Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

FTC cracks down on 100-plus ‘improper’ drug patents in comprehensive enforcement push

By Brian Buntz | November 8, 2023

FTC-DOJUnder the leadership of Lina Khan, the Federal Trade Commission (FTC) has stepped up its enforcement actions, complicating its clearances of mergers, including Amgen’s acquisition of Horizon Therapeutics, which concluded in early October. Most recently, FTC has challenged what it deems are “improper” patent listings. At the receiving end of the FTC drug patent crackdown are Big Pharma companies such as AbbVie, AstraZeneca, and Boehringer Ingelheim. 

FTC drug patent crackdown targets 100+ patent listings

More than 100 patent listings are improper in the eyes of FTC because they do not meet the relevant statutory and regulatory requirements for inclusion in the FDA’s Orange Book, a publication of “Approved Drug Products with Therapeutic Equivalence Evaluations.” That is, FTC contends that the patents in question are either inaccurately listed or are not relevant to the approved drug products they are thought to cover. The agency notes a variety of reasons for the  discrepancies, such as the patents in question not claiming the drug substance, the drug product, or the specific method of use in the approved product.

FTC said in a press release that the affected manufacturers may need to “remove the listing or certify under penalty of perjury that the listings comply with applicable statutory and regulatory requirements.” The process of updating the Orange Book can be detailed, requiring precise adherence to regulatory protocols and timely responses from patent holders.

In all, some 10 companies were targeted in FTC’s list. In addition to those mentioned earlier are Mylan Specialty and subsidiaries of GSK and Teva.

Product types in particular included some asthma and other inhaler devices, Restasis multidose bottles, and epinephrine autoinjectors (EpiPens).

FTC steps up enforcement in 2023

On May 16, FTC filed a lawsuit to block Amgen’s acquisition of Horizon Therapeutics, a $27.8 billion transaction that the commission argued would lead to monopoly control over drugs for treating two serious illnesses. In September 1, the agency settled with Amgen, which agreed to changes in its drug portfolio that FTC worried would disadvantage rivals and requiring prior approval for future related acquisitions.

On July 19, 2023, DOJ joined FTC to release draft merger guidelines for public comment, which seeks to prevent anticompetitive mergers. On August 10, the agencies extended the public comment period by 30 days on proposed changes to the premerger notification form.

In October, the pharma industry announced the launch of a coalition known as the Partnership for the U.S. Life Science Ecosystem (PULSE) aiming to resist FTC’s growing scrutiny. The consortium includes more than 30 companies and biopharma associations, including Amgen, AbbVie, Gilead, Merck, and Novartis.

Timeline | Vis.js

Filed Under: Regulatory affairs
Tagged With: Amgen Horizon acquisition, biopharma mergers, Biotech Innovation, FTC, industry regulation, pharmaceutical antitrust, PULSE coalition
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

Related Articles Read More >

Trump slams ‘global free ride’ on drug pricing in executive order, orders match to lowest global prices
FDA’s genAI push could save CDER hundreds of thousands of review hours annually
White House
Trump’s drug‑pricing order could extend small‑molecule runway 4 years
Washington DC, USA - July 3, 2017: Sign for Department of Health and Human Services in downtown
What RFK Jr.’s plans to cut 20,000 HHS job could mean for the pharma sector
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE