In a
July 26, 2013 decision, the Federal Circuit affirmed-in-part and reversed-in-part a ruling by Judge Barbara S. Jones finding infringement of Teva Pharmaceuticals' patents for Copaxone, which is used to treat multiple sclerosis. The patent claims at issue in the consolidated cases against Sandoz, Inc. and Mylan Pharmaceuticals Inc. had been placed in two groups, Groups I and II, for purposes of the infringement action. The claims in both groups used the term "molecular weight" without reference specifically to which of the multiple definitions of "molecular weight" was intended. The defendants argued before Judge Jones that all the claims in Groups I and II were indefinite for failing to specify which "molecular weight" of the active ingredient was referenced. Judge Jones rejected the indefiniteness argument (and other invalidity arguments), and found all the claims valid and infringed. The Federal Circuit reversed as to the Group I claims, finding them indefinite and therefore invalid, and affirmed the validity and infringement holding as to the Group II claims.
In invalidating the Group I claims, the Federal Circuit noted:
It is undisputed that Group I claims contain an ambiguity because their plain language does not indicate which average molecular weight measure is intended. Teva's attempt to resolve this ambiguity hinges in part on the prosecution history. But two of its prosecution statements directly contradict each other and render the ambiguity insoluble.
The Federal Circuit held that the Group II claims do not have the same ambiguity because, rather than reciting an average molecular weight as the Group I claims do, the Group II claims "refer to precise points" on a curve to define the specific molecular weight. The Court thus found the claims valid, and upheld Judge Jones' infringement ruling.