SINGAPORE Law and Practice Contributed by: Tony Yeo, Meryl Koh, Rozalynne Asmali and Javier Yeo, Drew & Napier LLC
2.2 Regulatory Data and Market Exclusivity
The Bolar provision is therefore a legal exemp - tion from infringement if the generic can prove that the acts which otherwise would have been infringing, were done for meeting the marketing approval requirements for the pharmaceutical product. 2.4 Publicly Available Drug and Patent Information There is no equivalent of the Orange Book in Singapore. 2.5 Reimbursement and Pricing/Linkage Markets Singapore has a patent linkage scheme, which is set out in Regulation 23 of the Regulations. HSA oversees the administration of these regulations. In specific relation to therapeutic products to be registered in Singapore, pursuant to the HPA and the Regulations, a 30-month moratorium on reg - istering the said products is available to patent proprietors who are put on notice that an appli - cant is seeking to register a therapeutic product which is related to a patent that is currently in force. This moratorium is automatic and will kick in on the date that the patent proprietor com - mences a patent infringement action against the applicant. In practice, this is a more viable option than the customary qua timet injunction to pre - vent an imminent threat of infringement. There is no public list of applications for mar - keting 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 falsely declared in its notice by excluding patents that are relevant to the drug for which the generic has applied for marketing approval.
Regulation 26 of the Regulations provide for protection of confidential information relating to innovative therapeutic product applications. Confidential information received in support of the registration of an innovative therapeutic product is protected for a period of five years from the date of receipt, during which HSA which will not use the information to determine whether to grant any other registration appli - cations. Confidential information here includes trade secrets and information that has commer - cial value which will be diminished by disclosure. Pursuant to Regulation 29 of the Regulations, a five-year period of exclusivity is granted for a therapeutic product for which safety and effi - cacy data has been generated in support of its registration. During the exclusivity period, a sub - sequent similar therapeutic product will not be able to rely on such data generated for the earlier therapeutic product to obtain registration. 2.3 Acceptable Pre-Launch Preparations The research exemption more commonly known as the “Bolar” provision protects generics who may need to conduct research and/or trials to prove that their generic version of the product is the bioequivalent of the patented drug or, who may, in the course of obtaining marketing approval for the release of a drug in Singapore, inadvertently infringe a patent. All pharmaceutical products have to be approved by the HSA before they can be marketed and/ or sold in Singapore. These approval processes can take very long, and a generic may apply for marketing approval near the expiry date of a pat - ent, with the intention of launching immediately once the patent expires.
293 CHAMBERS.COM
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