Supreme Court: Genes can’t be patented

This just happened, and information is sketchy, but the U.S. Supreme Court has ruled unanimously that naturally-occurring genes can’t be patented.  This ruling came from a case in which the company Myriad Genetics was challenged because it holds the patents on the breast cancer genes BRCA1 and BRCA2.  Those patents mean that no other organization, clinic, or company can test a woman for the presence of those genes, and Myriad now charges an unconscionable $3000 for such a test. (Having mutant forms of those genes means that your risk of breast and ovarian cancer is hugely elevated.) The test, of course, costs nothing like $3000 (it’s simply a DNA-sequencing technique that’s cheap), but Myriad argues that developing the test took millions of dollars.  But anybody with a lab and rudimentary DNA-sequencing equipment could test themselves for a very small sum.

It’s not clear at this point what the ruling means, for, as NBC News reports, synthetic genetifc material can still be patented, and a synthetic gene has the same structure as a natural one, except that it’s not embedded in a chromosome.

The Supreme Court ruled unanimously Thursday that natural human genes cannot be patented by companies, but it said that synthetically produced genetic material can — a mixed ruling for the biotechnology industry.

A naturally occurring piece of DNA is “a product of nature and not patent eligible merely because it has been isolated,” the court said.

The case centered on a Salt Lake City company called Myriad Genetics that was granted patents for isolating two genes, known as BRCA1 and BRCA2, that indicate a higher risk of breast and ovarian cancer. The company now markets tests for those genes.

BRCA1 is the gene carried by actress Angelina Jolie, who determined after a test that she was at higher risk of developing breast cancer and chose to have a double mastectomy.

The court said that Myriad had found something important and useful, but it ruled that “groundbreaking, innovative, or even brilliant discovery” does not by itself guarantee a patent.

The opinion was written by Justice Clarence Thomas.

On Wall Street, investors in Myriad seemed pleased. The company’s stock shot up 7 percent in the minutes after the Supreme Court decision came down.

If I read this decision right, this means that other companies can now test for the breast-cancer genes, since that involves sequencing natural genes: those present in a woman. And that would be a victory.

More on the arguments:

Gregory Castanias, a lawyer for Myriad, likened the isolation of genes to the creation of a baseball bat, which “doesn’t exist until it’s isolated from a tree.”

“But that’s still the product of human invention,” he said, “to decide where to begin the bat and where to end the bat.”

Doctors and scientists who challenged the patents said that their research had been hindered. The lawyer arguing for them said that Myriad deserved credit for unlocking the secrets of genes — just not a patent.

“One way to address the question presented by this case is: What exactly did Myriad invent?” asked the lawyer, Christopher Hansen of the American Civil Liberties Union. “And the answer is nothing.”

Justices on both sides of the ideological spectrum seemed concerned about whether companies like Myriad would scale back investment in research if they were not rewarded with patents.

“What does Myriad get out of this deal?” Justice Elena Kagan wondered. “Why shouldn’t we worry that Myriad or companies like it will just say, well, you know, we’re not going to do this work anymore?

Solicitor General Donald Verrilli, representing the Obama administration, argued that manipulating a gene into something new might qualify for patent protection, but that isolating what’s already there should not.

Who cares what Myriad gets out of the deal? If Myriad hadn’t rushed to find the gene and sequence it, it would certainly have been done by medical researchers. It’s simply a natural thing to do, and the technology for mapping and sequencing disease genes does not require the financial strength of companies like Myriad.  The lawyer for the ACLU was absolutely correct: Myriad invented nothing. No invention, no patent. And no exploitation of women.

58 Comments

  1. gbjames
    Posted June 13, 2013 at 8:14 am | Permalink

    Nice when the Supremes do the right thing.

    • Marta
      Posted June 13, 2013 at 8:54 am | Permalink

      And rare.

      • moarscienceplz
        Posted June 13, 2013 at 2:17 pm | Permalink

        So true!

        I was shocked to discover that Roberts, Scalia, and Thomas actually voted against the actions of a corporation. I can only guess that Myriad failed to donate enough scratch to Crossroads GPS.

  2. FloM
    Posted June 13, 2013 at 8:17 am | Permalink

    and quality science reporting: “BRCA1 is the gene carried by actress Angelina Jolie…”

  3. JBlilie
    Posted June 13, 2013 at 8:29 am | Permalink

    Although I agree with the ruling, one inevitable outcome will be: Similar discoveries will take longer and thereby cost more lives in the meanwhile.

    This is inevitable because many players (motivated ones) will drop out of the game. This is (IMO) not an spotless victory (though it is a victory.)

