연장된 의약특허존속기간의 유효 한도(캡)규정 도입방안

Abstract

The current patent law stipulates that the period required to obtain a drug product license under the Pharmaceutical Affairs Act is regarded as a period in which a drug patent holder could not carry out a drug patent invention for a business and the duration can be extended up to a maximum of five years. However, there is no regulation on the validity limit (cap) of the duration for the combined period the extended duration and the residual duration.
 As a result, regardless of the date on which the drug is licensed, the drug patent holder receives an extension of the duration of up to five years and controls the drug market with an exclusive status. Meanwhile, generic pharmaceutical companies do not have a cap on the validity of the extended duration, so entry into the market of generic (or biosimilar) drugs may be restricted for a long time. There is a problem that the market supply of cheap generic drugs is delayed, which rather hinders the promotion of national health.
 Under the current regulation that the duration can be extended for up to five years as a way to solve these problems, like the United States, the EU, and China, it is necessary to introduce a maximum valid limit (cap) regulation in the Patent Act that the combined period of “extended duration” and “residual duration” cannot exceed a certain period (e.g., 14 years).