SINGAPORE Law and Practice Contributed by: Tony Yeo, Meryl Koh, Rozalynne Asmali and Javier Yeo, Drew & Napier LLC
4. Patent Term Extensions for Pharmaceutical Products 4.1 Supplementary Protection Certificates Under Section 36A of the PA, the proprietor of a patent which subject includes any substance which is an active ingredient of any pharmaceu - tical product may apply to extend the term of the patent not exceeding five years if there was an unreasonable curtailment of the opportunity to exploit the patent caused by the process of obtaining marketing approval for a pharmaceuti - cal product, being the first pharmaceutical prod - uct to obtain marketing approval which uses the substance as an active ingredient; and the term of the patent has not previously been extended on this ground. 4.2 Paediatric Extensions There are no extended protections provided for paediatric indications over and above the allow - able five-year extension. 4.3 Paediatric-Use Marketing Authorisations Paediatric medicines are considered as thera - peutic products which are governed by the HPA. As with all health products, a company seeking to market a therapeutic product in Singapore must obtain marketing approval from HSA by submitting an application for product registra - tion under Section 30(1) of the HPA. 4.4 Orphan Medicines Extensions There are no extended protections provided for orphan drugs over and above the allowable five- year extension.
There has been no known suit against HSA for the refusal to list or grant marketing approval. Since HSA is a statutory body imbued with the authority to grant marketing approvals, any administrative suits will be a judicial review of HSA’s decision. 3. Biosimilar Market Entry 3.1 Infringing Acts There are no differences at present in this juris - diction. See 2.1 Infringing Acts . 3.2 Data and Regulatory Exclusivity There are no differences at present in this juris - diction. See 2.2 Regulatory Data and Market Exclusivity . 3.3 Acceptable Pre-Launch Preparations There are no differences at present in this juris - diction. See 2.3 Acceptable Pre-Launch Prepa- rations . 3.4 Publicly Available Drug and Patent Information There are no differences at present in this juris - diction. See 2.4 Publicly Available Drug and Patent Information . 3.5 Reimbursement and Pricing/Linkage Markets There are no differences at present in this juris - diction. See 2.5 Reimbursement and Pricing/ Linkage Markets .
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