The World Intellectual Property Organization adopted a landmark treaty mandating that members require disclosure of genetic resources (GR) and associated traditional knowledge (TK) in patent applications and limiting remedies for non-compliance.[1] The outcome may provide the ground rules for more countries to adopt disclosure rules and for companies to comply with them more regularly. Enough countries have signed the treaty that it could go into effect if and when most of them ratify. It appears that some of the ratifiers may have to change their existing legislation to comply, depending on how the terms of the instrument are interpreted. The treaty is a big victory for WIPO’s norm setting agenda as well as for Brazil, whose leadership helped make the agreement possible. 

Promoting harmonized disclosure 

The basic contours of the treaty followed the model of the President’s Proposal closely, which itself was very close to the draft the Conference began with. As described previously in “Trading Harmonization for Limitations on Revocation in the President’s Penultimate Draft,” the end text reflects a balance of interests of those who want to expand disclosure and the associated ability to require access and benefit sharing and those who desire to protect the rights of patent holders and bolster the stability of the global patent system.[2]

For the demandeurs, the main victory is contained in Article 3, which mandates disclosure of genetic resources and associated traditional knowledge in patent applications in a binding treaty. 

The likely beneficial result of the treaty for the interests of indigenous peoples and local communities may be a growth in the global patent system’s inclusion of disclosure obligations as a matter of course. As countries ratify the treaty, they will adopt local laws that will have a similar structure. Companies will in turn grow to include research on identification of genetic resources and associated traditional knowledge into their innovation documentation processes.

The likely growth of documentation is presaged in the Agreed Statement in footnote 4: 

Agreed Statement: The Contracting Parties request the Assembly of the International Patent Cooperation Union to consider the need for amendments to the Regulations under the PCT and/or the Administrative Instructions thereunder with a view towards providing an opportunity for applicants who file an international application under the PCT designating a PCT Contracting State which, under its applicable national law, requires the disclosure of genetic resources and traditional knowledge associated with genetic resources, to comply with any formality requirements related to such disclosure requirement either upon filing of the international application, with effect for all such Contracting States, or subsequently, upon entry into the national phase before an Office of any such Contracting State.[3]

One treaty cannot generally mandate what another treaty body does. Thus, the agreed statement is framed as a “request” of the PCT Assembly. But a request in a WIPO treaty of a WIPO body is likely to be paid attention to. Thus, one can assume that the PCT process, which processes over 250,000 patent applications a year, will one day include a standardized way for companies to report uses of GR and TK.[4] The application may need to include some representation of due diligence for countries like South Africa that require disclosure of information the applicant “ought reasonably to have known.” 

Restraining remedies

For the patent holders and their allies, the Treaty prohibits the use of revocation of patents as a standard remedy for failure to comply with GR and TK disclosures. The prohibition of uses of disclosure was negotiated until the last moment, with the following paragraphs in what is now Article 5 (formally Article 6) agreed to in the late hours of the last day:

5.2 Subject to Article 5.2(bis), each Contracting Party shall provide an opportunity to rectify a failure to disclose the information required in Article 3 before implementing sanctions or directing remedies.

5.2(bis) A Contracting Party may exclude from the opportunity to rectify under Article 5.2 cases where there has been fraudulent conduct or intent as prescribed by national law.

5.3 Subject to Article 5.4, no Contracting Party shall revoke, invalidate, or render

unenforceable the conferred patent rights solely on the basis of an applicant’s failure to disclose the information specified in Article 3 of this Treaty.

5.4 Each Contracting Party may provide for post grant sanctions or remedies where there has been fraudulent intent in regard to the disclosure requirement in Article 3 of this Instrument, in accordance with its national law.[5]

The end agreement maintained the change in the President’s Proposal that expanded the duty to provide an opportunity to rectify errors in disclosure beyond an “applicant.” This suggests that a government who finds a failure to adhere to disclosure of GR and TK would have to allow for the missing information to be provided before invalidating or otherwise sanctioning the patent holder in any post-grant review. This is a key protection for patent holders in enforcement litigation where normally a defendant can respond to an enforcement action by proving that the patent was invalid because of a lack of adequate disclosures, for example of relevant prior art.

New paragraph 5.2(bis) clarifies that sanctions can occur without an opportunity to rectify if there “has been fraudulent conduct or intent.” As reported earlier, only one country — Romania — is known to have a GR law that allows revocation only in case of “fraud.”[6] It is phrased in the past tense — “has been” fraud — leaving some question as to whether a finding (but perhaps not appeal) of fraud must occur at some level of government before the refusal of a rectification opportunity. What if fraud is merely alleged, but not yet found?

The final draft extends the sanction protection beyond revocation to any remedy that may “invalidate, or render unenforceable the conferred patent rights.” The only law in a WIPO document’s survey that alters patent rights without a revocation is Burundi, where the law requires a forced transfer of ownership of the patent to the government.[7] Other laws, such as Brazil’s, which penalize only with fines, may be implemented as long as a duty to rectify is offered first.

