AHF to Appeal Gilead AIDS Drug Patent Case

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–(BUSINESS WIRE)–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.”

AIDS Healthcare Foundation (AHF), the largest global AIDS
organization, currently provides medical care and/or services to over
666,000 individuals in 36 countries worldwide in the US, Africa, Latin
America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn
more about AHF, please visit our website: www.aidshealth.org,
find us on Facebook: www.facebook.com/aidshealth
and follow us on Twitter: @aidshealthcare

Contacts

AHF
Ged Kenslea, Senior Director, Communications
+1.323.791.5526
mobile
gedk@aidshealth.org