Argentina: Patent rejected on hepatitis C drug, sofosbuvir

A decision by the patent office in Argentina (INPI) to reject Gilead’s patent on key hepatitis C drug, sofosbuvir, is an important step forward to protect public health. It will now be possible to produce cheaper generics locally, meaning more people could be cured.

On 4 December 2017, the National Institute of Industrial Property (INPI) rejected Gilead Pharmasset LLC’s patent application on sofosbuvir, an essential medicine to treat hepatitis C.

In May 2015, our partner FGEP filed an opposition in which they highlighted how Gilead was not complying with the requirements of Argentine patent law. The requirements missing were any evidence of ‘“novelty, inventive step and industrial application”. In addition, the law requires the ‘invention’ to be described in a sufficiently clear and complete manner. This was not met by Gilead’s application.

Routine not novel

FGEP and other civil society organizations stated, and proved, that Gilead intended to claim a patent over an active ingredient of an already known product. According to the law, this 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 sought by Gilead.

Tackling the price barrier

“The exorbitant price of the medicines for hepatitis C 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.

In Argentina there are three local generic versions that have obtained registration from ANMAT, the Regulatory Authority. “These generics guarantee price competition and they should be protected”, said Lorena Di Giano, Executive Director of FGEP. These local producers joined civil society to oppose Gilead’s application, as they have invested in developing cheaper versions of the product.

“Today there is a public tender open by the Ministry of Health in which some of the local producers have offered significantly lower prices than Gilead,” added Lorena Di Giano . “The rejection of this patent is a step forward to protect local production and procurement of generics.”

In Argentina, it is estimated that there are 400,000 people living with hepatitis C, many of them are in an advanced stage of the illness and do not have access to the treatment due to the high prices. The existence of generics has a direct impact on the Ministry of Health’s budget and allows more people to obtain the cure.