Gilead Sciences Files Second Patent Infringement Lawsuit Against Teva Pharmaceuticals
May 14 2009 - 4:30PM
Business Wire
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has
filed a lawsuit in U.S. District Court in New York against Teva
Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd.
for infringement of U.S. Patent Numbers 6,642,245 and 6,703,396.
Both patents are associated with emtricitabine, a component of
Truvada� (emtricitabine and tenofovir disoproxil fumarate) and of
Atripla� (efavirenz 600 mg/emtricitabine 200 mg/tenofovir
disoproxil fumarate 300 mg), and are licensed exclusively to Gilead
Sciences by Emory University.
The lawsuit is based on an Abbreviated New Drug Application
filed by Teva Pharmaceuticals USA, Inc., which seeks approval to
manufacture and market a generic version of Atripla before the
expiration of both emtricitabine patents.
Gilead now has two lawsuits pending against Teva
Pharmaceuticals. The first was filed in December 2008 in response
to Teva�s attempts to seek approval for a generic version of
Truvada based on allegations that these same two emtricitabine
patents are invalid, unenforceable and/or will not be infringed by
Teva�s manufacture, use or sale of its generic product.
Gilead has full confidence in the strength of its patent
position and plans to vigorously defend the intellectual property
rights of Atripla.
Atripla is currently protected by 15 patents, which are listed
in the FDA's Approved Drugs Products List, and all 15 patents would
need to be invalidated or expired before a generic version of
Atripla could be marketed.
Atripla is indicated for use alone as a complete regimen or with
other medicines to treat HIV-1 infection in adults, and is
currently sold in the United States through a joint venture between
Gilead and Bristol-Myers Squibb Company.
About Gilead
Sciences
Gilead Sciences is a biopharmaceutical company that discovers,
develops and commercializes innovative therapeutics in areas of
unmet medical need. The company�s mission is to advance the care of
patients suffering from life-threatening diseases worldwide.
Headquartered in Foster City, California, Gilead has operations in
North America, Europe and Australia.
Forward-Looking
Statement
This press release includes forward-looking statements, within
the meaning of the Private Securities Litigation Reform Act of
1995, that are subject to risks, uncertainties and other factors,
including uncertainty related to whether the infringement lawsuits
pending against Teva Pharmaceuticals USA, Inc. will be successful.
These risks, uncertainties and other factors could cause actual
results to differ materially from those referred to in the
forward-looking statements. The reader is cautioned not to rely on
these forward-looking statements. These and other risks are
described in detail in Gilead's Annual Report on Form 10-K for the
year ended December 31, 2008 and Form 10-Q for the first quarter of
2009 as filed with the U.S. Securities and Exchange Commission. All
forward-looking statements are based on information currently
available to Gilead, and Gilead assumes no obligation to update any
such forward-looking statements.
Atripla is a registered trademark of
Bristol-Myers Squibb & Gilead Sciences, LLC.
Truvada is a registered trademark of
Gilead Sciences, Inc.
For more information on Gilead,
please call the Gilead Public Affairs Department at 1-800-GILEAD-5
(1-800-445-3235) or visit www.gilead.com
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