Argentina Repeals Pharmaceutical Patent Examination Guidelines

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Earlier this year, Argentine intellectual property law firm Berken IP reported that Argentina had signed a Reciprocal Trade and Investment Agreement with the United States that included several commitments to harmonize its intellectual property system with international standards. Among those commitments were “expeditiously” repealing the Guidelines for the Examination of Chemical-Pharmaceutical Patent Applications; submitting the Patent Cooperation Treatyto Congress for consideration and ratification vote by April 30, 2026; submitting the Budapest Treaty (Deposit of Microorganisms), Geneva Act of the Hague Agreement (Industrial Designs), Madrid Protocol (Trademarks), Patent Law Treaty, and UPOV 91 (Plant Varieties) for consideration and ratification vote before the end of 2027; and significantly reducing the patent backlog and pendency, including for pharmaceutical and biotechnological inventions, at the Instituto Nacional de la Propiedad Industrial (INPI).

Last month, Argentine law firm Marval O’Farrell Mairal reported that the 2012 patentability guidelines for pharmaceutical inventions had been abrogated. Marval noted that “[i]n a significant policy shift,” the Argentine Executive Branch had repealed the guidelines, “marking a major turning point in the country’s patent landscape.” According to the Marval report the 2012 pharmaceutical guidelines had introduced strict exclusions, denying patent protection to a wide range of subject matter, including crystalline forms, enantiomers, selection inventions, formulations, salts and esters, and Markush claims. Marval noted that the new regulatory framework would apply to pending patent applications as well as to future patent applications. However, Argentina’s new regulations will include a safe harbor provision, which will protect third parties that commercialized products during the validity of the former guidelines. Thus, patents granted under the new regulations, which cover pharmaceutical products already marketed locally by third parties, cannot be used to prevent continued commercialization of such products or to pursue damages.

Reports regarding the March 18, 2026 repeal of the 2012 pharmaceutical guidelines were also issued by Berken IP (announcement), the LATAM team of European IP firm UNGRIA (announcement), and Latin American IP firm Daniel Law (announcement).

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