Pharmaceutical patentability regulations in Argentina

pharmaceutical patentability regulations
On 17 March, the Argentinian Ministry of Health, Ministry of Economy and the Argentinian Patent Office (INPI) issued joined Resolution No. 1/2026 by means of which Joint Resolutions No. 118/2012, No. 546/2012, and No. 107/2012 are rescinded. It took over a month since the signing of the reciprocal Trade and Investment Agreement between Argentina and the US, to take the first step towards the improvement of IP protection in Argentina by this revocation of the patentability regulations applicable to pharmaceutical inventions.

Joined Resolution 1/2026 states that going forward each case should be assessed on a case-by-case scenario applying only Law 24.481 (current Argentinian Patent Law – and its official amendments) and TRIPS, thus, in principle, the restrictive criteria being applied for over 10 years over pharmaceutical patents cannot longer be applied during examination.

It is worth pointing out that the Directives amended in 2015 to introduce the restrictive criteria of the Joint Resolutions dated 2012 have not been directly mentioned, rescinded or revoked. Issues that might likely begin to change include, for example, selection inventions which were the clearest patentability exception in the Joint Resolutions and now would most probably not be rejected due to lack of novelty, and other inventions, like pharmaceutical compositions, polymorphs, salts, etc. that have been subjected to strict inventive step requirements under these resolutions.

On an additional note, the second article of the Joined Resolution 1/2026 includes a safe harbor for third parties that had commercialized pharmaceutical products covered by patents that could be now granted by the revocation of the 2012 Joint Resolutions. As per the safe harbor, patent holders would not be entitled to claim damages for the infringement of a patent right granted because the 2012 Joint Resolutions were revoked, by products commercialized by those third parties. This is clearly a measure to protect the strong generic companies in Argentina, preserve market stability and prevent the filing of infringement claims, but it could be challenged in the future.

27 Mar, 2026

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