[Ip-health] The Indenix HCV patents

Jamie Love james.love at keionline.org
Mon Jul 21 10:55:25 PDT 2014


On June 9, 2014, Merck announced it would acquire Indenix.   Idenix was
described a "a biopharmaceutical company engaged in the discovery and
development of medicines for the treatment of human viral diseases, whose
primary focus is on the development of next-generation oral antiviral
therapeutics to treat hepatitis C virus (HCV) infection."

Merck is paying $3.85 billion for the company.  The more recent Indenix
10-K report listed 2013 revenue of just $469 thousand dollars, and assets,
including cash on hand, of $141 million. The Indenix patent porfolio, whic
was probably main asset that Merck wanted, is described in the 10-K report,
as consisting of several patents licensed from the University of Cagliari,
in Italy, theUniversity in Montpellier, in France, and the French National
Centre for Scientific Research.

>From the Idenix Pharmaceuticals, Inc. 10-K report, for period ending
December 31, 2014.

http://www.sec.gov/Archives/edgar/data/1093649/000119312514073142/d638328d10k.htm#tx638328_11

Patents and Licenses

Our policy is to pursue patents and to otherwise protect our technology,
inventions and improvements that are important to the development of our
business. We also rely upon trade secrets that may be important to the
development of our business.

Hepatitis C Patent Portfolio

Our HCV patent portfolio includes at least 34 issued U.S. patents, at least
44 pending U.S. patent applications, at least 69 granted foreign patents
and at least 200 pending foreign patent applications. These patents are
directed to treatment of HCV and/or other Flaviviridae infections.

The HCV patent portfolio includes 11 issued U.S. patents that will expire
in 2021, absent a patent term extension: U.S. Patent Nos. 6,812,219,
6,914,054, 7,105,493, 7,101,861, 7,148,206, 7,163,929, 7,169,766,
7,157,441, 7,608,597, 8,343,937 and 8,299,038. We co-own these 11 patents
with the University of Cagliari, which has exclusively licensed its
interest in the patents to us under an agreement described under the
heading “Cooperative Laboratory Agreement”. The HCV patent portfolio also
includes the following seven issued U.S. patents that will expire in 2023,
absent a patent term extension: U.S. Patent Nos. 7,662,798, 7,456,155,
7,192,936, 7,582,618, 7,608,600, 7,625,875 and 7,635,689. We co-own these
seven patents with the University of Cagliari, the University of
Montpellier and CNRS, which have exclusively licensed their interest in the
patents to us under an agreement described under the heading “Cooperative
Laboratory Agreement”. In addition, the HCV patent portfolio includes U.S.
Patent No. 7,138,376, which will expire in 2022, absent a patent term
extension. We co-own this patent with CNRS, which has exclusively licensed
its interest in the patent to us under an agreement described under the
heading “Cooperative Laboratory Agreement”. The HCV patent portfolio
further includes U.S. Patent No. 7,824,851, which will expire in 2023,
absent a patent term extension. We co-own this patent with the University
of Cagliari, which has exclusively licensed its interest in the patent to
us under an agreement described under the heading “Cooperative Laboratory
Agreement”. The HCV patent portfolio also includes: U.S. Patent No.
7,598,373, which will expire in 2023; U.S. Patent No. 7,781,576, which will
expire in 2026; U.S. Patent No. 7,932,240, which will expire in 2028; U.S.
Patent Nos. 8,003,659 and 8,093,379, each of which will expire in 2029;
U.S. Patent Nos. 8,193,372, 8,309,737, 8,362,068, 8,377,962, 8,410,313,
8,481,748, each of which will expire in 2030; and U.S. Patent No.
8,507,460, which will expire in 2032, all expiration dates absent patent
term extension and all of which are owned exclusively by us. The HCV patent
portfolio also includes U.S. Patent Nos. 7,902,202 and 7,951,789, each of
which will expire in 2027, absent a patent term extension. We co-own these
two patents with the University of Montpellier and CNRS, which have
exclusively licensed their interest in the patents to us under an agreement
described under the heading “Cooperative Laboratory Agreement”.

