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
than the customary qua timet injunction to prevent an imminent threat of infringement. There is no public list of applications for marketing approval. Patent proprietors therefore rely solely on the generic’s notice identifying the relevant patents relating to the generic product. Patent proprietors can file a court declaration if the generic is found to have made a false declaration in its notice by excluding patents that are relevant to the drug for which the generic has applied for marketing approval. 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 2.1 Infringing Acts applies similarly in respect of bio ‑ logics or biosimilar products. 3.2 Data and Regulatory Exclusivity 2.2 Regulatory Data and Market Exclusivity applies similarly in respect of biologics or biosimilar products. 3.3 Acceptable Pre-Launch Preparations 2.3 Acceptable Pre-Launch Preparations applies similarly in respect of biologics or biosimilar products. 3.4 Publicly Available Drug and Patent Information 2.4 Publicly Available Drug and Patent Information applies similarly in respect of biologics or biosimilar products. 3.5 Reimbursement and Pricing/Linkage Markets 2.5 Reimbursement and Pricing/Linkage Markets applies similarly in respect of biologics or biosimilar products.
4.1 Supplementary Protection Certificates Under Section 36A of the PA, the proprietor of a patent relating to a substance which is an active ingredient of any pharmaceutical product may apply for an exten ‑ sion of the patent term for a period not exceeding five years. An extension may be granted if there was an unreasonable curtailment of the opportunity to exploit the patent caused by the process of obtaining market ‑ ing approval for a pharmaceutical product, provided that the product was the first pharmaceutical product to obtain marketing approval using that 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 pae ‑ diatric indications over and above the allowable five- year extension. 4.3 Paediatric-Use Marketing Authorisations Paediatric medicines are considered as therapeutic products which are governed by the HPA. As with all health products, a company seeking to market a ther ‑ apeutic product in Singapore must obtain marketing approval from HSA by submitting an application for product registration 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. 5. Relief Available for Patent Infringement 5.1 Preliminary Injunctive Relief See 1.3 Preliminary Injunction Proceedings . It is not common to apply for an interim injunction for patent cases involving pharmaceutical patents or health products in view of the patent-linkage scheme, which gives the patent proprietor a statutory right to, in effect, a qua-timet injunction of 30 months from the
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