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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.
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.
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