9 October, 2019
The most recently amended Pharmaceutical Affairs Act (“PAA”) was promulgated by the President on January 31, 2018, in which the data exclusivity for new indications and patent linkage system were introduced. The provisions relating to the patent linkage system in the amended PAA have taken effect since August 20, 2019. The main aspects of the newly established patent linkage system are set forth below.
1. New Drug Patent Listing
Starting August 20, 2019, the holder of a new drug permit is responsible for submitting the relevant patent information of the new drug to the Health Authority within 45 days of the receipt of the new drug permit or of the publication of patent grant, whichever comes later. Patents listed in the database should contain claims related to substances, compositions or formulations, or medical uses thereof. For a new drug permit obtained before August 20, 2019, the new drug holder may submit the relevant patent information within 3 months from the effective date of the amended PAA, i.e., by November 20, 2019.
2. Stay of Issuance of Generic Drug Permit and Grant of Market Exclusivity to the Generic Drug
Beginning August 20, 2019, an applicant for a generic drug permit should file a declaration concerning the listed patenta when applying for the drug permit, which should certify: (1) that there is no listed patent information corresponding to the new drug; (2) that the listed patents relating to the new drug have expired; (3) that the generic drug permit will be issued by the authority after the expiration of the listed patents; or (4) that the listed patents corresponding to the new drug should be invalidated or that the generic drug applying for the permit does not infringe the listed patents relating to the netw drug. The applicant of the generic drug permit who makes the declaration must notify the holder of the new drug permit, the patentee and exclusive licensee if the applicant asserts that the listed patents corresponding to the new drug should be invalidated or that the generic drug applying for the permit does not infringe the listed patents relating to the netw drug (i.e., Item (4) of the aforesaid declaration). While the authority may continue to review the application for the generic drug permit in such event, it should suspend the issuance of the permit for the generic drug for a period of 12 months unless that the patentee or exclusive licensee fails to file a patent infringement lawsuit within 45 days of receiving such notification from the applicant of the generic drug permit, that the court finds that the patent at issue is invalid or not infringed, that TIPO decides that the patent at issue should be invalid, the litigants settles, or that the patent at issue has expired. The first applicant for the generic drug permit that declares the invalidity of the listed patent(s) or non-infringement of the listed patent(s) will be granted a 12-month period for marketing exclusivity after receiving the drug permit.
3. The patent linkage provisions governing the drug approval application for generic drugs shall apply mutatis mutandis to biosimilar products
Although the PAA does not prescribe any definition or provision regarding “biosimilar drugs”, the Ministry of Health and Welfare promulgated the “Enforcement Rules for Patent Linkage” on July 1, 2019 to not only provide for the definition of “biosimilar drugs” but also indicate that the patent linkage provisions governing the drug approval application for generic drugs shall apply mutatis mutandis to biosimilar products. In addition, if a letter approving the clinical trial has been issued by the central health authority for a biosimilar drug prior to the effective date of the patent linkage provisions of the PAA, those patent linkage provisions are not applicable to said biosimilar drug.
For further information, please contact:
Ray Hsu, Partner, Tsar & Tsai Law Firm
rayhsu@TsarTsai.com.tw
