US Court Strikes Down Patent on Human Genes – Huge News for Genomics

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court case strikes down gene patent

US District Court ruled in favor of the ACLU against Myriad Genetics, striking down their patents on human genes.

In what is sure to become a landmark case for genomics, a US District Court Judge in New York (Robert Sweet) has ruled that patents on human genes held by Myriad Genetics are invalid. These patents, on the BRCA1 and BRCA2 genes, were issued more than a decade ago and gave Myriad exclusive rights to examine those sections of DNA. Mutations in BRCA 1 and 2 carry important links to breast and ovarian cancer, and Myriad’s BRAC Analysis (Be Ready Against Cancer) genetic screening is used to provide patients with a better understanding of their risk for the diseases. The court decision effectively eliminates Myriad’s rights to solely market tests on the BRCA genes, which may lower costs (previously up to $3000) for those interested in the tests . The American Civil Liberties Union (ACLU) lead the attack against the Myriad patents which it shares equally with the University of Utah Research Foundation. This case has wide ranging implications for the entire genomics community. 20% of human genes are patented, often along with the process of identifying the genes, and these patents are now drawn into question. It is almost certain that this ruling will be appealed and eventually reach the US Supreme Court. It may take years before a final decision is made, but for now it seems like the human genome may no longer be up for grabs as intellectual property. Thank goodness.

Biotech intellectual property rights are big business.  We’ve seen company stock prices surge with the grant of a new patent. Myriad’s price (NASDAQ: MYGN) had a rough drop since the announcement of the court ruling. Investors, not just in Myriad but in all firms with genetic patents, must be asking themselves how far reaching this decision may be.

Judge Sweet’s ruling is long (150+ pages), but you can find a copy of it here thanks to the Genomics Law Report. Likewise, the patents Myriad holds on the BRCA genes are numerous (1,2,3,4, ). Trying to sift through this legal material is difficult, but we can summarize the ruling down to two facts. Sweet found that:

  1. The DNA patented by Myriad Genetics (isolated from the human body in a lab, along with mutations there of) are not markedly different from natural DNA (that found in your body, mutated or otherwise).
  2. Comparing DNA sequences to identify BRCA genes and their mutations is an abstract mental process.

In other words, you can’t patent nature and you can’t patent a fundamental idea of science. There’s little doubt that the breadth of these two findings are likely to apply to the vast majority of patents on genes in the United States.

Human genes, that is. Patents on plants and animals are unlikely to be called into question at this time. That’s because many such patents are not held on ‘natural’ organisms, but on those that have been genetically modified. Whether it’s pest-resistant rice or artificial meat, GM foods are generally thought to represent an engineered good.

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Which begs the question, would Sweet’s ruling cover human genes that have undergone engineering. Probably not, but the germline mutations of humans is still largely opposed so the cases involved are likely to be small. One day, however, we may all carry a few genetic modifications. Gene therapies could alter the DNA (or maybe just the protein production) in our bodies. Would such variations then mean we are carrying some corporation’s intellectual property inside us? What if someone naturally developed such genes on their own…would their bodies be committing copyright infringement?

That’s the sort of terrifying prospect that could await us if we continue to allow patents on human genetic material. It’s one thing to patent a process on making a chemical, or even that chemical itself, but when the chemical is your DNA…your allowing ownership (at least in part) of a human.

Of course Myriad Genetics isn’t trying to enslave humanity. No biopharmaceutical company, as far I can tell, is so stupidly nefarious. MG’s products help patients identify their risks of cancer. That’s certainly not a bad thing – in fact it should be applauded. Indeed, Myriad Genetics has made the claim that such patents on genes allow the holding company to develop techniques secure in the knowledge that they can turn a profit to compensate for their investment. Without such guarantees to their work, MG lawyers have argued, research will be stifled.

But certainly research has been stifled in the other direction as well. By holding exclusive rights to the BRCA genes, Myriad Genetics keeps other companies from freely working on the same gene without fear of legal reprisal. Apply that scenario to the 20% of human genes patented and you begin to wonder how much research has been stunted by this hording of genetic territory. If we applaud MG for developing cancer risk assessments and treatments, we must also reprimand them for preventing others from doing the same.

We may need to rethink patents. Intellectual property as a whole is undergoing a metamorphosis (much like privacy) and it’s becoming increasingly clear that such restrictions may not be enforceable. China seems to violate patents whenever it feels like it. Brazil permitted the creation of generic versions of AIDS medications in spite of patents. Even within a single country (like the US) consumers are pirating copyrighted material. We are struggling with these legal issues (locally and globally) but it seems likely that the free exchange of information (via the internet) is counteracting the premise of intellectual property on a fundamental level.

