AHF to Appeal Gilead AIDS Drug Patent Case

In News by AHF

In January, AHF filed a federal lawsuit against Gilead Sciences, Inc. and two other defendants alleging drug patent manipulation and anti-trust claims regarding slightly different formulations of tenofovir, a key HIV/AIDS drug that is found in Gilead’s all-in-one Fixed Dose Combination (FDC) HIV/AIDS treatments.

Last week, the US District Court for the Northern District of California granted Gilead’s Motion to Dismiss; however, the Court’s order suggested that this case is ripe for reconsideration by higher courts.

LOS ANGELES (July 11, 2016) AIDS Healthcare Foundation (AHF) today announced that it will appeal the dismissal of its federal lawsuit filed against Gilead Sciences Inc. and other defendants alleging drug patent manipulation and anti-trust claims regarding slightly different formulations of tenofovir, a key HIV/AIDS drug. Last week, Judge William Alsup of the U.S. District Court, Northern District of California, granted a Motion to Dismiss sought by Gilead in the case [Case # 3:16-cv-00443]; however, the Court’s order suggested that this case is ripe for reconsideration by higher courts.

AHF’s case focuses on patents of certain Gilead drugs used in Fixed Dose Combinations (FDC), multiple drugs combined in one tablet or pill used in the treatment of people with HIV or AIDS. The drugs at the heart of AHF’s lawsuit are Gilead’s TAF (tenofovir alafenamide), which has fewer negative side effects than TDF (tenofovir disoproxil fumarate), but unlike TDF, is only available as a part of Gilead’s FDCs and not as a standalone medication.

“Although we are disappointed with the Court’s ruling, the Court made clear in the opinion its discontent at what it perceives to be the current state of the law.  The Court stated that AHF should have standing to bring its patent invalidity claims to clear the way for generic manufactures to obtain FDA approval.  AHF will seek to appeal the decision and firmly believes that pharmaceutical companies should not be permitted to game the patent system to prolong profits at the expense of patient welfare,” said Arti Bhimani, Assistant General Counsel for AHF.

Bhimani also noted the following reference in the Court’s order that suggests that this case is ripe for reconsideration by higher courts:

 “If we were writing on a clean slate, this order would hold that AIDS Healthcare, at least as a purchaser seeking to encourage manufacturers to prepare to make TAF-containing products as soon as Gilead’s NCE exclusivity expires, could pursue its invalidity theories in district court as the first step in solving a multi-layered problem. (This would contrast with the competitors that could not pursue declaratory judgment in the decisions addressed above.) If AIDS Healthcare were to succeed in clearing away the allegedly invalid patents, then generic manufacturers would be all the sooner poised to apply for FDA approval for TAF-containing products when the application period opens in three-plus years. This would reduce the barriers to speedily bringing low-cost effective drugs to victims of HIV and AIDS.”

AHF President Michael Weinstein added, “We intend to appeal all the way to the Supreme Court, if necessary, should that be required to prevent Gilead from using a faulty patent process to garner more profits at the expense of patient health.”

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