Publication
Government Investigations in Singapore 2025
We have contributed the Singapore chapter of Getting the Deal Through, Government Investigations 2025.
Australia | Publication | June 2024
This article was co-authored with Jerome Messiha.
In late 2020, following almost 18 months of public and industry consultations conducted by the Therapeutic Goods Administration (TGA), the Australian Government approved a range of transparency measures for innovator and generic medicines that are under evaluation for inclusion on the ARTG. We reported on these reforms in our December 2020 article Proposed TGA Transparency Reforms: Impact of the changes. The proposed measures included changes to Australia’s patent notification system to enable innovators to be notified earlier of biosimilar and generic competition.
In early 2021, the TGA implemented the transparency measures concerning innovator sponsors: the TGA now publishes information on applications under evaluation by the TGA for new prescription medicines, including new chemical entities, indications and combinations.1 However the proposed changes to the patent notification system were delayed.
On 21 December 2023, the TGA updated its website, and effectively confirmed that it would not progress the proposed changes to the patent notification system, citing a lack of consensus support.2
Australia has no Orange Book-style patent linkage system. The existing patent notification system in section 26B of the Therapeutic Goods Act 1989 (Cth) requires a generic or biosimilar applicant to certify to the TGA that either:
In practice, Section 26B(1)(b) Certificates are rarely, if ever, used.
The proposed transparency measures would have amended the existing patent notification arrangements such that:
These measures were intended to address innovator concerns that they may only become aware of a generic or biosimilar competitor at the time of the inclusion of a biosimilar or generic product on the ARTG, or by an application for listing of such a product on the PBS. It was hoped that these measures would provide greater opportunity for early negotiation and resolution of disputes on potential patent infringements and invalidity, and reduce the need for protracted and costly litigation.
The TGA stated that views were mixed regarding these measures and none of the options canvassed received consensus support. The proposed measures will therefore not be progressed.
Consequently, the first notification to innovators of potential biosimilar or generic competition remains either the listing of such products on the ARTG, disclosure on the agenda for a PBAC meeting (in relation to a biosimilar) or (in the case of a first generic product), notification to the innovator by the Department of Health of an upcoming statutory price reduction caused by the upcoming PBS listing of such products.
Publication
We have contributed the Singapore chapter of Getting the Deal Through, Government Investigations 2025.
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The private credit market and direct lending have grown and diversified immensely in the past decade, offering alternative sources and terms of debt compared to those historically provided by the syndicated leveraged loan and public issuance markets. Consequently, they are fast becoming pivotal components in the capital ecosystem, so much so that the Bank of England consider that the private credit market is currently responsible for approximately $1.8 trillion of debt issuance, which is four times its size in 2015. This growth has been particularly pronounced in Europe and the US but there has also been significant activity in Asia.
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The EU’s Artificial Intelligence Regulation, commonly referred to as the AI Act, is expected to come into force during the summer of 2024 (the AI Act). The AI Act will be the first comprehensive legal framework for the use and development of artificial intelligence (AI), and is intended to ensure that AI systems developed and used in the EU are safe, transparent, traceable, non-discriminatory and environmentally friendly.
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