Even if we somehow managed to find ways to rigidly enforce all patents, I don’t think we would want to extend that enforcement into genetics. We are our genes. Even as we learn to alter and influence how those genes are expressed, humans still need the inalienable rights to their DNA. Anything else would be socially disruptive on a grand scale, not to mention terrifying. In the more limited cases of research and development (patenting just the identification process or a certain technique to refine genetic material for testing) things may become gray. How can we best allow companies to find a return on their investment (and thus encourage investment) without preventing other firms from also developing similar work (thus encouraging research)? It’s a difficult question and one that is likely to be years in the answering. For now, it is enough to look at Judge Sweet’s ruling and wonder how long it will be until the next court case. We’ve only just begun.

[image credit:ACLU]
[Source: US District Court Ruling, Genomics Law Report, Myriad Genetics]

Discussion — 30 Responses

  • Chris Davison March 30, 2010 on 2:38 am

    To allow patents on unaltered human DNA (genetic or otherwise) is shortsighted to say the least, good to see the ACLU standing up for fundamental human rights.

  • Chris Davison March 29, 2010 on 10:38 pm

    To allow patents on unaltered human DNA (genetic or otherwise) is shortsighted to say the least, good to see the ACLU standing up for fundamental human rights.

  • Paul March 30, 2010 on 3:14 am

    This is excellent news! James Watson co-discoverer of DNA was opposed to such patents and when NIH overuled him he left, or was forced out, in 1992. As the judge correctly notes these are products of nature not intellectual products. Now we are in the absurd position of being able to cheaply and rapidly sequence a persons entire genome. Is every single nucleotide polymorphism found in the individual by the testing company open to being patented. It is to my mind akin to buying a microscope and then claiming a patent on whatever components of life I find there. What about, again as the judge noted, the problem with stifling scientific advance by not being able to openly study the gene in question. I would go one further and say that no DNA sequence whether created artificially or found through sequencing may be patented. Quite often these sequences end up in self replicating or potentially self replicating organisms. There is an interesting story http://healthjournalclub.blogspot.com/2010/03/astonishing-court-case-of-becky-mcclain.html of a microbiologist who is claiming she was inadvertently infected by a genetically engineered virus. The company however, is refusing to release the sequence of the virus in question. Well what if that virus or a future one turned out to be contagious? Can you even place a patent on a computer virus? How much more foolish to claim there is patent protection on a virus that might someday be able to kill you. At the very least, requests by health practitioners or public health officials should over rule patent claims, whether a sequenced part of a genome or one made from scratch. Glad to see this ruling.
    Paul
    http://healthjournalclub.blogspot.com/

  • Paul March 29, 2010 on 11:14 pm

    This is excellent news! James Watson co-discoverer of DNA was opposed to such patents and when NIH overuled him he left, or was forced out, in 1992. As the judge correctly notes these are products of nature not intellectual products. Now we are in the absurd position of being able to cheaply and rapidly sequence a persons entire genome. Is every single nucleotide polymorphism found in the individual by the testing company open to being patented. It is to my mind akin to buying a microscope and then claiming a patent on whatever components of life I find there. What about, again as the judge noted, the problem with stifling scientific advance by not being able to openly study the gene in question. I would go one further and say that no DNA sequence whether created artificially or found through sequencing may be patented. Quite often these sequences end up in self replicating or potentially self replicating organisms. There is an interesting story http://healthjournalclub.blogspot.com/2010/03/astonishing-court-case-of-becky-mcclain.html of a microbiologist who is claiming she was inadvertently infected by a genetically engineered virus. The company however, is refusing to release the sequence of the virus in question. Well what if that virus or a future one turned out to be contagious? Can you even place a patent on a computer virus? How much more foolish to claim there is patent protection on a virus that might someday be able to kill you. At the very least, requests by health practitioners or public health officials should over rule patent claims, whether a sequenced part of a genome or one made from scratch. Glad to see this ruling.
    Paul
    http://healthjournalclub.blogspot.com/

  • WalterSear March 30, 2010 on 4:39 am

    This good news, but will it turn investment away from genomics until a new way to monetize research is found?

    As much as it is reasonable to consider things that are inside other people and were there all along, this could stifle research as much as help it. At least until the governments stop wandering around in the dark and start funding the research pipeline in a sane manner: all the way to treatments.

    • Emanuel Hoogeveen WalterSear March 30, 2010 on 5:18 am

      They should still be able to patent any treatments they develop, I think. But these patents should never last more than say 5 years or risk stifling innovation.

