Journal of Intellectual Property (J Intellect Property; JIP)

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pISSN 1975-5945
eISSN 2733-8487
Research Article

Comparative Analysis of the Reasonable Expectation of Success Requirement in the Assessment of Inventive Step and Implications for Korean Patent Law: Focusing on EPO, UPC, and U.S. Case Law and Korean Pharmaceutical/Biotechnology Patent Cases

Patent Attorney, Executive Advisor, Seoul Semiconductor Co., Ltd., Republic of Korea

Correspondence to ChinSu Lee (chinsu.w.lee@gmail.com)

Volume 21, Number 3, Pages 31-50, September 2026.
Journal of Intellectual Property 2026;21(3):31-50. https://doi.org/10.34122/jip.2026.21.3.31
Received on June 05, 2026, Revised on June 29, 2026, Accepted on September 04, 2026, Published on September 30, 2026.
Copyright © 2026 Korea Institute of Intellectual Property.
This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives (https://creativecommons.org/licenses/by-nc-nd/4.0/) which permits use, distribution and reproduction in any medium, provided that the article is properly cited, the use is non-commercial and no modifications or adaptations are made.

Abstract

This study comparatively analyzes the Reasonable Expectation of Success (RES) requirement in the assessment of inventive step under the jurisprudence of the European Patent Office (EPO), the Unified Patent Court (UPC), and the United States and examines its implications for Korean patent law. In decisions T 0136/24 and T 0122/23, the EPO Boards of Appeal rejected the proposition that the initiation of a clinical trial or the disclosure of a clinical trial protocol automatically gives rise to a reasonable expectation of success; importantly, however, in T 0122/23, the Board ultimately found that a reasonable expectation of success existed on the basis of additional prior art evidence. In Amgen v. Sanofi (UPC_CoA_528/2024), the UPC Court of Appeal articulated guiding principles for assessing inventive step, including the role of a reasonable expectation of success in that assessment. This study maps technology-specific RES thresholds across predictable arts, pharmaceutical and biotechnology inventions, polymorph inventions, and AI-related inventions. It further argues that the Korean Supreme Court doctrines of “difficulty of composition” (2019Hu10609, Apixaban) and “ease of prediction” (2016Hu502) are functionally comparable to RES but differ in the degree to which the relevant assessment factors are explicitly articulated and structured. Rather than formally adopting RES as an independent statutory requirement for inventive step, this study recommends refining existing Korean doctrines through clearer assessment factors, technology-sensitive standards, and more precise evaluation of prior art relating to clinical trial protocols.
Keywords

reasonable expectation of success, inventive step, medical use invention, clinical trial protocol, difficulty of composition, hindsight bias, comparative patent law

Notes

Conflicts of Interest

No potential conflict of interest relevant to this article was reported.

Funding

The author received manuscript fees for this article from Korea Institute of Intellectual Property.

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