WASHINGTON, D.C. — (Mealey’s) The question of which standard — de novo or only for clear error — the Federal Circuit U.S. Court of Appeals should apply when reviewing a district court’s factual findings in support of a claim construction in patent cases will be argued at an upcoming term, the U.S. Supreme Court announced today (Teva Pharmaceuticals USA Inc., et al. v. Sandoz Inc., et al., No. 13-854, U.S. Sup.; See 3/3/14, Page 44) (lexis.com subscribers may access Supreme Court briefs for this case).
In its March 31 orders list, the Supreme Court granted the petition for certiorari by Teva Pharmaceuticals USA Inc., Teva Neuroscience Inc. and Yeda Research and Development Co. (Teva, collectively) which asks “whether a district court’s factual finding in support of its construction of a patent claim term may be reviewed de novo, as the Federal Circuit requires (and as the panel explicitly did in this case), or only for clear error, as Rule 52(a) [of the Federal Rules of Civil Procedure] requires.”
Respondents Sandoz Inc., Momenta Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Mylan Inc. and Natco Pharma Ltd. (Mylan, collectively) instead maintain that the question to be presented is “whether Federal Rule of Civil Procedure 52(a) requires an appellate court reviewing a district court’s construction of patent claims to defer to conclusions that are based on a litigation expert’s declaration that expressly contradicts the patent record.”
Mylan and Natco submitted abbreviated new drug applications (ANDAs) to the U.S. Food and Drug Administration for generic versions of the multiple sclerosis drug Copaxone, which is marketed by Teva. In response, Teva filed suit against Mylan and Natco in 2008 and 2009 in the U.S. District Court for the Southern District of New York, alleging infringement of U.S. patent Nos. 5,800,808, 5,981,589, 6,048,898, 6,054,430, 6,342,476, 6,362,161, 6,620,847, 6,939,539 and 7,199,098, each of which recites a product called copolymer-1 and includes claims reciting methods of making copolymer-1. The cases were ultimately consolidated.
The claims recite two ways to describe the distribution of molecular weight values — the use of statistical measures, including peak average molecular weight (Mp), number average molecular weight (Mn) and weight average molecular weight (Mw), as well as a description of how many molecules in a polymer sample have molecular weights that fall within an arbitrarily set range.
The six Group II claims are claims 1 and 2 of the ‘430 patent, claim 1 of the ‘476 patent, claim 1 of the ‘161 patent and claims 1 and 8 of the ‘098 patent. All remaining claims are considered Group I. The District Court issued a claim construction order in which it rejected Mylan’s argument that the term “molecular weight” was insolubly ambiguous because it could refer to Mp, Mn, Mw or another average molecular weight measure. The court construed “molecular weight” as Mp and held that the claims are not indefinite. After a bench trial, the District Court held that the asserted claims are not invalid for obviousness or lack of enablement and that Mylan’s two accused products infringe all of the asserted claims.
Mylan appealed to the Federal Circuit U.S. Court of Appeals, which in July 2013 (Teva Pharmaceuticals USA Inc. v. Sandoz Inc., et al., Nos. 12-1567, -1568, -1569, -1570, Fed. Cir.; See 8/5/13, Page 22) affirmed the District Court’s judgments of infringement and no invalidity with respect to Group II claims but reversed and remanded the court’s judgment of no invalidity with respect to Group I claims. Specifically, the Federal Circuit held that Group I claims are invalid for indefiniteness but that Group II claims have not been proven indefinite. It further held that the District Court did not err in its conclusions that the claims are infringed and that Mylan failed to prove that the claims would have been obvious and are not enabled.
Teva responded with a petition for certiorari and an application to recall and stay the Federal Circuit’s mandate. In November, Chief Justice John G. Roberts Jr. denied the application.
The case was distributed for conference three times: on March 7, March 21 and March 28.
The petitioners are represented by William M. Jay of Goodwin Procter in Washington. Deanne E. Maynard of Morrison & Foerster in Washington and Eric D. Miller of Perkins Coie in Seattle represent the respondents.
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