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Wednesday, 24 November 2010
Page: 2100

Senator HEFFERNAN (4:10 PM) —I move:

That this bill be now read a second time.

I table an explanatory memorandum and seek leave to have the second reading speech incorporated in Hansard and to continue my remarks later.

Leave granted.

The speech read as follows—

It was a little over two years ago, on 16 October 2008, that I first rose to bring this important matter to the Senate’s attention. At the time I questioned the legality of a practice which had allowed Myriad Genetics and its exclusive Australian licensee, Genetic Technologies Limited, to monopolise human genes BRCA 1 and BRCA 2 - genes linked to breast and ovarian cancers. No one invented these genes. Yet, relying on four patents granted by IP Australia, on 8 July 2008, Genetic Technologies attempted to close down all public laboratory genetic breast and ovarian cancer gene testing when it sent a letter threatening to sue each of them for patent infringement. I said then and I say now that this “is a disgrace”.

The bedrock principle of patent law, and one that has stood for nearly 400 years, is that an inventor receives a patent monopoly for disclosing an invention and how to make it. This principle, however, has been for the past 30 years the subject of a legal trick played by clever patent attorneys. As a result isolated biological materials, that is, naturally occurring biological materials that have been removed from their natural environment, such as the human body, are no longer regarded as products of nature, but as inventions, the product of humankind. This legal hocus-pocus has apparently satisfied IP Australia, the sole regulator of intellectual property in this country. And without even having the legality of this legal trick tested in the Australian courts IP Australia has participated in the subversion of this principle. Consequently, naturally occurring but isolated, purified or synthetically made genes, proteins and other biological materials identical or substantially identical to such materials found in nature are presently the subject of patent monopolies in this country.

On 11 November 2008, a Senate Inquiry into the impact of gene patents on the healthcare system of this country was established. The Senate Standing Committee on Community Affairs was asked to inquire into the granting of patent monopolies in Australia over human and microbial genes and non-coding sequences, proteins and their derivatives and after two years, the Final Report is to be handed down tomorrow.

During its investigation the Committee heard from scientists at the Peter MacCallum Cancer Centre that their research into BRCA 1 and BRCA 2 diagnostics was retarded by two years and ended up costing three times as much because of the four Australian patents over the BRCA 1 and BRCA 2 genes.

Other eminent scientists such as Nobel laureate Prof Sir John Sulston, the director of the UK’s human genome project, and former Australian of the Year, Prof. Ian Frazer, the inventor of the cervical cancer vaccine, have come out publicly against the gene patents. Prof Frazer has said: “restricting the use of a gene sequence could delay the development and testing of truly inventive and practical uses of the gene and its protein product for diagnosis and therapy” and has recommended that “the law be amended to exclude gene sequences from the definition of patentable subject matter”. In other words, one of Australia’s leading scientific experts and himself an inventor of an important medical therapy has asked this Parliament to close what is, undoubtedly, an illegal loophole.

A simple amendment to s.18 of the Patents Act 1990 will close the loophole in the law which has facilitated the implementation of the errant practice and recalibrate Australia’s patent system so that it properly and sensibly balances the needs of the medical and scientific community with the need to promote research and development for true inventions. Now, unsurprisingly patent attorneys, IP Australia and AusBiotech, the representative association of the Australian biotechnology industry, disagree and they suggest that if this Bill is passed it will undermine the biotechnology industry, thereby reducing jobs and research and development. None of these arguments, however, pass muster but let me briefly answer some of the points which they make.

First they say: “No Gene Patents No Biotech Industry”:

The Bill will not prevent or reduce investment in the biotech industry. The Bill is very narrow and only seeks to clarify and apply existing patent law.

While biological materials which are found in nature are not inventions even if they are isolated, purified or synthetically made, processes or methods involved in their isolation, purification and synthesis are and so long as they also meet the other patentability criteria of novelty, inventive step and have a practical application can be patented. Also, 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.

This leaves the biotechnology industry considerable scope to patent true inventions.

In fact the biotechnology industry will enjoy reduced costs for undertaking R&D because once patents over, what are really nothing more than naturally occurring biological materials are rendered obsolete, it will be able to use those materials freely and without risk of patent litigation. This will make R&D simpler, less expensive, less risky and less time consuming.

So rather than reducing jobs and R&D in the biotechnology sector this Bill, if passed, will create more jobs and lead to more R&D in this country.

Next they say that The Bill will mean that Australian patent law will be Out Of Step Internationally:

This is a false proposition. Only the European Union has passed a law to make isolated biological materials capable of being inventions. Outside of the EU no other country has done so. In the United States a US Federal Court ruled in March this year that seven US patents granted to Myriad over the BRCA 1 and BRCA 2 genes were invalid under current US patent law because they were not inventions. More recently the US Department of Justice has  filed an amicus brief (friend-of-the-court) in the appeal in that case stating that the “longstanding policy” which had been applied by the United States Patent Office over the grant of such patents was contrary to US patent law.

In fact, Australia is a leader in this debate not a follower. It is applying longstanding principles of patent law which have stood for nearly 400 years. Rather than being out-of-step this Bill reinforces this principle, a principle that has common roots with the patent laws of the United Kingdom (and its Commonwealth) and the United States.

Finally they say that The Bill Is Contravenes International Trade Agreements:

It must be understood that both the Agreement of Trade Related Aspects of Intellectual Property Law and the Australia-US Free Trade Agreement mandate that patents be granted only for inventions and only if those inventions are new, contain an inventive step and have a practical application. The word ‘invention’ in both of these agreements is undefined but that does not mean that anything can be the subject of a patent. Whatever the innovation it must be an invention. Biological materials which are identical or substantially identical to what exists in nature are not inventions. They are discoveries and therefore incapable of being inventions. The Bill merely seeks to apply the law as it is and this law is compliant with both of these agreements.

I would like to acknowledge my Senate colleagues for their input and assistance, special thanks to Dr Luigi Palombi, for his assistance, patience and tolerance in explaining this complex and technical issue to a farmer! Special thanks to Sarah Murdoch, Patron of the National Breast Cancer Foundation for her wonderful support and assistance.  

I know many scientists and researchers, numerous stakeholders and organisations such as the Peter McCallum Cancer Centre in Melbourne, Cancer Voices Australia, the AMA, Prof Ian Frazer from Cancer Council Australia and many other stakeholder groups, too many to mention, will all benefit with this Bill. But more importantly this Bill will benefit the affordable well-being and have long term benefits for the human race regardless of social, economic and racial background.