By Joseph Arshawsky, J.D.
Following a two-day bench trial, Sanofi and Sanofi-Aventis U.S. LLC (collectively, "Sanofi") met their burden of showing Watson Laboratories, Inc. and Sandoz Inc. (collectively, "Watson") induced infringement of claims 1, 7, 9, and 14 of U.S. Patent No. 9,107,900 ("the ’900 patent"), entitled "Use of Dronedarone for the Preparation of a Medicament for Use in the Prevention of Cardiovascular Hospitalization or Mortality," but failed to meet their burden on claims 6 and 8 of the ’900 patent, the federal district court in Wilmington, Delaware has ruled. Watson failed to show that claims 1, 7, 9, and 14 were invalid as obvious (Sanofi v. Lupin Atlantic Holdings S.A., October 23, 2017, Andrews, R.).
Sanofi-Aventis U.S. LLC is the holder of an approved New Drug Application for dronedarone tablets, which are prescribed under the trademark Multaq®. Sanofi makes and sells Multaq® in the U.S. The ’900 patent issued on August 18, 2015. The ’900 patent is a method patent and the claims at issue claim a method of reducing a risk of cardiovascular hospitalization in a patient by administering an effective amount of dronedarone. The court’s opinion followed a two-day bench trial on Sanofi’s claims that Watson infringed several claims of the ’900 patent. Sanofi prevailed on most of the claims.
Infringement. A person of ordinary skill in the art ("POSA") with respect to the ’900 patent is an M.D., board certified in cardiology or electrophysiology with at least two years of practice and knowledge of clinical studies. A POSA reading the labels of Watson’s products would review the clinical studies section and would understand that dronedarone’s indicated benefit extended to some patients with coronary artery disease. Watson’s labels encourage a POSA to administer the drug to some patients who meet the age criteria. Approximately 20-25% of the uses of Watson’s generic dronedarone infringe claims 1, 7, 9, and 14 of the ’900 patent. Watson’s labels therefore induce infringement of those claims. Watson knew about the ’900 patent and knew its generic dronedarone would be administered in a manner that infringes the ’900 patent. They intended that result. Sanofi has therefore met their burden of showing that Watson’s labels would induce infringement of claims 1, 7, 9, and 14 of the ’900 patent.
Approximately 3% of the uses of the drug infringe claims 6 and 8 of the ’900 patent. Therefore, on almost that basis alone, Watson’s labels do not induce infringement of claims 6 and 8 of the ’900 patent. In addition, the black box warning labels for Class III CHF patients would not encourage a POSA to prescribe the drug to that category of patients covered by claims 6 and 8 of the ’900 patent. A POSA would not believe that it was safe to prescribe the drug to that particular category of patient. Therefore, Sanofi failed to meet their burden of showing that Watson’s labels would induce infringement of Claims 6 and 8 of the ’900 patent.
Obviousness. The court reviewed extensive alleged prior art references, and other evidence, including statements by doctors. The court did not give any weight to secondary considerations of long-felt but unmet need, unexpected results, skepticism, or commercial success, because the record was largely inadequate. Nevertheless, the court held that Watson failed to show by clear and convincing evidence that claims 1, 7, 9, and 14 of the ’900 patent are invalid as obvious. The central dispute was whether a POSA would reasonably expect dronedarone to reduce the risk of cardiovascular hospitalization in atrial fibrillation with coronary heart disease meeting the age criteria. The court found that Watson failed to make such a showing as to the sicker, older patients. The court found substantial evidence teaching away from the conclusion that dronedarone would reduce hospitalizations in the claimed patient population.
The case is No. 15-415-RGA.
Attorneys: Jack B. Blumenfeld (Morris, Nichols, Arsht & Tunnell LLP) for Sanofi and Sanofi-Aventis US LLC. Frederick L. Cottrell, III (Richards, Layton & Finger, PA) for Lupin Atlantis Holdings SA, Lupin Ltd. and Lupin Pharmaceuticals Inc.
Companies: Sanofi; Sanofi-Aventis US LLC; Lupin Atlantis Holdings SA; Lupin Ltd.; Lupin Pharmaceuticals Inc.
MainStory: TopStory Patent DelawareNews
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