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Finland's Orion files US suit to protect key drug

Mon Dec 8, 2008 3:37pm EST

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HELSINKI, Dec 8 (Reuters) - Finnish drug firm Orion (ORNBV.HE) said on Monday it has filed a patent infringement lawsuit in the United States to protect its key drug Stalevo, used for treatment of Parkinson's disease.

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Indian drug maker Wockhardt Ltd (WCKH.BO) is seeking to sell a generic version of Stalevo in the United States and has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking to sell the drug, Orion said.

"Stalevo is an enhanced levodopa treatment originated by Orion Corporation and marketed in the United States by its exclusive licensee, Novartis (NOVN.VX)," Orion said in a statement.

Orion said by suing to enforce its patent, it is entitled to an automatic stay prohibiting the FDA from approving Wockhardt's application for 30 months -- or until an earlier court decision adverse to Orion's patent in the patent infringement lawsuit.

"As such, the realization of generic competition is neither certain nor imminent," Orion said, adding it would vigorously defend the intellectual property rights covering Stalevo. (Reporting by Tarmo Virki, editing by Gerald E. McCormick)



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