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Singapore: Health Sciences Authority seeks feedback on proposed amendments to health product patent declaration regulations

By 4 Mins Read

In brief

The Health Sciences Authority (HSA) is conducting a public consultation from 1 to 31 March 2024 on the proposed amendments to the Health Products (Therapeutic Products) Regulations 2016 (“Regulations“) on patent declaration.

The proposed amendments are intended to provide clarity to stakeholders on the types of patents that must be considered when making an application for registration of a therapeutic product, and for which the patent declaration regulations apply; and to minimize potential indiscriminate use of the patent declaration mechanism.  

In more detail

Background

Under Regulation 23 of the Regulations, the HSA is required to consider whether a patent is in force in respect of a therapeutic product that is sought to be registered.

Therapeutic product applicants must, at the time of their application, furnish to the HSA a patent declaration stating whether any patent is in force in respect of the relevant product and whether the applicant is the proprietor of the patent. Where the applicant is not the proprietor of the patent, the applicant must declare that:

  • the patentee has consented to or has acquiesced in the grant of the registration;
  • the patent is invalid; or
  • the patent will not be infringed by acts relating to the therapeutic product.

The patent declaration requirement is intended to minimize potential patent disputes before HSA’s grant of registration, and does so by notifying patent proprietors of registration of products subject to a patent during the patent term without their consent or acquiescence.

Any person who makes a false patent declaration shall be guilty of an offense and be liable on conviction to a fine not exceeding SGD 20,000 and/or imprisonment for up to 12 months. If an applicant fails to declare relevant patents, patentees may also bring an action for a declaration that the applicant infringed a patent or omitted to disclose material information when obtaining registration of a generic therapeutic product. Such a declaration can be used to seek cancellation of the product’s registration and marketing approval.

Key proposed changes

Having received feedback that the existing regulations lack clarity and create uncertainty as to the requirements for patent declarations, the HSA’s proposed regulations specify that the following patent declarations must be furnished to the HSA during registration of therapeutic products:

  • a patent containing a claim for an active ingredient of that therapeutic product;
  • a patent containing a claim for a formulation or composition of that therapeutic product;
  • a patent containing a claim for the use of an active ingredient in the manufacture of that therapeutic product for a specific therapeutic, preventive, palliative or diagnostic use.

Patents that do not fall within the abovementioned categories are not subject to the declaration requirement in Regulation 23 of the Regulations.

HSA intends for these legislative changes to provide clarity to organizations on the type of patents to be considered in patent declarations in order to better facilitate the therapeutic products registration system.

Public consultation

The HSA welcomes feedback on the proposed regulation for patent declarations. Feedback may be provided until 31 March 2024.

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Author

Andy Leck is the head of the Intellectual Property and Technology (IPTech) Practice Group and a member of the Dispute Resolution Practice Group in Singapore. He is a core member of Baker McKenzie's regional IP practice and also leads the Myanmar IP Practice Group. Andy is recognised by reputable global industry and legal publications as a leader in his field. He was named on "The A-List: Singapore's Top 100 lawyers" by Asia Business Law Journal 2018. In addition, Chambers Asia Pacific notes that Andy is "a well-known IP practitioner who is highlighted for his record of handling major trade mark litigation, as well as commercial exploitation of IP rights in the media and technology sectors. He's been in the industry for a long time and has always been held in high regard. He is known to be very fair and is someone you would like to be in the trenches with you during negotiations." Furthermore, Asian Legal Business acknowledges Andy as a leading practitioner in his field and notes that he “always gives good, quick advice, [is] client-focused and has strong technical knowledge for his areas of practice.” Andy was appointed by the Intellectual Property Office of Singapore (IPOS) as an IP Adjudicator to hear disputes at IPOS for a two-year term from April 2021. He has been an appointed member of the Singapore Copyright Tribunal since May 2010 and a mediator with the WIPO Arbitration and Mediation Center. He is also appointed as a Notary Public & Commissioner for Oaths in Singapore. He previously served on the International Trademark Association’s Board of Directors and was a member of the executive committee.

Author

Ren Jun Lim is a principal with Baker McKenzie Wong & Leow. He represents local and international clients in both contentious and non-contentious intellectual property matters. He also advises on a full range of healthcare, as well as consumer goods-related legal and regulatory issues. Ren Jun co-leads Baker McKenzie Wong & Leow's Healthcare as well as Consumer Goods & Retail industry groups. He sits on the Law Society of Singapore IP Committee and on the Executive Committee of the Association of Information Security Professionals. He is also a member of the Vaccines Working Group, Singapore Association of Pharmaceutical Industries, a member of the International Trademark Association, as well as a member of the Regulatory Affairs Professionals Association. Ren Jun is ranked in the Silver tier for Individuals: Enforcement and Litigation and Individuals: Prosecution and Strategy, and a recommended lawyer for Individuals: Transactions by WTR 1000, 2020. He is also listed in Asia IP's Best 50 IP Expert, 2020, recognised as a Rising Star by Managing IP: IP Stars, 2019 and one of Singapore's 70 most influential lawyers aged 40 and under by Singapore Business Review, 2016. Ren Jun was acknowledged by WTR 1000 as a "trademark connoisseur who boasts supplementary knowledge of regulatory issues in the consumer products industry." He was also commended by clients for being "very responsive to enquiries and with a keen eye for detail, he is extremely hands-on. His meticulous and in-depth approach to strategising is key to the excellent outcomes we enjoy."

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