Dronedarone – USA

On Nov 09, 2017, Court of Appeal for Federal Circuit affirmed the district court’s judgment of infringement & validity of two patents against Watson & Sandoz in Multaq (Dornedarone) case.

Sanofi owns U.S. Patent Nos. 8,318,800 and 8,410,167, which describe and claim compositions and uses of the cardiovascular (specifically, antiarrhythmic) drug dronedarone. The ’800 patent, which expires in 2019, claims pharmaceutical compositions containing dronedarone. The ’167 patent, which expires in 2029, claims methods of reducing hospitalization by administering dronedarone to patients having specified characteristics. After a three-day bench trial, the district court ruled that Watson’s and Sandoz’s sale of their proposed generic drugs, with their proposed labels, would induce physicians to infringe asserted claims and they did not prove that any of the asserted claims were invalid for obviousness. Watson and Sandoz appealed.

Federal circuit reviewed the district court’s finding of inducement based on encouragement and inferred intent for clear error. Federal circuit did not find error. It held that the reference to the Clinical Studies section (14) of the label expressly directs the reader to that section for elaboration of the class of patients for whom the drug is indicated to achieve the stated objective, i.e., reduced hospitalization. Section 14 leads with and features a subsection on the ATHENA study, which sets forth the positive results, relating to reduced hospitalization, for patients having the risk factors. There was considerable testimony that this label encourages—and would be known by Watson and Sandoz to encourage—administration of the drug to those patients, thereby causing infringement.

With respect to obviousness, Watson and Sandoz initially argued that the district court committed legal error by applying too high a standard for proving a reasonable expectation of success. Federal circuit however disagreed. Federal circuit held that Watson and Sandoz did not carry their burden of showing that a person of ordinary skill in the art in February 2008 would have had a reasonable expectation that dronedarone would succeed in reducing cardiovascular hospitalization in the ATHENA patient population.