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May 2, 2024

Lawsuit accuses Boehringer Ingelheim of false patent listings

Contributed Boehringer Ingelheim's U.S. headquarters in Ridgefield.
By David Krechevsky

A lawsuit filed in federal court in Connecticut accuses Boehringer Ingelheim Pharmaceuticals Inc. of manipulating the U.S. patent and drug approval system to “exclude generic competitors” and monopolize the market.

The lawsuit, first reported by law.com, seeks class action status and was filed Monday in U.S. District Court for the District of Connecticut by 1199SEIU National Benefit Fund, 1199SEIU Greater New York Benefit Fund, 1199SEIU National Benefit Fund for Home Care Workers and 1199SEIU Licensed Practical Nurses Welfare Fund.

The named defendants in the lawsuit are Boehringer Ingelheim Pharmaceuticals Inc., based in Ridgefield, and its parent company, Boehringer Ingelheim International GMBH, based in Germany.

The 191-page lawsuit focuses on two drugs used in inhalers to treat asthma and COPD (chronic obstructive pulmonary disease). The drugs — Combivent Respimat for COPD and Spiriva Respimat for both COPD and asthma — “are the only inhalation sprays for their active ingredients available in the United States,” the suit states.

It adds that the Food and Drug Administration (FDA) approved Combivent Respimat in 2011 and Spiriva Respimat in 2014, and that both sprays remain in wide use.

According to the lawsuit, for developing the drugs Boehringer received patents, which were then assigned to its parent company, and has earned more than $45 billion in profits since.

“But the patents on the underlying active ingredients expired in 2020,” the lawsuit states. “Both drugs should therefore now be available to the millions of Americans who suffer from asthma and COPD in a lower-cost generic format.”

The lawsuit claims that Boehringer’s monopoly on the sprays is maintained by listing non-drug patents in the FDA’s register of Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the “Orange Book.” 

“Listing a patent in the Orange Book gives drug companies like Boehringer a powerful tool — the ability to trigger an automatic, 30-month stay of approval of a generic competitor drug,” the lawsuit states.

It notes that because improper Orange Book listings can “effectively block competition,” Congress and the FDA have set strict limits on the types of patents that can be listed  — only “drug substance,” “drug product” and “method of use” patents qualify.

Boehringer, however, “knowingly and willfully listed 25 device-only patents in the Orange Book as covering Combivent Respimat,” the suit states. “Boehringer then listed 19 of these patents again as covering Spiriva Respimat,” which the plaintiffs claim means it wrongly listed 19 device-only patents twice.

The suit adds that while most of those patents’ “exclusivities have finally expired,” Boehringer still lists six unexpired device-only patents for each spray, wrongly listing “these six patents twice.”

The lawsuit claims Boehringer knew the device-only patent listings would break the law, and that the company “continues to list the patents despite the fact that regulators have explicitly advised Boehringer that it has abused the regulatory process.” 

In September 2023, the suit states, the Federal Trade Commission (FTC) issued a “Statement Concerning Brand Drug Manufacturers’ Improper Listing of Patents in the Orange Book,” and said such improper listings “may harm competitive conditions in pharmaceutical markets” and “constitute illegal monopolization.” 

The FTC also urged drug manufacturers to immediately remove any patents that “fail to meet listing requirements.”
 
In November, the FTC also sent a letter directly to Boeringer questioning the six device-only patents, the suit states.

While other drug makers withdrew some challenged Orange Book listings, Boehringer did not, the suit notes.

The plaintiffs state they are seeking “justice on behalf of themselves and all others similarly situated who paid” for the two sprays “at monopoly prices long after Boehringer’s drug patents expired and generic drugs should have entered the markets.”

Boehringer Ingelheim provided a statement on the lawsuit by email that denies the claim it wrongfully submitted patents to be listed 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,” the email states. “Should FDA regulations governing the Orange Book requirements change in the future, Boehringer remains fully committed to complying with regulations related to patent listings.”

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