A President’s draft was announced in the 9pm session on May 22 of the of the World Intellectual Property Organization’s negotiation of a treaty (see infra) on “Intellectual Property, Genetic Resources and Traditional Knowledge Associated with Genetic Resources” (aka the IGC Treaty, after the Intergovernmental Committee which did the preparatory work). If the draft was adopted as it now stands, it explains what could be described as a trade off between developed countries agreeing to internationalize a mandatory obligation of disclosure and developing countries agreeing to restrict patent revocations for non-compliance. That trade off is uncertain, however, because Article 6, which would require the restriction of revocation remedies, is still being finalized.
Article 3: Mandatory Disclosure
The key win for the proponents of the treaty are contained in Article 3, which mandates disclosure of genetic resources and associated traditional knowledge in patent applications in a binding treaty.
The obligation in Article 3 is mandatory. It uses “shall.” And the President’s Proposal is labeled a “WIPO Treaty” – not a joint recommendation or other form of soft law guidance. 44 countries are at the Conference with the “full powers” needed to create a binding treaty.[1]
The disclosure requirement is provided in Articles 3.1 and 3.2. The text, with changes from the initial text to the President’s Proposal indicated, states that for an invention in a patent application “based materially/directly” on” genetic resources or associated traditional knowledge, “each Contracting Party shall require applicants to disclose” the origin or source, unless the information “is not known to the applicant.”[2] There is a duty to allow an applicant to cure a failure to provide such information.[3] And there is a duty to prevent patent offices from attempting to “verify the authenticity of the disclosure.”[4]
The key benefit of Article 3 is harmonization. It will likely promote many other countries to adopt disclosure requirements and may enable the creation of compilations of information that make tracking uses of GR and TK more efficient and widespread, including to enable access and benefit sharing.
The President’s Proposal does not propose to explicitly cover digital sequence information, as some observers and delegations had proposed. The issue of covering DSI is discussed in https://infojustice.org/archives/45759
Article 6: Restrictions on Sanctions And Remedies
On the other side, the President’s Proposal contains a major win for the highly industrialized “Group B” countries who are most concerned with the rights of patent holders. Article 6 proposes that “no Contracting Party shall revoke or render unenforceable a patent solely on the basis of an applicant’s failure to disclose the information specified in Article 3.:
6.1 Each Contracting Party shall put in place appropriate, effective and proportionate legal, administrative, and/or policy measures to address
an applicant’sfailure to provide the information required in Article 3 of this Instrument.6.2 Subject to article 6.2(bis), e
Each Contracting Party shall providean applicantan opportunity to rectify a failure to include the minimum information detailed in Article 3 before implementing sanctions or directing remedies.6.2(bis) A Contracting Party may exclude from the opportunity to rectify under Article 6.2 cases where there has been fraudulent conduct or intent as prescribed by national law.
6.3 Subject to Article 6.4, no Contracting Party shall revoke or render unenforceable a patent solely on the basis of an applicant’s failure to disclose the information specified in Article 3 of this Instrument.
6.4 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.
The President’s Draft expands a duty to rectify failures to provide required information into post-grant processes. Previously, Article 6 had applied only to “applicants,” suggesting that it was for pre-grant procedures. The President’s Proposal deletes that term, making it applicable to post-grant revocation proceedings as well. In such proceedings, the government must offer an opportunity to rectify the omission, unless there is “fraud.” It is for countries to define what is fraudulent.
Article 6.3 bans the use of revocations “solely on the basis of an applicant’s failure to disclose the information specified in Article 3 of this Instrument.” 6.4 makes it clear that countries can revoke patents in cases where the withholding of information is with fraudulent intent.[5] But 6.3 allows countries to go further — defining a class of cases that do not involve fraud but also are not “solely on the basis of an applicant’s failure to disclose the information specified in Article 3 of this Instrument.” [6]
Article 6’s restriction on revocation proceedings is a major concession to patent holders. As described in https://infojustice.org/archives/45759, 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.[7]
Article 6 is still being negotiated as of the writing of this note. So the final balance may be changed. But it appears that some kind of restriction on remedies may be the cost of harmonizing a disclosure standard.
Deletion of Previous Article 4: Limitations and Exceptions
One major issue in the negotiation was largely avoided. The President’s Draft eliminates the proposed language in the first draft on limitations and exceptions.
An analysis of the initially proposed language on exceptions is available at https://infojustice.org/archives/45740 On one of the first days of the Conference, the Chair of Committee I announced in a public plenary that “There appears to be adequate support for eliminating Article 4, limitations and exceptions,” although at that time “Some parties were opposed.” The President’s Proposal does not include an exceptions article.
Conclusion
Negotiators are fond of saying nothing is agreed until everything is agreed. The President’s Proposal is not an official document. It is an attempt to describe a possible consensus. But word in the hallways is that it is close to expressing the landing zone.
[1] See ThiruGeneva, “.@WIPO Diplomatic Conference to Conclude an International Legal Instrument Relating to Intellectual Property, Genetic Resources and Traditional Knowledge Associated with Genetic Resources – Those with full powers (44 States) and those without full powers (131 delegations).” (May 21, 2024), https://x.com/ThiruGeneva/status/1792841763184681274
[2] See Article 3.3. (“In cases where none of the information in paragraphs 3.1 and/or 3.2 is known to the applicant, each Contracting Party shall require the applicant to make a declaration to that effect”).
[3] See Article 3.4 (3.4 Offices shall provide guidance to patent applicants on how to meet the disclosure requirement as well as an opportunity for patent applicants to rectify a failure to include the minimum information referred to in paragraphs 3.1 and 3.2 or correct any disclosures that are erroneous or incorrect).
[4] Art. 3.5.
[5] See https://infojustice.org/archives/45759 (reporting that Romania has the only revocation proceeding for fraud in a GR disclosure in laws reviewed in a WIPO document).
[6] See, e.g., 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.”).
[7] 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.”).
