In Sanofi v. Watson Laboratories Inc., Sandoz Inc.,, [2016-2722, 2016-2726] (November 9, 2017), the Federal Circuit affirmed the district court’s final judgment rejecting the obviousness challenge to claims 1–6, 8–13, and 16 of the U.S. Patent No. 8,410,167; finding inducement of infringement, by both defendants, of all of those claims except claim 5; and finding infringement by both defendants of claims 1–3, 5-9, and 12–15 of U.S. Patent No. 8,318,800, and by Watson of claims 10 and 11 as well.

On appeal, Watson and Sandoz challenged the district court’s inducement finding as to the ’167 patent, the district court’s rejection of their obviousness challenge to that patent, and the district court’s rejection of their prosecution disclaimer argument for limiting the scope of the ’800 patent claims.

On the inducement issues, the Federal Circuit said that it reviews the district court’s finding of inducement based on encouragement and inferred intent for clear error, which the Federal Circuit found was absent. The Federal Circuit noted that the label directed medical providers to information identifying the desired benefit for only patients with the patent-claimed risk factors. The Federal Circuit rejected Watson and Sandoz’s argument that substantial noninfringing uses not forbidden by the proposed labels prevented a finding of intent to encourage an infringing use. The Federal Circuit found no legal or logical basis for the suggested limitation on inducement.

On the obviousness issue, Watson and Sandoz only challenged the district court’s finding of no expectation of success. The Federal Circuit said that although the evidence might well have supported the opposite finding, it could not conclude that the district court clearly erred in its finding.

On the infringement issue, the Federal Circuit rejected the argument that Watson and Sandoz erred by failing to limit the claims of the ’800 patent to exclude polysorbate surfactants. While prosecuting the parent application, which issued as U.S. Patent No. 7,323,493, Sanofi amended the sole independent claims (hence all claims) so as expressly to exclude pharmaceutical compositions with a “polysorbate surfactant.” Based on that amendment, Watson and Sandoz contended that Sanofi made a “prosecution disclaimer” that also limits the scope of the claims of the ’800 patent, despite the absence of any limiting language in the ’800 patent’s claims.

The Federal Circuit said that a prosecution disclaimer occurs when a patentee, either through argument or amendment, surrenders claim scope during the course of prosecution. But when the purported disclaimers are directed to specific claim terms that have been omitted or materially altered in subsequent applications (rather than to the invention itself), those disclaimers do not apply. The general ruling being that a prosecution disclaimer will only apply to a subsequent patent if that patent contains the same claim limitation as its predecessor.

The Federal Circuit observed that in prosecuting the application that issued as the ’493 patent, was to write an express limitation into the claims: “provided that the pharmaceutical composition does not contain a “polysorbate surfactant.” This language does not appear in the ’800 patent claims at issue, and Sanofi did not argue during prosecution that the unamended claim language of the ’493 patent, or the disclosed invention generally, excluded polysorbate surfactants. The Federal Circuit said that the prosecution followed a familiar pattern:

An applicant adopts an explicit claim-narrowing limitation to achieve immediate issuance of a patent containing the narrowed claims and postpones to the prosecution of a continuation application further arguments about claims that lack the narrowing limitation.

The Federal Circuit said that without more than exists here, that process does not imply a disclaimer as to claims, when later issued in the continuation, that lack the first patent’s express narrowing limitation. The Federal Circuit affirmed the district court’s ruling that the scope of the claims of the ’800 patent should not be limited so as to exclude polysorbate surfactants.