USA
Federal Circuit Affirms that Medical Devices are Only Listable in the Orange Book if They Claim the Active Drug Ingredient
Josh Goldberg, Leia
Dingott, Nath, Goldberg & Meyer, USA
The
Court of Appeals for the Federal Circuit (CAFC) affirmed the decision by the
U.S. District Court in New Jersey, which ordered the delisting of five U.S.
Patents owned by TEVA on the ground “that the Inhaler Patents contain no claim
for the active ingredient at issue, albuterol sulfate,” but instead “are
directed to components of a metered inhaler device.” Teva Branded Pharm.
Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC, No. 23-20964, -- F.
Supp. 3d --, 2024 WL 2923018, at *6, *7 (D.N.J. June 10, 2024) (“Delisting
Order”).
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