For more than two years, the U.S. Federal Trade Commission (FTC) has been taking certain drugmakers to task over their alleged listing of "improper" patents in an FDA registry, a practice the agency says thwarts generic competition.
Now, after several prior wins with the effort, the agency is celebrating once again as Teva has agreed to remove more than 200 patents from FDA records, according to a Dec. 10 announcement.
Following pressure from the FTC, Teva has asked the FDA to delist patents on certain products for asthma, diabetes and chronic obstructive pulmonary disease as well as for epinephrine autoinjectors, the FTC said. The removals from the FDA's Orange Book registry will "pave the way for greater competition for generic alternatives" to more than 30 products, the agency explained.
The development marks the latest turn in the FTC's yearslong campaign to confront industry members for alleged patent abuses. Back in September 2023, the agency issued a policy statement warning the industry that the enforcement initiative was about to kick off.
Then, in November 2023 and April 2024, the agency challenged hundreds of patent listings from the likes of AbbVie, AstraZeneca, Boehringer Ingelheim, GSK, Teva, Novo Nordisk and other companies. While several drugmakers quickly acquiesced and sought removal of their patent listings, Teva has shown a desire to defend its listings.
After the company's initial refusal to comply with certain FTC requests, the agency sent a civil investigative demand to Teva requesting internal communications and other documents pertaining to the patents at issue, The Washington Post reported last year.
At the time, a Teva spokesperson told Fierce Pharma the company believed its patents were properly listed and that it would continue to ”stand behind" its intellectual property.
In an annual report (PDF) earlier this year, Teva acknowledged receiving the information request from the FTC. At the time, the company said the investigation could have a "material adverse effect" on Teva's "reputation, business, financial condition and results of operations," adding that it was cooperating with the FTC request.
Another turn in the case came last June, when a federal judge ruled that certain Teva inhaler patents were "improperly listed." An appeals court upheld that decision with its own opinion (PDF) late last year.
More recently, in May of this year, the FTC revived its enforcement push.
“When improper patent listings limit competition from generic alternatives, it hurts Americans’ bank accounts and more importantly, it can endanger their health," FTC Chairman Andrew Ferguson said in a statement Wednesday. "The Trump-Vance FTC is working hard to ensure that Americans have access to the affordable prescription drugs they need.”
A spokesperson for Teva didn't immediately respond to a request for comment.
In its 2023 policy statement (PDF), the FTC explained that branded drug makers can benefit from a 30-month stay of generic approvals when they list new patents and file litigation against generic rivals, regardless of whether the patents are ultimately found to be valid. The FDA, for its part, explains that this stay gives branded drug makers "a prescribed amount of time to assert patent rights in court before a generic competitor is approved and can market the drug."