GROUP QUESTIONS GILEAD'S HIV DRUG LICENSES

Advocacy group Knowledge Ecology International (KEI) has sent a petition to the U.S. FTC requesting an investigation of what it calls anticompetitive aspects of voluntary licenses issued by drugmaker Gilead. The company has licensed rights to its HIV drug Viread (tenofivir disoproxil fumarate) to several generic companies worldwide, including South African firm Aspen Pharmacare.

Gilead licenses rights to both the finished product and active pharmaceutical ingredient (API) for generic tenofivir, according to KEI. But the company only holds patents on the drug in very few countries. Last year, Aspen signed a voluntary nonexclusive license to manufacture and sell generic Viread.

But according to KEI, Gilead holds no patent on Viread in South Africa and many other countries, and therefore the company's license agreements may violate competition laws in the U.S. and elsewhere. For one, the licenses require royalty payments where Gilead does not hold a patent.

KEI believes Gilead is controlling the market for tenofovir. The company's actions are harmful to the generic companies, which shouldn't have to pay royalties where Gilead holds no patent rights, and the U.S. government, which is the largest purchaser of HIV drugs for the developing world, KEI says.

Additionally, Médecins Sans Frontières (MSF) has said that Gilead's deal with Aspen has only hindered access to tenofivir, for it has prevented the drug from being registered in South Africa. Groups, including MSF and the Treatment Action Campaign, are calling for South Africa's Medicines Control Council to register the drug.