The TGA first announced plans to publish drugs under evaluation in February 2019 [1]. This would change the current mode of operation, by which the TGA only notifies the public about new medicines following their registration.

The Administration has since given approval to implement enhanced transparency measures and in April 2020 published a paper to gather opinion on various implementation options [2].

The TGA proposed a notification scheme whereby the generic/biosimilar applicant would notify the innovator about the application after preliminary assessment (but before evaluation of the medicine).

It has offered two different options for implementation: notification only if the relevant patent has not expired, and notification in all circumstances. The TGA is open to feedback on these different options until 9 June 2020, which would be implemented in early 2021.

A recent post by independent law firm Corrs Chambers Westgarth explains the impact these regulatory changes might have on pharmaceutical patent disputes in the country.

The post outlines several important implications, summarized here:

• Earlier notification of generic and biosimilar medicine applications will encourage innovator companies to engage with generics manufacturers before listing on the Australian Register of Therapeutic Goods (to obtain information to determine whether the drug infringes on their patents, for example). If the generic manufacturer does not provide this information, the innovator will have more time to obtain information using a court application for preliminary discovery.
• It is questionable whether the changes will avoid legal injunctions (which can be used by the innovator to prevent generic launch until a patent dispute is heard). Generics manufacturers may not have completed their commercial plans and so may not be willing to start patent revocation proceedings at such an early stage.
• Generics manufacturers who are not ready to begin revocation proceedings are likely to offer innovators an undertaking to notify patentees before they seek listing under the Pharmaceutical Benefits Scheme (PBS)/launch.
• Innovators may accept these undertakings and use the time available to obtain information on the generic product, so that they are ready to begin patent infringement proceedings later on.
• The additional time may also provide greater opportunity for patent disputes to be resolved before litigation.
• It is unclear whether the new process will apply to only new applications, or existing ones too. If the former is true, there may be a rush by generics manufacturers to file applications before the process comes into force.

Related articles
Australia approves five biosimilars since June 2019

Australia plans reform of its generics authorization process

Australia’s TGA will keep same names for biologicals

References
1. GaBI Online - Generics and Biosimilars Initiative. Australia’s TGA considering whether to publish drugs under evaluation [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 22]. Available from: www.gabionline.net/Policies-Legislation/Australia-s-TGA-considering-whether-to-publish-drugs-under-evaluation
2. GaBI Online - Generics and Biosimilars Initiative. Australia’s regulatory body proposes transparency reforms [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 22]. Available from: www.gabionline.net/Policies-Legislation/Australia-s-regulatory-body-proposes-transparency-reforms

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