Cephalon Files Patent Infringement Lawsuit Against Watson.Cephalon, Inc. (Frazer, PA) and its wholly-owned subsidiary CIMA LABS INC. have filed a lawsuit in United States District Court United States District Court In the U.S., any of the 94 trial courts of general jurisdiction in the federal judicial system. Each state, as well as the District of Columbia and the Commonwealth of Puerto Rico, has at least one federal district court. in Delaware against Watson Pharmaceuticals, Inc. and its wholly-owned subsidiary, Watson Laboratories, Inc., for infringement of United States Patents 6,200,604 and 6,974,590, which cover methods of use for the Cephalon product FENTORA (fentanyl fentanyl /fen·ta·nyl/ (fen´tah-nil) an opioid analgesic; the citrate salt is used as an adjunct to anesthesia, in the induction and maintenance of anesthesia, in combination with droperidol (or similar agent) as a neuroleptanalgesic, and buccal tablet) (C-II). The 6,200,604 and 6,974,590 patents do not expire until 2019. FENTORA was approved by the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) 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. The lawsuit is based upon an Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA) filed by Watson seeking FDA approval for a generic equivalent of fentanyl buccal tablets to be sold in the United States. Watson alleges that the above two FENTORA patents are invalid, unenforceable and/or will not be infringed by Watson's manufacture, use or sale of the product described in its ANDA. "We believe that the proposed Watson ANDA product infringes our patents," said Jerry Pappert, Executive Vice President and General Counsel. "The FENTORA patents were approved by the United States Patent and Trademark Office The United States Patent and Trademark Office (PTO or USPTO) is an agency in the United States Department of Commerce that provides patent protection to inventors and businesses for their inventions, and trademark registration for product and intellectual property based on the results of extensive research by CIMA LABS. We continue to believe that our patent position for this product is strong and intend to vigorously defend our intellectual property." The filing of this lawsuit is provided for by the Hatch-Waxman Act, a federal statute governing certain aspects of generic drug approvals. Under that statute, the filing of the lawsuit stays any FDA approval of the Watson ANDA until the earlier of a district court judgment in favor of Watson or 30 months from the company's April 2008 receipt of a Paragraph IV certification letter from Watson. Founded in 1987, Cephalon is an international biopharmaceutical company dedicated to the discovery, development and commercialization of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. A member of the Fortune 1000, Cephalon currently employs approximately 3,000 people in the United States and Europe. United States sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania The Borough of West Chester is the county seat of Chester County, Pennsylvania.GR6 Philadelphia is 25 miles to the east and Wilmington 17 miles to the south. , Salt Lake City, Utah For ships of the United States Navy of the same name, see . Salt Lake City is the capital and the most populous city of the U.S. state of Utah. The name of the city is often shortened to Salt Lake, or its initials, S.L.C. , and suburban Minneapolis, Minnesota. The company's European headquarters are located in Maisons-Alfort, France. The company's proprietary products in the United States include: TREANDA (bendamustine hydrochloride) for injection, AMRIX (Cyclobenzaprine Hydrochloride Extended-Release Capsules), PROVIGIL (modafinil) Tablets (C-IV), FENTORA, TRISENOX (arsenic trioxide) injection, VIVITROL (naltrexone naltrexone /nal·trex·one/ (nal-trek´son) an opioid antagonist used as the hydrochloride salt in treatment of opioid or alcohol abuse. nal·trex·one n. An endorphin and narcotic antagonist. for extended-release injectable suspension), GABITRIL (tiagabine hydrochloride), NUVIGIL (armodafinil) Tablets (C-IV) and ACTIQ (oral transmucosal fentanyl citrate) (C-II). The company also markets numerous products internationally. Cephalon, Inc. +1-610-738-6493 www.cephalon.com |
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