Establishing Approval and Intellectual Property Portfolio Strategies in Response to the Introduction of the Data Protection System under the Amended Pharmaceutical Affairs Act

Following the amendment to the Pharmaceutical Affairs Act (“PAA”), which took effect as of February 21, 2025, a pharmaceutical data protection system has been introduced in Korea. The amendment restructured the previous re-examination system and now allows for exclusive protection of clinical trial data for new drugs and orphan drugs for a certain period. As a result, pharmaceutical companies are afforded clearer protection for their intellectual property rights and trade secrets under PAA, independently of patent rights.

Lee & Ko has advised various clients on the impact of this new system’s introduction, with a particular fucus on how scenarios involving generic drug approval applications for new drugs may change in comparison with the previous re-examination system. Especially, it was closely examined whether orphan drugs may enjoy a longer protection period under the new system than was granted under the former regime. Based on these analyses, Lee & Ko provided concrete timelines regarding expected generic entry under various approval scenarios, thereby enabling the clients to develop forward-looking portfolio strategies.

Lee & Ko’s healthcare experts possess in-depth expertise not only in the regulatory realm of PAA but also in patent and intellectual property disputes. With this cross-sectional expertise in regulatory affairs and intellectual property law, Lee & Ko has been recognized for delivering timely, customized, and effective legal solutions to its clients.