Brazilian National Institute of Industrial Property Rejects Truvada® Patent Application

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On 24 January 2017, Brazil’s National Institute of Industrial Property (INPI) made public a decision to reject the patent application filed by Gilead Sciences back in January 2004, covering the combination of tenofovir and emtricitabine known as Truvada®.

The decision is a victory for our partners in Brazil and the Make Medicines Affordable campaign.
It will allow Truvada to be marketed in Brazil, at low prices, which enables the Brazilian public health system to organize a public policy of prevention and treatment that places human rights at the center of its action. The medicine, which is used for the treatment of HIV infection and Hepatitis B as well as pre-exposure prophylaxis (PrEP) to prevent the transmission of the HIV, is now in the public domain and may be manufactured and sold by any generic manufacturer approved in the country.

Over the past seven years, the Working Group on Intellectual Property (GTPI), coordinated by the Brazilian Interdisciplinary AIDS Association (ABIA), actively worked to combat abusive patent protections for Truvada®. The medicine should have already been in the public domain since it does not meet Brazilian patentability criteria. In November 2010, GTPI filed an opposition to the patent application, with technical, legal and public health arguments, proving why the patent should be rejected.

In August 2016, Gilead’s patent request was rejected by the National Sanitary Surveillance Agency (Anvisa) that conducts the prior examination of pharmaceutical patents jointly with the patent office, based on arguments presented by GTPI in 2010. However, Gilead went to the courts and successfully reversed the decision, and the application examination went forward.

In November 2016, ABIA/GTPI, with the support of Make Medicines Affordable, sent new technical arguments to the patent office to highlight the lack of an inventive step in the patent application. This lack of an inventive step argument served as the basis for the rejection of Gilead’s application and is cited in the first paragraph of the decision published by the patent office[1].

“Truvada is only a combination of two old and well-known drugs that doesn’t constitute an invention. Brazil’s rejection of this HIV drug patent marks an important step toward ensuring Gilead or other companies cannot claim existing public knowledge as their own and create unfair monopolies at the expense of public health,” said Othoman Mellouk, Global Coordinator of Make Medicines Affordable Campaign at the International Treatment Prepardness Coalition (ITPC) a partner of GTPI/ABIA in this patent opposition.

While ABIA/GTPI welcomes the decision of the patent office, the organization maintains its requirement that Gilead refrain from appealing the decision, whether in the patent office, or by a judicial process. It is clear that any effort to put Truvada under monopoly by means of an undeserved patent must be understood as a way to create legal uncertainty and delay the entry of generic medicines into the country. ABIA/GTPI remains firm to its commitment to maintain Truvada free of patents.

“The increase in HIV and AIDS infections in Brazil is alarming. Any barriers to access to new forms of prevention – whether through conservatism or judicial actions – will constitute a serious violation of rights”, says Veriano Terto Jr., Access to Treatment Coordinator at ABIA.

Follow updates on Twitter

In July 2016, ABIA/GTPI started the #TruvadaLivre campaign (Free Truvada campaign), reinforcing the demand for the incorporation of the drug as a prevention technology and demanding Gilead to give up their patent applications for the combination. You can follow updates via the hashtag and by following Make Medicines Affordable.

[1] “Through the petition INPI 020160006847 of 11/01/2016, the Brazilian Interdisciplinary AIDS Association (ABIA) presented a supplement to the presented previously through the INPI petition no. 020100077610 of 20/08/2010, (…). According to this document, despite the fact that no document with the formulation itself, the physico-chemical characteristics of the substances enable the combined formulation of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). Since there are no unexpected technical effects, a technical expert should be able to propose a formulation involving the compounds.”, states the technical opinion issued by INPI.

 

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