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Regulatory Agenda Patents Proposed Rules

Axinn, Veltrop & Harkrider LLP

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

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

Fuerst Ittleman David & Joseph

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

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

Jones Day

USPTO Issues Notice of Proposed Rulemaking On Discretionary Denial, Serial and Parallel Petitions, and Settlement

Jones Day on

On April 19, 2024, the USPTO issued a Notice of Proposed Rulemaking (the “Notice”) regarding discretionary denial in post-grant proceedings and other issues. The Notice addresses stakeholder feedback responsive to the...more

Jones Day

USPTO Requests Comments Regarding Motion to Amend Pilot

Jones Day on

The USPTO continues to seek public feedback on PTAB procedures and potential rule changes. In addition to soliciting comments on the many proposed rule changes announced on April 21, 2023, the USPTO also recently issued a...more

Mintz - Intellectual Property Viewpoints

Reduced Scope of March-in Rights Under Bayh Dole Rules Revisions

The Bayh Dole Act was enacted to provide incentives to promote commercialization of federally funded inventions and was designed to capitalize on the significant government investments in small business, university research,...more

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