Decision in Class Action Under the Tucker Act, Plus FDA Determination Upheld

In Wyeth Holdings Corp. v. Sebelius, No. 09-1368, the Federal Circuit faced a challenge to the 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.  First, the court rejected the petitioner's argument that section 156(g) unambiguously indicates that an application is initially submitted when a sponsor submits its first technical section in concluding that the section 156(g) is ambiguous.  Second, the court held that FDA's interpretation is permissible and that it is not arbitrary and capricious, in affirming the district court's judgment. 

Bright v. US, No.09-5048, involved a putative class action lawsuit, brought by landowners seeking compensation under the Fifth Amendment pursuant to the Tucker Act for the alleged taking of their respective property interests under the National Trail Systems Act, 16 U.S.C. sections 1241-1251.  In reversing the United States Court of Federal Claims' dismissal of the second amended complaint as to all named plaintiff except for one, the court held that when a class action complaint is filed in the Court of Federal Claims and a class certification is sought prior to expiration of the section 2501 limitations period, the limitations period is tolled, and is tolled during the period the court allows potential class members to opt into the class. 

Related Resources:

• Full text of Wyeth Holdings Corp. v. Sebelius
• Full text of Bright v. US