Anne McEwen (SA, Australian Labor Party) Share this | Link to this | Hansard source

I present the report of the Legal and Constitutional Affairs Legislation Committee on the Patent Amendment (Human Genes and Biological Materials) Bill 2010, together with the Hansard records of proceedings and documents presented to the committee.

Ordered that the report be printed.

Bill Heffernan (NSW, Liberal Party) Share this | Link to this | Hansard source

(New South Wales) (18:32): I move:

That the Senate take note of the report.

This is a very important bill. We have moved in the dissenting report to amend the bill to narrow down the description of discoveries, which should not be patentable. A lot of generous patents have been issued on inventive work that includes discovery work—that is, the discovery of genes. Nearly three years ago I rose to thank the Senate for its generosity in agreeing to an inquiry into the impact of gene patents on the provision of health care in Australia. The trigger for that inquiry was Myriad Genetics, the owner of Australian patents containing claims relating to genetic mutations in the BRCA 1 and 2 human genes linked to breast and ovarian cancers. Myriad has been granted not one but four patents giving it a monopoly over these genetic mutations in an isolated form. That is, they have been removed from the human genome. As well, Myriad had patent rights to any kind of BRCA 1 and 2 genetic testing.

The Australian patents were exclusively licensed to Genetic Technologies, which proceeded to send a 'cease and desist' letter to every laboratory in Australia providing BRCA genetic testing, threatening to sue them for patent infringement if they did not stop testing—and this included fine institutions such as Westmead Hospital in Sydney. But the public outrage, media attention and the Senate's action in agreeing to an inquiry—for which I am eternally grateful—forced Genetic Technologies to back off. The lawsuit never happened and laboratories got on with providing the much-needed BRCA test to Australian women.

The argument with Genetic Technologies, Myriad and IP Australia, which granted the patents in the first place, was not about the principle behind the Australian patent system that says that an invention should be rewarded with a patent. It was not about the incentives that are needed to encourage invention and innovation. It was not about compensating those undertaking risky and expensive research. It was about whether Myriad Genetics had actually invented anything in the first place. Common sense should tell us that a human gene and the human protein it codes for are natural phenomena. No-one invented the human genome. Certainly Myriad Genetics did not invent the genetic mutations that cause breast and ovarian cancer. That is what these Australian patents stand for. It is absurd in the 21st century, with everything that science knows about human genetics and the role that genes play in the production of proteins, that the materials that make us who we are and what we are can be monopolised and commoditised.

The patent system was never designed to grant patents for discoveries. That is what Myriad Genetics did: it patented certain genetic mutations in the BRCA 1 and 2 human genes which were linked to breast and ovarian cancer. The objective of the bill—which former Senator Coonan, Senator Xenophon, Senator Siewert and I sponsored in the Senate last November, which was introduced into the lower house by Peter Dutton, Rob Oakeshott and Malcolm Turnbull and which is the subject of the report tabled in the Senate today—is to make the distinction between discovery and invention clear when it comes to biological materials that are identical to those that exist in nature.

The bill had the support of not only the Cancer Council of Australia, the Royal College of Pathologists of Australasia, the Human Genetics Society of Australasia, the Royal Australasian College of Physicians, the Australian Medical Association, the Generic Medicines Industry Association, Cancer Voices Australia, Cancer Voices New South Wales, Cancer Voices South Australia, Cancer Voices Tasmania but also the federal Department of Health and Ageing. Each of these organisations made it clear that the current policy of allowing the patenting of biological materials that are naturally occurring and which no-one invented needs to be stopped. But it was not only these organisations that raised objections. In the United States, 20 plaintiffs sued Myriad Genetics to invalidate the patents which the US patent office had granted for the same genetic mutations. The US government, a co-owner of two of the four Australian patents, even went to the US Court of Appeals for the Federal Circuit, agreeing with the plaintiffs. In its amicus brief to the court, the US government said:

Genomic DNA itself, however, is a product of nature that is ineligible for patent protection, whether or not claimed in “isolated” form.

