Victory: Gilead forced to withdraw Truvada® patent application in Argentina

 

Gilead prevented from obtaining an illegitimate monopoly at the expense of people’s health

Activists in Argentina, including our partner Fundación GEP, are celebrating the forced withdrawal of an unmerited patent application on Gilead’s HIV drug Truvada®. The decision was taken in November, but only recently reported, as published by Fundación GEP here.

Argentina invests an yearly sum of $12,054,528 (USD) in Truvada®. The amount represents 23% of the annual budget of the National AIDS Office, and a millionaire business for Gilead. The arguments presented by GEP in its patent opposition significantly contributed to the patent withdrawal and paves the way for cheaper, generic versions of the drug to be made available in Argentina.

GEP argued, and proved, that Gilead intended to claim a combination of two known active ingredients that had already been patented and which, according to the current legislation, is not patentable as a combination. Argentina’s patent office (the National Institute of Industrial Property – INPI) agreed, stating that Gilead’s application “does not meet legal and regulatory requirements” to receive a patent and v iolated Argentine Patent Law since “treatment methods are not considered an invention”.

Similar arguments resulted in the patent on Truvada® in Brazil being rejected earlier this year.

Lorena Di Giano, Executive Director of GEP, says: “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.”

Othoman Mellouk, ITPC’s Intellectual Property and Access to Medicines lead, says: “At ITPC, we believe the public has the right to participate in the patent system in order to oppose the grant of bad patents. Pre-grant oppositions by civil society and non-governmental organizations that represent the interests and will of citizens are a key measure to monitor the system to mitigate any abuses by pharmaceutical companies.”

“However, we are worried for the future given Argentina may little by little abandon its strict patent examination process by relying on other patent offices that are more permissive like the United States one. This may be one of the negative consequences of the recent agreement signed between patent offices of both countries“.

Truvada® and PrEP

Truvada® is a very important drug in the HIV response in Argentina, where approximately 50% of people on treatment take this combination of drugs as part of their ARV regime.

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 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 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 a patent on these drugs.

 

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