Recent updates to Singapore’s Patent Linkages Scheme

Singapore’s Patent Linkage Scheme has been recently updated, with the most important change clarifying the types of patents that must be listed in a Patent Declaration to the Health Sciences Authority (HSA) when seeking marketing authorisation for a drug.

The relevant amendment is to Regulation 23 of Singapore’s Health Products (Therapeutic Products) Regulations, which became effective on 1 August 2024. The change simplifies the Patent Declaration procedure for generics, as it seeks to bring Singapore’s Patent Linkage Scheme more into line with that of the US. The patent declaration requirements are now as follows.

Patents that must be declared:

• Patents containing a claim to the active ingredient of the therapeutic product.
• Patents containing a claim to a formulation or composition that includes the therapeutic product.
• Patents containing a claim to the use of the active ingredient in the manufacture of the therapeutic product for a specific therapeutic, preventive, palliative, or diagnostic use. That is, first or second medical use claims.

Patents excluded from declaration:

• Process patents, other than process patents that contain a claim to the use of an active ingredient in the manufacture of a therapeutic product for a specific therapeutic, preventive, palliative or diagnostic use. That is, patents only directed to the manufacture of the therapeutic product.
• Patents that only contain claims relating to the packaging, metabolites, or intermediates of a therapeutic product.

Previously, Regulation 23 simply stated that the HSA must consider patents in force “in respect of” the therapeutic product. No distinction was made between process patents and product patents, leaving room for interpretation by the Singapore courts.

This ambiguity was addressed by the Court of Appeal in Zyfas Medical Co v Millennium Pharmaceuticals, Inc. [2020] SGCA 84, where the court held that process patents fell within the broad language of previous Regulation 23 and therefore must be declared. As Singapore has no Orange or Purple Book equivalents, the applicant for marketing authorisation has to conduct their own searches to establish which patents should be listed in their Patent Declarations to the HSA. The need to list process patents significantly increased the burden on applicants seeking to meet their obligations and raised the risk of losing authorisation (and possible criminal sanctions) if the authorisation did not include patents that may be considered relevant by the HSA.

As such, the amendment to Regulation 23 clarifies and narrows the scope of the Patent Declaration requirements, reducing the burden on applicants for marketing authorisation of a therapeutic product in Singapore. 

This amendment is expected to be welcomed by generic companies looking to enter the Singapore market.