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A historic turning point in patent protection in Argentina.

The repeal of the “Tripartite Resolution” and the new outlook for pharmaceutical investment.

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The 18th of March 2026 marks a turning point for intellectual property in our country. Through Joint Resolution 1/2026, published in the Official Gazette, the National Government has repealed the administrative restrictions which, over the last 14 years, have limited the patenting of chemical and pharmaceutical innovations.

This regulation provides for the complete derogation of Joint Resolutions No. 118/12 (Industry), 546/12 (Health) and 107/12 (INPI), collectively known as the “Tripartite Resolution”.

1. Background: The origins of protectionism and isolation from the rest of the world.

To fully appreciate the scale of this change, it is necessary to recall the context of 2012. Against a backdrop of extreme protectionism and hostility towards foreign intellectual property, restrictive patentability guidelines were imposed which acted as an administrative barrier. Those rules assumed that polymorphs, salts, esters and manufacturing processes were not inventions, but mere discoveries or attempts to artificially ‘extend’ the life of a patent.
This criteria placed our country in the position of an international pariah, being repeatedly pointed out in the Priority Watch List of the United States’ Special 301 Report. For over a decade, the country maintained a standard that conflicts with the practices of the world’s most advanced patent offices.

2. A breath of fresh air for national policy.

The current repeal is not an isolated technical measure, but rather a political decision to open up to the world and align with the standards of the United States of America and the Organisation for Economic Co-operation and Development (OECD).
By removing these discretionary requirements, the national government is sending a clear signal to the world. Argentina is once again a reliable partner for global innovation. The measure ensures strict compliance with international treaties and restores transparency to the system, bringing local regulations into line with the TRIPS Agreement (WTO).

3. The INPI regains its jurisdiction.

From now on, the National Institute of Industrial Property (INPI) regains its exclusive jurisdiction to examine each patent application relating to chemical and pharmaceutical products. Innovations will no longer be automatically rejected on the basis of their category, but will be examined against the substantive standards established by Patent Law No. 24,481: Novelty, Inventive Step and Industrial Applicability.

4. Impact on the substantive protection of patents

The repeal of the tripartite resolution represents a genuine and far-reaching expansion of the scope of patentability, namely:

- Recognition of incremental innovation: It is recognised that a new solid form (polymorph) or a specific salt may offer critical advantages in terms of stability, solubility or bioavailability. The patent holder now protects not only the base molecule, but the actual product optimised for the patient.

- End of technological discrimination: The vulnerability of Argentine patents in international courts is eliminated by ending the de facto discrimination against the pharmaceutical and biotechnology industries.

- Revaluation of intangible assets: The value of portfolios in Argentina will rise significantly. The ability to protect manufacturing processes and new formulations makes it possible to safeguard the product lifecycle legitimately, preventing competitors from taking technical shortcuts that were previously enabled by lax regulations.

5. Key points of the new regime

- Legal security and predictability: Barriers that made it difficult to protect incremental innovations have been removed, providing confidence for foreign direct investment in pharmaceutical R&D.

- Promotion of innovation: The strengthening of rights seeks to increase the availability and speed of launch of new drugs on the local market.

- Solution for litigiousness: Proceedings or lawsuits arising from refusals based on the repealed resolution now have a key regulatory basis for review. The administration now acknowledges that the 2012 guidelines unduly restricted the jurisdiction of the agency, providing a strong legal argument for seeking the revocation of refusals.

- Safeguard for commercialisation (Section 2 of the new Joint Resolution): An exception is established for products which, on the date of entry into force, were already being marketed locally by third parties. In such cases, the holder of a new patent may not prevent the continuation of such marketing nor demand any compensation. This exception is broad and covers everything from the active ingredient to manufacturing and import methods.

6. Operational challenges and final conclusion.

The new landscape presents challenges, as the INPI will need to manage an efficient transition to process the backlog of applications that were previously systematically rejected. Furthermore, the exception provided for in Section 2 of Joint Resolution 1/2026 entails a temporary limitation of rights vis-à-vis competitors with an established presence.

Finally, the overall assessment is strongly positive. Adequate and effective protection of inventions creates conditions that facilitate timely access to new medicines for the benefit of public health and general well-being, re-establishing Argentina as a serious and competitive destination for global science.

 

Jonathan Montero
jonathan@sbm.com.ar

April, 2026

SENA & BERTON MORENO
law@sbm.com.ar