미국 바이오 시밀러 의약품 허가특허연계제도와 미국 연방대법원 Sandoz 판결

Biologics are rapidly increasing in the global drug market. Thus, the U.S. Congress had introduced an abbreviated approval pathway through the enactment of the BPCIA Act to improve public accessibility to biologics and to promote innovation of the biologics industry in 2010. On June 12, 2017, the U.S. Supreme Court had ruled through Sandoz decision that biosimilar applicants could notify biologics manufacturers before obtaining the FDA approval, creating a legal environment in which the release date of biosimilar could be advanced. In this respect, the Sandoz decision is in favor of the biosimilar manufacturers. Furthermore, the Sandoz decision can be evaluated as a “proper and delicate balance” between the “industrial aspect” of innovation in the biologics industry and the “basic right” aspect of health and welfare that the public should enjoy justly as a human being. Thus, the Supreme Court’s patent policy in Sandoz’s decision is a “good policy”. Currently, Republic of Korea is operating an approval patent linkage system similar to an abbreviated new drug application in the U.S. The system was introduced to implement the Korea-U.S. FTA agreement signed in 2007. However, Korea is applying the system to biologics, even though it is not part of the implementation of the Korea-U.S. FTA. It is not appropriate to apply the system to biologics, because there are many concerns that the system is disadvantageous to Korean drug manufacturers who are less competitive in the drug industry. Therefore, it is desirable for Korea to separate biologics from traditional drugs and regulate them under its own system like the U.S.