Supreme Court: You can't patent (naturally occurring) genes

In an unanimous decision, the United States Supreme Court ruled today that companies can't patent genes, or parts of genes — at least, so long as that genetic material is identical to what occurs in nature. The lawsuit dealt specifically with Myriad Genetics, the company that isolated and has claimed a patent on BRCA 1 and BRCA 2 — genes associated with an increased risk of breast and ovarian cancers. From a practical perspective, Myriad's hold on the genes has meant that tests for genetic cancer risk are strikingly expensive — Xeni paid more than $3000 for hers. It's also meant that, if you get a positive result, there's been nowhere you could go for a second opinion.

That's a big deal. Mutations in the BRCA 1 and 2 genes mean an increased risk of cancer, but there's more than one kind of mutation that can happen. In fact, BRCA 1, alone, has hundreds of known mutations. Some increase your risk of cancer. But, even if you narrow it down to just those, they don't all increase the risk by the same amount. The health choices you make could be very different depending on whether you have an 80% risk of developing breast cancer by age 90 (the worst-case scenario for BRCA 1 mutations), or something much lower. That's the kind of situation where you might really like to have more than one lab run more than one kind of test.

This ruling opens the door for that, and the competition should (theoretically) also lower the cost.

It's worth noting that the ruling does not apply to synthetically created DNA, which, based on the Myriad context, seems to apply to lab-created genes that are different from what happens in nature, as opposed to lab-created versions of natural genes (Myriad had previously cloned BRCA 1 and BRCA 2). For a little more clarity on what does not fall under the scope of this ruling, here's a quote from Justice Clarence Thomas' description of the Court's decision. It's the cDNA Thomas describes here that would still be patentable.

DNA’s informational sequences and the processes that create mRNA, amino acids, and proteins occur naturally within cells. Scientists can, however, extract DNA from cells using well known laboratory methods. These methods allow scientists to isolate specific segments of DNA—for instance, a particular gene or part of a gene—which can then be further studied, manipulated, or used. It is also possible to create DNA synthetically through processes similarly well known in the field of genetics. One such method begins with an mRNA molecule and uses the natural bonding properties of nucleotides to create a new, synthetic DNA molecule. The result is the inverse of the mRNA’s inverse image of the original DNA, with one important distinction: Because the natural creation of mRNA involves splicing that removes introns, the synthetic DNA created from mRNA also contains only the exon sequences. This synthetic DNA created in the laboratory from mRNA is known as complementary DNA (cDNA).

Read More:
The Washington Post on the Court decision
• The full Supreme Court decision itself
• Rebecca Skloot, who literally wrote the book on the ethics of genes and genes patents, is answering questions at Facebook.

Image: Breast cancer cells, a Creative Commons Attribution Non-Commercial Share-Alike (2.0) image from thejcb's photostream


  1. It’s worth noting that the ruling does not apply to synthetically created DNA…

    That’s why designer genes are so expensive. Every pair of genes I own are hand-me downs.

        1. I’m not usually one to spread gossip, but it’s common knowledge that all it took to unzip Felton’s genes back then was a mild compliment and a DNA helicase enzyme.

          1. It’s true.  In those days you’d often see me out in public wearing nothing but a GATC-string.

    1. If they didn’t apply for a patent before releasing their product (or within 1 year in the US), those deities are SOL.

      1. With 20 year patent terms, and the nonexistence of all legal systems for most of biological history, it’s moot.

      2. As I understand the info from their respective legal teams, they are not claiming patent rights — they are claiming copyright…  Those rights are good for 70 years after death of the author.  So, it remains up to all of you mortals to prove that they are dead…

  2. I’d be upset about the patents on which I’m an inventor being tossed out, if only I could ever remember which genes I’m supposed to have invented.

  3. A brief moment of sanity from the SCOTUS.  Likely buttering us up for when they refuse to hear any cases related to the NSA.

    1. A brief moment of sanity from the SCOTUS.

      While the ruling was unanimous, it’s worth noting that Scalia didn’t sign on to some parts of the decision stating “I am unable to affirm those details on my own knowledge or even my own belief.” In this case that “belief” being that genes are encoded in DNA.

      1. Wow, Gawker…  Or perhaps he’s being honest and ethical (I know… I know…), and not signing onto to science he isn’t quite sure of and doesn’t truly understand for himself.  
        If that is the case, I don’t blame him.  Once you go down past the high school level stuff, genetics get mired in about as many layers of opacity as quantum mechanics.

        But then again, this is the internet, and I should always assume the worst, especially with people who hold ideologies different than my own.

        1. If he’d left “belief” out of it and just said something along the lines of “I don’t understand all this science-y gobbledy-gook” then I’d at least credit him for his honesty. But the content of the specific passage he was referring to wasn’t anything beyond that basic high school level stuff.

