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Parliament relaxes requirements for Therapeutic Goods Act patent certificates

In brief: Allens Partner Sarah Matheson and Law Clerk Fiona Galbraith discuss the relaxation of requirements in relation to the submission of patent certificates as part of an application to register many types of therapeutic goods in Australia.

In brief

Changes to the Therapeutic Goods Act 1989 (Cth) (TG Act) effective from 3 April 2006 will now remove the recently introduced requirement to submit patent certificates as part of an application to register many types of therapeutic goods.

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Summary of changes

Prior to 3 April 2006, all applicants seeking to register therapeutic goods under the TG Act were required to provide a certificate stating, in essence, whether the therapeutic goods did or did not fall within the scope of a valid patent.  This requirement  had been criticised as being unduly onerous to industry, burdensome to those applicants seeking registration of complementary medicines and over-the-counter medicines and in relation to innovators seeking additional registrations in relation to their own products.

The changes are brought into effect by the Therapeutic Goods Amendment Act (No. 2) 2006 (Cth) (Amending Act). Under the Amending Act, certificates will only be required if the applicant relies on safety and efficacy data that another person has previously submitted to the Therapeutic Goods Administration (TGA). According to the Second Reading Speech of the Bill, the intent of this amendment is to exempt the following from the requirement to submit a patent certificate:

  • The majority of complementary medicines and over-the-counter products (because these products contain active ingredients whose safety and efficacy is shown with readily accessible or well known data).
  • Originator medicines (because originator pharmaceutical companies submit their own safety and efficacy data).

The Second Reading Speech specifically notes that the amendments will ensure that sponsors of generic medicines will have to provide a patent certificate.

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Why a patent certificate? Australia – US Free Trade Agreement

Since 1 January 2005, applicants seeking registration of therapeutic goods have been required to submit patent certificates following amendments to the TG Act by reason of the Australia-US Free Trade Agreement (FTA), in particular Article 17.10.04. Under Article 17.10.04, if an applicant relies on safety and efficacy data that has been previously approved either by the Party, or by an equivalent body in another territory, the Party must:

  • provide measures in its marketing approval process to prevent that applicant from marketing a product where that product is claimed in a patent; or
  • require the patent owner to be notified of any request for marketing approval for a product identified as being claimed by a patent.
The former requirements – Section 26B

Prior to the Amending Act becoming effective on 3 April 2006, section 26B(1) of the TG Act required all applicants seeking to register therapeutic goods to provide either:

  • 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 in circumstances, that would infringe a valid claim of a patent that has been granted in relation to the therapeutic goods; or
  • a certificate to the effect that:
    • a patent has been granted in relation to the therapeutic goods;
    • the applicant proposes to market the therapeutic goods before the end of the term of the patent; and
    • the applicant has given the patentee notice of the application for registration or listing of the therapeutic goods under section 23 of the TG Act.
Amending Act – Section 26B

Under the Amending Act a certificate is only required under amended section 26B(1) if:

  • the applicant is required to submit evidence or information to establish the safety or efficacy of the goods as part of the process of applying for registration or listing; and
  • in order to satisfy that requirement, the applicant relies on information another person has submitted to the TGA to:
    • establish the safety or efficacy of other therapeutic goods that have already been registered or listed; and
    • as part of the process of applying for the registration or listing of those other goods.

The Amending Act does not alter the content of a certificate required under section 26B(1). If a certificate is not required under amended section 26B(1), an applicant must submit a notice stating to that effect

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The consequences of a patent certificate

A certificate from a generic manufacturer that its product falls within the scope of a patent, is no bar to registration of the product under the current TG Act or the Amending Act.

However, the provision of a certificate triggers additional obligations on the parties affected by the potential infringement, ie the patentee or exclusive licensee (Affected Party), if the court's intervention is sought in relation to the alleged infringement. These obligations are not changed by the Amending Act.

For a summary of these obligations, please follow the link to a previous AAR publication from late 2004 entitled 'Australia-US Free Trade Agreement Amendments to the Australian Therapeutic Goods Act' which examines the legislation implementing these obligations.

For further information, please contact:

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