应对公共健康危机的药品专利强制许可实施困境与对策

药品专利强制许可作为一项应对公共健康危机的制度在国内外均得到了立法与政策体认.鉴于其所关涉利益关系的复杂性,这项制度从产生至今仍然争议不断.具体到这项制度的实施,其程序和效果存在更多不确定性.尽管当前一些国家已经通过实施强制许可以应对新冠肺炎疫情,但是围绕发展中国家能力不足、除了专利之外药品所涉其他知识产权许可的不确定性以及《与贸易有关的知识产权协定》第31条修正案的低援引率等方面仍然存在诸多争议.中国虽然建立了从立法到政策的专利强制许可规则体系,但是对于在公共健康危机背景下由政府部门决定实施的药品专利强制许可仍然缺乏更为明确细化的程序规定.我国需要在谦抑性、审慎性、灵活性的理念指引下,在切实保障专利权人权益的基础上完善药品专利强制许可的实施机制.

Dilemmas and Countermeasures on Implementing Compulsory Licensing of Pharmaceutical Patents to Cope with Public Health Crisis

Compulsory licensing of pharmaceutical patent as a system coping with the public health emergency has been acknowl-edged by legislations and policies both at national and international level.Controversies have surrounded it due to the complexity of diverse interests involved since it came into being.When it comes to implementation,there are even more uncertainties concerning both process and effect.Although some countries have enforced compulsory licensing to address COVID-19 pandemic,controversies still exist regarding the poor capability of developing countries,uncertainties in addressing intellectual property rights within the pharmaceuticals other than patents and low invocation of TRIPS 3 1bis.China has established a systematic set of rules including legis-lations and policies on compulsory licensing.However,it still lacks clear procedural provisions in terms of compulsory licensing of pharmaceutical patents decided by government in the context of the public health crisis.Guided by the approaches of modesty,pru-dence and flexibility,China needs to perfect the implementing mechanism of compulsory licensing of pharmaceutical patents on the basis of effective protection of the patentee's rights.