News & Analysis as of

Executive Orders Patent Trial and Appeal Board

WilmerHale

PTAB/USPTO Update - August 2024

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On July 7, the Senate passed a resolution “[r]ecognizing the importance of trademarks in the economy and the role of trademarks in protecting consumer safety, by designating the month of July as ‘National Anti-Counterfeiting...more

Axinn, Veltrop & Harkrider LLP

Will the PTO's Proposed Expansion of Filing Settlement Agreements Help to Reduce Drug Prices?

In a recent Federal Register notice, the PTO announced a proposed rule requiring that any settlement agreement resolving a PTAB proceeding, even if such agreement occurs prior to a decision to institute an inter partes review...more

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO Guidance on Use of AI-Based Tools

The USPTO has issued several recent Federal Register Notices this calendar year. The latest, entitled Guidance on Use of Artificial Intelligence-Based Tools in Practice Before the United States Patent and Trademark Office, 89...more

Womble Bond Dickinson

Patent Practitioners Take Note: (Even) if You Use AI, Read Before You File

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On February 6, 2024, the USPTO weighed in with guidance for practitioners using—or considering using—AI in preparing submissions to the USPTO. In essence, Director Kathi Vidal has reminded practitioners that they must sign...more

Davis Wright Tremaine LLP

White House Ushers in New Era of Regulation With Landmark Executive Order on Artificial Intelligence

The AI executive order moves the U.S. closer to a broader unified approach on federal AI regulation, expanding on the AI Bill of Rights and NIST AI Risk Management Framework and focusing on the responsible development and...more

WilmerHale

PTAB/USPTO Update - November 2023

WilmerHale on

USPTO News - On October 23, 2023, the USPTO Office of the Chief Economist released a report detailing patenting activity related to COVID-19 diagnostic technology....more

Dechert LLP

Initiatives to Increase Communication Between the USPTO and the FDA Concerning Pharmaceutical Patent Applications

Dechert LLP on

President Biden, in July 2021, issued an Executive Order (“E.O.”) observing that “too often, patent and other laws have been misused to inhibit or delay — for years and even decades — competition from generic drugs and...more

MoFo Life Sciences

The USPTO And The FDA Join Hands To Promote Competition

MoFo Life Sciences on

On November 15, 2022, the Berkeley Center for Law and Technology hosted a webinar to address the recent, unprecedented collaboration between the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration...more

Foley & Lardner LLP

USPTO Ideas For Bolstering Robustness And Reliability Of Patents Demand Attention And Stakeholder Input

Foley & Lardner LLP on

The USPTO has issued a Federal Register Notice soliciting comments on “proposed initiatives directed at bolstering the robustness and reliability of patents to incentivize and protect new and nonobvious inventions while...more

Goodwin

USPTO Doubles Down Calling Out Pharmaceutical Industry

Goodwin on

​​​​​​​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

McDermott Will & Emery

PTO Requests Comments on Initiatives to Ensure Patent Robustness, Reliability

McDermott Will & Emery on

The US Patent & Trademark Office (PTO) is seeking public input and guidance on proposed initiatives directed at bolstering the robustness and reliability of patents. The request for comments was spurred in part by US...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

Fish & Richardson

Biosimilars 2021 Year in Review

Fish & Richardson on

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...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

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

PTAB Strategies and Insights - July 2018: Do You Want An Inferior Judge? Why PTAB Judges May Be Unconstitutional And What Happens...

Is the appointment of PTAB administrative patent judges (APJs) constitutional? The patent bar is asking in the wake of the Supreme Court’s decision in Lucia v. SEC....more

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