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Monday, 21 February 2011
Page: 581

Mr DUTTON (11:00 AM) —The purpose of the Patent Amendment (Human Genes and Biological Materials) Bill 2010 is to clarify current Australian patent law in relation to human genes and biological material. It will amend the Patents Act 1990 to reinforce the distinction between discovery and invention. It will expressly exclude from patentability human genes and biological materials which are identical to, or substantially identical to, such materials as they exist in nature.

A similar bill was introduced into the Senate late last year. It was co-sponsored by the coalition, Independent Senator Nick Xenophon, and the Greens. In this chamber the bill is co-sponsored by the coalition and Independent member for Lyne, Robert Oakeshott. The introduction and debate of an extensive motion by a member of the government late last year, which called for this very amendment to the Patents Act, indicates that there is indeed wide support within this parliament for this change to take place. It is a sentiment that the government should take note of, and I believe should act upon, by supporting this bill.

The issuing of patents on human genes has been and remains a highly contentious issue within Australia and, more widely, internationally. It has been the subject of debate in this House; it has been the focus of a committee inquiry in the Senate also. On one side of the argument are scientists, doctors, patients and organisations that argue that patents on human genes and biological material impede scientific research, restrict development of new and alternative medical tests and in so doing deprive us of chances of the discovery of medicines and cures for some of our most frightening illnesses.

On the other hand though, there are other scientists, doctors, research institutes and biotechnology companies that argue equally forcefully that the granting of patents provides the incentives for discovery, development and invention that can quickly bring us closer to better medical diagnoses, medicines and the cures that we all would seek to alleviate the pain and suffering that so many endure. By some estimates it is believed that 40 per cent of the human genome has now been patented around the world since a United States Supreme Court decision in 1980 determined that life forms were patentable under US law. Prior to that, the US Patent Office had a position not to patent a biological organism. Since then thousands of patents have been granted with an estimated 25,000 DNA patents issued by the year 2000.

But increasingly, the issuing of patents over human genes and biological material is under challenge. A decade ago President Clinton and British Prime Minister Blair issued a joint statement saying the human genome should be freely available to scientists everywhere. Research institutes and national governments in Europe are calling for such patents to be brought into question, members of the European Parliament have passed resolutions criticising the Euro Patent Office position on genes; and in Canada, state jurisdictions are ignoring gene patents by supporting public health institutes to ignore patents on tests for cancer. The British House of Lords Judicial Committee invalidated patent claims because the synthetic human protein being claimed as an invention was not ‘new’.

In the United States and here in Australia court challenges have been launched against gene patents. While the Australian case has not proceeded, the American outcome resulted in a finding that a corporation’s patents over breast and ovarian cancer genes had been improperly granted and, indeed, were invalid under law. The case is under appeal and is sure to drag on for years. But significantly, the US government has signalled to the courts that it considers that the longstanding policy of the US Patent Office to grant patents over genes was, in fact, contrary to US patent law. At the heart of the American Federal Court decision that the gene patents were invalid was that they were not inventions. That is at the heart of this bill: the distinction between discovery and invention. Only an invention can be patented. Human genes and biological material are not inventions. They exist; they are naturally occurring. Scientists and researchers discover them; they do not invent them. The amendments to the Patents Act provided in this bill will enshrine that distinction in Australian patent law.

To do otherwise will leave considerable ongoing uncertainty for the scientific community and society generally. Two years ago an Australian company, as licensee for an American biotechnology company, sought to prevent Australian hospitals and medical laboratories from testing for breast and ovarian cancer, threatening to sue them for breach of patents if they proceeded without paying thousands of dollars for the company to perform the ‘patented’ genetic testing. Under wide public pressure, rightly, it backed down, but its actions highlighted the disturbing situation that people suffering life-threatening diseases could be denied the tests and treatments that could help them, because a corporation held a patent on the naturally occurring genes that were part of the make-up of their bodies. To retreat to the fundamental basis of patent law: patents are granted for inventions, as we say, not for discoveries of naturally occurring biological materials such as our genes.

That is what this bill strikes. It will clarify that important difference. In doing so it will remove the threat that patents on genes hold to monopolise and therefore restrict vital research. It could indeed accelerate scientific competition and innovation which lead to the knowledge and the breakthroughs to understanding illnesses and disease and eventually the medical inventions that provide cures or better treatments. While the very genes and biological material that form our make-up will not be patentable, unique processes that provide for their isolation, purification or synthesis will be, thus affording patent protection to biotechnology breakthroughs, just as now. The biotechnology industry will continue to have the scope to patent true inventions.

Two years ago at the height of the concerns over gene patents in Australia, the Senate Community Affairs Committee began an inquiry into this complicated issue. Its report was handed down just three months ago. While that report did not call for a ban on gene patents, it did call for patent laws to be updated to ensure that research into cancer and other diseases could proceed unhindered by threats of patent infringement. It also called for a government response to various national reviews, reports and inquiries into gene patents by mid 2011.

This bill is now being scrutinised by a Senate committee, which should ensure that there are no unintended consequences from these amendments and alleviate concerns that it holds a threat to scientific innovation and research. That committee is also due to report in June. No doubt there will be amendments to the bill, but the parliament will be able to proceed on this critical matter if the government does not.

As renowned scientist Professor Ian Frazer warned in late 2009:

Science sits on the cusp of a surge in the use of genes in the diagnosis and treatment for major illnesses.

…            …            …

It is crucial we address this issue now, before the wave of gene technology breaks.

As the inventor of the cervical cancer vaccine, Gardasil, Professor Frazer has benefited greatly from patent law. But he, like so many others, believes that genes are not inventions and they should not be patented. Nobody should be able to own part of each and every one of us. I commend the bill to the House.

Bill read a first time.

The DEPUTY SPEAKER (Hon. BC Scott)—In accordance with standing order 41, the second reading will be made an order of the day for the next sitting.