Page 48 - 2018食藥署年報(英文版)

Section 2 Establish Drug Patent Linkage System

Origin of Policy

The focused topics of intelligence protection among international medicinal products lately
consist of the linkage system (“patent linkage system”) between exclusive protection, drug patent
and listing approval in terms of drug permit applications.
Patent linkage system refers to the linkage between new drug listings and disclosure of
patent information and the linkage between the review process of generic drug listings and the
possibility of infringing new drug patents which allows pharmaceutical companies to resolve

disputes (patent infringement issues) over patent-related issues within a certain time frame (before
the listing of generic drugs). It is also a reference for central competent health authorities to
approve/reject the listing of generic drugs.

Implementation Measures

By referencing regulations of the US, Canada and South Korea, and the current status of the
pharmaceutical industry development in Taiwan, the TFDA added Chapter 4-1 “Patent Linkage of

Drugs” in the Pharmaceutical Affair Act, and promulgated this section in the Government Official
(Presidential Order) on January 31, 2018. The contents included that the holder of a new drug permit
permit to submit patent information regarding substance, composition or formulation and medical
use within the statutory limitation. The applicant for a generic drug permit must provide a statement
describing the patent status of the approved new drugs. The applicant for a generic drug permit
must notify the holder of the new drug permit, the Central Competent Health Authority, patentee or
the exclusive licensee, in advance to allow the person of interest to clarify the validity of a patent
or the possibility of patent infringement. After that, the Central Competent Health Authorities may
continue reviewing the application of the generic drug permit application. However, the issuance

of a drug permit may be temporarily suspended under special circumstances within 12 months. The
first successful application of a generic drug permit without the fact of a patent infringement or
patent around will be granted a 12-month period of marketing exclusivity.

Outcomes and Benefits

By implementing the patent linkage system and issuing patent rights to the inventor, it is
expected to advocate the idea of patent right protection and affirm the great contribution of the drug

permit holder, encouraging them to devote themselves to the development of medical/pharmaceutical
research. It is also helpful to allow the holder of a new drug permit to control relevant patents before
listing and to encourage and urge pharmaceutical companies devoted to novel drug development
or patent around designs, in order to increase the volume of generic drug development, facilitate
industrial potential and international competitiveness, and achieve the governmental goals of
promoting emerging industries (e.g. biomedicine/pharmaceuticals/biotechnology).

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