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
