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Executive Orders Pharmaceutical Industry

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

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Sheppard Mullin Richter & Hampton LLP

Recent Healthcare-Related Artificial Intelligence Developments

AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down. From a governmental perspective, many federal agencies are embracing...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Morrison & Foerster LLP - Government...

Biden Administration Proposes Novel Use Of Price As Justification For Agency Exercise Of March-In Rights For Government-Funded...

Presented as part of its effort to lower what it views as excessive prices for prescription drugs, the Biden administration on December 7, 2023, announced the release of a proposed framework to expand the use of government...more

Sheppard Mullin Richter & Hampton LLP

The March on Pharmaceutical Patents?

December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may...more

Holland & Knight LLP

New Artificial Intelligence Executive Order Contains Numerous Healthcare Implications

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President Joe Biden on Oct. 30, 2023, signed a sweeping executive order (EO) and invoked the Defense Production Act to establish the first set of standards for using artificial intelligence (AI) in healthcare and other...more

Saiber LLC

President Biden Signs Landmark Executive Order on use of Artificial Intelligence

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On October 31, 2023, President Biden signed an Executive Order on the “Safe, Secure and Trustworthy Development and Use of Artificial Intelligence” in order to advance “a coordinated, Federal Government-wide approach to...more

Holland & Knight LLP

Holland & Knight Health Dose: October 31, 2023

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more

Axinn, Veltrop & Harkrider LLP

Will the FDA-PTO Collaboration Pay Off?

Since President Biden's July 2021 executive order directing the FDA Commissioner to collaborate with the PTO on potential misuse of the patent system, I've been skeptical as to whether such efforts will have any impact on the...more

Foley Hoag LLP

President Biden Issues Executive Order on Use of Artificial Intelligence in Healthcare Settings

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On October 30, 2023, President Biden issued an executive order (EO) to guide federal agencies on the development and use of artificial intelligence (AI). The administration views AI as holding numerous benefits but at the...more

Goodwin

USPTO Extends Deadline for Comments on USPTO-FDA Collaboration Initiatives

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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

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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

FDA Commissioner Delivers Remarks at FDA-U.S. Patent and Trademark Office Public Workshop

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On January 19, 2023, the FDA Commissioner, Robert M. Califf, delivered remarks at the FDA-USPTO Public Workshop. He noted that, since the issuance of President Biden’s 2021 Executive Order on Promoting Competition, the FDA...more

Goodwin

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

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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

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​​​​​​​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

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - October 2022 #2

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2022 Medicaid Drug Rebate Program Summit Concludes: The annual Medicaid Drug Rebate Program Summit took place Oct. 12-14 in Chicago. Latham partner Christopher H. Schott spoke at two sessions: the panel “Ask the Attorneys:...more

Goodwin

Request for Comments on USPTO Initiatives To Promote Generic Drug and Biosimilar Competition

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The U.S. Patent and Trademark Office (USPTO) recently published a request for comments addressing a variety of topics related to generic drug and biosimilar competition. In July 2021, President Biden issued an Executive Order...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

Goodwin

Executive Order for Advancing Biotechnology and Biomanufacturing Innovation Signed by President Biden

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​​​​​​​On September 12, 2022, President Biden signed the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. The objective of the Executive Order...more

McDonnell Boehnen Hulbert & Berghoff LLP

President Biden's Biotechnology and Biomanufacturing Executive Order: Funding

President Biden announced his signing of an Executive Order launching a major effort to enhance U.S. capabilities in biotechnology and biomanufacturing last week (see "President Biden Signs Executive Order on Biotechnology...more

Goodwin

USPTO Publishes Notice Calling Out Pharmaceutical Industry

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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

Foley & Lardner LLP

One Year of Action Since President Biden’s Executive Order on Competition

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Earlier this month — July 9, 2022 — marked the one-year anniversary of President Biden’s Executive Order on Promoting Competition in the American Economy (Executive Order). The Executive Order was notable in its breadth and...more

Goodwin

CA Gov. Newsom Announces Budget Approval for Biosimilar Insulin Initiative

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On Thursday, July 7, 2022, California Governor Gavin Newsom announced that the most recent state budget, signed last week, includes a $100 million allotment for California to “contract to make [its] own insulin at a cheaper...more

Goodwin

USPTO Outlines New Initiatives Regarding Drug Pricing

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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

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