Sunday, March 23, 2014

UCB, Ranbaxy Resolve Case over Anti- Epilepsy Drug

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 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

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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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