Por: Shasta Darlington

Reuters

SUMMARY: The battle over AIDS drug patents has moved to Brazil, where the government says Merck has threatened legal action over importation of a knockoff drug.

U.S. drug maker Merck and Co Inc. has threatened to take Brazil’s state-owned pharmaceutical firm to court for allegedly violating the patent on an AIDS drug, Brazilian officials said on Monday.

Merck says Brazil’s Far-Manguinhos laboratory violated its patent on Stocrin by importing a generic form of the drug known as Efavirenz from India. The company sent an informal letter to Far-Manguinhos requesting the purchase be stopped.

Far-Manguinhos, which is part of the government’s Oswaldo Cruz research foundation, said it imported only a small amount of the drug for research purposes, which is permitted under Brazilian law. It does not use the imported version of the drug commercially.

"They are demanding that we cancel the purchase and halt our studies and if we don’t they say they are going to take us to court," said Eloan dos Santos Pinheiro, director of drug technology at Far-Manguinhos.

The Brazilian laboratory and research firm said the letter was sent at the beginning of the month and must be responded to by April 3.

"We did send a letter … asking them to reconsider that activity because from our view it would be a violation of the patent in Brazil," said Merck spokesman Gregory Reaves. Reaves declined to comment on whether Merck would take Far-Manguinhos to court if it does not stop purchasing the Indian-manufactured drug.

Still, the latest standoff is just part of an ongoing feud between Brazil and U.S. pharmaceutical companies.

Brazil openly admits that it is researching the make-up of Efavirenz so that it can violate Merck’s patent starting in June if the company does not agree to lower its prices.

"If they negotiate a lower price, we are not going to manufacture it, but if they don’t, we want to be prepared," Pinheiro said.

Model in AIDS Fight

Brazil’s controversial law allowing it to violate patents under certain conditions has helped make the country a model in the global AIDS fight. But it has also sparked criticism from the international pharmaceutical industry.

U.S. drugs makers pushed the U.S. government to submit a request to the World Trade Organization (WTO) to establish a dispute panel to examine charges that Brazil’s patent law discriminates against imports.
Under Brazilian law, foreign firms are required to start manufacturing drugs locally within three years of winning a patent concession or they lose exclusive rights in Brazil.

Local industry can also violate patents in emergency situations in "the interest of the public."

"It would be in the interest of the public to manufacture Efavirenz if Brazil didn’t have the capital to meet the high costs," said Maria Fernanda Macedo, one of Pinheiro’s advisors at Far-Manguinhos.

Starting in 1996, Brazil’s government started making drugs to treat AIDS as part of its policy of free treatment for all patients. Brazil now legally makes eight of the 12 drugs used in the so-called AIDS cocktails.

As a result, AIDS drug prices have plummeted more than 70 percent – a typical treatment for an AIDS patient in Brazil costs about $4,400 a year compared with up to $15,000 in the United States — but prices on those like Efavirenz that do not face competition from locally produced versions have remained high.

Efavirenz, which is only used in a relatively small number of cases, consumes more than 10 percent of Brazil’s $305 million AIDS drugs budget. Still, Merck plans to offer Brazil "an extremely aggressive discount" on the drug in the very near future, Reaves said. "We believe that patent protection and affordable prices are compatible."

At the beginning of the month, Merck said it would offer AIDS drugs at no profit to the poorest of the world’s developing countries and to those where AIDS is infecting more than 1 percent of the population, although Brazil does not fall into those categories.

In absolute numbers, Brazil suffers from a high rate of AIDS infection with 190,000 HIV cases registered, and 500,000 suspected cases. But only 0.6 percent of the adult population is infected compared to 35.8 percent in Botswana. 

Fonte: http://lists.essential.org/pipermail/ip-health/2001-March/001138.html
Acessado em 04/12/2006