Commentaries

兑现中国知识产权改进承诺的时机已至

Publisher's note: the English language version of this article may be found here . 两年前的今天,2017年10月8日,中共中央和国务院的最高机构制定了知识产权改革的路线,下决心推动中国进入全球医药创新的生态系统。可惜这一宏伟规划尚未付诸实施。 当中美谈判代表本周在华盛顿举行新一轮贸易谈判之时,中国有机会将这一承诺变为现实。 中国实施其在2017年作出的改进知识产权保护的规划将为提升中美互信取得突破,同时激励中国的新药研发企业为中国乃至全球的患者创造新药。 美好愿景  2017年的两办意见宣布改进中国药品审查和注册制度、鼓励创新、应对公共卫生挑战,为行业带来了希望的春风。 中共中央办公厅、国务院办公厅印发的《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》(两办意见)包含36项改革措施,并要求政府有关部门认真贯彻落实。 两办意见特别列出了药品知识产权保护的四项改进措施: 措施15:建立上市药品目录集(在制药行业称为“橙皮书”),载入新药专利保护和试验数据保护等信息。 措施16:探索建立专利链接制度,并要求药品监管机构在批准仿制药之前等待法院就专利纠纷作出裁决。 措施17:开展药品专利期限补偿制度试点,以补偿因冗长的临床试验和审评审批而丧失的专利期。 措施18:完善和落实药品试验数据保护制度,对创新药、罕见病治疗药、儿童专用药、创新生物制剂和挑战专利成功的仿制药申请人的试验数据提供保护。 维持现状的结果是中国自加入WTO以来对药品知识产权的低水准保护被固定下来。 来自各国的新药研发企业都对两办意见表示赞赏。为新药发明和投资提供世界领先的知识产权保护力度这一承诺尤其对新兴的一批立足中国的新药研发公司提供了巨大的推动。 自两办意见发布以来,风险投资对中国药物研发公司的投资激增。 资本市场应声而动,香港交易所于2018年更改了上市要求,允许还没有收入,但拥有后期临床候选药物和有力知识产权的制药公司上市。 国外制药公司也加快了速度向中国市场提供挽救生命的新药,或自行引入、或与国内药企通过知识产权许可开展合作。 在两办意见推出后,中国宣布将加快修订《药品管理法》和《专利法》。中外创新药企都希望2017年两办意见中的四项知识产权保护措施被纳入法律修订中。 严峻现实  业界的憧憬在2019年仍然渺茫。 全国人大在8月份通过了新修订的《药品管理法》,令人失望地忽略了试验数据保护和专利链接的内容。 9月30日,国家药品监督管理局公布了《药品注册管理办法(修订草案征求意见稿)》,以落实修订后的《药品管理法》,该征求意见稿的内容更加揪心。...

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