        2. Or perhaps he’s being honest and ethical (I know… I know…), and not signing onto to science he isn’t quite sure of and doesn’t truly understand for himself.

          Then he should quit his job and go work at McDonalds.  If he doesn’t have the intellectual capacity to study and learn things, then he’s not fit for purpose.

      2. “…my own knowledge or even my own belief”:  I’ll bet he doesn’t grasp English grammar and syntax well enough to realize he just admitted that factual knowledge is a higher form of proof than belief.

      3. Well, at least the asshat voted the sane way even if his opinion boils down to “science is too hard for me, besides there’s no mention of DNA in the bible.”

      4. Translation:  “It wasn’t in the Bible.  Therefore it’s not real.  So we can’t patent something that isn’t real, amiright?  Also, this might be taken as an endorsement of evolution, and we can’t have that.” 

        1. Scalia isn’t a fundamentalist, he’s Roman Catholic, and last time I checked, the Pope had no issues with Crick and Watson. So Scalia isn’t being religious here; he’s just being proud of his ignorance.

          1. That was a joke.  Whatever religion or ideology  you follow, I hope they believe in humor.

          2. The Supreme Court’s standard for humor is about like their standard for porn – they’ll know it when they see it.  In this case, gratuitous bigoted comments don’t really rise to the level of humor, especially when pointed at the wrong target. 

            (And not only does the Catholic Church not have a problem with Crick&Watson, they don’t have a problem with evolution, and you can ask the Pope’s astronomer whether they’ve gotten over the Galileo thing.)

          3. Of course they have a problem with evolution: they haven’t evolved their stance on gay marriage, birth control, equality for women, pedophilia, and a whole host of social issues. If anything, the whole idea behind religion is to resist any change which would violate their little storehouse of erroneous knowledge and the perceived control that goes with it. Although I’m sure, after a few hundred years, like Galileo, they’ll come to their senses, ‘evolve’, and accept the truth.

          4. Well, yeah, duh. It’s also to make a lot of money to help perpetuate the cancerous organism and elevate its status in relation to competing ideologies, in the hope of attracting more converts, or all else fails, eliminating the followers of the competing sect.
            Full disclosure: not an atheist.

          5.  The Pope publicly accepted science as real, but a large number of the Catholic laity have been swayed by religious extremists here in the States to reject that official stance in favor of Young Earth Creationism and/or Intelligent Design.

        2. DNA is not specifically mentioned in the Constitution; thus, it does not have any meaningful existence.

  4. It’s a good decision, but it looks like it still leaves the door open for Monsanto to continue shaking down farmers who have never bought their products, but have fields neighboring those who have and their plants had the audacity to cross pollinate. 

    1. Perhaps, or perhaps not. If Monsanto actually created the gene that provides resistance to Roundup as a cDNA, then their pattents are likely to stand. However, if it turns out that Monsanto found a naturally occuring, or natural mutation to a plant that either was already tollerant of Roundup, or developed a tollerance, and they simply found the relavent gene in that plant, and have spliced it into their strains of seeds, then it is likely that those patents will be thrown out.  They may be able to geneticly mark their seeds with a cDNA strand that allows them to validate that crops contain the product of their legaly pattented cDNA material (the marker in this case) but  that may not help them with the roundup portion.

      Of concern may very well be a geneticly sensitive “bug” that Monsanto develops that ‘eats” grasses and broadleaf plants that do not contain the cDNA marker for Monsanto. However I have a suspcion that with the range of species that such a ‘bug’ would be likely to consume, the hazards to Monsanto of releasing, o possibly even testing) such a bug in a non-isolated region would be leathal to the company. Which is not to say that we won’t see something like that happen at some point.

      1. I’m pretty sure the first “synthetic gene” is still in the future. And then comes the awful task of deciding just how many base pairs have to be modified before something is an original creation… something I doubt Scalia is qualified to decide.

  5. Wait, that’s not possible!  Justice Thomas never says anything.  Have they replaced him with a clone?  

    1. In moments of great importance, Justice Thomas will use his hand puppet, Mr. Cuddles, to address the court.   

      1. “Talk to the hand.” 
        While Thomas almost never talks in court, he does write.

        1. You mean his court clerks write for him.  After he explains it to them in a barely discernible whisper.  

  6. This ruling, sadly, isn’t anything to get excited about.

    Reading it in close detail, there are some good things SCOTUS declared regarding the patentability of DNA. The court ruled that “Myriad[‘s]…claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.” This means that the ruling covers any patent on naturally occuring information (but not lab-induced structure modifications). Because the DNA sequences in question were naturally occurring (and for that matter, all discovered mutations), that information cannot be patented. In short, you can’t patent the natural structure or sequence of a gene.

