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Gene patenting: Australian court rules BRCA1 patent is legal

“The issue that arises in this case is of considerable importance. It relates to the patentability of genes, or gene sequences, and the practice of gene patenting”. So began the reasons for judgement of…

The BRCA1 gene is thought to account for 45% of hereditary breast cancer, and at least 80% of hereditary cancer involving both breast and ovarian cancers. Tips Times

“The issue that arises in this case is of considerable importance. It relates to the patentability of genes, or gene sequences, and the practice of gene patenting”. So began the reasons for judgement of the Federal Court of Australia in Cancer Voices Australia v Myriad Genetics Inc, published on Friday.

This is the first Australian court decision on the patentability of isolated DNA or RNA sequences. Myriad Genetics, claiming a patent related to the BRCA1 gene, won the case and the challenge to their patent was dismissed.

Three things will help understanding why.

What is BRCA1?

It’s a human breast and ovarian cancer-disposing gene. According to the disputed patent, mutation of the BRCA1 gene is thought to account for 45% of hereditary breast cancer, and at least 80% of hereditary cancer involving both breast and ovarian cancers.

Can genes as such be patented?

No. Patents cannot be granted for products of nature. There’s no doubt that naturally occurring DNA and RNA as they exist inside the cells of the human body cannot be the subject of a valid patent.

Was this particular patent valid?

This was the core of the debate. Myriad Genetics argued that its patent related to isolated DNA and RNA, extracted from cells removed from human body and purged of other biological material with which it is associated in the cell.

Cancer Voices Australia argued that there’s no significant or material difference between nucleic acid in its natural and isolated states. Scientific experts gave evidence on these issues, to assist the court.

Key question

In analysing the competing arguments, the Court said that a composition of matter may be patentable if it consists of an artificial state of affairs, with some discernible effect, of economic utility and the result of some human intervention.

The Judge said:

The real problem lies in knowing, or rather not knowing, what degree of human intervention is necessary before it can be concluded that the requisite artificial state of affairs exists. It is an especially difficult problem in the present case, not so much because the authorities provide no clear solution to it, but because the problem has an almost metaphysical dimension to it.

The outcome

Ultimately, the court decided that there was the necessary artificial state of affairs, explaining:

  • earlier cases binding on the court regarding similar issues had used expansive language,

  • in the absence of human intervention, naturally occurring nucleic acid does not exist outside the cell, and isolated nucleic acid does not exist inside the cell, and

  • it would lead to very odd results if a person whose skill and effort culminated in the isolation of an DNA sequence could not be independently rewarded by the grant of a patent.

An appeal

The Australian judicial system is transparent and reviewable. Transparent, so anyone can freely access online the full reasons for judgement in Cancer Voices Australia v Myriad Genetics Inc. Reviewable, so dissatisfaction with the outcome may be tested in an appeal from the decision - perhaps even two appeals, should the issues warrant determination by the High Court.

Changes to the law

The Patents Act is crafted by the Australian parliament. Should it wish, the parliament may amend the legislation to provide a different balance between private and public rights. Reform in this area has been considered in the past.

In its report Genes and Ingenuity: Gene Patenting and Human Health, the Australian Law Reform Commission recognised that concerns could be raised in relation to patents for isolated biological materials.

The Australian government’s 2011 response accepted the recommendation that the legislation not be amended to exclude genetic materials and technologies from patentable subject matter, though some other amendments to intellectual property laws have recently been made.

What next?

Similar arguments about gene patients are soon to be considered by courts elsewhere. CNN quickly reported the recent Australian decision, noting that that the same gene, along with BRCA2, is at the centre of a high-profile lawsuit set to be heard by the United States Supreme Court in April of this year.

The frontier of genetic medical research seems likely to remain on the Australian and international judicial and parliamentary agenda for some time to come.

Join the conversation

27 Comments sorted by

  1. Ulf Steinvorth

    Doctor

    If our society, parliament and courts decide that medical progress should lead to financial gain it makes legal sense to patent genes, vaccinations, treatments, plants and anything that is able to alleviate mankind's suffering.

    Whether that is the morally right decision is another question altogether and one that might need addressing. Obviously it is no longer an issue just for the 'poor' nations of the world who have difficulties affording even the most basic preventions, medicines and cures offered (and patented) by international medical companies - the mantra of profitability might well be starting to affect health care in the super-affluent nations.

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  2. Geoff Taylor

    Consultant

    It is one thing to patent the method for isolating this gene. It is quite another for an Australian judge to grant a patent over the naturally occurring genetic material which is extracted.
    This presumably means that any researcher who wants to use BRCA1 to develop a gene based therapy has to pay Myriad to utilise a naturally occurring sequence, even if that researcher has isolated it in a different way.
    What is next, a patent on the morphogenetics Sheldrake suggests may influence gene organisation and forward flow in time?

