Intellectual Property Legal News: Volume 2, Number 1

TEVA PHARMACEUTICALS: IS IT TIME TO RETHINK HOW YOU WILL ARGUE CLAIM CONSTRUCTION? H. Jonathan Redway, Washington, D.C. Office The United States Supreme Court decided in Teva Pharmaceuticals USA Inc. v. Sandoz Inc. that the Federal Circuit must review all subsidiary factual findings in patent litigation claim construction proceedings that are on appeal for clear error. The January 20, 2015 decision overturned two long-standing Federal Circuit en banc decisions that previously held that all aspects of claim construction were to be reviewed de novo. See Cybor Corp. v. FAS Techs. Inc., 138 F.3d 1448 (Fed. Cir. 1998) and Lighting Ballast Control LLC v. Phillips Elecs. N. Am. Corp., 744 F.3d 1272 (Fed. Cir. 2014). The Court found that while the district court's ultimate ruling should continue to be reviewed on appeal de novo, the resolution of any subsidiary factual disputes must be reviewed for clear error. Claim construction (interpretation of the meaning of the words in a patent claim) is the most important analysis in any patent dispute because it is the first step toward determining (1) whether the patent is invalid for failing to meet the conditions and requirements of patentability and (2) whether the patent is infringed. In 1996, the Supreme Court decreed that claim construction is to be carried out by judges -- not juries -- because the interpretation of patent claims is a legal exercise. See generally Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996). Following Markman, the Federal Circuit consistently reviewed all claim construction determinations de novo because they are legal exercises. In claim construction, the district court first looks to intrinsic legal evidence (the claims, specification, and prosecution history) to construe the meaning of the claim. The district court may resort to extrinsic factual evidence, but only when the intrinsic evidence is insufficiently clear to construe the meaning of the claim to determine if the conditions and requirements of patentability have been satisfied or the claim is infringed. Extrinsic factual evidence often plays an important role in claim construction -- whether received informally through a tutorial at the start of the claim construction proceeding or as formal evidence -- because it can shed light on the true meaning of the intrinsic evidence. The dispute in Teva Pharmaceuticals concerned the meaning of the words "molecular weight". The petitioners, Teva Pharmaceuticals, asserted a patent that claimed a manufacturing method for a drug used to treat multiple sclerosis. The claim language at issue described the active ingredient in the drug as having "a molecular weight of 5 to 9 kilodaltons" (emphasis added). When the respondents, Sandoz, Inc., tried to market a generic version of the drug, it was sued by Teva for patent infringement. Sandoz argued the claim was invalid because it failed to meet a condition of patentability in that it failed to "particularly poin[t] out and distinctly clai[m] the subject matter ... regard[ed] as [the] invention. 35 U.S.C. § 112, ¶ 2. Sandoz argued that the term "molecular weight" as used in the patent claim might mean any one of three different things. Sandoz argued that because the term...