by Dennis Crouch
For many years, there have been concerns about “biopiracy” – the misappropriation of genetic resources (GR) and traditional knowledge (TK) from indigenous peoples and local communities, often in developing countries. Biopiracy involves researchers or companies obtaining GR or TK, using it to develop commercial products like medicines, and obtaining patents without adequately compensating or getting permission from the original TK/GR holders.
Some well-known examples of alleged biopiracy include: patents on wound-healing properties of turmeric, which had long been known in India; patents related to neem tree extracts, also used for centuries in India; Japanese and American patents on extracts of the African “Hoodia” cactus, traditional used by San people to stave off hunger; and a US patent on the Amazonian “ayahuasca” vine, considered sacred and used in ceremonies by indigenous peoples. You can see a Sean Connery look-alike doing this in my image below.
World Intellectual Property Organization (WIPO) member states have adopted a groundbreaking new treaty addressing patent rights in the context of these genetic resources and traditional knowledge associated with genetic resources. The WIPO Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge, finalized on May 24, 2024, marks the first WIPO treaty in over a decade and the first to specifically address the rights of Indigenous Peoples and local communities. This historic agreement aims to enhance transparency by requiring patent applicants to disclose the country of origin of any Genetic Resources and the “Indigenous Peoples or local community” who provided any Associated Traditional Knowledge. The disclosure requirement is triggered when a “claimed invention” is “based on” the GR or TK. The treaty only becomes effective once 15 eligible member nations ratify the agreement. The agreement here also relates directly to the UN Convention on Biological Diversity (CBD), adopted in 1992, establishing that states have sovereign rights over their GR, and that access to GR should be subject to prior informed consent and equitable benefit-sharing.
We know that US patentees have a duty to disclose information material to patentability, but this agreement takes things a substantial step further – requiring additional disclosures when the invention is based upon a GR or associated TK.
Some definitions for the new treaty:
- Genetic Resources (GR): “Genetic material of actual or potential value” but not including “human genetic resources.” The definition generally includes material, regardless of origin, “containing functional units of heredity.”
- Traditional Knowledge (TK) associated with Genetic Resources: This is not expressly defined within the agreement, but TK has been defined previously by WIPO to include “knowledge, know-how, skills and practices that are developed, sustained and passed on from generation to generation within a community, often forming part of its cultural or spiritual identity,” including know-how, practices, skills, and innovations.
- Based on: A claimed invention is only “based on” GR or TK if they “must have been necessary for the claimed invention” and, “the claimed invention must depend on the specific properties of the genetic resources and/or on the traditional knowledge.” In this final version, the disclosure requirement was significantly weakened — an earlier draft would have required disclosure if the GR/TK was “material to development of the claimed invention.”
Disclosure Requirement: The key provision is that each nation (or EU) must require patent applicants to disclose whenever inventions are based on GRs or associated TK. Under Article 3, contracting parties must require applicants to disclose the country of origin or source of the GRs and the Indigenous Peoples or local community who provided the associated TK. This disclosure requirement applies to all applicants seeking patents within a contracting party’s jurisdiction, including foreign applicants not subject to similar requirements in their home jurisdictions.
Remedy for Failure to Disclose: The treaty indicates that each country should create an effective and proportional sanction for situations where a party fails to disclose. However, the treaty indicates that the law cannot “revoke, invalidate, or render unenforceable” an issued patent “solely on the basis of an applicant’s failure to disclose” absent additional evidence of “fraudulent conduct or intent.” A potential result is some form of compulsory license or perhaps a profit sharing requirement. In addition, the obligations are not retroactive, meaning they do not apply to patent applications filed prior to the treaty’s entry into force. However, the treaty does not indicate whether the non-retroactive clause applies to the priority filing date or to the actual national stage or continuation filing date.
Information Systems and Relationship with Other Agreements: The treaty allows (but does not require) contracting parties to establish information systems, such as databases, for GRs and associated TK, in consultation with Indigenous Peoples, local communities, and other stakeholders. These information systems should be accessible to patent offices for search and examination purposes, subject to appropriate safeguards. The treaty also emphasizes its mutually supportive implementation with other relevant international agreements.
