BioCentury
ARTICLE | Company News

Gilead, Japan Tobacco, AIDS Healthcare Foundation, Emory University infectious news

February 15, 2016 8:00 AM UTC

The foundation filed a lawsuit in the U.S. District Court for the Northern District of California alleging that Gilead “manipulated the patent system and engaged in anticompetitive practices” to block generic entry and maintain inflated pricing of HIV drugs containing tenofovir alafenamide fumarate (TAF). TAF is a prodrug of tenofovir, a nucleotide analog prodrug reverse transcriptase inhibitor that was discovered 30 years ago and known to exhibit anti-HIV effects but could not be absorbed orally in its original form. In its complaint, AHF argued that TAF should not have been unpatentable because “the formulation of prodrugs was well known at the time as was the anti-HIV effectiveness of tenofovir.”

AHF accused Gilead of scheming to maintain a monopoly over TAF “despite the weakness of Gilead’s patents covering TAF.” The non-profit said Gilead’s November 2015 launch of HIV drug Genvoya TAF/elvitegravir/cobicistat/emtricitabine “is indicative of the anti-competitive strategy employed by Gilead to protect TAF from a patentability challenge directly.” Instead of developing TAF as a standalone drug, AHF argued Gilead “knowingly, willfully, and wrongfully maintained its monopoly power by improperly bundling” TAF into Genvoya, knowing that a generic manufacturer wishing to enter the market would have to invalidate all 12 Orange Book patents covering Genvoya and its four components instead of just the three TAF patents. ...