    However, there are some seriously negative things about this ruling. Despite the fact that Myriad’s DNA and cDNA patents covered the sequence and not the structure, and despite the fact that “[t]he nucleotide sequence of cDNA is dictated by nature, not by the lab technician..,” the court ruled that “cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a ‘product of nature’ and is patent eligible.” This poses a serious problem for researchers as the mRNA sequence is naturally occuring, but if a patent exists on the cDNA molecule, it follows that Myriad would maintain the “‘right to exclude others from making’ its patented composition of matter under the Patent Act” thus preventing scientists from using reverse transcriptase legally on the BRCA1 or 2 mRNAs. This is held despite the rare, but natural possibility of a virus generating such a cDNA as “[t]he possibility that an unusual and rare phenomenon might randomly create a molecule similar to one created synthetically through human ingenuity does not render a composition of matter nonpatentable.” Further, the court’s ruling “does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes” and stated that “Myriad was in an excellent position to claim applications of that knowledge.” In summary, Myriad maintains patents over the cDNA sequence and structure, which means they control the right to its generation and its use for medical diagnoses and other applications.

    While this ruling, in theory, opens the door to RNA sequencing approaches and other probes of the naturally occuring sequence, the basic, tried and true methods of molecular biology to test these things are still patentable.

    1. TLDR version follows…

      Good: natural DNA information isn’t patentable, including mutations.

      Bad: recreating natural information (mRNA) in a new form (cDNA) is.

      Good result: new techniques of probing natural DNA can be invented by companies other than Myriad and are patentable.

      Bad result: basic laboratory techniques involving reverse transcription (PCR-testing of mRNA, RNA-Seq, etc.) technically create a patentable intermediate whose right to create lies solely with the patent-holder (Myriad).

    2. That’s how it looked to me, too.  They’re saying “oh, we aren’t allowing the patent of DNA sequences, just the most obvious possible way of working with them”.  The principle of non-obviousness is as dead as the “flash of genius” doctrine at this point; as you point out, even non-sentient organisms can make cDNA.

      It’s like saying “we aren’t going to let them patent your appearance, but we are going to let them patent your reflection in a mirror.”

      1. We can’t look to the supreme court to make the right decision on the basis of law, because patent law is the problem, not the solution.

        It doesn’t matter how important setting up mirrors next to things you want to study are, the court doesn’t care about whether patients are harmed or helped by their decision because patent law isn’t used practically in that way.

        We need to raze the patents system and build it again from the ground up. The copyright clause of the constitution is a great place to start. The test of whether a grant of exclusively is right is whether or not it promotes progress in the discipline. The length of periods of exclusivity should be determined based the net benefit to the discipline as a whole, not the rights-holder.

  7. Myriad’s unlikely to give Xeni her $3000 lab fees back, but 23&Me’s testing is now down to something like $99, and includes three of the BRCA genes and 5 other breast-cancer-related snips, as well as a whole lot of other tests about disease and ancestry.  I don’t know if that covers all the same ones that Myriad tests, and of course 23&Me’s tests have the usual disclaimers about “not for diagnostic purposes”, etc. 

    (And Myriad’s business model doesn’t include telling you what percentage Neanderthal you are, either.)

    1. 23andMe’s test is not diagnostic, but it can be informative at a base level.

      It was useful for me to be able to tell my doctors which of those SNPs I had: no to BRCA, but yes to a few Ashkenazi-related cancer genes.  It gave them enough info that they felt I didn’t need to shell out $3,000 for the official  Myriad test.

  8. The Robert Gallos of the world, petty little medical tyrants, must be grinding their teeth tonight.

  9. Another benefit is that now those with variants of the BRCA1/2 genes should be able to receive better analysis.

    Myriad and Second Opinions | Mike the Mad Biologist

    Not only are uninsured and lower income women particularly vulnerable to Myriad’s monopoly, so are women of color. This is because, for some women, Myriad is unable to provide a clear yes or no answer, and instead returns a result that the woman’s BRCA gene has a “variant of unknown significance.” This means that a woman may—or may not—be at high risk for breast and ovarian cancer, a result that can be deeply confusing for patients and their doctors. Variants of unknown significance have been especially problematic for black, Latino and Asian women, who are disproportionately likely to get these ambiguous test results, and to thus have a more difficult time getting the information they need to make crucial treatment decisions. Because of Myriad’s patent, women have been unable to get second opinions about ambiguous test results from other labs, and other labs, in turn, have been unable to work on developing more definitive tests.

  10. So now we just have to sequence everything and publish, thereby creating a genetic ‘rainbow table’ to prevent patents on synthetic reproduction and patent of genes that already exist?

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