허가 등에 따른 특허권 존속기간 연장(Patent Term Extension) 제도 개정안에 대한 더 나은 개정안

A Better Amendment Proposal for an Amendment Proposal on the Patent Term Extension System, Caused by Approval, etc.

Regarding the patent term extension (PTE) system, caused by approval, etc., several law review papers and the amendment to the Korea Patent Act proposed by Representative Koh Dong-jin in September 2024 (hereinafter referred to as the “Koh Dong-jin Amendment”) claim that international harmonization is the justification for (1) setting the upper limit (cap) of the effective term to 14 years and (2) the so-called “single patent restriction system” that limits the number of patents that can be extended per product approval to one. This paper reviewed and analyzed the arguments and found the following shortcomings in the arguments. First, the Koh Dong-jin Amendment maintains the existing calculation method, which is based on the American calculation method, so it carries over the existing complexity and uncertainty. Second, the Koh Dong-jin Amendment only remedies items that are disadvantageous to generic companies, while ignoring items that are disadvantageous to new drug patent holders. Third, several papers and the Ko Dong-jin Amendment all claim international harmonization as the most important justification. However, it is difficult to consider following the American method as international harmonization. In order to solve these problems, this paper proposes a better amendment as follows. First, the European method of calculating the extension period should be introduced. This method is very simple and clear because it is based only on the patent application filing date and the product approval date. This calculation method solves several existing problems at once. The European method is attractive in that it is an international harmonization agreed upon by all EU member countries. For this reason, Australia and China also follow the European method. Second, the introduction of a single patent limitation system is necessary for international harmonization. Third, with regard to the scope of right of patent with extended duration, the legal principle presented in the Supreme Court 2017(Da)245798 decision (so-called Solifenacin decision) should be introduced as a clear provision. Third, with regard to the current deadline for filing an extension application, Article 90(2) of the Patent Act limits it to 6 months before the expiration of the patent term, but the deadline should be relaxed in the European manner. In other words, it should be possible to file an extension application during the term, but an additional 6 months from the later date of the patent registration date or product approval date should be established.