Australia-US Free Trade Agreement

Approved certificate and notification templates

How to access a pdf document

• Approved subsection 26B(1) certificate (pdf,76kb)
• Approved subsection 26C(3) certificate (pdf,76kb)
• Approved form for notification that 26B(1) certificate is not required (pdf,59kb)

Schedule 7 - US Free Trade Agreement Implementation Act 2004

10 August 2006

The Australia-US Free Trade Agreement (the Agreement) came into force on 1 January 2005. Australia's obligations under the Agreement have been implemented by the US Free Trade Agreement Implementation Act 2004 (the Implementation Act).

In January 2005 the Therapeutic Goods Act 1989 ("the Act") was amended to give effect to Australia's obligations under the Australia-United States Free Trade Agreement (AUSFTA), in relation to applications for the marketing approval of therapeutic goods in Australia.

The January 2005 amendments to the Act require an applicant seeking to include therapeutic goods in the Australian Register of Therapeutic Goods (ARTG) to provide one of two certificates in relation to patents (refer to subsection 26B(1) of the Act) prior to the listing or registration of therapeutic goods in the ARTG. Subsection 26B(1) of the Act requires applicants to provide one of the following certificates:

1. a certificate to the effect that the applicant, acting in good faith, believes on reasonable grounds that it is not marketing and does not propose to market, the therapeutic goods in a manner or circumstances, that would infringe a valid claim of a patent that has been granted in relation to the goods; or
2. a certificate to the effect that a patent has been granted in relation to the goods and the applicant proposes to market the goods before the end of the term of the patent and the applicant has notified the patentee of the application for registration or listing of the goods under section 23 of the Act.

Amendments to the Act have also been made to impose requirements on parties who intend to commence infringement proceedings against the applicant for the registration or listing of goods ("the applicant") who has lodged a patent certificate mentioned above. The amendments to the Act also impose requirements on the person who applies for an interlocutory injunction to restrain the applicant from marketing the therapeutic goods on the ground that such conduct will constitute an infringement of its patent.

Therapeutic Goods Amendment Act (No.2) 2006

10 August 2006

The subsequent amendments made by the Therapeutic Goods Amendment Act (No.2) 2006 have restricted the application of the patent certification requirements. These amendments commenced on 3 April 2006.

These amendments restrict the application of the patent certification requirements under subsection 26B(1) of the Act to only those applicants who are required to submit safety or efficacy data of the goods as part of the process of applying for registration or listing, and in order to satisfy that requirement rely on the safety or efficacy data previously submitted to the Therapeutic Goods Administration (the TGA) by another person to establish the safety or efficacy of other goods that have already been registered or listed, as part of the process for applying for the registration or listing of those other goods.

These changes mean that requirements for patent certificates will not apply to applicants for registration or listing of medicines who are not required to submit evidence or information to establish the safety or efficacy of the goods as part of the registration or listing process. In these circumstances, the applicants are only required to notify the Secretary in the approved form that the subsection 26B(1) patent certificate is not required in relation to the application.

As a consequence of the restriction in the application of subsection 26B(1) of the Act, amendments were also introduced in the Act to require applicants for registration or listing of medicines under section 23 of the Act to either:

1. notify the Secretary using the approved form that the patent certification under subsection 26B(1) is not required in relation to the application; or
2. provide a certificate required under subsection 26B(1) of the Act.

These new requirements apply to all applications for registration or listing lodged on or after 3 April 2006.

Applications for registration or listing under subsection 23 of the Act lodged on or after 1 January 2005 and before 3 April 2006 are still required to provide a patent certificate specified under subsection 26B(1) of the Act. The option of providing a notice to the Secretary that a patent certificate under subsection 26B(1) is not required is not available to applicants who lodged their applications for registration or listing under section 23 on these dates (ie applications lodged to the TGA from 1 January 2005 to 2 April 2006).

Application for registration of medicines or for listing of export only medicines (sections 25 and 26 of the Act)

For applications for the registration of medicines or the listing of export only medicines, notification to the Secretary that the subsection 26B(1) patent certificate is not required should be made using the approved notification form.

What does this mean for the section 26A listing process and the Electronic Listing Facility (ELF)?

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