Law firm BKL announced on September 7 that it successfully concluded its seminar on 'Key Issues in Pharmaceutical Patent Law' held on September 4 at its headquarters in Jongno-gu, Seoul.
The seminar, hosted by BKL's Intellectual Property (IP) group, attracted over 100 participants from corporate and academic sectors, reflecting significant interest in current pharmaceutical patent law issues.
Key topics included the skinny label strategy and patent infringement issues related to medical use inventions, which have garnered attention in the generic industry. The seminar analyzed the U.S. Supreme Court's ruling in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., and discussed the implications of recent amendments to domestic patent law that include 'export' as an act of indirect infringement, particularly affecting companies exporting pharmaceutical intermediates.
The first session featured BKL attorney Han Ye-in, a patent expert in the pharmaceutical and biotech fields, who presented on 'Skinny Labels and Medical Use Invention Infringement – Understanding the Hikma v. Amarin Ruling and Its Implications for Korea.' Han emphasized that the market entry strategies for generics through skinny labels should not be easily recognized as patent infringement.
He stated, 'If the patent holder's medical use inventions are overly broadly protected, it could effectively block the market entry of generics, similar to substance patents. This concern is reflected in the recent U.S. Supreme Court ruling.' He also explained the latest trends in the legal principles surrounding medical use invention infringement and the skinny label strategy available for generics in Korea.
Following the presentation, a discussion was moderated by BKL attorney Kwon Taek-soo. Professor Kim Dong-jun from Chungnam National University introduced case law from Germany and the Unified Patent Court (UPC), discussing legal frameworks to apply the indirect infringement principles from Hikma v. Amarin in Korea. Professor Lee Mi-jeong from Seoul National University suggested that, considering the realities of healthcare in Korea, the ability of generics to be sold without a doctor's prescription should also be factored into the assessment of medical use invention infringement.
The second session featured Professor Kim Kyung-jin from Sungkyunkwan University, who presented on 'Legislative Proposals for Normalizing Legal Principles Related to Medical Use Inventions.' He argued for amendments to patent law that align with the nature of medical use inventions and legislative solutions to the issues of skinny label patent infringement and the liability of physicians and pharmacists.
During the subsequent discussion, patent attorney Geum Sim-seong advised a cautious approach to avoid imposing excessive infringement prevention obligations on generic developers. BKL attorney Choi In-kyung emphasized the need for amendments considering the current state of medical use invention protection abroad and the legal stability, raising the necessity for further review of criteria for injunctions and damage calculations.
The third session featured Jeong Cha-ho, head of the KTP Patent Law Research Institute, who presented on 'Interpretation and Legislative Issues Regarding Indirect Infringement of Patent Rights in Exporting Parts and Intermediate Products.' Jeong pointed out that the recent amendment to Article 127 of the Patent Act includes 'export' as an act of indirect infringement, raising concerns about the overly broad scope of indirect infringement. He stressed, 'Article 127 should be interpreted restrictively based on the premise that finished products are produced domestically, and ultimately, there is a need to re-amend this provision.'
The third session was chaired by Shin Hye-eun from Chungbuk National University. BKL attorney Yeom Ho-jun stated, 'The addition of 'export' to the acts of patent implementation under patent law does not necessitate a change in the interpretation of the subject of implementation,' and argued for a strict interpretation of Article 127 in light of the principle of territoriality. He added, 'If interpreted beyond the dual domestic relevance requirement, it could lead to unprecedented excessive protection, placing a serious burden on companies exporting intermediate products, and it cannot be said that the dual domestic relevance requirement has been discarded based on the amendment's background.'
Meanwhile, BKL's Pharmaceutical and Biotech IP team comprises experts in pharmacy, life sciences, chemistry, and engineering, as well as attorneys with backgrounds as patent court judges and Supreme Court research judges. They provide comprehensive legal services across the pharmaceutical and biotech sectors, including regulatory patent linkage, market entry strategies, patent disputes, and IP transactions such as licensing and co-development.
* This article has been translated by AI.
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