TGA shelves biosimilar and generic transparency measures

This article was co-authored with Jerome Messiha.

Key take-aways

• Proposed changes to Australia’s patent notification system to enable innovators to be notified earlier of biosimilar and generic competition will not be implemented.
• The first notification to innovators of potential biosimilar or generic competition remains either:
  • the listing of biosimilar or generic products on the Australian Register of Therapeutic Goods (ARTG); or
  • the appearance of biosimilar products on the agenda for a Pharmaceutical Benefits Advisory Committee (PBAC) meeting; or
  • (in the case of a first generic product), the Department of Health notifying the innovator of an upcoming statutory price reduction caused by the impending Pharmaceutical Benefits Scheme (PBS) listing of such products.
• Innovators should continue to monitor the market for signs of potential generic or biosimilar competition and be ready to enforce relevant intellectual property rights as soon as a potential competitor launch is detected.

Introduction

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

Notification to innovators of biosimilar or generic applications

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:

• the applicant, acting in good faith, believes on reasonable grounds that it is not marketing, and does not propose to market, its generic medicine in a manner, or in circumstances, that would infringe a valid claim of a patent that has been granted in relation to the registered innovator medicine (a Section 26B(1)(a) Certificate); or
• a patent has been granted in relation to the medicine in question, and the applicant proposes to market the therapeutic goods before the end of the term of the patent and has given the patentee notice of the application (a Section 26B(1)(b) Certificate).

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:

• sponsors of the first generic or biosimilar medicine in respect of an innovator medicine would notify the patentee that their application for inclusion on the ARTG had been accepted for evaluation by the TGA before the TGA commences the evaluation; and
• the existing section 26B regime would continue to apply to all other generic and biosimilar applications.

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.