United States Federal Circuit

District court's rejection of petitioner's challenge to the FDA's determination of the date on which the approval phase of its phased regulatory review process begins for purposes of calculating patent term extensions, related to an animal drug for the treatment and control of parasites in beef and dairy cattle, is affirmed where: 1) petitioner's argument that section 156(g) unambiguously indicates that an application is initially submitted when a sponsor submits its first technical section is rejected as section 156(g) is ambiguous; 2) the FDA'a interpretation is permissible; and 3) the FDA interpretation challenged by petitioner is not arbitrary and capricious.

Appellate Information

• Decided 05/03/2010
• Published 05/03/2010

Judges

Court

• United States Federal Circuit

Counsel