Teva Pharmaceuticals USA, Inc. et al. v. Sandoz Inc. et al.

Docket Nos. 2012-1567, -1568, -1569, -1570

July 26, 2013

Brief summary: The term “molecular weight” was found indefinite; claims found enabled and not obvious because of preference expressed by and teaching away within prior art and supportive secondary considerations.

Summary: Sandoz appealed DC finding that claims of nine patents relating to Teva’s product Copaxone® were not invalid and were infringed. Copaxone® is a mixture of four amino acids (“copolymer-1”) combined in a certain ratio which may be described based on different molecular weight values (peak average molecular weight, Mp; number average molecular weight, Mn; weight average molecular weight, Mw) or by how many molecules in a sample have molecular weights that fall within an arbitrarily set range (e.g., 99% between 1kDa and 100 kDa = 99% of its mole fraction within that molecular weight range). The claims in this case were separated into Group I (identified by molecular weight values) and Group II (identified by arbitrarily set range). In a Markman hearing, the DC rejected Sandoz’ argument that the term “molecular weight” in both groups of claims was insolubly ambiguous (indefinite) because it could refer to Mp, Mn, Mw or another measure. The FC panel agreed that the Group II claims are not indefinite but found the Group I claims to be indefinite. As explained in the opinion: “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.” In one of its patents, Teva argued that “molecular weight” means Mp and, in another, that it means Mw and these “two definitions cannot be reconciled” (and “[t]he specification does not resolve the ambiguity.”) And Teva’s expert testimony was not helpful. The DC also found that Sandoz failed to prove that because “a person of skill in the art would be able to measure it using either of two known calibration methods, ‘self-standards’ or ‘universal calibration'” the claims were not enabled. The DC disagreement was based on “polymer literature at the time of filing [that] described both methods in detail and that those methods could be adapted to copolymer-1”, post-filing experimentation and expert testimony. The FC found no clear error with the DC decision, citing Edwards Lifesciences, FC 2012 (explaining that failure to enable a commercial embodiment does not demonstrate nonenablement). Sandoz also argued that the claims were obvious in view of prior art showing copolymer-1 compounds with a molecular weight higher than 10 kDa but the DC found it “disclosed a preference for copolymer-1 compositions having molecular weights of 18-20 kDa and greater”, “that other references explicitly taught away from the claimed lower molecular weight copolymer-1”, and supportive secondary considerations. The FC panel saw no error in the DC analysis (e.g., a nexus between the product and the claims (citing Brown & Williamson, FC 2000)). Sandoz also argued that the DC improperly found infringement by focusing on the proportions of the amino acid s relative to the whole composition rather than the relative ratios of the four amino acids to one another in its accused product. The FC panel found, however, that the DC did not clearly err in its conclusion and also that there was no prosecution history disclaimer.

This entry was posted in Enablement, Generics / ANDA, Indefiniteness, Infringement, Obviousness. Bookmark the permalink.

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