Brazil To Break Patent, Allow Generic Production of Antiretroviral Kaletra Unless Abbott Lowers Price of Drug
Brazilian Health Minister Humberto Costa on Friday informed Abbott Laboratories that it will break the company's patent on the antiretroviral drug Kaletra within 10 days unless the company lowers the drug's price 42% to 68 cents per pill from its current price of $1.17 per pill, London's Financial Times reports. If the patent is broken, generic drug manufacturers could begin producing versions of the drug, which is a combination of the antiretrovirals lopinavir and ritonavir (Bowe/Colitt, Financial Times, 6/25). Costa at a news conference on Friday said researchers at the state-run laboratory Farmanguinhos could produce a generic version of Kaletra for 68 cents per pill, saving the country $54 million each year. Brazil said its decision to break the patent would be based on national and international trade legislation allowing compulsory licenses for drug production as a matter of public interest or during national emergencies, the Wall Street Journal reports (Moffett/Won Tesoriero, Wall Street Journal, 6/27). Costa said that the Kaletra patent is of public interest, adding that if the patent is broken, it would be the first time Brazil has broken a patent on any drug and the first antiretroviral patent to be broken worldwide (Pariz, Reuters, 6/24).
However, Abbott said the Brazilian government does not have a legal basis to issue a compulsory license in the case, adding that the company already sells Kaletra to Brazil at the lowest price anywhere outside of Africa, the New York Times reports (Benson, New York Times, 6/25). "A compulsory license is not in the best interest of Brazilian patients because it puts the government's desire to cut health care spending ahead of patients' need for new and better treatments," according to an Abbott statement (Azzoni, AP/Yahoo! News, 6/24). The company did not say how it would respond to Brazil's ultimatum, but did say it is willing to work with the government to find a "mutually agreeable solution." However, the negotiations could put the Brazilian government at odds with the Bush administration, which during trade negotiations has been pushing Brazil to increase protection of intellectual property rights, according to the Times .
Brazil Negotiating on Other Antiretrovirals
Brazil also is negotiating price reductions for Merck's efavirenz and Gilead's tenofovir, the Times reports (Benson, New York Times, 6/25). Brazil's National STD/AIDS Programme already manufactures and distributes generic versions of antiretrovirals, providing them at no cost to all HIV-positive people in the country. The program ignores all patents issued before 1997, when Brazil signed an intellectual property law in order to join the World Trade Organization. The government over the past three years repeatedly has said it might break patent laws in order to negotiate price reductions with pharmaceutical companies (Kaiser Daily HIV/AIDS Report, 6/3). Brazilian HIV/AIDS advocates said the lower antiretroviral drug prices are needed because the number of HIV-positive people receiving the drugs at no cost is projected to increase from 170,000 currently to 215,000 in 2008 (Wall Street Journal, 6/27). "The government will keep taking steps to give the public access to AIDS drugs," Costa said, adding, "We want to guarantee access to new drugs" (Smith, Bloomberg, 6/24). Brazil's Ministry of Health estimates that 600,000 HIV-positive people live in the country (BBC News, 6/25).