Argentina| Pharmaceutical Patents: New Patentability Framework

New Joint Resolution (Ministry of Health – Ministry of Economy – INPI) has been published and is therefore in force, repealing Joint Resolutions No. 118/2012, 546/2012, and 107/2012, which established the guidelines for the examination of patentability of chemical-pharmaceutical inventions.

Key aspects of the new framework:

The specific restrictive criteria applicable to pharmaceutical inventions have been eliminated, restoring the full application of the general standards set forth in Law No. 24,481.

The INPI resumes its authority to assess the patentability of such inventions on a case-by-case basis, in accordance with the requirements of novelty, inventive step, and industrial applicability.

The measure is grounded on the need to align the local system with the standards of the TRIPS Agreement, particularly the principle of non-discrimination by field of technology; to promote innovation and increase the availability of new chemical-pharmaceutical products; and to create conditions of predictability and legal certainty that ensure access to new medicines and treatments for the benefit of public health and general welfare.

A transitional regime is established, creating an exception to patent rights for patents granted under the new framework that involve pharmaceutical products already being commercialized in Argentina by third parties at the time the new resolution enters into force. Accordingly, patent holders will not be entitled to prevent the continuation of such commercialization and will not be entitled to claim any economic compensation. 

This exception must be interpreted broadly, encompassing products, active ingredients, processes, and related activities (including manufacturing, importation, and commercialization), insofar as they were affected by the repealed resolution.

For further information or to assess the specific impact on your portfolio or strategies in Argentina, please do not hesitate to contact us.