Antitrust Law Daily Wrap Up, ANTITRUST—D. Mass.: Court pares claims in Respimat Orange Book putative class action, (Mar 28, 2025)

By Seth Abrams, J.D., M.A.

While substantial claims remain, several state antitrust, consumer protection, and unjust enrichment claims were dismissed.

The federal district court in Boston, Massachusetts granted in part and denied in part Boehringer Ingelheim Pharmaceuticals Inc. and Boehringer Ingelheim International GMBH’s motion to dismiss a putative class action brought by Massachusetts Laborers’ Health and Welfare Fund (“Massachusetts Laborers”). The court held that the motion to dismiss is granted with respect to (1) the sham litigation claim; (2) the antitrust claims raised under Illinois, Massachusetts, Mississippi, and Utah laws; (3) the consumer protection claims raised under Arkansas, Illinois, Maryland, Utah, Oklahoma, Massachusetts, and Wyoming laws (Massachusetts Laborers’ Health & Welfare Fund v. Boehringer Ingelheim Pharmaceuticals, Inc., No. 1:24-cv-10565-DJC (D. Mass. Mar. 27, 2025)).

Boehringer’s products are both drug-device combinations: Combivent Respimat and Spiriva Respimat. The two relevant patents for Combivent Respimat had expired. The relevant patents for Spiriva Respimat were also expired. The disputed patents are six of the patents “that do not claim the drug ingredients are still in the Orange Book.” As alleged, the “disputed patents either claim the Respimat inhaler or a component of it.”

In March 2023, Anobri Pharmaceuticals submitted two ANDAs to the FDA. The first was for generic Spiriva Respimat and other was for a generic version of Combivent Respimat. Anobri filed a paragraph IV certification in both cases. In June 2023, Boehringer sued Anobri for patent infringement. In July 2024, the parties in that case entered a stipulation that Anobri was no longer seeking FDA approval and to amend its ANDAs to recertify as being submitted under paragraph III.

Boehringer argued that Massachusetts Laborers had failed to plausibly allege a causal relationship between Boehringer’s alleged wrongful listing of the Disputed Patents in the Orange Book and Massachusetts Laborers’ antitrust injury. The court found that “whether the Disputed Patents are valid or would not be infringed by a generic product is immaterial, because, as alleged it is not their validity or non-infringement that prevent the entry of the generic products, but their inclusion in the Orange Book.” In addition, the allegations that Anobri had filed the relevant ANDAs are sufficient to permit the conclusion that the company had the “intent and preparedness” to enter the generic market. Thus, the court denied the motion regarding failure to plead causation.

Next, Boehringer argued that Massachusetts Laborers failed to plausibly allege that Boehringer engaged in sham litigation with its lawsuit against Anobri. It contended that any “reasonable drug company in Boehringer’s position would have known they did not have standing to sue Anobri for infringing Boehringer’s device patents.” However, the court found that Boehringer could believe that it had standing to challenge Anobri and succeed on the merits of its infringement claims. Thus, the court granted the motion to dismiss as to Massachusetts Laborers’ sham litigation claims.

Finally, Boehringer argues that Massachusetts Laborers has failed to plead many of its state law claims. These included state antitrust claims, consumer protection claims, and unjust enrichment claims, all under the law of several different states. The motion to dismiss was granted with respect to the antitrust claims raised under Illinois, Massachusetts, Mississippi, and Utah laws due to these laws barring indirect purchasers such as Massachusetts Laborers. It was also granted regarding consumer protection claims raised under Arkansas, Illinois, Maryland, Utah, Oklahoma, Massachusetts, and Wyoming laws. Next, the court granted the motion regarding unjust enrichment claims raised under the laws of Alabama, Florida, Michigan, North Dakota, and Ohio. The court also denied the motion to dismiss injunctive relief under Section 16 of the Clayton Act.

The Case is No. 1:24-cv-10565-DJC.

Judge: Casper, D.

Attorneys: Carl Nils Hammarskjold (Berman Tabacco) for Massachusetts Laborers' Health & Welfare Fund. Christopher N. Sipes (Covington & Burling LLP) for Boehringer Ingelheim Pharmaceuticals, Inc.

Companies: Massachusetts Laborers' Health & Welfare Fund; Boehringer Ingelheim Pharmaceuticals, Inc.

Cases: Antitrust ConsumerProtection MassachusettsNews GCNNews