Teva Loses Inhaler Patent Case Against Amneal, Must Delete or Amend Orange Book Listing
2024-06-12
专利侵权
Pictured: Facade of a U.S. courthouse/iStock, PierreDesrosiers
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.
更多内容，请访问原始网站
文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。
靶点
-热门报告
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。