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

I will continue my remarks on this report. Just to put it into context, obviously this is a bill which has been brought on to focus not only Australia but the rest of the world—it is the first time it has been dealt with by a parliament in the way it has in the Australian parliament—on the 35 years of flawed interpretation of patent law which is being acknowledged in the American court system and is now working its way up through that system. It will cost not only public health dearly with lack of research because of the monopolisation but also the future capacity of governments to fund public health.

The Intellectual Property and Competition Review Committee said:

The committee considers that 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 the inventions that apply this understanding to useful products and processes, and obviously commercialisation. Within such a policy only the latter should qualify for patent protection.

That is generally acknowledged by most people. There are one or two that do not and one or two who argue that the isolation of a gene makes it patentable, but of course there is no material difference between the gene in isolation and the gene in situ. The committee also said:

The distinction is vitally important not only to the people of Australia and the scientists who work and strive to help develop new diagnostics, medicines, therapeutics and hopefully cures but to the integrity of Australia's patents system. As the US said on the issue, the extent to which basic discoveries in genetics have been patented is a question of great importance to the national economy, to medical science and to the public health.

And so it is to the Australian economy, to Australian science and the health of Australian people. It is only by chance that Australian women are not today facing the crisis facing women in the United States. Let me read a little from an article published last month in the New York Times:

In 2006, Professor King and colleagues published a paper showing that Myriad's test, known as the Comprehensive BRACAnalysis, actually failed to detect a significant number of genetic alterations in the two genes.

Myriad then developed a test for these alterations.

It did not fix the patent test it had.

But instead of incorporating it into its main product—

which cost $4,000 for the test because of the monopoly—

it offered it as a supplemental test at a price of $700. Many insurers do not pay for it, and therefore many women do not get it.

Myriad's data shows that for Latina women in particular, 20 per cent of all mutations found are detectable only by the supplemental test.

"The comprehensive testing they are advertising is not really comprehensive," said Ellen T. Matloff, director of cancer genetic counselling at Yale, who is also a plaintiff in the patent lawsuit. "This would not happen in a competitive market. It simply would be unacceptable."

More than 200 doctors, genetic counsellors and other health care professionals have signed an open letter to Myriad urging it to incorporate the supplemental testing into the main test.

Kathleen Maxian says that if that had been done earlier, she might not be fighting for her life against ovarian cancer.

Her sister developed breast cancer at age 40 about five years ago, but tested negative for mutations on Myriad's main test. She was not offered the supplemental test.

Two years ago, Ms Maxian developed ovarian cancer. It turned out that both she and her sister had genetic alterations that were detectable only by the supplemental test.

"If my sister had had that test and had gotten a positive result, I would have gone to a genetic counsellor and have been tested," said Ms Maxian, who is 49 and lives in Pendleton, NY, near Buffalo. She would then have had the option of having her ovaries removed to avoid getting ovarian cancer.

"I don’t want to see this happen to anyone else," she said. "Women should have this test."

Before I sit, I implore you to read and study the dissenting report and to remember that the Australian patent system is not there for the benefit of sectoral interests which have deep pockets and have armies of lawyers and patent attorneys only too willing to look after their own interest. Rather it is there, if this is to be of any relevance in the 21st century, to balance the rights and interests of all Australians.

I will point out to the chamber what happened when Gene Technologies Ltd first got the licence for Australia, just as an instance of this particular patenting problem. Clearly bankers, lawyers, IP Australia and the industry do not want anyone to draw the line between what you can patent on the inventive side and what you cannot patent on the discovery side. It is a 'don't ask, don't tell' sort of a proposition. The federal Department of Health and Ageing agrees with what we are saying, that we have got to learn to draw this line. But the department of industry says, 'No, let's keep going—we are all going to get a big quid out of this.' When I rang the CEO of Genetic Technologies before we kicked this debate off—and I am eternally grateful to this parliament and to the Minister for Health and Ageing, Nicola Roxon, for letting us have this debate—he said to me, 'Bill, why are you doing this?' and I said, 'Because we should not have a patent on discoveries.' He said, 'We have offered our licence to Australia as a gift to the people of Australia, but you have just given a litigation lever to every public laboratory in Australia, putting them on notice to desist from testing for BRCA 1 and BRCA 2 mutations and surrender all their data to the laboratory in Melbourne, as a monopoly.' He then said, 'That is a good thing for Australia. Lucky that we discovered that Myriad in America was breaching one of our patents and as part of the legal settlement they allowed us to do the testing under this licence in Australia. Otherwise we would have had to send all the samples back to America to be tested, as Japan has to do.' He also said, 'But we are going broke and we have got to call up all our capacity to earn money, so we are putting them all on notice that they have to surrender all their testing to us.' This is in a situation where the law clearly states that you can patent an invention that is unique, has a commercial purpose and has an inventive step. It clearly states that discovery work cannot be patented.

What we have done—and I have got truckloads of patents in my office if anyone wants to see them—is include the gene in the patent. All these patents would still be valid under what is proposed in this bill. All the inventive work would still be patented and commercialised, but the gene would be taken out so that someone else—say, Senator Chris Back's laboratory—could get access and would be able to do research without having to go to the phoney political solution, which is an exemption for research. In the case of the BRCA 2 test, which is a flawed test, what a hide Myriad America has, not to fix a flawed patented test that is proven to be not working but to include an extra test you have to go through to see if the flawed test did not pick you up. What a disgrace that is.

