Taiwan FDA completes draft of Enforcement Rules for Western Pharmaceuticals Patent Linkage

E190701Y1 Jul. 2019(E236)
 Taiwan Food and Drug Administration under the Ministry of Health and Welfare issued a press release with respect to the Enforcement Rules for Western Pharmaceuticals Patent Linkage on July 1, 2019.  

 According to the press release, 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 marketing 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.

 Ministry of Health and Welfare has formulated and completed the draft of the “Enforcement Rules for Western Pharmaceuticals Patent Linkage” in accordance with Taiwan Pharmaceutical Affairs Act.  The draft compiles and mainly sets forth the contents as summarized below, which are in connection with (1) method of filing patent information, content of patent information to be filed, amendment, deletion, publication and/or disclosure of the patent information filed and listed, (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 and biosimilars other than those of new chemical entity, and (6) exclusion of indications, declaration and statement, and other compliance matters.  

  After announcement and compilation on September 11, 2018 and January 30, 2019, respectively, this draft promulgated on July 1, 2019 also incorporates and lays down the applicability of the provisions governing the drug approval application for generic drugs to biosimilar products for protecting the patents regarding biologics.  Also based on the conclusions made in the public meeting held for the supporting measures of the inclusion of biosimilars into patent linkage system on May 15, 2019, the draft rules stipulate a transitional clause that the relevant provisions of the chapter of patent linkage system shall not apply to the biosimilars, for which official approval for clinical trials has been issued by the central competent authority before the patent linkage is officially implemented.  

 In addition, in response to the launch of patent linkage system, the Ministry of Health and Welfare will work with relevant agencies and departments to formulate relevant supporting measures and policies for international market expansion.  (July 2019)

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