By Suresh Pillai --
Settlement Announced in Carbatrol® Suit
The U.S. District Court for the District of New
Jersey has approved a settlement of the infringement suit between plaintiff
Shire LLC and defendant Nostrum Pharmaceuticals Inc. concerning
the alleged infringement of U.S. Patent Nos. 5,326,570 and 5,912,013. According to Shire's complaint, filed
in 2008 (see "Court Report," July 6, 2008),
Nostrum's proposed generic version of Shire's epilepsy drug, Carbatrol®, would
infringe both of the patents-in-suit. The patents cover extended-release, immediate-release, and
enteric-release versions of Carbatrol®. Shire was made aware of Nostrum's intent to market its generic version of the drug upon
Nostrum's filing of an Abbreviated New Drug Application (ANDA) with the FDA.
Under the terms of the settlement agreement, Shire
has will grant Nostrum a license to both of the patents-in-suit in
exchange for Nostrum's acknowledgment that both patents are valid and
enforceable. Other terms of the
settlement agreement were not disclosed.
Read the District Court's Judgment and Order of Permanent Injunction here.
Genentech Files Counterclaims in Arzerra®
Infringement Suit
In the latest development in GlaxoSmithKline's declaratory judgment suit concerning U.S. Patent No. 6,331,415,
the patent holder, Genentech, recently filed its answer and counterclaims. In its complaint, GSK contended that its cancer drug Arzerra®
does not infringe the
'415 patent, and that the '415 patent is invalid and unenforceable (see "Court Report,"
February 21, 2010). In response, Genentech has alleged that GSK's marketing of Arzerra® infringes the '415 patent.
The patent-in-suit concerns methods of
using recombinant techniques for designing antibodies that act in a manner
similar to those produced naturally. GSK had originally filed for an accelerated approval for Arzerra®, and
upon the FDA's approval of the drug in October, GSK immediately began marketing
it. In addition to the answer and
counterclaims, Genentech also filed a motion seeking to transfer the case from
the District Court for the Northern District of California to the District
Court for the Central District of California. Read Genentech's Answer here.
Covidien
Prevails in Infringement Suit Versus
Applied Medical
The U.S. District Court for the
Eastern District of
Texas has found Applied Medical Resources Corp.
liable for infringement of U.S. Patent No. 5,895,377,
which is held by Covidien
PLC. The '377 patent, which is directed to a valve
system for cannula
assembly in a surgical device, was issued to U.S. Surgical,
a Covideien subsidiary and co-plaintiff in the suit. In
addition to the finding of infringement, the District Court also found
that another
patent-in-suit, U.S. Patent No. 5,895,377
(also issued to U.S. Surgical) was invalid on grounds of obviousness.
The original suit was filed by Tyco
Healthcare Group
in 2006. Subsequently, Covidien
was formed as a spin-off from Tyco. U.S. Surgical was
added as a party following Applied Medical's assertion
that U.S. Surgical was the true owner of all the patents-in-suit.
The District Court
concluded that Applied Medical had
infringed a single claim of the '377 patent and ordered Applied Medical
to pay $4.8 million in damages.
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