In H. Lundbeck A-S v. Lupin Ltd., Case No. 2022-1194 (Fed. Circ. December 7, 2023), Plaintiffs, H. Lundbeck A/S (“Lundbeck”) and Takeda Pharmaceutical Company Ltd., Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals...more
2/13/2024
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Takeda Pharmaceuticals
\On August 29, 2023, Health and Human Services (“HHS”) announced the first ten drugs covered by Medicare Part D selected for negotiation under President Biden’s Inflation Reduction Act of 2022 (“IRA”), which was signed into...more
On May 15, 2023, the Supreme Court of the United States denied Teva Pharmaceuticals USA, Inc.’s (“Teva”) petition for certiorari in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline, LLC, ending a nearly nine-year court...more
6/9/2023
/ Appeals ,
Denial of Certiorari ,
Food and Drug Administration (FDA) ,
GlaxoSmithKline ,
Healthcare ,
Induced Infringement ,
JMOL ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Product Labels ,
SCOTUS ,
Teva Pharmaceuticals ,
Teva Pharms USA Inc v GlaxoSmithKline LLC
Procedural History -
Regents of the University of Minnesota v. Gilead Sciences, Inc., Case No. 2021-2168 (Fed. Cir. Mar. 6, 2023) is an appeal by the Regents of the University of Minnesota (“Minnesota”) from a final...more
3/9/2023
/ Food and Drug Administration (FDA) ,
Gilead Sciences ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art
Procedural History -
Jazz Pharms., Inc., v. Avadel CNS Pharms., LLC, Case No. 2023-1186 (Fed. Cir. February 24, 2023) is an appeal by Jazz Pharmaceuticals, Inc. (Jazz) from a District of Delaware order granting a motion...more
2/28/2023
/ Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Intellectual Property Protection ,
Jazz Pharmaceuticals ,
Life Sciences ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
In this episode of our Exclusively Life Sciences webinar series, our experts from our EU team will share best practices for innovators to protect their competitive advantage when generics enter the market....more
Preparing the Orange Book listing sheet (i.e., Form FDA 3542) for a U.S. patent is more than just checking the boxes.
Generic drug companies have recently argued that statements made in those listing sheets could be used to...more