US biopharmaceutical company Cephalon (Nasdaq: CEPH) has filed a patent infringement lawsuit against Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) over Teva's application to market a generic version of Cephalon's sleep disorder drug Nuvigil.
Nuvigil is used to treat excessive sleepiness, often resulting from obstructive sleep apnea, shift work sleep disorder, (also known as shift work disorder), or narcolepsy.
Frazer, Pennsylvania-based Cephalon claimed in its filing with the US District Court in Delaware that it has a three-year period of marketing exclusivity for Nuvigil that extends until June 15, 2010. In addition, including the six-month pediatric extension, three patents expire on April 6, 2015, May 29, 2024, and June 18, 2024.
The lawsuit is based upon an Abbreviated New Drug Application (ANDA) filed by Teva seeking FDA approval for a generic equivalent of Nuvugil (armodafinil) to be sold in the United States. Teva alleges that the above Nuvigil patents are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in its ANDA.
"Cephalon executive VP and general counsel Jerry Pappert said, "We believe that our Nuvigil patents, approved by the US Patent & Trademark Office, are valid, enforceable and are infringed by the proposed Teva ANDA product ."
Under the Hatch-Waxman Act, the filing of the lawsuit stays any FDA approval of the Teva ANDA until the earlier of entry of a district court judgment finding the patents invalid or not infringed or 30 months from the company's October 2009 receipt of a Paragraph IV certification letter from Teva.
Teva shares closed at $53.94 yesterday, giving a market cap of $47.52 billion.
Published by Globes [online], Israel business news - www.globes-online.com - on December 3, 2009
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