THERAPEUTIC GOODS ACT 1989 - SECT 26B Certificates required in relation to patents

THERAPEUTIC GOODS ACT 1989 - SECT 26B

  (1A)   A certificate is required under subsection   (1) in relation to an application for registration or listing of therapeutic goods only if:

  (a)   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

  (b)   in order to satisfy that requirement, the applicant relies (in whole or in part) on evidence or information that another person submitted to the Secretary:

  (i)   to establish the safety or efficacy of other therapeutic goods that have already been registered or listed; and

  (ii)   as part of the process of applying for the registration or listing of those other goods.

  (1)   The certificate required under this subsection is either:

  (a)   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

  (b)   a certificate to the effect that:

  (i)   a patent has been granted in relation to the therapeutic goods; and

  (ii)   the applicant proposes to market the therapeutic goods before the end of the term of the patent; and

  (iii)   the applicant has given the patentee notice of the application for registration or listing of the therapeutic goods under section   23.

The certificate must be signed by, or on behalf of, the applicant and must be in a form approved by the Secretary.

  (2)   A person commits an offence if:

  (a)   the person gives a certificate required under subsection   (1); and

  (b)   the certificate is false or misleading in a material particular.

Penalty:   1,000 penalty units.

  (3)   For the purposes of this section, a patent is taken to have been granted in relation to therapeutic goods if marketing the goods without the authority of the patentee would constitute an infringement of the patent.

  (4)   In this section:

"patent" has the same meaning as in the Patents Act 1990 .