The new WIPO Treaty on Intellectual Property, Genetic Resources, and Traditional Knowledge integrates patents with sustainability, but poses serious challenges for patent applicants.
After nearly a quarter-century of discussions, the World Intellectual Property Organization (WIPO) approved on May 24, 2024, a significant IP treaty: the WIPO Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge.
Upon ratification by 15 contracting parties, the Treaty will establish a mandatory requirement on patent applicants to disclose the country of origin or source of genetic resources ("GRs") and/or the indigenous peoples or local communities involved in providing traditional knowledge associated ("ATK") with an invention. The Treaty aims to ensure proper acknowledgment of the origins of these resources and compliance with Access and Benefit-Sharing ("ABS"), aligning with the principles outlined in the Convention on Biological Diversity ("CBD") of 1992 and the Nagoya Protocol.
As the inaugural WIPO treaty to tackle the complex intersection of intellectual property and sustainability, namely GRs, and ATK, it has been hailed as a "historic breakthrough." For skeptics who thought IP multilateralism was a relic of the past, this new instrument proves otherwise. Yet, the treaty falls short of satisfying patent owners, who must be especially vigilant regarding this new disclosure requirement when applying for and enforcing their patents.
This article provides an analysis of the new treaty, shedding light on the nature, scope, and implications of the recently introduced disclosure requirement.
Background
The journey to the treaty has been long and intricate. Initiated by Colombia in 1999, the proposal for this treaty sparked discussions that formally began at WIPO in 2001. The negotiations have included a wide range of stakeholders, from governments to indigenous communities, reflecting the treaty's broad and inclusive nature. Efforts to implement a comparable disclosure regime were initially pursued under the TRIPS Agreement in 2008 and later during the negotiations on the Nagoya Protocol for ABS from GRs. However, the proposal for "compliance checkpoints and mandatory transparency disclosure information requirements" was ultimately unsuccessful. Nonetheless, these types of disclosure obligations have subsequently been adopted under nearly 30 national regimes, including in countries like Indonesia, India, Spain, and Switzerland.
After nearly a quarter of a century of deliberations, the final stage of negotiations took place from May 13-24, 2024, culminating in the approval of the treaty by consensus of the 193 member states.
The treaty introduces an international and mandatory disclosure obligation, with potential non-compliance resulting in sanctions, including the refusal or cancellation of a patent. The treaty centers on GRs like medicinal plants, crops from farms and some animal breeds
While indigenous communities see the treaty as a milestone towards the recognition of some of their rights, organizations like Intellectual Property Owners Association ("IPOs") describe the treaty as "an additional unnecessary burden for patent applicants." They contend that ABS rules are already established in the Nagoya Protocol, which boasts over 100 member countries. Therefore, there is no necessity to introduce these rules as part of a new international instrument. Generally, patent owner associations strongly oppose utilizing the patent system to enforce unrelated legal requirements.
GRs, and ATK
GRs are defined in the CBD as genetic material of plant, animal, microbial or other origin containing functional units of heredity that have actual or potential value. GRs themselves, as encountered in nature, cannot be directly protected as IP. However, inventions based on or developed using GRs are eligible for protection through either a patent or through other IP rights.
GRs are subject to ABS regulations, in particular within the international regime on ABS of the CBD, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (the Nagoya Protocol), as well as complementary instruments, including the International Treaty on Plant Genetic Resources for Food and Agriculture ("ITPGRFA"), the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization and the Pandemic Influenza Preparedness (PIP) Framework of the World Health Organization (WHO).
Key Provisions of the treaty
i. Nature and scope of the patent disclosure
The new disclosure condition is mandatory. Patent applicants must disclose the country of origin or source of the GRs used in their inventions. If the invention is based on ATK, applicants must also disclose the indigenous peoples or local communities that provided this knowledge. The mandatory requirement only applies if the claimed inventions are "based on" GRs and/or ATK.
"Based on" means that the GRs and/or ATK "must have been necessary" for the claimed invention, and that the claimed invention "must depend on the specific properties" of the GRs and/or on the ATK. Essentially, this trigger suggests a direct causal connection between the invention and the GRs, implying that only information about those GRs and/or ATK indispensable for the invention's creation should be disclosed.
