Opinion ID: 212098
Heading Depth: 3
Heading Rank: 4

Heading: Teva's declaratory judgment action

Text: 19 On January 24, 2003, Teva filed a declaratory judgment action in the United States District Court for the District of Massachusetts, seeking a declaration that its generic version of Zoloft(R) does not infringe the '699 patent and a declaration that the '699 patent is invalid. On March 10, 2003, Pfizer moved to dismiss the action, arguing that the court lacked subject matter jurisdiction because of the absence of an actual controversy, as required by Article III of the Constitution. On December 8, 2003, the court granted Pfizer's motion to dismiss. 20 In addressing Pfizer's motion, the district court applied the two-part test formulated by this court to determine whether an actual controversy exists in a patent infringement suit. Under that test, there must be both (1) an explicit threat or other action by the patentee which creates a reasonable apprehension on the part of the declaratory judgment plaintiff that it will face an infringement suit, and (2) present activity by the declaratory judgment plaintiff which could constitute infringement, or concrete steps taken by the declaratory judgment plaintiff with the intent to conduct such activity. See Amana Refrigeration, Inc. v. Quadlux, Inc., 172 F.3d 852, 855 (Fed.Cir.1999). The district court determined that Teva had satisfied the second prong of the test by filing its ANDA for generic sertraline hydrochloride. However, the court concluded that Teva had failed to satisfy the reasonable apprehension prong of the test. 21 Before the district court, Teva argued that Pfizer had created a reasonable apprehension of suit based upon the following considerations: (1) Pfizer had listed the '699 patent in the Orange Book; (2) Pfizer had refused to grant Teva a covenant not to sue; (3) Pfizer had aggressively asserted its patent rights against alleged infringers of other patents; (4) Pfizer sued Ivax, the first generic manufacturer of sertraline hydrochloride; and (5) it was in Pfizer's self-interest to leave a cloud of litigation hanging over Teva. With respect to the final consideration, Teva argued that Pfizer's settlement with Ivax gave Pfizer a vested interest in seeing Ivax preserve its 180-day exclusivity period. 22 The district court rejected Teva's contentions. First, the court noted that a blanket inference that, by listing a patent in the Orange Book, a patentee has declared its intention to sue any potential infringer would virtually eliminate the reasonable apprehension prong of the two-part test. Second, the court stated that there is nothing in the Federal Food, Drug, and Cosmetic Act that requires Pfizer to respond one way or another to Teva's request for a covenant not to sue. Third, the court found that Teva's subjective belief that it would be sued because Pfizer sued Ivax does not amount to an explicit threat indicating the imminence of suit. Finally, the court reasoned that, if anything, Pfizer's self-interest in protecting Ivax's exclusivity period makes the prospect of an immediate lawsuit against Teva even less likely. 23 Teva timely appealed the district court's decision. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1) (2000).