Seemingly unsatisfied by two recent Senate Inquiry Reports which
rejected proposals to legislate against gene patents, the
proponents of gene patent reform appear to have resurrected their
cause via a new Private Members' Bill which once again seeks to
ban gene patents in Australia.
In September 2011, we reported that an attempt to ban gene
patents through the Patent Amendment (Human Genes and Biological
Materials) Bill 2010 was effectively quashed by a recommendation of
a Senate Committee report, that the Senate should not pass the
Bill. (For further information refer to the following link,
http://www.shelstonip.com/news_story.asp?m=9&y=2011&nsid=203).
Since that time major changes to the Australian Patents Act have
been introduced by the passing into law of the Intellectual
Property Laws Amendment (Raising the Bar) Bill 2011. These changes
include raising the standard of granted patents by, for example,
increasing the inventive step threshold and raising support
requirements for patent applications. The changes also include the
introduction of an "experimental use" exemption to
infringement. (For further details on the "Raising of the
Bar" Bill refer to the following link,
http://www.shelstonip.com/news_story.asp?m=3&y=2012&nsid=222).
However, these changes do not appear to have been sufficient for
those who are in favour of banning gene patents. On 14 May 2012, a
report by the ABC program, Lateline detailed a new Private
Members' Bill seeking to ban gene patents. The proposed Bill is
to be introduced by Melissa Parke, a Labour party backbencher. The
Report was followed by an interview with Melissa Parke and Senator
Bill Heffernan, the "political strongman" of Luigi
Palombi, the man who drafted the Patent Amendment (Human Genes and
Biological Materials) Bill 2010 and who some have described as the
driving force behind the gene patent reform movement in
Australia.
According to Ms Parke, the proposed Bill has not been finalized.
However, during the Lateline report the following text was
shown which appears to be a draft replacement for s18(2) of the
Patents Act which currently only excludes from patentability human
beings and the biological processes for their generation.
18 (2) The following are not patentable inventions:
human beings, and the biological processes for their
generation;
genetic materials that exist in nature, or are the same as
or not markedly different from those existing in nature, whether
such materials are in situ, isolated or purified;
any method that involves the mere comparison of genetic
materials or genetic sequences in the provision of a diagnosis for
a human being.
(2A) A reference in subsection (2) to genetic materials
includes, but is not limited to, DNA or RNA whether in whole or in
part or in fragments, however made.
One of the major criticisms of the previous Bill was its
breadth. In the text above, it appears from part (b) that the
proposed exclusion relates only to "genetic material"
rather than the previously proposed "biological
material". However, the definition of the term "genetic
material" in part (2A) is not limited to DNA or RNA, thus
leaving the scope of the term "genetic material" open to
speculation. It is also not clear what would be encompassed by
genetic material that is "not markedly different from those
existing in nature".
Most significantly, part (c) encompasses genetic testing.
Previously, those in favour of gene patent reform did not seek a
specific ban on the use of genes in methods such as genetic
testing. Thus, if the above text does represent the new Private
Members' Bill there is at least an argument that it goes beyond
the scope of the previous Human Genes and Biological Materials Bill
2010.
We will continue to monitor progress in this area and provide
further commentary once the new Private Members' Bill is
finalized and becomes public.
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guide to the subject matter. Specialist advice should be sought
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Specific Questions relating to this article should be addressed directly to the author.
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