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.
首席地区法官 Thomas Kleeh 驳回了再生元制药公司 (NASDAQ:REGN) 阻止安进公司 (NASDAQ:AMGN) 销售 Eylea 生物仿制药的企图。
Regeneron向美国联邦巡回上诉法院提交了上诉通知。
上诉来自于2024年9月23日发布的命令,该命令驳回了Regeneron的初步禁令请求以及与该命令相关的任何相关命令、决定、裁决、调查结果或结论。
路透社强调,安进发言人表示该公司对这一决定感到满意。安进将 “在适当时候” 公布其生物仿制药Pavblu的发布时间表。
Regeneron在一月份起诉了安进,指控安进正在开发一种违反Eylea关键专利保护的生物仿制药。该诉讼声称侵犯了30多项专利,该制药公司声称,如果没有 “禁止” 安进违反这些保护措施,这些专利将 “无法弥补地” 损害其业务。
诉讼还指出:“在'106年专利到期之前,安进在美国境内商业制造、使用、要约销售和/或销售,或向美国进口ABP 938将造成Regeneron损害,使Regeneron有权获得损害赔偿和/或其他金钱救济。”
2023年10月,安进表示,美国食品药品管理局接受了其缩写的ABP 938的生物制剂药物申请,这是Eylea的生物仿制药副本。
统计新闻指出,法官的裁决出人意料,因为同一位法官此前曾批准了Regeneron对其他试图发布Eylea生物仿制药的制药公司的禁令请求。
12月,一项法院裁决认定,维亚特里斯公司(纳斯达克股票代码:VTRS)的Regeneron's Eylea复制品侵犯了专利权。