The U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court’s granting of summary judgment for the U.S. Food and Drug Administration (FDA) ruling that the Hatch-Waxman amendments do not prohibit the holder of an approved new drug application (NDA) from marketing a "branded generic" version of its drug during the 180-day exclusivity period provided to the first to file an abbreviated new drug application (ANDA) to market a generic drug. Teva Pharmaceutical Industries v. Crawford, Case No. 05-5004 (D.C. Cir. June 3, 2005) (Ginsburg, C. J.).

Teva began marketing Gabapentin, the generic equivalent of Pfizer’s name brand Neurontin, pursuant to an ANDA application. Pfizer began direct competition with Teva during Teva’s 180-day exclusivity period provided to the first ANDA filer by marketing its own "generic" version of Gabapentin, using a generic trade dress and distributing its "branded generic" Gabapentin through the same distribution channels as Teva.

Teva petitioned the FDA to prohibit the marketing and distribution of "authorized generic" versions of brand name products until after the expiration of the 180-day exclusivity period. In the alternative, Teva demanded the FDA require Pfizer to submit a supplemental new drug application before marketing or distributing any generic version of its name brand drug. The FDA denied Teva’s petition, finding no statutory basis for imposing additional requirements on drugs already approved under an NDA that are marketed as "authorized generics." Teva sued in the FDA district court, which agreed with the FDA that nothing in the Hatch-Waxman amendments prohibit an NDA holder from entering the market with an authorized generic drug during the exclusivity period provided the first filer upon approval of an ANDA application.

Teva appealed, arguing a literal interpretation of §355(j)(5)(B)(iv) would defeat the statutory purpose since it would permit the holder of the name brand drug to encroach upon the 180-day exclusivity period in the generic market provided to the generic drug manufacturer and urging the adoption of a "functional" interpretation. The D.C. Circuit rejected this argument, noting the statutory language does not limit how the holder of an approved NDA may market its drug. The court held the statutory language could not be interpreted to prevent the holder of an approved NDA (who does not need to file an ANDA and certainly would not challenge its own patent) from marketing a "branded generic" product—even during the exclusivity period provided to other companies who must file an ANDA to obtain approval for a generic equivalent.

The court also refused to require the holder of an approved NDA to submit a supplemental new drug application for its own generic, holding the FDA may not require such supplemental applications for reasons unrelated to safety or efficacy of the brand company’s product.

Practice Note
This opinion effectively approves of the rapidly emerging strategy of branded-drug pharmaceutical companies protecting their overall market share by introducing "brand-generic" versions during the 180-day exclusivity period, thereby disrupting generic drug manufacturers’ efforts to gain market share.

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