Case Filed: Mar 14, 2014
Case Summary:
Cephalon hit Sun Pharmaceutical
Industries with a suit in Delaware District Court alleging its attempts to
market a generic version of an anti-cancer drug infringed a Cephalon patent. Cephalon
is a biopharmaceutical company developing and marketing products to treat
neurological disorders, cancer and pain.
The plaintiff claims that Sun is
infringing a patent on its Treanda® product by seeking U.S. Food and Drug
Administration approval to manufacture generics in the liquid form, of 25
mg/vial and 100 mg/vial intravenous infusion bendamustine hydrochloride. The
patent that revolves around the suit, US8609863 entitled ’Bendamustine
pharmaceutical compositions’ was issued on Dec 17, 2013 and expires[i]
by Jan 12, 2026.
The complaint alleges that Sun
infringed claims of the ‘863 patent by filing Abbreviated New Drug Application
(ANDA) No. 205653 seeking approval to sell generic versions of Cephalon’s
Treanda® while the patent is still in effect. It added further that if approved
and marketed, the generic would infringe the ‘863 patent.
Cephalon currently holds[ii]
New Drug Application (NDAs) No. 22249 for Treanda® (source: Patent Marker). According
to the complaint, Sun alerted Cephalon that it had asked the FDA to approve its
request to market bendamustine hydrochloride for injection. The letter alleged
that the claims in the ‘863 patent were invalid, unenforceable and/or would not
be infringed by the manufacture, use, importation, sale or offer for sale of
Sun’s bendamustine hydrochloride product.
Cephalon seeks permanent
enjoinment of Sun’s ANDA products or damages, if Sun engages in the commercial
manufacture of the ANDA products.
See 1:14-cv-00333
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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.