AHF Files Federal Lawsuit Against Gilead to Invalidate Patents on Key AIDS Drug

Legal action, filed today in U.S. District Court, Northern District
of California, asserts that, “…Gilead manipulated the patent system and
engaged in anticompetitive practices to prevent economical access to…”

Tenofovir, a key component in Genvoya, Gilead’s four-in-one Fixed
Dose Combination (FDC).

AHF lawsuit also names Japan
Tobacco Inc. and Emory University and asserts anti-competitive
violations of the Sherman Act. In 2013, Gilead unsuccessfully sought US
patent extension on Stribild, a similar FDC that also included
Tenofovir, which was first synthesized over thirty years ago in the
Czech Republic.

LOS ANGELES–(BUSINESS WIRE)–AIDS
Healthcare Foundation
(AHF) filed a federal lawsuit today against Gilead
Sciences Inc.
seeking to invalidate patents on key AIDS drugs held
by the Bay Area drug maker. The legal action was filed today in U.S.
District Court, Northern District of California, [Case
# 3:16-cv-00443
] and concerns Tenofovir, a key HIV/AIDS drug which
was first synthesized over thirty years ago in the Czech Republic.
Tenofovir is a component in Genvoya,
Gilead’s four-in-one Fixed Dose Combination (FDC) to treat HIV/AIDS
patients as well as Gilead’s similar predecessor FDC, Stribild.

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 &
2.

AHF currently cares for over 575,000 HIV/AIDS patients in 35 countries
and purchased millions of dollars of antiviral drugs from Gilead in 2015
alone. In its legal filing, AHF asserts that:

“In a relentless effort to maximize its profits, Gilead manipulated
the patent system and engaged in anticompetitive practices to prevent
economical access to TAF – an antiviral agent used in the treatment of
HIV.
TAF is not a new compound. TAF is a prodrug1
of the compound Tenofovir, which was first synthesized over thirty years
ago in the Czech Republic.
Nor was TAF the first prodrug of
Tenofovir.
Several years before Gilead obtained a patent on TAF,
Gilead had patented a similar prodrug called Tenofovir Disoproxil
(“TDF”).
Despite similarities between TAF and TDF and the
weakness of the patents covering TAF, Gilead illegally seeks to extend
the period of patent exclusivity for drugs incorporating Tenofovir by
decades.

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.
Gilead’s
actions have directly harmed AHF, which in 2015 alone purchased millions
of dollars of antiviral drugs from Gilead.”

1 Prodrugs are medicines that are converted into their active
form once they are processed inside the body. In the case of TAF, it is
taken orally and after absorption it passes into the blood.

“In 2013, Gilead unsuccessfully petitioned the FDA for a patent
extension from three to five years on Stribild—which at $28,500 per
patient, per year when it was introduced in January 2013 was the most
expensive fixed-dose first-line combination HIV/AIDS therapy on the
market,” said Michael Weinstein, President of AIDS Healthcare
Foundation. “In November 2015, after the FDA approved Gilead’s Genvoya,
we said the updated combination, with admittedly fewer potential side
effects, was also developed as a means to extend prior patent
protections. We believed then—as now—that Gilead is trying to monopolize
the market by price gouging on its HIV/AIDS treatments, actions that
severely diminish access to these lifesaving medications and serve as
catalyst for our legal action today.”

“Gilead’s illegal acts prevent people living with HIV/AIDS from
accessing lifesaving treatment and cost the public billions of dollars
because of Gilead’s unwarranted monopoly,” said Daniel Hipskind, AIDS
Healthcare Foundation’s attorney from the firm Olavi Dunne LLP. “Gilead
must stop manipulating patent and FDA law in order to charge exorbitant
prices for HIV drugs.”

“This case sends a message to the pharmaceutical industry. Gilead
shouldn’t be able to line its pockets by manipulating access to its HIV
drugs,” said Dorian Berger AIDS Healthcare Foundation’s
attorney from the firm Olavi Dunne LLP. “It is illegal to block access
to lifesaving drugs by manipulating the law and through this legal
action we intend to hold Gilead accountable.”

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
cause
kidney
damage
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 — elvitegravir,
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 that Genvoya is now based on, Gilead filed a citizen’s
petition
with the FDA seeking an extension on its patent protection
on Stribild 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 &
2.

About AIDS Healthcare Foundation

AIDS Healthcare Foundation (AHF), the largest global AIDS
organization, currently provides medical care and/or services to over
575,000 individuals in 35 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

AIDS Healthcare Foundation
Ged Kenslea, Senior Director,
Communications
+1.323.791.5526 mobile
gedk@aidshealth.org