ACLU prevails: US Fed Judge invalidates gene patent

United States District Court Judge Robert W. Sweet has invalidated Myriad Genetics's infamous "breast cancer patent" -- a patent on genetic mutations that cause breast cancer, which Myriad has exercised in the form of a high lab-fee for analysis on samples (Myriad threatens to sue any independent lab that performs the analysis).

The suit was brought by the ACLU and the Public Patent Foundation, who argued that US Patent and Trademark Office was wrong to grant patents on genes, as these are not patentable subject matter. The judge agreed, saying that gene patents are patents on a "law of nature" and called the isolation of genes and filing patents on them "a lawyer's trick that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result."

Which sounds to me like a precedent against all patents that rely on isolated genes. Of course, this isn't over: the pharma/biotech stalwarts interviewed in the linked NYT piece are talking appeal, and I'm sure they'll try to go all the way to the Supreme Court.

I think that the problem here is in the untested idea that imparting exclusive rights to the genome will incentivize more research than allowing anyone to build on discoveries in the genome. It's clear that some exclusive rights provide an incentive so some people to do work. But these exclusive rights also scare off people who have good ideas but are worried about being bankrupted by someone who beat them to the patent.

Combined with that is the natural abhorrence many of us feel at the thought that genes might be patented. Genes aren't a good subject for propertization. Your genes aren't even yours -- you didn't create them. Your parents didn't really create them, either. You're your genes' steward, as are we all, and so many of us have a strong intuition that when someone else claims to own something from our genome, they're being ridiculous, or evil, or both.

Myriad Genetics, the company that holds the patents with the University of Utah Research Foundation, asked the court to dismiss the case, claiming that the work of isolating the DNA from the body transforms it and makes it patentable. Such patents, it said, have been granted for decades; the Supreme Court upheld patents on living organisms in 1980. In fact, many in the patent field had predicted the courts would throw out the suit.

Judge Sweet, however, ruled that the patents were "improperly granted" because they involved a "law of nature." He said that many critics of gene patents considered the idea that isolating a gene made it patentable "a 'lawyer's trick' that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result."

The case could have far-reaching implications. About 20 percent of human genes have been patented, and multibillion-dollar industries have been built atop the intellectual property rights that the patents grant.

ACLU Challenges Patents On Breast Cancer Genes: BRCA

Judge Invalidates Human Gene Patent

(Thanks, Gimpy!)

(Image: Dna rendering, a Creative Commons Attribution (2.0) image from ynse's photostream)


  1. You’re your genes’ steward

    Even that is nonsense, since they are just tiny scraps of information that is individually duplicated in a million other people.

    Say I have £9 in my bank account. Does that make me the steward of the number 9? It’s the same thing. This is not property in any sense.

  2. What about the right to patent a gene for a certain use? Certainly if I put the time and resources into developing an enzyme for, let’s say, detergent, I should be able to claim some sort of claim for my work? Especially if I put money into optimizing the gene? I know companies like Merck and New England Bio Labs have put significant rezources into sequences and exploring the genomes of extremophiles (I think I’ve spelled that wrong, as a warning) and it seems like they should have commercial rights to what they’ve found.

    I guess one question I’m not-quite-positing here is should any gene be allowed to be patented? What if I express the gene is a different host (for example, I use a human gene in bacteria to produce protein more quickly)? What if it’s a plant gene?

    And I’d like to point out that I agree with the judge throwing this patent out – they aren’t making anything here, they’re just sequencing and claiming. It’s almost like domain squatting.

    1. There’s a difference from developing a new enzyme and documenting existing genes, though. What has happened in this case is just that they were the first (and probably not even by a great margin) to document one of the genes where variants are strongly correlated with breast cancer. That’s not invention, it’s documentation.

      And yes, I do work with breast cancer genetics. Patenting BRCA? I didn’t even know anyone were that impudent – if we were to patent every gene we found that might have significant effects (and more to the point, if everyone did), no one would ever get anything done.

    2. I know companies like Merck and New England Bio Labs have put significant rezources into sequences and exploring the genomes of extremophiles (I think I’ve spelled that wrong, as a warning) and it seems like they should have commercial rights to what they’ve found.

      Sensibly so. But why should these be exclusive commercial rights? The traditional answer is that there will be freeriders who benefit from the development without paying for the R&D. Given that Merck (and all big pharma) R&D spending is a fraction of its advertising budget, I think this is and will always remain a specious argument.

      Can we please start developing new technologies for the good of the fracking planet and its people instead of upholding the hegemony of the vectoralist class? Pretty, pretty please?

