Fundación GEP filed an opposition to the patent application claimed by Gilead over the combination Sofosbuvir + Velpatasvir. This is the third opposition filed by GEP on medicines to cure Hepatitis C. The former oppositions filed allowed us to stop monopolies and to reduce significantly the prices of medicines.
Buenos Aires, July 1, 2019. Sofosbuvir + Velpatasvir is a key combination to treat the main Hepatitis C genotypes and it is also recommended in Argentina to treat people with advanced liver fibrosis. Since patent applications over combinations do not meet the legal requirements in the country, we filed oppositions before the National Institute of Industrial Property, to contribute with arguments and key evidence for its rejection.
Article 4 of the National Patent Law (24.481) establishes that only products or proceedings that are new, that show inventive step and that have an industrial application can be patented in Argentina. Combinations of already known drugs such as Sofosbuvir + Velpatasvir, are not patentable in our legal system since according to the current standards of patentability: “Combinations… have already been proven in medical practice by administering the components separately … in practical terms they are equivalent to claims on medical treatments”, it is a subject excluded by the law.
Gilead intends to obtain a monopoly over the manufacturing and marketing of medicines for Hepatitis C in Argentina: this pharmaceutical company filed at least 14 different patent applications over sofosbuvir during the last years in violation of the law. GEP has been working for sofosbuvir and its combinations to be in the public domain in order to be produced locally.
“It is crucial that people with Hepatitis C have Access to the treatment that cure the infection. According to our Patent Law, the application over the combination sofosbuvir + velpatasvir must be rejected. Our actions straightened to eliminate IP barriers, to promote national production of generics and to lower prices by market competition” stated Lorena Di Giano, Executive Director of Fundación GEP.
According to the Vademecum of ANMAT, (National Administration of Medicines, Food and Medical Technologies) a bottle of 28 pills of the combination Epclusa®, Brand name which Gilead uses to sell its drugs – through Gador- in Argentina, is priced AR$572.117,23.
The price of the treatment for 12 weeks in Argentina goes up to AR$1.716.351,69 equivalent to US$ 40.518, while the generic version produced by India available in the international market, according to MSF, is sold to US$ 286.
If we look at sofosbuvir, since the entry of generics into the market in Argentina, prices went down significantly. INPI ́s rejection of the patent applications on the prodrug and the base compound of sofosbuvir had a major impact in the Argentine market, as it allowed 4 registrations on sofosbuvir own by national manufacturers.
Patent opposition work undertaken by Fundación GEP on sofosbuvir allowed price competition that lead to the reduction of its price from USD 11,000 to US$ 358,62 per person per treatment course achieved by the last public purchase of the Ex Ministry of Health (March 2018).
The patent opposition system (article 28 Patent Law) has shown to be effective to eliminate barriers of access to essential medicines in Argentina.
“We hope that INPI rejects sofosbuvir + velpatasvir patent application very soon, a first necessary step forward to guarantee Access for all People who urgently need the treatment” remarked Lorena Di Giano.