From the cogent Australian Parliamentary Library Bills Digest 107 of 2010–11 [
PDF] by Roger Beckmann & Sharon Scully on the
Patent Amendment (Human Genes and Biological Materials) Bill 2010 [No. 2], which seeks to ban gene patenting in Australia -
Uncertain effect of the proposed amendments
It is stated in the Explanatory Memorandum that:
The purpose of this Bill is to advance medical and scientific research and the diagnosis, treatment and cure of human illness and disease by enabling doctors, clinicians and medical and scientific researchers to gain free and unfettered access to biological materials, however made, that are identical or substantially identical to such materials as they exist in nature.
It is then explained that the legislation has been expanded to ensure that 'biological materials', '[including DNA, RNA, proteins, cells and fluids]', and 'including their components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature' are expressly excluded from patentability to ensure that natural phenomena are not patentable inventions and thus subject to restricted use.
The application of the proposed amendments is uncertain and is likely to significantly expand the scope of subsection 18(2) of the Patents Act with respect to what would not be patentable inventions under the Act.
Should genes be excluded from patenting?
In the various inquiries mentioned above, those arguing that genes should not be patentable base their argument on several grounds. These grounds include that:
• the commercial exploitation of gene patents has the potential to:
– adversely affect matters such as incentives to conduct genetic and biotechnological research; as well as costs of and access to genetic testing, and
– reduce competition, and
• genes are discoveries not inventions and, consequently, are not patentable.
On the other hand, those arguing that genes should be patentable argue that:
• prohibiting gene patents may result in:
– creating a situation where Australia breaches its international law obligations – creating a situation incompatible with global obligations to harmonise patent laws
– adverse impacts on domestic and international investment in Australian genetic and biomedical research and development
• the distinction between discoveries and inventions is not clear cut, and
• there is insufficient empirical evidence to prove that gene patents adversely affect matters such as costs and access to genetic testing
The authors conclude -
The amendments proposed in the Senate Bill go much further than the longstanding debate as to whether to prohibit gene patents.
The proposal to exclude particular subject matter from the Patents Act would effectively extend to all naturally occurring biological materials per se, not simply human genes and human biological materials as the title of the Senate Bill suggests. As mentioned in several submissions, this would have the potential to affect a wider cross-section of biotechnological industries other than simply the medical industry.
Comments made by major interest groups in relation to the Senate Bill reflect evidence already provided at the various inquiries on the impacts of human gene patents, and in particular, those conducted by the ALRC and the Community Affairs References Committee discussed earlier. ....
Parliament may wish to keep in mind the arguments and counter-arguments for and against the Senate Bill as previously outlined. These are summarised as follows.
Arguments supporting the Senate Bill
Arguments for supporting the Senate Bill include:
• genes are discoveries not inventions — consequently, should not be patentable
• gene patents hinder genetic and biological research, and
• gene patents hinder access to genetic and biomedical testing and treatments.
Counter-arguments
Counter-arguments not supporting the Senate Bill include:
• under the current patent system in Australia, genetic and biological materials in their natural form are not patentable
• the existence of a patent over genetic or biological material does not constitute 'ownership' of such material
• concerns relating to gene patents, and the subject matter of patents generally, have already been extensively reviewed with a similar conclusion — there is insufficient empirical evidence of adverse effects resulting from gene patents to warrant prohibiting the patenting of genes and biological materials
• at this stage in any case, the nature and scope of patent applications relating to human genes have changed over time with changes in examination practices and, in the words of the ALRC "the time for taking this approach to the patenting of products and materials has long since passed"
• the proposed amendments go much further than simply excluding human genetic materials — the proposed wording could apply to all biological materials, thereby potentially affecting a broad range of industries, such as biotechnological and pharmaceutical industries; agricultural and animal protection industries; and bio-prospecting
• the proposed amendments may result in unintended adverse consequences to that broad range of industries, such as making it more difficult to patent novel genetically modified organisms in areas unconnected with human genes (for example agricultural plants)
• prohibiting the patenting of genes and biological materials may represent a significant departure from international practice with respect to genetic inventions in many developed countries and may adversely affect investment in the Australian biotechnology industry, and
• alternative methods — such as Crown use and compulsory licensing provisions, as well as a research use exemption and competition laws — have been proposed to address concerns regarding any monopoly arising from the existence of gene patents; and the development of and access to genetic and biomedical testing.
Some background to the Bill is
here.
