By Suresh Pillai --
Exela Files Appeal to Alphagan® Decision
Following a ruling by the U.S. District Court for
the District of Delaware that Exela PharmSci's proposed generic
version of Allergan's
Alphagan®
glaucoma treatment infringed an Allergan patent, Exela has filed a notice
of appeal, seeking to have the District Court's decision reviewed by the Court
of Appeals for the Federal Circuit. The patents-in-suit, U.S. Patent Nos. 6,627,210,
6,641,834,
6,673,337,
6,562,873,
and 5,424,078,
cover methods and formulations related to the manufacturing of Alphagan®. Allergan filed its original suit
against Exela in 2007 following Exela's announced intent to enter the market
for brimonidine ophthalmic solutions (see "Court Report," April 23,
2007). The suit was later consolidated into
other related suits within the District of
Delaware.
Last month, the District Court ruled that a generic
version of Alphagan® manufactured by Apotex,
another defendant in the infringement suit, infringed all five of the
patents-in-suit (see "Biotech/Pharma Docket," October 26, 2009). In the same ruling, the District Court concluded
that Exela infringed one of the patents-in-suit. Although the defendants
had alleged that the patents-in-suit were invalid on grounds of obviousness,
nonenablement, lack of written description, failure to disclose a best mode,
indefiniteness, lack of utility, inoperability, and incorrect inventorship, the Court disagreed and held that the patents were valid.
Teva Announces Intent to Appeal Vigamox® Decision
Teva Pharmaceuticals USA has announced its
intention to appeal a ruling of the U.S. District Court for the District of
Delaware that Teva infringed Alcon's patent related to
Vigamox®, an anti-bacterial eye drop drug. Alcon filed its original suit in April 2006 after Teva filed
an Abbreviated New Drug Application with the FDA, seeking permission to market
a generic version of Vigamox®. The
patent-in-suit, U.S. Patent No. 6,716,830,
covers moxifloxacin hydrochloride, the active ingredient in Vigamox.
At trial, Teva alleged that the patent
was invalid for anticipation, obviousness, failure to satisfy best mode,
lack of written description, and lack of enablement. Last month, the District Court entered final judgment, having earlier
ruled at the conclusion of the 2008 bench trial that Teva's generic product
infringed Alcon's patent (see "Biotech/Pharma Docket," October 21,
2009). Alcon followed this ruling with a
request that the Court amend to the order to enjoin Teva from marketing the
generic drug until after the patent's 2020 expiration date.
Novartis Prevails over Teva in Famvir® Suit
A jury in the U.S. District Court for the District
of New Jersey has found that Teva Pharmaceuticals USA infringed U.S. Patent No. 5,246,937, which covers Novartis'
genital herpes drug Famvir®. Novartis filed suit alleging infringement in 2005 after Teva's filing of
an Abbreviated New Drug Application with the FDA seeking permission to market a
generic version of Famvir®. At the time, Novartis had also
sought an injunction that would prevent Teva from marketing its generic, but
the District Court denied Novartis' request for injunctive relief.
Novartis then filed willful
infringement claims, which Teva argued should be dismissed based on the District Court's denial of injunctive relief. In February 2009, the Court dismissed Novartis' willful
infringement claims against Teva, holding that in light of the Court's earlier
denial of injunctive relief that would have prevented Teva from marketing its
drug, Novartis would have difficulty proving willful infringement on the part
of Teva. Having conceded that it infringed, Teva argued at
trial that the patent was invalid as obvious, but the jury disagreed.
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