AHF: Gilead Says it “Had No Duty to Develop …” Less Harmful AIDS Drug in Legal Motion on Patent Lawsuit

In January, AHF filed a federal lawsuit against Gilead Sciences, Inc.
and two other defendants alleging drug patent manipulation and
anti-trust claims regarding Genvoya, Gilead’s new four-in-one Fixed Dose
Combination (FDC) to treat HIV/AIDS patients. Gilead unsuccessfully
sought US patent extension on Stribild, its similar but earlier FDC that
includes a form of Tenofovir, the drug at the heart of AHF’s lawsuit.

According to the legal news website, Law360, Gilead attorneys, in a
motion to dismiss AHF’s lawsuit, wrote, “Just as Gilead was under no
antitrust duty to bring a standalone TAF product to market, it likewise
had no duty to develop, test, seek approval of or launch its new product
on any particular timetable.”

LOS ANGELES–(BUSINESS WIRE)–In a motion to dismiss the federal lawsuit filed by AIDS
Healthcare Foundation
(AHF) against Gilead
Sciences Inc.
seeking to invalidate patents on key AIDS drugs held
by the Bay Area drug maker, lawyers for Gilead wrote that the company “…
had no duty to develop …”
a less harmful HIV/AIDS drug.

AHF’s lawsuit was filed in January 2016 in U.S. District Court, Northern
District of California, [Case
# 3:16-cv-00443
]. AHF’s patent and anti-trust case centers on
slightly different formulations of Tenofovir, a key HIV/AIDS drug which
was first synthesized over thirty years ago in the Czech Republic. One
formulation of Tenofovir (tenofovir alafenamide or TAF) is a component
in Genvoya,
Gilead’s newest four-in-one Fixed Dose Combination (FDC) to treat
HIV/AIDS patients, which was approved by the FDA in November 2015.

Gilead’s similar predecessor four-in-one Fixed Dose Combination, Stribild,
includes an earlier formulation of Tenofovir (tenofovir
disoproxil fumarate
or TDF, commercially branded as Viread). TDF has
potentially harmful side effects including kidney damage and bone loss.
The Tenofovir formulation known as TAF has far fewer side effects, a
fact that Gilead is using in its marketing and promotion of Genvoya.
TDF, the earlier formulation of Tenofovir, is also now nearing the end
of its patent protection.

“The legal news website Law
reports that Gilead and its attorneys, in its motion to dismiss
our lawsuit, actually say that they had no obligation whatsoever to
develop this newer, less harmful form of Tenofovir. Despite the fact
that Gilead is now widely touting its updated formulation of Tenofovir’s
reduced risk of causing kidney damage and bone loss, it doesn’t matter
one bit legally if they purposely delay bringing it to market. Instead,
so they could continue to maximize profits—and run the patent clock—on
its older, potentially more harmful Tenofovir formulation. Gilead
delayed bringing TAF to market and has yet to do so for TAF as a
standalone drug,” said Michael Weinstein, President of AIDS
Healthcare Foundation. “An indefensible excuse by Gilead on moral
grounds as well as a brazen defense on legal grounds that we will
continue to challenge.”

According the Law 360 article (March 23, 2016, Stan Parker): “AIDS
Healthcare Foundation alleged in its complaint that Gilead intentionally
postponed clinical studies of TAF until its exclusivity period for TDF
was about to expire, putting its market position ahead of patients who
need the treatments. It also alleged that patent protections relating to
Genvoya must be nixed because TAF was an anticipated, not novel,
improvement on TDF.”

Law 360 also noted, “Just as Gilead was under no antitrust duty to
bring a standalone TAF product to market, it likewise had no duty to
develop, test, seek approval of or launch its new product on any
particular timetable,” the company wrote.

AHF’s lawsuit also names Japan Tobacco Inc. and Emory University and
asserts anti-competitive violations of the Sherman Act,15 U.S.C. §§ 1 &

AHF currently cares for over 605,000 HIV/AIDS patients in 36 countries
and purchased millions of dollars of antiviral drugs from Gilead in 2015
alone. In its legal filing, AHF asserts that:

Gilead’s attempt to extend the period of patent exclusivity for drugs
incorporating Tenofovir arises from Gilead manipulating the patent
system, entering into a licensing agreement with Japan Tobacco, and
using a preexisting patent licensing agreement with Emory University to
block entry by potential competitors and prevent competition.
actions have directly harmed AHF, which in 2015 alone purchased millions
of dollars of antiviral drugs from Gilead.

According to a New
York Times
article at the time of Genvoya’s approval by the FDA in
November 2015, Genvoya “…contains the same four drugs as Stribild,
but with the tenofovir disoproxil fumarate replaced by tenofovir
alafenamide. The new form of the inhibitor, Gilead said, enters cells
where H.I.V. replicates more efficiently, resulting in 91 percent less
tenofovir in the bloodstream. That should make the pill less likely to
or loss of bone density…”

In response to FDA approval of Gilead’s Genvoya, the Indian online news
site ‘The Hindu’ published a November 8, 2015 article titled, “Magic
Pill, or Just an Old Cocktail?’
The article noted:

“There are two things one needs to know about this drug. First, it is
not a new drug. It is a combination of four old drugs
cobicistat, emtricitabine, and tenofovir alafenamide (TAF). This is
called a Fixed Dose Combination (FDC).

And while FDCs are good for improving adherence among patients, this
is no magic pill. ‘Technically, this is simply not a breakthrough. No
new drug has been discovered
older drugs have been brought
together in the FDC form. This is important as it improves compliance,
which is a great thing but to call it a breakthrough is a stretch,’ said
Dr Manish Kakkar, a public health specialist in communicable diseases at
the Public Health Foundation of India (PHFI).”

In January 2013, shortly after the FDA approved Stribild, the Fixed Dose
Combination on which Genvoya is now based, Gilead filed a citizen’s
with the FDA seeking an extension on its patent protection
on the drug from three years to five years.

In October 2014, the FDA denied
Gilead’s petition for the patent extension.

AHF’s lawsuit, which demands a jury trial, seeks “Declaratory Judgment
of Patent Invalidity and Violation of the Sherman Act, 15 U.S.C. §§ 1 &

AIDS Healthcare Foundation (AHF), the largest global AIDS
organization, currently provides medical care and/or services to over
605,000 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


AIDS Healthcare Foundation
Ged Kenslea, +1.323.791.5526
Senior Director, Communications