The Health Products (Therapeutic Products) Regulations were amended on 1 August 2024 to provide clarification on the types of patents that need to be declared when applying for registration of a therapeutic product before the Health Sciences Authority (HSA) in Singapore.
Patent linkage system in Singapore
Under Regulation 23, an applicant for registration of a therapeutic product (i.e., marketing approval) for a therapeutic product is required to furnish to HSA at the time of application a patent declaration stating whether any patent is in force in respect of the therapeutic product and whether the applicant is the proprietor of the patent.
If the applicant is not the proprietor of the patent, then the applicant must declare whether: i) the proprietor has consented to or has acquiesced in the grant of the registration; or ii) in the opinion of the applicant and to the best of the applicant’s belief, the patent is invalid or will not be infringed by the doing of the act for which registration is sought.
If the applicant declares that the patent is, in the applicant’s opinion and belief, invalid or will not be infringed, HSA may require the applicant to serve a notice on the patent proprietor.
On being notified, a patent proprietor can intervene in the application process and prevent the therapeutic product from being registered. To do so, the patent proprietor must, within 45 days of receiving the notice, file court proceedings to seek an injunction or a declaration that the relevant patent is valid or will be infringed and notify HSA. A 30-month moratorium will then be imposed on the registration process until court proceedings are concluded or the 30-month moratorium concludes, whichever is earlier.
Patents to be declared
Previously, it was unclear whether all types of patents (including process patents) that are in force in respect of the therapeutic product were required to be declared. In August 2020, the Court of Appeal in Zyfas Medical Co v Millennium Pharmaceuticals, Inc. [2020] SGCA 84 clarified that the broad scope of the previous Regulations can include process patents that are relevant in relation to the therapeutic product. This also suggested that any types of patents that may be potentially relevant to the therapeutic product must be declared.
The Regulations are now amended to clarify that only the following patents will need to be declared:
- a patent containing a claim for an active ingredient of the relevant therapeutic product;
- a patent containing a claim for a formulation or composition of the therapeutic product; and
- a patent containing a claim for the use of an active ingredient in the manufacture of the therapeutic product for a specific therapeutic, preventive, palliative or diagnostic use.
The amended Regulations also clarify that the following patents do not need to be declared:
- a process patent, other than a process patent that contains a claim for the use of an active ingredient in the manufacture of a therapeutic product for a specific therapeutic, preventive, palliative or diagnostic use;
- a patent that contains only claims relating to packaging;
- a patent that contains only claims relating to metabolites; and
- a patent that contains only claims relating to intermediates.
The amendments to Regulation 23 provide greater clarity on the types of patents that need to be declared. These amendments bring the patent linkage system in Singapore more in line with that in United States, where patents directed to processes, packaging, metabolites and intermediates are not listed in the Orange Book of the Food and Drug Administration (FDA).
If you have any questions in relation to the patent linkage system in Singapore, please contact Kian Hoe Khoo (kkhoo@dcc.com) or Jie An Yang (jyang@dcc.com).