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news.Cephalon and its wholly-owned subsidiary Cima Labs have filed a lawsuit in the US District Court in Delaware against Watson Pharmaceuticals and its wholly owned subsidiary, Watson Laboratories for infringement of US patent, which cover methods of use for the Cephalon product Fentora.
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The US patents do not expire until 2019. The lawsuit is based upon an abbreviated new drug application (ANDA) filed by Watson seeking FDA approval for a generic equivalent of fentanyl buccal tablets to be sold in the US.
Watson alleges that the above two Fentora patents are invalid, unenforceable and will not be infringed by Watson’s manufacture, use or sale of the product described in its ANDA.
Fentora was approved by the FDA in September 2006 for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
Jerry Pappert, executive vice president and general counsel of Cephalon, said: “We believe that the proposed Watson ANDA product infringes our patents. The Fentora patents were approved by the US Patent and Trademark Office based on the results of extensive research by Cima Labs.”