Teva loses US appeal to keep inhaler patents on FDA protected drug list

By Blake Brittain

Dec 20 - Teva Pharmaceuticals failed to convince a U.S. appeals court on Friday to reverse a decision that would remove patents related to its ProAir HFA inhaler from the U.S. Food and Drug Administration's Orange Book, which lists patents that protect drugs the FDA has deemed safe and effective.

The U.S. Court of Appeals for the Federal Circuit instead affirmed a win for Amneal Pharmaceuticals , which plans to market a generic version of the inhaler and had argued that Teva's patents were incorrectly included on the FDA list.

The U.S. Federal Trade Commission, which has warned pharmaceutical companies against submitting irrelevant patents to the FDA to limit generic competition, supported Amneal's lawsuit.

A Teva spokesperson said the company disagrees with the decision and is considering next steps. Spokespeople for Amneal and the FTC did not immediately respond to requests for comment.

Israel-based Teva sued Amneal in New Jersey last year for infringing patents covering ProAir HFA, which treats bronchial spasms caused by pulmonary diseases. Teva stopped making ProAir HFA in 2022.

Bridgewater, New Jersey-based Amneal counterclaimed that Teva had improperly submitted the patents for the Orange Book. U.S. District Judge Stanley Chesler agreed with Amneal in June, finding the patents only cover parts of an inhaler device and "do not claim or even mention" ProAir HFA's active ingredient.

The Federal Circuit panel upheld the decision on Friday.

"To list a patent in the Orange Book, that patent must, among other things, claim the drug that was approved," U.S. Circuit Judge Sharon Prost wrote for a three-judge panel. "And to claim that drug, the patent must claim at least the active ingredient."

The case is Teva Branded Pharmaceutical Products R&D Inc v. Amneal Pharmaceuticals of New York LLC, U.S. Court of Appeals for the Federal Circuit, No. 24-1936.

For Teva: Willy Jay of Goodwin Procter

For Amneal: Steven Maddox of Procopio

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