Singapore HSA starts public consultation on therapeutic product regulation changes

The Health Sciences Authority (HSA) of Singapore has begun a public consultation immediately that may go on all through the month of March, based on a authorities media launch.

Public suggestions is invited on proposed amendments to Regulation 23 of the Health Products (Therapeutic Products) Regulations (“TPR”) on patent declaration. The public consultation runs from March 1 to March 31, 2024. The consultation doc and draft laws can be found on the HSA web site (https://go.gov.sg/hptp-reg-amend).

Background

Under Regulation 23 of the TPR, the HSA should take into account whether or not a patent below the Patents Act 1994 is in pressure in respect of the therapeutic product present process registration software.

The applicant in search of to register a therapeutic product is required to make and furnish a patent declaration to the HSA, and notify the patent proprietor if a registration software for a therapeutic product that’s topic to a patent is made through the patent time period with out the consent or acquiescence of the proprietor.

The legislative mechanism was applied to fulfil Singapore’s obligation below the US-Singapore Free Trade Agreement. It seeks to facilitate well timed decision of any potential patent disputes previous to the HSA’s granting of registration for a therapeutic product.

Objectives

The proposed amendments goal to:

1. Provide readability to business stakeholders on the kinds of patents that have to be thought-about when making a registration software for a therapeutic product, and for which the provisions below Regulation 23 apply.
2. Ensure a system that facilitates all business stakeholders in making registration functions and minimises any potential indiscriminate use of the mechanism below Regulation 23.

Key proposed legislative changes

Regulation 23 shall be amended to use to the next classes of patents which can be in pressure in respect of the therapeutic product present process registration software:

1. a patent containing a declare for an lively ingredient of that therapeutic product;
2. a patent containing a declare for a formulation or composition of that therapeutic product;
3. a patent containing a declare for using an lively ingredient within the manufacture of that therapeutic product for a selected therapeutic, preventive, palliative or diagnostic use.

Patents which can be in pressure in respect of the therapeutic product however don’t fall below the abovementioned classes are usually not topic to the necessities below Regulation 23.

Regulations 24 and 25 shall be up to date to mirror the jurisdiction below which patent infringement issues reside and make clear the offences associated to creating a false declaration, respectively.