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

Amneal Pharmaceuticals

20/12/2024 20:02

(Adds comment from FTC in paragraph 4)
    By Blake Brittain
       Dec 20 (Reuters) - Teva Pharmaceuticals  TEVA.TA  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  AMRX.O , 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. Hannah Garden-Monheit,
the director of the FTC's Office of Policy Planning, said in a
statement that the decision was "important not only for lowering
asthma inhaler costs, it also sets the stage for removal of junk
listings on a range of other critical medications."
    Spokespeople and an attorney for Amneal did not immediately
respond to a request for comment on the decision.
    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
     
    Read more:
    US FTC warns drugmakers over patent listings
    US FTC disputes over 100 medical patents listed with FDA
including asthma inhalers
    Amneal, US FTC win order removing Teva inhaler patents from
FDA list