Repeal of Pharmaceutical Patentability Guidelines (Joint Resolution No. 1/2026)
On March 18, 2026, Joint Resolution No. 1/2026 was published in the Official Gazette, through which the Argentine Government introduced a substantial modification to the patent system by repealing the restrictive guidelines governing the patentability of chemical-pharmaceutical inventions since 2012.
The now-repealed system—established by Joint Resolutions Nos. 118/2012, 546/2012, and 107/2012—had set forth specific criteria that limited access to patent protection, particularly with respect to incremental innovations, such as second medical uses, new formulations, polymorphs, and combinations of known compounds. In practice, these guidelines significantly restricted the scope of protection available in Argentina, especially for the pharmaceutical industry.
With the entry into force of Joint Resolution No. 1/2026, these limitations are no longer applicable. Consequently, the assessment of patentability will once again be governed exclusively by the general standards set forth in Patent Law No. 24,481—namely novelty, inventive step, and industrial applicability— restoring a case-by-case analysis by the National Institute of Industrial Property (INPI), without being subject to predefined restrictive criteria for specific technological sectors.
However, the resolution introduces a relevant provision regarding the effects of patents. In particular, it establishes that, with respect to patents granted after its entry into force concerning pharmaceutical products already being commercialized in the country by third parties, patent holders may not prevent the continuation of such commercialization nor claim any form of compensation. In practice, this rule operates as a safeguard for pre-existing situations, limiting the practical scope of new patents vis-à-vis parties already active in the local market.
This regulatory change will have a significant impact both legally and strategically. From a patent law perspective, it represents a shift from a highly regulated and restrictive system to a more flexible framework based on the technical assessment of the examiner. This could result in a broader interpretation of patentability requirements, particularly in the pharmaceutical and biotechnology sectors, where incremental innovation plays a central role.
From a business standpoint, the new scenario may enhance Argentina’s positioning as a jurisdiction for the protection of innovations, aligning its system with international standards.
In conclusion, Joint Resolution No. 1/2026 constitutes a turning point in the Argentine patent system. By removing long-standing restrictions on patentability while preserving pre-existing commercial situations, it establishes a new balance between innovation protection and market stability, the ultimate scope of which will depend on its practical implementation by the INPI.
For further information or specific advice regarding the impact of this measure, please do not hesitate to contact us at ip@ojamip.com
