3.12.2.1 Documentation Required

Date Published

Introduction

An application for an extension of term must be in the approved form (Form P/00/052b available on the IP Australia website).

The application must include the following:

  • applicant (patentee) and patent details;
  • information regarding the pharmaceutical substance on which the application for an extension of term is based and the goods containing, or consisting of, the substance; and
  • information to the best of the patentee’s knowledge about the first regulatory approval date relating to the substance and the earliest first regulatory approval date applying to the patent;
  • information concerning the inclusion of the goods in the ARTG; and.

  • state that there are no relevant proceedings in relation to the patent, or provide details of the relevant proceedings.


Applicant and Patent Details

The following information must be provided:

  • the name of the patentee (or their agent);
  • the address of the patentee (or agent);
  • an address for service; and
  • the patent number.


Pharmaceutical Substance and Goods Containing, or Consisting of, the Substance

The application must identify the relevant pharmaceutical substance and the related goods containing or consisting of the substance that are included in the Australian Register of Therapeutic Goods (ARTG).

Regulation 6.8(3) requires the application to be accompanied by information identifying the substance, as it occurs in the goods, in the same way (as far as possible) as the substance is identified in the complete specification of the patent. Therefore, requests which merely mirror the claims may not properly reflect the proportions of the ingredients as they occur in the goods. (Southern Cross Pharma Ltd v Euro-Celtique S.A. [2016] APO 1).

The application must also separately indicate:

  • how the pharmaceutical substance per se or when produced by a process that involves the use of recombinant DNA technology is in substance is disclosed in the complete specification; and
  • how the pharmaceutical substance per se or when produced by a process that involves the use of recombinant DNA technology in substance falls within the scope of a claim or claims.


First and earliest first regulatory approval date

The patentee must identify, to the best of their knowledge, the first regulatory approval date for goods containing, or consisting, of the relevant substance as well as the earliest first regulatory approval date in relation to the patent.

Often this will be the same date but may be different where, for example, the patent covers multiple substances.

The first regulatory approval date can include a listing for export however pursuant to ss 70(5A) an inclusion in the ARTG is to be disregarded if it was sought for the sole purpose of exporting goods containing the pharmaceutical substance from Australia to be used in an eligible importing country in circumstances governed by the TRIPS Protocol.


Information concerning the inclusion of the goods in the ARTG

The application must include

  • A copy of a print out from the ARTG, or other document, showing that the goods are currently included in the ARTG; and
  • A certificate issued under the Therapeutic Goods Act 1989, or other document, showing the date of commencement of the first inclusion in the ARTG of goods that contain, or consist of, the substance.​​​​​​​


Information about relevant proceedings

The patentee must state either that there are no relevant proceedings (as defined in the Act) or identify the Court proceedings, usually by providing the court number, for example VID99/1999.

If there are relevant proceedings no decision can be made in relation to the application without leave of the Court. The application should be referred to Patent Oppositions.