Teva Pharmaceuticals v. Crawford (FDA), No. 05–5004, (D.C. Cir. 2005).
As the first ANDA filers on a generic version of gabapentin (Neurontin), Purepac & Teva (joint agreement) were eligible for a 180–day exclusivity period during which no other ANDA for the same drug may be approved.
However, Teva also sued to stop the patentee Pfizer from selling a generic version of its name brand Neurontin during the 180 day period of exclusivity. After losing at the district court level, Teva appealed to the D.C. Circuit, arguing for a “functional” interpretation of the statute (21 USC 355(f)(5)(B)(iv)).
Teva argued that the purpose of the statute was to grant the first ANDA filer complete generic exclusivity for 180 days, and that allowing the patentee to sell the generic would “defeat the statutory purpose.”
Writing for the panel, Chief Judge Ginsberg affirmed the lower court’s judgment.
[A]s Teva’s counsel conceded at oral argument, prior to the Hatch-Waxman Amendments, nothing in the Act prohibited the holder of an approved NDA from marketing a “brand-generic” version of its drug; thus Teva asks the court to declare that a previously lawful practice became unlawful when the Congress passed a statute that said nothing about that practice.
Thus, the court affirmed that the exclusivity provision “clearly does not prohibit the holder of an approved NDA from marketing, during the 180–day exclusivity period, its own ‘brand-generic’ version of its drug.”
Links: