Therapeutic product registration could be jeopardised by omitting to disclose a pertinent patent, regardless of whether the omission was wilful

By Anan Sivananthan, Yuet Ping Tai

03-2020

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' omission was not intentional. The declaration would enable Millennium to apply to the HSA to cancel the registration of Zyfas' therapeutic product.

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