Stat News

By Ed Silverman

Amid a push to crack down on patent abuse by the pharmaceutical industry, a key U.S. lawmaker is urging six large drug companies to remove dozens of patents that were identified by regulators as improperly or inaccurately listed with a federal registry.

In a series of letters sent on Thursday, Sen. Amy Klobuchar (D-Minn.) demanded the companies explain why they have, so far, not responded to warnings issued two months ago by the Federal Trade Commission to remove more than 100 patents from the registry. The agency threatened the drug companies with litigation if they failed to comply.

The FTC had challenged a total of 10 companies over listings for patents on such medicines as asthma inhalers and epinephrine auto-injectors as part of an effort to mitigate actions that thwart competition. Among the companies to which the agency sent warnings are AbbVie, AstraZeneca, Mylan Specialty, Boehringer Ingelheim, and subsidiaries of GSK and Teva Pharmaceutical.

The FTC contended the brand-name companies had failed to follow requirements for listing patents in the registry known as the Orange Book, which is maintained by the Food and Drug Administration. These listings areused to put generic companies on notice about certain types of patents that are claimed by a brand-name company for a medicine.

The move came in response to increasing complaints that pharmaceutical companies too often pursue inconsequential patents that do not reflect true innovation. As a result, patents are granted that do not add sufficient value to a medicine, but the company, nonetheless, is awarded additional patent protection, which is a monopoly on competition.

This allows a pharmaceutical company to benefit from additional time in which to sell its medicine at a high price — and sometimes, continue to raise the price — since lower-cost generic alternatives are not yet available. In pursuing patents that were improperly or inaccurately listed, the FTC is arguing such steps reflect an attempt by the companies to forestall competition.

For this reason, the FTC targeted patents for asthma inhalers, which are sold by GSK and AstraZeneca. In 2021, Medicare spent roughly $15 billion on such products although generics accounted for 53% of usage and the average price was about $200. By comparison, generic versions of statins, which are used to lower cholesterol, accounted for 98% of usage and the average prescription cost $16.

So far, though, very few companies have responded to the FTC — Impax Labs, Kaléo, and two GSK subsidiaries. And a total of 18 patents have been removed from the Orange Book. As a result, Klobuchar sent letters to AbbVie, AstraZeneca, Boehringer Ingelheim, GSK, Mylan and Teva, urging the companies to remove all of the patents identified by the FTC by the end of January.

“As you know, improperly listing a patent in the Orange Book can harm consumers, raise prices, and stifle competition by preventing cheaper generic drugs from entering the market for up to 30 months, and drives up the cost of entry by generic drug manufacturers by pushing them into expensive litigation before entering themarket,” wrote Klobuchar, who chairs a Senate subcommittee on competition policy, antitrust, and consumer rights.

“Patients in the United States pay more for prescription drugs than those in any other developed nation. The reasons for this are many, but one reason is the continued abuse of patent rights to extend monopoly control over a drug. While your inventions that benefit consumers deserve strong patent protections, those patents should not be used to box out generic drug competition long after legitimate patent protections have expired.”

A Boehringer Ingelheim spokesman wrote to say the company “follows the statutory requirements and FDA regulations regarding the listing of patents in the Orange Book, and we believe transparency surrounding patents is paramount. We are confident that all Boehringer patents that are the subject of the FTC’s letter are properly listed under FDA regulations and applicable law.”

An AstraZeneca spokeswoman sent a note saying the company “has a rigorous process through which we evaluate whether a patent should be listed in the Orange Book and believe we have complied with the statutory requirements governing which patents are required to be listed. The patents listed in the FTC letter have not been asserted in any patent litigation related to Symbicort (an asthma inhaler) and there is a generic version of Symbicort currently available in the U.S. market.”

We asked the other companies for comment and will update you accordingly.