艾尔建（Allergan）的部族豁免策略与专利诉讼

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Time of issue:2018-08-31 14:46
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(Summary description)近日，美国专利审判和上诉委员会否决了圣雷吉斯莫霍克部落（美国印第安部落）动议，驳回了艾尔建（Allergan）旗下药物Restasis六项专利相关的诉讼请求。

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艾尔建（Allergan）的部族豁免策略与专利诉讼

Categories:最新消息
Author:
Origin:
Time of issue:2018-08-31 14:46
Views:

Information

近日，美国专利审判和上诉委员会否决了圣雷吉斯莫霍克部落（美国印第安部落）动议，驳回了艾尔建（Allergan）旗下药物Restasis六项专利相关的诉讼请求。

Restasis是一种含有0.02%浓度环孢素的滴眼液，环孢素是一种免疫调节剂，用于治疗青光眼以及慢性干眼症(一种由于炎症引起的眼泪分泌减少的疾病)，此药2003年上市，在美国专利2014年到期，但2013年FDA就向仿制药敞开了大门，艾尔建为此上诉到美国专利局，获得了将专利延长10年的批复，不过美国Actavis/Watson公司在专利诉讼结束前已经有仿制药生产出来，因此专利纠纷持续不断。2016年Restasis为艾尔建带来总计超越15亿美元的收入，占Allergan盈利的15％左右，销售额仅次于最畅销的保妥适。

美国专利审判及上诉委员会内部有一个内部审查流程，通常会挑战专利有效性。根据美国现行法律，拥有主权的部落被视为一个免受民事诉讼的主权国家，在专利审判及上诉委员会上拥有豁免权；利用这一“漏洞”，一些持有具有潜在问题专利的公司会支付一些费用，把这些专利先转让给部落，如果专利成功得到保护，那么他们只需缴纳特许权使用费，就可以直接使用专利了。艾尔建公司此前已经与圣雷吉斯莫霍克部落之间签订了一项专利协议，将Restasis专利转让给了莫霍克部落，并希望借此举动获得专利保护的豁免特权，法律专家称这笔交易可以在行政诉讼中屏蔽公司的专利，也可以用来保护他们免受联邦法院的挑战，而这最终可能会对竞争者造成打击，进而对对仿制药市场产生重大影响。

一旦该专利案件获批，那么市场上就不能销售、使用与Restasis具有相同活性成分的仿制药，艾尔建就能获得在这一领域里的垄断地位，但这一举动引发了业内对于撤销部落在专利保护中主权豁免特权的呼声。2017年德克萨斯州地方法院一名法官判定，艾尔建没有权利续展Restasis专利保护权，这也为Restasis仿制药尽早上市提供了条件。

2018年2月23日，美国专利审判和上诉委员会以多项理由驳回了圣雷吉斯莫霍克部落的动议。该委员会认为，无法确立部族主权豁免原则适用于双方审查（IPR）程序，此外，即使部落主权豁免适用此案，知识产权诉讼也可继续进行，因为艾尔建保留了该药物的专利所有权。

参考资料：https://mp.weixin.qq.com/s/DrgDS6PySMHh1cNCjzdU4w

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Electronic Arts pledges free use for five accessibility patents

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