Boehringer Ingelheim sued for allegedly using expired patents to control inhaler market

Boehringer Ingelheim, the world’s largest private pharmaceutical company, was hit with an antitrust class action lawsuit alleging that the company is using expired patents to delay competition between brand name and generic inhalers.

The lawsuit, filed last month in Connecticut federal court, was followed by the Federal Trade Commission’s announcement that it sent warning letters to 10 companies, including Boehringer Ingelheim, disputing the “accuracy or relevance” of patent listings in the Food and Drug Administration’s Orange Book.

“By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” FTC Chair Lina M. Khan said in a news release. “By challenging junk patent filings, the FTC is fighting these illegal tactics and making sure that Americans can get timely access to innovative and affordable versions of the medicines they need.”

Related: Boehringer Ingelheim joins pharma battle over drug price negotiation

This is not the first letter the FTC has sent to Boehringer Ingelheim. On Nov. 7, 2023, the FTC issued a warning to the pharmaceutical company disputing its patent listings.

The named plaintiffs in the Connecticut lawsuit—National Benefit Fund, Greater New York Benefit Fund, National Benefit Fund for Home Care Workers and Licensed Practical Nurses Welfare Fund—are jointly administered health and welfare funds.

Their lawsuit targets Boehringer Ingelheim Pharmaceuticals, based in Connecticut, and Boehringer Ingelheim International.

The complaint alleges Boehringer Ingelheim developed two inhalers, Combivent Respimat and Spiriva Respimat, and received patents in exchange.

In 2020, the patents for the active ingredients expired, which allegedly should have led to a lower-cost generic version of the drug joining the market, according to the complaint.

“Instead, to this day only Boehringer produces and sells Combivent Respimat and Spiriva Respimat, continuing to earn billions in profits after the expiration of the patents referencing the drugs’ active ingredients,” the complaint alleges.

Boehringer Ingelheim allegedly “knowingly and willfully” listed the expired patents, and the plaintiffs are seeking “injunctive relief to open the markets and damages for purchases and reimbursements” of the inhalers that continued to be sold at “monopoly prices,” the complaint claims.

Counsel for the defendants has yet to appear.

But Jason Ginenthal, a spokesperson for Boehringer Ingelheim, said the company “has never wrongfully submitted patents for listing in the Orange Book.”

“We are confident that our patents, including the ones challenged in the meritless antitrust lawsuit filed against Boehringer, are valid, enforceable, and properly listed in the Orange Book under FDA regulations and applicable law,” Ginenthal said. “Should FDA regulations governing the Orange Book requirements change in the future, Boehringer remains fully committed to complying with regulations related to patent listings.”

“Moreover,” Ginenthal continued, “we are deeply committed to the patients we serve and recently capped out-of-pocket costs at $35 per month for eligible patients for all our inhaler products, dramatically decreasing costs at the pharmacy counter for the most vulnerable patients. More reform is needed because while we provide discounts and rebates of 70% off the list price of our inhaler products to insurers, pharmacy benefits managers and other parties, unfortunately, these discounts rarely get passed along to the patient.”