Federal Circuit Addresses Infringement of Method-of-Use Patents by Generics in Yasmin® Case

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 an FDA-approved drug where the U.S. Food and Drug Administration 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.