Ortho-McNeil Pharmaceutical, Inc. et al. v. Mylan Laboratories, Inc.
Economic Advice in Litigation
The Situation
United States Patent No. 5,053,407 discloses the anti-infective drug levofloxacin, sold by NERA’s client Ortho-McNeil under the brand name Levaquin®. Mylan contended that the patent was invalid due to obviousness and other reasons and announced its intention to introduce a generic equivalent before the '407 patent expired. In February 2002, the plaintiffs filed suit in the U.S. District Court for the Northern District of West Virginia, contending that the '407 patent is not invalid and that Mylan would infringe the patent if it made or sold generic levofloxacin in the United States before the patent expired. A trial was scheduled for November - December 2003.
NERA's Role
Retained by Ortho-McNeil, NERA analyzed Levaquin®'s performance in the anti-infectives marketplace and concluded that the invention described in the patent had been a commercial success. In December 2003, NERA Special Consultant Dr. Marion Stewart testified on Ortho-McNeil's behalf and explained NERA's research and analysis to the court.
The Result
Exactly one year later, on December 23, 2004, Judge Irene Keeley ruled that the '407 patent is not invalid and that Mylan would infringe the patent if it introduced a generic version of levofloxacin prior to the patent’s expiration. Citing several NERA calculations, Judge Keeley wrote: “The patented invention in this case has indisputably enjoyed extraordinary commercial success…Levofloxacin was a commercial success on its own merits, a factor which weighs in favor of nonobviousness.”
