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Healthcare Intellectual Property Litigation Food and Drug Administration (FDA)

Troutman Pepper Locke

Trade Dress Disputes Continue To Be a Bitter Pill in Pharma

Troutman Pepper Locke on

A recent federal court decision highlights the delicate balance between U.S. Food and Drug Administration (FDA) guidance and trade dress protections for drugs administered in a tablet or capsule form. Last month, a district...more

McDonnell Boehnen Hulbert & Berghoff LLP

Five Years Ago Today . . .

On March 11, 2020, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," and cautioned that the WHO has "rung the alarm bell loud and clear."  At...more

Robins Kaplan LLP

Novartis Pharms. Corp. v. Becerra

Robins Kaplan LLP on

Entresto® (sacubitril/valsartan) - Case Name: Novartis Pharms. Corp. v. Becerra, Civ. No. 24-cv-2234 (DLF), 2024 WL 4492072 (D.D.C. Oct. 15, 2024) (Friedrich, J.)  Drug Product and Patent(s)-in-Suit: Entresto®...more

Robins Kaplan LLP

Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC

Robins Kaplan LLP on

ProAir® HFA (albuterol sulfate) - Case Name: Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC, No. 2024-1936, 2024 WL 5176737 (Fed. Cir. Dec. 20, 2024) (Circuit Judges Prost, Taranto, and Hughes...more

Fuerst Ittleman David & Joseph

The GLP-1 Saga Continues: FDA Ends the Tirzepatide Shortage: Frequently Asked Questions

On December 19, 2024, FDA formally announced the end of the tirzepatide shortage in a Declaratory Order issued to Eli Lilly & Co. (“Lilly”). Lilly is tirzepatide’s patentholder and the manufacturer of the two branded versions...more

Foley Hoag LLP

Previewing Generic’s Skinny Label: Supreme Court to Rule on Teva’s Certiorari Petition

Foley Hoag LLP on

The Supreme Court is expected to consider Teva’s pending petition for certiorari in the highly anticipated GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. on May 11, 2023, a case that could carry enormous implications for the...more

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