News & Analysis as of

Trump Administration Pharmaceutical Patents

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

McDermott Will & Schulte

FTC Revives Orange Book Listing Challenges

On May 21, 2025, the Federal Trade Commission (FTC) issued its third round of warning letters – and its first under the Trump administration – against pharmaceutical manufacturers for allegedly improper listing of patents in...more

WilmerHale

Healthcare & Antitrust: What to Expect in the New Trump Administration

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Antitrust scrutiny of healthcare markets is nothing new. The Biden Administration and first Trump Administration focused antitrust enforcement efforts across the healthcare and life sciences industries. The newly installed...more

Jones Day

Innovative Insights: Legal Updates in Life Sciences | First Quarter 2025

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Artificial intelligence is revolutionizing life science R&D (particularly in the realm of drug discovery) and challenging the traditional "human inventorship" requirement for U.S. patents. Recent guidance from the USPTO...more

American Conference Institute (ACI)

[Event] 21st Annual Conference on Paragraph IV Disputes - April 29th - 30th, New York, NY

Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more

McDermott Will & Schulte

[Webinar] IP Focus | US Patent Law Under the New Trump Administration - February 5th, 10:00 am JST

McDermott is committed to providing insightful commentary on intellectual property (IP) developments from around the world to our Japanese clients. During these sessions, a variety of speakers from McDermott’s offices in the...more

McDermott Will & Schulte

An Early Holiday Present for Generics? Legislation Requiring Greater Disclosure by Brands Passes the Senate

McDermott Will & Schulte on

Earlier this month, two bills intended to promote generic competitiveness by presenting a clearer idea of the patent landscape covering reference products passed the full Senate, albeit with amendments. These laws, if...more

Herbert Smith Freehills Kramer

USMCA: Implications for Biologics and Innovation

On Wednesday, President Donald Trump signed the United States-Mexico-Canada Agreement (USMCA) into law. The USMCA contains a number of key and last-minute revisions that implicate biologic medicines and patent obligations. ...more

Mintz - Intellectual Property Viewpoints

HHS HIV Drug Lawsuit: Setting Precedent for Other High Priced Medications or Government Collaborations?

On November 6, 2019, the bonds between the U.S. government and pharmaceutical companies were stretched when the U.S. Department of Health and Human Services (“HHS”) filed a patent infringement lawsuit against Gilead Sciences...more

BakerHostetler

Capitol Hill Healthcare Update

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FDA NOMINATION HEARING DRIVES THE WEEK IN HEALTH POLICY - President Trump’s nominee to lead the Food and Drug Administration, Dr. Stephen Hahn, will appear Wednesday before the Senate Health, Education, Labor and Pensions...more

Patrick Malone & Associates P.C. | DC Injury...

Big Pharma under fire over quality, safety, and patents on costly brand drugs

When Big Pharma insists its sky-high prices are justified, patients may want to keep in mind key findings just revealed about prescription drugs and their makers...more

Wilson Sonsini Goodrich & Rosati

FDA Updates Paragraph IV Certification List to Help Spur Investment in Generic Drug Development

Recently, the U.S. Food and Drug Administration, or the FDA, announced enhancement of the FDA's Paragraph IV Patent Certification List (the List) as part of the agency's stated goal of bringing more generic drugs to market...more

BakerHostetler

The Weekly Hill Update

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Below is the Federal Policy team’s weekly preview, published when Congress is in session. HEADLINES - • Chinese Vice Premier Liu He is scheduled to visit Washington, but President Donald Trump’s Twitter threats to raise...more

White & Case LLP

Peak performance: US M&A in 2018: Next big thing drives healthcare M&A

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Although deal volume and value in the pharma, medical and biotech sector fell in 2018, down by 3 percent to 580 deals and 27 percent to US$111.8 billion respectively, pharma companies have invested aggressively in strategic...more

Dorsey & Whitney LLP

The Supreme Court - January 22, 2019

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The Supreme Court of the United States issued the following decision this morning: Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., No. 17-1229: Every patent statute over the past two centuries has included an...more

Fenwick & West LLP

Key IP Takeaways from the United States-Mexico-Canada Agreement

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On September 30, 2018, the United States, Mexico and Canada reached a trade agreement to supersede the North American Free Trade Agreement. The aptly named United States-Mexico-Canada Agreement includes intellectual property...more

Knobbe Martens

Patent Law Update for Medical Device Companies 2018 (Presentation)

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Knobbe Martens Partners Paul Conover, Irfan Lateef, and Curtis Huffmire presented "Patent Law Update for Medical Device Companies 2018" at the MedTech Innovation Summit in San Francisco, CA on November 28, 2018. This session...more

Goodwin

President Signs Bill Requiring FTC and DOJ Review of Biosimilar Patent Litigation Settlements

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Following up on our prior reports, last week President Trump signed into law the “Patient Right to Know Drug Prices Act” (S.2554). Among other changes, the bill amends the Medicare Prescription Drug, Improvement, and...more

Dorsey & Whitney LLP

Expected Executive Order to take on High Drug Prices; Senate Committee Hears Recommendations on Drug Supply Chain from Experts

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According to an article posted today on the BioCentury website, the Trump administration is drafting an executive order that will take on the high costs of pharmaceuticals by instructing “executive agencies to use value-based...more

Dorsey & Whitney LLP

US China Trade War — Stock Market Crash, Presidential Trade Politics, Trade Policy, Customs, Antitrust and Securities

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The Chinese stock market crash and world- wide effect on stock markets around the World has created a crisis with day to day developments. The World Stock market crash stated on August 24, 2015 and went through to August...more

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