In brief

The Health Sciences Authority (HSA) is conducting a public consultation from 1 to 31 March 2024 on the proposed amendments to the Health Products (Therapeutic Products) Regulations 2016 (“Regulations“) on patent declaration.

The proposed amendments are intended to provide clarity to stakeholders on the types of patents that must be considered when making an application for registration of a therapeutic product, and for which the patent declaration regulations apply; and to minimize potential indiscriminate use of the patent declaration mechanism.  

Background

Under Regulation 23 of the Regulations, the HSA is required to consider whether a patent is in force in respect of a therapeutic product that is sought to be registered.

Therapeutic product applicants must, at the time of their application, furnish to the HSA a patent declaration stating whether any patent is in force in respect of the relevant product and whether the applicant is the proprietor of the patent. Where the applicant is not the proprietor of the patent, the applicant must declare that:

• the patentee has consented to or has acquiesced in the grant of the registration;
• the patent is invalid; or
• the patent will not be infringed by acts relating to the therapeutic product.

The patent declaration requirement is intended to minimize potential patent disputes before HSA’s grant of registration, and does so by notifying patent proprietors of registration of products subject to a patent during the patent term without their consent or acquiescence.

Any person who makes a false patent declaration shall be guilty of an offense and be liable on conviction to a fine not exceeding SGD 20,000 and/or imprisonment for up to 12 months. If an applicant fails to declare relevant patents, patentees may also bring an action for a declaration that the applicant infringed a patent or omitted to disclose material information when obtaining registration of a generic therapeutic product. Such a declaration can be used to seek cancellation of the product’s registration and marketing approval.

Key proposed changes

Having received feedback that the existing regulations lack clarity and create uncertainty as to the requirements for patent declarations, the HSA’s proposed regulations specify that the following patent declarations must be furnished to the HSA durin...