Orion Sues Sun Pharmaceuticals In The U.S. To Enforce A Patent For Stalevo
Espoo, Finland, Nov 14, 2007 - (Hugin via ABN Newswire) - Company states the realisation of generic competition is neither certain nor imminent
Orion Corporation has filed a patent infringement lawsuit in the United States to enforce its formulation patent, U.S. Patent No. 6,500,867, against Sun Pharmaceutical Industries Inc. and Sun Pharmaceutical Industries Limited, who seek to market generic versions of Stalevo® tablets (25/100/200 and 37.5/150/200 mg strengths of carbidopa/levodopa/entacapone) in the United States. Stalevo is an enhanced levodopa treatment originated by Orion Corporation and marketed in the United States by its exclusive licensee, Novartis, for the treatment of Parkinson's disease. Orion Corporation and Novartis will vigorously defend the intellectual property rights covering Stalevo.
As previously reported, Orion Corporation was notified in October 2007 that a generic drug company had submitted an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) that included a Paragraph IV certification challenging two of Orion Corporation's formulation patents protecting Stalevo. By suing to enforce its patent within 45 days from receipt of the Paragraph IV certification notice, Orion Corporation is entitled to an automatic stay prohibiting the FDA from approving the applicant's ANDA for 30 months, or until an earlier court decision adverse to Orion Corporation's patent in the patent infringement lawsuit. As such, the realisation of generic competition is neither certain nor imminent.
ABOUT ORION
Orion Corporation is dedicated to treating and preventing disease by discovery and developing innovative medicinal treatments. In 2006, Orion Corporation generated sales of EUR 641.1 million, invested EUR 84.1 million in research and development and employed approximately 3,060 people. Orion corporate headquarters are in Espoo, Finland. For more information, please visit: http://www.orion.fi/english/.