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Part 5 · Registration of Therapeutic Products

24. Cancellation of registration of therapeutic product subject to patent dispute

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Amended

Last amended by an amending law of 2024. 2 amendments in all.

(1)

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.

(2)

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

Subregulation 1

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.

Report

Part 6

Duties and Obligations of Manufacturers, Importers, Etc., of Therapeutic Products

Part 7

Exceptions — Manufacture, Import and Wholesale of Therapeutic Products Without Licence

Part 8

Exceptions — Supply of Therapeutic Products Without Registration

Part 8A

Exception — Emergency Therapeutic Products

Part 9

Miscellaneous

Schedules