赛诺菲/再生元与安进的PCSK9抗体专利战落幕

Categories:最新消息
Author:华讯知识产权
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Time of issue:2019-03-15 21:52
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(Summary description)2月25日，安进公司宣布美国特拉华州地区陪审团作出判决，陪审团裁定安进专利中声称的权利要求有效，并拒绝赛诺菲/再生元的专利主张。同时，据赛诺菲/再生元在一份声明中表示，他们不同意这份裁决，或有继续上诉的可能。PCSK9抗体法国制药巨头赛诺菲(Sanofi)与合作伙伴再生元(Regeneron)联合开发的Praluent（Alirocumab）和安进公司的Repatha（Evolocumab）同为单

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赛诺菲/再生元与安进的PCSK9抗体专利战落幕

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2019-03-15 21:52
Views:

Information

2月25日，安进公司宣布美国特拉华州地区陪审团作出判决，陪审团裁定安进专利中声称的权利要求有效，并拒绝赛诺菲/再生元的专利主张。同时，据赛诺菲/再生元在一份声明中表示，他们不同意这份裁决，或有继续上诉的可能。

PCSK9抗体

法国制药巨头赛诺菲(Sanofi)与合作伙伴再生元(Regeneron)联合开发的Praluent（Alirocumab）和安进公司的Repatha（Evolocumab）同为单抗药物，靶向一种名为前蛋白转化酶枯草溶菌素9 (PCSK9)的蛋白，该蛋白可降低肝脏从血液中清除低密度脂蛋白胆固醇(LDL-C)的能力，而LDL-C被公认为心血管疾病(CVD)的主要风险因子。PCSK9抑制剂提供了一种全新的治疗模式来对抗LDL-C，被视为他汀类药物(如Lipitor和Zocor)之后降脂领域取得的最大进步。两者于2015年7月和8月先后被FDA批准用于高风险人群（如家族性高胆固醇血症、他汀不耐受等）控制LDL水平。

PCSK9被认为是极具潜力的降脂药物，尽管Repatha、Praluent上市以来销售放量缓慢，但不影响安进和赛诺菲为此展开激烈竞争。

专利战争始末

将时间追溯到2014年10月17日，安进控告赛诺菲/再生元的Praluent侵犯了其Repatha三项专利权（US8563698、US8829165和US8859741）。

2016年2月22日，赛诺菲/再生元承认侵犯了安进专利中声称的某些权利要求，并把矛头转向了专利本身该不该被认定：“该专利超出了安进的发现，使其不正当地覆盖了新一类的疗法”。

2016年3月8日，双方的焦点在于安进专利中声称的某些权利要求是否有效。

2016年3月16日，陪审团裁定安进专利中声称的权利要求有效。

2016年3月23-24日，法院听取了原告申请对Praluent实施永久禁制令所提供的证据。

2017年1月5日，法院宣布对Praluent实施永久禁制令，不能在美国市场生产及销售Praluent，并决定延迟30天执行；赛诺菲向当地法院提起紧急动议，要求延缓执行永久禁售的禁令至上诉结束。

2017年1月9日，当地法院驳回动议，但是同时将延缓的30天改为45天，判决书中写道，45天将给赛诺菲足够的时间上诉至联邦巡回法庭。

这场专利持久战惊动整个医药界，观望的吃瓜群众为双方的博弈捏了把汗，最终在1月6日，美国特拉华州地区法官Sue Robinson判决赛诺菲/再生元停售Praluent十二年，因该药侵犯了安进的同类药物Repatha的专利。

安进的专利布局

此次涉及争端的三项专利US8563698、US8829165和US8859741均来自于2009年2月26日安进以WO2009026558通过PCT途径全球申请，目前该母案专利在美国除此三项专利外还有九项授权专利，同时该母核专利目前在中国有三项专利正在申请中，有一项于2014年06月25日得到授权。这一系列专利分别对PCSK9抗体的序列、抗原表位和适应症等进行了保护。

案件启示

安进的专利拓展至表位的保护，大大延伸了专利保护范围，给后来者制造了专利障碍，如果表位的保护成为一种潮流，专利挑战的难度可想而知，可以预计以后市场上难以出现bio-too抗体，即使有也要借助结构生物学花费很多功夫来避开被保护的表位。

这一变化或将改变抗体药物甚至药物的研发格局，大大增加同靶点抗体药物的研发难度，但同时也会利好基于其他机理的药物研发格局，比如反义RNA及siRNA等避开表位这一层面而进行的药物研发。

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Electronic Arts pledges free use for five accessibility patents

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