FTC Ramps Up Efforts to Crackdown on Inaccurate Patent Listings in the FDA’s Orange Book

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The Federal Trade Commission (FTC) announced that it has expanded its focus in its crusade against improper or inaccurate patent listings in the FDA's Orange Book, which has the potential to hinder the development and entrance of cheaper generic versions of drugs by falsely extending patent protections. This includes medications for diabetes, weight loss, asthma, and chronic obstructive pulmonary disease, with Novo Nordisk’s weight-loss drug Ozempic standing out as one of the biggest treatments involved. According to the federal agency, the crackdown focuses on over 300 different listings and 20 products across the pharmaceutical industry.

The FTC sent out warning letters to 10 organizations, which include:

• Boehringer Ingelheim
• AstraZeneca
• Teva Pharmaceuticals
• Amphastar
• Novo Nordisk
• GSK
• Glaxo Group Limited
• Covis Pharma
• Novartis
• Norton (Waterford) Limited

The FTC alleges that the aforementioned pharmaceutical companies engaged in practices that aim to block competition and keep drug prices high, with a deadline of 30 days to edit the patents.¹

“By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” said Lina M. Khan, chair, FTC, in a press release. “By challenging junk patent filings, the FTC is fighting these illegal tactics and making sure that Americans can get timely access to innovative and affordable versions of the medicines they need.”

Back in November, the agency initiated a challenge of more than 100 patents, which included brand-name asthma inhalers and epinephrine autoinjectors, with the belief that they were also inaccurately listed. AstraZeneca, Boehringer Ingelheim, GSK, and Teva were also a part of this warning, along with Impax Laboratories, Kaleo, and Mylan Specialty.²

Boehringer Ingelheim, GSK, and AstraZeneca all announced out-of-pocket caps of $35 for inhaler products earlier this year.^3,4

“Wrongfully listed patents can significantly drive up the prices Americans must pay for medicines and drug products while undermining fair and honest competition,” said Khan, in a press release. “The FTC’s action today identifies over 100 patents that we believe are improperly listed, affecting products ranging from inhalers to EpiPens. We will continue to use all our tools to protect Americans from illegal business tactics that are hiking the cost of drugs and drug products.”

As a precursor to these actions, the FTC first announced its crackdown plans in a September press release.⁵

“The Commission will consider whether to issue a policy statement concerning the improper listing of patents in the Food and Drug Administration’s publication of Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the ‘Orange Book.’ The policy statement will discuss whether improper listing of patents in the Orange Book may increase the cost of and reduce access to essential prescription drugs, imposing costs on individuals and society alike. The policy statement also assesses whether the listing of patents in the Orange Book that do not comport with listing requirements may constitute an unfair method of competition,” the FTC wrote in a statement.

References

1. FTC Expands Patent Listing Challenges, Targeting More Than 300 Junk Listings for Diabetes, Weight Loss, Asthma and COPD Drugs. FTC. April 30, 2024. Accessed May 1, 2024. https://www.ftc.gov/news-events/news/press-releases/2024/04/ftc-expands-patent-listing-challenges-targeting-more-300-junk-listings-diabetes-weight-loss-asthma

2. FTC Challenges More Than 100 Patents as Improperly Listed in the FDA’s Orange Book. FTC. November 7, 2023. Accessed May 1, 2024. https://www.ftc.gov/news-events/news/press-releases/2023/11/ftc-challenges-more-100-patents-improperly-listed-fdas-orange-book

3. Boehringer Ingelheim Unveils New Out-of-Pocket Cap Initiative for its Inhaler Product Portfolio. PharmExec. March 8, 2024. Accessed May 1, 2024. https://www.pharmexec.com/view/boehringer-ingelheim-unveils-new-out-of-pocket-cap-initiative-for-its-inhaler-product-portfolio

4. GSK Follows Rivals, to Cap Out-of-Pocket Inhaler Cost in US. Yahoo!finance. March 21, 2024. Accessed May 1, 2024. https://finance.yahoo.com/news/gsk-follows-rivals-cap-pocket-162900339.html

5. FTC Announces Tentative Agenda for September 14 Open Meeting. FTC. September 7, 2023. Accessed May 1, 2024. https://www.ftc.gov/news-events/news/press-releases/2023/09/ftc-announces-tentative-agenda-september-14-open-meeting