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Orion Sues Sun Pharmaceuticals In The U.S. To Enforce Orion's U.S. Patent No. 5,446,194 Covering Its Proprietary Drug StalevoŽ
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 StalevoŽ tablets (25/100/200 and 37.5/150/200 mg strengths of carbidopa/levodopa/entacapone) in the United States. StalevoŽ 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 StalevoŽ.