In Australia, the only current exclusion from patentability in the area of biotechnology relates to human beings and biological processes for their generation. However, Australia has a long history of questioning the patentability of biotechnological inventions. Recent examples include a report by the House of Representatives Standing Committee on Industry, Science and Technology in 1992 – which addressed in particular the patenting of living genetically modified organisms – and a 2004 paper from the Australian Law Reform Commission (ALRC) that reviewed several issues relating to gene patenting and the provision of health services.

Australia’s most recent reviews into patentable subject matter initially focused on genetic diagnostics and the costs of providing health services, but soon meandered into other areas such as gene patenting and genetically modified organisms. Here is a look at those two reviews.

1) Australian Senate Inquiry into Gene Patents

In November 2008, the Australian Senate referred an inquiry into the patenting of genes to the Senate Community Affairs Committee. The terms of reference for the inquiry were: ‘The impact of the granting of patents in Australia over human and microbial genes and non-coding sequences, proteins, and their derivatives, including those materials in an isolated form.’ This was with particular reference to:

i) The impact that the granting of patent monopolies over such materials has had, is having, and may have had on the provision and costs of healthcare; the provision of training and accreditation for healthcare professionals; the progress in medical research, and the health and wellbeing of the Australian people;

ii) identifying measures that would ameliorate any adverse impacts arising from the granting of patents over such materials – including whether the Patents Act 1990 should be amended – in light of any matters identified by the inquiry; and

iii) whether the Patents Act 1990 should be amended so as to expressly prohibit the grant of patent monopolies over such materials.

Following a significant period of public consultation and numerous delays, the Senate Committee issued their report in November 2010, complete with 16 recommendations. In broad terms, those recommendations adopted a cautious tone and called for:
• Research into the actual impact of genetic-testing patents on society
• Greater transparency in the patent system
• Higher standards for obtaining a patent in Australia
• Clearer provisions on Crown use, where branches of government can appropriate IP for national-interest purposes without the rights owner’s authorisation
• An amendment of Australian patent laws to include a broad research exemption

As well as having an impact across different technological areas, the recommendations were generally consistent with those of the 2004 ALRC report and have now been included in the 2011 Intellectual Property Laws Amendment – aka Raising the Bar – Bill. Raising the Bar aims to make it more difficult to obtain a patent in Australia by increasing standards in line with examination procedures prevalent in other jurisdictions, such as Europe and the US.

2) Human Genes and Biological Materials Bill 2010

Seemingly unhappy with the 16 recommendations that arose from the Senate Inquiry, a number of senators introduced a Private Members Bill into the Federal Australian Parliament late last year. Currently under review by the Australian Senate’s Legal and Constitutional Affairs Committee, this Bill seeks to exclude from patentability ‘biological materials, 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’.

Scope of the proposed exclusion
Both in the media and during the Senate Inquiry, terms such as ‘human gene patents’ have been used in a loose and inconsistent manner. Despite much of the attention focusing on human genes, and/or human genetic diagnostics, the proposed amendments include defining ‘biological materials’ to cover ‘DNA, RNA, proteins, cells and fluids’ and possibly any chemical entity produced by an organism. Interestingly, the Bill is not limited to human biological material, but encompasses biological material from any source such as fish, plants, fungi, bacteria or viruses.

Players in the biotechnology industry have raised concerns over exclusions relating to ‘derivatives’ and materials that are ‘substantially identical’ to biological matter. Arguably, these terms are sufficiently broad to exclude many man-made biological materials from patentability. Following public submissions on the Bill, an amendment was tabled so that the proposed exclusion reads: ‘biological materials, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature’.

This amendment also sought to define ‘identical’ as ‘a biological material which is structurally and functionally identical’.

Research exemptions
One of the key arguments against the scope of subject matter for which patent protection can be obtained in Australia is that current laws allegedly stifle research. However, there are very few examples to suggest that this is the case.

The contention that patenting ‘biological materials’ inhibits scientific advances in relation to human health is perplexing: many other technologies are also essential to medicine. While it seems much less controversial in Australia to say that current laws on research exemptions need to be clarified, action on this issue has dragged on for far too long.

‘Invention’ versus ‘discovery’
Another major argument of the Bill’s supporters is that biological material is a discovery, not an invention. Regrettably, this stance ignores the fact that the actual means of obtaining a temporary monopoly to promote scientific endeavour while ensuring early public disclosure of an ‘invention’ useful to mankind – namely, the patent system - is indeed man made.

All areas of science are bound by the laws of nature and pre-existing raw materials. With that in mind, it can be argued that any advances in the field of engineering are discoveries because it has been ‘discovered’ by man that some naturally occurring entities – such as atoms, chemical elements, sound waves etc – can be manipulated in a certain way to produce an industrially useful effect. Notably, the term ‘discovery’ and variations thereof (discovered, etc) are often used to describe inventions in patent applications that do not relate to biological material.

International obligations
Many interested parties who do not support the Bill have highlighted that the proposed amendments are in conflict with international agreements to which Australia is party, such as the World Trade Organisation’s Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS). Unfortunately, the ‘invention versus discovery’ debate is being used by supporters of the Bill to argue that no such conflict exists. Or, more specifically, that an isolated gene (for example) is not an ‘invention’, so therefore it is not contrary to TRIPS to exclude this subject matter.

Only time will tell how the Australian government will balance the gene-patenting debate with their international obligations.

Practical implications
In a speech to the Australian Senate in November 2010, Senator Bill Heffernan – one of the architects of the Private Members’ Bill – argued that there would still be reasonable scope for obtaining at least some patent protection. As the senator noted, ‘Biotechnological inventions which make use of biological materials in such things as new and inventive diagnostics, medicines and treatments will continue to be afforded patent protection just as they are now.’

If the amendments are passed by the Australian Parliament, this would mean in practical terms that applications for biotechnology patents in Australia are more likely to be granted solely through method claims, rather than claims to both the product and the methods for using it. However, Heffernan’s use of the term ‘medicines’ as being patentable is confusing. Does it mean that medicines of a non-biological nature are still patentable, or that rights will be granted for pharmaceutical formulations containing the biological material?

Summary

It seems that some members of the Australian Parliament have turned the issue of gene patenting into their own personal crusade, so even if the current Senate Inquiry recommends that the Bill should not be adopted (whether amended or not), the likely scenario is that this will not be the end of Australia’s scrutiny of the topic.

By contrast, there seems to be a much wider consensus for adopting many of the proposals in the original Raising the Bar Bill. IP Australia is currently considering public submissions on Raising the Bar before finalising it. In the light of this Bill, it is likely the Australian Patents Act will have to be amended in the future to increase the standards required to obtain a relevant patent in any technological field – and hopefully to provide a sensible, codified research exemption from patent infringement.


Dr Ian Rourke is a partner at FB Rice, where he handles validity, due-diligence and freedom-to-operate analyses for holders of global biotechnology patent portfolios