In Argentina, Gilead’s patent applications for lenacapavir have been rejected

The National Institute of Industrial Property of Argentina (INPI) has rejected patent applications from Gilead for the drug lenacapavir – an innovative long-acting injectable drug that has proven effective as an option for PrEP and the treatment of HIV with multi-drug resistance.

Previously, the Argentine organization FGEP (Foundation for the Study and Research of Patent Law) filed five oppositions against various Gilead patent applications for lenacapavir, citing a lack of novelty and inventive step.

As part of the proceedings, INPI officially rejected application AR109364A1 (‘Antiviral compounds’), while application AR115865A2 (‘Therapeutic compounds’) was deemed abandoned. The agency explained that the key reasons for the rejection were a violation of Article 4 of Law 24481, which governs patent law, as well as the existence of similar compounds in publicly available scientific sources. This means that lenacapavir is not considered a fundamentally new invention and cannot be patented in Argentina.

Earlier, we reported that Gilead excluded 12 Latin American countries, including Argentina, Brazil, Mexico, and Peru, from the licensing agreement for lenacapavir, despite their participation in the drug’s clinical trials. However, according to the Helsinki Declaration, countries that contribute to the testing of new drugs should have the opportunity to access them at affordable prices. Moreover, all of these countries have the potential for local drug production.

‘This is a victory for public health. In countries excluded from voluntary licensing, including all of South America, it is essential that both organized communities and governments actively use legal mechanisms to protect access to treatment. Especially when we have the capacity for local production,’ emphasized Lorena Di Giano, Executive Director of FGEP.

FGEP continues its fight for access to life-saving medicines and has already filed 29 oppositions to patent applications for drugs to treat HIV, hepatitis C, cancer, tuberculosis, and COVID-19. Sixteen of these have been rejected or withdrawn, saving hundreds of millions of dollars. According to FGEP’s monitoring center, the rejection of patents for combinations with tenofovir (TDF) alone saved $525 million USD in public procurement costs between 2015 and 2023.

The use of patent opposition mechanisms helps remove barriers created by intellectual property, encourages local production, and ensures universal access to treatment at fair prices. ‘The INPI decision is an important step in the fight for access to essential drugs. We will continue to use all available legal tools to protect patients and prevent abuses by pharmaceutical corporations,’ concluded Lorena Di Giano. »