The decision, for which the Fundación GEP contributed with/to decisive arguments, paves the way to generic versions to facilitate access to treatments.

Por: Julia Varela

May 23, 2017 – In a resolution that means a step forward in safeguarding the right to health, Argentina’s patent office (the National Institute of Industrial Property – INPI) forced Gilead withdrawal of the patent application for the antiretroviral combination of drugs tenofovir-emtricitabine (TDF+FTC) known by Its trade name Truvada®. The decision was taken in November 2016 but recently made public.

Fundación GEP participated in the case by filing an opposition to the patent application in April 2015, noting that the application does not meet legal requirements for the patent to be granted. Likewise, GEP argued and proved that Gilead intended to claim a combination of two known active ingredients that had already been patented and that, according to the current legislation, is not patentable as a combination. The evidence filed by GEP is part of the justification of the INPI’s examiners report for rejecting Gilead’s application, which in its words «does not meet legal and regulatory requirements» to receive a patent and «violates Article 6e» of the Argentine Patent Law since «Treatment methods are not considered an invention«.

With similar arguments, shortly after INPI’s decision, the patent on Truvada in Brazil was rejected in January of this year. In Argentina’s case the current patentability guidelines, globally considered an example of public health safeguard due to its strict criteria pro health and judicially questioned by the multinational pharmaceutical companies, prevented Gilead from obtaining an illegitimate monopoly at the expense of people’s health.

Truvada is very important in the response to HIV / AIDS in Argentina, where approximately 50% of people under treatment take this combination of drugs as part of their ARV regime. For this reason, according to 2015 research, Argentina invests an yearly sum of U$S12,054,528 in Truvada®. The amount represents 23% of the annual budget of the National AIDS Office (DNSyETS), meaning a millionaire business for Gilead. However, according to the publication «Untangling the Web» of the international humanitarian organization Médecins Sans Frontières, the generic version of TDF + FTC is available in the international market at US$ 74 per person per year, which shows that the manufacturing cost of this drug is significantly low. In contrast, according to the last public purchase registered to Gador S.A. (Gilead’s licensee in Argentina) Argentina pays US $ 2797 per person per year buying from Gilead. According to this data, if the DNSyETS purchase the generic version produced in India, Argentina could save approximately US$ 11,246,000 per year.

 …The withdrawal of the patent application on Truvada® means a victory in favor of the health of our population. In GEP we are analyzing other similar patent applications of ever-greening that Gilead seeks in the country to claim undeserved monopolies on other tenofovir (TAF) and in the combination TAF + emtricitabine…» stated Lorena Di Giano, GEP’s Executive Director.

 Truvada and PrEP: opportunities and challenges

The chance of acquiring or manufacturing generic versions of Truvada® would also have a huge impact on preventive policies such as «PrEP» (Pre-Exposure Prophylaxis) recommended by the World Health Organization and by Unicef ​​in their HIV/AIDS treatment guidelines, which consists of HIV-negative people taking Truvada® to reduce their risk of acquiring HIV. If this policy were implemented in Argentina, as is strongly promoted by UN agencies, the availability of medicines and the sustainability of public budgets could benefit from the acquisition of low-cost generic versions enabled by the absence of patent on these drugs.

However, as stated by FGEP’s Secretary José María Di Bello, the PrEP strategy has been challenged by numerous civil society networks and organizations since «Scientific evidence is not questioned, although at least two people using PrEP have contracted resistant HIV infection to one of the components of Truvada®, but the risk for the population is to contract other sexually transmitted infections such as syphilis, whose prevalence has increased in recent years. This strategy generates a false belief of safety, discourages the use of condoms and means the medicalization of HIV prevention.”

Fundación GEP celebrates the INPI’s decision to force the withdrawal of the patent on the tenofovir + emtricitabine combination (TDF + FTC ) against the abusive action of Gilead, which clearly tried to illegitimately appropriate medicines that as social goods should be in the service of public health.