Patent notification stalemate: TGA’s decision leaves the medicines industry hanging

Pharma News: The patent notification scheme for generic and biosimilar medicines proposed by the Therapeutic Goods Administration (TGA) appears to have lost priority, despite the TGA’s consultation process, and its impact on innovators and generics.

Currently, the Australian pharmaceutical regulatory framework considers patent rights in a limited and indirect manner. There is no equivalent to the US ‘Orange Book’ system and it seems unlikely that a patent notification scheme for generic and biosimilar medicines will be implemented soon.

This is a significant issue for both innovators and generics as it impacts launch strategies and potential patent disputes.

In December 2023, the TGA updated a webpage to state that the proposed patent notification scheme for generic and biosimilar medicines “was not progressed,” whereas previously it indicated that “information on implementation arrangements will be included on the TGA website in due course.”

The current regulatory framework requires a sponsor seeking registration for a generic medicine or biosimilar to provide a certificate under section 26B of the Therapeutic Goods Act 1989. This certificate must assert that the product would not infringe a valid patent claim or that notice has been given to the patent owner.

In practice, notice may not always be provided to the patent owner based on the belief that the relevant patent claims are not valid, even if validity has not been challenged. Patent owners may only become aware of generic or biosimilar products intended for the Australian market upon regulatory approval.

The patent notification scheme proposal involved two consultations conducted by the TGA in 2019 and 2020 to address this issue. In October 2020, the TGA announced a revised form of the proposed scheme to address concerns from the generic and biosimilar sector. However, none of the options received consensus support.

It remains uncertain whether or when the TGA will revisit this issue. Arguably, a patent notification scheme for generic and biosimilar medicines may be necessary to comply with the Australia-United States Free Trade Agreement (AUSFTA), which mandates notification to the patent owner if another party submits a medicine for marketing approval during the term of an existing patent.

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