Article 6, including authorizations to revoke patents for a failure to disclose genetic resources (“GR”) or associated traditional knowledge (“TK”) has emerged as another contentious issue in this week’s negotiation of the World Intellectual Property Organization (WIPO) diplomatic conference on an instrument 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). This note explains the debate and shares research on how national laws treat the issue. At bottom, including the current Article 6.3 and 6.4 of the treaty would require the amendment of nearly every developing country law on genetic resources toward the adoption of the EU standard, which treats disclosure of genetic resources differently than other types of required disclosures in a patent application.
ARTICLE 6, SANCTIONS AND REMEDIES
Article 6 provides the text on sanctions and remedies. Among the controversies in the section is Article 6.3, which states 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,” unless, as permitted by 6.4, there has been “fraudulent intent” in the failure to disclose (Article 6.4). The text of the draft instrument states in relevant part:
6.1 Each Contracting Party shall put in place appropriate, effective and proportionate legal, administrative, and/or policy measures to address an applicant’s failure to provide the information required in Article 3 of this Instrument.
6.2 Each Contracting Party shall provide an applicant an opportunity to rectify a failure to include the minimum information detailed in Article 3 before implementing sanctions or directing remedies.
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 disclosure requirement is provided in Articles 3.1 and 3.2, which provide:
Where the invention in a patent application is based [materially/directly] on genetic resources [or, by virtue of 3.2, associated traditional knowledge], each Contracting Party shall require applicants to disclose:
(a) The country of origin of the genetic resources, or,
(b) In cases where the information in sub paragraph (a) is not known to the applicant, or where sub paragraph (a) does not apply, the source of the genetic resources.
Article 3.3 clarifies that the disclosure requirement only applies where such information is “known.”
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
There is also a duty to allow an applicant to cure a failure to provide such information:
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.
It is important that Article 3 refers only to applications for a patent. Once the patent is granted, then Article 6.3 and 6.4 govern when a patent may be revoked based on the failure to disclose the required information. Thus, the revocation authorization applies only when an applicant fails to disclose known information on GR and TK in an application and has been given an opportunity to rectify a failure to include the minimum information or correct any disclosures that are erroneous or incorrect.
Revocation for Failing to Disclose GR in Developing Countries
Article 6.3 is contrary to the laws of most developing countries that require disclosure of GR or TK in patent applications. Such laws all make patent rights depend on disclosure and most explicitly authorize revocation of granted patents if it becomes known that they did not comply with the disclosure mandates.[1] None of the laws require that the failure to disclose have a “fraudulent intent” in order to invalidate a patent that fails to disclose required GR information. In essence, these laws would permit or require revocation for a failure to disclose known GR or TK information as required by Article 3 of the IGC Treaty. The laws would have to be changed if the countries ratified a treaty including current articles 6.3 and 6.4. Thus, one ironic effect of adopting the Treaty may be to restrain existing GR and TK disclosure laws.
The European Standard
Proposed Article 6.3 reflects the law in the EU, where non-disclosure of GR information does not have any effect on the validity of the patent.[2] Romania, a member of the EU, is the only known country that provides for revocation in case of a “fraudulent” misrepresentation or failure to disclose.[3]
It is important to note that the EU’s prohibition of allowing a lack of disclosure in the case of genetic resources is an exception to the normal rule, which is that a lack of disclosure of relevant information in the patent application can be grounds for revocation. The European Patent Convention (EPC) provides that a patent must be revoked if it fails to “meet the requirements of this Convention,” (art 101), including if “the European patent does not disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.” (Art 100).
United States
The United States does not have a law requiring disclosure of genetic resources in patents, and seems unlikely to sign the IGC Treaty. But it does authorize revocation of patents for failures to disclose required information in patent applications. US law permits a declaration of invalidity of a patent for “on any ground specified … as a condition for patentability,” including for failure to comply with and of the mandated disclosure requirements in the Act, “except that the failure to disclose the best mode shall not be a basis on which any claim of a patent may be canceled or held invalid or otherwise unenforceable.” 35 U.S. Code § 282(b).
[1] See 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 IndustrialProperty, 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.”); India, Article 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, Article 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, Section 65 (providing that the “Tribunal must invalidate the patent” for on grounds that ”any of the requirements of [GR disclosure law] has not been complied with”); Peru (“Failure to comply with this obligation shall be a cause of refusal or invalidation”); Uganda Sec. 90 (requiring invalidation by a court if “the patent does not fully describe and ascertain the invention” as required by GR law). Ecuador, Article 303 (authorizing declaration of invalidity of a patent “at the request of any person demonstrating a legitimate interest”);Samoa, Art 17 (‘Any interested person may apply to the Supreme Court to invalidate a patent” including for noncompliance with GR disclosure law); South Africa (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.”)
[2] 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). See EU (“whereas this is without prejudice to the processing of patent applications or the validity of rights arising from granted patents“). See, e.g., Denmark (“Lack of information about the geographical origin of the material or about the applicant’s nonawareness thereof shall not affect the examination and other processing of the patent application or the validity of the rights conferred by the granted patent.”).
[3] 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.”).
