News & Analysis as of

Final Rules Proposed Rules Patents

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

USPTO Issues Final Rule on Director Review of PTAB Decisions

On October 1, 2024, the USPTO published a new final rule, Rules Governing Director Review of Patent Trial and Appeal Board Decisions. 89 Fed. Reg. 79744 (October 1, 2024). The new rule codifies many aspects of the PTAB’s most...more

WilmerHale

PTAB/USPTO Update - May 2024

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On April 30, the USPTO announced a Request for Comments (RFC) seeking public feedback on how AI could affect USPTO evaluations on patentability, including what qualifies as prior art and the assessment of the level of...more

WilmerHale

PTAB/USPTO Update - June 2023

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On May 23, the USPTO announced a request for comments seeking public input on whether to make permanent or modify the PTAB’s Motion to Amend (MTA) Pilot Program. The USPTO is also seeking related input on the rules of...more

WilmerHale

PTAB/USPTO Update - December 2021

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USPTO Leadership - ..Drew Hirshfeld is still performing the functions and duties of Director. Kathi Vidal, the Biden Administration’s nominee to be the next Director, testified at the Senate Judiciary...more

WilmerHale

PTAB/USPTO Update - June 2021

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USPTO Leadership - ..Drew Hirshfeld is still performing the functions and duties of Director.  No announcement from the Biden Administration as to who will be nominated to become the next Director. IP Toolkit - ...more

WilmerHale

PTAB/USPTO Update - December 2020

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USPTO News - ..David Berdan has been appointed USPTO’s General Counsel. As General Counsel, Mr. Berdan will serve as the principal legal advisor to the Director. He will also supervise the Office of General Counsel and...more

WilmerHale

PTAB/USPTO Update - November 2020

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USPTO News - ..USPTO releases report on artificial intelligence and intellectual property policy. ..Mary Critharis has been appointed the USPTO’s Acting Chief Policy Officer and Director for International Affairs. Ms....more

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