The Intellectual Property Office (TIPO) held a public hearing on 19 September 2017 for the draft bill of the Patent Act and draft amendments to the Patent Examination Guidelines (hereafter referred to as "Guidelines") regarding patent term extension (hereafter referred to as "PTE").

The draft bill of the Patent Act introduces amendment to Article 53 by setting a 14-year limitation on the length of a patent term from obtainment of first market approval.

The issues in the draft amendments to the Guidelines include (1) patents eligible for PTE; (2) market approval holder of the first market approval; (3) determination of the first market approval; (4) statutory period of filing a PTE application; (5) correlation between the active ingredient and indication in the first market approval and the claims; (6) foreign and domestic clinical trial periods of a medicament; (7) domestic regulatory review period of agricultural chemical; (8) market approval holder not being the PTE applicant; (9) determination of correlation between the first market approval and claims; and (10) non-acting period attributable to the PTE applicant.

Since the amendments to the Patent Act introduce a limitation to the patent term period, and it is arguable for the determination of the first market approval and non-acting period attributable to the PTE applicant in the draft amended Guidelines, the amendments may cause a negative impact on foreign and domestic originators.