Schering-Plough says that it is pleased with an appeals court ruling that it did not break antitrust laws in patent litigation settlements involving its heart drug, K-DUR — a controlled-release dispersible potassium chloride tablet.
Earlier this week, the appeals court rejected a December 2003 Federal Trade Commission ruling that the firm had broken the law by conspiring with two other companies to keep generic versions of K-DUR off the market [[19/12/03a]]. The FTC had alleged that patent litigation settlements reached in 1997 with Upsher-Smith and in 1998 with ESI Lederle were anti-competitive and broke the law by preventing cheaper alternatives to a popular prescription drug from coming to market. It had originally cleared S-P of blame [[05/07/02d]], but then decided that the decision had been based on “fundamental errors of law and fact” [[19/12/03a]].
The company has consistently maintained that the patent litigation settlements complied with the law and benefited consumers by allowing generic product to enter the market two to five years before the expiration of the relevant patent.
S-P’s formulation patent for K-DUR is not set to expire until next year but, in 1995, Upsher- Smith and ESI Lederle filed separate applications with the US Food and Drug Administration seeking to market copycat versions of the drug. S-P filed patent infringement lawsuits, but these settled these before trial by allowing Upsher-Smith and ESI Lederle to bring their products to market in September 2001 and January 2004 respectively.