News & Analysis as of

Patent Infringement Federal Food Drug and Cosmetic Act (FFDCA) Pharmaceutical Industry

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

Rothwell, Figg, Ernst & Manbeck, P.C.

Defining an Orange Book ‘Drug’

The Federal Circuit heard oral argument on November 8, 2024, grappling with the issue of what patent claims may properly be listed in the Orange Book. In late 2023, Teva filed a complaint for patent infringement in response...more

Proskauer - The Patent Playbook

A Guiding Light for the Research Safe Harbor and “Research Tools”?

Allele v. Pfizer – The Basics. On April 23, 2021 Pfizer, Inc., BioNTechSE, and BioNTech US, Inc. (“Pfizer and BioNTech”) filed a joint reply supporting of their previously filed motion to dismiss a patent infringement...more

Hogan Lovells

Hogan Lovells ITC Section 337 Monthly Highlights

Hogan Lovells on

The latest news round-up from our Hogan Lovells ITC Section 337 practice, including a new section featuring "tips from the bench" by former ITC Judge Theodore (Ted) R. Essex. ...more

Womble Bond Dickinson

Basics of the BPCIA

Womble Bond Dickinson on

The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - November 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Janssen Biotech Inc. et al. v. Par Pharmaceutical Inc. et al. 1:15-cv-00679; filed August 3, 2015 in the District Court of...more

Robins Kaplan LLP

Otsuka Pharmaceutical Co., Ltd. v. Burwell

Robins Kaplan LLP on

Case Name: Otsuka Pharmaceutical Co., Ltd. v. Burwell, Civ. No. GJH-15-852, 2015 U.S. Dist. LEXIS 68230 (D. Md., May 27, 2015) (Hazel, J.) - Drug Product and Patent(s)-in-Suit: Abilify® (aripiprazole); N/A - Nature...more

Robins Kaplan LLP

Classen Immunotherapies, Inc. v. Elan Pharms., Inc.

Robins Kaplan LLP on

Case Name: Classen Immunotherapies, Inc. v. Elan Pharms., Inc., 786 F.3d 892 (Fed. Cir. May 13, 2015) (Circuit Judges Prost and Lourie, and District Judge Gilstrap presiding; Opinion by Lourie, J.) (Appeal from D. Md.,...more

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