Argentina has made an important step forward to protect  local production of generics of an essential medicine to treat Hepatitis C. This brings significant advantages for Public Programs which procure the medicines.

Buenos Aires, December 4, 2017. In Argentina, the INPI (National Institute of Industrial Property) rejected GILEAD PHARMASSET LLC patent application on Sofosbuvir prodrug, an essential medicine to treat HepC.

The resolution PN 066898 of INPI that rejects the patent, is based on the same arguments filed by FGEP in the oppositions. In May, 2015, FGEP filed an opposition in which we highlighted Gilead does not comply with the legal requirements of Argentine patent Law. The article 4 requires novelty, inventive step and industrial application. In addition, the Law in articles 12 and 20 requires the invention must be described in the application in a sufficiently clear and complete manner. All requirements that were not met by Gilead application.

 GEP and other CSOs stated and proved Gilead intended to claim a patent over an active  ingredient of an already known product, that according to the regulation it is not patentable. Sofosbuvir was developed based on knowledge already known and the scientific techniques used to develop Sofosbuvir are routine for chemical-pharmaceutical practices. These arguments were used in the INPI resolution to reject  the patent seek by Gilead.

 In Argentina there are three generic local versions that obtained registration from ANMAT, the Regulatory Authority. “These generics guarantee price competition in the tenders of the Ministry of Health and they should be protected”, highlighted Lorena Di Giano, Executive Director of FGEP, who is working in the filling as a Lawyer and Agent of Industrial Property.

The exorbitant price of the medicines for HepC is the main barrier for access, many people are in waiting lists to get the treatment. Some of them may not make it. This is unacceptable”, stated Pablo  García, President of FGEP.

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