There is some room for interpretation of the connection between 5.3 and 5.4. Clearly a country may use revocation or invalidation as a remedy for a failure to disclose if there is a finding of “fraudulent intent.” But 5.3 seems to define a larger class of cases where revocation or invalidation may be a remedy as long as it is not a sanction “solely” for a failure to disclose. For example, what if in addition to the failure to disclose the applicant also did not rectify the failure within a reasonable time? That might be more than “solely” failing to disclose, even though it might be for reasons (failure of diligence, etc.) less than fraudulent intent. 

In the end, the mood in the negotiation rooms was that delegates were willing to restrict more aggressive remedies in order to promote voluntary disclosures with less fear of the repercussions of mistakes. How many countries will feel compelled to amend their existing laws remains to be seen. 

The Signatories to the Treaty   

Article 17 states that the Treaty will enter into force three months after 15 parties deposit an instrument of ratification or accession. Under international law, for most countries ratification and signature are separate, with ratification often requiring a legislative act whereas signature may take place by an executive with “full powers” to bind the country. Signature of the treaty was opened at the end of the conference and at least 30 countries signed. As shown in the table below, many of the countries that signed do not presently have a law requiring disclosure of GR or TK, suggesting that the treaty may indeed help expand the number of countries with such laws. Only two of the signatories (South Africa and Namibia) appear to allow revocation of patents as a standard remedy, suggesting that amendment of their domestic law may be required for them to ratify. Notably, India did not sign the treaty yet. 

Treaty Signatories[8]

SignatoryNational Law on GR or TK DisclosureRevocation as Sanction
South AfricaPatents Amendment Act 2005 (Act No. 20 of 2005) (Section 2) (requires disclosures of genetic resources and traditional knowledge)Section 61 (authorizes revocation of a patent for “a false statement or representation which is material and which the patentee knew or ought reasonably to have known to be false”
AlgeriaNo law
Bosnia HerzegovinaNo law
BrazilLaw No. 13.123 of May 20, 2015 (Access and Benefits Sharing of Genetic Resources and Associated Traditional Knowledge) NA. See Art. 80 (defining fines, not revocation, as remedy).
Burkina FasoNo law
ChileNo law
ColombiaNo law
CongoNo law
Cote d’IvoireNo law
EswatiniNo law
GhanaNo law
Marshall IslandsNo law
LesothoNo law
MadagascarNo law
MalawiNo law
NamibiaIndustrial Property Act, 2012 (Act No. 1 of 2012) (Amended by Act No. 8 of 2016) Application for a patent Section 24 (2) biological resources or associated indigenous or traditional knowledge Section 65 (providing that Tribunal “must invalidate the patent if the person requesting the invalidation proves that any one of the following grounds for invalidation applies,” including failure to disclose GR or TK 
NicaraguaNo law
NigerNo law
NigeriaNo law
ParaguayNo law
Central Africa RepublicNo law
Democraric People’s Republic of KoreaNo law
Republic of TanzaniaNo law
Sao Tome and PrincipeNo law
Saint Vincent and the GrenadinesNo law
SenegalNo law
UruguayNo law
VanuatuPatents Act No. 2 of 2003 PART 12 INDIGENOUS KNOWLEDGE REGISTRATION OF PATENT INVOLVING INDIGENOUS KNOWLEDGE 47. NA. 47. […] (4) (providing that if the required agreement with a community has not been made, then the patent may still be granted and used but the Registrar “is to determine the amount payable to the custom owners” as “an equitable share of the benefits from exploiting the patent.”

As described in “Article 6 of the WIPO IGC Treaty: Restraining Revocation,” many laws in developing countries explicitly authorize revocation of granted patents for non-compliance with genetic resource disclosure requirements that may have to be changed if the Treaty is ratified by them.[9]

A Victory for WIPO and Brazil

The conclusion of the treaty was a victory for the leadership of WIPO and Brazil.

There has been a tone in WIPO for many years that the age of norm setting in the institution may be threatened, if not over. This treaty has been on the agenda at WIPO for over 20 years. But suddenly there is a www vigor to moving treaties. Another long languishing treaty, the Design Law Treaty, will also go to a diplomatic conference this year. And the 20+ year old Broadcast Treaty is likely to be sent to finalization next year. Three international treaties by the end of Daren Tang’s term will be a great, and unexpected, accomplishment. 

The treaty would not have happened without the leadership of Brazil. When the Diplomatic Conference was announced, no country agreed to host it — and provide the high level leadership normally required to reach the outcome. WIPO had to host the conference in Geneva. But Brazil agreed to provide the sophisticated and experienced leadership of ambassador Guilherme de Aguiar Patriota to see the treaty through. He and the Brazil delegation provided able facilitation and mediation. And it cemented Brazil in a leadership role in the global south, orchestrating a win that was long sought by its African counterparts that Brazil desires closer diplomatic ties to.

