College of Pharmacy, Ewha Womans University, Seoul, Republic of Korea.
Milken Institute School of Public Health, George Washington University, Washington, DC, USA.
Global Health. 2018 Oct 24;14(1):101. doi: 10.1186/s12992-018-0423-0.
The inclusion of patent linkage mechanisms in bilateral and plurilateral trade and investment agreements has emerged as a key element in the United States' TRIPS-Plus intellectual property (IP) negotiating agenda. However, the provisions establishing patent linkage mechanisms in several agreements appear to reflect a degree of ambiguity, potentially enabling some flexibility in their implementation. In this study, we reviewed the features of the prototypic patent linkage mechanism established by the Hatch-Waxman Act in the United States, and compared these with the implementation of systems in three countries whose agreements with the US include patent linkage obligations. From these analyses, we draw lessons for moderating the impact of these mechanisms on access to generic medicines.
We reviewed the features of the patent linkage mechanism in the US, and undertook a detailed analysis of relevant treaty provisions and the manner of implementation in Canada, Australia, and South Korea.
A key difference between the US implementation of patent linkage and that of its trading partners is the disparate treatment afforded to biologics. Because of the significant differences in the regulatory frameworks applying to small molecule and biologic medicines in the US, the Hatch- Waxman provisions do not apply to biologics and they are not subject to patent linkage. By contrast, the regulatory frameworks in Canada, Australia and South Korea do not reflect similar distinctions and thus patent linkage mechanisms also capture biologics. Additional variations in implementation, mainly the result of constructive ambiguities in the respective treaty texts, offer potential opportunity for mitigating the adverse impact of patent linkage provisions on market entry of generic medicines. Practical measures include ensuring the availability of an accessible, transparent and easily searchable database of patent information; avoiding automatic stays of generic marketing approval where possible; and requiring certification by rights holders to prevent abuse of the system.
Where countries accept treaty obligations to establish patent linkage mechanisms, the impact on access to generic medicines may be moderated to a degree by retaining and exploiting constructive ambiguities in the treaty text and addressing practical aspects of implementation.
专利链接机制被纳入双边和多边贸易和投资协定，已成为美国 TRIPS-Plus 知识产权（IP）谈判议程的关键要素。然而，几项协议中确立专利链接机制的条款似乎反映出一定程度的模糊性，这可能为其实施提供了一定的灵活性。在本研究中，我们回顾了美国《哈奇-沃克斯曼法案》（Hatch-Waxman Act）确立的原型专利链接机制的特点，并将这些特点与三个在与美国的协议中包含专利链接义务的国家的系统实施情况进行了比较。从这些分析中，我们汲取了一些经验教训，可以缓和这些机制对获得仿制药的影响。
我们回顾了美国专利链接机制的特点，并对加拿大、澳大利亚和韩国的相关条约规定和实施方式进行了详细分析。
美国实施专利链接与贸易伙伴之间的一个关键区别是对生物制剂的不同待遇。由于美国适用于小分子和生物药物的监管框架存在显著差异，《哈奇-沃克斯曼法案》的规定不适用于生物制剂，也不受专利链接的约束。相比之下，加拿大、澳大利亚和韩国的监管框架并没有反映出类似的区别，因此专利链接机制也涵盖了生物制剂。实施方面的其他差异，主要是由于各自条约文本中的建设性模糊性，为减轻专利链接规定对仿制药市场准入的不利影响提供了潜在机会。实际措施包括确保专利信息可访问、透明和易于搜索的数据库的可用性；在可能的情况下避免对仿制药营销批准的自动中止；并要求权利持有人进行认证以防止系统滥用。
如果各国接受建立专利链接机制的条约义务，那么通过保留和利用条约文本中的建设性模糊性，并解决实施方面的实际问题，对获得仿制药的影响在一定程度上可以得到缓和。
