Summary of Responses to Feedback from Public Consultation on the Proposed Amendments to Regulation 23 of the Health Products (Therapeutic Products) Regulations

1        The Health Sciences Authority (HSA) invited stakeholders to provide feedback on the proposed amendments to regulation 23 of the Health Products (Therapeutic Products) Regulations 2016 (“Regulations”). The public consultation commenced on 1 March 2024 and closed on 12 April 2024.

2        We received a total of 36 responses to this consultation. The summaries of the respondents and their feedback by category are provided in Table 1 and Table 2.

3        The consultation responses were positive and supported the proposed implementation of restraining patents and amendments to regulations 23 of the Regulations. Most of the feedback relate to queries on the scope of patents, as well as the patent declaration process under the revised regulation 23. HSA has published information detailing the scope of patents and the patent declaration process in Annex 1 to provide the necessary clarity.

4        HSA has also received suggestions on additional measures to the mechanism under the revised regulation 23. We will review the suggestions taking into consideration the applicability of the measures in our local context while ensuring that Singapore’s international obligations continue to be met.

Table 1: Respondents by Category

Table 2: Feedback by Category

5        HSA would like to thank all stakeholders who have participated in the public consultation on the proposed amendments to regulation 23 of the Regulations.

HEALTH PRODUCTS REGULATION GROUP
HEALTH SCIENCES AUTHORITY
31 MAY 2024

ANNEX 1

A. Types of patents to be considered under regulation 23

1        Regulation 23 of the Health Products (Therapeutic Products) Regulations will be amended to apply to the following categories of patents that are in force in respect of the therapeutic product to which the application for registration relates (hereafter referred to as “restraining patents”):

(i) a patent containing a claim for an active ingredient of that therapeutic product;

(ii) a patent containing a claim for a formulation or composition of that therapeutic product;

(iii) 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.

2        Patents that are in force in respect of the therapeutic product but do not fall under the abovementioned categories are not subject to the requirements under regulation 23. A non-exhaustive list of patents to which regulation 23 does not apply can be found under regulation 23(11) of the Regulations.

3        Some examples on the types of patents that are subject to the requirements under regulation 23:

(i) A patent that contains a mixture of claims specified in regulation 23(1)(a), and claims specified in regulation 23(11). E.g., A patent containing claims for both an active ingredient of that therapeutic product, and its metabolites;

(ii) A patent containing a claim for the same polymorphic form of an active ingredient of that therapeutic product.

4        The circumstances in which a patent would not need to be considered under regulation 23 may include:

(i) A patent specified in regulation 23(1)(a)(i) is in force in respect of a polymorphic form X of the active ingredient. The application for registration is for a polymorphic form Y of the same active ingredient, and the patent claims for polymorphic form X of the active ingredient will not be infringed by the act for which the registration of the therapeutic product containing polymorphic form Y is sought;

(ii) A patent specified in regulation 23(1)(a)(iii) is in force in respect of indication X of the therapeutic product for which registration is sought. The application for registration is for indication Y, and the patent claims for indication X will not be infringed by the act for which the registration of the therapeutic product is sought in respect of indication Y.

B. Patent declaration process

5        An applicant for registration of a therapeutic product is required to make a declaration on whether the therapeutic product for which registration is sought is subject to a subsisting restraining patent specified in regulation 23(1)(a) of the Regulations. The declaration must be furnished at the time of making the application, as well as at any other such time prior to the determination of the application as HSA may require, in the form specified in Appendix 1 of the Guidance on Therapeutic Product Registration in Singapore published on HSA website. Detailed information on the patent declaration procedure is provided in Chapter A, Section 3, of the Guidance document.

6        HSA will process the applications for registration based on the application category declared in the patent declaration form. For information regarding the subsisting patents in force in respect of a therapeutic product, applicants may wish to refer to the online resources available on the IPOS website ↗ (opens in new tab).