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Pharmaceutical Industry › Patents › Regulatory Reform

Knobbe Martens

Eyeing the Prize of the U.S. Patent System, the Trump Administration Proposes Patent Maintenance Fee Overhaul

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The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay 1%–5% of the estimated...more

Foley & Lardner LLP

Patent Fees Reimagined: Evaluating the Trump Administration's Value-Driven Fee Structure and Its Impact on Innovators

Foley & Lardner LLP on

The WSJ reports the Trump administration wants to charge patent holders 1% to 5% of their patent’s value to maintain the patent after grant. If implemented, this would mark a dramatic departure from the traditional flat-fee...more

Troutman Pepper Locke

FTC Holds Its First Listening Session on Practices and Regulations Impacting Pharmaceutical Generic or Biosimilar Competition

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On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as...more

Axinn, Veltrop & Harkrider LLP

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

Axinn, Veltrop & Harkrider LLP on

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

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report – January 2025

Wilson Sonsini Goodrich & Rosati on

This latest edition features an interview with retiring longtime Wilson Sonsini IP partner Vern Norviel and articles on MedTech and pharma trends for 2025, the eligibility of life sciences companies for qualified small...more

Jones Day

U.S. Senate Unanimously Passes Bill Limiting Number of Patents Asserted Against Biosimilar Applicants

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The Situation: Senate Bill 150 ("S.B. 150")—the Affordable Prescriptions for Patients Act of 2023—unanimously passed the Senate and would amend 35 U.S.C. § 272(e) to limit, under certain circumstances, the number of patents...more

Knobbe Martens

PREVAIL Act Proposes Significant Changes PTAB Proceedings

Knobbe Martens on

IP rights can be vital to the success of medical device companies.  Significant legislative changes governing some of these rights may be on the horizon.  Senators Coons (Delaware), Durbin (Illinois), Hirono (Hawaii), and...more

Wilson Sonsini Goodrich & Rosati

Selected Favorable Pharmaceutical Intellectual Property Provisions of the USMCA

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After more than a year of negotiations, the U.S., Mexico, and Canada recently concluded the United States-Mexico-Canada Agreement (USMCA). The USMCA, when it takes effect, will replace the North American Free Trade Agreement...more

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