The proposed patent notification scheme for generic and biosimilar medicines by the Australian Therapeutic Goods Administration (TGA) seems to have fallen off its priority list. Gavin Adkins, from our Law and Trade Marks team, reflects on the TGA’s consultation process, its subsequent announcements and the impact on innovators and generics.
The Australian pharmaceutical regulatory framework currently takes account of patent rights in a limited and indirect manner. There is nothing comparable to the ‘Orange Book’ system in the USA for example, and it appears unlikely that a patent notification scheme for generic and biosimilar medicines will be implemented in the near future.
As best we can tell there has been no announcement. However, on 21 December 2023, the TGA updated a page of its website such that it now says the proposed patent notification scheme for generic and biosimilar medicines “was not progressed”, whereas previously the page said “information on implementation arrangements will be included on the TGA website in due course”.
This is an important issue for both innovators and generics as it impacts strategies for anticipated pharmaceutical patent disputes.
The current regulatory framework
A sponsor applying to the TGA for registration of a generic medicine or biosimilar that relies on the safety or efficacy of an already approved product must provide a certificate under section 26B of the Therapeutic Goods Act 1989. The certificate must state that, either the sponsor believes that the product would not infringe a valid claim of a granted patent, or that it has provided the owner of any relevant patent with notice of the application for inclusion on the Australian Register of Therapeutic Goods (ARTG).
In practice, notice may not be provided to the patent owner in accordance with the section 26B certificate mechanism on the basis of an opinion that any relevant patent claims are not valid and therefore not infringed, even if validity has not been challenged. Patent owners may only become aware of the first generic or biosimilar products intended for the Australian market only upon the receipt of regulatory approval. In other words, they find out at the same time as everyone else.
The (discontinued) patent notification scheme proposal
Between February 2019 and June 2020, the TGA conducted two consultations into the earlier notification of generic medicine and biosimilar applications to the patent owner (and in relation to an additional transparency measure) to address this issue.
In October 2020 the TGA announced a revised form of the proposed scheme (which was not specifically the subject of consultation) to address “some of the concerns expressed by the generic/biosimilar sector” noting that “[n]one of the options canvassed during consultation received consensus support”.
On 21 March 2023 the TGA updated the relevant page of its website to state:
“Due to the impact of the COVID-19 pandemic, implementation of this measure has been delayed. Further information about implementation timeframes will be published in the coming months.”
On 21 December 2023 the TGA made a further update deleting the above message such that it now states:
“None of the options canvassed during consultation received consensus support and therefore the proposed measure (see table 2, below) was not progressed.”
Where to now?
Arguably a patent notification scheme for generic and biosimilar medicines is necessary to comply with the Australia-United States Free Trade Agreement (AUSFTA). Article 17.10(4) of the AUSFTA requires notification to the patent owner if another party submits a medicine for marketing approval during the term of an existing patent which is not qualified by reference to validity like the current section 26B certificate mechanism.
It is not clear when or even if the TGA will take up this issue again. We are nonetheless watching closely for developments.
