A subsequent ANDA filer has a legally cognizable interest in when the first filer’s exclusivity period begins, such that delay in triggering that period qualifies as “injury-in-fact” for the purposes of Article III.

Teva Pharmaceuticals USA Inc., v. Eisai Co., Ltd., 2009-1593 (Fed. Cir. Oct. 6, 2010).

Two drug manufacturers sought to make and market a generic version of the drug donepezil, an approved and patented treatment for Alzheimer’s disease. To market a generic version of a previously approved drug, manufacturers must file and receive approval of an Abbreviated New Drug Application (“ANDA”). The first manufacturer to file what is called a “Paragraph IV Certification” is entitled to 180 days of generic marketing exclusivity. Until this exclusivity period has run, the FDA may not approve ANDA applications by other manufacturers. The first filer’s exclusivity period can be triggered by entry of a court judgment finding the patent covering the approved drug invalid or not infringed.

Here, the second filer brought a declaratory judgment action against the patent holder for non-infringement. The district court determined that the second filer failed to establish the existence of an Article III controversy, and dismissed the case.

The Federal Circuit reversed, finding that the subsequent Paragraph IV filer has a legally cognizable interest in when the first filer’s exclusivity period begins, such that delay in triggering that period qualifies as “injury-in-fact” for the purposes of Article III. Here, FDA approval of the second filer’s ANDA could not occur until the exclusivity period for the first-filer has run, and the second filer could trigger the first filer’s exclusivity period with a favorable declaratory judgment action.

The Federal Circuit also explained that while the Hatch-Waxman Act does not require district courts to exercise jurisdiction in all declaratory judgment cases (assuming jurisdiction exists), here the district court abused its discretion in declining to exercise jurisdiction. In particular, this case did not present any of the typical factors warranting the exercise of any such discretion—for example, it was not duplicative of another pending or decided litigation, and in the absence of the action, the validity or infringement of the patents would not be litigated.

A copy of the opinion can be found here.