Merck Threatens Brazilian Lab With Legal Action Over Patent ProtectionsMerck & Co. has "threatened" to take legal action against a Brazilian pharmaceutical company over allegations of patent violation, Reuters reports. Merck stated that Brazil's Far-Manguinhos laboratory violated the company's patent on Stocrin by importing a generic form of the drug from India. In an informal letter to Far-Manguinhos, which is part of the Brazilian government's Oswaldo Cruz Research Foundation, Merck asked the laboratory to halt the importation of the generic drug, also known as efavirenz. The laboratory said that it has only imported a "small amount of [efavirenz] for research purposes" and has not used the drug commercially. The importation of the drug for research is permitted under Brazilian law, and Brazil has "openly admit[ted]" that it is studying the formula of efavirenz so it can "violate Merck's patent" starting in June if the company does not lower the price of Stocrin, Reuters reports. According to Eloan dos Santos Pinheiro, director of drug technology at Far-Manguinhos, Merck "demand[ed]" that the laboratory "cancel the purchase" of efavirenz and "halt" its studies involving the drug. If the lab does not comply, Merck will file suit, he added. Merck spokesperson Gregory Reaves said that the drug firm did send the laboratory a letter, but did not comment on whether the company plans to pursue a lawsuit against Far-Manguinhos. Brazil must respond to the letter, which was sent at the beginning of March, by April 3.
Not Backing Down
Stocrin is used in "a relatively small number of [AIDS] cases" in Brazil, but the drug's cost accounts for more than 10% of the country's $305 million budget for AIDS medicines (Darlington, Reuters, 3/26). Earlier this month, Merck offered to sell Stocrin at a discounted rate of $500 per patient per year to sub-Saharan African countries, but did not include Brazil in the offer ( Kaiser Daily HIV/AIDS Report, 3/9). Reaves said, however, that Merck plans to offer Brazil an "extremely aggressive discount" on Stocrin in the "near future" (Reuters, 3/26). Brazil's production of generic drugs is also the subject of a complaint filed by the United States with the WTO. The complaint argues that Brazil's law requiring drug firms to reduce the price of AIDS drugs and permitting the compulsory licensing of generic drugs if the companies do not lower prices violates international trade rules. Brazil, however, "shows no sign of backing down," and plans to defend its case before the WTO. Brazilian Foreign Affairs Minister Celso Lafer said he believe Brazil's case is aided by "legal arguments based on Brazilian patent and intellectual property law" and the "moral dimension" of the issue (Rohter, New York Times, 3/27).