Case Filed: Jul 07, 2013
Case Closed: Mar 18, 2014
Court: Delaware District
Court
Judge: Leonard P. Stark
Case Summary:
Belgium-based UCB Inc., a
global biopharmaceutical company focusing on central nervous system and immunology
treatment and research, along with others filed a patent infringement case
against Ranbaxy, a generic drug maker to prevent the latter from entering the
market with versions of its epilepsy treatment drug Vimpat (lacosamide.)
UCB’s civil action states
that the defendant infringed one or more claims of the reissued patent RE38551
by filing the ANDA seeking approval for the commercial manufacture, use, offer
for sale, sale and/or import of a generic version of Vimpat before the expiration
of the ’551 patent. The patent claims therapeutic composition comprising
lacosamide and a method of treating central nervous system disorders in humans.
The plaintiffs requested Court to issue a permanent injunction and enjoining
defendant from infringing activities.
The patent-in-suit is
entitled ‘Anticonvulsant enantiomeric amino acid derivatives’, issued by USPTO
on Jul 07, 2004 and expires[i]
by Mar 17, 2017. According to the complaint, the patent belonged to RCT and was
granted license to Harris which in turn sub-licensed to Schwarz and was later acquired
by UCB along with the rights on Lacosamide.
UCB currently holds[ii]
the FDA approved new drug applications (NDA) nos. 022253, 022254 and 022255 for
Vimpat tablets and solution (source: Patent Marker)
with active ingredient as lacosamide.
It appears that Ranbaxy have
amended ANDA No. 204682 to remove the certification with respect to the ‘551 patent
and no longer seeks FDA approval prior to the expiration of the patent. The Court dismissed the case for lack of
subject matter jurisdiction with each party to bear its costs, disbursements
and attorney fees.
Separate suits were also
filed against drug makers such as Aurobindo, Sun, Glenmark, Sandoz, Aurobindo,
Watson, etc. which are still pending in the Delaware District Court asserting
the same patent.
See 1:13-cv-01215
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[i]
Expected expiration date. Patent Term Estimator is a free web-based tool that
automatically calculates patent terms and expiration dates for U.S. utility
patents.
[ii]
Patent Marker provides an online environment
where patentees can virtually mark products and search products for
patent-related information.
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