Search for:
Category

Asia-Pacific

Category

In a recent article, The Cybersecurity of Gen-AI and LLMs: Current Issues and Concerns, the Cyber Security Agency of Singapore provides helpful commentary on the security and privacy challenges associated with generative artificial intelligence and large language models. The article outlines issues such as accidental data leaks, vulnerabilities in AI-generated code and potential misuse of AI by malicious actors, before providing recommendations on the steps that technology companies can take to address these concerns.

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.

* * * * *

LOGO_Wong&Leow_Singapore

© 2024 Baker & McKenzie.Wong & Leow. All rights reserved. Baker & McKenzie.Wong & Leow is incorporated with limited liability and is a member firm of Baker & McKenzie International, a global law firm with member law firms around the world. In accordance with the common terminology used in professional service organizations, reference to a “principal” means a person who is a partner, or equivalent, in such a law firm. Similarly, reference to an “office” means an office of any such law firm. This may qualify as “Attorney Advertising” requiring notice in some jurisdictions. Prior results do not guarantee a similar outcome.

On 30 August 2024, the Australian Treasury released a consultation paper on the proposed monetary and market share thresholds that will trigger a requirement to notify an acquisition to the Australian Competition and Consumer Commission (ACCC) under the Federal Government’s proposed new mandatory merger control regime. It is proposed that transactions which meet either of the thresholds must be notified to, and approved by, the ACCC, with penalties imposed for any failure to notify or for implementation of a notifiable merger without prior notification to the ACCC. The closing date for submissions is 20 September 2024.

A new workplace right – a ‘right to disconnect’ – has been introduced by the Fair Work Legislation Amendment (Closing Loopholes No. 2) Act 2024, with effect from 26 August 2024 (or 26 August 2025 for small business employers). On 23 August 2024, a Full Bench of the Fair Work Commission finalized the new “right to disconnect” model term, which will soon be inserted into all modern awards. Whilst we wait for the Fair Work Commission (FWC) to issue its guidance on the new workplace right, here’s what you should know, and what we think you should do to prepare for the introduction of the right to disconnect.

Where an employment contract expressly states that a bonus is “discretionary” or is within the employer’s “absolute right” to declare, does an employer have an unfettered discretion to decide whether to declare bonuses? In BGC Partners (Singapore) Ltd and another v Sumit Grover [2024] SGHC 206, the General Division of the High Court reiterated that employers owe an implied duty to exercise their contractual discretion reasonably. What is considered reasonable would depend on the specific facts of the case.

Malaysia’s Cyber Security Bill 2024 was passed by both houses of the Malaysian Parliament on 27 March 2024 (Dewan Rakyat) and 3 April 2024 (Dewan Negara) respectively. Subsequent to its Royal Assent on 18 June 2024 and publication in the Official Gazette on 26 June 2024, the Malaysia Cyber Security Act 2024, together with four subsidiary regulations, came into force on 26 August 2024.

The National Privacy Commission (NPC) recently issued NPC Circular No. 2024-02 (“Circular“), which provides an updated policy framework on the use of closed-circuit television (CCTV) systems. The Circular is intended to address emerging privacy risks arising from the use of CCTV systems, and to enable data controllers and processors to properly manage personal data processing carried out through such systems.

The Circular took effect on 27 August 2024.

Following the passing of the Personal Data Protection (Amendment) Bill 2024 by the Malaysian Parliament in July 2024, three public consultation papers have been issued in relation to the implementation of the following impending new legal obligations:

  • Notifying the Personal Data Protection Commissioner and affected data subjects for personal data breach.
  • Appointing data protection officer(s).
  • Effecting the data subject’s right to data portability.

The deadline to provide feedback is 6 September 2024 (Friday).

On 25 June 2024, the Government proposed to enact a new piece of cybersecurity legislation, tentatively entitled the Protection of Critical Infrastructure (Computer System) Bill, to enhance the protection of computer systems of critical infrastructures (CIs). On 2 July 2024, the proposed legislative framework was tabled to the Legislative Council Panel on Security for consultation. The proposed legislation would require CI operators to fulfill certain statutory obligations and take appropriate measures to strengthen the security of their critical computer systems and minimize the chance of essential services being disrupted or compromised due to cyberattacks.