    I hope this ruling is applied in law to stop the attempts (some successful) to patent plants that are either naturally occuring or have been cultivated by local farmers around the world. It’s one thing to produce and patent a mutant plant (that you developed) that is resistant to Roundup. It’s another thing to try to patent an already-existing plant.

    People may not be aware of this; but the US patent office has changed from a “first idea” model to a “first filer” model for patent awards. This means that, regardless of who actually comes up with the idea, the first “person” to apply gets the patent. (Not sure how this works in the EU and other places.)

    • Posted June 13, 2013 at 8:52 am | Permalink

      Ah, you don’t know how it work.

      NIH funds research. Companies take government research and patent it after making some minor refinements or changes.

      And it’s pretty common regardless of source. This is why you have all these different erectile dysfunction medicines. Viagra came out and a couple of other drug companies took it, reverse engineered it, made some minor changes and BOOM, a whole new patentable drug.

      But as for the original research that got us there… It was almost all government funded research done in the 1970s that was taken by a drug company who tried to synthesize a drug, based on the medical research, that would combat hypertension…

      Raging boners was just a side-effect. A very marketable side-effect. But a side-effect nonetheless.

      And, ironically, as hypertension medicine, the PED5 inhibitors really didn’t work all that well. There are more effective drugs for hypertension, even if they don’t give you raging boners.

      • Andrew van der Merwe
        Posted June 13, 2013 at 9:59 am | Permalink

        Great comment! Thanks.

      • JBlilie
        Posted June 13, 2013 at 10:38 am | Permalink

        “Ah, you don’t know how it work. [sic]

        NIH funds research. Companies take government research and patent it after making some minor refinements or changes.”

        That is a remarkably confident and categorical statement.

        For instance, the company I work for (creates new medical devices and procedures) has been pursuing new basic research and clinical research for several decades: self-funded (needed to prove Safety and Effectiveness for any new product).

        There is some truth in your answer (the NIH does fund significant basic research); but I stand by my previous statement: BRCA1 and BRCA2 would have taken longer to isolate and make useful for diagnoses (had it not been for the work of Myriad, motivated primarily by profit). Other similar findings will be delayed.

        (The motive for a whole set of important findings has been removed for private companies.* Again: I agree with the ruling (it seems pretty obvious to me). I’s saying it’s not an unmitigated benefit. On balance, I think it will be better for citizens in the long run (no one should own a product of nature).)

        (* Individuals who do this work (like me) may be primarily motivated “helping” others; but the people that put up the money to actually get the work done, expect to make a good profit.)

        Your statement assumes that all breakthroughs come from NIH research alone and that companies that commercialize products invest more or less nothing in the process. That is absurd on its face. (It also savors of an ignorance of what engineering is.)

        And what about all the research programs (that I can assure you, private companies are pursuing) that are not on the NIH agenda?

        • Andrew
          Posted June 13, 2013 at 4:10 pm | Permalink

          Actually, the research was performed at a public university. The scientists involved then patented the gene and the sequencing method. These were then sold to Myriad, who further refined the sequencing method.

          So Myriad did no real original research, and their sequencing method is now almost obsolete (although still faster than other more common methods used to isolate the gene)

    • David Duncan
      Posted June 13, 2013 at 9:16 am | Permalink

      I don’t agree, for the reasons stated by others, and also because the unconscionable high costs of some of these tests are a huge barrier to their use. If the charge was more reasonable the test would be used more frequently and the testing companies might come out ahead.

      It’s good to see that all the justices got it right.

      • JBlilie
        Posted June 13, 2013 at 10:43 am | Permalink

        My statement said nothing about the price of the test.

        It’s a basic statement that this ruling will remove many active and motivated players from the business of similar findings. That will slow down some findings. I’m not seeing any substantive counter-argument to that.

        “It’s good to see that all the justices got it right.” Again: I agree.

    • Jeremy Pereira
      Posted June 13, 2013 at 9:59 am | Permalink

      And charging $3,000 to take the test that should be pretty cheap is not costing lives?

      • JBlilie
        Posted June 13, 2013 at 10:50 am | Permalink

        I agree.

        And this ruling may drop the cost of this one test; but it will also delay future similar possibilities.

        My point is that this is NOT black and white. People may think it is but it’s not.

        Your comment is (IMO) more an indictment of the US healthcare system: Safe and effective tests/procedures/medicines should be available to all citizens (and visitors as applicable) in the US (I favor a single-payer Canada-style system) and paid for by the nation as a whole. Health care should be a basic right in the US. $3000 one-time cost per person (for ~1/2 the population) is peanuts in the lifetime cost for healthcare.

    • Diana MacPherson
      Posted June 13, 2013 at 10:04 am | Permalink

      And as others have intimated there will be other players – enormous amounts of money isn’t the only motivator for things like this.

