Millennium Pharmaceuticals, Inc v Zyfas Medical Co (sued as a firm)  SGHC 28
The Singapore High Court (“Court”) has recently held that a failure to declare relevant patents under Singapore’s patent linkage requirement need not have been a knowing or intentional failure, in order to attract the associated sanctions.
The defendant obtained a therapeutic product registration for a product containing the active ingredient bortezomib and sold under the name “Myborte”.
Bortezomib was itself not covered by any existing product patent in Singapore. The plaintiff was the proprietor of patents (“Patents”) relating to the manufacture of bortezomib. The defendant was of the view that only product patents that were in force in respect of a therapeutic product had to be declared. As a result, the defendant failed to disclose that the Patents were in force.
Obiter, the Court noted that disclosure of whether a patent is in force in respect of a therapeutic product included the disclosure of existing process patents in respect of the therapeutic product.
More importantly however, the defendant had submitted that in determining whether the declaration omitted to disclose any matter that was material to the application, the Court must examine the defendant’s knowledge or intention at the time the declaration was made.
After analysing relevant provisions of the Interpretation Act and the Health Products (Therapeutic Products) Regulations 2016 (S 329/2016), the Court rejected the defendant’s argument. The plaintiff was simply required to show that the defendant had failed to disclose any matter that was material to its application.
This case highlights the stringent application of Singapore’s patent linkage system. Would – be registrants of therapeutic products in Singapore should err on the side of caution in making declarations.