Scope of Protection

Article 3 - On the biological and genetic heritage and traditional knowledge

The Member Countries shall ensure that the protection granted to intellectual property elements shall be accorded while safeguarding and respecting their biological and genetic heritage, together with the traditional knowledge of their indigenous, African American, or local communities. As a result, the granting of patents on inventions that have been developed on the basis of material obtained from that heritage or that knowledge shall be subordinated to the acquisition of that material in accordance with international, Andean Community, and national law.

The Member Countries recognize the right and the authority of indigenous, African American, and local communities in respect of their collective knowledge.

The provisions of this Decision shall be applied and interpreted in such a way that they do not contravene the stipulations of Decision 391 and its effective amendments.

Article 26 - On patent applications

Applications for patents shall be filed with the competent national office and shall contain:

      i) if applicable, a copy of the document that certifies the license or authorization to use the traditional knowledge of indigenous, African American, or local communities in the Member Countries where the products or processes whose protection is being requested was obtained or developed on the basis of the knowledge originating in any one of the Member Countries, pursuant to the provisions of Decision 391 and its effective amendments and regulations.

Article 75 - On the invalidation of the patent

The competent national authority may, either ex officio or at the request of a party, and at any time, declare a patent null and void, where:

      h) when pertinent, the products or processes whose protection is being requested have been obtained or developed on the basis of traditional knowledge belonging to indigenous, African American, or local communities in the Member Countries, if the applicant has failed to submit a copy of the document certifying the existence of a license or authorization for use of that knowledge originating in any one of the Member Countries.

Article 136 - On registration requirements

Those signs the use of which in commerce may constitute an impediment to the rights of third parties, may likewise not be registered as trademarks, in particular where:

      g) consist of the name of indigenous, African American, or local communities, or of such denominations, words, letters, characters, or signs as are used to distinguish their products, services or methods of processing, or that constitute an expression of their culture or practice, unless the application is filed by the community itself or with its express consent.

Trigger of Disclosure

Article 26.

The application for a patent shall be filed with the competent national office and shall contain the following:

…

(h) where applicable, a copy of the access contract where the products or processes for which a patent is sought have been obtained or developed from genetic resources or products derived therefrom of which any of the member countries is the country of origin;

(i) where applicable, a copy of the document accrediting the licensing or the authorization of the use of the traditional knowledge of the indigenous Afro-American or local communities of member countries where the products or processes for which protection is sought have been obtained or developed from such knowledge of which any of the member countries is the country of origin, in accordance with the provisions of Decision 391 and such of its amendments and implementing regulations as are in force.

Content of Disclosure

Article 26.

The application for a patent shall be filed with the competent national office and shall contain the following:

[…]

(h) where applicable, a copy of the access contract where the products or processes for which a patent is sought have been obtained or developed from genetic resources or products derived therefrom of which any of the member countries is the country of origin;

(i) where applicable, a copy of the document accrediting the licensing or the authorization of the use of the traditional knowledge of the indigenous Afro-American or local communities of member countries where the products or processes for which protection is sought have been obtained or developed from such knowledge of which any of the member countries is the country of origin, in accordance with the provisions of Decision 391 and such of its amendments and implementing regulations as are in force.

Consequences of Non-Compliance

Article 39.

If it emerges from the examination as to form that the application does not meet the conditions specified in Articles 26 and 27, the competent national office shall inform the applicant accordingly, so that he may meet those conditions within a period of two months following the date of notification. That period may be extended once by an equal amount at a request of a party without any loss of priority.

If, on the expiry of the period specified, the applicant has not met the conditions mentioned, the application shall be considered abandoned and its priority shall be lost. The competent national office shall nevertheless respect the confidentiality of the application.

Article 75.

The competent national authority shall decree the absolute invalidity of a patent at any time, either ex officio or at the request of any person, where:

[…]

(g) where applicable, a copy of the access contract has not been filed where the products or processes to which the patent application relates have been produced or developed with genetic resources or derived products of which any of the member countries is the country of origin;

(h) where applicable, a copy of the document evidencing the licensing or authorization of the use of traditional knowledge of the indigenous Afro-American or local communities of the member countries has not been filed where the products or processes for which protection is sought have been produced or developed on the basis of such knowledge of which one of the member countries is the country of origin.