특허권 존속기간 연장등록 출원의 거절결정 후 구제수단

Remedies Following a Rejection Decision on an Application for Extension of Patent Term

Unlike other technological fields in which successful new developments can be immediately commercialized, pharmaceuticals face an additional hurdle: approval from the Ministry of Food and Drug Safety. To ensure fairness with other patented inventions, the patent term extension (PTE) system compensates for periods during which the patented invention could not be practiced due to efficacy and safety examinations, etc. The ultimate goal of patent law is industrial development. Only when the two wheels driving the pharmaceutical industry—originals and generics—achieve balance can the ultimate goal of patent law, industrial development, be realized. Ultimately, the most important thing is finding the proper balance between protection and utilization. The Korean Patent Act, effective July 2025, introduces an upper limit on the maximum duration of valid patent rights and restricts the number of extendable patent rights. However, a significant issue remains unresolved: under the all-or-nothing principle, if any portion of the extension period requested in a PTE application is denied, the entire application must be rejected. Accordingly, commentators have noted the need to establish appropriate appeal procedures for patent holders. This paper examines institutional improvement measures to address the procedural limitations of the patent term extension system. As a result, introducing a reexamination system for patent term extension registrations was judged to be the most realistic alternative under the current circumstances. Other options, such as granting an opportunity for amendment at the trial stage, introducing divisional applications, or implementing a partial rejection system, could also be considered. However, as many prerequisite issues remain unresolved, it is necessary to first introduce the reexamination system for term extension registrations and then consider phased implementation through more in-depth review.