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From Intellectual Property Law Daily, November 9, 2017

Companies hoping to sell generic versions of Sanofi’s cardiovascular drug Multaq lose appeal

By Cheryl Beise, J.D.

The federal district court in Wilmington, Delaware, did not err in concluding following a bench trial that two patents directed to compositions and methods relating to Sanofi’s antiarrhythmic cardiovascular drug Multaq were valid and infringed by generic manufacturers Watson Laboratories Inc. and Sandoz Inc., the U.S Court of Appeals for the Federal Circuit has held (Sanofi v. Watson Laboratories Inc., November 9, 2017, Taranto, R.).

Sanofi owns U.S. Patent Nos. 8,318,800 (the ’800 patent) and 8,410,167 (the ’167 patent), which describe and claim compositions and uses of the antiarrhythmic cardiovascular drug dronedarone. The ’800 patent claims pharmaceutical compositions containing dronedarone. The ’167 patent claims methods of reducing hospitalization by administering dronedarone to patients having specified characteristics. Sanofi’s subsidiary, Sanofi-Aventis U.S., LLC, received approval in mid-2009 for New Drug Application (NDA) No. 022425 for 400 mg tablets of dronedarone, sold as Multaq. Both the ’800 and the ’167 patents are listed in the Food and Drug Administration’s publication Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") as patents claiming either Multaq or a method of using Multaq.

When Watson Laboratories Inc. and Sandoz Inc., filed abbreviated new drug applications (ANDAs) with the FDA to market generic versions of Multaq, Sanofi and Sanofi-Aventis U.S., LLC (together, "Sanofi") sued Watson and Sandoz for infringement of the two patents. After a three-day bench trial, the district court largely ruled in favor of Sanofi. As to the ’167 patent, the court found Sanofi proved that Watson’s and Sandoz’s sale of their proposed generic drugs, with their proposed labels, would induce physicians to infringe all but one of the asserted claims, and Watson and Sandoz did not prove that any of the asserted claims were invalid for obviousness. As to the ’800 patent, the district court, rejecting the non-infringement argument made by Watson and Sandoz, concluded that the asserted claims do not exclude compositions containing polysorbate surfactants. The district court then entered a final judgment rejecting the obviousness challenge to claims 1–6, 8–13, and 16 of the ’167 patent; finding inducement of infringement, by both defendants, of all of those claims except claim 5; and finding infringement by both defendants of claims 1–3, 5–9, and 12–15 of the ’800 patent and by Watson of claims 10 and 11 as well.

On appeal, Watson and Sandoz challenged the district court’s validity and inducement finding as to the ’167 patent, and the district court’s rejection of their prosecution disclaimer argument for limiting the scope of the ’800 patent claims.

The ’167 patent. The district court found that Sanofi had proven that the defendants’ proposed labels intentionally induced physicians to infringe independent claims 1 and 8 of the ’167 patent by encouraging them to prescribe dronedarone to patients with at least one of the cardiovascular risk factors claimed in the patent. The Federal Circuit found no clear error by the district court. The label directed medical providers to information (i.e., the ATHENA study) identifying the desired benefit (reduced hospitalization) for only patients with the patent-claimed risk factors. Considerable testimony at trial confirmed that this label would be known by Watson and Sandoz to encourage the administration of the drug to those patients. Approximately 77% of Multaq prescriptions have actually been written for patients with claimed risk factors. The label also described another study (the ANDROMEDA study) that warned of the safety concerns of using dronedarone on patients other than those for whom the ATHENA trial showed reduced hospitalization.

Watson and Sandoz contended that inducement was precluded because Multaq also had substantial noninfringing uses not forbidden by the proposed labels. There is no legal or logical basis for such a limitation on inducement in the patent context, the court said. The facts undergirding a finding of inducement may be inferred from circumstantial evidence.

Watson and Sandoz also argued that the district court erred in finding that as of February 2008, a person of ordinary skill in the art "would not have had a reasonable expectation that dronedarone would reduce the risk of cardiovascular hospitalization and hospitalization for [atrial fibrillation] in patients with paroxysmal or persistent [atrial fibrillation] and the associated risk factors of the ATHENA patient population." Watson and Sandoz failed to show that the district court applied an erroneous "reasonable expectation" standard. There was sufficient evidence presented at trial to support the district court’s finding of nonobviousness. "Although the evidence might well have supported the opposite finding, we cannot conclude that the district court clearly erred in its finding," the Federal Circuit said.

The ’800 patent. In challenging the district court’s finding that they infringed the ’800 patent, Watson and Sandoz argued that the court erred by failing to limit the claims of the ’800 patent to exclude polysorbate surfactants. They did not point to any limiting language in the ’800 patent claims; instead they pointed to prosecution history of a related patent (the ’493 patent) in which Sanofi amended the claims expressly to exclude pharmaceutical compositions with a "polysorbate surfactant." However, Sanofi did not argue during prosecution that the unamended claim language of the ’493 patent, or the disclosed invention generally, excluded polysorbate surfactants. Like the district court, the Federal Circuit declined to find that Sanofi expressly limited the scope of the ’800 patent claims.

The case is Nos. 2016-2722, 2016-2726.

Attorneys: William E. Solander (Fitzpatrick, Cella, Harper & Scinto) for Sanofi and Sanofi-Aventis US, LLC. Natalie Christine Clayton (Alston & Bird LLP) for Watson Laboratories Inc. Maureen L. Rurka (Winston & Strawn LLP) for Sandoz Inc.

Companies: Sanofi; Sanofi-Aventis US, LLC; Watson Laboratories Inc.; Sandoz Inc.

MainStory: TopStory Patent FedCirNews

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