Teva Loses Inhaler Patent Case Against Amneal, Must Update Orange Book

A New Jersey federal court ruled against Teva Pharmaceuticals on Monday, determining that five of its key patents for the inhaler product ProAir HFA (albuterol sulfate) are wrongly listed in the FDA’s Orange Book. District Judge Stanley Chesler sided with the plaintiffs—Amneal Pharmaceuticals, supported by the Federal Trade Commission (FTC)—finding that Teva's patents pertain only to the inhaler device, not the albuterol sulfate drug formulation itself.

Judge Chesler's decision stated that the patents in question do not cover a “finished dosage form” of the drug, thereby granting Amneal the opportunity to develop a generic version of albuterol sulfate. Chesler noted, “It is undisputed that no claim in any of the Inhaler Patents discloses albuterol sulfate,” and mandated Teva to either modify or remove its patent listings in the FDA’s Orange Book to align with the court's ruling.

Amneal had filed an Abbreviated New Drug Application (ANDA) back in July 2023 for a generic version of ProAir HFA, focusing specifically on inhalable albuterol sulfate. Following Amneal’s ANDA submission, Teva launched a lawsuit in 2023, alleging that the ANDA infringed on its patents related to the drug-device combination. Amneal promptly countersued, asserting that Teva’s patents should never have been listed in the Orange Book.

The patents at the center of Teva’s lawsuit are identified as the ‘712, ‘289, ‘587, ‘808, and ‘889 patents, which collectively protect aspects of Teva’s inhaler device and its metered dose system. Teva aimed to extend this coverage to include the albuterol sulfate formulation used by the inhaler. Chesler, however, rejected this expansion, stating that while the term “drug” has a broad definition that could encompass devices or components for disease treatment, the Orange Book’s listing statute limits this definition with the phrase “for which the applicant submitted the application.” Thus, Teva's interpretation was invalidated by this statutory limitation.

Judge Chesler elaborated, “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.’”

This ruling coincides with the FTC intensifying its examination of what it deems “junk” patents listed in the FDA’s Orange Book. The antitrust regulator initiated its scrutiny in November 2023, challenging over 100 patents from companies including AbbVie, GSK, and Teva. The initial review encompassed a variety of pharmaceutical products, ranging from autoinjectors to inhalers.

In April 2024, the FTC furthered its efforts by sending a warning letter to Novo Nordisk, questioning the patent of its diabetes drug Ozempic (semaglutide). Additionally, the agency reached out to GSK to express concerns regarding the patent of its asthma inhaler Trelegy Ellipta (fluticasone, umeclidinium, vilanterol).

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!