Merck, Upsher-Smith pharmaceuticals news
The U.S. Court of Appeals for the Third Circuit said in an opinion that pay-for-delay deals, or reverse payment settlements, violate antitrust laws. Under pay-for-delay deals, a branded drug company will pay a generic company to drop a patent challenge and refrain from producing a generic for a specified period. The ruling overturns a lower court ruling that upheld the validity of a pay-for-delay deal between Merck's Schering-Plough subsidiary and Upsher-Smith for Schering-Plough's drug K-Dur, a sustained-release potassium chloride supplement used to treat potassium deficiencies. Merck acquired Schering-Plough in 2009.
Schering-Plough held a formulation patent on the controlled-release coating for K-Dur. In 1995, Upsher-Smith filed an ANDA containing a paragraph IV certification that Schering-Plough's patent, which expired in September 2006, was invalid. Schering-Plough and Upsher-Smith reached a settlement in 1997 under which Upsher-Smith agreed to drop its patent litigation and to delay its generic version of K-Dur until Sept. 1, 2001. Under the deal, Upsher-Smith also granted Schering-Plough licenses to manufacture and commercialize several Upsher-Smith products. In exchange, Schering-Plough agreed to pay Upsher-Smith $60 million over three years. ...