Amid FTC crackdown, judge says Teva inhaler patents are 'improperly listed' in FDA Orange Book

After being called out on some intellectual property claims late last year, Teva has fallen victim to the Federal Trade Commission’s (FTC’s) ongoing crusade against questionable drug patents.

This week, a federal judge in New Jersey ruled that five of Teva’s patents on the metered dose inhaler for its asthma med ProAir HFA are “improperly listed” in the FDA’s Orange Book. In turn, Teva has been ordered to "correct or delete" the relevant patents, court documents show. 

The Orange Book is a catalog of brand-name drug patents and serves as a key resource for generic drug developers. Since November, the FTC has been campaigning to purge bunk patent listings, which the antitrust agency claims can harm competition by delaying the entry of more affordable generic drugs.

The ruling potentially lifts a barrier to the market for Amneal Pharmaceuticals as it works to launch its generic version of ProAir HFA.

Amneal lists its ProAir copycat as a key potential launch for the company. The drugmaker is hoping (PDF) to roll out the generic in 2024 or 2025, according to a recent investor presentation.

A Teva spokesperson told Fierce Pharma that the company stands behind its intellectual property and intends to appeal the latest ruling in New Jersey. Teva stopped making brand-name ProAir HFA in October 2022, though the company continues to offer an authorized generic.

Amneal did not immediately respond to Fierce Pharma’s request for comment.

The problem with Teva’s claims, to hear District Judge Stanley Chesler tell it, is that the protections in question list the company’s inhaler device patents as “drug product” patents, which traditionally refer to a finished dose form like a tablet, capsule or solution that contains a drug substance. Because the patents in question only concern Teva’s delivery device, they do not claim the “finished dosage form” that constitutes the basis of the legal dispute, the judge ruled.

After Amneal called out Teva on its “improper" Orange Book listings last year, the FTC in March weighed in on the case. The agency filed an amicus brief calling for the delisting of the five ProAir patents in question, arguing Teva used those patents to block Amneal’s approval bid for its generic inhaler.

Teva’s legal loss comes amid a much larger brouhaha around suspected sham patents in the FDA’s Orange Book.

Back in November, the FTC filed a challenge against more than 100 patent listings, targeting companies like AbbVie, AstraZeneca, Boehringer Ingelheim, GSK and Teva.

By December, GSK had removed four patents tied to its inhaler products Advair, Arnuity, Flovent and Ventolin. At the same time, Amneal’s Impax Laboratories and Kaleo also delisted certain Orange Book patents.

More recently, the FTC in early May set its sights on more than 300 additional patent listings by eight different pharma firms. In particular, the agency called out Novo Nordisk’s GLP-1 meds Ozempic, Saxenda and Victoza.