The current Australian Patents Act 1990, in section 119A, provides an exemption (i.e. defence) to patent infringement in respect of acts for obtaining regulatory approval of pharmaceuticals. This enables ‘generic’ pharmaceutical manufacturers to conduct the trials and experiments necessary to obtain data for approval of a drug for inclusion in the Australian Register of Therapeutic Goods (ARTG), during the term of a patent covering the drug.
This limited ‘experimental’ use exemption enables so-called ‘springboarding’, i.e. the preparation during the patent term to commence sales of a generic product immediately upon expiry of the patent. The exemption does not cover registered goods other than drugs, such as medical or therapeutic devices.
There are also infringement exemptions in section 118 and section 119 covering, respectively, use of patented technology on vessels in transit, and prior use – i.e. where someone other than the patentee was already using an invention in secret and without making an anticipating public disclosure, prior to the patentee filing a patent application.
IP Australia’s proposed reforms include new exemptions covering acts for obtaining regulatory approval of goods other than pharmaceuticals, and acts conducted for ‘experimental purposes’.
