Teva Pharmaceuticals lost its patent row with Amneal Pharmaceuticals on Monday as a New Jersey court ruled that some of Teva’s claims over its inhaler product ProAir HFA were improperly listed on the FDA’s Orange Book.
A New Jersey federal court on Monday ruled against Teva Pharmaceuticals, finding that five key patents for its inhaler product ProAir HFA (albuterol sulfate) are “improperly listed” on the FDA’s Orange Book.
District Judge Stanley Chesler agreed with the plaintiffs—Amneal Pharmaceuticals, with the backing of the FTC—that Teva’s patents only apply to the inhaler device of ProAir HFA and not to its albuterol sulfate drug formulation. The judge ruled that Teva’s inhaler patents do not claim a “finished dosage form” of albuterol, allowing Amneal to develop a generic version of the drug.
“It is undisputed that no claim in any of the Inhaler Patents discloses albuterol sulfate,” Chesler wrote in his decision, adding that Teva must either “correct or delete” its patent listings in the FDA’s Orange Book to reflect the court’s judgement.
Amneal in July 2023 submitted an Abbreviated New Drug Application (ANDA) for a generic version of ProAir HFA, though its filing specifically focused on inhalable albuterol sulfate. Teva in 2023 sued Amneal, claiming that the ANDA infringed on its patent protection for its drug-device combination product. Amneal filed a countersuit soon after claiming that Teva’s patents should not have been listed on the Orange Book in the first place.
Teva’s lawsuit focuses on five key patents, dubbed the ‘712, ‘289, ‘587, ‘808 and ‘889 patents. Together, these patents protect aspects of Teva’s inhaler device and its metered dose system. However, in its suit, the pharma sought to expand this coverage to also include the albuterol formulation that the inhaler delivers.
In his opinion, Chesler agreed with Teva that the term “drug” has a “broad scope” and could include devices or other components “intended for use for the treatment of disease.” However, the Orange Book’s listing statute modifies this definition with the restrictive phrase “for which the applicant submitted the application,” which Chesler argues nullifies Teva’s argument.
“The fact that the statutory definition of ‘drug’ expressly includes devices for treating disease, and their components, does not nullify the restrictive action of the modifying phrase, ‘for which the applicant submitted the application,’” Chesler wrote.
Monday’s ruling comes as the FTC is ramping up its scrutiny of “junk” patents listed on the FDA’s Orange Book. The antitrust watchdog launched its initial salvo in November 2023, challenging more than 100 patents by companies including AbbVie, GSK and Teva. The FTC’s opening campaign included a wide range of pharmaceutical products, including autoinjectors and inhalers.
In April 2024, the FTC sent a warning letter to Novo Nordisk calling into question the patent of its blockbuster diabetes drug Ozempic (semaglutide). The federal agency also wrote to GSK to raise concerns about its asthma inhaler Trelegy Ellipta (fluticasone, umeclidinium, vilanterol).
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
