SINGAPORE Law and Practice Contributed by: Tony Yeo, Meryl Koh, Rozalynne Asmali and Javier Yeo, Drew & Napier LLC
able to prove that the generics intend to market that product for that second medical use. An issue closely intertwined with the infringement of patents with Swiss-type claims is whether the exclu ‑ sion of the patent-protected indications from the product labels of potentially-infringing medical prod ‑ ucts would preclude a claim of patent infringement. The practice of excluding patented indications is often referred to as “skinny-labelling” or “carving out”. This is a developing area of the law, both in Singapore and in the UK. On the one hand, there have been some obiter comments in English case law that the prob ‑ lem of infringement posed by “skinny labels” is more theoretical than real, since product manufacturers often have to provide details of the approved indica ‑ tions on its product information leaflets. On the other hand, there have also been decisions in the UK and the Netherlands which suggest that manufacturers of “skinny-labelled” products may infringe a second medical use claim if there is a subjective intention on the part of the manufacturer that the pharmaceuti ‑ cal composition will be used for treating the patented indication. It should be noted that unlike in the UK Pat ‑ ents Act, there is no provision for indirect infringement in the Singapore PA. As there have been no reported local cases on this issue, it remains to be seen how the Singapore courts will decide on it. 2.2 Regulatory Data and Market Exclusivity Regulation 26 of the Regulations provides for protec ‑ tion of confidential information relating to innovative therapeutic product applications. Confidential infor ‑ mation received in support of the registration of an innovative therapeutic product is protected for a peri ‑ od 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 applications. Confidential information here includes trade secrets and information that has commercial 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 efficacy data has been generated in support of its registration. During the exclusivity period, a subsequent similar therapeutic product will not be able to rely on such data generated
for the earlier therapeutic product to obtain registra ‑ tion. 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 must be approved by the HSA before they can be marketed and/or sold in Singapore. These approval processes can take a very long time, and a generic may apply for market ‑ ing approval near the expiry date of a patent, with the intention of launching immediately once the patent expires. The Bolar provision is therefore a legal exemption from infringement if the generic can prove that the acts which otherwise would have been infringing, were done to meet 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 Singa ‑ pore. 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 reg ‑ istered in Singapore, pursuant to the HPA and the Regulations, a 30-month moratorium on registering the products is available to patent proprietors who are put on notice that an applicant is seeking to reg ‑ ister 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 proprie ‑ tor commences a patent infringement action against the applicant. In practice, this is a more viable option
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