Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories Inc. and Mylan Pharmaceuticals Inc.
Economic Advice in Litigation
The Situation
Ortho-McNeil manufactures and sells TOPAMAX®, which contains the active ingredient topiramate and treats epilepsy. Research scientists at Ortho-McNeil discovered and patented the invention that topiramate had unexpected powerful anticonvulsant properties. Subsequently, Mylan sought approval to market a generic version of topiramate by filing an Abbreviated New Drug Application with the US Food and Drug Administration asserting Ortho-McNeil's associated patent is invalid or not infringed. In response, Ortho-McNeil filed an infringement suit in the US District Court of New Jersey (Civil Action No. 3:04-1689 (SRC)).
NERA's Role
NERA Special Consultant Dr. Richard Rozek prepared an analysis of the commercial success of TOPAMAX® for Ortho-McNeil.
The Result
In March 2008, the US Court of Appeals for the Federal Circuit affirmed the District Court ruling in favor of Ortho-McNeil in all respects, holding that the basic patent for topiramate was infringed, was not invalid for obviousness or lack of enablement, and was not unenforceable for inequitable conduct. Specifically, the CAFC Decision states that "[t]he record ... shows skepticism of experts and copying -- other respected sources of objective evidence of nonobviousness -- as well as commercial success."