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  3. Charles Lawson

    Law academic

    This was seriously flawed litigation in the first instance and doomed to fail spectacularly as it has. This same issue has been around for 25 years and the arguments well rehearsed though a whole range of patent office decisions around the world. We just have to accept that genes and sequences are patentable. What we need to focus on now is the other critical areas in patent law that control how patent holders deal with their patents. Our present system essentially excludes patent holders from competition…

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    1. Yoron Hamber

      Thinking

      In reply to Charles Lawson

      No, you're soo wrong. We don't have to accept anything, unless we want to. And to patent genes stink, and will slow down all research and cheap use of genetically manipulated medicaments. And above all it is a ethical and moral issue, Where does this 'owning and patenting of nature' ends? Can I own you too, by implication? I can 'own' your genes, what you wear, the materials you use. It's a really unsound thinking implied, well fitting a greed society, but not a democracy.

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  4. Ric Thomas

    Clinical Educator at Prehospital Care

    Hi all,

    What do I have to do to take out a patent on my genome?

    This is a deplorable situation enabling multinational pharma companies to exploit vulnerable populations. My response is to patent my own genome, and encourage all who can afford to do so to do the same, now where do I start?

    V.concerned
    Ric

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  5. Paul W.

    logged in via email @unsw.edu.au

    "in the absence of human intervention, naturally occurring nucleic acid does not exist outside the cell"

    "it would lead to very odd results if a person whose skill and effort culminated in the isolation of an DNA sequence could not be independently rewarded by the grant of a patent."

    This sounds very much like a patent on two of the most basic skills in molecular biology: DNA and RNA extraction. I would hardly call this an innovation. Am I no longer able to work on any "isolated" nucleic acid?

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  6. Rob McInnes

    logged in via Twitter

    Couple of things from someone who makes a living managing and licensing life sciences patents. First, the case doesn't establish that genes can be patented, it expressly finds that genes as found in the body can not be patented. Genes only become a ‘manner of manufacture’ once isolated, purified, and put to a use (such as diagnosing a disease).

    Secondly, the case is about whether isolated, purified DNA/RNA with a stated use can possibly be the subject of a patent. It doesn't say that every…

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    1. Sean Lamb

      Science Denier

      In reply to Rob McInnes

      Thanks for revealing your interest, as it allows us to put your misinformation into its appropriate context.
      " if companies cannot patent diagnostic tests using genes, they will not develop them. It would be nuts for a company to spend tens or hundreds of millions of dollars on research to develop a test,"
      You are obviously far too well informed to believe what you wrote so you won't object to my inquiry as to why you are attempting to deceive the readership here?
      A genetic test for predisposition…

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    2. Sean Lamb

      Science Denier

      In reply to Rob McInnes

      Oh, and you are right about one thing: the woolly emotionalism that is often deployed is annoying.
      These are unjustified on purely legal and scientific grounds, employing arguments about the good of humanity are a waste of time in a court room and in this case simply unnecessary.

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    3. Rob McInnes

      logged in via Twitter

      In reply to Sean Lamb

      Hi Sean, you ask a good question, and I can't give you a firm answer because I don't know which side I may have to argue in future :-) All I'll say is that in the USA the Prometheus case may be relevant, suggesting that comparing a reference sequence against a test sequence in the USA may be in the nature of a discovery not an invention. The general principle is that discovering a natural phenomenon (this sequence implies that predisposition), and applying it using conventional, known means, is…

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    4. Reema Rattan

      Health + Medicine Editor at The Conversation

      In reply to Rob McInnes

      I'm not sure I understand whether it's the test for the gene or its isolation that you are saying should be patentable. They are different things and my understanding is that no one has a problem with a diagnostic test being patented. The isolated gene, on the other hand, is a different matter, and whether it contains an act of 'manufacture' or 'manner of manufacture' is debatable.

      It's not that 'gene patents' sap our vital essence as you suggest but rather that they may pose a grave danger to…

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    5. Rob McInnes

      logged in via Twitter

      In reply to Reema Rattan

      Hi Reema,

      I think both should be patentable if, and only if, they are novel, inventive and useful. But as Phil John ably points out, the point is pretty moot now that the human genome has been sequenced and published.

      A number of commenters seem to have trouble with the pretty simple concept that a class of things can be potentially patentable subject matter (that is, not legally excluded from being patentable), but that this doesn't mean that every member of that class of things can be…

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    6. Ulf Steinvorth

      Doctor

      In reply to Rob McInnes

      Dear Rob,

      thank you for shedding some light on this dark issue and sharing your experience and expert knowledge - shines some more light on the issue than the original article.

      I especially appreciate your honesty regarding the profit interests of our medical companies surrounding new medical developments and inventions. It's hard to find a more succinct and down to earth explanation of why a profit-driven medical industry will always cater for the most profitable market.

      Profits are of…

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    7. Greg Boyles

      Lanscaper and former medical scientist

      In reply to Ulf Steinvorth

      I hate to persist with this point and upset a lot of sensibilities here, but malaria and TB also serve an ecological purpose here even if they take a terrible human toll. I.E. Population control.

