BY SYLVIA Y. S. HONG

The Legislative Yuan passed the third reading of the Amendment of the Pharmaceutical Affairs Act on December 29, 2017. The enforcement date of the amendment is not specified yet.

The Pharmaceutical Affairs Act introduced the well-known patent-linkage system. New drug application holders may, if deemed necessary, submit patent information (invention patents regarding substance, composition/formulation, or medical use) to the Food and Drug Administration (Taiwan FDA). A generic drug applicant must make a certification with respect to each listed patent:
 

1. No patent listed
2. The patent is expired
3. The approval will not be issued until patent expires
4. The patent should be canceled or the generic drug will not infringe the patent
 

The Taiwan FDA will stay the review of the approval for a period of 12 months if there is a patent dispute. The first generic drug applicant who contests the listed patent and wins can be granted 12 months of generic market exclusivity.
 

With regard to data exclusivity, the current Pharmaceutical Affairs Act provides a three year data exclusivity period and a five year market exclusivity period for drugs containing a new active ingredient. The amendment of the Pharmaceutical Affairs Act additionally provides a two year data exclusivity period and a three year market exclusivity period for drugs with a new indication or newly changed indication. In the case that a domestic clinical trial for such drug is performed, a five year market exclusivity period will be granted.
 

The Taiwan FDA confirmed that they will begin establishing a patent information database and enacting relevant regulations.

1 立法院三讀通過藥事法部分條文修正草案，建立專利連結制度及新適應症新藥資料專屬保護, Ministry of Health and Welfare News, retrieved from https://www.mohw.gov.tw/cp-16-39059-1.html
2 Patent Attorney