Boehringer Ingelheim accused of misusing US patents to delay asthma-drug rivals
German drugmaker Boehringer Ingelheim was accused in a federal lawsuit in Boston on Wednesday of improperly submitting patents to the U.S. Food and Drug Administration to delay generic competition and inflate prices for its lung disease drugs Combivent Respimat and Spiriva Respimat.
The Massachusetts Laborers' Health and Welfare Fund said in the lawsuit that Boehringer misused several patents related to its Respimat inhaler to extend its monopoly on the drugs by up to 10 years, from 2020 to 2030.
The proposed class-action lawsuit accused Boehringer of costing the employee benefit fund and other drug purchasers "many millions, if not billions, of dollars in overcharges over the past three years."
"We stand by our patents and our adherence to FDA guidelines," Boehringer said in a statement.
An attorney for the laborers' fund declined to comment on the lawsuit.
The U.S. Federal Trade Commission last year sent notices to several drugmakers including Boehringer to dispute 110 patents submitted to the FDA's Orange Book, which features lists of patents covering drugs that the FDA has deemed safe and effective. The FTC claims the patent submissions may have been misused to delay generic competition.
A Boehringer spokesperson responded at the time that the company follows all FDA regulations for listing patents in the Orange Book.
A U.S. Senate committee also announced in January that it would investigate Boehringer and three other major drugmakers for allegedly manipulating the Orange Book to raise the prices of their asthma inhalers.
The laborers' fund said in Wednesday's lawsuit that pharmaceutical companies like Boehringer patent aspects of their inhaler devices and improperly list them in the Orange Book as covering the drugs they deliver.
The complaint said that such patents have given drugmakers "unconscionably long exclusivity periods, far in excess of what the FDA ever envisioned." It said that Boehringer changed its delivery system for Combivent and Spiriva from generic inhalers to Respimat so it could "improperly stuff the Orange Book" with device patents to maintain exclusivity over the drug and gouge patients.
The fund said that Spiriva Respimat costs nearly $600 in the U.S. but ranges from $21 to $54 in Germany, France, Japan, Canada and the UK.
The case is Massachusetts Laborers' Health & Welfare Fund v. Boehringer Ingelheim Pharmaceuticals Inc, U.S. District Court for the District of Massachusetts, No. 1:24-cv-10565.
For the laborers' fund: Kristie LaSalle, Leslie Stern, Steven Groopman, Todd Seaver and Matthew Pearson of Berman Tabacco; Gregory Asciolla and Matthew Perez of DiCello Levitt; Natasha Fernandez-Silber and Yaman Salahi of Edelson; Marvin Miller, Matthew Van Tine, Lori Fanning, Andy Szot and Kate Boychuck of Miller Law.
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