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Australia-United States Free Trade Agreement

Implementation of the Australia-US Free Trade Agreement
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Certificates and notification form

The Australia-US Free Trade Agreement (AUSFTA) came into force on 1 January 2005.

In January 2005 the Therapeutic Goods Act 1989 (the Act) was amended to give effect to Australia's obligations under the AUSFTA. An applicant seeking to include therapeutic goods in the ARTG was required to provide one of two certificates in relation to patents prior to the listing or registration of therapeutic goods in the ARTG.

Subsequent amendments restricted 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 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.

As a consequence of the restriction in the application of subsection 26B(1) of the Act, amendments were 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.

Prior to 6 March 2018, this requirement applied in relation to applications under section 23 of the Act for registration or listing in the ARTG under section 25AB (registered medicines), section 26 (export only medicines) and section 26A (listed medicines).

Changes to the legislative framework for listed medicines

On 6 March 2018, amendments to the Act commenced, providing for a new 'assessed listed medicines' pathway for sponsors to apply for listing of medicines in the Australia Register of Therapeutic Goods (ARTG). Medicines listed through the assessed listed medicines pathway will be included in the ARTG under section 26AE of the Therapeutic Goods Act 1989 following self-certification of the safety and quality of the product, and TGA pre-market assessment of efficacy evidence supporting the proposed indications.

The new assessed listed medicines pathway was implemented in response to Recommendation 39 of the Review of Medicines and Medical Devices Regulation.

The application of section 26B was extended to assessed listed medicines included in the ARTG under section 26AE, such that a certificate under section 26B(1), or notification in the form approved by the Secretary that the patent certification under subsection 26B(1) is not required, must be provided before the Secretary will include the goods in the Register under section 26AE.

Application for registration of medicines (section 25AB), listing for export only (section 26), or listing of assessed listed medicines (section 26AE)

For applications for the registration of medicines under section 25AB, the listing of export only medicines under section 26, or the listing of assessed listed medicines under section 26AE, where a section 26B(1) certificate is not required, notification to the Secretary that the subsection 26B(1) patent certificate is not required must be made using the approved notification form.

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

The online ELF application entitled 'Subsection 26B(1) Notification'' electronically notifies the Secretary that the certification requirements under subsection 26B(1) do not apply to the application. Therefore, applicants for listing under section 26A do not need to complete the approved notification form.

For further advice on using ELF please call the ELF Helpdesk on 1800 773 312.

Approved certificate and notification templates

Approved subsection 26B(1) certificate

Approved subsection 26C(3) certificate

Approved form for notification that 26B(1) certificate is not required

Schedule 7 - US Free Trade Agreement Implementation Act 2004

11 February 2005

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).

More information

Amendments to the Therapeutic Goods Act 1989 - Implementation of the Australia-US Free Trade Agreement

Commencement

Amendments to the Therapeutic Goods Act 1989 (the Act) for the purpose of implementing obligations under the Australia-US Free Trade Agreement took effect on 1 January 2005. These amendments apply to applications for the registration or listing of a therapeutic good (other than devices), under section 23 of the Act made on or after 1 January 2005.

However, subsequent amendments made by the Therapeutic Goods Amendment Act (No.2) 2006 have restricted the application of the patent certification requirements.

The amendments in relation to legal proceedings under section 26C and 26D apply to proceedings commenced on or after 1 January 2005.

Certificates required in relation to patents (subsection 26B(1) of the Act)

From 1 January 2005 an applicant seeking to include therapeutic goods, other than devices, in the Australian Register of Therapeutic Goods (ARTG) under section 23 of the Act must provide a certificate required under subsection 26B(1) of the Act.

Note that this requirement does not apply to applications for inclusion in the ARTG of therapeutic devices under Chapter 3 of the Act or medical devices under Chapter 4 of the Act.

The applicant must either certify to the effect that:

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

Subsequent amendments were introduced in the Act to 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 who 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 that product.

These amendments have been implemented by the Therapeutic Goods Amendment Act (No.2) 2006 (the Amendment Act). The Amendment Act received its Royal Assent on 1 March 2006 and commenced on 3 April 2006 by Proclamation.

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 that restriction, amendments were also introduced in the Act to require applicants for registration or listing of medicines to either:

  1. notify the Secretary using the approved form that the patent certification under subsection 26B(1) is not required; 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.

