Recently, interest in compulsory licensing of pharmaceuticals has been growing regardless of a country’s income- level. We aim to investigate the use of compulsory licensing as a legitimate part of the patent system and tool for the government to utilize by demonstrating that countries with a mature patent system were more likely to utilize compulsory licensing of pharmaceuticals. We used a multivariate logistic model to regress attempts to issue compulsory licensing on the characteristics of the intellectual property system, controlling for macro context variables and other explanatory variables at a country level. A total 139 countries, selected from members of the World Trade Organization, were divided into a CL-attempted group (N = 24) and a non-CL-attempted group (N = 115). An attempt to issue compulsory licensing was associated with population (+) and a dummy variable for other regions, including Europe and North America (−). After controlling for macro context variables, mature intellectual property system was positively associated with attempting compulsory licensing. Our study provided evidence of an association between attempting compulsory licensing and matured patent systems. This finding contradicts our current understanding of compulsory licensing, such as compulsory licensing as a measure to usurp traditional patent systems and sometimes diametrically opposed to the patent system. The findings also suggest a new role of compulsory licensing in current patent systems: compulsory licensing could be a potential alternative or complement to achieve access to medicines in health systems through manufacturing and exporting patented pharmaceuticals.

中文翻译：

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知识产权制度在药品强制许可中的重要性：横断面分析

最近，无论一个国家的收入水平如何，对强制许可药品的兴趣一直在增长。我们旨在通过证明拥有成熟专利制度的国家更有可能利用药品的强制许可，来调查将强制许可作为专利制度和政府使用的工具的合法组成部分。我们使用了多元逻辑模型来回归尝试对知识产权制度的特征进行强制许可的尝试，以控制国家范围内的宏观背景变量和其他解释变量。从世界贸易组织成员中选出的总共139个国家分为CL尝试组（N = 24）和非CL尝试组（N = 115）。发行强制许可的尝试与人口（+）和其他地区（包括欧洲和北美（-））的虚拟变量相关。在控制了宏观环境变量之后，成熟的知识产权制度与强制许可的尝试正相关。我们的研究提供了证据，表明强制许可尝试与成熟的专利制度之间存在关联。这一发现与我们目前对强制许可的理解相矛盾，例如，强制许可是篡改传统专利制度的一种手段，有时甚至与专利制度截然相反。调查结果还表明强制许可在当前专利制度中的新作用：