Wednesday, March 5, 2014

B&L Files Lawsuit against Sandoz Alleging Patent Infringement

Case Filed: Mar 02, 2014

Court: New Jersey District Court

Judge: Michael A. Shipp

Case Summary:
Plaintiffs Bausch & Lomb, Mitsubishi Tanabe and Ube Industries jointly filed a complaint against generic drug maker Sandoz accusing the latter of infringing a patent owned by Mitsubishi Tanabe and Ube (as per the face page). Bausch & Lomb is the current holder[i] of approved New Drug Application (NDA) No. 022288, which covers Bepreve® (source: MaxVal Patent Marker). The lawsuit concerned the filing of an abbreviated new drug application with U.S. Food and Drug Administration (FDA) for bepotastine besilate ophthalmic solution intended to be a generic version of Bepreve®.

Bepreve™ (bepotastine besilate) is a prescription eye drop used to treat eye allergies. Bepreve is manufactured by Bausch & Lomb and is currently under the protection of U.S. patent no. 6780877. Bausch & Lomb holds the exclusive rights to market Bepreve until at least 2014.

The patent US6780877 entitled ‘Acid addition salt of optically active piperidine compound and process for preparing the same’ was issued by the U.S. Patent and Trademark Office (PTO) on Aug 24, 2004 and expires[ii] by Dec 26, 2016. The ’877 patent is currently assigned[iii] to Mitsubishi Tanabe (source: MaxVal’s Assignment Database). The ’877 patent claims bepotastine besilate and a pharmaceutical composition including it.

The complaint alleges that Sandoz has infringed at least one claim of the ’877 patent by submitting ANDA No. 206080 to the FDA seeking approval for commercial marketing of Sandoz’s generic bepotastine besilate ophthalmic solution before the expiration date of the ’877 patent. It further claimed that if approved and marketed, the generic would infringe at least one claim of the ’877 patent.

The suit sought a judgment of infringement, a court order postponing the effective date of the Sandoz ANDA until after the patent-in-suit expires, attorneys' fees and court costs.
See 3:14-cv-01325 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

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[i] Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.
[ii] 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. 
[iii] MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.

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