Routine Experimentation Not Always Enough to Fend Off Enablement Challenge

On February 26, 2013, we analyzed Cephalon, Inc. et al. v. Watson Pharmaceuticals, Inc., where the Federal Circuit held that proving lack of enablement requires more than an expert saying it would be “complex” or “difficult.” The Federal Circuit’s unanimous decision in Wyeth v. Abbott Laboratories further clarified the enablement requirement and affirmed a lower […]

Federal Circuit Rules Novo’s Diabetes Drug Patent is Obvious

On June 18, 2013, the Federal Circuit held that Novo Nordisk’s patent covering Prandin, a diabetes treatment, was obvious, and reversed the lower court’s finding of inequitable conduct. Prandin is a Type II diabetes drug therapy that combines repaglinide, an insulin-release stimulator (secretagogue), with metformin, a glucose production suppressant (sensitizer).  Novo began experimenting with repaglinide […]

Supreme Court Partially Sides with FTC in Ruling that Reverse Payment Settlements in Hatch-Waxman Disputes May Violate Antitrust Laws

Yesterday, the U.S. Supreme Court held that reverse payments in Hatch-Waxman disputes including may violate federal antitrust laws, and that the traditional “rule-of-reason” will govern the determination.  In the 5-3 decision, the Court reversed the Eleventh Circuit decision that reverse payments are not subject to federal antitrust laws because they fall within the exclusionary rights […]