Argentina: Key Changes in Pharmaceutical Patents

In a significant policy shift, the Argentine Executive Branch has repealed the restrictive patentability guidelines for pharmaceutical inventions that had been in force since 2012, marking a major turning point in the country’s patent landscape.

The 2012 Pharmaceutical Guidelines had introduced strict exclusions, denying patent protection to a wide range of subject matter, including crystalline forms, enantiomers, selection inventions, formulations, salts and esters, and Markush claims, among others. With their abrogation, these categories are no longer automatically excluded, signaling a clear shift toward a more flexible and internationally aligned approach to patent examination.

The comparative chart below illustrates the most relevant types of pharmaceutical inventions that were excluded from patentability under the former guidelines, but which would now be eligible for patent protection:

Importantly, the new regulatory framework will apply to both pending and future patent applications. Ongoing examinations will proceed without regard to the previously applicable restrictive criteria.

A notable feature of the new regulations is the introduction of a safe harbor provision. This mechanism seeks to protect third parties that commercialized products during the validity of the former guidelines. Specifically, for patents granted after the entry into force of the new regulations—covering pharmaceutical products already marketed locally by third parties—patent holders would not be entitled to prevent continued commercialization of such products or to claim damages.

While this provision aims to preserve market stability, it raises important questions regarding its scope and, potentially, its constitutional validity, particularly in relation to the rights of patent holders.

Overall, the repeal represents a substantial and positive shift in Argentina’s patent system, bringing greater openness to pharmaceutical innovation. However, the practical implications—especially concerning the safe harbor clause—will require close monitoring.

We will continue to follow these developments and remain available to discuss how these changes may impact your patent strategy in Argentina.