10 November 2017Americas

Sanofi patents not obvious, rules Fed Circuit in Sandoz clash

The US Court of Appeals for the Federal Circuit has affirmed a lower court’s ruling that two Sanofi-owned patents are not invalid as obvious.

Yesterday, November 9, a three-judge panel handed down the decision in a 25-page precedential opinion.

US patent numbers 8,318,800 and 8,410,167, which describe and claim compositions and uses of the cardiovascular drug dronedarone.

In 2009, Sanofi’s subsidiary, Sanofi-Aventis, received approval for 400 mg tablets of dronedarone, sold as Multaq.

Multaq is an anti-arrythmic drug used to treat atrial fibrillation or atrial flutter, types of abnormal heart rhythms.

Both patents are listed in the Orange Book as claiming either Multaq or a method of using Multaq.

Watson Laboratories and Sandoz filed Abbreviated New Drug Applications to market generic versions of the drug.

Sanofi responded by suing both filers at the US District Court for the District of Delaware and, after a three-day bench trial, the court found that Sanofi had proved that the sale of generics would induce physicians to infringe all but one of the asserted claims of ‘167 patent.

Watson and Sandoz did not prove that any of the asserted claims of the ‘167 patent were invalid for obviousness.

The district court also rejected the argument of non-infringement of the ‘800 patent put forward by Watson and Sandoz.

A final judgment was entered, rejecting the generic companies’ obviousness challenge, and finding an inducement of infringement and infringement.

Watson and Sandoz appealed, challenging the district court’s inducement finding, the rejection of their obviousness challenge to the ‘167 patent, and the rejection of their argument for limiting the scope of the ‘800 patent claims.

Circuit Judge Richard Taranto, on behalf of the court, said: “We review the district court’s finding of inducement based on encouragement and inferred intent for clear error. We find no such error.”

On obviousness, the Federal Circuit said that it rejected Watson and Sandoz’s argument that the lower court had adopted an incorrect legal standard on the issue.

Taranto added that the Federal Circuit was “unpersuaded that the district court was clearly erroneous in determining that Watson and Sandoz failed to prove the required reasonable expectation”.

Watson and Sandoz had also tried to reverse the finding of infringement of the ‘800 patent by arguing that the court erred by failing to limit the claims of the patent to exclude polysorbate surfactants.

Again, the Federal disagreed, affirming the lower court’s ruling that the scope of the claims should not be limited in this way.

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