By means of Joint Resolution No. 1/2026, issued by the Ministry of Health, the Ministry of Economy, and the National Institute of Industrial Property (INPI), Joint Resolution No. 118/2012, 546/2012, and 107/2012 was repealed. That prior regulation had established guidelines for the examination of patentability of chemical-pharmaceutical inventions.
The repealed regulation had set forth specific criteria applicable to the assessment of patentability in the pharmaceutical field. Under the new resolution, it is established that INPI will determine, on a case-by-case basis, the patentability of chemical-pharmaceutical inventions in accordance with Law No. 24,481 and its amendments.
The resolution also establishes a transitional regime for certain situations. In particular, it provides that, with respect to patents granted after its entry into force and relating to pharmaceutical products that are already being commercialized by third parties in the country, patent holders will not be entitled to prevent the continuation of such commercialization or to claim any remuneration.
In this context, the repeal of the prior regulation implies that the patentability analysis of chemical-pharmaceutical inventions will henceforth be conducted under the general criteria set forth in the applicable legislation, subject to case-by-case evaluation by INPI.
