In more detail
On 31 May 2024, the HSA published a summary of the respondents and feedback collected following the close of its public consultation on the Regulations. You may refer to our previous newsletter article here, where we provided a summary of the Regulations.
In total, 36 responses were received. The feedback from the public consultation was overall positive, with support for the proposed amendments to the Regulations on patent declaration. The majority of the feedback focused on questions regarding the scope of patents and the patent declaration process under the Regulations. To that end, the HSA had provided further information in response to such feedback.
1. Scope of patents considered under the Regulations
In particular, the circumstances in which a patent would not need to be considered under the Regulations may include the following:
- A patent specified in Regulation 23(1)(a)(i) is in force in relation to 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.
- A patent specified in Regulation 23(1)(a)(iii) is in force in relation to 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 relation to indication Y.
2. Patent declaration process
Applicants must declare any subsisting restraining patent in relation to the therapeutic product for which registration is sought at the time of application and as required by the HSA. The HSA will then process registration applications based on the declared application category in the patent declaration form. More information regarding the subsisting patents in force in relation to a therapeutic product is available here.
The HSA also received suggestions on additional measures to the mechanism under the Regulations, which it is currently reviewing. The HSA has stated that the suggestions proposed by the public would be weighed against the applicability of the measures in Singapore's local context while ensuring that Singapore's international obligations continue to be met.
The full HSA announcement can be found here.
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