We—

that is, the US government—

acknowledge that this conclusion is contrary to the longstanding practice of the Patent and Trademark Office, as well as the practice of the National Institute of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA. The district court’s judgment in this case, however, prompted the United States to reevaluate the relationship between such patents and the settled principle under Supreme Court precedent that the patent laws do not extend to products of nature. For the reasons below, the United States has concluded that isolated but otherwise unaltered genomic DNA is not patent-eligible subject matter under 35 U.S.C. § 101.

Unfortunately, that patent fight is nowhere near being over. In the meantime, the 20 plaintiffs who brought this action on behalf of the American people must wait for years before they have a definitive answer. It will not matter to Myriad Genetics, because by that time the BRCA patents will have expired.

We in the Senate, with the help of our colleagues in the lower house, are in a unique position to get this right, now—once and for all. We know that those that have most to gain financially by keeping things as they are, the patent attorneys, the patent lawyers and the biological and pharmaceutical industry, have been working hard to make sure this bill is ultimately defeated. It would seem, based on the majority report of the Senate today, that they have managed to convince some members of the Senate that a human gene is an invention. Let me assure the Senate that is a furphy. You do not have to take my word for it. Professor Sir John Sulston, a Nobel laureate and one of the leaders in the mapping of the human genome has said:

Promoters of gene patents argue that genes are patentable when they are "isolated and purified," or removed from the body and placed in a form so that they can be replicated outside the human body. This argument seems absurd to me. The essence of a gene is the information it provides—the sequence. Copying it into another format makes no difference. It is like taking a hardback book written by someone else, publishing it in paperback and then claiming authorship because the binding is different.

Professor Ian Frazer agrees with Professor Sulston. He has said:

If we allow patenting of genes we’re allowing patenting of ourselves. The patent system should protect inventive medicines developed from research using data on gene sequences. But a gene sequence used to develop the invention should not qualify the gene’s sequencer to receive benefits.

Along with Senators Siewert and Xenophon, we dissented from the majority report of the Legal and Constitutional Affairs Legislation Committee. In our dissenting report we explain that the Australian patent system has lost its way.

In 1989, Barry Jones, as Minister for Science and Technology, said during the second reading speech for the bill that became the Patents Act 1990 that one of the objectives was to strengthen Australia's patent law. Australia is now a soft entry point to the patent world. The bill was the result of a report prepared by the Industrial Property Advisory Committee, IPAC, which recommended the retention of the manner of manufacture test. One of the objectives of the bill was to restore the full scope of this test after two full Federal Court decisions removed the ability of the courts to strike down a patent on public policy grounds. Sixteen years after that report, the Intellectual Property and Competition Review Committee likewise agreed that the manner of manufacture test should be retained. More than that, the committee reinforced the importance of maintaining the distinction between discovery and invention. It said:

… the goals underpinning the National Competition Policy are well served by a patent policy that rigorously distinguishes between discoveries that advance our understanding of the nature, structure and properties of matter, and inventions that apply this understanding to useful products and processes. Within such a policy, only the latter should qualify for patent protection.

The distinction that is— (Time expired)

I seek leave to incorporate three little pages into Hansard.

Anne McEwen (SA, Australian Labor Party) Share this | Link to this | Hansard source

No.

Louise Pratt (WA, Australian Labor Party) Share this | Link to this | Hansard source

Leave is not granted.

Anne McEwen (SA, Australian Labor Party) Share this | Link to this | Hansard source

I would like to make a statement explaining my reasons for denying leave. As Senator Heffernan and everybody in this chamber should know, it has long been the rule that incorporation of speeches will not occur except in the situation of the illness of a senator or of valedictory speeches. However, I am sure if Senator Heffernan wanted to seek leave to continue his remarks he could continue his remarks when the report comes onto the red as a document for debate.

Bill Heffernan (NSW, Liberal Party) Share this | Link to this | Hansard source

Thank you, very much for that guidance. That would be preferable to tabling the document.