The recent updates to Singapore's Health Products (Therapeutic Products) Regulations have clarified an often onerous aspect of registering a therapeutic product that includes elements relevant to a patent.
In Singapore, the patent drug linkage system requires that an applicant seeking to register a therapeutic product which utilises patented elements must make a declaration to the Health Science Authority (HSA).
This declaration to HSA needs to include information on the patent and the patent proprietor relating to the therapeutic product. Where the applicant is not the patent proprietor, HSA then requires the applicant to serve a notice on the patent proprietor.
The patent proprietor may then halt the marketing approval process for up to 30 months by applying to a Singapore Court for an injunction or a declaration that the patent is valid, and will be infringed by the doing of the act for which the registration of the therapeutic product is sought. The 30-months period is applicable regardless of the merit or the result of the application to the Court of the patent proprietor.
In the past, there has been no guidance on what types of patents should be declared, as the law simply requires declaration of patents "in respect of the therapeutic product".
The general practice has therefore been to declare any patent as long as it relates to the active ingredient of the therapeutic product to be marketed.
In the case of Zyfas Medical Co v Millennium Pharmaceuticals, Inc. [2020] SGCA 84, the Singapore Court of Appeal decided that patents directed to manufacture processes of a therapeutic product are considered patents "in respect of the therapeutic product" as "the active ingredient in that product could have been made using the patented processes". Hence, patents that are directed to manufacture processes need to be included in the declaration.
The latest amendment to the Health Products (Therapeutic Products) Regulations came into effect on 1 August 2024 and provided clarity on patents that should be declared by applicants of marketing approval of therapeutic products.
When a patent should be listed in the declaration
It is specified in the amended Regulations that a patent should be declared when seeking for marketing approval of a therapeutic product if the patent contains any one of the following:
- a claim for an active ingredient of that therapeutic product;
- a claim for a formulation or composition of that therapeutic product; or
- 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.
Point (iii) above refers to the language of Swiss type medical use claims. In Singapore, such claim format is generally used to define a second or subsequent medical use of a therapeutic product, instead of manufacture processes per se. It is stated in the Examination Guidelines that:
"Normally, "for" is interpreted as "suitable for". However, in a "Swiss-type" claim, "for" is interpreted as "suitable and intended for" treatment of the indication specified."
When a patent need not be listed in the declaration
It is further specified that a patent need not be declared if it is a patent that contains only claims:
- directed to manufacture processes
- relating to packaging
- relating to metabolites, or
- relating to intermediates.
For the sake of clarity, a patent needs to be declared as long as it contains one claim as listed in points (i) to (iii) above (while the remaining claims can be directed to those listed in points (a) to (d) above).
How we can assist
These amendments to the Regulations effectively removed the patent proprietor's right to hold the applicant's application for marketing approval for 30 months based on patents relating only to manufacture processes, packaging, metabolites or intermediates.
For patent proprietors, it is therefore important to consider these changes when formulating claims for their Singapore applications to ensure that they are still able to take advantage of this 30-month stay on the marketing approval process.
With a rounded, 360° view of the Singapore patent system and all of the applicable contributing factors, our team can assist and guide you in your patent strategies for the region. Don't hesitate to reach out for advice on your particular circumstances and considerations.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
