From The Field

September 12, 2019

Article III of the Constitution empowers federal courts to adjudicate only “Cases” and “Controversies.” The controversy must not only be real and substantial, it must also be extant at all stages of review. The Federal Circuit’s recent decision in Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Labs., Inc., 933 F.3d 1367 (Fed. Cir. 2019), illustrates one of the scenarios in which this doctrine can come into play.

Sanofi involved an ANDA litigation between Sanofi and some generic drug manufacturers. The patent claims at issue included claims 7, 11, 14-16, and 26 (collectively, the “disclaimed claims”) of U.S. Patent No. 8,927,592 (“the ’592 patent”) and some other claims. While the district court litigation was pending, the Patent Trial and Appeal Board invalidated certain claims of the ’592 patent – including the disclaimed claims – in an IPR proceeding and further denied Sanofi’s motion to amend the claims. Sanofi appealed the Board’s decision denying its motion to amend with respect to several claims, but it did not appeal the decision with respect to the disclaimed claims. Instead, Sanofi filed a statutory disclaimer that disclaimed those claims.

Despite the statutory disclaimer, the district court still entered an order holding that the disclaimed claims were invalid as obvious. Sanofi appealed the district court’s decision with respect to the disclaimed claims on the ground that there was no case or controversy that existed regarding those claims at the time of the district court’s decision. The Federal Circuit agreed with Sanofi that Sanofi’s disclaimer of the disclaimed claims mooted any controversy over them. The court stated that when Sanofi disclaimed those claims, it effectively eliminated those claims from the patent as if they had never existed.

The defendants in the case tried to salvage the district court’s decision by arguing that the judgment of invalidity might be relevant to a possible issue preclusion defense should Sanofi in the future obtain amended claims of the ’592 patent and assert the new claims against the same defendants. The Federal Circuit rejected this argument as too speculative.

Author: Hui Liu