LACK OF CASE AND CONTROVERY IN ANDA CASE

Janssen Pharlaceutica, N.V. v. Apotex, Inc., [2008-1062] (September 4, 20080 [MOORE, Michel, Rader] The Federal Circuit affirmed dismissal of a declaratory judgment action for noninfringement.
DISCUSSION: After granting a covenant not to sue, Janssen requested that Apotex withdraw its counterclaims. Apotex refused, but the district court granted Janssen’s motion to dismiss Apotex’s counterclaims for lack of subject matter jurisdiction. Apotex wanted a declaration because of invalidity to trigger TEVA’s period of exclusivity under Hatch-Waxman. The Federal Circuit found that Apotex’s inability to launch its generic product immediately upon the expiration of the ’663 patent—is not sufficient to give rise to declaratory judgment jurisdiction. Even if Apotex successfully invalidates the ‘425 and ‘527 patents, it cannot obtain FDA approval until the expiration of the ‘663 patent because of its stipulations with respect to that patent. Instead, the harm to Apotex that has continuously existed is its exclusion from selling its alleged noninfringing product during Teva’s statutorily entitled 180-day exclusivity period. Apotex is being excluded from the market by Teva’s 180-day exclusivity period—a period which Teva is entitled to under the Hatch-Waxman Act. This is a different injury than that alleged in Caraco.