Regulatory Approval and Therapeutic Patenting in Australia

The Australian government’s regulatory body for therapeutic goods is the Therapeutic Goods Administration (TGA). In order to lawfully supply goods classified as therapeutic goods (including biologicals, pharmaceuticals, and medical devices) in Australia, the goods must be subjected to an approval process by the TGA and listed in the Australian Register of Therapeutic Goods (ARTG).

The Australian government has recently announced changes relating to information on applications for TGA approval, with a stated aim of increasing transparency.

TGA Publication

Under current practice, no information regarding applications submitted to the TGA is published until after approval, when the goods are included in the ARTG. However, changes to this policy have been the subject of recent discussion, as set out in the following policy document:

In October this year it was announced that new measures were being introduced for applications submitted to the TGA for approval of prescription medicines. The announcement can be found here:

In summary, from January 2021, the following information will be made publicly available for certain TGA applications once the application has been accepted for evaluation:

  • Product sponsor;
  • Product name;  
  • Active ingredients; and
  • Application type

This provision will apply to new medicines (application type A); new combinations of medicines (application type B); and new therapeutic indications for existing medicines (application type C).

It is important to be aware of the potential implications of these changes for patent protection. The new provisions are expected to result in substantially earlier public disclosure of details of medicines subject to an application for TGA approval. Previously, there has been a significant window available after filing of an application for TGA evaluation, and before publication of details upon approval and listing in the ARTG.

Although it is typical for applications for patent protection to be filed prior to seeking regulatory approval for an associated medicine – including through the TGA – this may not always be the case. Under the new publication provisions, applicants should therefore take additional care to ensure that all necessary patent applications are in place, prior to submission of a corresponding application for TGA approval. These provisions create the possibility of relatively rapid publication of details by the TGA that could prevent patent protection where an applicant is not in possession of an earlier priority date.

Notification to Patent Holders

It has also recently been announced that changes to notification requirements for patent holders regarding TGA applications for generics and biosimilars are to be introduced into Australian parliament.

The changes to be proposed will oblige applicants for first generic or biosimilar forms of a patented product to formally notify the patent holder when an application is accepted for evaluation by the TGA. The stated intention of this change is to bring forward the commencement date of Australian pharmaceutical patent disputes. It is hoped that these changes will reduce the need of interlocutory injunctions, and allow for resolution of disputes prior to the commercial launch of generics/biosimilars.

Final Remarks

Parties active in the Australian pharmaceutical space should be aware of impending changes associated with approval of medical products through the TGA.

Applicants for approval of medical products through the TGA should take extra care to ensure that publication of details upon acceptance for evaluation cannot jeopardise prospects for patent protection.

Manufacturers of both original medications and generics should be aware of impending new requirements for notification of patent holders where approval for generics or biosimilars is sought through the TGA.

The IP Gateway team would be happy to answer any questions in relation to these or any other life sciences matters.

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