Prior to this last round of negotiations, the USPTO received comments from a number of parties. As two examples, both the U.S. Chamber of Commerce and Biotechnology Innovation Organization (BIO), both raising negative concerns. The Chamber argued that new patent disclosure requirements would create legal uncertainties and hinder innovation, emphasizing the lack of clear definitions for GRs and TK, which could lead to inconsistent interpretations and enforcement on a global level. The Chamber also questioned the need for a new treaty, suggesting that existing IP frameworks are sufficient. BIO similarly argued that the proposed obligations are ambiguous and would increase legal uncertainty for biotechnology firms. They highlighted the critical role of strong and predictable patent protection in fostering biotechnology innovation and attracting investments. BIO strongly opposed linking non-compliance with disclosure obligations to sanctions such as patent invalidation or compulsory licensing.
A Spicy IP post by Praharsh Gour notes that the treaty would actually weaken Indian Law by limiting sanctions already provided in its law associated with non-disclosure of genetic resource origin.
As far as I understand this, the treaty only requires acknowledgement, not compensation or even permission to use GR or TK. Nor does the treaty prevent anyone from using TK as a “lead” in the invention, as long as it does not constitute lack of novelty in the country where the application is being filed (which would have been the case without the treaty). As far as I can tell, this just creates a little extra paperwork, and if a patent practitioner hates paperwork, they are probably in the wrong field. (Inventors filing pro se may be a different story).
One could argue that the treaty doesn’t go far enough, but I don’t see that it does much harm to inventors or patent practitioners if implemented.
US has its own issues (which need to heed my past advice).
link to youtu.be
I was initially skeptical of protecting GR and TK when I took BioTech IP as part of my LLM in IP but there is some merit behind the idea. In India, they have created a patent office documenting GR and TK which is a good thing since it will lead to sharing the knowledge with the rest of the world. The WIPO treaty not providing any remedy for failure to disclose pirated GR and TK is a little troubling given how even inequitable conduct has been curtailed. Bottom line: GR and TK has more merit than it appears.
Are you conflating ‘promoting innovation’ with (merely) ‘publication and access?’
The Indian “..patent office documenting GR and TK which is a good thing since it will lead to sharing the knowledge with the rest of the world.” I.e., if that is a free public internet-searchable database of prior art it is indeed a good idea. But that is completely different in IP operation, IP public burden and IP public confusion from “The WIPO Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge, finalized on May 24, 2024”
Given the numerous conditions, limitations, exceptions, undefined terms, grey areas, etc. of what is at most a suggestion or recommendation, this “Treaty” is:
All show and no go.
D.O.A. R.I.P.
p.s. Back in 1968 my mother applied a poultice of specific herbs and spices (an old family recipe from the 1300’s) to a bad wound from a bicycle fall in the street.
Healed completely in less than 72 hours.
Accordingly, please send me my share of the license fees anyone receives from this poultice. Or else!
Recently reported is an observation of a wild orangutan applying chewed leaves of a particular local plant to its wounds. Since that must have been learned from other members of the local orangutans, could exploiting that medical information be covered in this treaty under its scope of “local community”?
This has been the law in Brazil for decades now, and it is a nothingburger. There is a box that one must check on the pre-exam notice indicating whether the invention is made from Brazilian genetic material or Brazilian indigenous knowledge. Never once have I ever had to check that box. It would not have made any difference if one replaced “Brazilian” with some other nationality. Long experience suggests that—even if this treaty is ratified—it will make no real-world difference.
How Martha Vineyards of you (even as you continue to signal with the likes of Noah and Yglesias….
This WIPO treaty contains important statements but their enforcement requires a different approach in indexing and making available biological sequence information in patent literature, starting from WIPO itself. Until when:
– a PCT filing date can be obtained and overall PCT proceedings can be pursued in absence of any sequence listing (even if such sequences are explicitly cited in the text) and
– WIPO does not provide users with a trustworthy and efficient search engine to identify biological sequence information within patent documentation (by the way, to be filed with according own ST.25/ST.26 standard);
The means to achieve Art.1 ambitious objectives are limited and relying upon the intermediation of other organisations (INSDC, EMBL-EBI, DDBJ, NIH-NCBI, Lens.org) having own practices and standards for retrieving, organising, indexing, and making available patent-disclosed sequences that possibly not many users and stakeholders actually know or understand.
Thus it is of major importance how/when the working groups indicated in 7.3 will trigger the implementation of the dedicated processes and databases for proper access, indexing and search in biological sequence information that is disclosed within patent documentation.
Finally, given the quick developments in AI-Driven drug discovery, we cannot exclude the possibility of “re-discovery” of biological tools and products present (but poorly or not understood) in genetic resources present from specific environments or organisms using AI technologies, with interesting patentability questions to be evaluated.
