Patent Opposition for sofosbuvir requested in Argentina

Organizations of people with Hepatitis C have filed an opposition for a patent application that would prevent 800,000 people from having access to treatment in Argentina

Fundación Grupo Efecto Positivo (FGEP) leads the opposition to pharmaceutical patents movement as a key strategy to ensure universal access to medicines

The growing global movement to guarantee access to medicines for people with HepC and fight Gilead’s abuse of the patent system reaches three continents

BUENOS AIRES – Fundación Grupo Efecto Positivo and the Argentinian Network of Positive People (Redar Positiva) in collaboration with Initiative from Medicines, Access & Knowledge (I-MAK), introduced a wake-up call to Argentina’s Patent Office to reject the patent application of GILEAD and Pharmasset Laboratories, LLC on the prodrug of an essential medicine to treat Hepatitis C. According to FGEP, the pharmaceutical company Gilead is seeking to obtain illegally a patent for this drug, fact that would prevent approximately 800,000 people to get access to the treatment they need. This coordinated action has a huge impact on the global movement to fight the HepC epidemic that causes 700,000 deaths each year worldwide.

FGEP (Argentina), Redar Positiva (Argentina), the Working Group on Intellectual Property (WGIP/ABIA, Brazil), the Ukrainian Network of People Living with HIV / AIDS (Ukraine) and the International Treatment Preparedness Coalition (ITPC, New York) in coordination with I-MAK (New York) have filed patents oppositions in Argentina, Brazil, China, Russia and Ukraine, revealing how Gilead is abusing of the patent system to claiming ownership of pre-existing and public knowledge – thus preventing people with Hepatitis C from receiving adequate treatment.

Patent oppositions against Sovaldi® -trademark name of Gilead’s version of sofosbuvir– clearly demonstrate that sofosbuvir was developed using scientific information previously published and it is based on an existing chemical compound.



José María Di Bello (Red Mundial Personas con VIH de Cruz Roja); Lorena Di Giano (FGEP’s Executive Director); Roberto Aramburu (President, INPI) and Alex Freyre (President, FGEP) at the moment of filing the opposition to Gilead’s sofosbuvir patent request.

‘With this patent opposition we want to make sure that Gilead will not use illegitimate patents to charge exorbitant prices for the treatment for Hepatitis C, also preventing our countries to have access to cheaper generic versions. Gilead is a menace not only for people with Hepatitis C in Argentina but also in other middle-income countries” said Mrs Lorena Di Giano, Executive Director of FGEP.

It is estimated that the drug will be sold at high prices in Argentina and in Latin American countries, at an approximate price of U$S 7,000 for a 12 week treatment of a person. That price would have catastrophic consequences on the public health budget in Argentina. A recent study by the University of Liverpool has shown that the same treatment could be produced for U$S 101.

‘Gilead tries to appropriate knowledge and technology that are in the public domain and seeks to create monopolies applying for illegitimate patents, to charge huge prices that deprive us of access to the Hepatitis C cure. These medicines must be accessible to all people that urgently need it. In my case, I’ve already gone through an existing treatment used in Argentina which failed, so taking sofosbuvir is the only chance to save my life’, said Pablo Garcia, Redar Positiva’s General Secretary and signatory of the opposition, who lives with HIV and Hepatitis C.

‘The global approach to patents is clear: they are reserved for drugs that prove to be new, useful and non-obvious’ remarked Tahir Amin, I-MAK’s co-founder. ‘When seeking exclusivity on science that is already in the public domain, Gilead does the same as a landlord charging an exorbitant rent for a property that he does not rightfully own.’

Access to sofosbuvir without paying Gilead’s monopolistic prices is very important in our country to ensure treatment for people with Hepatitis C, as our patent law and the Guidelines for Examination of Pharmaceuticals do not allow patents on old or compound formulations that are already in the public domain.

While sofosbuvir represents a very important therapeutic advance to treat Hepatitis C, the molecule is not sufficiently innovative from a chemical point of view so as to apply for a new patent that would provide exclusivity / monopoly for 20 years.