United States DC Circuit

Summary judgment for plaintiffs, on request that the FDA relist patents held by Merck that Merck requested removed from the "Orange Book" after plaintiffs challenged Merck's patents, thereby precluding plaintiffs from obtaining a period of marketing exclusivity of their competing drug, is affirmed where the FDA's requirement that a generic manufacturer's patent challenge give rise to litigation as a condition of retaining exclusivity when a patent is delisted is inconsistent with the Act, which provides that the first generic manufacturer to file an approved application is entitled to exclusivity when it either begins commercially to market its generic drug or is successful in patent litigation.

Appellate Information

• Decided 11/14/2006
• Published 11/14/2006

Judges

• Before:  GINSBURG, Chief Judge, and GRIFFITH and KAVANAUGH, Circuit Judges.

Court

• United States DC Circuit

Counsel

• For Appellant:
  
• Howard S. Scher, Attorney, U.S. Department of Justice, argued the cause for appellants.   With him on the briefs were Peter D. Keisler, Assistant Attorney General, Kenneth L. Wainstein, U.S. Attorney, Douglas N. Letter, Attorney, and Eric M. Blumberg, Deputy Chief Counsel, U.S. Department of Health and Human Services.  Drake S. Cutini, Attorney, U.S. Department of Justice, entered an appearance., Simon E. Dance was on the brief for amicus curiae Blue Cross & Blue Shield Association, Inc. in support of appellants.


• For Appellees:
  
• Carmen M. Shepard argued the cause for appellees Ranbaxy Laboratories Limited, et al.   With her on the brief were Kate C. Beardsley and William B. Schultz., Jay P. Lefkowitz argued the cause for appellee Teva Pharmaceuticals, USA, Inc. With him on the brief were John C. O'Quinn and Michael D. Shumsky., Theodore Case Whitehouse was on the brief for amicus curiae Generic Pharmaceutical Association in support of appellees.