Market Overview

AHF Files Petition for Review of Gilead AIDS Drug Patent Case with U.S. Supreme Court

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In January 2016, 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 found in Gilead's all-in-one Fixed Dose
Combination HIV/AIDS treatments.

In July 2016, the US District Court for the Northern District of
California granted Motion to Dismiss by Gilead; however, the Court's
order suggested that the case was ripe for reconsideration by higher
courts.

AIDS
Healthcare Foundation
(AHF) has filed a petition for writ of
certiorari (a petition for review) with the Supreme Court of the United
States last week seeking the Court's review of the dismissal of a
federal lawsuit filed by AHF in January 2016 against Gilead
Sciences Inc.
and other defendants alleging its patent for a key
HIV/AIDS drug, tenofovir alafenamide (TAF) is invalid because Gilead
manipulated the patent system.

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?"

"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," said Tom Myers,
General Counsel and Chief of Public Affairs for AHF.

"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."

AIDS Healthcare Foundation (AHF), the largest global AIDS
organization, currently provides medical care and/or services to over
965,000 individuals in 41 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

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