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Latham & Watkins LLP

Drug Pricing: FDA Considerations Under Recent Executive Orders and Congressional Bills

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President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more

Womble Bond Dickinson

Codifying the Experimental Use Exception? USPTO Seeks Public Input

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The United States Patent and Trademark Office (USPTO) released a Notice on the Federal Register (“the Notice”) today requesting public commentary and input on the current state of the experimental use exception. The USPTO is...more

Goodwin

USPTO Extends Deadline for Comments on USPTO-FDA Collaboration Initiatives

Goodwin on

On February 24, the USPTO extended the written comment period for Joint USPTO–FDA Collaboration Initiatives until March 10, 2023....more

Foley & Lardner LLP

USPTO-FDA Listening Session — Voices from Patient and Patent Advocates

Foley & Lardner LLP on

On January 19, 2023, the U.S. Patent and Trademark Office (USPTO) and Food and Drug Administration (FDA) held a “listening session” focusing on USPTO-FDA collaboration initiatives proposed pursuant to President Biden's...more

Goodwin

Year in Review: Top Biosimilars-Related Regulatory Developments of 2022

Goodwin on

As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more

Goodwin

Request for Comments on USPTO-FDA Collaboration Initiatives to Promote Generic Drug and Biosimilar Competition

Goodwin on

​​​​​​​On November 7, the U.S. Patent and Trademark Office (USPTO) published a request for comments on areas for USPTO-FDA collaboration and engagement. The USPTO also announced a related public listening session to be held...more

Goodwin

USPTO Doubles Down Calling Out Pharmaceutical Industry

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​​​​​​​The new Director of the U.S. Patent and Trademark Office (USPTO), Katherine Vidal, published a stern reminder regarding the duties of disclosure and reasonable inquiry during examination of a patent application,...more

Foley & Lardner LLP

USPTO Underscores Duty of Disclosure Pertaining To FDA Submissions

Foley & Lardner LLP on

The USPTO has issued a Federal Register Notice discussing how the duty of candor and good faith in dealing with the USPTO applies to “information and statements material to patentability … received from or submitted to the...more

Goodwin

USPTO Publishes Notice Calling Out Pharmaceutical Industry

Goodwin on

President Biden’s Executive Order on Promoting Competition in the American Economy, 86 FR 36987 (2021), expressed concerns about the patent system being misused to unnecessarily inhibit or delay entry of generic drugs or...more

Goodwin

USPTO Outlines New Initiatives Regarding Drug Pricing

Goodwin on

On July 6, 2022, Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published her response to the letter sent by Janet Woodcock (former acting FDA Commissioner) to the former...more

Haug Partners LLP

FDA Acting Commissioner of Food and Drugs Seeks Collaboration Between FDA and USPTO to Address Pharmaceutical Patent-Related...

Haug Partners LLP on

On September 10, 2021, Janet Woodcock, Acting Commissioner of the U.S. Food and Drug Administration (FDA), sent a letter to Andrew Hirshfeld, Director of the U.S. Patent and Trademark Office (USPTO), which raised several of...more

WilmerHale

PTAB/USPTO Update - October 2021

WilmerHale on

USPTO News - On September 9, 2021, Senators Patrick Leahy and Thom Tillis wrote a letter to Acting Director Andrew Hirshfeld requesting that the USPTO “take steps to reduce patent applicants’ making inappropriate...more

Goodwin

FDA’s Woodcock Reviews Patents Practices as a Way to Effect Drug Pricing

Goodwin on

On September 10, 2021, Janet Woodcock, the acting FDA Commissioner of Food and Drugs at the FDA, sent a letter to Andrew Hirshfield, Under Secretary of Commerce for Intellectual Property and Director of the United States...more

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