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
Procedural History -
United Therapeutics Corporation v. Liquidia Technologies, Inc. is an appeal and cross appeal from a District of Delaware decision that found (1) claims 1, 4, and 6–8 of U.S. Patent 10,716,793 (“the...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 -
Sanofi-Aventis Deutschland GMBH v. Mylan Pharmaceuticals Inc. is an appeal from a final written decision in an inter partes proceeding (“IPR”) of the Patent Trial and Appeal Board (“PTAB”) that found...more
Executive Summary -
In Amgen Inc. v. Sanofi, the United States Supreme Court affirmed the lower courts’ judgment that the asserted claims of U.S. Patent No. 8,829,165 (“the ’165 Patent”) and U.S. Patent No. 8,859,741 (“the...more
Procedural History -
UCB, Inc. v. Actavis Laboratories UT, Inc., is an appeal from a judgment in a Hatch-Waxman suit in the District of Delaware that found the asserted claims of U.S. Patent No. 10,130,589 (the “’589...more
Procedural History -
Arbutus Biopharma Corp. v. Modernatx, Inc. is an appeal from a final written decision in an inter partes proceeding of the Patent Trial and Appeal Board (“PTAB”) that found claims 1-22 of U.S. Patent...more
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
This is an appeal from a District of Delaware summary judgment order that held that the asserted claims of U.S. Patent No. 9,186,208 (the ’208 Patent) are anticipated under the public use bar of pre-AIA 35 U.S.C. § 102(b). ...more
Procedural History -
This is an appeal from a District of Delaware summary judgement order that held that the asserted claims of U.S. Patent No. 8,197,807 (the ‘807 Patent), entitled “Nicotinamide riboside kinase...more
On January 5, 2023, President Joe Biden signed into law the Protecting American Intellectual Property Act of 2022 (PAIP). PAIP requires that the President identify to Congress individuals and entities associated with theft of...more
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
In late 2019, Congress enacted the “CREATES Act”, which established a private right of action in which generic or biosimilar manufacturers may sue an innovator for an injunction and monetary award for not selling samples of...more
9/6/2022
/ Anticompetitive Behavior ,
Biosimilars ,
Continuing Legal Education ,
CREATE Act ,
Generic Drugs ,
Injunctions ,
Innovator Liability ,
Life Sciences ,
Pharmaceutical Industry ,
Private Right of Action ,
Webinars