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Reported Monday June 10, 2024 "Amneal, U.S. FTC Win Order Removing Teva Inhaler Patents From FDA List" - Reuters News

Reported Monday June 10, 2024 "Amneal, U.S. FTC Win Order Removing Teva Inhaler Patents From FDA List" - Reuters News

据路透社资讯,2024年6月10日星期一报道:Amneal公司与美国联邦贸易委员会赢得裁决,移除Teva inhaler专利从FDA清单中。
Benzinga ·  06/11 10:40

Drugmaker Amneal Pharmaceuticals (AMRX.O), opens new tab with the backing of the U.S. Federal Trade Commission convinced a New Jersey federal court on Monday to remove five Teva Pharmaceutical (TEVA.TA), opens new tab patents from a U.S. Food and Drug Administration list of patents covering Teva's breathing drug ProAir HFA.

药品制造商amneal pharmaceuticals (AMRX.O) 在美国联邦贸易委员会支持下,成功说服新泽西联邦法院于周一移除五个 Teva Pharmaceutical (TEVA.TA) 的专利从美国食品药品监督管理局管理的列明 Teva 呼吸药品 ProAir HFA 的专利列表中。

U.S. District Judge Stanley Chesler agreed with Amneal and the FTC, opens new tab that Teva's patents only covered inhaler device technology, ordering it to remove the listings from the FDA's Orange Book and clearing an obstacle for Amneal's proposed generic.

美国地区法官 Stanley Chesler 同意 Amneal 和 FTC,认为 Teva 的专利仅覆盖了吸入设备技术,命令其将这些列明 Teva 呼吸药品 ProAir HFA 的专利移除 FDA 的 Orange Book,为 Amneal 的所提的通用药物清除了障碍。

The decision follows the FTC's warnings to drugmakers including Teva over the misuse of Orange Book patent listings to wrongly extend patent monopolies on brand-name drugs. Chesler on Monday also rejected Teva's bid to dismiss Amneal's allegations that Teva violated state and federal antitrust law.

这个决定是在 FTC 警告药品制造商包括 Teva 在内滥用 Orange Book 专利目录错误地延长品牌药物专利垄断后做出的。周一,Chesler 还驳回了 Teva 的出价,以驳斥 Amneal 的指控,即 Teva 违反了州和联邦反垄断法。

Spokespeople for Teva, Amneal and the FTC did not immediately respond to requests for comment on the decision.

Teva,Amneal 和 FTC 的发言人没有立即回复关于这个决定的评论请求。

Teva sued Amneal for patent infringement last year based on its proposed generic version of ProAir HFA, which treats bronchial spasms caused by diseases like asthma. Teva stopped making ProAir HFA in 2022.

去年,Teva 根据其所提出的 ProAir HFA 仿制药起诉 Amneal 侵犯其专利。ProAir HFA 用于治疗哮喘等疾病引起的支气管痉挛。Teva 在2022年停止生产 ProAir HFA。

Amneal counterclaimed that Teva had improperly submitted the patents to the Orange Book, which lists patents that cover drugs that the FDA has deemed safe and effective.

Amneal 反诉道,Teva 不当地向 Orange Book 提交了这些专利,这些专利是 FDA 认为安全有效的药物的专利列表。

The FTC last year sent notices to Teva and other drugmakers disputing 110 of their Orange Book patents, and said the companies may have improperly submitted them to the FDA to delay generic competition. The commission filed a brief supporting Amneal in the New Jersey case.

去年,FTC 向 Teva 和其他药品制造商发送通知,争议他们的 110 项 Orange Book 专利,并称这些公司可能已经不当地向 FDA 提交了专利以推迟通用药物竞争。该委员会在新泽西州案件中支持 Amneal。

Chesler agreed with Amneal and the FTC that Teva's patents only cover parts of a "metered inhaler device" and "do not claim or even mention" ProAir HFA.

Chesler 同意 Amneal 和 FTC,认为 Teva 的专利仅覆盖 "计量吸入设备" 的部分,"根本没有做出或提到" ProAir HFA。

The case is Teva Branded Pharmaceutical Products R&D Inc v. Amneal Pharmaceuticals of New York LLC, U.S. District Court for the District of New Jersey, No. 2:23-cv-20964.

本案件为 Teva Branded Pharmaceutical Products R&D Inc 诉 Amneal Pharmaceuticals of New York LLC,美国新泽西地区法院,案号 2:23-cv-20964。

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