Fed. Circ. Guidance For Pharma Method-Of-Use Patent Cases

By Preston Ratliff, Mi Zhou and Mark Sperling (November 28, 2017, 12:55 PM EST) -- On Nov. 9, 2017, the Federal Circuit confirmed that the overall content of a generic drug manufacturer's labeling, as well as real-world evidence of physician practices, inform the induced infringement analysis in Hatch-Waxman cases.[1] Specifically, Chief Judge Sharon Prost and Circuit Judges Evan Wallach and Richard Taranto unanimously affirmed the Delaware district court's trial finding of inducement based on various sections of the proposed product labeling, as well as expert testimony that showed how actual practices were consistent with the labeling.[2] In addition, the Federal Circuit held that there was "no legal or logical basis" for limiting inducement liability where the pharmaceutical product has substantial noninfringing uses permitted by the product labeling.[3] As explained in further detail below, this decision provides practitioners with additional guidance for evaluating infringement of pharmaceutical method-of-use patents....

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