Company states the realisation of generic competition is neither certain nor imminent
Orion Corporation filed a patent infringement lawsuit in the United States to enforce its U.S. Patent No. 5,446,194 ("the '194 patent") against Sun Pharmaceutical Industries Limited ("Sun"), who seeks 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.
As reported in January 2008, Orion Corporation was notified that Sun had amended its Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) that included a Paragraph IV challenge of Orion Corporation's '194 patent. Orion Corporation has now sued Sun for infringement of two Orion Corporation patents in response to Sun's Paragraph IV challenges. The other patent is U.S. Patent No. 6,500,867. Due to recent developments, Orion Corporation has removed Sun Pharmaceutical Industries Inc. from the prior lawsuit. Orion Corporation, however, maintains the prior action against Sun Pharmaceutical Industries Limited, the parent company and ANDA holder.
By suing to enforce its patent by the new lawsuit within 45 days from the receipt of Sun's latest Paragraph IV certification notice, Orion is entitled to an automatic stay prohibiting the FDA from approving Sun's ANDA for 30 months, or until an earlier court decision adverse to Orion Corporation's patent. The realisation of generic competition is neither certain nor imminent. Orion Corporation and Novartis will vigorously defend the intellectual property rights covering Stalevo®.
Orion Corporation is dedicated to treating and preventing disease by discovery and developing innovative medicinal treatments. In 2007, Orion Corporation generated sales of EUR 683.6 million, invested EUR 97.6 million in research and development and employed approximately 3,180 people. Orion corporate headquarters are in Espoo, Finland. For more information, please visit: http://www.orion.fi/english/.
Timo Lappalainen Olli Huotari
President and CEO Senior VP, Corporate Functions
Timo Lappalainen, President and CEO, phone +358 10 426 3692
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.
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