SINGAPORE Law and Practice Contributed by: Tony Yeo, Meryl Koh, Rozalynne Asmali and Javier Yeo, Drew & Napier LLC
1.2 Defendants/Other Parties to an Action Patent infringement in Singapore is territorial in nature. Consequently, only parties who carry out infringing acts within the jurisdiction can be sued for patent infringement. If the patent covers a product, then as long as the party makes, disposes of, offers to dis - pose of, uses or imports the product or keeps it whether for disposal or otherwise, he/she can be sued for infringement. If the patent covers a method of manufacture, then as long as the party uses the process or he/ she offers it for use in Singapore when he/she knows, or it is obvious to a reasonable person in the circumstances, that its use without the con - sent of the proprietor would be an infringement of the patent, he/she can be sued for infringe - ment. Relatedly, any product made from the said infringement process, would also constitute an infringement of the patent. In Singapore, the typical defendant in life sci - ences/pharma cases is the generic that applies for marketing approval in Singapore for the sale of the pharmaceutical drug. Under Regulation 23 of the Health Products (Therapeutic Products) Regulations 2016 (Reg - ulations), when the Health Sciences Authority (HSA) is determining whether to approve a thera - peutic product registration application or grant a product licence for a therapeutic product, it considers: • whether a patent under the Patents Act 1994 is in force in respect of the product; • whether the applicant is the patent proprie - tor, or has obtained the patent proprietor’s consent; and
• whether the patent is invalid, or will not be infringed by doing the act for which the licence is sought. This means that when the generic applies for marketing approval, it is required to notify the patent proprietor that it intends to apply for mar - keting approval, and submit a declaration that the patent (if there is one in force) is invalid or will not be infringed by doing the act for which the licence is sought. The patent proprietor then has the right to oppose the licence application by commencing a patent infringement action within 45 days from receiving notice of the generic’s licence application and declaration. Once the patent proprietor commences the action, it will inform HSA that it has done so, and HSA will not register the therapeutic product for a period of 30 months. At the expiry of the 30-month mora - torium period, if the patent proprietor has not obtained an order and/or declaration of infringe - ment from the court, HSA may proceed to regis - ter the therapeutic product without further notice to the patent proprietor. If a generic makes a false declaration to HSA by omitting to disclose the existence of certain pat - ents that were in force at the time of its applica - tion for a therapeutic product, the patent propri - etor may seek a declaration from the court that the generic has made a false declaration, and pursuant to Regulation 24 of the Regulations, HSA may cancel the registration (see Millennium Pharmaceuticals, Inc v Zyfas Medical Co (sued as a firm) [2020] SGHC 28). Any person who makes a false declaration may also be liable on conviction to a fine not exceed - ing SGD20,000 or to imprisonment for a term not exceeding 12 months or to both.
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