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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