Orion Sues Sun Pharmaceuticals in the U.S. to Enforce a Patent for Stalevo
Company states the realisation of generic competition is neither
certain nor imminent
ESPOO, Finland, Nov. 13, 2007--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.
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/.
Jukka Viinanen Olli Huotari
President and CEO Senior VP, Corporate Functions
Jukka Viinanen, President and CEO, phone +358 10 426 3710
Olli Huotari, Senior VP, Corporate Functions, phone +358 10 426 3054
Statements in this news release other than historical information are forward-looking statement subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in Annual Report for 2006.
Orionintie 1A, FI-02200 Espoo
Posted: November 2007