The following section will discuss:
According to section 119B, a person may undertake an act that would otherwise be an infringement of a patent claim:
if the act is done solely for purposes connected with obtaining an approval required by a law…to exploit a product, method or process; or purposes connected with obtaining a similar approval under a law of another country or region.
Prior to April 2012, there was no legislative provision that exempted acts done for obtaining regulatory approval of non-pharmaceutical subject matter from patent infringement. Section 119A applied (and will continue to apply) for exemption from patent infringement for those acts done solely for purposes in connection with obtaining regulatory approval of a pharmaceutical.
The concern with the pre-April 2012 law was that it put Australian manufacturers at a competitive disadvantage to those companies that have operations in other countries that allow ‘springboarding’ (ie undertaking infringing acts required for regulatory approval of a non pharmaceutical product before patent expiry), in the sense that the latter companies, in having a head start in obtaining regulatory approval, would then be able to launch products in Australia or elsewhere shortly after patent expiry and in advance of the Australian manufacturer.
The new law is not prescriptive of what acts would be considered to be exempted, although it is clear that the acts done must be in connection with a regulatory approval process required by law. This lack of prescription makes sense given that the new law is intended to cover current regulatory approval regimes, and those that may be established in the future. It also recognises that processes required under current regimes may change from time to time,
necessitating particular acts at one time that were not required at another time.
Having said this, it is clear that the exemption will not apply to acts done in respect of a regulatory approval for a pharmaceutical, nor will it apply to acts done for experimental or research purposes, as these exemptions are dealt with under section 119A and section 119C of the legislation.
The phrase ‘solely for purposes’ is intended to exclude those acts done predominantly for a commercial purpose that might otherwise occur during the process of obtaining regulatory approval, including for example, stockpiling and export of the relevant product.
According to section 119C, a person may undertake an act that would otherwise be an infringement of a patent claim ‘if the act is done for experimental purposes relating to the subject matter of the invention’.
‘Experimental purposes’ is non-exhaustively defined as including:
Interestingly, an act that improves or modifies an invention is exempted from infringement, even if the improvement or modification is proposed for later commercialisation.
Further, section 119C requires that the experimental activities be ‘related to’ the subject matter of the invention. This achieves two outcomes:
Acts that remain outside the infringement exemption include those where the purpose is commercialisation. These include:
Prior to April 2012 there was no legislative provision that exempted acts done for experimental purposes relating to the subject matter of a claimed invention, and the common law that applied in the relevant circumstances was uncertain. In this context, this exemption is perhaps a welcome introduction into the Australian patent law. Having said this, the very language of the relevant provision, particularly in being inclusive with respect to the types of acts that might be within the exemption, seems unclear. We strongly recommend seeking professional advice as to whether the exemption is likely to apply in given circumstances.