Written by: Kendall Loebbaka & Cesar A. Estrada

GENENTECH, INC. V. SANDOZ INC.

Before Newman, Lourie, and Prost. Appeal from the United States District Court for the District of Delaware.

Summary: The district court did not clearly err in considering evidence of actual physician practice when determining whether generic drug’s instructions encourage, recommend, or promote infringement.

Genentech brought a Hatch-Waxman suit against Sandoz for infringement of its patents directed to dose modification methods for managing side effects when using pirfenidone to treat idiopathic pulmonary fibrosis (IPF). The District Court concluded that Genentech’s liver function test (LFT) patents were unpatentable as obvious and the sale of Sandoz’s generic product would not directly infringe Genentech’s drug-drug interaction (DDI) patents. Genentech appealed.

The Federal Circuit held that the district court properly found that the dose modifications claimed in the LFT patents would have been obvious over the prior art in view of well-known standard medical practices. The district court’s analysis of the prior art properly relied on extensive record evidence including expert testimony and FDA guidance. The Federal Circuit also found Genentech’s evidence of objective indicia of nonobviousness unpersuasive since Genentech did not provide evidence showing skepticism or an unmet need for the claimed methods.

Regarding the DDI patents, the Federal Circuit held that the district court did not clearly err in weighing all relevant evidence, including Sandoz’s proposed label and physician practice. Genentech argued that there was no evidence to negate the language of the proposed label, which encourages, recommends, and promotes infringement. The Federal Circuit explained that evidence of actual physician practice suggested that Sandoz’s instructions would not result in direct infringement of the DDI patents. Thus, the Federal Circuit concluded that the district court “did not clearly err by considering physician evidence, weighing it against the language in Sandoz’s proposed label, and finding that Genentech failed to prove direct infringement.” Accordingly, the Federal Circuit affirmed the district court’s findings of obviousness and noninfringement.

Editor: Paul Stewart