Brazilian organization files opposition to Gilead's antiretroviral patent application in India

The Brazilian group Interdisciplinary AIDS Association, or ABIA, has joined Indian patient advocacy groups to oppose a patent application for Gilead Science's antiretroviral drug Tenofovir, saying that the patent would have a direct impact on Brazil's ability to produce and access affordable generic versions of the drug, India's Business Standard reports. Opponents of the patent say that the drug consists of a previously known compound and, therefore, cannot be patented under India's Patents Act.

The Indian nongovernmental organization Centre for Residential Care and Rehabilitation also joined ABIA in the suit. In addition, civil society groups have filed an opposition to Gilead's patent application in Brazil. Veriano Terto, ABIA's general coordinator, said, "Although we are confident that [the] patent will not be granted in Brazil, we must ensure that the option of importing affordable generic versions from India remains open to our AIDS program." Terto added, "This will contribute to the sustainability of our national AIDS program's universal access policy, on which 180,000 Brazilians depend on for their lives" (Business Standard, 6/27).

According to The Hindu, this is the first time a foreign group has challenged a patent pending in India since the introduction of product patents there in 2005. Gabriela Chavez, a pharmacist with ABIA, said, "We want more options to promote competition in the market and bring down drug prices." She added, "If the patent is granted in Brazil but not in India, Brazil has the option to apply for a compulsory license to buy the drug at lower cost from Indian companies. If the patent is not granted in Brazil or India, Brazil has the option to import either the key ingredients or the finished medicines from Indian companies."

Chavez said an estimated 31,000 HIV-positive people in Brazil are expected to receive Tenofovir, known generically as viread, through the country's national AIDS program by the end of 2008. According to The Hindu, the Brazilian government is buying the drug directly from Gilead at the negotiated price of $1,387 per patient annually, and the lowest-priced generic versions of the drug are available in the Indian domestic market for $158. Some Indian pharmaceutical companies in 2006 signed an agreement with Gilead enabling them to manufacture the drug, but preventing them from exporting it or its raw materials to some middle-income countries, including Brazil. If the patent is not granted in India, companies will be able to compete for the domestic market; however, only those that have not signed the agreement with Gilead will be able to export (Hiddleston, The Hindu, 6/27).

The Times of India reports that the patent offices in both India and Brazil will review the case in July (Raaj, Times of India, 6/27).