Idenix Pharmaceuticals Announces Decision by the United States Patent and Trademark Office Patent Trial and Appeal Board in t...
January 29 2014 - 4:01PM
Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical
company engaged in the discovery and development of drugs for the
treatment of human viral diseases, today announced that the United
States Patent and Trademark Office Patent Trial and Appeal Board
(USPTO) issued a decision in the first patent interference
proceeding (No. 105,871) concerning one of the Company's patent
applications (U.S. Patent Application 12/131,868) and an issued
patent (U.S. Patent 7,429,572) owned by Gilead Pharmasset LLC
("Gilead") that covers certain 2'-methyl-2'-fluoro nucleoside
compounds useful in the treatment of the hepatitis C virus (HCV).
The USPTO determined that Idenix is not entitled to priority of
invention and judgment was entered in favor of Gilead.
"We intend to challenge this decision in proceedings outside the
USPTO. We are confident in our patent portfolio and will continue
to defend it vigorously, and this specific matter before the USPTO
represents just one part of our overall effort," said Ronald
Renaud, President and Chief Executive Officer at Idenix. "Idenix
has several patent families that provide coverage for 2'-methyl
nucleoside compounds and 2'-methyl, 2'-fluoro nucleoside compounds
specifically."
Idenix does not believe that the patent application at issue in
the interference is relevant to any of the compounds currently
under clinical development, including samatasvir, its NS5A
inhibitor which is in two ongoing 12-week phase II all-oral HCV
combination studies, or IDX21437, its lead uridine nucleotide
prodrug which is in an ongoing phase I/II clinical trial.
About Patent Interferences
An interference is an adversarial proceeding declared by the
USPTO when a party has a U.S. patent application that covers the
same invention as another patent application or issued patent to
determine priority of invention in the United States. An
interference proceeding is divided into two stages. The first phase
determines the application filing dates each party will have
benefit of for the interfering subject matter. The party with the
benefit of the earliest application filing date is deemed the
'senior party' and the party with the later date is deemed the
'junior party'. The junior party bears the burden of proof to
demonstrate that it invented the technology in question before the
senior party. The second phase determines who was first to
invent.
Other Ongoing Patent Disputes
In December 2013, the USPTO declared a second patent
interference between Idenix's U.S. Patent 7,608,600 and Gilead's
U.S. Patent Application 11/854,218, both related to the use of
certain 2'-methyl, 2'-fluoro nucleoside compounds to treat HCV
infections. In this proceeding, the USPTO has initially determined
that Idenix is the senior party and that Gilead is the junior
party.
In December 2013, Idenix announced it filed two lawsuits against
Gilead: a patent infringement lawsuit in the United States District
Court in Boston, Massachusetts (Idenix U.S. Patents 6,914,054 and
7,608,597) and a separate patent infringement and interference
lawsuit in the United States District Court in Wilmington, Delaware
(Idenix U.S. Patent 7,608,600 and Gilead U.S. Patent 8,415,322).
The patents asserted by Idenix in its Massachusetts infringement
lawsuit are not the same patents at issue in the U.S. patent
interferences or in ongoing foreign litigation. The patent in the
Delaware lawsuit is the same as the patent involved in the second
patent interference.
Foreign litigation is ongoing related to lawsuits Gilead has
filed against Idenix in various jurisdictions outside the United
States to invalidate granted Idenix patents covering certain
2'-methyl-2'-fluoro nucleoside compounds and their use in treating
HCV or other Flaviviridae virus infections.
ABOUT IDENIX
Idenix Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts, is a biopharmaceutical Company engaged in the
discovery and development of drugs for the treatment of human viral
diseases. Idenix's current focus is on the treatment of patients
with hepatitis C infection. For further information about Idenix,
please refer to www.idenix.com.
FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking statements" for
purposes of the safe harbor provisions of The Private Securities
Litigation Reform Act of 1995, including but not limited to the
statements regarding the Company's future business and financial
performance. For this purpose, any statements contained herein that
are not statements of historical fact may be deemed forward-looking
statements. Without limiting the foregoing, the words "expect,"
"plans," "will," and similar expressions are also intended to
identify forward-looking statements, as are expressed or implied
statements with respect to the Company's litigation strategy.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of risks and uncertainties,
including but not limited to the following: the Company's ability
to maintain and enforce patent and other intellectual property
protection for its product candidates and its discoveries. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause actual results to be
materially different from any future results, performance or
achievements expressed or implied by such statements. These and
other risks which may impact management's expectations are
described in greater detail under the heading "Risk Factors" in the
Company's annual report on Form 10-K for the year ended December
31, 2012 and the quarterly report on Form 10-Q for the quarter
ended September 30, 2013, each as filed with the Securities and
Exchange Commission (SEC) and in any subsequent periodic or current
report that the Company files with the SEC.
All forward-looking statements reflect the Company's estimates
only as of the date of this release (unless another date is
indicated) and should not be relied upon as reflecting the
Company's views, expectations or beliefs at any date subsequent to
the date of this release. While Idenix may elect to update these
forward-looking statements at some point in the future, it
specifically disclaims any obligation to do so, even if the
Company's estimates change.
CONTACT: Idenix Pharmaceuticals Contact:
Teri Dahlman (617) 995-9807
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