SOUTH KOREA Trends and Developments Contributed by: Samuel Lee, Ye In Han, Inkyoung Choi and Jaeyoung Seol, Bae, Kim & Lee LLC
Defining the boundaries: the link to regulatory approval The ruling also defines the boundaries by empha ‑ sising the unreasonable impairment test, where the Court has implicitly drawn a line against stockpiling or launch-at-risk strategies. If a company manufactures commercial quantities of a drug before patent expiry under the guise of process validation or research, and these quantities vastly exceed what is needed for reg ‑ ulatory approval, they are unlikely to be protected. The exemption is now clearly defined as supporting regulatory approval, not commercial preparation. Conclusion The Supreme Court of Korea’s decision in Case No 2025Da202970 represents a maturation of the nation’s patent jurisprudence. It reflects a sophisticated under ‑ standing of the global pharmaceutical ecosystem, acknowledging that innovation relies on a complex network of researchers, manufacturers and clinical sites that often span multiple borders.
For patent holders, the ruling clarifies the boundaries of their monopoly, assuring them that “sham” research will not be tolerated while validating the unreasonable impairment standard as a tool for enforcement. For developers and CDMOs, it provides the legal certainty needed to invest in R&D and manufacturing partner ‑ ships. As the industry moves forward into 2026, the unrea ‑ sonable impairment test will likely become the central focus of patent litigation in this area. Market partici ‑ pants will need to carefully document the purpose, quantity and non-commercial nature of their pre-expi ‑ ry activities to ensure they remain on the right side of this new legal equilibrium.
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