    3. Just because you invest in something, doesn’t mean you’re entitled to squat as a result.

      People always have ways to claim their work. Let’s hope this is a good precursor to bilski helping to stop patenting of abstract concepts.

  3. Certainly if I put the time and resources into developing an enzyme for, let’s say, detergent, I should be able to claim some sort of claim for my work?

    An interesting proposal, but one which has got nothing to do with patent law; it does not behave in this way. Patent law neither rewards nor requires any expenditure of time and resources, other than lawyers. A patent is a claim based on writing a vague and verbose description, not a claim based on doing any development work.

    There is some merit in the idea of scrapping patent law, and replacing it with a scheme of ‘contributory value’, where each contributor to a project is entitled to claim a fraction of the value of the project proportionate to their contribution; that appears to be roughly what you are asking for. Under such a scheme, an organisation that spent years carefully testing and developing the method would receive a large fraction of the value, while an organisation that just wrote down a list of ideas and numbers would receive quite a small fraction.

    Unfortunately I can’t think of any reasonable way to implement it that would not result in a lot more lawyers.

  4. Doing away with patent law completely is the obvious answer to these sorts of problems. And there is no need for a “contributory value scheme” which would be as arbitrary, confused, and litigation friendly as the current system.

  5. I could understand a patent on the process to isolate the gene, patent on a use of a gene but a gene itself just is, do you sue people who get breast cancer for using it? it’s just a piece of data and the medium its stored on is a few molecules. As data, a fact if you will it would be immune from both patent and copyright law.

  6. Actually I was quite disappointed with the decision. Ownership also implies distinct legal responsibility; if I own a dog and it bites someone, I’m responsible for their medical bills (even though I’m not in complete control over dog, which is why I use this example rather than, say, a car). There is plenty of precedence in law for this. If Myriad wants to claim they own the gene, then they should they should equally be held responsible for anyone who gets cancer as a result of “their” gene. The courts would actually have a hard time rejecting this as it have a direct impact on all civil liability cases

  7. Hi, Cory! Good post. I want to clarify and answer some of the questions in comments. The idea that you can’t patent a natural gene is not a new one in US patent law, nor is this a precedent-setting case in that sense. The precedent is already there. What Myriad Genetics attempted to do was to argue that develop a test based on BRCA1 was a patentable innovation, and to try to prevent other labs for testing for the gene. The court found that no, this was not a sufficiently original idea to be patentable all by itself, and that in effect what Myriad was doing was attempting to enforce a patent on a naturally-occurring gene, which it is already WELL established that you cannot do.

    In regard to the effect of this ruling on the field in general, it will probably be surprisingly little. May companies may have filed similar patents on other genes. However, the trends in the field indicate that BRCA is very unique in that it is a single gene that can reveal a substantially increased risk of a disease. There are almost no other genes that, all by themselves, predict a high probability of developing a disease. Many of them could predict a slightly increased probability, but that makes them terrible candidates for a laboratory test. It is very probable that future genetic tests will include panels of at least 6 or 8 genes that together predict a person’s risk of disease. The creation of such a panel would safely be considered to be a patentable innovation and would not prevent competitors or other scientists from developing their own technology using the genes.

    To answer some of the questions above, yes, you can patent a gene that you have engineered, mutated, or modified for a specific purpose. Also, to those who hate the idea of patenting anything, remember that a patent is only 17 years and that often development is not complete when the clock starts running. A patent only gives you a head start.

    Hope this helps.

    Catherine Shaffer, Biotech writer

    1. While it is true that single gene association with disease development is a rare event, it is not true that knowing single gene status is not important. FLT3 mutation status, for instance, if interpreted in concert with NPM1 mutation status renders prognostic information for patients with Acute myeloid leukemia.
      A company which purchased the patent about a year ago went postal and has rather effectively curtailed FLT3 testing in other labs– labs that had used public scientific information to develop in-house tests. The company required a special sample be sent for testing– sample being a bit of bone marrow drilled out of the patients hip bone…. whereas before a portion of one specimen could be used for many things, now the patient had to have a special sample drilled to be sent to the company. If the physician hadn’t predetermined that this test might be necessary there either wasn’t a sample or the patient had to be re-drilled. This is not patient care… this was patent care and greed. Hopefully the ruling will bring down companies in health care whose revenue goals leave patient care outside the boardroom door.

  8. Cory,
    I agree with your conclusion on how abhorrent it is for companies to think they can “own” something they did not create. I’ll take it a step further in saying that “ownership” of anyone or any living things genome is tantamount to slavery. If someone can “own” what makes you you, then we are all in trouble.

