Brazil Plans to Produce Copy of Roche’s Viracept if Prices Not Lowered

Brazil will produce and market a generic version of Roche's Viracept early next year if the pharmaceutical firm does not lower the drug's price, Reuters reports. Roche had offered to cut Viracept's price by 13% earlier this year, but the Brazilian Health Ministry rejected the offer. The two sides are still negotiating prices, but Eloan Pinheiros, the director of the government-owned Far-Manguinhos laboratory, said that her facility is preparing to produce the drug by January. Pinheiros added that Far-Manguinhos has completed a copy of nelfinavir and will request a "bioequivalency test" next week to find out whether it is "equivalent" to Viracept. The bioequivalency test will likely take three to four months, after which time the government might issue a compulsory license to produce the drug (Reuters, 8/20). Brazilian patent law states that "a foreign company must forfeit patent rights to a product after three years if the company does not begin to manufacture the product in Brazil during that time" (Kaiser Daily HIV/AIDS Report, 2/6). In May 2000, the United States "complained" about the provision to the World Trade Organization and asked the WTO to review the law. However, the United States dropped its complaint in June 2001, in exchange for an agreement from Brazil that the country would notify U.S. patent holders if it intends to use generic copies of their drugs. As part of the agreement, the United States reserved the right to "revive its complaint if the consultation process fails" (Kaiser Daily HIV/AIDS Report, 6/26). Brazil currently produces eight antiretrovirals locally and distributes them free of charge as part of its AIDS program (Reuters, 8/20).