A footnote to the treaty further clarifies that "genetic resources" is intended to align with the understanding of the term in the context of the CBD – not intended to include human genetic resources. The treaty could potentially apply also to GRs obtained in areas beyond national jurisdiction such as marine GRs.
The treaty allows for national variations in the application of disclosure requirements, especially the expression "based on" which could lead to inconsistencies and increased litigation risks.
A straightforward approach could consist in the following test:
If an applicant files claims referring to specific GRs/material, then the applicant implicitly states that the invention is "based on" such material and the disclosure requirement should apply. For example:
US8206721B2
◦ 1. A method for delaying skin aging comprising applying to the skin of a subject in need thereof a product comprising an effective amount of lysed Chlamydocapsa sp CCryo 101-99 snow algae.
EP2538917B1
◦ 1. Use of a composition comprising an extract of Dionaea muscipula in cosmetic treatment of the skin, especially skin changes due to accelerated or chronological aging e.g. wrinkles, loss of firmness and elasticity, and increased pigmentation. (Dionaea muscipula is the scientific Latin name for the Venus Flytrap plant).
In contrary, ff patent description mentions GRs, but claims do not, the GRs should not be considered "necessary" to the development of the claimed invention, and the claimed invention does not depend on the specific properties of those GRs (i.e. it is a novel process that can be used with any of a wide variety of nut pastes). The disclosure requirement should not apply.
However, the description should not be completely ignored in performing the disclosure test. Below is an example where ATK might need to be disclosed, since the description of the invention mentions the name of the fruit "Quipara o Quepara: (native language of tribe etnia embera) iwhich is also found in claim 1 under another name "Genipa americana":
US 2010/0083448 A1
"A method of manufacturing a colorant comprising: A. Peeling off a Genipa americana fruit from its skin, wherein said skin is discarded, and wherein said fruit without skin is Genipa American fruit pulp; obtaining raw liquid juice from the Genipa americana fruit pulp; mixing the raw liquid juice with glycine; and, warming up the raw liquid juice mixed with glycine for a determined period of time."
Once the obligation has been triggered, applicants will need to disclose:
- either the "country of origin of the GRs" / "the indigenous peoples or local community that provides the Associated TK"; or
- if this information is not available to the applicant – the "source of the GRs" / "source of the Associate TK".
The Instrument defines "Source of the GRs" as:
any source from which the applicant has obtained the GRs, such as a research centre, gene bank, the Multilateral System of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), or any other ex situ collection or depository of GRs (emphasis added),
while "Source of Traditional Knowledge Associated with Genetic Resources" is defined as:
any source from which the applicant has obtained the traditional knowledge associated with genetic resources, such as scientific literature, publicly accessible databases, patent applications and patent publications (emphasis added).
These definitions are broad and provide a non-exhaustive lists as to from where GRs and ATK may have been sourced.
If none of this information is available, the patent applicant may produce a declaration to that effect, which will allow companies to still apply for patents if for justified reasons the relevant information is not known to them. However, this is an exception and applied in exceptional circumstances such as relevant documents having been destroyed. Upon disclosure, patent offices will not be obligated to authenticate the provided information. Nevertheless, as this information will be publicly accessible in accordance with national patent procedures, and a dedicated "Information system" on GRs and ATK will be established under the treaty, such disclosures could still activate ABS compliance reviews.
ii. Consequences of a failed disclosure
Patents would only be refused if applicants fail to disclose the required information in cases involving fraudulent intent.
Correctable Formality The disclosure requirement is classified as a formality, not a substantive condition for patentability. This means that failure to comply with the disclosure requirement should not affect the validity or enforceability of the patent.
Fraudulent Intent While non-compliance due to genuine oversight will not invalidate a patent, the treaty allows for sanctions or remedies in cases of fraudulent intent.