    And, considering how poorly many companies treat their customers, I’d rather not have one as a master.

  9. I do hope this decision stands. From the Times article, this lab hasn’t patented the process by which they isolated the gene (which may be patentable). Rather they have filed a patent on the mutation itself which they neither created nor modified in any way. Their claim that they’ve “transformed” the mutation is false on it’s face.

    Keep fighting the good fight, ACLU!

  10. Looking at some of the odd convolutions in our current legal system, sometimes I can’t help but think the members of our legislative and judicial branches just haven’t read enough science fiction in their lives, since life seems so frequently to be imitating dystopian art these days (though “Yeah!” for the judge in this case).

    Apropos of the topic at hand:
    Patent Infringement by Nancy Kress.

  11. It’s inherently absurd to claim to own the rights to genes when it’s in the nature of living things to reproduce (which, naturally, means spreading those genes). Which is why Monsanto are even more evil than most people think: through eventual cross-pollination they will have contaminated all the world’s soy and corn crops with their patented genes and then see themselves as “owning” most of the world’s food.

  12. I decided to patent oak trees and maybe maples too, so if you have one in your yard or park please seed 1 dollar to…

  13. I must admit that I was buoyed with cheer when I read about this ruling.
    Intellectual property “rights” have long extended past what would be reasonable entrepreneurial economic development aid (corporate welfare?).
    Then I read the stories in the business media (WSJ et al) where they decry the great loss for start-ups attempting to attract funding.
    Alas, I’m now pessimistically sure that deep-pocket interests will keep kicking this around in court until they win yet another unfair “right” to the ordinary.

  14. “…the untested idea that imparting exclusive rights to the genome will incentivize more research than allowing anyone to build on discoveries in the genome…”

    Untested? Maybe in the legal sense, but in the most practical sense everything in genomics and bioinformatics that has succeeded has done so BECAUSE of open-source collaboration and sharing. The databases (embl, NCBI, iHop), the tools (R, Bioconductor) and the results of studies (where datasets must actually be shared to publish papers – e.g. GEO) – all of them are based on shared tech, shared data, shared ideas.

    Big pharma and the patent trolls like Myriad that aspire to be acquired by them have contributed so little to this process, but made so much PR out of whatever contribution they make.

  15. Hey Monsanto! You gonna patent my genome, then sue me for infinging your patent? Go marry yourself.

  16. The ability to patent genes is a government sanctioned lie that it’s possible to steal from god.

  17. The granting of absurdly broad patents has been stifling innovation for years.

    An example would be biotech giant ABI’s patent on the fact that there are 4 DNA bases(A, C, T, and G). When any smaller company or startup tried to make sequencers for a far lower cost, ABI threatened to bury them in court. The Human Genome Project ended up costing hundreds of millions of dollars to the taxpayers.

    Now, whenever a company wants to make a new sequencing innovation, they have 2 lousy choices. The first choice is to come up with some needlessly expensive, slow, and complicated extra Rube-Goldberg steps which don’t require the use of a different die for each of the 4 bases. The second choice is to try and talk ABI into allowing them a license (good luck) and then handing most of their profits over to ABI.

    This has caused the price of sequencers to rise even more as well as killing a great many innovations.

  18. “Which sounds to me like a precedent…”

    Not yet. This decision is from the federal district court in NY. District courts don’t have to follow each other’s rules- they generally don’t even have to be consistent with their own prior decisions.

    Precedential decisions in patent cases are made by the Court of Appeals for the Federal Circuit. That court is notoriously pro-patent. Myriad will appeal the NY decision to the Fed Cir, and it’s likely the Fed Cir will reverse the NY decision. And then PubPat and the ACLU will likely appeal to the US Supreme Court… and who knows what the hell they will do.

  19. i want this to be a good thing–but it’s not.

    tell me, PLEASE, where precisely is the incentive to continue to research cancer genetics and their relation to disease. what would normally flow from this work is the development of therapeutics that combat disease and improve the welfare of human beings.

    that type of work just became unprofitable. it has to be published to become accepted in the medical community. as soon as it’s published, everyone knows. if the therapeutics are based on the gene in question (which is not patentable, some of you seem to desire) then there’s no control and therefore no money to be made here.

    guess what happens next? nothing at all, because it’s no longer worth investing in genetics research.

    way to go, judicial system. you just killed some people by making the development of anticancer therapeutics take longer.

    1. Why do the genes need to be patented for the therapy to be developed? Does public knowledge of bacteria remove incentive to create antibiotics?

