Wednesday, March 30, 2005
From March 21 World Generic Reports:
"Schering-Plough has reported the Federal Court of Appeals for the 11th Circuit, based in Atlanta, Georgia, has ruled that the company did not violate antitrust laws in its patent litigation settlements regarding its controlled-release potassium chloride supplement, K-Dur 20. In reaching the decision, the Appeals Court set aside a December 2003 decision by the Federal Trade Commission, which had reversed a June 2002 initial decision of an FTC administrative law judge.
"The case dated back to 1995, when Upsher-Smith Laboratories and ESI Lederle filed separate ANDAs for generic versions of K-Dur. Schering-Plough brought separate actions against the two firms, alleging patent infringement, but in each case, Schering-Plough settled before the lawsuits reached trial. Under the settlements, licences were agreed, enabling Upsher-Smith to market its version in September 2001, and ESI Lederle's in January 2004. The settlements led to the FTC's Bureau of Competition filing a complaint in March 2001, alleging that the litigation settlements were anti-competitive and violated the Federal Trade Commission Act. It further argued that the agreements acted to delay the entry of generic competition.
"The June 2002 decision had found that Schering-Plough's patent litigation settlements regarding K-Dur had complied with the law, and dismissed all charges filed against the company by the FTC's Bureau of Competition. However, this was overturned in December 2003, in a ruling which has now in turn been reversed. Unsurprisingly, Schering-Plough has always maintained that the patent litigation settlements complied with the law and benefited consumers by allowing generic products to enter the market two to five years before the expiration of the relevant patent."