India's Patent Office has granted Johnson & Johnson a patent for its antiretroviral drug etravirine, patent attorney Varoon Chhonkar said recently, the Economic Times reports. According to the Times, etravirine, which is marketed by J&J subsidiary Tibotec Pharmaceuticals, already has a U.S. patent and is used in the U.S. in combination with other antiretrovirals to treat HIV-positive people with a history of drug resistance (Singh, Economic Times, 2/11).
The drug, which was approved by the U.S. FDA in January, is sold under the brand name Intelence. Etravirine is a non-nucleoside reverse transcriptase inhibitor that helps to block an enzyme that HIV needs to multiply. The approval was based on studies conducted among people who took combination therapies that included etravirine or a placebo for 24 weeks. According to Tibotec, the studies found that the viral loads of 60% of participants treated with etravirine were suppressed to undetectable levels, compared with 40% of people who were given the placebo. The company added that etravirine is the first NNRTI for HIV-positive people who have developed resistance to drugs in the same class of antiretrovirals (Kaiser Daily HIV/AIDS Report, 1/23).
Some industry sources said that J&J might use the approval to target the Indian market or as a tool to prevent Indian generic drug makers from manufacturing and exporting the drug worldwide. According to the Times, the Indian patent will assist J&J when the company seeks patents for etravirine in other developing countries. Nongovernmental organizations are studying the potential impact of the patent before deciding whether to file a post-patent opposition for the drug, the Times reports (Economic Times, 2/11).
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View drug information on Intelence.