Addressing Breach of Method-of-Use Patents by Generics

The U.S. Court of Appeals for the Federal Circuit on April 16, 2012, in Bayer Schering Pharma AG v. Sandoz Inc., Nos. 2011-1143, -1228 (Yasmin), affirmed a district court’s holding that as a matter of law, generic drug makers could not infringe patent claims reciting a method of use of a U.S. Food and Drug Administration (FDA)-approved drug where the FDA had not approved the drug for the claimed uses, and where the FDA-approved labeling did not indicate instructions or intent to encourage the claimed use.