Major Shift in the Argentine Patent System: Repeal of the 2012 Pharmaceutical Guidelines

Today, March 18, 2026, marks a significant turning point with the publication of Joint Resolution 1/2026 in the Official Gazette (signed by the Ministries of Health and Economy, alongside the INPI).

This new regulation formally repeals the 2012 Joint Resolution, which imposed specific restrictive guidelines for the evaluation of chemical-pharmaceutical inventions.

Key points of the new regulatory framework:

✅ Repeal of the 2012 Guidelines: The restrictive directives that limited the patentability of chemical-pharmaceutical inventions (such as polymorphs, salts, esters, formulations, and second uses) have been set aside.

✅ Case-by-Case Evaluation: The INPI regains the exclusive authority to evaluate applications by applying only the general criteria of the Patent Law (No. 24,481): novelty, inventive step, and industrial applicability.

✅ International Alignment: The Government bases this decision on the need to harmonize the Argentine system with TRIPS Agreement standards and to facilitate access to therapeutic innovations.

✅ Continuity of Existing Products: The resolution establishes that for patents granted under this new framework covering products already marketed in the country by third parties, the owners may not prevent the continuation of such commercialization nor demand retroactive compensation.

This regulatory update represents a significant step toward the modernization and legal certainty of the patent system in Argentina. Given the relevance of these changes, we recommend that rights holders and applicants conduct a strategic review of their patent portfolios, particularly in the pharmaceutical and agrochemical sectors.

Our team of Intellectual Property specialists is at your full disposal to analyze the impact of this resolution on your current proceedings and future applications.