Case Name: Astellas Pharma, Inc. v. Sandoz
Inc., Nos. 2023-2032, 2023-2063, 2023-2089, 2024 WL 4219374
(Fed. Cir. Sept. 18, 2024) (Circuit Judges Lourie, Prost, and Reyna
presiding; Opinion by Lourie, J.) (Appeal from D. Del., Bataillon,
J.)
Drug Product and Patent(s)-in-Suit:
Myrbetriq® (mirabegron); U.S. Patent No. 10,842,780 ("the
'780 patent")
Nature of the Case and Issue(s) Presented:
During the development of Myrbetriq, a drug that treats overactive
bladder ("OAB"), Astellas discovered that
immediate-release formulations of mirabegron exhibited an
undesirable "food effect," meaning that the
bioavailability of the drug was affected by the presence or absence
of food in the stomach. Astellas developed sustained-release
formulations of mirabegron, which got around the food effect, and
claimed those formulations in the '780 patent.