      If every last TB and malaria victim was saved now and in the future then a great many of those could potentially live in terrible poverty and starve to death.

      I am not saying that no effort should be made to alleviate the suffering TB and malaria cause but I would like to ask you Ulf, since you are…

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    8. Phil John

      Biotech Patent Attorney

      In reply to Ulf Steinvorth

      Last week in the news it was reported that the highest paid profession in Australia (on average) was again doctors.

      Doctors are paid a good portion - most of their money (directly or indirectly) from tax dollars administered by Medicare.

      So, in my opinion, I find it harsh for you to have a crack at the medical industry that provides a whole range of medications and devices for doctors to be able to do their jobs and treat their patients. Not all of us get good money from the tax payers. Medical/pharma companies have to find private monies and lots of it over many years to produce those products doctors are so happy to use and dispense. The people who lend that private money want a return - it's pretty simple really. Maybe if you can convince the government to pump billions of tax payers dollars into the Development side of R&D as opposed to just the Research and we might not have a need for patents and can focus on the important diseases. Yes?

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    9. Ulf Steinvorth

      Doctor

      In reply to Phil John

      Dear Phil,
      you point out that medics are top earners in Australia and that might well be unneccessary or even inappropriate - but that is not the main point you make I believe.

      You say that doctors get paid predominantly by the tax payer whereas the pharmaceutical industry does not and that is probably true and a change would require more research funding by tax money i.e. higher taxes.
      But there also is a considerable private market in medicine where people have to pay out of pocket to see…

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    10. Greg Boyles

      Lanscaper and former medical scientist

      In reply to Ulf Steinvorth

      "that 'we need those killer diseases to wipe out surplus population' "

      Ulf I did not say that we should NOT help people suffering from those diseases.

      I asked you a simple question that you have not answered.

      In the conext of the medical profession providing mass medical aid in third world countries affected by those diseases, does your profession take wider responsibility for the long term and wider consequences of that aid regarding the issue of over population.

      Or does your profession…

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    11. Greg Boyles

      Lanscaper and former medical scientist

      In reply to Greg Boyles

      I aint no bible thumper but I think that the Catholic Churches' (and others) general idea of slowing down a little re technology has SOME merit.

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    12. Ulf Steinvorth

      Doctor

      In reply to Greg Boyles

      Greg, what you are saying is that we should think again about saving people in poor countries from treatable diseases because of overpopulation.

      What you are conveniently 'forgetting' to say in spite of me specifically challenging you to do so is that 'we should think again about saving patients in rich countries from treatable diseases because of overpopulation'.

      To me that kind of thinking is very bitter 'medicine' you try to hand out and one that I will never be part of.

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    13. Greg Boyles

      Lanscaper and former medical scientist

      In reply to Ulf Steinvorth

      "Greg, what you are saying is that we should think again about saving people in poor countries from treatable diseases because of overpopulation."

      No Ulf, that is what you are saying that I am saying, incorrectly, in an attempt to avoid answering my original question.

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    14. Greg Boyles

      Lanscaper and former medical scientist

      In reply to Greg Boyles

      My question stands.....

      Does the medical community take any wider responsibility for its effect on the local population dynamics when deivering its commendable medical aid?

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  7. Greg Boyles

    Lanscaper and former medical scientist

    "This was the core of the debate. Myriad Genetics argued that its patent related to isolated DNA and RNA, extracted from cells removed from human body and purged of other biological material with which it is associated in the cell."

    What bullshit!

    If that is the case then I could put a patent on sodium metal because that does not exist in pure form in nature and requires me to purge it from sodium chloride and expel all other elements and impurities.

    Clearly the law needs to be changed such that patents cannot granted naturally occuring things nor on things that are extracted from nature.

    Patents should only be granted on genuine inventions, perhaps including any novel techniques used to extract DNA.

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  8. Anneliese Ford

    Senior Consultant

    If a company can 'own' a gene which kills women, I look forward to the test case to sue that company for the harm it inflicts.

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    1. Greg Boyles

      Lanscaper and former medical scientist

      In reply to Anneliese Ford

      Hmmmm.....good point.

      It would be interesting to see some one try such a lawsuit.

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  9. CH Soames

    Cytogeneticist

    Tacks would be spat if this weren't so scary. Wrong, wrong, wrong! So if i remove some of the pages of a book you have written- no, better, chip out some of the letters from the Ten Commandments slab of rock- I can patent those bits of stuff, because pages aren't usually seen outside books/text isn't usually read in isolation???

    Watch the rich-poor divide exponentially increase now. There has to be a better, more equitable way to fund research.

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  10. Phil John

    Biotech Patent Attorney

    Hmmm, some common arguments have been raised here. I would like to add some info but I will do it from the perspective of answers to a series of questions which may or may not help:

    Key Question: If you apply for a patent claiming an isolated human gene tomorrow, will the Australian Patent Office grant the patent.
    A: No.
    Why: Because the human genome project and other publically available genetic databases have the whole human genome sequenced. So any patent claim to an isolated human gene…

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