CEPH returns fire:
>>WEST CHESTER, Pa., March 31 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH - News) announced today that it has filed a lawsuit in U.S. District Court in New Jersey against four generic drug companies for infringement of Cephalon's U.S. Patent No. RE37516. The '516 patent covers the pharmaceutical compositions of the form of modafinil contained in PROVIGIL® Tablets [C-IV] and does not expire until 2014.
The lawsuit against Teva Pharmaceuticals USA, Inc., Mylan Pharmaceutical Inc., Ranbaxy Pharmaceuticals Inc., and Barr Laboratories, Inc. is based upon Abbreviated New Drug Applications (ANDAs) filed by each of the companies seeking U.S. Food and Drug Administration (FDA) approval for a generic equivalent of modafinil to be sold in the United States. A company may file an ANDA requesting permission to market a generic drug prior to expiration of a pioneer company's patent only if it alleges that the patent either is invalid, unenforceable, or would not be infringed by the proposed generic product. In their filings, Teva and Mylan principally claimed that Cephalon's '516 patent is invalid, and Ranbaxy and Barr principally claimed the '516 patent would not be infringed by their respective generic products.
"We have reviewed each of these filings in detail. We have not found anything in them that is surprising or unanticipated. Our patent was approved by the United States Patent and Trademark Office based on the results of extensive research by Cephalon, and we continue to believe that our patent position for this product is strong," said John E. Osborn, Senior Vice President and General Counsel of Cephalon.
Even if the lawsuit is unsuccessful and an ANDA application eventually is approved by the FDA, it will be years before a generic equivalent modafinil product can be sold in the United States. In addition to the pharmaceutical composition patent that protects PROVIGIL until 2014, the drug has orphan drug exclusivity that prevents the approval of any ANDA for a modafinil product prior to June 2006, provided the FDA grants the company a six-month extension to the December 2005 orphan drug exclusivity upon completion of a pediatric study.
Also, the lawsuit triggers a stay that precludes the FDA from approving any ANDA for up to 30 months to allow the court adequate time to resolve the infringement lawsuit. Because this lawsuit commenced prior to the end of the New Chemical Entity exclusivity period for PROVIGIL and within 45 days of the date of notice by a generic company, the 30-month stay effectively begins at the expiration of the NCE exclusivity period on December 24, 2003.
PROVIGIL was approved by the FDA for the treatment of excessive daytime sleepiness associated with narcolepsy in December 1998 and was launched in the United States by Cephalon in February 1999. In December 2002, the company filed a Supplemental New Drug Application with the FDA seeking to expand its U.S. labeling to cover the treatment of excessive sleepiness associated with disorders of sleep and wakefulness in adults.<<
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Cheers, Tuck |
