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In brief

The regulations relating to patent linkage in the Health Products (Therapeutic Products) Regulations (“Regulations“) were recently amended through the Health Products (Therapeutic Products) (Amendment) Regulations 2024. The amendments came into force on 1 August 2024.

The changes aim to clarify for stakeholders which patents need to be considered when applying to register a therapeutic product and which patents fall under the patent declaration regulations. Additionally, they seek to reduce the potential for indiscriminate use of the patent declaration process.


Key takeaways

  • The amended patent declaration requirements aim to reduce potential patent disputes before the Health Sciences Authority (“HSA“) grants registration for therapeutic products. To achieve this, HSA will notify patent owners about the registration of products covered by a patent during its term without their consent or agreement. In particular, it is now clear that process patents do not fall within Regulation 23 of the Regulations.
  • Anyone who makes a false patent declaration when applying to register a therapeutic product, such as: (a) by making any statement or furnishing any document which the person knows or has reason to believe is false in a material particular; or (b) by intentionally suppressing any material fact, and furnishing information that is misleading, shall be guilty of an offense and liable on conviction to a fine of up to SGD 20,000 (approx. USD 15,500) and/or imprisonment for up to 12 months.

In more detail

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 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.

Following feedback received that the existing regulations lack clarity and create uncertainty as to the requirements for patent declarations, and following a public consultation held from 1 to 31 March 2024, HSA’s amendments to the Regulations specify that the following patent declarations must be furnished to HSA during registration of therapeutic products (see our previous client alert here):

  • 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

The amendments also clarified that the patent declaration requirement does not apply to the following patents:

  • A process patent, other than a process patent that contains a claim for the use of an active ingredient in the manufacture of a therapeutic product for a specific therapeutic, preventive, palliative or diagnostic use
  • A patent that contains only claims relating to packaging
  • A patent that contains only claims relating to metabolites
  • A patent that contains only claims relating to intermediates

HSA further clarified that the types of patents that are subject to the requirements under Regulation 23 include the following:

  • A patent that contains a mixture of claims specified in Regulation 23(1)(a) and claims specified in Regulation 23(11), e.g., a patent containing claims for both an active ingredient of that therapeutic product and its metabolites
  • A patent containing a claim for the same polymorphic form of an active ingredient of that therapeutic product

Applicants must declare any subsisting restraining patent in relation to the therapeutic product for which registration is sought at the time of application and as required by HSA. HSA will then process registration applications based on the declared application category in the patent declaration form.

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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."