    2. Anon #26 that is absolute BS. And I say this as a Ph.D. cell & molecular biologist, who has commercialized stuff in the past. The only effect this will have on the search for genetic markers of cancer will be that once they are discovered, they will benefit more people. Myriad’s position is that you are *not allowed to know the sequence of your own BRCA genes* without paying them money. How fucked in the head do you have to be to think that could possibly be a good thing?

  20. Anon 27: why wouldn’t they? …or, more fairly, at least the tests themselves? i mean–the work that discovered the sequence or the ability to ascertain it–these are peoples JOBS, here…are you suggesting that they are supposed to slave away in the lab after earning multiple graduate degrees and then NOT get paid for the work?

    as much as i wish it were true, scientists are not mother theresa–they have their own motivations, including careers and retirement savings. this is not a black and white situation.

    if you prefer a world with ONLY government-funded research, fair enough. there’s been lots of successful work. again, it isn’t black and white…but i can promise you we would be far behind our current position if this were reality.

    Anon 28: Fair enough, but what are you going to do with the sequence of your own BRCA gene? If you’re legitimately interested beyond just curiosity, it’s likely to make a choice of therapy regimen based upon data that’s been collected. (Other people in the past may have had the same polymorphism as you and respond in different ways to different treatments, as you’re certainly aware. you use the collected and processed info to make a treatment decision. you thus benefit.)

    Of course, if you’re speaking in general, then it’s not **YOUR** copy, it’s someone else’s that was identified years ago. That’s not what we’re talking about here. If it’s the product of a test–some extracted DNA was run through a sequencer and generated an output–(the actual thing being patented here), then what’s the issue? are you suggesting that you would own the rights to an x-ray image of your knee? i have to admit i don’t know the copyright law in this domain, but the idea seems ludicrous. the physician would never pay you to have access to “your info” so that he/she could interpret it.

    So, my original claim stands, IMHO: as with every economic decision, you will get precisely the output that is incentivized. By removing the incentive in this case, less research (both screening of genes and development of tests, etc) will be privately funded and conducted.

    That doesn’t mean NO research will be done (NIH is a huge funder, right?) but we did just effectively make the horizon for new tests and therapies FARTHER away than it may have been yesterday…and that is harmful in a way that, I believe, many commenters have totally glossed over. Everybody on this board is just accepting that “big business” loses and society gains here…but the situation is so much more complicated than that.

    That was my only point. You’re free to disagree. I wish everybody did everything for free and that lab people and PIs were legitimately motivated only by a sense of beneficence. I’m sorry to say that such a world hasn’t been my experience in grad school or work.

  21. Keep fighting ACLU. Awesome start.

    Living organisms patents are just absurd. A simple example: just because Newton discovered Gravity should then its be patented and we all pay royalties for doing it? That would be absurd.
    Same goes for any live organism. It is a bogus argument that scientists will not research into genes just because they cant patent discoveries. As long as there is a need in a market for a cure or a pill they will fill it. Just they wont do it in a monopolistic style which now will require them to actually innovate over time. Patents in this industry do only one thing, result in a monopoly which is a failing point of capitalistic society. If only one company could make cars we’d have no choice and pay high prices. Because that’s not patentable, there are many car manufacturers. Which in turn drives up competition, better quality and prices. That was another argument which invalidates the common lie that patents actually keep innovation going, all patents in this industry do is stifle innovation.

  22. Whatever our position on patent law:

    Unless you invent or fashion something original, you cannot patent it.

    When they will produce an artificial gene they will be able to claim a patent on it. And nothing else.

    When they restrict their patent to a very specific and thus well-described procedure regarding a very specific gene (or other natural phenomenon), they will have a right to a patent on that very specific procedure. And nothing else.

  23. This decision goes against a boatload of precedent, and will be overturned so decisively by the Federal Circuit that the Supreme Court will most likely deny cert.

    It’s understandable that the subject matter stirs up strong feelings. One constructive way to deal with these feelings is to learn patent law.

  24. Wives May Patent Husbands?
    RNA Or DNA Genes, Organisms, Should Not Be Patentable
    Organisms Should Not Be Patentable

    Key Cancer Patents Killed

    All organisms, regardless of size, natural or modified by humans, should not be patentable.

    Otherwise where is the limit???

    My wife of few years might yet apply to patent me…?!

    Dov Henis
    (Comments From The 22nd Century)
    03.2010 Updated Life Manifest

  25. It also follows another boatload on precedent (Information found in nature? Not innovation), so it might well stand. The judge’s argument is sound and sensible, and I look forward to the shape of the actual counterarguments that’ll be used.

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