Five of Teva’s inhaler patents are “improperly listed” in the FDA’s Orange Book, a federal judge ruled Monday, in a win for Amneal Pharmaceuticals’ efforts to market a generic version of one of Teva’s drugs.
Amneal has applied to market a generic version of Teva’s inhaler ProAir HFA, an albuterol-based product that can be used to treat breathing difficulty. The New Jersey judge’s ruling is also a win for the FTC, which has been cracking down on what it calls “junk listings” in the FDA’s database of approved products and patent information, also called the Orange Book.
“The FTC applauds the district court’s decision which further puts all companies on notice that they need to remove their unlawful Orange Book listings,” an FTC spokesperson told Endpoints News on Tuesday.
Teva filed suit against Amneal in October, alleging that its generic ProAir HFA candidate would infringe six patents. Teva dropped one of those patents from the lawsuit later that month. On Monday, Judge Stanley Chesler ruled that the remaining five are “not properly listed in the Orange Book” because they don’t meet a key requirement that involves claiming the relevant drug.
The five patents, dubbed ‘712, ‘289, ‘587, ‘808 and ‘889, relate to aspects of the ProAir HFA’s metered dose counting mechanism. Teva stopped manufacturing its brand-name ProAir HFA in 2022, but distributes an authorized generic in the US.
“It is undisputed that no claim in any of the inhaler patents discloses albuterol sulfate,” Chesler wrote in his opinion. As a result, Teva has been ordered to “correct or delete the relevant Orange Book patent information listings.”
Teva told Endpoints that it stands behind its intellectual property and will appeal the ruling. Amneal did not respond to a request for comment.
The FTC challenged the same Teva patents late last year as part of its campaign to remove improper Orange Book listings. The agency has targeted more than 300 patents covering treatments for asthma, diabetes, weight loss and more. All five of Teva’s patents remained in the Orange Book as of Tuesday afternoon.