In another significant step toward a more innovation-friendly patent framework in Argentina, on June 19, 2026, the Argentine Patent and Trademark Office (INPI) repealed the biotechnology patentability guidelines that had been in force since 2015.
This development follows the recent repeal of the restrictive pharmaceutical patentability guidelines and of a prior regulation that limited the review of patentability criteria for biotechnology inventions.
The 2015 Guidelines had imposed several restrictions on biotech patent protection that were widely viewed as inconsistent with the TRIPS Agreement. Their repeal restores a more flexible framework and broadens the scope of patent protection available for biotechnology inventions.
Among the key changes, patent claims directed to genetic material are no longer required to specify that the material is isolated or incapable of developing into a complete organism, reinforcing the patentability of transformation events under Argentine law. The repeal also removes the exclusion of claims directed to modified DNA sequences defined by structural or sequence similarity criteria and eliminates the requirement to provide flanking sequences of at least 100 base pairs for transformation events.
As was the case in the repeal of the pharmaceutical guidelines, this regulation also introduces a safe harbor provision designed to protect third parties that commercialized products while the 2015 Guidelines were in force. As a result, patent holders may be unable to prevent the continued commercialization of products already on the market or seek damages in connection with those products.
While this mechanism appears intended to preserve market stability, questions remain regarding its scope and potential constitutional implications.
We will continue to monitor these developments. Should you need assistance regarding potential impact on your patent strategy in Argentina, please contact our patent team at info@lermanszlak.com
