Wednesday, November 13, 2013

Teva Pharmaceuticals USA, Inc. v. Novartis Pharmaceuticals Corp. case brief

Teva Pharmaceuticals USA, Inc. v. Novartis Pharmaceuticals Corp. case brief summary
482 F.3d 1330 (2007)

Appellant generic drug manufacturer brought an action against appellee patent owners, seeking a declaration that its drug did not infringe the owners' patents. The manufacturer appealed the order of the United States District Court for the District of New Jersey which dismissed the action for lack of jurisdiction based on the manufacturer's failure to establish a reasonable apprehension of imminent suit.

After the manufacturer applied for federal approval of its generic drug, the owners brought an infringement action against the manufacturer only with regard to an active-ingredient patent, and the manufacturer then sought a declaratory judgment that its drug did not infringe related therapeutic-use patents.


  • The appellate court held that, under recent U.S. Supreme Court precedent, the manufacturer was not required to show a reasonable apprehension of imminent suit in order to obtain declaratory relief and, under all of the circumstances, the manufacturer presented a justiciable controversy to support the declaratory judgment action. 
  • The manufacturer properly alleged an injury in fact based upon potential multiple infringement suits arising from the manufacturer's single application for federal approval, the application itself which was a statutory act of infringement, and the manufacturer's interest in obtaining patent certainty. 
  • Further, the owners' pending infringement action was related litigation involving the same technology and the same parties, and the owners' selective action created uncertainty concerning the manufacturer's rights under its federal application.

The order dismissing the manufacturer's action was reversed.

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