联邦上诉法院重启礼来(LLY)专利诉讼 仿制药上市争议再度发酵

金吾财讯
Jul 14

金吾财讯 | 美国联邦上诉法院正式恢复梯瓦制药工业公司(TEVA)针对礼来公司(LLY)的专利相关诉讼,案件核心围绕双方此前达成的骨质疏松药物Forteo(特立帕肽)仿制药上市协议展开,本次诉讼重启将重新审理仿制药上市延迟引发的权责纠纷,为医药行业专利和解协议的边界判定提供司法参考。

涉案纠纷缘起双方2018年达成的和解约定,协议明确梯瓦制药可最早于2019年推出特立帕肽仿制药。2020年,美国FDA为原研药Forteo追加三年独家销售权限,直接延后仿制药合规上市窗口期。梯瓦制药直至2023年12月才正式推出对应仿制药产品,随后在2024年发起诉讼,主张礼来公司依托新增独家销售权,人为阻碍仿制药如期上市,损害自身合法经营权益。

联邦上诉法院给出明确审理判定依据,认为2018年双方签署的和解协议条款模糊,未明确协议存续周期、契约到期时间等关键内容,仅凭协议文本与起诉状内容,无法得出有利于礼来公司的判决结论,因此重启案件完整审理流程。本次诉讼重启再度揭开原研药独家销售权限与仿制药上市权益的行业矛盾,后续法院判决结果将直接影响两家药企的产品商业化节奏,同时重塑同类医药专利和解案件的裁判逻辑。

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