Therapeutic product registration could be jeopardised by omitting to disclose a pertinent patent, regardless of whether the omission was wilful
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Partner
Singapore
I am an Intellectual Property litigation partner in Singapore, where my commercial insights into our clients' needs enable me to effectively manage IP litigation matters in Singapore and the ASEAN region.
Pursuant to the Health Products (Therapeutic Products) Regulations ("HPR"), applicants for registration of a therapeutic product with the Health Sciences Authority ("HSA") in Singapore must declare whether "a patent is in force in respect of the therapeutic product" ("pertinent patent"). This requirement is part of the patent linkage system in Singapore, which ensures that no therapeutic product would be approved before the expiration of the pertinent patent, except with the consent of the owner of the pertinent patent.
In the recent decision of Millennium Pharmaceuticals, Inc, vs Zyfas Medical Co [2020] SGHC 28, the High Court granted a declaration that Zyfas had omitted to disclose matter that is material to its application for the registration of a therapeutic product, even though Zyfas'…
