With 10 days to go, only one company has responded to a demand by the U.S. Federal Trade Commission for several brand-name drugmakers to delist dozens of patents that were improperly or inaccurately listed in a government registry, according to a source familiar with the matter.
As a result, the agency is readying plans to file lawsuits against the other companies, some of which are among the biggest drugmakers in the world, such as AbbVie, AstraZeneca, and GSK. The FTC notified the companies on Nov. 7 that they must withdraw or amend the patent listings, or an individual must certify under penalty of perjury that the listings comply with federal law and regulations.
The FTC gave the companies until Dec. 16 to withdraw or amend the wayward patent listings, but except for one of the 10 companies to receive the warning, the agency has “heard nothing,” according to the source, who spoke on condition of anonymity. “The letters were not empty threats. If the companies don’t take action, there will definitely be consequences.”
The registry where patents are listed is maintained by the U.S. Food and Drug Administration and is known in the pharmaceutical industry as the Orange Book, because of the color of the original printed book. The listings are used to put generic companies on notice about certain types of patents that are claimed by a brand-name company for a medicine.
The FTC issued its letters amid a campaign by the Biden administration to crack down on patent abuse by the pharmaceutical industry. Two years ago, for instance, the White House issued an executive order directing the FDA and the U.S. Patent and Trademark Office to work together to promote more competition and lower drug prices.
These various moves came in response to increasing complaints that pharmaceutical companies too often pursue inconsequential patents that did 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 contending such moves 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, the source explained. In 2021, Medicare spent roughly $15 billion on such products although generics accounted for 53% of usage and the average price was about $200, the source noted. 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, Impax Laboratories, which is owned by Amneal Pharmaceuticals, has agreed to withdraw two patents for Adrenaclick. This is an auto-injector pen that contains epinephrine and is used to treat severe allergic reactions and competes with the better-known EpiPen. We asked Amneal for comment and will pass along any reply.
A GSK spokeswoman wrote to say the company takes its “regulatory obligations seriously and follow[s] a careful and deliberate process before listing patents in the FDA’s Orange Book. In following the FDA’s regulations and guidance, and as required by law, we list patents in the FDA’s Orange Book that legitimately cover the drug product. We do not list patents to prevent legitimate and lawful competition of any kind.” She added that GSK is awaiting communication from the FDA and will review issues raised.
An AstraZeneca spokesman sent a message 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 certified or asserted in any patent litigation related to Symbicort and there is a generic version of Symbicort currently available in the U.S. market.”
We also asked the other companies that were warned by the FTC — AbbVie, AstraZeneca, Teva, Boehringer Ingelheim, Mylan and Kaleo — and will update you accordingly.
Industry critics acknowledge that inventors should be rewarded for innovation that helps drive the economy, but they also argue that issuing patents for small changes to medicines may hurt the economy if enough people are delayed access to lower-cost drugs and must pay more for their prescriptions for a few more years.
STAT’s coverage of patent issues is supported by a grant from the Commonwealth Fund. Our financial supporters are not involved in any decisions about our journalism.