Argentina: Joint Resolution No. 1/2026 on pharmaceutical patents

Joint Resolution No. 1/2026, published on March 18, 2026, represents one of the most significant changes in recent years to the pharmaceutical patent system in Argentina. The Resolution was jointly issued by the Ministry of Health, the Ministry of Economy, and the Argentine National Institute of Industrial Property (INPI).

The main aspects of the Resolution are summarized below.

1. Repeal of the 2012 patentability guidelines

The most important feature of the Resolution is the repeal of Joint Resolution No. 118/2012 (Ministry of Industry), No. 546/2012 (Ministry of Health), and No. 107/2012 (INPI).

These guidelines established specific criteria for the examination of pharmaceutical and chemical patent applications and were well known for applying a restrictive approach to the grant of pharmaceutical patents.

2. Case-by-case examination

Following the entry into force of the Resolution, the INPI must examine pharmaceutical patent applications on a case-by-case basis, applying directly the requirements set forth in Argentine Patent Law No. 24,481, without the limitations imposed by the 2012 Guidelines.

Accordingly, the examination will once again focus on the general patentability requirements, including novelty, inventive step, industrial applicability, sufficiency of disclosure, and all other requirements established by the Argentine Patent Law.

3. Change in pharmaceutical patent policy

The recitals of the Resolution expressly state that adequate protection of inventions promotes innovation and legal certainty, reflecting a significant shift in Argentina’s pharmaceutical patent policy.

4. Entry into force

The Resolution entered into force on the date of its publication in the Official Gazette, namely March 18, 2026.

5. Practical implications

From a patent law perspective, the Resolution represents a substantial change in public policy.

Whereas the 2012 Guidelines sought to restrict the grant of pharmaceutical patents in order to prevent unjustified extensions of patent exclusivity (evergreening), Joint Resolution No. 1/2026 abandons that approach and requires the INPI to apply directly the patentability standards established by the Argentine Patent Law, assessing each application on its own merits.

At the same time, the Resolution introduces a specific safeguard designed to preserve the continued commercialization of pharmaceutical products that were already being marketed in Argentina by third parties before the corresponding patent was granted. This measure seeks to protect existing market situations while implementing the new examination policy.