Chief District Judge Thomas Kleeh denied Regeneron Pharmaceuticals, Inc.'s (NASDAQ:REGN) effort to prevent the sale of Amgen Inc's (NASDAQ:AMGN) Eylea biosimilar.
Regeneron filed a notice of its appeal to the U.S. Court of Appeals for the Federal Circuit.
The appeal is from the Order issued on September 23, 2024, which denied Regeneron's request for a preliminary injunction, along with any related orders, decisions, rulings, findings, or conclusions connected to that Order.
Reuters highlighted that an Amgen spokesperson expressed the company's satisfaction with the decision. Amgen will reveal the timeline for launching its biosimilar Pavblu "in due course."
Regeneron sued Amgen in January, alleging that it was developing a biosimilar that violated key patent protections for Eylea. The lawsuit claims the infringement of over 30 patents, which the pharma claims will "irreparably" harm its business if Amgen is not "enjoined" from violating these protections.
The lawsuit also notes, "Amgen's commercial manufacture, use, offer for sale, and/or sale within the United States, or importation into the United States, of ABP 938 before the expiration of the '106 patent will cause Regeneron injury, entitling Regeneron to damages and/or other monetary relief."
In October 2023, Amgen said the FDA accepted its abbreviated Biologics Drug Application for ABP 938, a biosimilar copy of Eylea.
Stat News noted that the judge's decision came as a surprise, given that this same judge had previously approved Regeneron's requests for injunctions against other pharmaceutical companies attempting to release Eylea biosimilars.
In December, a court ruling found that Viatris Inc's (NASDAQ:VTRS) replica of Regeneron's Eylea violated patent rights.
首席地區法官 Thomas Kleeh 駁回了再生元製藥公司 (NASDAQ:REGN) 阻止安進公司 (NASDAQ:AMGN) 銷售 Eylea 生物仿製藥的企圖。
Regeneron向美國聯邦巡迴上訴法院提交了上訴通知。
上訴來自於2024年9月23日發佈的命令,該命令駁回了Regeneron的初步禁令請求以及與該命令相關的任何相關命令、決定、裁決、調查結果或結論。
路透社強調,安進發言人表示該公司對這一決定感到滿意。安進將 「在適當時候」 公佈其生物仿製藥Pavblu的發佈時間表。
Regeneron在一月份起訴了安進,指控安進正在開發一種違反Eylea關鍵專利保護的生物仿製藥。該訴訟聲稱侵犯了30多項專利,該製藥公司聲稱,如果沒有 「禁止」 安進違反這些保護措施,這些專利將 「無法彌補地」 損害其業務。
訴訟還指出:「在'106年專利到期之前,安進在美國境內商業製造、使用、要約銷售和/或銷售,或向美國進口ABP 938將造成Regeneron損害,使Regeneron有權獲得損害賠償和/或其他金錢救濟。」
2023年10月,安進表示,美國食品藥品管理局接受了其縮寫的ABP 938的生物製劑藥物申請,這是Eylea的生物仿製藥副本。
統計新聞指出,法官的裁決出人意料,因爲同一位法官此前曾批准了Regeneron對其他試圖發佈Eylea生物仿製藥的製藥公司的禁令請求。
12月,一項法院裁決認定,維亞特里斯公司(納斯達克股票代碼:VTRS)的Regeneron's Eylea複製品侵犯了專利權。