News & Analysis as of

Federal Trade Commission (FTC) Life Sciences

Polsinelli

Device Patents in the Orange Book: May 21, 2025, FTC Warning Letters Appear to have Minimal Impact

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Key Takeaways The Federal Trade Commission (FTC) has continued its scrutiny of Orange Book listings for device patents, signaling bipartisan concern over potential anti-competitive practices....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

American Conference Institute (ACI)

[Virtual Conference] Inaugural Summit on GLP-1 Law & Policy - July 24th, 8:15 am - 5:15 pm ET

The $100B+ Weight-Loss Drug Market Is Red Hot—But So Are the Legal, Regulatory, and Compliance Risks. As the GLP-1 revolution reshapes the future of metabolic health, life sciences companies face mounting scrutiny from...more

Goodwin

Antitrust Life Sciences Quarterly Update 2025 Q1

Goodwin on

While M&A activity slowed in the first quarter of 2025, including in life sciences, there have been plenty of noteworthy developments in the antitrust space in the first 100 days of the Trump administration....more

Morgan Lewis

Executive Order Targets Regulatory Barriers to Competition Across US Economy

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President Donald Trump signed the executive order “Reducing Anti-Competitive Regulatory Barriers” on April 9, 2025, directing federal agencies to identify and reform regulations that unnecessarily restrict market competition....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

Fenwick & West LLP

2025 Life Sciences M&A Trends in Earnouts and Antitrust

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Life sciences M&A comes with unique challenges that require thoughtful and creative structuring. Bridging valuation gaps between buyers and sellers and navigating regulatory scrutiny need careful planning....more

Goodwin

Antitrust and Competition Life Sciences Year in Review 2024

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The last year (and particularly the last few months) of the Biden Administration brought a flurry of activity from the Federal Trade Commission (FTC) in the life sciences space, continuing a yearslong pattern of close...more

Fenwick & West LLP

CLE Takeaways: 2025 Life Sciences M&A Trends

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While life sciences M&A activity surges in today’s markets, the shift in regulatory enforcement priorities, constant innovation in technology, and strategic growth opportunities are changing the way dealmakers are approaching...more

Morrison & Foerster LLP

2024 M&A Annual Review

Our M&A team is honored to have represented clients in some of the most compelling transactions in 2024, from advising the iconic rock band KISS and its co-founders Gene Simmons and Paul Stanley in the sale of all assets...more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

Goodwin

Life Sciences M&A Boom and Other Trends to Watch in 2025

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In mid-January, Goodwin and KPMG brought together innovators, practitioners, regulators, and others for an annual symposium on the future of life sciences and healthcare. This event marked the sixth year that Goodwin...more

Mintz - Antitrust Viewpoints

PBM Update: Special Edition - FTC Releases Second Interim Staff Report in PBM Inquiry

On January 14, 2025, the Federal Trade Commission (FTC) Office of Policy Planning released a second Interim Staff Report titled Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit...more

Goodwin

How the Trump Administration Could Reshape Regulation in the Life Sciences Sector

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Based on recent policy signals and statements from incoming administration officials, a picture of potential regulatory and policy changes that could affect biotech, pharmaceutical, and medical device companies in coming...more

Wolf, Greenfield & Sacks, P.C.

A Look Ahead: Key Intellectual Property Legal Developments in 2024 - and What to Expect in 2025

From potential legal challenges to Chinese biopharma supply chains, Europe’s new Unified Patent Court (UPC), landmark decisions in life sciences, pharma’s Orange Book listings, design patent rejections, and likely shifts at...more

Goodwin

Year in Review: Top Regulatory Developments of 2024

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As 2025 begins, we would like to reflect on last year’s regulatory developments in the biologics and biosimilars space. Here are some of the top regulatory developments from 2024....more

DLA Piper

Life Sciences Year in Review and What's Ahead

DLA Piper on

2024 was eventful in the life sciences space – and key trends are expected to continue in the new year. ...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Federal Circuit: Patent Must Claim Active Ingredient for Orange Book Listing

On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. ...more

Jones Day

Vital Signs: Digital Health Law Update | Fall-Winter 2024

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We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more

Ropes & Gray LLP

Stem Cell Litigation Update: FDA Won the Latest Battle, but the Future of HCT/P Enforcement Remains Unclear

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On September 27, 2024, the U.S. Court of Appeals for the Ninth Circuit reversed the district court’s decision in U.S. v. California Stem Cell Treatment Center, Inc. (“California Stem Cell”), holding that a clinic’s stem cell...more

Smart & Biggar

Evolving pharmacy landscape signals more stringent regulatory scrutiny of “patient steering”

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The pharmacy landscape has evolved considerably over the past year, shining a spotlight on pharmacy “patient steering”, the practice of directing patients to certain preferred pharmacies. Though Quebec has long required that...more

Goodwin

Antitrust and Competition Life Sciences Quarterly Update Q2 2024

Goodwin on

To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more

Wilson Sonsini Goodrich & Rosati

[Event] Biotech Summit 2024 - October 9th - 10th, Boston, MA

Wilson Sonsini’s inaugural Biotech Summit will address topics of critical importance to Biotech and Biopharmaceutical companies, including early and late-stage venture financing, partnering strategies, current and future AI...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust and Life Sciences - July 2024

WilmerHale on

Federal Circuit Allows Teva Patents to Remain in Orange Book.  - The Federal Circuit recently granted Teva Pharmaceutical’s motion for a stay of removal of its patents from the Orange Book in its ongoing dispute with...more

Orrick, Herrington & Sutcliffe LLP

Life Sciences and Health Care Companies Under the Competition Microscope: New Cross-Government Initiatives Seek to Expose...

U.S. antitrust enforcers launched a flurry of initiatives in the first half of 2024 to identify and prevent antitrust and other violations in life sciences and health care. Among these are two cross-agency Requests for...more

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