SOUTH KOREA Trends and Developments Contributed by: Samuel Lee, Ye In Han, Inkyoung Choi and Jaeyoung Seol, Bae, Kim & Lee LLC
The unique interpretative challenge in Korea While the text of the Korean statute regarding “research or experiment” appears broad, its applica ‑ tion to the modern, fragmented supply chain remained legally ambiguous until 2025. Unlike the US statute, which explicitly links the exemption to “developing information”, the Korean statute focuses on the act of “research”. This textual difference led to two critical interpretative gaps. • The separation of entities problem: Does the exemption apply if the entity producing the drug (eg, a CDMO) is different from the entity conduct ‑ ing the research (eg, a foreign biotech)? Can a manufacturer claim the exemption when their immediate commercial objective is to supply a cli ‑ ent and generate revenue, rather than to conduct the scientific research themselves? • The territorial problem: Does the exemption cover activities where the research itself takes place out ‑ side Korea? If a Korean company manufactures a batch solely for a clinical trial in Russia or the USA, does the research exemption apply? These statutory gaps fuelled conflicting interpretations between originators and developers, culminating in a legal battle concerning the 13-valent pneumococcal conjugate vaccine. Case background: anatomy of a high-stakes dispute The technology: pneumococcal conjugate vaccines The dispute centred on a patent for a 13-valent pneu ‑ mococcal conjugate vaccine. Conjugate vaccines are complex biological products where polysaccharide antigens from the bacteria are chemically linked (con ‑ jugated) to a carrier protein to enhance the immune response. Due to the technical difficulty of the con ‑ jugation process and the stringent quality control required, few manufacturers globally possess the capability to produce them. This technical complex ‑ ity underscores the necessity for developers to rely on specialised manufacturing partners.
The parties and the conduct The parties were as follows:
• the plaintiff – a global pharmaceutical company holding the Korean patent for the vaccine composi ‑ tion; • the defendant: a domestic Korean pharmaceutical company seeking to develop a biosimilar version of the vaccine; and • the third party (company M) – a Russian pharma ‑ ceutical company partnering with the defendant. Crucially, the defendant did not launch the product in the Korean market. Instead, prior to the expiration of the plaintiff’s patent, the defendant manufactured several batches of the vaccine substance at its Korean facility. These batches were then exported to com ‑ pany M in Russia. The evidentiary record showed that company M used these exported samples exclusively for the following purposes: • non-clinical trials – to verify the safety profile and toxicity of the biosimilar in animal models; • clinical trials – to generate the efficacy data required for regulatory approval by the Russian Ministry of Health; and • analytical testing – to confirm the successful trans ‑ fer of the complex manufacturing technology. The plaintiff’s legal theory The patent holder argued that the defendant’s actions constituted clear patent infringement, advancing a strict interpretation of “working” the invention. Their argument rested on two pillars. • Commercial intent of the producer: The plain ‑ tiff contended that while company M might be conducting research, the defendant’s role was merely that of a manufacturer and exporter. From the defendant’s perspective, the transaction was a commercial act of manufacturing and transfer. Since the defendant itself was not conducting the trials, the plaintiff argued the exemption could not apply. • Territorial limits: They argued that the research exemption is intended to promote domestic tech ‑
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