Lara Cresser

Raising the bar part 8: Free access to patented inventions for regulatory approvals and research

Lara Cresser

14 May 2013


Upon passing into law on 15 April 2012, two important aspects of Intellectual Property Laws Amendment (Raising the Bar) Act 2012 [“the Act”] took effect immediately, despite the majority of reforms coming into force on 15 April 2013:

  • Regulatory use exception from patent infringement for non-pharmaceutical patents; and
  • Experimental use exemption from patent infringement.

Regulatory use exception

The Act amends the Patents Act 1990 by inserting section 119B which provides for an exemption to patent infringement which enables generic manufacturers to conduct the testing necessary for regulatory approvals prior to the expiry of the relevant patent term. The exception does not apply to pharmaceutical patents/products and applies only to work done for purposes connected with obtaining the regulatory approval required by law.

After the expiration of a patent term, anyone is able to market the previously patented technology in competition with the previous patent holder. The subsequent products are referred to as being ‘generic’. However, depending upon the nature of the product, the generic producer may have to require regulatory approval before their product can be marketed.

Previously, the generic producer had to wait until the expiry of the relevant patent term before being able to take steps to obtain regulatory approval. Otherwise they risked infringing the patent. The effect of this was that the length of time in which a generic producer was prevented from marketing their product was extended beyond merely the patent period as they could not market their product until they obtained regulatory approval and were restrained from obtaining such approval until after the patent expired. This effectively gave the patent holder an extension of the patent term beyond that provided for in the Patent Act 1990.

This exception does not apply to pharmaceutical products/patents as they have already been exempted separately by the introduction in 1998 of section 119A in to the Patents Act 1990. The new exemption allows other forms of patentable products subject to pre-market regulatory approval to seek these approvals prior to the expiry of the patent term.

The exemption came into force on 16 April 2012 and is found in section 119B of the Patents Act 1990.

Experimental use exemption

The Act amends the Patents Act 1990 by the insertion of section 119C which exempts experiments on patented inventions from being subject to patent infringement. It extends to various kinds of research, a non-exhaustive list of which is included within the new section.

This exemption was introduced to limit the ability of patent rights to impinge on research and to allow researchers to focus on their research without the risk of patent infringement litigation. Previously, uncertainty about the extent of patent rights has been attributed to discouraging researchers from working in areas where they were at risk of patent infringement. The introduction of the experimental use exemption means that researchers no longer have to expend time and money in obtaining advice on patents within their chosen areas of research and removes inherent inefficiencies which detract from scientific inquiry and subsequent innovation.

The exemption came into effect on 16 April 2012 and is found in section 119C of the Patents Act 1990.