All applicants for registration or listing under subsection 23 of the Act lodged on or after 1 January 2005 and before 3 April 2006 are required to provide a patent certificate required under subsection 26B(1) of the Act. The option of providing a notice to the Secretary that a patent certificate is not required in relation to the application is not open to these applicants (ie applications lodged from 1 January 2005 to 2 April 2006).

The patent certificate must be signed by the applicant or an authorised signatory. Alternatively, two company directors, a company director and company secretary, or a sole company director who is also the sole company secretary may sign the patent certificate.

If the signatory is not a company director, company secretary or the company's legal counsel, the applicant must provide an authorisation letter stating that two persons can sign on behalf of the applicant. The authorisation letter should state the names of the authorised personnel and should be signed by two company directors or a company director and company secretary.

As of May 2022, the patent certificate can be signed electronically, digitally, or in person. In addition, there is no longer any requirement for these signatures to be witnessed.

The applicant must use the form of the certificate approved by the Secretary of the Department of Health. The requirements under subsection 26B(1) are not satisfied if a certificate other than those approved by the Secretary is used by the applicant. Copies of the approved form can be downloaded from the TGA or the Department of Health's website.

Notification to the Secretary that a patent certificate is not required in relation to the application should be made using the approved form which can be downloaded from the TGA website.

Applications for registration (section 25AB) and listing of assessed listed medicines (section 26AE)

The subsection 26B(1) certification or a notification that the patent certificate under subsection 26B(1) is not required is a mandatory requirement for the registration of a medicine under section 25AB of the Act and the listing of an assessed listed medicine under section 26AE of the Act.

However, the subsection 26B(1) patent certificate or the notification is only required once the evaluation has been completed under section 25 or section 26AE of the Act, and the Secretary decides to register or list the goods in the ARTG. At this stage of the process the Secretary will notify the applicant in writing that the goods will be included in the ARTG once the applicant gives the Secretary the certificate required under subsection 26B(1) or a notice (in accordance with a form approved in writing by the Secretary) that a certificate under that subsection is not required in relation to the application.

Applications for listing under section 26 and 26A of the Act

In contrast to applications for the registration of therapeutic goods under section 25AB of the Act and the listing of assessed listed medicines under section 26AE of the Act, an application for the listing of a medicine under sections 26 or 26A must be accompanied by a subsection 26B(1) certificate or a notification (in accordance with a form approved, in writing, by the Secretary) that a patent certificate is not required i.e. the certificate or notification is required at the time of lodging the application, rather than after a decision is made in respect of the application.

No evaluation relating to the safety, efficacy and quality is required for listable goods under section 26A prior to inclusion in the ARTG. Rather, the applicant certifies that it holds information or evidence to support any claim the applicant makes relating to the medicine. Therefore, a subsection 26B(1) certificate is not required, and the applicant is required to notify the Secretary at the same time as the lodgement of their section 26A application that no such certificate is required. This notification is made through ELF, through the part entitled 'Subsection 26B(1) Notification'.

For further advice on using ELF please call the ELF Helpdesk on 1800 773 312.

Applications for listing of export only medicines under section 26 may, in some instances, require an applicant to submit evidence or information to establish the safety of the goods, and therefore may require a subsection 26B(1) certificate. An applicant for listing under section 26 must provide either a subsection 26B(1) certificate, or notification (using the approved form) that a subsection 26B(1) certificate is not required, at the time of submitting the application.

Correctness of a certificate under section 26B(1) or notice

Assuming all other requirements for inclusion of the goods in the ARTG are met under sections 25AB, 26, 26A and 26AE of the Act and the subsection 26B(1) certificate or notice has been provided by the applicant, the Secretary will include the goods in the ARTG without inquiring into the correctness of the certificate or the notice that the certificate is not required. The responsibility to ensure the correctness of the certificate or notice lies with the applicant.

Civil proceedings cannot be instituted against the Secretary (or a delegate of the Secretary) in respect of loss, damage or injury of any kind suffered by another person as a result of the Secretary (or the delegate) including the therapeutic goods in the ARTG in reliance on the subsection 26B(1) certificate given by the applicant.

A person is guilty of an offence if the applicant gives a certificate required under subsection 26B(1) of the Act and the certificate is false or misleading in a material particular. The maximum penalty which can be imposed if a person is convicted of this offence is $210,000 for an individual and $1,050,000 for a body corporatefor an individual and $1,050,000 for a body corporate.

