Brazil has decided that the drugmaker's Viread is "in the public interest," suggesting a patent will be rejected over pricing. If that happens, the country may import a generic. The Health Ministry published a decree that patenting the drug in Brazil would generate "expectations of monopoly rights with an impact on the price of the product,"Reuters writes.
The ministry requested a priority examination of the patent filing by Gilead with the Brazilian INPI patent body, which will have to review 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.
The Health Ministry says 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. A Gilead official in Brazil declined to comment, but the drugmaker is in contact with the ministry to discuss the case. Do you speak Portuguese? If so, look here.
Earlier this year, the US Patent & Trademark Office invalidated four HIV/AIDS patents belonging to Gilead for tenofovir disoproxil fumarate, or TDF, which the drugmaker markets in the US under the brand name Viread and as part of its Atripla combo product. Last summer, the Public Patent Foundation challenged the patents because the FDA won’t allow any other entity to distribute TDF in the US and Gilead claims the four patents offer exclusive rights.
A Health Ministry source says the case is not the same situation as last year when the government broke the patent on Merck's Efavirenz AIDS drug. Last May, President Luiz Inacio Lula da Silva authorized Brazil to 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 drg "in the public interest" and saying it was too expensive, Reuters notes.
This year, Brazil says 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, Reuters writes.
If the Tenofovir patent is rejected, Brazil may choose to import generic drug using a clause in World Trade Organization rules to break 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 WHO 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, Reuters notes.
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.