의약품 특허권 존속기간의 연장기간 산정기준에 관한 연구

Abstract

In 1987, the patent system was introduced to extend the patent terms to a maximum of 5 years. According to Korean Patent Law Article 89, the term of a patent on an invention may be extended only once by up to five years to compensate for the period during which the invention cannot be executed, if the invention is specified by Presidential Decree and requires permission, registration, etc. under any other statute to execute patented invention but it takes a long time to undergo necessary tests for validity, safety, etc. for such permission, registration, etc. Since the sales of pharmaceuticals tend to increase sharply at the expiration of the patent terms, there has been a sharp conflict of interest between the patent holders of the original drugs and the generic drug makers as a matter of Extension of Patent Terms relating to Pharmaceuticals. The Purpose of this study is to research the calculation standard for extension of patent terms relating to pharmaceuticals. A comparative legal analysis is conducted through foreign legislation, and the precedents of the Patent Court are reviewed and to suggest also the rational interpretation of patent law and legislative measures for the fair and reasonable profit adjustment.