Importance of the intellectual property system in attempting compulsory licensing of pharmaceuticals: a cross-sectional analysis.

BACKGROUND

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.