Taiwan FDA completes proposed draft of Enforcement Rules for Western Pharmaceuticals Patent Linkage
K180912Y1．K180911Y1 | Oct. 2018（K227）
Taiwan Pharmaceutical Affairs Act has incorporated a new chapter of “Patent Linkage of Western Pharmaceuticals” since its amendment passed the third reading at the Legislative Yuan at the end of 2017 and the amendment was promulgated by presidential order on January 31, 2018. Under the patent linkage system, a new drug approval holder may complete listing and reporting of the patent information with respect to his/her pharmaceutical patent(s). On the other hand, a generic drug approval applicant who seeks grant of drug approval for his/her generic drug shall make relevant certification or declaration in regard to the patent(s) listed by the new drug approval holder with the competent authority, and the competent authority will stay issuance of drug approval for a period of 12 months to clear relevant patent disputes. The first applicant of generic drug approval to successfully challenge patent validity or make non-infringement declaration against the new drug and to have produced complete in full the materials required of his/her application for approval of the generic drug will be granted an exclusive marketing term of 12 months. The introduction of this system will clear potential patent infringement dispute before the marketing of generic drugs, which will ultimately upgrade the research and development of Taiwan’s pharmaceutical industry and expand international market.
On September 11, 2018, Taiwan Food and Drug Administration completed and announced a proposed draft of the “Enforcement Rules for Western Pharmaceuticals Patent Linkage” to facilitate implementation of the patent linkage and fulfill IP right protection for pharmaceuticals. The proposed draft was compiled and formulated in accordance with the 3rd paragraph of Article 48-20 and Article 48-22 of the Taiwan Pharmaceutical Affairs Act. Main points of the draft are summarized below.
1. Method of filing patent information, content of patent information to be filed, amendment, deletion, publication and/or disclosure of the patent information filed;
2. Generic drug approval applicant’s patent-related declaration or statement, required written notices, examination procedure for generic drug approval applications, and issuance of drug approval;
3. Required notice to be issued by the new drug approval holder with respect to the patent infringement action initiated by the patentee or exclusive licensee or with respect to the final judgment that sustains occurrence of infringement;
4. Grant and duration of exclusive marketing term;
5. The applicability of provisions, with appropriate and necessary alterations, to the drug approval applications for the new drugs other than those of new chemical entity; and
6. Exclusion of indications, declaration and statement, and other compliance matters. (September 2018)