Orion comments on new challenge by Sun Pharmaceutical Industries Ltd., India, of Orion's U.S. Patent covering Stalevo in the US
Company states the realisation of generic competition is neither certain nor imminent
Orion Corporation has been informed that Sun Pharmaceutical Industries Ltd., India (Sun), has amended its Abbreviated New Drug Application (ANDA) with the U.S. food and Drug Administration (FDA) seeking authorisation to produce and market generic versions of Stalevo® tablets (25/100/200 and 37.5/150/200 mg strengths of carbidopa/levodopa/entacapone) in the United States. Sun's amendment to its ANDA involves a Paragraph IV challenge to Orion's U.S. Patent No. 5,446,194. The ANDA review process has recently just begun and the realisation of generic competition is neither certain nor imminent. 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.
Sun previously filed Paragraph IV certifications against Orion's U.S. Patents 6,500,867 and 6,797,732, and Orion subsequently sued Sun (November 2007) in the United States for patent infringement. Of the six Orion patents listed in the FDA's Orange Book, three have not received Paragraph IV certifications from Sun (U.S. Patent Nos. 4,963,590, 5,112,861, and 5,135,950), and the latest of these expires 31 October 2010.
Paragraph IV certifications are not uncommon in the USA. Orion is, together with Novartis, currently evaluating its legal options to protect its rights. Under the U.S. system, if a patent owner brings a lawsuit against an ANDA applicant within a certain time limit, there will be a 30-month stay of final FDA approval. During that time, the FDA can give only a tentative approval to the ANDA applicant unless the applicant obtains a favorable decision on all challenged patents in the lawsuit.
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