In the context of the recent agreement with the United States, the Argentine Executive Branch has repealed the guidelines for the examination of patentability of pharmaceutical inventions that had been in force since 2012, bringing about a significant change in the local patent system.
These guidelines—whose constitutionality had been widely challenged by innovative companies—established strict limitations, excluding from patent protection various categories of inventions in the pharmaceutical field, such as crystalline forms, enantiomers, selection inventions, formulations, salts, esters, and Markush-type claims, among others.
As a result of their repeal, these types of inventions are no longer automatically excluded from patentability, reflecting a shift toward an approach aligned with international standards in patent examination.
The Resolution, signed by the Ministry of Health, the Ministry of Economy, and the Argentine Patent and Trademark Office (INPI), provides that this new regime will apply both to future patent applications and to those currently pending. The latter will be examined under the current criteria, without taking into account the previously applicable restrictive limitations.
It should be noted, however, that Article 2 of the resolution introduces a mechanism aimed at protecting third parties that were already commercializing pharmaceutical products during the period in which the now-repealed guidelines were in force. Specifically, where patents are granted under this new framework covering pharmaceutical products already being marketed locally by third parties, patent holders will not be entitled to prevent the continued commercialization of such products or to claim damages.
In summary, the repeal represents a significant and positive transformation of the Argentine patent system, fostering a more open environment for pharmaceutical innovation. However, its practical effects—particularly regarding the scope and constitutionality of the mechanism set forth in Article 2—will need to be closely monitored in practice.
For more information on how these changes may affect patent applications, please contact our Patent team at info@lermanszlak.com
