In July 2016, 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]. The Federal Circuit Court affirmed, but the District Court’s order suggested that the case was ripe for reconsideration by higher courts. As such, a petition for writ of certiorari was filed with the Supreme Court Tuesday, August 7th.
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. AHF alleges Gilead’s patent on TAF is invalid and that it and others should be able to introduce generic and cheaper versions of TAF into the market immediately.
The Question AHF Presents to the Supreme Court: (taken directly from AHF’s petition for writ of certiorari)
“Many patients with HIV depend on lifesaving, low-cost drugs provided by Petitioner AIDS Healthcare Foundation, Inc. (“AHF”), a non-profit organization. Respondent Gilead Sciences, Inc. has patented HIV drugs including Tenofovir Alafenamide (“TAF”).
“In addition to its patents on TAF, Gilead also obtained five years of exclusivity for drugs containing TAF from the U.S. Food and Drug Administration (“FDA”). During this five-year exclusivity period, AHF and its generic drug suppliers are prevented from filing an application with the FDA for approval of generic TAF.
“AHF seeks to introduce generic TAF to its patients as soon as possible (once Gilead’s exclusivity period runs out) but is prevented from doing so by Gilead’s patents on TAF. AHF led a declaratory judgment action alleging invalidity of the patents, but the lower courts found that AHF lacked jurisdiction. This case presents the following question:
In the context of patent cases involving pharmaceutical products, does the ‘actual controversy’ requirement of the Declaratory Judgment Act, 28 U.S.C. § 2201(a), require a party seeking to introduce a generic drug product to file an application for FDA approval of that generic drug product before it can file suit for declaratory relief for patent invalidity?”
AHF public affairs chief and general counsel Tom Myers said: “Although we were disappointed with the District Court’s ruling in 2016, the Court made clear in the opinion its discontent at what it perceived 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 manufacturers to obtain FDA approval.”
“AHF firmly believes that pharmaceutical companies should not be permitted to game the patent system to prolong profits at the expense of patient welfare. That is why we are petitioning the Supreme Court to review this critical question.”
Myers also noted the following reference in the Court’s 2016 order that suggested 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, “At the time of the 2016 ruling, AHF vowed that it would appeal to the Supreme Court, if necessary, to prevent Gilead from using a faulty patent process to game the system and garner more profits at the expense of patient health. This week, with the filing of our writ, we honor that vow.”
Source: Company Press Release