Wednesday, March 19, 2014

Cephalon Challenges Sun's Anti-Cancer Generic

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 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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