By Suresh Pillai --
Purdue Pharma Products Inc. has filed
an appeal with the U.S. Court of Appeals for the Federal Circuit seeking
to overturn an earlier federal court decision that invalidated Purdue's patents
(U.S. Patent Nos. 7,074,430 and
6,254,887 covering their product, Ultram ER®.
Purdue originally filed suit in August 2007 in the
wake of Par Pharmaceutical's
filing of an Abbreviated New Drug Application (ANDA) with the FDA, claiming that Par
infringed Purdue's Ultram® patents. In August, the District Court concluded that, though Par infringed the patents-in-suit, the patents themselves were invalid in view of certain prior
art references. In that decision, the District Court reasoned that under 35 U.S.C. § 103, both pre- and
post-KSR, Purdue's selection of
tramadol as the active ingredient for Ultram® would have been obvious (see
"Biotech/Pharma Docket," August 18, 2009). At the time, Purdue argued that the
existence of numerous other eligible analgesics at the time of patenting would
have rendered the choice of tramadol nonobvious to a person having ordinary
skill in the art.
Navinta Appeals District Court Ruling in Naropin®
Case
Earlier this month, Navinta LLC filed notice in the
U.S. District Court for the District of New Jersey announcing its intent to
appeal the District Court's finding of infringement with respect to three patents covering Abraxis BioScience's pain drug
Naropin®,
U.S. Patent Nos. 4,870,086,
5,670,524,
and 5,834,489. At the conclusion of an eight-day bench
trial, the District Court ruled that the proposed generic described in Navinta's 2006
Abbreviated New Drug Application (ANDA) fell within the asserted claims of the patents-in-suit. The Court ordered that Navinta be
denied permission to market and manufacture its generic version of Naropin®
until after the expiration of the patents-in-suit in September 2014.
The original lawsuit was filed in March 2007
following Navinta's entrance into a collaboration with Sandoz AG
that provided Sandoz's U.S. subsidiary with the exclusive rights to make,
market, and distribute their generic form of Naropin® within the United States
(see "Court Report," March 26, 2007). Abraxis' lawsuit claimed that Navinta's
2006 ANDA filing evidenced infringement of the three patents currently in
suit. Navinta countersued,
claiming that Abraxis' suit was a sham litigation designed to extend
Abraxis' monopoly on the drug through a conspiracy between Abraxis and AstraZeneca.
Endo Files Motion to Intervene in Renegal®
Infringement Dispute
Endo Pharmaceuticals Inc. has filed a motion in the
U.S. District Court for the District of Maryland seeking permission to
intervene in the Renegal® patent infringement dispute between Genzyme Corp. and Impax
Laboratories, Inc. In its motion, Endo argued that the
only reason Impax challenged a second patent's validity in the case was for the
sole purpose of forcing Endo, the first-filer of an ANDA based upon the patent,
to forfeit its exclusivity period. The patents-in-suit, U.S. Patent Nos. 6,733,780
and 5,667,775,
cover formulations of sevelamer hydrochloride, the active ingredient in Renegal®.
Genzyme originally filed suit in April 2009,
alleging that Impax's filing of an ANDA seeking permission to market and
manufacture generic versions of Renegal® infringed the '775 patent (see
"Court Report," April 6, 2009). Genzyme had also previously granted
Impax a covenant not to sue over the '780 patent. Based on this covenant, Endo and Genzyme have argued that
the absence of a justiciable case or controversy creates a lack of subject
matter jurisdiction over Impax's attempt to have the '780 patent declared
invalid and noninfringed. Although
both Endo and Genzyme seek to have Impax's challenged dismissed, Endo still
seeks to intervene, as Endo has argued that Genzyme has no direct interest in
helping Endo retain its 180-day exclusivity period for manufacturing
generics based upon the '780 patent.
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