Publication
Ontario’s Working for Workers Five Act receives royal assent
On October 28, Bill 190, Working for Workers Five Act, 2024 received royal assent.
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
On October 28, Bill 190, Working for Workers Five Act, 2024 received royal assent.
Publication
The Federal Court of Appeal’s 2023 decision in Canada (Attorney General) v Benjamin Moore & Co [Benjamin Moore FCA] overturned the Federal Court’s decision in Benjamin Moore & Co. v. Canada (Attorney General) [Benjamin Moore FC] that had previously established a new test for patentable subject matter in computer-implemented inventions.
Subscribe and stay up to date with the latest legal news, information and events . . .
© Norton Rose Fulbright LLP 2023