Fundación GEP, Argentina, files patent opposition on Hepatitis C treatment

Our partner in Argentina, Fundación GEP (FGEP), has filed an opposition against Gilead’s patent application for the combination, sofosbuvir + velpatasvir. This is the third opposition filed by FGEP on Hepatitis C medicines. Previous oppositions filed have prevented monopolies and significantly reduced the prices of medicines.

Assortment of tabletsSofosbuvir + velpatasvir is a key combination used to treat the main Hep C genotypes, and it is also recommended in Argentina to treat people with advanced liver fibrosis. Applications on combinations do not meet Argentina’s legal requirements for patenting, and so oppositions were filed with the National Institute of Industrial Property (INPI), to contribute the necessary arguments and key evidence required to reject Gilead’s application.

Article 4 of Argentina’s National Patent Law establishes that only products or proceedings that are new, that show inventive step, and that have an industrial application can be patented. Although it’s clear that combinations of already known drugs, such as sofosbuvir + velpatasvir, are not legally patentable, it appears that Gilead is attempting to obtain an illegitimate monopoly over the manufacturing and marketing of Hep C medicines in Argentina: The company has filed at least 14 different patent applications over sofosbuvir during recent years in violation of the law. FGEP has been working to ensure that sofosbuvir, and its combinations, enter the public domain in order for effective, affordable Hep C treatment to be produced locally.

Crucial price reductions

“It is crucial that people with Hepatitis C have access to the treatment that cures the infection. According to our patent law, the application over the combination sofosbuvir + velpatasvir must be rejected,” stated  Lorena Di Giano, Executive Director of FGEP.

According to ANMAT (National Administration of Medicines, Food and Medical Technologies), a bottle of 28 pills of Epclusa® (Gilead’s brand name for the combination in Argentina) is priced at AR$572,117.23. The price of a 12 week course of treatment is therefore AR$1,716,351.69 (US$40,518), while the generic version produced by India available in the international market is sold to US$286.

Since the entry of generic sofosbuvir into the market in Argentina, prices have gone down significantly. INPI ́s rightful rejection of the patent applications on the prodrug and the base compound of sofosbuvir had a major impact in the Argentine market, as it paved the way for four registrations of generic sofosbuvir by national manufacturers.

FGEP’s work on patent oppositions, and the patent opposition system, has shown to be effective in eliminating barriers of access to essential medicines in Argentina. “We hope that INPI rejects the sofosbuvir + velpatasvir patent application very soon, a first necessary step forward to guarantee access for all people who urgently need the treatment,” said Lorena Di Giano.