Cert. Granted In Teva V. Sandoz (“April Fool” Lightning Ballast!)

On Monday, the Supreme Court granted cert. in the somewhat overlooked panel decision, Teva Pharm., Inc. v. Sandoz, Inc., 727 F.3d 1363 (Fed. Cir. 2013)(Sup. Ct. 13-854) (a copy can be found at the end of this post). Most commentators had predicted that the Supreme Court would review the en banc decision in Lightning Ballast, but it is not to be.

The panel, Judge Moore writing (who at least has taken some chemistry courses), reviewed a district court decision that had found two groups of claims from eight Teva patents on Copaxone valid. Defendants in this Hatch-Waxman litigation had argued that both the Group I and Group II claims failed s.112(2) as insolubly ambiguous due to multiple definitions of the molecular weight in the specification. The district court, construed the term “molecular weight” as determined by a single methodology and so disagreed as to both sets of claims.

The panel cited Biosig v. Nautilus, currently before the Court, for the appropriate standard of review: “A claim is indefinite only when it is not amenable to construction or [is] insolubly ambiguous,” and stated that “indefiniteness is a question of law that we review de novo.” The panel went on to find that the spec’s multiple definitions, conflicting definitions of average molecular weight in the prosecution history, and conflicting expert testimony rendered the ambiguity in the Group I claims insoluble. However the Group II claims, which recited the percentage of the copolymer-1 molecules in a sample falling within an arbitrarily set molecular weight range defined by precise endpoints, were held to be not indefinite.

This holding lead to the “Question Presented: ‘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) requires.” Of course, this does not present the issue in Biosig v. Nautilus as to what the appropriate standard should be for s.112 indefiniteness. If the Fed. Cir.’s standard is repudiated, it would not change the outcome of this decision, since the Group I claims would fall as simply “ambiguous” on remand and both courts agreed that the Group II claims were definite.

Cybor was only cited for its holding that claim construction is an issue of law that is reviewed de novo in Part IV of the decision “Infringement.” The claims in question had been construed so that the relative amounts of four amino acids in copolymner-1 was a simple ratio: 6:2:5:1. In determining infringement, the district court had converted the ratio into percentages of each amino acid, in order to measure the amount of variation present in two accused products. The court found that the permissible variation in the aggregated percentages must be greater than 12% to avoid infringement. The two products were found to vary by less than 12% and so literally infringed.

The panel held that the construction (the ratio) was not in dispute, and that an infringement analysis, based on that construction is a question of fact, and is reviewed for clear error. Defendants argued that the per cent variation should be calculated using four individual ratios, which would give certain amino acid weights in their products a greater variation that 12%. The panel accepted the judge’s approach to resolving the infringement question (both products infringed). The panel found no clear error in the district courts finding of no disclaimer, obviousness or lack of enablement.

Of course, this grant of cert. pretty much sidetracks the Lightning Ballast appeal, since the petition for cert. has not been filed to date. At least the polypeptides in question in Teva are not natural products.


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