Diplomatic Conference: Intellectual Property, Genetic Resources and Associated Traditional Knowledge

If the gestation period for dogs is two months, for humans it is nine months, and for African elephants it is a whopping twenty-one months, what is the gestation period for an international legal instrument—patent treaty—designed to ensure patents do not inadvertently incorporate traditional knowledge?

If you guessed twenty-four years, congratulations!  You have a preternatural understanding of how difficult it is for states with conflicting interests to reach consensus on this kind of instrument. (Thirteen African elephants can be born successively to the same mother in twenty-four years.)

In a mere few days, for 12 days between May 13th and 24th, the World Intellectual Property Organization’s (WIPO) Diplomatic Conference of the Intergovernmental Committee (IGC) will convene for the final stage of negotiations and the adoption of an international legal instrument (Instrument) that will link patent systems with protection of traditional knowledge (TK) associated with genetic resources (GR).

How will the Instrument Work?

When this Instrument is signed by national delegates to the Conference and ratified later by the states they represent, how will this change the patent landscape? Who will reap the benefits and who will fund those benefits? Answers to those questions, are given in the WIPO publication, “Key Questions on Patent Disclosure Requirements for Genetic Resources and traditional Knowledge” (Second Edition, 2020, p. 10, hereinafter “Key Questions on PDR”).

The Instrument will include a Patent Disclosure Requirement (PDR), which will obligate patentees to consider whether their invention includes a genetic resource associated with traditional knowledge. If so, the patentee would need to disclose such information in their applications. Specifically, the Key Questions on PDR states:

“By extending that disclosure obligation, it is argued that it may be possible to simultaneously enhance the transparency of the patent system and monitor the contribution of traditional knowledge and genetic resources to new patentable inventions, potentially helping to ensure that such knowledge and resources are used with the permission of the countries and/or communities from which they originated, and that some benefits from the resulting inventions are shared with those countries and/or communities.” (at p. 8, emphasis added)

The text reformulates these same themes in language appeasing the more assertive advocates of protecting TK:

“In other words, it is claimed that disclosure requirements may help to prevent the misappropriation of genetic resources and traditional knowledge by ensuring that they are used with the prior informed consent (PIC) of the provider countries and/or their legitimate holders, on mutually agreed terms (MAT).” (emphasis in the original text)

[IGC publications are chock-full of acronyms, which is a bit annoying until one gets used to them, after which they do facilitate reading flow]

In the evolution of the IGC process (i.e. the twenty-four year “gestion” period), a leap towards its now-imminent fruition was made a few years ago when the “Basic Proposal for an International Legal Instrument” was drafted. It would establish the aforesaid new mandatory PDR. Patent applicants would be required to disclose the area and (if known) the indigenous peoples or local community providing the associated TK (the ATK) in cases where the claimed inventions are “materially/directly based on” GRs with ATK.

There will be flexible velvet-lined hammers for non-compliance with the PDRs. I use the term “flexible” because the penalties would be “proportional and appropriate” and crafted according to national law. I say “velvet-lined” because failure to disclose would not result in patent revocation or unenforceability unless there has been fraudulent intent.

What about pending patent applications? Will the Instrument reach into the past? The Basic Proposal provides for non-retroactivity; it will not apply to a patent application filed prior to the ratification of the Instrument by a WIPO member state. But how will patent applicants learn about GRs with ATK that they would be required to disclose? Information systems (e.g. databases) would be established that are accessible to patent offices and examiners.

Why is this Instrument Important?

The Key Questions on PDR helps explain this through the example of the Oubli berry. The West African people of Gabon originally discovered and nurtured the Oubli climbing plant, which produces the Oubli berry. The berry is named as such because it is so sweet and West Africans have long used it to help nursing infants “forget” (oublier) their mother’s milk.  A researcher from the University of Wisconsin (UW) observed people and apes in the region eating the berries and brought the berries to the attention of the University. UW isolated and reproduced a protein, Brazzein, derived from the berry, which is up to 2,000 times sweeter than sugar and is used as a natural, low-calorie sweetener.

