Boehringer Ingelheim Faces Allegations of Market Monopoly in Inhaler Market

Millions of Americans with asthma and COPD rely on inhalers to manage their conditions. These medications can mean the difference between an active life and constant struggle. But a new class action lawsuit alleges a disturbing practice by Boehringer Ingelheim, a drug company, that keeps these medications unreasonably expensive.

Extended monopoly through strategic patenting

The lawsuit filed April 29th in Connecticut federal court details how Boehringer allegedly exploited the patent system to extend its monopoly illegally. After the original drug patents expired in 2020, Boehringer is said to have engaged in "product hopping" by repackaging Combivent into a new inhaler device called Respimat. By securing patents on this new delivery device rather than on the drug itself, and listing these device-only patents in the FDA’s Orange Book, Boehringer managed to block generic competition effectively.

According to the complaint, Boehringer's actions defy U.S. regulatory frameworks designed to foster competition post-patent expiration by allowing generic entries. The lawsuit argues that Boehringer manipulated the patent and drug approval system to maintain its monopoly over Combivent Respimat and Spiriva Respimat, thus continuing to reap significant profits from these products.

The lawsuit cites that “Boehringer’s monopoly on ipratropium-albuterol and tiotropium inhalation sprays defies a U.S. regulatory scheme designed to promote generic entry on the expiration or invalidation of patents,” expanding that the U.S. patent system allows drug makers to sell new medications on the market, and bars others from making generic versions, for a set period of time. 

The filing further alleges that “to protect this prize,” Boehringer manipulated the U.S. patent and drug approval system to illegally keep out generic drug competitors, monopolize the markets for Combivent Respimat and Spiriva Respimat, and reap “monopoly profits” from drugs that should have been available in generic forms years ago. 

Specifically, the lawsuit alleges Boehringer of manipulating the way patents are listed with the FDA. The complaint alleges that “Boehringer repackaged its old drug (Combivent) in a new inhaler device (Respimat), and then used patents on the device to block generic competition,”

“In other words, it listed nineteen device-only patents twice,” the lawsuit contests. “While most of those patents’ exclusivities have finally expired, Boehringer still lists six unexpired device-only patents in the Orange Book as covering both Combivent Respimat and Spiriva Respimat ‘drug products’ – in other words, it lists these six patents twice.” 

Impact on consumers and healthcare costs

The filing highlights the tangible impact of Boehringer's alleged monopoly on consumers, particularly those in poor and underserved communities who suffer disproportionately from asthma and COPD. It points out that these communities are historically exposed to higher rates of allergens and pollutants, making affordable access to treatment critical. Despite this need, Boehringer reportedly charges up to $600 per month for inhalers in the U.S., prices substantially higher than in countries like Germany, France, Japan, Canada, and the UK.

“In the United States, Native Americans (12%) and Black Americans (10.9%) have the highest rates of asthma. Black children are nearly eight times more likely to die from asthma. People living in rural areas—with higher smoking rates and half as many per capita health providers and specialists—are far more likely to develop COPD, suffer complications, and die from the disease. And yet, Americans everywhere pay exorbitant prices for medications needed to prevent these outcomes.” 

The company is also facing a separate class action lawsuit filed in March in Massachusetts federal court over the same allegations brought by the Massachusetts Laborers’ Health and Welfare Fund. 

The New York plaintiffs are represented by Gregg D. Adler and Dan Livingston of Livingston Adler Pulda Meiklejohn & Kelly PC.

The Boehringer inhaler monopoly class action lawsuit is 1199SEIU National Benefit Fund et al v. Boehringer Ingelheim Pharmaceuticals Inc, Case No. 3:24-cv-00783 in the U.S. District Court for the District of Connecticut.