Patents, Drug Compounding

Pounding the Compounders: FDA’s “No Compound” Lists

Axinn, Veltrop & Harkrider LLP on 2/17/2025

Novo Nordisk recently made headlines petitioning FDA to stop the compounding of its blockbuster GLP-1 products so it can sell its patented semaglutide drugs exclusively. Compounding is the practice of creating new drug...more

Compounded GLP-1 Drugs: is the Party Over? These Are the Legal and Regulatory Issues for Game Changing Weight Loss Products and...

Fuerst Ittleman David & Joseph on 11/4/2024

Author’s Note: This is an updated version of the post to our blog dated October 30, 2024. Later that day, FDA announced the resolution of Novo Nordisk’s semaglutide shortage, which altered the conclusion of our original post...more

Large Quantity of Routine Experimentation Can Be “Undue Experimentation”

Knobbe Martens on 11/4/2019

IDENIX PHARMACEUTICALS LLC v. GILEAD SCIENCES INC. Before Prost, Newman, and Wallach. Appeal from the United States District Court for the District of Delaware. Summary: Synthesizing and screening tens of thousands of...more

Patenting Considerations for Artificial Intelligence in Biotech and Synthetic Biology

Mintz - Intellectual Property Viewpoints on 9/30/2019

Artificial Intelligence (AI) inventions have aided development in nearly every industry, but perhaps none more so than synthetic biology. For synthetic biology researchers, AI has developed into a vital tool to create cutting...more

Fireworks for Animal Compounding and More at ACI’s Inaugural Animal Health and Veterinary Drugs and Therapeutics Conference-Part...

McGuireWoods LLP on 9/25/2015

On September 10-11, the American Conference Institute (ACI) held its inaugural Animal Health and Veterinary Drugs and Therapeutics Conference in New York City. The Conference featured two workshops: a pre-conference overview...more

IGPA 2015 Focuses on Biosimilars, Quality, and Harmonization in Toronto-Part One of Two