Fundación GEP opposes patent on HIV drug Tenofovir (TAF) in Argentina

Pharmaceutical patent would block access to HIV medicines. Our partner is opposing the patent application in a bid to make essential HIV treatment accessible for all.

Our campaign partner in Argentina, Fundación Grupo Efecto Positivo (FGEP), filed an opposition on 2 March 2018, at the Argentinean patent office (INPI) to achieve the rejection of the patent application filed by Gilead Sciences for the antiretroviral TAF (Tenofovir Alafenamide Fumarate), used to treat people living with HIV. The opposition is a legal tool that civil society can use to prevent the granting of undeserved patents with the aim to protect public health and guarantee access to medicines.

The medicine, tenofovir, and the combination with emtricitabine (TDF+FTC) are in the public domain and it can be produced by local companies. These drugs are key to treat and prevent HIV. Gilead sells the combination TDF+FTC in Argentina under the commercial name, Truvada®, Gilead was forced to withdraw a patent on this in 2016, since it did not comply with the patent law requirements. FGEP had filed an opposition against this patent.

Gilead’s new patent application on TAF is an attempt to evergreen their ownership of this medicine. According to Article 4 of Argentina’s patent paw, this patent should not be granted since it does not comply with the main requirements: novelty, inventive step and industrial application. Even though Gilead is introducing the medicine as an innovative, in fact it is a simple change in the existing molecule which is in the public domain. The patent application is still pending at INPI, and FGEP asks for its rejection because it does not comply with the current patentability standards.

A patent could have serious consequences for the access to essential medicines to treat and prevent HIV – Di Giano

“Gilead intends to patent a medicine that is under public domain. This new patent request on tenofovir (TAF) must be rejected by INPI. The company did not get the monopoly over the drug so now it attempts to create a monopoly around the introduction of TAF to the market. The granting of patents over TAF could have serious consequences for the access to essential medicines to treat and prevent HIV”, explains Lorena Di Giano, Executive Director of Fundación GEP.

In Argentina, the regulatory agency, ANMAT, authorized registration of two of Gilead´s combinations of drugs that include TAF: Descovy® that combines TAF with emtricitabine, and Genvoya® that combines TAF with Elvitegravir, Cobicistat and Emtricitabine. If INPI grants the patent on TAF, Gilead would have the monopoly over TAF and over its combinations. Gilead could charge abusive prices and it could wipe out generics.

In 2016 the National AIDS Program of the Ministry of Health procured FTC+FTC combination from Gilead at US$ 19.950.9 per person per year. When the generic version entered the market the Ministry of Health could purchase from a local Argentine producer at US$ 10.931 per person per year, this shows generics competition significantly reduces the prices of treatments when products are off patent.

“This is a new strategy of the pharmaceutical company; since in 2016 the patent application over Truvada® was rejected (FGEP filed an opposition to that application as well), Gilead seeks to patent a change of the same compound in order to replace Truvada® in the treatments for HIV and generate a monopoly. This company has been using the same strategy to try to obtain the patent over the prodrug of sofosbuvir, an essential medicine to cure Hepatitis C, which was also opposed by FGEP and rejected by Argentine Patent Office”, stated José María Di Bello, Secretary of Fundación GEP.

FGEP conducted a price study based on the most updated information published by the National AIDS Program and STDs of the Ministry of Health, which shows that between 2012 and 2015, the procurement of medicines impacted between 60% and 80% of total budget of the National AIDS Program. This means that this program could invest only between 20% and 40% of the total budget to implement very important complementary policies such as diagnostics and prevention. During 2016, the investment on medicines reached a 96% of the budget for the program.

Approximately, 50% of the people living with HIV that are on treatment in Argentina use tenofovir. According to the publication, Untangling the Web , of MSF, the generic version of the combination tenofovir (TDF) + emtricitabine (FTC) is available in the market at US $74 per person per year; this shows that cost of production of this medicines is significantly low.

The patent Gilead seeks over TAF in Argentina must be rejected; it is key that the different health subsystems in Argentina are able to procure generic medicines at affordable prices in order to guarantee the sustainability of universal access to medicines.

Medicines are social goods to protect health – not commodities.