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
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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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