On January 5, 2004, Skadden obtained a major court victory for firm client Endo Pharmaceuticals Inc., clearing the way for Endo to market a generic version of the blockbuster prescription pain medication OxyContin. The favorable decision by Judge Sidney Stein of the U.S. District Court for the Southern District of New York follows a month-long bench trial conducted in June 2003.
In 1999, Endo began the process of obtaining FDA approval to market a generic version of OxyContin, manufactured by Purdue Pharma and the Purdue Frederick Company. Endo’s filings with the FDA spurred lawsuits by Purdue, claiming that Endo’s generic drug would infringe three Purdue patents. Endo defended the suits, claiming that Purdue’s patents were fraudulently obtained and should be held unenforceable. In particular, Endo presented evidence at trial demonstrating that while Purdue was making representations to the U.S. Patent and Trademark Office about certain properties of OxyContin in order to obtain patents on the drug, those properties had not been proven to exist and were believed by some Purdue scientists to be unprovable.
In his 50-page January 5 decision, Judge Stein accepted Endo’s position and concluded that “[t]he record as a whole reflects a clear pattern of intentional misrepresentation of a material fact.” Judge Stein proceeded to hold that Purdue’s “repeated intentional misrepresentations are so serious as ‘to warrant the severe sanction of holding the patent[s] unenforceable.”
With Judge Stein’s January 5 decision, Endo is poised to capture a substantial share of the approximately $1.5 billion in revenue Purdue currently obtains from sales of OxyContin. Moreover, Judge Stein’s fraud finding sets the stage for Endo to proceed with its previously bifurcated antitrust counterclaims against Purdue.