The patentability guidelines for pharmaceutical inventions in force since 2012 and recently repealed as a consequence of the agreement between Argentina and the United States, had been judicially challenged by the chamber representing innovative pharmaceutical laboratories in Argentina (CAEMe) in the case “Cámara Argentina de Especialidades Medicinales y Otros c/ Estado Nacional Ministerio de Industria De La Nación y Otros s/ Nulidad De Acto Administrativo”, File No. 4960/2013.
Taking the view that these guidelines were unconstitutional because they excluded various categories of pharmaceutical inventions from patent protection — including crystalline forms, enantiomers, selection inventions, formulations, salts, esters, and Markush-type claims, among others — contrary to the provisions of the TRIPS Agreement and the Patent Law, which does not allow discrimination based on the field of technology, CAEMe filed a lawsuit seeking the administrative act, namely, the Joint Resolution that had brought those guidelines into force, to be declared null and void.
After more than 12 years of litigation, the court of first instance recently dismissed the claim. CAEMe appealed, and when the case reached the Court of Appeals to hear the appeal, Chamber II declared the case moot, given that the regulation being challenged had already been repealed.
Accordingly, following the publication of Joint Resolution 1/2026, which repealed the patentability guidelines challenged by CAEMe, the Court held that the factual and legal basis necessary to rule on the validity of the challenged acts had ceased to exist. The first-instance order imposing costs to the losing party was also set aside, and the costs of both instances were ordered to be borne by each party, in light of the exceptional legal complexity of the dispute.
For more information on how this key amendment applies to patent applications, please contact our Patent team at info@lermanszlak.com
