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Knobbe Martens

Dec 16, 2024

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Patent Litigation

Edwards v. Meril at the Supreme Court: Testing the Scope of Hatch-Waxman’s Safe Harbor

Written by:Ari Feinstein and Joseph Mallon, Ph.D. On October 11, 2024, Edwards[1] filed a petition for a writ of certiorari... Read More

Knobbe Martens

Dec 13, 2024

End of an Era: The After Final Consideration Pilot Program 2.0 Concludes

Written by: Jason J. Jardine, Justin Culbertson, Ph.D. & Phillip J. Minnick, Ph.D. The sun is officially setting on the United... Read More

Knobbe Martens

Dec 10, 2024

Novo Nordisk Seeks to Block Compounded Versions of Diabetes / Weight Loss Drug

Written by: Makoto Tsunozaki, Ph.D. & Agnes Juang, Ph.D. On October 22, 2024, Novo Nordisk made a submission to the U.S.... Read More

Knobbe Martens

Nov 25, 2024

CDRH Announces Pilot Program to Improve Recall Communication

Written by: Alistair J. McIntyre and Eric Furman, Ph.D. On November 21, 2024, the FDA’s Center for Devices and Radiological Health... Read More

Knobbe Martens

Nov 22, 2024

FDA Provides Perspective on Goals and Challenges for Regulation of Artificial Intelligence in Medical Devices, Drug Design, and Clinical Research

Written by: Douglas W. Crandell, Ph.D. and Joseph Mallon, Ph.D. A recent article[1] authored by Haider J. Warraich, MD[2]; Troy Tazbaz[3];... Read More

Knobbe Martens

Nov 18, 2024

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Patent Litigation

Settlements Don’t Close the Door: Antitrust Claims Follow IPR Challenges in Life Sciences

Written by: Kenneth O. Aruda, Ph.D. & Jason J. Jardine In the ongoing case of Carefirst of Maryland Inc. v. Johnson... Read More