      • JBlilie
        Posted June 13, 2013 at 10:40 am | Permalink

        Yeah, but it’s the one that actually gets the work done.

        • Posted June 13, 2013 at 10:50 am | Permalink

          But it doesn’t have to be, and, indeed, it shouldn’t be.

          If the Tea Partiers didn’t have everybody afraid of the “socialism” boogeyman, it’d be no problem to expand the NIH to the point that it was capable of doing all the basic research imaginable.

          In my ideal world, it’d be the NIH that did (or paid for) virtually all the basic research, published everything free without restriction, and then left it to the private sector to duke it out amongst who’s better able to do the manufacturing grunt work.

          That way, we could happily spend the tens of millions of dollars developing exotic treatments for rare diseases; we wouldn’t have to waste far more money on marketing boner pills to dirty old men; and the pill manufacturers could make honest (but not obscene) profits on making pills to the requisite specifications. And, in such a market, the pills would cost little more than the raw ingredients plus actual manufacturing costs, as all the R&D costs were paid for by the people. Any company that started over-charging would soon be under-cut by a competitor — exactly as Randian Free Market worshippers would have it.

          True, nobody would get filthy, stinking rich in this plan. But that’s a feature, not a bug.

          Cheers,

          b&

          • JBlilie
            Posted June 13, 2013 at 10:51 am | Permalink

            I’m with you all the way Ben: The money has to come from somewhere; and I’d be very happy to pay more tax money to expand the NIH (well, maybe if they got Collins out of the driver’s seat! :) )

          • JBlilie
            Posted June 13, 2013 at 10:56 am | Permalink

            My Mom is very conservative (while receiving Social Security, Medicare, etc.).

            She constantly grumbles about “socialism” this, “socialism” that. I asked her: Well, do you like your Medicare? Oh yeah, it’s great, I need it. Well, Mom, that’s your socialism.

            She doesn’t get that no private insurance company would touch a 78-year-old cancer survivor with a 10-foot pole! She’s always shocked when she hears how much people have to pay for their share of medical coverage.

          • Timothy Hughbanks
            Posted June 13, 2013 at 2:08 pm | Permalink

            Of all the disingenuous statements to come from Myriad in this story, there was this: “Myriad officials say about 95% of its patients receive insurance coverage, often without co-payments, so that most patients pay only about $100.”

            Of course, this says nothing about how many women don’t get tested because they don’t have insurance coverage or do have big co-pays. And, of course, the cost of their test is just another thing making the insurance premiums skyrocket. Talk about chutzpah.

    • eric
      Posted June 13, 2013 at 11:42 am | Permalink

      I remember hearing a similar complaint after Exxon Valdez – double hulled requirements will kill industry! The margins are so tight, that fewer corporations will want to be in shipping and gas prices will skyrocket!

      Never, ever trust corporate claims about the impact of regulation on themselves. At best you will get an honestly developed worst-case scenario. But more likely, you’ll get an estimate that is dishonest and built on ridiculous assumptions.

      In this case, what’s happened is that the biotech industry has been informed that they only get patent rights for the actual genetic test they develop, rather than getting an exclusive right to gene being tested. But I expect the genetic testing market will suffer just as much as, um, “much” as the oil shipping market did when they suffered from more restrictive rulings.

      • Posted June 13, 2013 at 3:19 pm | Permalink

        All those folks who “don’t trust the gov’t.” Ugh. The gov’t does goof up a bit – after all, it’s composed of humans. But I trust the gov’t a hell of a lot more than I trust corporations!

        • Filippo
          Posted June 14, 2013 at 3:11 pm | Permalink

          Corporations – private corporate tyrannies, seeking welfare payments from the government; treating flesh-and-blood human beings as human “resources” and “capital;” seeking to socialize risk and privatize profit. Yea, verily, apparently one of those “American Values” on behalf of which “human resources” are expected to join the military and go in harm’s way and risk being killed or maimed for life.

          (There would never have been rural electrification – No. 20 on the list of “Greatest Engineering Acheivements of the 20th Century” according to the National Academy of Engineering – without the federal gov’t. Private enterprise would never have touched it – no money to be made.)

  4. Posted June 13, 2013 at 8:30 am | Permalink

    This is a good ruling.

    But our “intellectual property” laws are seriously fucked up.

    Companies such as Boosey and Hawkes have stolen — yes, stolen — our cultural heritage and are holding it ransom. If you want to perform century-old masterworks by long-dead composers such as Ravel or Stravinsky or Bartok Respighi or countless others, your only option is to pay a lot of money to B&H for the privilege of not getting sued out of existence for doing so.

