United States DC Circuit

In an action to force the Food and Drug Administration to grant a period of market exclusivity for plaintiff's generic version of the drug Risperdal, judgment for plaintiff is reversed and injunction vacated where the patent cited by plaintiff in its application had been delisted, and even though it was still listed in the FDA's reference guide, plaintiff was not entitled to cite it as the basis for its application.

Appellate Information

• Decided 11/07/2008
• Published 11/07/2008

Judges

• Before:  BROWN and KAVANAUGH, Circuit Judges, and WILLIAMS, Senior Circuit Judge.

Court

• United States DC Circuit

Counsel

• For Appellant:
  
• Gerald F. Masoudi, Associate General Counsel, U.S. Department of Health and Human Services, argued the cause for appellants.   With him on the briefs were Gregory G. Katsas, Acting Assistant Attorney General, U.S. Department of Justice, C. Frederick Beckner III, Deputy Assistant Attorney General, Eugene M. Thirolf, Director, Drake Cutini, Attorney, and Eric M. Blumberg, Deputy Chief Counsel, U.S. Department of Health and Human Services.


• For Appellees:
  
• Jay P. Lefkowitz argued the cause for appellee.   With him on the brief were Michael D. Shumsky and Gregory L. Skidmore.