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Brazil may reject Gilead's AIDS drug patent
  Thu Apr 10, 2008
By Maria Pia Palermo
RIO DE JANEIRO, April 10 (Reuters) - Brazil has decreed U.S. pharmaceutical firm Gilead's (GILD.O: Quote, Profile, Research) AIDS drug Tenofovir "in the public interest", signaling it may reject a patent request due to its high price and import a generic version.
The Health Ministry said in a decree published on Wednesday that patenting the drug in Brazil would generate "expectations of monopoly rights with an impact on the price of the product."
Latin America's largest country has an internationally-lauded AIDS prevention and treatment program, in which patients get free antiretroviral treatment.
The ministry said it had requested a priority examination of the patent filing by the company with the Brazilian INPI patent body, which will have to take into account the ministry's objections.
"If no patent is issued, Brazil will be free to negotiate prices of the drug, be it generic or brand name," a health ministry source told Reuters on Thursday, adding that the case was "not about compulsory licensing" or breaking patents.
A representative of Gilead Sciences Inc in Brazil declined to comment on the issue but said high-ranking Gilead officials were in contact with the ministry to discuss the case.
The Health Ministry said Tenofovir accounts for 10 percent of the money the government spends on its AIDS treatment program, which encompasses a cocktail of various drugs, including Tenofovir in some cases.
It said that this year, 31,300 Brazilians would be treated with Tenofovir at a cost of $1,387 per patient. The annual cost per patient, for some 180,000 people treated under Brazil's AIDS program, is about $2,500 worth of medicines a year.
The Health Ministry source said the case was different from last year's bypassing of a patent on Merck & Co Inc (MRK.N: Quote, Profile, Research) AIDS drug Efavirenz.
Last May, President Luiz Inacio Lula da Silva authorized Brazil to sidestep the patent on Efavirenz and import a generic version from India. It was the first time Brazil bypassed a patent to acquire cheaper drugs for its AIDS program.
That process also started with the government declaring the drug "in the public interest" and saying it was too expensive.
If the Tenofovir patent is rejected, Brazil may choose to import generic drug using a clause in World Trade Organization rules to flout drug patents in the name of public health.
Other countries, including Canada, Italy and Thailand, have also used the WTO clause to gain access to cheaper AIDS drugs.
The World Health Organization considers Brazil's AIDS strategy -- which also includes large-scale distribution of free condoms as well as free and fast testing for the HIV virus -- a model for developing nations.
Brazil's AIDS infection rate, after climbing until the early 1990s, has steadied and even reversed course. The prevalence of the HIV virus dropped to 0.5 percent in 2006 from 0.6 percent in 2005, its first fall in seven years. The numbers of new AIDS cases and AIDS deaths have also been declining. Brazil has an estimated 600,000 people infected with HIV/AIDS. (Additional reporting by Pedro Fonseca and Andrei Khalip) (Writing by Andrei Khalip; Editing by Tim Dobbyn)
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