On 29 February 2024, the Health Sciences Authority (“HSA“) issued a public consultation on the proposed amendments to Regulation 23 of the Health Products (Therapeutic Products) Regulations (“TPR“) on the registration of therapeutic products. The public consultation runs from 1 March 2024 to 31 March 2024.
Under Regulation 23 of the TPR, HSA, in dealing with an application for the registration of a therapeutic product, must consider whether a patent under the Patents Act 1994 is in force in respect of the therapeutic product for which registration is sought. This is implemented to fulfil Singapore’s obligation under the US-Singapore Free Trade Agreement.
Currently, an applicant for the registration of a therapeutic product is required to assess any patent that needs to be declared in the registration form. Industry stakeholders have given feedback to HSA that the requirements under Regulation 23 lacked clarity, resulting in potential inappropriate use of the legislative mechanism.
The proposed amendments seek to: (i) identify the types of patents that must be considered when making a registration application for a therapeutic product, and for which the provisions under Regulation 23 apply; and (ii) ensure a system that facilitates registration applications by industry stakeholders and minimise any indiscriminate use of the legislative mechanism set out in Regulation 23.
Key Proposed Changes
The key proposed changes relate to the types of patents to be considered under Regulation 23 and the consequential amendments to Regulations 24 and 25 of the TPR.
Types of patents to be considered
The proposed amended Regulation 23 stipulates that this will apply to the following categories of patents that are in force in respect of the therapeutic product to which the application for registration relates:
(a) a patent containing a claim for an active ingredient of that therapeutic product;
(b) a patent containing a claim for a formulation or composition of that therapeutic product; and
(c) a patent containing a claim for the use of an active ingredient in the manufacture of that therapeutic product for a specific therapeutic, preventive, palliative or diagnostic use.
It is to be noted that patents that are in force in relation to the therapeutic product that do not fall under the abovementioned categories are not subject to the requirements under Regulation 23.
Consequential revisions to Regulations 24 and 25
Following the above amendments to be introduced, consequential changes will also be made to Regulations 24 and 25 of the TPR. Regulation 24 will be updated to reflect the jurisdiction under which matters relating to patent breaches reside. Regulation 25, on the other hand, clarifies the offences for making false declarations.
Click on the following links for more information:
- HSA Press Release titled “HSA Invites Feedback on Proposed Changes to Regulation 23 of the Health Products (Therapeutic Products) Regulations (available on the SG Press Centre platform at www.sgpc.gov.sg)
- Proposed Health Products (Therapeutic Products)(Amendment) Regulations 2024 (available on the HSA website at www.hsa.gov.sg)
