의약품 특허권 존속기간 연장과 허가규제기관의 역할

Patent Term Extension system for pharmaceutical inventions was first implemented in the United States through the enactment of the Hatch-Waxman Act in conjunction with the drug approval-patent linkage system, and has since been introduced and implemented in many countries, including Korea. The key elements of patent term extension (“PTE”) includes the scope of right during the extended patent term and the calculation of the PTE period. The calculation of the PTE period is based on the approval of the drug product developed according to the patented invention, and the scope of right during the extended patent term is also affected by the drug product approval. The PTE system is constantly changing through amendments to relevant laws and administrative regulations, and in 2023, the KIPO announced some amendments to the law in the form of a legislative proposal to the National Assembly. Based on these trends, it can be assumed that differences with major countries in the scope of right during the extended patent term and the calculation of the PTE period will affect future changes or revisions to the PTE system. Since both the scope of right during the patent term and the calculation of the PTE period are related to drug product approval, it is necessary for those in charge of regulatory approval at pharmaceutical companies and the regulatory agency to understand the PTE system and consider their possible role in improving the system. To this end, we studied the status of PTE system operation and differences between countries in terms of limiting the scope of right during the extended patent term and calculating the PTE period, and in particular, the role and judgment of the examiners at the regulatory agency in calculating the PTE period in Korea is necessary. In this regard, we look forward to a more active role of the MFDS as a regulatory agency