In Reverse Decision, Sunovion Wins Patent Infringement Suit
A federal appellate court ruled last week that a planned generic sleep aid would infringe on Sunovion Pharmaceuticals Inc. patent for its Lunesta drug, rerversing a lower-court ruling against the Marlborough firm.
That previous decision in January found the generic proposed by Dr. Reddy’s Laboratories Inc. had enough chemical differences from Sunovion’s brand-name drug.
Sunovion’s patent covers a compound that contains less than 0.25 percent of an unwanted chemical entity. Dr. Reddy’s applied to market a version of the insomnia medication that contained between zero and 0.6 percent of the chemical entity.
Dr. Reddy’s later submitted a statement to the court saying it wouldn’t market a product with less than 0.3 percent of the chemical entity, but the Federal Circuit ruled the pledge was unenforceable and incompatible with patent law. The court said Dr. Reddy’s would instead need to amend its application to avoid infringement.
Sunovion filed an infringement suit in March 2009 against 10 companies, including Dr. Reddy’s, which filed applications to make generic versions of Lunesta. Sunovion has reached settlements with some of those generic makers.
Sunovion didn’t immediately return calls for comment Tuesday.
Sales of Lunesta generated $136 million of revenue in North America and China during the second quarter of 2013, according to Sunovion’s parent company, Dainippon Sumitomo Pharma.
5:35 p.m. Update
A Sunovion spokeswoman responded Tuesday afternoon and provided the following comment: "Sunovion is pleased with the decsion from the Court of Appeals. The Court's decision ensures that Lunesta will retain market exclusivity through April 15, 2014 as planned."
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