Wyeth Holdings Corp. v. Sebelius, 603 F.3d 1291, CPLRG 0061(Fed. Cir. 2010) (MOORE, Bryson & Folsom, district judge) Wyeth05032010
MAJOR ISSUES: patent term extension; Food and Drug Administration (FDA) regulatory review period; animal drugs; deference to administrative agency interpretation of statute
COMMENT: The statutory provisions on extending patent terms for human and animal drugs because of regulatory review delay impact only a small category of patent holders but are extremely important to those holders and to the public, given the price differential between drugs that are on patent and those that are off patent (generic). The provisions are complex and implicate not only patent issues but also the distinct regulatory structures and procedures of the Food and Drug Administration (FDA).
Most cases involve regulatory review of applications for human drugs. The 1984 Hatch-Waxman Act provided for extensions. This case involves the similar 1988 statute extending certain animal drugs.
The case focuses on the statutory distinction between delays during a testing phase and an approval phase. The latter begins when a drug sponsor “initially” submits the application for approval based on the prior testing for safety and efficacy. A patent owner receives extension for the full approval phase but only for half the testing phase. After 1988, the FDA adopted procedures that blurred the line between the testing phase and the approval phase, allowing for serial submission of parts of an application. Hence arose the question: when is the “initial” submission? At the beginning or end of the serial submission?
CROSS REFERENCES. On patent term extension (restoration), see Chisum Patent Law Digest 5143; Chisum on Patents 16.04.