      This is true of all patents, where 10 years or so should really be the upper limit. Research has shown that you get 97% of any money you’re likely get out of a piece of music in the first 7 years, I believe, and even then most of it won’t go to the artist. This is why the various ‘Pirate’ parties of the world are striving for such a change – interestingly there is at least one ‘serious’ political party in my country (The Netherlands) which has said it wants to do the same. But there is little support on the European level, where instead we see them undemocratically hiding ACTA negotiations from everyone and, if the leaks are anything to go by, blatantly lying about their contents.

  • WalterSear March 30, 2010 on 12:39 am

    This good news, but will it turn investment away from genomics until a new way to monetize research is found?

    As much as it is reasonable to consider things that are inside other people and were there all along, this could stifle research as much as help it. At least until the governments stop wandering around in the dark and start funding the research pipeline in a sane manner: all the way to treatments.

    • Emanuel Hoogeveen WalterSear March 30, 2010 on 1:18 am

      They should still be able to patent any treatments they develop, I think. But these patents should never last more than say 5 years or risk stifling innovation.

      This is true of all patents, where 10 years or so should really be the upper limit. Research has shown that you get 97% of any money you’re likely get out of a piece of music in the first 7 years, I believe, and even then most of it won’t go to the artist. This is why the various ‘Pirate’ parties of the world are striving for such a change – interestingly there is at least one ‘serious’ political party in my country (The Netherlands) which has said it wants to do the same. But there is little support on the European level, where instead we see them undemocratically hiding ACTA negotiations from everyone and, if the leaks are anything to go by, blatantly lying about their contents.

  • Alex Fogerty March 30, 2010 on 1:00 pm

    I must admit that this news leaves me feeling a little uneasy. Without the profit motive most of these genes wouldn’t have been found by now and it would have set us back by quite a while. In the pharmaceutical industry the patent on a new medicine lasts for 20 years, though it takes about 10 to 15 of those years to test the drug on animals and humans before it gets FDA approval so the company only gets 5 to 10 years to market the drug and try and remake the costs of development, make money for future development, all while trying to turn a profit for the shareholders. Without the profit motive there is little reason to get involved in biomedical sciences other than altruistic reasons, and we all know what happened to Soviet Russia that tried to built a system on altruism alone.

  • Alex Fogerty March 30, 2010 on 9:00 am

    I must admit that this news leaves me feeling a little uneasy. Without the profit motive most of these genes wouldn’t have been found by now and it would have set us back by quite a while. In the pharmaceutical industry the patent on a new medicine lasts for 20 years, though it takes about 10 to 15 of those years to test the drug on animals and humans before it gets FDA approval so the company only gets 5 to 10 years to market the drug and try and remake the costs of development, make money for future development, all while trying to turn a profit for the shareholders. Without the profit motive there is little reason to get involved in biomedical sciences other than altruistic reasons, and we all know what happened to Soviet Russia that tried to built a system on altruism alone.

  • Mike March 30, 2010 on 5:37 pm

    I think I hear Craig Venter crying in a corner.

  • Mike March 30, 2010 on 1:37 pm

    I think I hear Craig Venter crying in a corner.

  • Peniel Dimberu March 31, 2010 on 1:52 am

    @ Alex. I think your assessment is wrong. The vast majority of advancements are made in academic laboratories that are mostly funded by taxpayer dollars from a variety of government agencies. Sure, part of this disparity comes from the fact that there are many more academic laboratories than research companies, whether they be biotech or pharma. And while this ruling may cut off one source of profit for corporations (which is the correct ruling in my opinion), they will find other, more legitimate ways to earn the almighty dollar. I’m fairly confident that this will not significantly decrease the pace at which new and important discoveries are made.

  • Peniel Dimberu March 30, 2010 on 9:52 pm

    @ Alex. I think your assessment is wrong. The vast majority of advancements are made in academic laboratories that are mostly funded by taxpayer dollars from a variety of government agencies. Sure, part of this disparity comes from the fact that there are many more academic laboratories than research companies, whether they be biotech or pharma. And while this ruling may cut off one source of profit for corporations (which is the correct ruling in my opinion), they will find other, more legitimate ways to earn the almighty dollar. I’m fairly confident that this will not significantly decrease the pace at which new and important discoveries are made.

  • Josh April 3, 2010 on 12:46 pm

    I think any gene engineered enough to render it patentable would be practically impossible to arise through a de novo mutation. It’s almost not even worth worrying about.

  • Josh April 3, 2010 on 8:46 am

    I think any gene engineered enough to render it patentable would be practically impossible to arise through a de novo mutation. It’s almost not even worth worrying about.