Supreme Court To Consider Federal Circuit De Novo Review Of Claim Construction In Teva Pharmaceuticals USA Inc. V. Sandoz Inc.

On March 31, 2014, the Supreme Court granted writ of certiorari in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. to hear Teva's appeal of a Federal Circuit decision invalidating several patents on Teva's multi-billion dollar multiple sclerosis drug, Copaxone. The Supreme Court will address the Federal Circuit's standard of review of district court claim construction. On appeal, the standard of review determines the amount of deference an appeals court will give in reviewing a lower court's decision. Typically, an appeals court will review the lower court's factual findings for clear error, under Federal Rule of Civil Procedure 52(a). Under the "clearly erroneous" standard, an appeals court will not overturn the lower court decision unless definitely and firmly convinced that the lower court made a mistake. However, after its 1998 Cybor Corporation v. FAS Technologies, Inc. decision, the Federal Circuit reviews claim construction de novo. Under de novo review, the appeals court gives no deference to the lower court's findings, and will rule on the evidence and matters of law as if considering them for the first time. In Cybor Corp., the Federal Circuit held that "as a purely legal question, we review claim construction de novo on appeal including any allegedly fact-based questions relating to claim construction." 138 F.3d 1448, 1456 (Fed. Cir. 1998).

In the Teva case, the Federal Circuit reversed the district court's claim construction determination on appeal. The district court had construed the term "molecular weight" to refer to the peak average molecular weight of the claimed synthetic polypeptide. The district court rejected defendants' argument that the claim term could refer to three different average molecular weight measures, and was therefore indefinite. Instead, the lower court credited Teva's expert's testimony that a person of ordinary skill in the art would know to use the peak average molecular weight. Teva Pharm. USA, Inc. v. Sandoz, Inc., 876 F. Supp. 2d 295, 400 -01 (S.D.N.Y. 2012) aff'd in part, rev'd in part, 723 F.3d 1363 (Fed. Cir. 2013) cert. granted, 13-854, 2014 WL 199529 (U.S. Mar. 31, 2014).

On appeal, the Federal Circuit overturned the district court's finding of indefiniteness, noting that "[i]ndefiniteness is a question of law that we review de novo." Teva Pharm. USA, Inc. v. Sandoz, Inc., 723 F.3d 1363, 1368 (Fed. Cir. 2013) cert. granted, 13-854, 2014 WL 199529 (U.S. Mar. 31, 2014). Accordingly, the Federal...