Argentina: Key Changes in Biotech Patents

Today, June 19, 2026, the Argentine Patent and Trademark Office (AR PTO) repealed the restrictive patentability guidelines for biotechnology inventions that had been in force since 2015, marking yet another significant turning point in Argentina’s patent landscape.

This development follows the recent repeal of the restrictive pharma guidelines and of a prior regulation that imposed constraints on the revision of patentability criteria for biotechnological inventions.

The 2015 Biotech Guidelines had introduced substantial limitations on patent eligibility for biotech inventions, in a manner widely regarded as inconsistent with the TRIPS Agreement. Their repeal restores the prior framework and signals a more open and innovation-friendly approach to biotechnology patents in Argentina.

Most notably, the repeal eliminates the requirement that patent claims directed to genetic materials must specify that such materials are isolated or incapable of developing into a complete organism. This also reinforces the patentability of transformation events under Argentine law.

In addition, the repeal removes two previously applicable restrictions: 

1.    the exclusion from patentability, per se, of claims directed to modified DNA sequences defined by structural or sequential similarity (e.g., homology percentages); and 

2.    in the case of events, the requirement to provide—in addition to the sequence of the inserted construct—flanking sequences of at least 100 base pairs.

The new framework also paves the way for broader protection of biotechnology inventions involving significant human intervention, which had previously faced restrictive interpretations.

A particularly noteworthy aspect of the repeal is the introduction of a safe harbor provision, similar to that adopted following the repeal of restrictive pharma guidelines. This provision seeks to protect third parties that commercialized products while the 2015 Guidelines were in force. Specifically, for patents granted as a result of the repeal, right holders would not be entitled to enjoin the continued commercialization of, or seek damages in respect of, products already on the market.

While this mechanism appears aimed at preserving market stability, it raises important questions regarding its scope and potential constitutional implications, particularly in relation to the rights of patent owners.

Overall, the repeal represents a substantial and welcomed shift in Argentina’s patent regime that enhances alignment with international standards and fosters greater opportunities for biotech innovation. However, the practical implications—especially concerning the safe harbor clause—will need to be closely monitored.

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