New Class Action Lawsuit Accuses Boehringer Ingelheim of Holding Monopoly on Asthma, COPD Inhaler Drugs

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A proposed class action lawsuit alleges Boehringer Ingelheim Pharmaceuticals holds an illegal monopoly on two drugs used in inhalation sprays to treat chronic obstructive pulmonary disease (COPD) and asthma, even though its patents on the underlying active ingredients expired roughly four years ago.

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The 191-page case shares that the brand-name drugs Combivent Respimat, for COPD, and Spiriva Respimat, for COPD and asthma, are the only inhaler sprays for their active ingredients available in the United States. The drugs were approved by the U.S. Food and Drug Administration (FDA) in 2011 and 2014, respectively, and today both sprays are widely used to help asthma and COPD patients manage their diseases, the filing relays.

In exchange for developing the drugs, Boehringer received patents that the case says allowed the pharma giant to earn more than $45 billion in profits. However, Boehringer’s patents on the inhaler ingredients at issue, which gave the company a monopoly on the drugs, expired in 2020, the lawsuit claims.

According to the suit, both drugs should now be available to millions of COPD and asthma patients nationwide in a lower-cost, generic variety, yet Boehringer, to this day, is the only company that produces and sells Combivent Respimat and Spiriva Respimat.

“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,” the lawsuit argues, 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 new class action lawsuit claims that, “[t]o 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.

According to the suit, Boehringer first attempted to extend its monopoly on the active ingredients in its Combivent and Spiriva products by what’s known as “product hopping”—i.e., developing a purportedly new product that uses the same drugs but a different form of delivery.

“Boehringer repackaged its old drug (Combivent) in a new inhaler device (Respimat), and then used patents on the device to block generic competition,” the complaint alleges.

Per the case, Boehringer then improperly listed non-drug patents—i.e., device-only patents—for its inhalers in the FDA’s register of “Approved Drug Products with Therapeutic Equivalence Evaluations” (known as the Orange Book) to secure its monopoly through 2030. The suit points out that listing a patent in the FDA’s so-called Orange Book gives drug makers like Boehringer the ability to trigger an automatic 30-month pause of approval of a generic competitor drug. Despite the clear language of the FDA statute, Boehringer intentionally listed 25 device-only patents in the Orange Book as covering Combivent Respimat, then listed 19 of these patents again as covering Spiriva Respimat, the case claims. 

“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.”

Finally, the case claims that when a drug maker attempted to manufacture and approve generic versions of Combivent Respimat and Spiriva Respimat, Boehringer “engaged in sham litigation” against the company based on its improper Orange book listings and thereby triggered an automatic 30-month delay of FDA approval for the generic drugs.

The filing emphasizes that the availability of generic drugs has “tangible, cost and life-saving effects” on patients and insurers. The suit adds that those most likely to suffer from asthma and COPD are “those least likely to be able to afford inhalers,” as consumers in poor and underserved communities are historically exposed to allergens and pollutants at higher rates.

“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.”

In the U.S., Boehringer charges as much as $500, and more than $600 after retail markups, per month for inhalers that sometimes cost substantially less abroad, the case shares.

The lawsuit looks to cover all persons and entities in certain jurisdictions who indirectly bought, paid and/or provided reimbursement for some or all of the purchase price for Combivent Respimat and/or generic versions of the drug, other than for resale, from February 23, 2020 through the present.

The case also looks to cover all persons and entities in certain jurisdictions who indirectly bought, paid and/or provided reimbursement for some or all of the purchase price for Spiriva Respimat and/or generic versions of the drug, other than for resale, from August 23, 2020 through the present.

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