Revised draft of Enforcement Rules for Patent Linkage is published
On September 11, 2018, the Ministry of Health and Welfare made an announcement to enact the “Enforcement Rules for Patent Linkage” and published a draft version thereof and further held public hearings to seek comments and opinions from all sectors on November 6, 2018 and November 27, 2018. After thorough compilation and revisions, a revised draft version of the “Enforcement Rules for Patent Linkage” was presented on January 30, 2019. The differences between the two draft versions are summarized below.
1. As suggested and by reference of the legislation of the US, Korea, and Canada that different polymorphs are eligible for listing in patent linkage system with one condition that test data thereof substantiating their curative effects should be provided as well, the 2nd paragraph of Article 3 of the revised version sets forth that for substance invention that covers different polymorphs of an active ingredients, the test data proving that the polymorph has the equal effect to the active ingredient is required to be produced for application for registration and market approval. Also as indicated in the same Article, the relevant process, intermediate, metabolite, or packaging of a drug is not eligible for listing.
2. According to the 3rd paragraph of Article 8 of the revised version, where a generic drug approval applicant who originally made his/her declaration based on item (1), (2), or (3) of Article 48-9 of the Pharmaceutical Affairs Act changed and made a declaration based on item (4) instead, the said applicant does not have to “withdraw” his/her original application, while the date of his/her application will be the date when the form of his/her change of declaration is submitted to the central competent authority.
3. For facilitating international economic and trade negotiations and encouraging domestic biotechnology development and domestic R&D of biosimilar products, biosimilar products are eligible for listing into patent linkage system in the revised version of the “Enforcement Rules for Patent Linkage”, and the revised version lays down the applicability of the provisions governing the drug approval and permit application for generic drugs to biosimilar products for protecting the patents regarding biologics.
The revised version is to be published for sixty (60) days for gathering public opinions. (January 2019)