Singapore’s Health Products (Therapeutic Products) (Amendment) Regulations 2024 take effect
08 October 2024
Singapore’s Health Products (Therapeutic Products) (Amendment) Regulations 2024 came into effect on August 1, 2024.
The amended regulations were those in connection with patent linkage. The amendments, among others, stated that the following must be provided to the Health Sciences Authority (HSA) during the registration of therapeutic products: 1) patent containing a claim for an active ingredient of a therapeutic product; 2) patent containing a claim for a formulation or composition of a therapeutic product; and 3) patent containing a claim for the use of an active ingredient in the manufacture of a therapeutic product for a specific therapeutic, preventive, palliative or diagnostic use.
Natalie Huang | Senior Associate @ Baker & McKenzie Wong & Leow, Singapore.
“The recent amendments to the Health Products (Therapeutic Products) Regulations 2024 are welcome, insofar as they create certainty that the patent declaration requirement only applies to patents containing these types of claims,” said Natalie Huang, senior associate at Baker & McKenzie Wong & Leow in Singapore.
The amendments also stated that the patent declaration requirement does not apply to the following: 1) process patents, other than that containing a claim for the use of an active ingredient in the manufacture of a therapeutic product for a specific therapeutic, preventive, palliative or diagnostic use; 2) patents containing only claims related to packaging; 3) patents containing only claims related to metabolites; and 4) patents containing only claims relating to intermediates.
“Pre-amendment, the wording of Regulation 23 ostensibly covered all patents in force in respect of a therapeutic product and it was not fully clear, among others, whether process patents were covered. These latest amendments make clear that any patents not falling within the above categories do not need to be declared,” added Huang.
A problem remains, however. Huang explained: “While they bring about greater clarity, for patent holders of branded drugs, limiting the patent declaration requirement to these specific categories may result in narrower protection offered by the patent linkage scheme, and consequently a greater need to stay vigilant about developments in the market.”
The amendments to the Health Products (Therapeutic Products) Regulations 2024 were introduced following a public consultation conducted by HSA from March 1 to 31, 2024.
- Espie Angelica A. de Leon
