Amneal, US FTC win order removing Teva inhaler patents from FDA list

Amneal Pharmaceuticals

10/06/2024 23:25

By Blake Brittain
       June 10 (Reuters) - Drugmaker Amneal Pharmaceuticals
 AMRX.O  with the backing of the U.S. Federal Trade Commission
convinced a New Jersey federal court on Monday to remove five
Teva Pharmaceutical  TEVA.TA  patents from a U.S. Food and Drug
Administration list of patents covering Teva's breathing drug
ProAir HFA.
    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 follows 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.
    Spokespeople for Teva, Amneal and the FTC did not
immediately respond to requests for comment on the decision.
    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.
    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.
    The FTC last year 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.
    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
    
    Read more:
    US FTC warns drugmakers over patent listings
    US FTC disputes over 100 medical patents listed with FDA
including asthma inhalers