Two manufacturing activities, two legal inquiries
On 15 May 2025, the Supreme Court of Korea dismissed the appeals in case 2025Da202970, affirming the Patent Court’s 3 December 2024 decision, 2023Na10914. The plaintiffs were the patent proprietor and exclusive licensee. Claim 1, corrected on 21 March 2017, concerned a 13-valent immunogenic composition for use as a pneumococcal vaccine.
The defendant made 13 individual polysaccharide–protein conjugate bulk substances in Korea and exported them to a Russian company, which mixed them into the composition. Separately, the defendant produced completed vaccine in Korea on four occasions and supplied it free of charge for research or testing. Those activities required separate analysis.
Direct infringement: mixing was a substantive step
The claim did not require a final, immediately injectable dosage form. It required immunogenicity against all 13 serotypes sufficient for use as a vaccine after formulation. Korean patent rights are territorial, and direct infringement generally requires every claimed element and their combined relationship.
A narrow exception can treat domestic production as complete where all principal components are made, export to one entity for a merely trivial final operation is planned, and the invention’s combined effects can already be achieved. Here, quantities, mixing ratios and sequence, pH, temperature, stirring speed and time could materially affect immunogenicity. Producing the separate substances did not yet achieve the claimed 13-valent effect. Direct infringement was therefore rejected.
Indirect infringement and the location of production
Article 127(1) of the Korean Patent Act treats specified dealings in articles used exclusively to produce the patented product as infringement. However, the relevant production must take place in Korea. If the finished product is produced abroad, preceding domestic activity cannot establish indirect infringement under that provision.
All the individual bulk substances were exported for completion abroad. The indirect-infringement claim therefore failed for a territorial reason distinct from the direct-infringement analysis. The decision does not make every export arrangement permissible: the substance of each domestic and foreign step still matters.
The four domestic batches and the research exception
The four completed vaccines, produced between 7 November 2018 and 27 May 2020, did fall within claim 1. Batches 1, 2 and 4 were intended for non-clinical or clinical studies in Russia; batch 3 was for analytical testing of successful manufacturing-technology transfer. They were supplied free and identified as research or test material, not for sale or distribution. There was no evidence of commercial supply of those batches or other completed-vaccine production.
Article 96(1)(1) can exclude research or testing from the patent’s effect where the proprietor’s legitimate exclusive interests are not unreasonably impaired. The Court found that condition satisfied on these facts. Merely labelling commercial output as research would not establish the exception.
Outcome and practical documentation
The unfair-competition claim also failed: production of the individual conjugates lay in the public domain, and even assuming a protectable achievement, the evidence did not establish unfair unauthorised appropriation. Dismissal of the appeals did not invalidate the patent itself.
Businesses should map each claim element and technical effect to the actual manufacturing location, preserve evidence of the significance of the final process, and document quantities, recipients, test plans and actual use. Separating research supply from commercial distribution is a practical implication of this case, not a blanket exemption.
The original figure labels and forms are preserved; the text explains the facts and the court’s reasoning.