23 March 2020 | Anan Sivananthan Partner, Yuet Ping Tai

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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About the Author

anan sivananthan module

Anan Sivananthan
I am a partner in our Intellectual Property Group in Singapore where my commercial insights into our clients' needs enables me to design and implement global patent monetisation strategies.

Direct: +65 6534 5266

[email protected]

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