Argentina Repeals Restrictive Pharmaceutical Patentability Guidelines: What Applicants Should Know
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Argentina has repealed the 2012 joint resolution that for more than a decade imposed restrictive patentability guidelines on chemical and pharmaceutical inventions.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.
Questions?
Please feel free to contact us if you have any questions or would like to discuss how these developments may affect your patent strategy in Argentina.