Argentina Repeals Restrictive Pharmaceutical Patentability Guidelines

JD Supra Trade Law

Published March 18th, 2026

Detected March 20th, 2026

Summary

Argentina has repealed restrictive 2012 patentability guidelines for chemical and pharmaceutical inventions, effective March 18, 2026. This change is expected to improve patent protection for pharmaceutical technologies and align examination standards with international norms. Applicants with pending cases may need to reassess their prosecution strategies.

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What changed

Argentina's Ministry of Health, Ministry of Economy, and the National Institute of Industrial Property (INPI) have issued Joint Resolution No. 1/2026, formally repealing the 2012 joint resolution that imposed restrictive patentability guidelines on chemical and pharmaceutical inventions. This repeal, effective March 18, 2026, is expected to bring patent examination in areas such as pharmaceutical formulations, Markush claims, polymorphs, and second medical uses closer to Argentina's Patent Law and international standards.

Applicants with pending Argentine patent applications in the pharmaceutical and chemical sectors should review their strategies, as previously rejected claims or limited scopes may now be viable. However, potential limitations exist, including a possible safe harbor for existing market products that might infringe patents granted under the new framework, necessitating case-by-case assessment of enforceability and commercial impact.

What to do next

Review pending Argentine patent applications for chemical and pharmaceutical inventions.
Reassess prosecution strategies for chemical and pharmaceutical portfolios in Argentina.
Evaluate potential enforcement actions and commercial impact under the new patent framework.

Source document (simplified)

March 19, 2026

Argentina Repeals Restrictive Pharmaceutical Patentability Guidelines: What Applicants Should Know

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Overview

Argentina has repealed the 2012 joint resolution that for more than a decade imposed restrictive patentability guidelines on chemical and pharmaceutical inventions. Effective March 18, 2026, Argentina’s Ministry of Health, Ministry of Economy, and National Institute of Industrial Property (INPI) issued Joint Resolution No. 1/2026, formally repealing the prior resolutions. This development is expected to materially improve the outlook for patent protection in Argentina for pharmaceutical and related technologies.

What Changed

The 2012 guidelines had been applied to sharply limit or deny protection for a range of claim types and subject matter, including:

Pharmaceutical formulations and compositions
Markush claims
Polymorphs
Pseudo-polymorphs
Analogous processes
Prodrugs
Metabolites
Selection inventions
Enantiomers
Combinations
Salts
Esters and other derivatives of known substances
Dosage claims
Second medical use claims Their repeal is expected to bring patent examination in these areas closer to the standards set out in Argentina’s Patent Law and, more broadly, to a framework more closely aligned with international norms.

What This Means for Applicants

For applicants with pending Argentine cases, the change could be significant. Applications that previously faced narrow examination positions or limited claim scope under the 2012 guidelines may warrant renewed review. In particular, applicants may wish to revisit pending prosecution strategies for chemical and pharmaceutical portfolios, including whether broader claim approaches, additional argumentation, or other procedural steps may now be viable.

Potential Limitations

Recent commentary also suggests that any transition may come with practical limits. In particular, the new resolution appears to provide a potential safe harbor for pharmaceutical products already on the market that may infringe patents granted under the updated framework, which could limit enforcement and the availability of compensation in those circumstances. However, it remains unclear whether this exception will extend to the commercialization of new infringing products going forward, or whether innovators will be able to pursue infringement actions under the new regime. As a result, the commercial impact and enforceability of any newly granted rights should be assessed on a case-by-case basis.

Looking Ahead

This repeal appears to be part of a broader shift in Argentina’s patent policy. In recent weeks, multiple sources have noted Argentina’s commitment to remove restrictive patentability rules affecting pharmaceutical and biotech inventions and to move toward a more predictable and internationally aligned patent system.

Companies with pending or contemplated Argentine patent filings in the pharmaceutical, chemical, and life sciences sectors should consider promptly reviewing their portfolios in light of these changes.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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