Orion sues generic drug companies in the U.S. to enforce patents for entacapone
Orion Corporation has filed a patent infringement lawsuit in the United States to enforce U.S. Patent No. 5,446,194 and U.S. Patent No. 5,135,950 against generic drug companies Wockhardt USA, Inc. and Wockhardt Limited, who seek to market generic entacapone (200 mg tablets) in the United States. Entacapone is the active ingredient in Comtan®, a product originated by Orion Corporation and marketed in the United States for the treatment of Parkinson's disease by its exclusive licensee, Novartis. Orion Corporation and Novartis will vigorously defend the intellectual property rights covering Comtan.
Orion Corporation was notified in August 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 three of Orion Corporation's patents. By suing to enforce its patents 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 patents in the patent infringement lawsuit. As such, the realisation of generic competition is neither certain nor imminent.
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