UW was granted three US patents related to this protein. Their success in licensing these patents to make and market this protein has obviated the need to collect, cultivate, and sell the plant in Gabon. Some claim that the synthetic substitute of Brazzein, produced using the UW patents,  has caused a significant fall in the price of Brazzein and, therefore, that many Gabonese women who once harvested the fruit have lost their source of income.

UW maintains that Brazzein is “an invention of a UW-Madison researcher” and UW offers no recognition or benefit-sharing to the people of Gabon. Some activist organizations advocating for protection of and remuneration for TK call this “Biopiracy.”

The Brazzein illustration provides a vivid glimpse of what is at stake in the completion of the treaty negotiations at the Diplomatic Conference this May. Had the Instrument and its Patent Disclosure Requirement been in force in the United States at the time of filing of the UW patent applications, UW would have been legally obligated to consider whether Brazzein is a genetic resource associated with traditional knowledge they would need to disclose in their applications.

Naturally, (in both senses of the word!) GRs include many kinds of things besides berries. They include: microorganisms, plant varieties, animal breeds, genetic sequences, nucleotide and amino acid sequence information, traits, molecular events, plasmids, and vectors, among other things.

Why has it Taken so Long to Finalise the Instrument?

Of course, it does not normally take twenty-four years, from conception to birth, to finalize a patent treaty. Here, the parties involved have interests that greatly diverge. On one side are the inventors and their assignees, and the implementers of modern technologies. It was for them that the patent system was shaped to incentivize and protect their research and development. On the same side, in this context, are those, such as generic drug suppliers and the public at large, who benefit from the “patent bargain” when inventions become public domain at the end of the patent term.

On the other side and in some sense at the margins, are the indigenous people and local communities who have not at all benefited when it is their TK that forms or has formed the basis of a twenty-year patent monopoly, as in the case of Brazzein.

The IGC was established in 2000 and a year later it had its first meeting. In 2003, the question arose whether it was premature to embark on setting normative outcomes, which the countries in favour of protection of GRs with ATK (in this case, the “demandeurs”) were asking for.

The “non-demandeurs” wanted the “issues” explored first, (for example, what exactly is “traditional knowledge” and “GR with ATK”?) This disagreement can be framed as the “Topics vs. Treaty” divide. In 2005, to prevent the project from stagnating in the doldrums, the Secretariat of the IGC prepared analyses of the gaps between current IP systems and the aspiration of Indigenous Peoples. WIPO also created a Voluntary Fund to support indigenous participation in IGC sessions and hired an indigenous person to contribute to the TK Division.

In 2010, a decade after inception, a major step was accomplished with “text-based” negotiations. As well, smaller informal groups were formed, to meet between annual plenary sessions and to energize those ponderous sessions. A “this is a Marathon not a sprint” perspective was adopted, which helped to counter debilitating pessimism. In 2012, what we now know to be the half-way point of the IGC, a single text was created to chew on, and a new patent disclosure requirement emerged as the operative mechanism.

However, during the next seven years, until 2019, another period of languor occurred; there was little wind, and the sails were barely fluttering. The opposing camps of demandeurs and non-demandeurs were repeating their well-known positions and there were no negotiations taking place to find common ground and create compromise.

In 2019, the wind picked up when the IGC Chair prepared a draft internal legal instrument on GRs and ATK, and in 2020 the Second Edition of the Key Questions on PDR, weighing in at 95 pages, was published. By the fall of 2023 the wind was blowing steadily. The IGC held a special session, in which revisions to substantive articles was agreed to and a Preparatory Committee approved the modalities of the Diplomatic Conference set for May 2024.

Now and the Immediate Future for Patent Practitioners

Today, nearing the end of the IGC gestation, in the time that thirteen sibling African elephants have been born, delivery of the Instrument is only days away. It will be highly interesting to see how many countries sign it at the end of the Conference, how many sign it in the months that follow, and how quickly the signees’ governments ratify their adherence.

When Canada ratifies the Instrument, we will await with bated breath to see how often patent disclosure of GR and ATK occurs in Canadian patent applications, as IP practitioners learn the ropes on making disclosure themselves.

Author: RICHARD S. LEVY*, Levy IP Law and Dispute Resolutions (Member of the IPIC Indigenous IP Committee)

*the author wishes to thank Meika Ellis for editing and improving this article.