Sale of Generic Drug to Physician With “Extensive Information” on the Label May Induce Infringement

In Sanofi v. Watson, No. 2016-2722, the Federal Circuit affirmed the district court’s decision, upholding induced infringement and validity of Sanofi’s patents covering compositions of, uses for, and methods for administering the drug dronedarone.

As to induced infringement, the district court found inducement based on the sale of a generic drug to physicians bearing “extensive information” on labels describing the intended use.  The Federal Circuit affirmed the district court, finding inducement because the information on the labels included “information identifying the desired benefit for only patients with the patent-claimed risk factors.” The label thus “encouraged” administration of the drug to certain patients, inducing infringement of Sanofi’s patent.

With respect to validity, the district court found that one of ordinary skill in the art at the time of the invention would not have had a reasonable expectation of success that administration of the drug would reduce hospitalization.  The Appellants argued that the district court applied too high a standard, requiring “near certainty” rather than a “reasonable expectation.” The Federal Circuit disagreed, holding that there was no clear error or indication that the district court used a higher standard.