Post-Grant Implications Contracting parties are prohibited from revoking, invalidating, or rendering unenforceable patent rights solely based on non-compliance with the disclosure requirement, except where there has been fraudulent intent.
iii. Confidentiality
According to the treaty a patent office needs to make the disclosed information available in accordance with patent procedures, however this is without prejudice to the protection of confidential information.
iv. Entry into force
Despite there already being several mandatory disclosure regimes at the national (e.g. India) and regional levels (Andean Community) the treaty includes a non-retroactivity clause, i.e. no obligations of this instrument should be imposed in relation to patent applications filed prior to the ratification of or accession to this instrument.
Challenges
Despite the treaty's ambitious goals, serious concerns have been raised by patent owners regarding its implementation:
i. Legal Uncertainty
Ambiguities in terms like "Based on", "source" and "country of origin" are likely to create legal uncertainties. The treaty defines "country of origin" as "the country which possesses those genetic resources in in situ conditions;" and "in situ conditions" as "conditions where genetic resources exist within ecosystems and natural habitats, and, in the case of cultivated species, in the surroundings where they have developed their distinctive properties."
These definitions could lead to more than one country having a claim of origin. GRs may be found in situ in more than one jurisdiction and could lead to patent applicants being unable to satisfy the requirements of one or more jurisdictions and be forced to choose jurisdictions and potentially surrender patent rights in some jurisdictions. For example, extensive research conducted in the 1950s focused on material from vinca alkaloid plants. The plants utilized in commercial products were sourced from commercial suppliers in the United States. Additionally, evidence indicated that vinca plants were also present in Italy, South Africa, Australia, and the United Kingdom.
ii. Digital Sequence Information
Due to recent technological advances, GRs can be described with increasing ease and speed through digital sequence information (DSI). DSI often lacks clear geographical origins, complicating compliance. One question the treaty leaves unanswered is whether it encompasses DSI of GRs. Although "DSI" is not explicitly mentioned in the Treaty, earlier drafts did require applicants to have access to the "physical samples" of GRs. This provision was ultimately removed due to differing opinions, leaving the issue unresolved. This ambiguity is probably caused by the fact that the Global Mechanism for benefit-sharing from the use of DSI is under review following the COP 15, and the WIPO may await to align with the new mechanism and their definition of DSI.
iii. Confidentiality
According to the treaty the patent office needs to make the disclosed information available in accordance with patent procedures, however this is without prejudice to the protection of confidential information. It will be interesting to see the level of justification required from patent applicants for the relevant patent office to maintain confidentiality.
iv. Databases
Although the treaty does not place an obligation on patent offices to verify the authenticity of the disclosure, the development and use of GRs and TK databases is critical for the successful implementation of the treaty. Such databases will allow patent applicants and examiners worldwide to learn about the prior art effect of GRs and non-secret ATK with genetic resources. Currently such database are lacking.
v. Innovation Ecosystem
The disclosure requirements could impose significant burdens on patent applicants, particularly in the biotech, pharma, cosmetic, food and seed sectors. The need to trace the origins of GRs and ATK could discourage innovation and increase the costs and risks associated with patent filings.
vi. Benefit Sharing
There is skepticism about whether the new disclosure requirement will effectively ensure ABS and prevent biopiracy.
vii. International Variations:
The treaty allows for national variations in the application of disclosure requirements, especially the expression "based on" which could lead to inconsistencies and increased litigation risks.
viii. Entry into force:
While any instrument should be non-retroactive per the Vienna Convention on the Law of Treaties, it's notable that the non-retroactivity doesn't extend to the date of collection of GRs and ATK. This presents a significant challenge since GRs and ATK are typically collected prior to the filing of a patent application, often before applicants knew that such information will be required for assessing patentability.
Moving Forward
The forthcoming years will prove pivotal as member states endeavor to align their national legislation with the new disclosure requirement, aiming to strike a delicate balance between the interests of patent holders, researchers, and indigenous communities. The successful implementation of the treaty will set a precedent for future agreements at the intersection of intellectual property and sustainability, including trade marks, plant variety etc. The disclosure requirement will serve as an indirect means to bolster the implementation of the CBD and Nagoya Protocol by enhancing their effectiveness, underscoring the importance of careful claims drafting and description concerning GRs and ATK for patent owners.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.