The department of industry are now arguing that you will get a licence to do experimental work. But if I hold the licence and I give Senator Chris Back's laboratory an exemption to do the research and his laboratory is smarter than mine and beats me to the prize for the inventive step and the commercialisation, he can come back to me and say, 'Now, Bill, can I have an exemption so that I can commercialise the thing, including the gene that you hold the patent for?' If I say yes, what does that say about the patent system? Why have I got the patent in the first place if I am going to give it away? If I say no he makes the point that the exclusivity and the monopoly and cartel thinking in all this is absolutely adding billions of dollars to public health. One patent alone cost $1.9 billion in licence fees because it included the gene, besides the inventive work.

My absolute plea to the Australian parliament and to everyone in the Australian parliament is to look at the facts in all their starkness and have the courage to say: 'Well, for 35 years the US government said to the US courts, "We have made a mistake on the interpretation of patent law. Let's fix it so that we can fund public health in the future and look after the human race."'

Christopher Back (WA, Liberal Party) Share this | Link to this | Hansard source

I rise to speak on this matter as my colleague Senator Heffernan has—and I would never deal with his laboratory in such a desultory way, I can assure him! I think it goes to an absolutely critically important point, and that is that naturally occurring biological features or phenomena, such as genes or anything of that nature, should not be patentable. They are not an invention; they are a discovery, and I think it is absolutely critical that we go back to basics in this particular regard.

People will say, 'Well, where is the incentive for medical research?' We know that it is horrifically expensive, we know it is time consuming and we know that the proportion of chemicals tested that ever actually come to fruition is very low. But I want to make one point particularly strongly, in support of the comments made by the previous speaker, and that is that in the inventive side there is plenty of scope. I say again that the isolation of a gene, a gene sequence, chromosomes or whatever of themselves should not be patentable, because they are merely the discovery of a naturally occurring phenomenon. But the difference arises here: if a research organisation, a company, a group of researchers, a university or whoever were to modify that gene sequence, were to add value to it, were to establish a test to which those genes could be subjected to establish whether or not a member of a family, a person, an animal, a plant or whatever may have genes that are defective, of course that does constitute invention. It constitutes adding of value. It constitutes something upon which protection should be afforded to the research organisation or company.

Going further, if that group were to develop a vaccine that would allow for the control or even the prevention of that disease, it is patently obvious that it should be patentable, but not the original gene sequence itself. If that company, university, group or individual were to go to the expense of developing pharmaceuticals for the purpose of treating a disease that may arise as a result of those gene sequences, again you can see the logic of that. Surely that is where we as lawmakers should be directing our efforts here in Australia. Also, we should be encouraging those overseas, as indeed we are seeing in the United States and Japan and other jurisdictions, where they have come to realise that patents were handed out far too easily for what were actually discoveries of natural phenomena.

I do not want to speak for much longer on this, except to reflect on how far we have now come from the early days of medical research, where there was tremendous sharing of information. One can go back to Pierre and Marie Curie, when they first looked at and came to discover microscopic organisms. They were, of course, the subject of derision amongst the scientific community. But imagine if in those days they had gone and put a patent on the discovery of bacteria. Where would we be? Think of Fleming and his co-workers and the discovery of penicillin. The only reason it was discovered was that an agar plate was left out over the weekend. When Monday morning came along there was this unusual looking growth on it. They said, 'What is it? Let's throw it out. No, let's not throw it out; let's examine it.' The end result of that, of course, was the discovery of the antibiotic penicillin because someone discovered a bare area within all of the moss that was growing. That bare area was the substrate of that antibiotic. Let us imagine for a moment that, instead of sharing that with the world's scientific and medical community, Fleming and his co-workers had said, 'The best thing we can do here is put a patent on this and make sure that nobody else gets access to it.' If we go to polio and its vaccines, we are now so close to eradicating that in this world, including through the oral vaccine—the so-called Sabin vaccine.

My concern is for protecting the goodwill of the past that had such a profound effect on human health and in getting on top of so many of those infectious diseases that killed so many people in the world. I remind people again that the influenza epidemic of 1918-19 killed more people than died during the course of the First World War from military related activity. So we must surely protect that and ensure that we do not move away from that international goodwill that has always existed, that international goodwill that has allowed the sharing of information around the world to allow scientific peers in other places of the world to replicate and validate the work done by other scientists for the good of humanity, whether in human disease, animal disease, plant disease or whatever. We are facing a crisis. The last thing we need is a sense of protectionism.

But, at the same time, I recognise, as everybody must, that the cost of research is horrifically expensive. The proportion of pharmaceuticals that ever get to the market and yield a return for their developers is very small. Whilst we must accept the commercial reality, we must continue to encourage research and researchers. We should not ever get to the stage where naturally occurring phenomena—genes, gene sequences, chromosomes et cetera—are the subject of a patent on behalf of any person because they or someone associated with them happened to discover it. I seek leave to continue my remarks later.

Leave granted; debate adjourned.