SINGAPORE Law and Practice Contributed by: Tony Yeo, Meryl Koh, Rozalynne Asmali and Javier Yeo, Drew & Napier LLC
tion means that no further action is taken against the patent apart from the fact that the court has declared that the patent is invalid. Consequently, if any party wishes to launch a standalone action challenging the validity of the patent, it must be for the revocation of the patent. Infringement and/or validity opinions are not available from IPOS. 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 dispose of, uses or imports the product or keeps it whether for disposal or otherwise, they can be sued for infringement. If the patent covers a method of manufacture, then as long as the party uses the process or they offer it for use in Singapore when they know, or it is obvious to a reasonable person in the circumstances, that its use without the consent of the proprietor would be an infringement of the patent, they can be sued for infringement. Relatedly, any product made from the said infringement process, would also constitute an infringement of the patent. In Singapore, the typical defendant in life sciences/ pharma cases is the generic that applies for marketing approval in Singapore for the sale of the pharmaceuti ‑ cal drug. Under Regulation 23 of the Health Products (Thera ‑ peutic Products) Regulations 2016 (Regulations), when the Health Sciences Authority (HSA) is deter ‑ mining whether to approve a therapeutic product reg ‑ istration 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 proprietor, 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 market ‑ ing approval, it is required to notify the patent proprie ‑ tor that it intends to apply for marketing 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 proprie ‑ tor 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 moratorium period, if the patent pro ‑ prietor has not obtained an order and/or declaration of infringement from the court, HSA may proceed to register 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 patents that were in force at the time of its application for a therapeutic product, the patent proprietor 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 exceeding SGD20,000 or to imprisonment for a term not exceed ‑ ing 12 months or to both. 1.3 Preliminary Injunction Proceedings An application for an interim injunction in patent litiga ‑ tion follows similar principles as those in civil cases. The applicant must show that there is a serious ques ‑ tion to be tried, that damages are not an adequate remedy and that the balance of convenience lies in favour of granting an injunction. The procedure for obtaining an interim injunction is set out in Order 13 of the Rules of Court 2021 (ROC 2021). In exchange for obtaining an interim injunction, the claimant may
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