「知的財産、遺伝資源及び関連する伝統的知識に関するWIPO条約」の最終文書が世界知的所有権機関（WIPO）で採択　― 特許出願における遺伝資源等の出所開示義務化へ ―

“Genetic material” means any material of plant, animal, microbial or other origin containing functional units of heredity.

“Genetic resources”¹ are genetic material of actual or potential value.

“Source of genetic resources” refers to any source from which the applicant has obtained the genetic resources, such as a research center, gene bank, Indigenous Peoples and local communities, the Multilateral System of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), or any other ex situ collection or depository of genetic resources.

“Source of traditional knowledge associated with genetic resources” means any source from which the applicant has obtained the traditional knowledge associated with genetic resources, such as scientific literature, publicly accessible databases, patent applications and patent publications.

¹ The definition of “genetic resources” is, in line with the manner in which the term is understood in the context of the Convention on Biological Diversity, not intended to include “human genetic resources”.

3.1 Where the claimed invention in a patent application is based on genetic resources, each Contracting Party shall require applicants to disclose:

(a) the country of origin of the genetic resources² , or,

(b) in cases where the information in Article 3.1(a) is not known to the applicant, or where Article 3.1(a) does not apply, the source of the genetic resources.

² Agreed Statement: In cases where there is more than one country of origin, the applicant shall disclose the country of origin from which the genetic resources were actually obtained.

3.2 Where the claimed invention in a patent application is based on traditional knowledge associated with genetic resources, each Contracting Party shall require applicants to disclose:

(a) the Indigenous Peoples or local community, as applicable³, who provided the traditional knowledge associated with genetic resources, or,

(b) in cases where the information in Article 3.2(a) is not known to the applicant, or where Article 3.2(a) does not apply, the source of the traditional knowledge associated with genetic resources.

³ Agreed Statement: It is understood that the term “as applicable” in Article 3.2(a) shall not be interpreted as providing flexibility to the Contracting Parties to not require applicants to disclose the information required in Article 3.2(a). For greater certainty, Article 3.2(a) will be implemented without having any effect on the scope of the disclosure requirement in Article 3.

5.1 Each Contracting Party shall put in place appropriate, effective and proportionate legal, administrative, and/or policy measures to address a failure to provide the information required in Article 3 of this Treaty.

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 Treaty, in accordance with its national law.