In February 2012, an interference was declared by the USPTO concerning a
patent application co-owned by us and a patent owned by Gilead. Both the
application and patent claim certain nucleoside compounds useful in
treating HCV. 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’. In March 2013,
the USPTO issued a decision where we were determined to have a later
application filing date than Gilead and therefore we were determined to be
the ‘junior party’ and Gilead the ‘senior party’ in the interference. The
second phase of the interference commenced in the second quarter of 2013
and in January 2014, the USPTO determined that we are not entitled to
priority of invention and judgment was entered in favor of Gilead. We have
challenged this decision in the U.S. District Court for the District of
Delaware.
In December 2013, a second interference was declared by the USPTO
concerning a patent co-owned by us and a patent application owned by
Gilead. Both the patent and application in the second interference claim
the use of certain nucleoside compounds in the treatment of HCV. In this
case, the USPTO has initially determined that Idenix is the ‘senior party’
and that Gilead is the ‘junior party’, although that determination may
change after the first phase of the interference. We cannot predict if the
decision in the first interference will influence the timing and/or outcome
of the second interference.

In June 2012, Gilead filed suit against us in Canadian Federal Court
seeking to invalidate one of our issued Canadian patents. Our patent, which
is the subject of the Canadian litigation, covers similar subject matter to
that patent application at issue in the first U.S. interference and the
patent at issue in the second U.S. interference. In September 2012, Gilead
filed suit against us in the Norway District Court of Oslo seeking to
invalidate one of our issued Norwegian patents. Our patent at issue in the
potential Norwegian litigation covers similar subject matter to that patent
application at issue in the first U.S. interference and the patent at issue
in the second U.S. interference. In January 2013, Gilead commenced
proceedings in the Federal Court of Australia seeking a declaration that
certain claims of one of our issued Australian patents, covering similar
subject matter to that patent application at issue in the first U.S.
interference and the patent at issue in the second U.S. interference, are
invalid. We do not believe the respective patents at issue in these cases
are relevant to any compounds we currently have under clinical development.
Gilead may make similar claims or bring additional legal proceedings in
other jurisdictions where we have granted patents.

In August 2013, we filed a request with the PRB to invalidate Gilead’s
Chinese Patent No. ZL.200480019148.4. Gilead’s patent relates to
2’-fluoro-2’-methyl-nucleoside compounds that are useful for treating HCV
infections. The request alleges that Gilead’s patent is invalid for lack of
novelty over a prior filed Idenix co-owned Chinese patent application. We
cannot predict whether our request will be granted by the PRB.

In December 2013, we filed a lawsuit against Gilead in the U.S. District
Court for the District of Massachusetts alleging infringement of U.S.
Patent Nos. 6,914,054 and 7,608,597. These two patents relate to methods
for treating HCV using nucleoside compounds. In our complaint, we allege
that Gilead’s method of treating HCV using its Sovaldi™ (sofosbuvir)
product infringes the two asserted patents. Also, in December 2013, we
filed a lawsuit against Gilead in the U.S. District Court for the District
of Delaware for infringement of a third U.S. Patent, U.S. Patent No.
7,608,600. This patent also relates to methods for treating HCV using
nucleoside compounds. Similar to the Massachusetts action, the Delaware
action alleges that Gilead’s method of treating HCV using its Sovaldi™
product infringes the asserted patent. In the Delaware action, we also
filed an interference claim between our co-owned U.S. Patent No. 7,608,600
and U.S. Patent No. 8,415,322, which is owned by Gilead. As part of that
claim, we are asking that U.S. Patent No. 7,608,600 be deemed to have
priority of invention over U.S. Patent No. 8,415,322. Our co-owned U.S.
Patent No. 7,608,600 is the same patent at issue in the second interference
described above.


-- 
James Love.  Knowledge Ecology International
http://www.keionline.org, KEI DC tel: +1.202.332.2670, US Mobile:
+1.202.361.3040, Geneva Mobile: +41.76.413.6584,   twitter.com/jamie_love



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