Singapore legislation

Regulation 24

of Health Products (Therapeutic Products) Regulations 2016

Regulation 24

Cancellation of registration of therapeutic product subject to patent dispute

Amended byS 436/2023 wef 31/12/2021S 610/2024 wef 01/08/2024

Subregulation 1

Amended byS 436/2023 wef 31/12/2021S 610/2024 wef 01/08/2024

Without prejudice to the generality of section 37(1) of the Act, the Authority may, upon an application by any interested person, cancel the registration of a therapeutic product, if the Authority is satisfied —

(a)

that —

(i)

a court has determined that the doing of an act authorised by the registration infringes a patent under the Patents Act 1994; or

(ii)

a court has determined that the declaration made under regulation 23(2) contains a statement that is false or misleading in a material particular or omits to disclose any matter that is material to the application; and

(b)

that the determination mentioned in sub-paragraph (a)(i) or (ii) is final.

Subregulation 2

For the purposes of paragraph (1)(b), a determination is final if it is not subject to further appeal.