That guy is not a Sean Connery “look alike”. Looks a lot more like James Garner with white hair and beard.
What an absolute waste of resources. Traditional Knowledge??? Poppycock. Double standards for IP rights to pander to whinging nations and to give the academic communities something to do.
A solution in search of an imaginary problem [and creating a new one] in view of AIA 102 1(a) [& thus also 103 art] rendering unpatentable anything anywhere in the world published or “in public use” or on sale “or otherwise available to the public” more than one year prior, which terms are broadly judicially defined.
Not even to mention all the historical and socialogical and national boundaries issues of which group within which modern country may have first used a particular native plant with a particular [unisolated and unpurified] active ingredient for a particular problem?
Amen. The patent system exists to encourage publication of useful inventions to make them available to the public. If I secure a patent on turmeric as a treatment for wounds, complete with documentation of clinical results and dosage guidelines for maximum effectiveness, and you complain that your grandmother always used to tell you that turmeric was good for cuts (along with ten thousand other dubious folk remedies she told you about), why on earth should that prejudice my rights? You and your grandmother had the same opportunity to take advantage of the patent system — and disclose your “knowledge” to the public — that I did. Instead you decided to keep it secret, just like any corporation choosing to roll the dice on trade secret protection instead of public disclosure. But in this case… what, you get to have your cake and eat it too?
And are we to understand that this double standard will apply on the basis of group membership? If so, group membership based on what? The good old blood quantum used to determine membership in a tribe? My god, it feels like we’re living in 1924, not 2024. I though we’d left this idiotic race-science tribal barbarism long behind us.
“Instead you decided to keep it secret, just like any corporation choosing to roll the dice on trade secret protection instead of public disclosure.”
Grandmas and their Grandma secrets! They can’t keep getting away with it!
In any event, anyone looked into the supposed trade secret misappropriation etc. where Boeing apparently gave Virgin Galactic their super secret equations by mistake and is now hitting them with a trade secret suit?
“Colonialism bashing” as an excuse for defective national economic policies, even in countries independent for a long time, is still alive and well.
If the claim is on use of turmeric to treat wounds, then under your scenario the claim is anticipated – the claimed method was known.
But if I identified the specific compound or combination of compounds in turmeric that work, and claim that combination – that’s novel. And, depending on the specifics, non-obvious as well.
My beef is with the countries that want to prevent the grant of patent claims in the latter situation.
Are you not merely ‘releasing’ the baseball bat already present in the block of wood?
After all, if all that you are doing is “identifying,” you are just noting something already there, eh?
/s (fyi)
Before making that assumption that identifying the specific compound that works in a preexisting naturally occuring plant or animal used for the same or similar purposes is validly patentable in the U.S., take a look at Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948), the exceptions listed in Diamond v. Chakrabarty, 447 U.S. 303, 309, (1980), and especially Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589-91, 106 (2013).
… “Equity.”
What, you don’t like this?
Re: “Some well-known examples of alleged biopiracy include: patents on wound-healing properties of turmeric, which had long been known in India,…” I don’t know about the other allegations listed after that, but as I recall a couple of Indian American doctors filed a patent application on that subject a few years ago, which was rejected based on old prior publications, as expected. i.e., no such “biopiracy.” Has anyone checked the truth of the other allegations?
See 1209 OG 1954 – the April 21 OG – notice of B1 5,401,504 — cancelling claims 1-6 of the notorious U. Miss. Tumeric [it is NOT spelled Turmeric in the title, but it IS in the claim, for further confusion] wound healing patent protested by the Indian Government. [Turmeric is even a central ingredient of curry.]
However, I had also noted another report, on a 5/18/2012 issued U.S patent to the University of Rochester and two other entities for the use of compounds related to turmeric [not just turmeric itself] against cancer, acne, baldness, and other medical conditions. As reported “the patent is for research led by Chawnshang Chang, Ph.D., director of the George Whipple Laboratory for Cancer Research at the University of Rochester Medical Center. Chang was one of many researchers worldwide investigating the potential biomedical benefits of compounds related to curcumin. Two dozen patents dating back to 2004 have been issued to the University for Chang’s work on compounds related to curcumin. Chang’s work at the University was licensed to AndroScience Corp. of San Diego, a biotech company co-founded by Chang. The University owns a stake in the company.”