Jessica Chong breaks down the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge and its effects on patent prosecution.

On 24 May 2024, Member States of the World Intellectual Property Office (“WIPO”) approved a groundbreaking new treaty. The WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge (“Treaty”) is not only the first WIPO treaty to address the interface between intellectual property (“IP”), genetic resources (“GRs”) and traditional knowledge (“TK”), but is also the first WIPO treaty to include provisions specifically to safeguard the rights of indigenous peoples and local communities. The Treaty will come into force 3 months after 15 WIPO Member States have ratified or acceded to the Treaty.[1]

What are Genetic Resources?

GRs are genetic material (i.e., any material of plant, animal, microbial or other origin containing functional units of heredity) of actual or potential value.[2] In other words, they are parts of biological materials that: (a) contain genetic information of value; and (b) are capable of reproducing or being reproduced. Examples include medicinal plants, agricultural crops and animal breeds.[3]

What is meant by Traditional Knowledge?

TK is a living body of knowledge that is developed, sustained and passed on from generation to generation within a community, often forming part of its cultural or spiritual identity. In general, TK is understood as:

• knowledge, know-hows, skills, innovations or practices;
• that are passed between generations;
• in a traditional context;
• that form part of the traditional lifestyle of indigenous and local communities who act as their guardian or custodian.[4]

TK includes environmental or medicinal knowledge, or knowledge associated with GRs,[5] e.g. methods of extracting or preparing traditional medicines from plants.

Biopiracy Blues: Why is it Important to Safeguard GRs and TKs?

Biopiracy may be defined as the unethical or unlawful appropriation or commercial exploitation of biological materials (such as medicinal plant extracts) that are native to a particular country or territory without providing fair financial compensation to the people or government of that country or territory.[6] For decades, biotech companies from more developed countries have obtained GRs and/or associated TKs from local indigenous communities in less developed but biodiversity rich countries, then established a monopoly over such GRs and/or TKs by way of patent protection, for the purposes of commercial exploitation.

The issues that arise from this practice are manifold. From an ethical standpoint, the patent owner will be able to exploit these GRs / TKs and reap the full benefits, with no profits or recognition accruing to the indigenous peoples from whom the GRs / TKs were obtained. The indigenous community may even be excluded from continuing to profit off its own products using the GRs / TKs, as the patent owner now has monopoly rights over the GRs / TKs.

From a legal standpoint, the patent should not have been granted for lack of novelty, as the indigenous community has known about the GRs / TKs on which the patented invention is based for generations. However, as there is no recordal system for such GRs / TKs, the local IP office has no way of knowing this during examination of the patent application.

In general, the Treaty adopted by WIPO seeks to address these issues by requiring the source of the GRs / TKs on which a patent application is based to be disclosed, and providing for a database in which GRs and TKs may be recorded for reference by the local IP office.

Key features of the Treaty

Disclosure

The Treaty imposes an obligation on patent applicants, in respect of inventions based on GRs and/or TK associated with GRs, to disclose the country of origin of the GRs and/or the indigenous peoples or local community providing the associated TK.[7] If such information is not known, the applicant must make a sworn declaration to that effect.[8] The local IP office will not be required to verify the authenticity of the disclosure.[9] The information disclosed must be made available in accordance with patent procedures, without prejudice to the protection of confidential information.[10] The said disclosure obligation will not be imposed retroactively on patent applications filed before the entry into force of the Treaty.[11]

Sanctions and Remedies

Contracting Parties to the Treaty (“CPs”) are free to put in place any appropriate, effective and proportionate legal, administrative and/or policy measures to address a failure to make the necessary disclosure.[12] A patent applicant who makes such a failure to disclose will be given an opportunity to rectify this failure before any sanction or remedy is implemented,[13] unless there has been fraudulent conduct or intent, in which case CPs may not allow any opportunity to rectify the failure.[14] A patent may not be revoked, invalidated or rendered unenforceable solely on the basis of failure to provide the necessary disclosure, except where there has been fraudulent intent in regard to the disclosure requirement, in which case CPs may provide for post-grant sanctions or remedies in accordance with its national law.

Databases

CPs may, but are not obligated to, establish databases or other information systems of GRs and their associated TKs, in consultation with indigenous peoples and local communities where applicable.[15] Such database should be made available to local IP offices for the purposes of search and examination of patent applications, with appropriate safeguards developed in consultation with indigenous peoples and local communities, and other stakeholders. Access to the database may be restricted only to those authorised by the relevant CP.[16]

Applicability

Malaysia has yet to ratify or accede to the Treaty, though we anticipate it is likely to do so in the future as Malaysia is home to a rich and diverse range of indigenous peoples, each with its own unique culture and heritage, who would benefit from the added protections against biopirates provided for in the Treaty. In the meantime, while limited in scope as compared to the Treaty, breeders of new plant varieties may consider protecting the same under the plant variety protection laws in Malaysia.

Conclusion

A Treaty of this nature has been a long time coming. The WIPO Intergovernmental Committee on IP and GRs, TK and Folklore (“IGC”) was established in 2000 with the intention of giving a voice to indigenous peoples and local communities who were left vulnerable to exploitation, falling through the gaps in the IP legal framework as we know it. The adoption of this Treaty shows that its work over the past 25 years has not gone to waste.

The IGC is not planning to rest on its laurels, either. In December 2024, the IGC will be convening to continue negotiations for a sui generis legal instrument for the protection of indigenous peoples’ TK and traditional cultural expressions (“TCEs”).[17]

In the meantime, this Treaty will serve as a long-awaited first step towards bridging some of those gaps and making the IP framework fairer for all.

 Jessica is an Associate at Wong Jin Nee & Teo. Her practice covers a wide range of fields relating to intellectual property, including litigation, brand protection and enforcement, regulatory compliance, franchising and trademark prosecution.

[1] Article 17 of the Treaty.

[2] Article 2 of the Treaty. Note that the definition of “genetic resources” is in line with that under the Convention on Biological Diversity and does not include “human genetic resources”.

[3] Intellectual Property and Genetic Resources, Traditional Knowledge and Traditional Cultural Expressions (WIPO, 2020), p 18.

[4] ibid, p 13.

[5] ibid, p 14.

[6] “biopiracy.” Merriam-Webster.com. <https://www.merriam-webster.com/dictionary/biopiracy> Accessed 21 August 2024.

[7] Articles 3.1 and 3.2 of the Treaty.

[8] Article 3.3 of the Treaty.

[9] Article 3.5 of the Treaty.

[10] Article 3.6 of the Treaty.

[11] Article 4 of the Treaty.

[12] Article 5.1 of the Treaty.

[13] Article 5.2 of the Treaty.

[14] Article 5.2(bis) of the Treaty.

[15] Article 6.1 of the Treaty.

[16] Article 6.2 of the Treaty.

[17] Also sometimes referred to as folklore, TCEs are the forms in which traditional culture is expressed, e.g. songs, dances, handicraft, designs, ceremonies, tales and other artistic or cultural expressions. See Intellectual Property and Genetic Resources, Traditional Knowledge and Traditional Cultural Expressions (WIPO, 2020), p 15.