The passing of the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 ("the Bill") was reported in March 2012 ShelstonIP news (link: http://www.shelstonip.com/news_story.asp?m=3&y=2012&nsid=222). The Intellectual Property Laws Amendment (Raising the Bar) Act 2012 ("the Act") has since passed into law with the Governor General's assent on Sunday 15th April 2012. The majority of provisions in the Act come into effect on 15 April 2013. However, the exemptions for research and regulatory use will apply immediately.
As noted in our previous article, one of the schedules of the Bill was to provide freedom of access to patented inventions for the purposes of obtaining regulatory approval for non-pharmaceutical patents and conducting research. One of the aims of this schedule was to allow researchers to conduct genuine scientific inquiry without concerns regarding patent infringement. Under this new law, experimental activities conducted on or after 16 April 2012 are explicitly exempt from patent infringement. To clarify, the exemption will apply where1:
- A researcher may be undertaking research on a purely non-commercial basis, or may be contracted and paid to undertake experiments;
- Research may be conducted with a view to "ultimately" commercialising the end-products of the experimentation; or
- Research may be undertaken with, and partially funded by, a commercial partner.
It is important to note that the exemption applies where the predominant purpose of the research is to gain new knowledge or test a principle about an invention. The exemption will not apply where the main purpose of the research is to commercialise a patented invention. The boundaries of "ultimately" commercialising a product and "predominant" purpose of research have yet to be defined.
An inclusive list of activities determined to be "experimental" has been included in section 119C of the Patents Act 1990 (Cth). The following activities have been legislated as exempt from patent infringement:
- determining the properties of the invention;
- determining the scope of a patent claim relating to the invention;
- improving or modifying the invention;
- determining the validity of the patent or of a patent claim relating to the invention; and
- determining whether the patent for the invention would be, or has been, infringed by the doing of an act.
In the absence of any relevant case law, this list is not exhaustive and may be expanded upon by the courts at a later stage.
It is also important to note that the use of patented "research tools' is NOT exempt from patent infringement2. A research tool is used to "facilitate" an experiment but is not the subject of the experiment.
Further, the new law includes a regulatory approval exemption from patent infringement for the experimentation and trials necessary for gaining regulatory approval for non-pharmaceutical products. Pharmaceutical patents are not the only types of patentable product where pre-market regulatory approval is required. For example, agricultural chemicals and some medical devices may require regulatory approval. It has been determined that there is no reason why such products should not also be afforded an extension of patent term to compensate for the time necessary to obtain such approval.
This new law has yet to be interpreted by the Australian courts and information provided herein is based on the currently understood intention of the amendments to the Act. If you require specific advice on your particular situation in light of this new law, please feel free to contact one of our attorneys who can further advise you.
Footnotes
1
http://www.ipaustralia.gov.au/about-us/what-we-do/ip-reforms/factsheet-experimental-use/
2
http://www.ipaustralia.gov.au/about-us/what-we-do/ip-reforms/factsheet-experimental-use/
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.