Therapeutic Goods Act 1989

This section applies if:

a person gives a certificate required 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 person referred to in paragraph (1)(a) for infringement of a patent that has been granted in relation to the therapeutic goods (the proceedings).

The second person, before the date upon which the proceedings are commenced, must give to the Secretary and to the person referred to in paragraph (1)(a) the certificate required by subsection (3).

The certificate required by this subsection is a certificate to the effect that the proceedings:

are to be commenced in good faith; and

have reasonable prospects of success; and

will be conducted without unreasonable delay.

For the purpose of paragraph (3)(b), proceedings have reasonable prospects of success if:

the second person had reasonable grounds in all the circumstances known to the second person, or which ought reasonably to have been known to the second person (in addition to the fact of grant of the patent), for believing that he or she would be entitled to be granted final relief by the court against the person referred to in paragraph (1)(a) for infringement by that person of the patent; and

the second person had reasonable grounds in all the circumstances known to the second person, or which ought reasonably to have been known to the second person (in addition to the fact of grant of the patent), for believing that each of the claims, in respect of which infringement is alleged, is valid; and

the proceedings are not otherwise vexatious or unreasonably pursued.

The person referred to in paragraph (1)(a), with leave of the court, or the Attorney‑General, may apply to a prescribed 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 (3) and:

the certificate is false or misleading in a material particular; or

the second person breaches an undertaking given in the certificate.

A pecuniary penalty ordered under subsection (5) must not exceed $10,000,000.

When determining the extent of a pecuniary penalty to be ordered pursuant to subsection (5), the court must take into account:

any profit obtained by the second person; and

any loss or damage suffered by any person;

For the avoidance of doubt, subsection (6) does not limit the matters the court may take into account when determining a pecuniary penalty ordered pursuant to subsection (5).

If:

the second person has sought and obtained in the proceedings an interlocutory injunction restraining the person referred to in paragraph (1)(a) from infringing a patent; and

section 26D does not apply; and

a prescribed court declares that the second person has given a certificate required under subsection (3); and

a prescribed 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;

In this section: