In the recent case of Zyfas Medical Co (Sued as a firm) v Millennium Pharmaceuticals, Inc (Zyfas), the applicant for the patent of an anti-cancer drug did not declare an existing process patent for the production of an active ingredient in the anti-cancer drug sought to be patented.
According to Regulation 23(2)(a) of the (Therapeutic Products) Registration 2016 (TPR), an applicant for a patent, in applying for the patent, must declare whether a patent under the Patents Act is in force in respect of the therapeutic product being patented, and whether the applicant is the proprietor of the patent. The patent that is already in force must also be “in respect of” the therapeutic product, pursuant to Regulation 23(1) of the TPR.
Does “patent” apply to not only product patents, but also process patents?
Notably, the patent linkage scheme in Singapore has been modelled on the scheme in the United States of America (US). Under the US scheme, process patents are not protected.
However, in Zyfas, the Court of Appeal held that a broad interpretation of “patent” under the TPR is preferred. This was because a plain reading of the word “patent” in the Patent Act did not distinguish between patent processes and patent products. Furthermore, Regulation 23 of the TPR is intended to help notify patent proprietors of pending applications for the registration of therapeutic products that might infringe upon their patents. A narrow interpretation would not allow the patent proprietors to intervene appropriately.
Although a broad interpretation may make it onerous for applicants, by requiring applicants to wait 30 months before the therapeutic products could be registered, applicants can shorten the 30 month wait by proactively taking out a declaration of non-infringement.
If you are seeking to apply for a patent for a therapeutic product, do take care in ensuring that not only do no product patents are in existence, but also process patents. If they do, ensure that the existing patents are declared in your patent application.
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