Amneal, FTC reportedly win order removing Teva inhaler patents from FDA list
With the backing of the U.S. Federal Trade Commission, Amneal convinced a New Jersey federal court on Monday to remove five Teva Pharmaceutical patents from a Food and Drug Administration list of patents covering Teva's breathing drug ProAir HFA, per a Reuters report.
The report said that U.S. District Judge Stanley Chesler agreed with Amneal and the FTC, that Teva's patents only covered inhaler device technology, ordering it to remove the listings from the FDA's Orange Book and clearing an obstacle for Amneal's proposed generic.
The decision comes after the FTC's warnings to drugmakers including Teva over the misuse of Orange Book patent listings to wrongly extend patent monopolies on brand-name drugs. Chesler on Monday also rejected Teva's bid to dismiss Amneal's allegations that Teva violated state and federal antitrust law, the report said, noting that Teva sued Amneal for patent infringement last year based on its proposed generic version of ProAir HFA, which treats bronchial spasms caused by diseases like asthma. Teva stopped making ProAir HFA in 2022.
[Read more: Amneal debuts 2 generics]
Amneal counterclaimed that Teva had improperly submitted the patents to the Orange Book, which lists patents that cover drugs that the FDA has deemed safe and effective, per the report.
Last year, the FTC sent notices to Teva and other drugmakers disputing 110 of their Orange Book patents, and said the companies may have improperly submitted them to the FDA to delay generic competition. The commission filed a brief supporting Amneal in the New Jersey case, the Reuters report said, adding that Chesler agreed with Amneal and the FTC that Teva's patents only cover parts of a "metered inhaler device" and "do not claim or even mention" ProAir HFA.
The case is Teva Branded Pharmaceutical Products R&D Inc v. Amneal Pharmaceuticals of New York LLC, U.S. District Court for the District of New Jersey, No. 2:23-cv-20964.
For Teva: Daryl Wiesen and Natasha Daughtrey of Goodwin Procter
For Amneal: Rebekah Conroy of Stone Conroy; Steven Maddox and Jeremy Edwards of Procopio