from misappropriation. For Nigeria, this Treaty represents both a challenge and an opportunity to strengthen its intellectual property framework in alignment with international standards.
Nigeria should leverage the Treaty to enhance its existing regulatory framework. The Regulation provides a solid foundation, but the Treaty’s mandatory disclosure requirements offer an opportunity to refine and expand the Regulation. By incorporating the Treaty’s provisions, Nigeria can better address biopiracy and ensure that GRs and TK are not misappropriated through erroneous patent grants. This could involve updating the regulatory framework to include clearer guidelines on patent disclosure, implementing robust mechanisms for tracking and managing GRs and TK, and establishing a comprehensive information system or database like India’s Traditional Knowledge Digital Library (TKDL) or Venezuela’s BioZula. Several countries already have similar databases in place.
The information systems and databases are essential for enhancing transparency in the patent system. The national database of GRs and TK would facilitate easier access to information for patent examiners, researchers, and local communities. This system should be designed to be inclusive, incorporating input from indigenous peoples and local communities to ensure that their rights and contributions are appropriately acknowledged and protected.
To prevent the issuance of erroneous patents, Nigeria’s patent offices should adopt practices that align with the Treaty’s objectives. This includes developing procedures for evaluating the novelty and inventiveness of inventions that involve GRs and TK. Training for patent examiners on recognizing prior art related to GRs and TK and incorporating mandatory disclosure requirements into the patent application process, will be crucial steps in ensuring that only genuinely innovative and novel patents are granted. Also, as provided for in the national laws of some other countries, the patent law should be amended such that not only is disclosure compulsory, but patent revocation is also part of post-grant sanctioning for non-disclosure.
Although the Treaty is crucial for protecting indigenous communities and TK holders, it has some limitations. The Treaty should be reviewed to address gaps and create a fair balance for the indigenous communities and interested users of GR and ATK. Successful implementation will depend on comprehensive legal reforms and active participation from all stakeholders.
In summary, the Treaty offers Nigeria a pivotal opportunity to enhance its intellectual property landscape and ensure the protection of its genetic resources and traditional knowledge. By updating national regulations, improving patent examination processes, establishing transparent information systems, and strengthening support for indigenous rights, Nigeria can effectively implement the Treaty’s provisions and safeguard its valuable cultural and biological heritage for future generations.
