对药品专利及其强制许可的研究——以“达拉斯买家俱乐部”的困境为视角  

Study on Pharmaceutical Patent and Its Compulsory License: From the Perspective of the Dilemma of Dallas Buyers Club

作　　者：李阁霞[1] 

机构地区：[1]烟台大学知识产权研究院

出　　处：《知识产权》2015年第6期61-67,77,共8页Intellectual Property

基　　金：中央高校基本科研业务费专项资金资助(No.3095012102)

摘　　要：购买仿制药问题涉及到药品专利及其强制许可制度。在后TRIPS时代,发达国家正致力于通过如《跨太平洋伙伴关系协议(TPP)》这样的诸边贸易谈判,将《TRIPS协定》所确立的药品专利保护标准提升至所谓的TRIPS-plus标准,在药品专利的授权条件、保护期限及药品的市场准入等方面都采用更高的保护标准,但这种努力目前很难为发展中国家所接受。为公共健康目的,《TRIPS协定》及《多哈宣言》就药品的强制许可作了明确规定,但这种权利限制措施在实施时应作严格限定,仅仅是专利药品的高价不能成为实施药品专利强制许可的理由。在不能实施专利强制许可的情况下,无法负担高价专利药品的病人为自用目的而非营利性购买国外仿制药的行为不应认定为非法。The acts of buying generic drugs are related to the system of pharmaceutical patent and its compulsory license system. In the post TRIPS era, the developed countries are committed to so called TRIPS-plus high standard to pharmaceutical patent protection through Plurilateral Trade negotiations. They want to adopt high standard to protect pharmaceutical patent in patent licensing conditions, length of patent protecting and pharmacy market accessing. But it＇s difficult for developing countries to accept such goal so far. For the purpose of public health, TRIPS agreement and the Doha declaration made explicit provisions on pharmaceutical compulsory license, but the implementation of restricting patent rights should be strictly limited, and high price of patent drugs itself should not be the reason to implement compulsory license. The action of patients who buy generic drugs for themselves with nonprofit purpose from abroad because of unaffordable high price of patented drugs should not be recognized as illegal.

关 键 词：达拉斯买家俱乐部 药品专利 强制许可 公共健康 药品监管 

分 类 号：D997.1[政治法律—国际法学] D923.42[政治法律—法学]