Orion has filed a patent infringement lawsuit in the US to enforce U.S. Patent Nos. 5,135,950; 5,446,194; and 6,500,867 against Wockhardt USA, Inc. and Wockhardt Limited. Wockhardt seek to market a generic version of Orion Corporation's proprietary drug, Stalevo® (specifically 12.5/200/50 mg strength of carbidopa/entacapone/levodopa) in the United States.
Stalevo is an enhanced levodopa treatment originated by Orion Corporation and marketed in the US by its exclusive licensee, Novartis, for the treatment of Parkinson's disease. In November 2008, Orion was notified that Wockhardt submitted an ANDA with the USFDA that included a Paragraph IV challenge to several of Orion Corporation's patents. By suing to enforce its patents within 45 days from receipt of the Paragraph IV certification notice, Orion is entitled to an automatic stay prohibiting the FDA from approving the applicants ANDA for 30 months, or until an earlier court decision adverse to Orion Corporation's patents in the infringement lawsuit. Orion and Novartis will vigorously defend the intellectual property rights covering Stalevo.
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