Antitrust Lawsuit Brought Against Drug Manufacturer Based on Its Allegedly Improper Listing of Device Patents in the FDA’s Orange Book

| Ari FeinsteinJane Dai, Ph.D.

As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”).  Rahul Rao, the deputy director of the FTC’s Bureau of Competition and the person who signed the warning letters, recently explained the FTC’s position in unequivocal terms: “The Orange Book is only supposed to list patents covering active drug ingredients.  So, we focused on device patents that have nothing to do with the active drug.”[1]

One of the drug manufacturers that received a warning letter was Boehringer Ingelheim (“Boehringer”).  The FTC’s November 7, 2023 letter to Boehringer identified a number of device patents that, in the FTC’s view, are improperly listed in the Orange Book for the following products: Atrovent® HFA, Combivent® Respimat®, Spiriva®, and Spiriva® Respimat®.

Perhaps emboldened by the FTC’s warning letter, the Massachusetts Laborers’ Health & Welfare Fund (“Mass. Laborers’ Health”) filed a class action lawsuit against Boehringer on March 6, 2024, alleging violation of antitrust laws, as well as unfair competition and consumer protection laws.[2]  In its complaint, Mass. Laborers’ Health specifically cited to the FTC’s November 7, 2023 letter and noted that, while other drug manufacturers that received warning letters from the FTC “engaged in the dispute process in good faith, leading them to remove improperly listed patents from the Orange Book[,]” Boehringer did not.[3]  The complaint also states that the United States Senate Committee on Health, Education, Labor and Pensions “launched an investigation into the price of asthma inhalers” and “sent letters to the four biggest manufacturers of inhalers sold in the United States, including Boehringer.”[4]

One day after the complaint against Boehringer was filed, Boehringer announced “it will cap out-of-pocket costs at $35 per month for eligible patients for all of the company’s inhaler products.”[5]  This includes, but is not limited to, the Atrovent® HFA, Combivent® Respimat®, and Spiriva® Respimat® products that were the subject of the FTC’s warning letter and Mass. Laborers’ Health’s class action lawsuit.  For reference, the complaint alleges that Spiriva® Respimat® “costs about $600 in the United States . . . .”[6] 

How Boehringer’s capping of out-of-pocket costs will impact the pending lawsuit—and, more broadly, whether the lawsuit is the harbinger of a wave of lawsuits against drug manufacturers based on their allegedly improper listing of device patents in the Orange Book—both remain to be seen.  It is important to note that Mass. Laborers’ Health’s complaint spans 242 pages and includes numerous factual allegations regarding the particular history of Boehringer’s patents, including their expiration, the timing of pediatric exclusivity, and the particular steps Boehringer took to allegedly unlawfully extend its monopoly in the market with the latest-expiring Orange Book patents set to expire in 2030.       

Editor: Brenden S. Gingrich, Ph.D.

[2] Massachusetts Laborers’ Health & Welfare Fund v. Boehringer Ingelheim Pharms., Inc. et al., Civ. No. 1:24-cv-10565, D.I. 1 (D. Mass. Mar. 6, 2024) (“Complaint”). 

[3] Id. at ¶¶ 591, 594. 

[4] Id. at ¶ 597.

[6] Complaint ¶ 165.