Footnotes

[1] World Intellectual Property Organization. WIPO TREATY ON INTELLECTUAL PROPERTY, GENETIC RESOURCES AND ASSOCIATED TRADITIONAL KNOWLEDGE, adopted by the Diplomatic Conference. GRATK/DC/3, May 24, 2024. Diplomatic Conference to Conclude an International Legal Instrument Relating to Intellectual Property, Genetic Resources and Traditional Knowledge Associated with Genetic Resources, Geneva, May 13 to 24, 2024. https://www.wipo.int/edocs/mdocs/tk/en/gratk_dc/gratk_dc_7.pdf

[2] Sean Flynn, TRADING HARMONIZATION FOR LIMITATIONS ON REVOCATION IN THE PRESIDENT’S PENULTIMATE DRAFT, InfoJustice (May 23, 2024), https://infojustice.org/archives/45774.

[3] World Intellectual Property Organization, WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, adopted by the Diplomatic Conference, GRATK/DC/3, footnote 4 (May 24, 2024). https://www.wipo.int/edocs/mdocs/tk/en/gratk_dc/gratk_dc_7.pdf.

[4] World Intellectual Property Organization, IP Facts and Figures. https://www.wipo.int/en/ipfactsandfigures/patents.

[5] World Intellectual Property Organization, WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, adopted by the Diplomatic Conference, GRATK/DC/3, page 5 (May 24, 2024). https://www.wipo.int/edocs/mdocs/tk/en/gratk_dc/gratk_dc_7.pdf.

[6] See Disclosure Requirements Table related to genetic resources and/or traditional knowledge, https://www.wipo.int/export/sites/www/tk/en/docs/genetic_resources_disclosure.pdf (Romania, Art. 53: “Failure to meet one or more of the formal requirements concerning the patent application shall only constitute grounds for revocation or cancellation of the patent, either wholly or in part, where said failure resulted from fraudulent intentions.”).; See also Sean Flynn, ARTICLE 6 OF THE WIPO IGC TREATY: RESTRAINING REVOCATION, InfoJustice (May 22, 2024), https://infojustice.org/archives/45759.

[7] Disclosure Requirements Table, supra (Burundi, Law No. 1/13 of July 28, 2009, Article 406: “The competent authority shall be entitled to claim ownership of any patent application filed or any patent granted in a manner which does not comply with the provisions of Article 21 concerning genetic resources.”).

[8] This table was created with research assistance from PIJIP fellow Haddija Jawara.

[9] See Disclosure Requirements Table related to genetic resources and/or traditional knowledge, https://www.wipo.int/export/sites/www/tk/en/docs/genetic_resources_disclosure.pdf (collecting laws), quoting Andean Region, Decision 391, Common Regime on Access to Genetic Resources (“The Member Countries shall not acknowledge rights, including intellectual property rights, over genetic resources, by-products or synthesized products and associated intangible components, that were obtained or developed through an access activity that does not comply with the provisions of this Decision. Furthermore, the Member Country affected may request nullification and bring such actions as are appropriate in countries that have conferred rights or granted protective title documents.”); Burundi, Law No. 1/13 of July 28, 2009 relating to Industrial Property, art. 406 (“The competent authority shall be entitled to claim ownership of any patent application filed or any patent granted in a manner which does not comply with the provisions of Article 21 concerning genetic resources.”); India, Patents Act, 1970, § 64 (providing for revocation of patents on a petition of any person interested or of the Central Government by the Appellate Board or on a counter-claim in a suit for infringement, including “that the complete specification does not disclose or wrongly mentions the source or geographical origin of biological material used for the invention”); Iran, Patents, Industrial Designs and Trademarks Registration Act, art. 67 (providing that “[t]he competent court shall invalidate a Patent” for “furnishing of false information” or “non-compliance with the laws and regulations related to the manner of access to genetic resources”); Namibia, Industrial Property Act, 2012, § 65 (providing that the “Tribunal must invalidate the patent” on grounds that “any of the requirements of [GR disclosure law] has not been complied with”); Peru, Decision 391, Common Regime on Access to Genetic Resources (“Failure to comply with this obligation shall be a cause of refusal or invalidation”); Uganda, Industrial Property Act, 2014, § 90 (requiring invalidation by a court if “the patent does not fully describe and ascertain the invention” as required by GR law); Ecuador, Industrial Property Law, art. 303 (authorizing declaration of invalidity of a patent “at the request of any person demonstrating a legitimate interest”); Samoa, Patents Act 2013, art. 17 (“Any interested person may apply to the Supreme Court to invalidate a patent” including for noncompliance with GR disclosure law); South Africa, Patents Act 57 of 1978, § 61 (“Any person may at any time apply in the prescribed manner for the revocation of a patent” if the application “contains a false statement or representation which is material and which the patentee knew or ought reasonably to have known to be false at the time when the declaration statement or representation was made.”).; See also See also Sean Flynn, ARTICLE 6 OF THE WIPO IGC TREATY: RESTRAINING REVOCATION, InfoJustice (May 22, 2024), https://infojustice.org/archives/45759.