Certificates required in relation to patent infringement proceedings (Section 26C)

If a person ("the first person") gives a certificate under subsection 26B(1) in relation to therapeutic goods and another person ("the second person") intends to commence proceedings under the Patents Act 1990 against the first person for infringement of a patent that has been granted in relation to the therapeutic goods, the second person is required to give the Secretary and to the first person before the commencement of the infringement proceedings ("the proceedings"), a certificate required under subsection 26C(3).

The certificate required under subsection 26C(3) is a certificate to the effect that the infringement proceedings:

  1. are to be commenced in good faith;
  2. have reasonable prospects of success; and
  3. will be conducted without unreasonable delay.

The first person, with the leave of the Federal Court or the Attorney-General, can apply to a prescribed court ("the court") for an order that the second person pay to the Commonwealth a pecuniary penalty, if the second person gives a certificate required under subsection 26C(3) and the certificate given is false or misleading in material particular, or the second person breaches an undertaking given in the subsection 26C(3) certificate. The maximum pecuniary penalty that can be imposed by the court is $10 million. In determining the extent of the pecuniary penalty, the court may take into account any profit obtained by the second person and any loss or damage suffered by any person, by reason of the second person exploiting the patent during the infringement proceedings. However, these are not the only considerations that the court may take into account in determining the level of pecuniary penalty to be imposed on the second person.

The subsection 26C(3) certificate must be signed in writing by the second person using the form approved by the Secretary of the Department of Health. Copies of the approved subsection 26C(3) certificate can be downloaded from the TGA or the Department of Health's website.

The second person may also be ordered by the court to pay to the Commonwealth, a State or Territory compensation for any damages sustained or costs incurred by the Commonwealth, a State or a Territory, as a result of the grant of an interlocutory injunction. This order is able to be made in circumstances where:

  1. the second person has sought and obtained in the infringement proceedings an interlocutory injunction restraining the first person from infringing the patent; and
  2. section 26D does not apply; and
  3. the court has declared that the second person has given a certificate required under subsection 26C(3); and
  4. the court declares that the certificate is false or misleading in a material particular or the second person has breached an undertaking given in the certificate.

Requirements for Interlocutory injunction (Section 26D of the Act)

Section 26D applies where:

  1. the applicant for the inclusion of a therapeutic good in the ARTG has notified the patentee of the application for registration or listing of the therapeutic goods under section 23 ("the applicant") in accordance with subparagraph 26B(1)(b)(iii); and
  2. the patentee and/or its exclusive licensee applies for an interlocutory injunction to restrain the applicant from marketing the therapeutic goods (the subject of the application) on the ground that such conduct will constitute an infringement of its patent.

Before applying for interlocutory relief, the patentee is required to first notify the Attorney-General of the Commonwealth, or of a State or of a Territory, in writing of the application. The Attorney-General of the Commonwealth shall be deemed to be a party to the proceedings unless the Attorney-General gives written notice to the court that he or she does not desire to be a party.

Where section 26D applies, the court may, in addition to other relief which it believes should be granted to any person, make any other orders if the following circumstances occur after an interlocutory injunction is granted to a patentee:

  1. the patentee subsequently discontinues the principal proceedings without the consent of the other parties; or
  2. the principal proceedings are dismissed; and
  3. in either case, the court declares that:
    1. the patentee did not have reasonable grounds, in all the circumstances known to the patentee, or which ought reasonably have been known to the patentee to believe that it would be granted final relief by the court against the applicant for infringement by the applicant of the patent; or for believing that each of the claims, in respect of which infringement is alleged in the proceedings, would have reasonable prospect of being held to be valid if challenged by the applicant; or
    2. the application for the interlocutory injunction was vexatious or not reasonably made or pursued.

If the court makes a declaration pursuant to paragraph (c) immediately above, the court may, pursuant to the usual undertaking as to damages given by the patentee to the court to obtain the interlocutory injunction, order the following:

  1. assess and award compensation to the applicant on the basis of an account of gross profits of the patentee arising from the patentee's sale of the therapeutic goods in Australia during the period of the interlocutory injunction, without requiring the applicant to establish or quantify actual loss, or on such other basis as the court determines to be appropriate; and
  2. award to the Commonwealth, a State or a Territory, compensation for any damages sustained, or costs incurred, by it as a result of the grant of the interlocutory injunction.

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