IP SPOTLIGHT MAY 11

It is with no doubt that we expect innovator companies to advocate for option 2, citing reasons of earlier transparency being in the interest of the public good, whereas generic and biosimilar manufacturers will advocate for option 1, citing the need to protect proprietary confidential information. Regardless of which option is adopted by the TGA, these reforms will change the landscape and the starting point for pharmaceutical patent disputes. The reforms will bring the TGA system closer to those adopted by Health Canada, the European Medicines Agency and Medsafe New Zealand which already have greater transparency. Earlier notification will allow innovator companies time to seek assurances from the generic sponsor and if an assurance is not provided, time to seek further information on the generic’s potential infringement by way of a discovery action. The TGA has requested feedback on these two options by 9 June 2020 and it is understood that this new notice scheme will be implemented in early 2021. It is unclear whether these new measures will apply retrospectively to

and seek an urgent interlocutory injunction to prevent the launch and listing on the Pharmaceutical Benefits Scheme (PBS), which results in a price drop of 25% in the subsidized price of the innovator’s product. THE PROPOSED REFORMS The TGA is entertaining proposed changes to provide much earlier notification to innovators that a competitor is seeking registration of a generic or biosimilar product which references the data of the innovator’s product. The changes will reduce the degree of discretion currently with sponsors of generic or biosimilar products in determining whether a relevant valid patent exists, and if so, whether the product would infringe the patent. THE TGA I S CONS I DER I NG TWO OPT IONS . Option 1 – Provide early notification to the innovator of a generic or biosimilar application, regardless of whether or not the applicant believes that marketing of its generic product would infringe one or more relevant patents. However, Option 1 still gives the applicant some degree of discretion as to whether a relevant patent exists and we question whether option 1 goes far enough in achieving the government’s objective of bringing in more transparency into the process. Option 2 seeks to remove that discretion. Option 2 – Early notification for all generic and biosimilar applications regardless of the applicant’s belief as to the existence of any relevant patent(s) and even if the applicant considers that no valid patent claim would be infringed by the marketing of its product.

The reforms were published in February 2019 in the consultation paper 1 . A total of 39 submissions received from government, industry and interest groups were published by the TGA in April 2020. The Federal Government approved the implementation of measures to enhance transparency for prescription medicines on 8 April 2020. The TGA is now seeking feedback on options for implementing the proposed Prescription medicines transparency measures by 9 June 2020. THE CURRENT PROCESS I N AUSTRAL I A The TGA does not disclose information about the submission or acceptance of an application for evaluation of a prescription medicine. The information is only disclosed publicly after the medicine has been listed on the Australian Register of Therapeutic Goods (ARTG). It is usually only upon listing on the ARTG that an innovator company will be made aware of the planned launch of a competitor’s generic or biosimilar. If a sponsor for a generic or biosimilar seeks to rely on safety or efficacy data for a reference, it must certify under section 26B of the Therapeutic Goods Act 1989 that it either believes on reasonable grounds that its product will not infringe a valid claim of a relevant patent or it has notified the patentee. Given this large degree of discretion, in practice this means sponsors seeking marketing approval for a generic or biosimilar, do not notify the innovator of their application. This leaves little time for the innovator to act once it is aware of a generic’s approval on the ARTG The paper can be found here .

TGA UPDATE

Proposed changes to enhance transparency of the evaluation of prescription medicines in Australia

approval applications filed before implementation of this scheme.

CRAIG HUMPHRIS Principal

This paper considers the proposed reforms to generic and biosimilar medicine applications and potential effect on pharmaceutical patent litigation in Australia. The reforms relate to greater transparency of information pertaining to medicines under evaluation by the Therapeutic Goods Administration (TGA).

1 Consultation: Whether the TGA should publish that a prescription medicine is under evaluation, TGA, February 2019.

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