FTC Targets 'Junk' Patents for Drugs Including Ozempic and Trelegy Ellipta

The U.S. Federal Trade Commission (FTC) recently sent warning letters to 10 pharmaceutical companies, challenging the patents of several drugs, including Novo Nordisk’s diabetes treatment Ozempic (semaglutide) and GSK’s asthma inhaler Trelegy Ellipta (fluticasone, umeclidinium, vilanterol). These warnings were issued as part of the FTC's initiative to address what it claims are improper or inaccurate patent listings in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book.

FTC Chair Lina Khan stated that these pharmaceutical companies are filing deceptive patent listings to block competition, which inflates the cost of prescription drugs and places a financial burden on Americans. Khan emphasized that by challenging these patents, the FTC aims to counter illegal tactics and ensure that affordable and innovative medicines are accessible to the public.

In addition to Ozempic and Trelegy Ellipta, the FTC's recent patent challenges target several other medications. These include Novo’s Saxenda (liraglutide) and Victoza (liraglutide), both prescribed for type 2 diabetes, as well as Novartis’ inhaler products Seebri Breezhaler (glycopyrronium bromide) and Utibron Neohaler (indacaterol and glycopyrrolate), which are used for treating chronic obstructive pulmonary disease.

The pharmaceutical companies have been given a 30-day period to either withdraw or amend their disputed listings or to confirm under penalty of perjury that these patents comply with statutory and regulatory requirements. GSK has responded that it is reviewing the FTC's letter and will conduct its own analysis before responding to both the FDA and FTC. Similarly, a spokesperson for Boehringer Ingelheim stated that the company has never wrongfully submitted patents for listing in the Orange Book.

This round of warnings follows an initial action by the FTC in November 2023, when it challenged over 100 patents from 10 pharmaceutical companies, including AbbVie, AstraZeneca, and subsidiaries of GSK and Teva Pharmaceuticals. That earlier action targeted a variety of pharmaceutical products, such as inhaler devices, multidose bottles, and epinephrine autoinjectors.

The FTC is not the only entity scrutinizing the high cost of medications in the U.S. Recently, members of Congress have also begun addressing this issue, with particular focus on Ozempic. Last week, Senator Bernie Sanders, who chairs the Senate health committee, initiated an investigation into the high prices of Ozempic and its weight-loss counterpart, Wegovy (semaglutide). Sanders has requested additional information from Novo Nordisk’s CEO Lars Fruergaard Jørgensen about the revenue, pricing strategies, R&D expenditures, and exclusivity tactics related to these drugs.

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