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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

據路透社資訊,2024年6月10日星期一報道:Amneal公司與美國聯邦貿易委員會贏得裁決,移除Teva inhaler專利從FDA清單中。
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.

藥品製造商amneal pharmaceuticals (AMRX.O) 在美國聯邦貿易委員會支持下,成功說服新澤西聯邦法院於週一移除五個 Teva Pharmaceutical (TEVA.TA) 的專利從美國食品藥品監督管理局管理的列明 Teva 呼吸藥品 ProAir HFA 的專利列表中。

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.

美國地區法官 Stanley Chesler 同意 Amneal 和 FTC,認爲 Teva 的專利僅覆蓋了吸入設備技術,命令其將這些列明 Teva 呼吸藥品 ProAir HFA 的專利移除 FDA 的 Orange Book,爲 Amneal 的所提的通用藥物清除了障礙。

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.

這個決定是在 FTC 警告藥品製造商包括 Teva 在內濫用 Orange Book 專利目錄錯誤地延長品牌藥物專利壟斷後做出的。週一,Chesler 還駁回了 Teva 的出價,以駁斥 Amneal 的指控,即 Teva 違反了州和聯邦反壟斷法。

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

Teva,Amneal 和 FTC 的發言人沒有立即回覆關於這個決定的評論請求。

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 根據其所提出的 ProAir HFA 仿製藥起訴 Amneal 侵犯其專利。ProAir HFA 用於治療哮喘等疾病引起的支氣管痙攣。Teva 在2022年停止生產 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 反訴道,Teva 不當地向 Orange Book 提交了這些專利,這些專利是 FDA 認爲安全有效的藥物的專利列表。

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 和其他藥品製造商發送通知,爭議他們的 110 項 Orange Book 專利,並稱這些公司可能已經不當地向 FDA 提交了專利以推遲通用藥物競爭。該委員會在新澤西州案件中支持 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,認爲 Teva 的專利僅覆蓋 "計量吸入設備" 的部分,"根本沒有做出或提到" 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.

本案件爲 Teva Branded Pharmaceutical Products R&D Inc 訴 Amneal Pharmaceuticals of New York LLC,美國新澤西地區法院,案號 2:23-cv-20964。

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