Singapore: Amendment to the Patent Declarations Regulations

brief

The Health Products (Therapeutic Products) Regulations (“Regulation”) was recently amended through the Health Products (Therapeutic Products) (Amendment) Regulations 2024. The amendments came into effect on August 1, 2024.

These changes are intended to provide clarity to stakeholders about which patents need to be considered when applying to register a therapeutic product and which patents fall under the patent claims regulations. In addition, they seek to reduce the potential for abuse of the patent claims process.

• The revised patent declaration requirements are intended to reduce the number ofHuman serum albuminTo achieve this, the HSA will notify patent owners of the registration of products covered by them during the patent’s validity period without requiring their consent or approval. In particular, it is now clear that process patents do not fall within the scope of Article 23 of the Regulation.
• Any person who makes a false patent claim in an application for registration of a therapeutic product, such as: (a) making any statement or providing any document which the person knows or has reason to believe is false in a material particular; or (b) intentionally concealing any material fact and providing misleading information, shall be guilty of an offence and shall be liable on conviction to a fine of up to S$20,000 (approximately US$15,500) and/or imprisonment for up to 12 months.

Under section 23 of the Ordinance, the Health Sciences Authority must consider whether a patent for a therapeutic product for which registration is sought is valid. When making an application, a therapeutic product applicant must provide the Health Sciences Authority with a patent statement stating whether any patent is in force for the relevant product and whether the applicant is the patent owner. If the applicant is not the patent owner, the applicant must declare:

• The patent owner agrees to or acquiesces to the registration;
• the patent is invalid; or
• Actions related to the therapeutic product would not infringe the patent.

Following feedback received that the existing regulations lacked clarity and created uncertainty about the requirements for patent statements, and following a public consultation held from 1 to 31 March 2024, the HSA’s amendments to the regulations provide that the following patent statements must be provided to the HSA during registration of a therapeutic product (see our previous client alert):

• Patents containing claims directed to the active ingredient of the therapeutic product
• Patents containing claims directed to the formulation or composition of the therapeutic product
• Patents covering the use of active ingredients to make therapeutic products for specific therapeutic, preventive, palliative or diagnostic uses

The amendment also clarifies that the following patents are not subject to patent declaration requirements:

• Process patents, other than patents covering the use of an active ingredient to make a therapeutic product for a specific therapeutic, prophylactic, palliative or diagnostic use
• Patents containing only packaging-related claims
• Patents containing only metabolite-related claims
• Patents containing only claims related to intermediates

The HSA further clarifies that the types of patents subject to the provisions of Article 23 include:

• A mixed patent containing claims under Section 23(1)(a) and claims under Section 23(11), for example, a patent containing claims to the active ingredient of the therapeutic product and its metabolites
• Patents containing claims for the same polymorphic form of the active ingredient of the therapeutic product

Applicants must declare any current limiting patents relating to the therapeutic product for which registration is sought at the time of application and upon request by the HSA. The HSA will then process the application for registration according to the application class declared in the Patent Declaration Form.

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