Carving Out A Patented Indication From A Generic-Pharmaceutical Label Will Not Always Avoid Infringement

The patentee sued the alleged infringer over a generic version of the pharmaceutical drug Coreg® (carvedilol). Coreg® was approved by the FDA for three indications: (i) hypertension, (ii) congestive heart failure ("CHF"), and (iii) post-myocardial infarction left ventricular dysfunction ("post-MI LVD"). From 2007 to 2011, the accused infringer deleted the indication for CHF from its FDA-approved label and included only the indications for hypertension and post-MI LVD. The question was whether the accused infringer's label nevertheless induced infringement of a patent over a method of decreasing mortality caused by congestive heart failure. After a jury verdict of infringement, the district court granted the accused infringer's renewed motion for judgment as a matter of law ("JMOL") of noninfringement, on the basis that the accused infringer's so-called "skinny" label did not cause or encourage the patented use. On appeal, the Federal Circuit vacated the grant of