    I’m at the point now where I’d actually favor abolition of copyrights and patents both over the current situation.

    Our society doesn’t lack for ideas. People are going to keep coming up with new ideas regardless. The hard part is the actual implementation — and it’s also the only thing worth charging for in the first place.

    Make everything a “work for hire” and be done with it.

    You know? Just like every other profession?

    Cheers,

    b&

    • eric
      Posted June 13, 2013 at 11:55 am | Permalink

      I’d be wary of complete abolition, but a serious scaling back seems in order. 20 years max, doesn’t matter whether its Mr. Fusion or (the next) Moby Dick, then its everyone’s.

      Let’s face reality here. In the past two decades or so, ~1.4 billion of people (China) started ignoring international copyright laws. That’s 23% of the world’s population. There hasn’t been a 23% reduction in innovation; we’re still producing new stuff at a geometric rate. So obviously the rate of innovation is not wholly dependent on (or even proportionate to) the legal protections given to it.

    • Posted June 13, 2013 at 12:02 pm | Permalink

      Maybe soon I can stop telling guests to stop recording birthday festivities on their cell phones at least during the tricky part.

    • Dave
      Posted June 13, 2013 at 4:10 pm | Permalink

      Copyright should not be in force on century old master works by long dead composers. Now, did I read correctly that you just suggested putting hundreds of thousands of lawyers out of work? Remind me not to come to close to you when lawyers know where you are!

    • Filippo
      Posted June 14, 2013 at 3:23 pm | Permalink

      Yep, a John Williams or Jerry Goldsmith or Elmer Bernstein or a host of other luminaries compose glorious film scores on a “work for hire” basis, and then some corporate entity owns them, as if owning a musical composition or work of art is somehow the equivalent of creating it.

      In the 6/14/2013 N.Y. Times is a story about a lawsuit over “Happy Birthday to You” (“Good Morning to You”), which is still allegedly under copyright control, though multitudes believe it to be in the public domain, and perhaps it is according to the plaintiff.

  5. Posted June 13, 2013 at 8:30 am | Permalink

    This is really good news!

  6. Posted June 13, 2013 at 8:32 am | Permalink

    If the initial reports are accurate, this is really good news.

    Here’s the text of the ruling. I haven’t read it yet.

    I’ve now read part. May not be as good as I thought: cDNAs are patentable.

  7. JBlilie
    Posted June 13, 2013 at 8:35 am | Permalink

    Apparently Just. Thomas wrote the opinion. I’m surprised — he doesn’t usually do much.

    • Matt G
      Posted June 13, 2013 at 8:37 am | Permalink

      Unless voting with Scalia counts as something….

      • JBlilie
        Posted June 13, 2013 at 10:58 am | Permalink

        Ha1 Good one!

    • Posted June 13, 2013 at 11:35 am | Permalink

      Thomas’s opinion, in full. “The constitution does not explicitly state that genes can be patented; therefore, genes can not be patented.” Now what’s for lunch?

    • Filippo
      Posted June 14, 2013 at 3:26 pm | Permalink

      Well, he doesn’t talk much in court. Perhaps he feels that the Court has enough bloviating interruptors. From recordings of court proceedings I’ve heard, it’s hard for a lawyer to complete a sentence without being cut off by a justice.

  8. Posted June 13, 2013 at 8:36 am | Permalink

    This is why we have research grants from the NIH. And, interesting, if only to me, the argument for this public funding of science is made by Kagen.

    After all, why would a company do anything if they couldn’t immediately make money from it? And the answer is: they don’t.

    This Company didn’t do crap in this area until the general location of the gene was found by researchers using an NIH grant four years earlier. In fact, the Company didn’t even exist until there was a potential money-trough to repay the investment.

  9. Karl Withakay
    Posted June 13, 2013 at 9:07 am | Permalink

    “Gregory Castanias, a lawyer for Myriad, likened the isolation of genes to the creation of a baseball bat, which “doesn’t exist until it’s isolated from a tree.””

    Wrong analogy. You can’t cut open a tree and discover a baseball bat. You have to create a baseball bat out of raw materials based on a design you invent.

    The better analogy is likening the isolation of genes to the isolation of a peach pit. The pit already exists in the peach for you to discover. You may patent some novel way of extracting the pit, but you cannot patent the pit itself.

  10. mrclaw69
    Posted June 13, 2013 at 9:09 am | Permalink

    I get the feeling Craig Venter’s not going to like this…

    • darrelle
      Posted June 13, 2013 at 10:03 am | Permalink

      I haven’t heard him speak on this specific issue, but based on what I have heard from him regarding his work I think he will be just fine with this.

    • darrelle
      Posted June 13, 2013 at 10:29 am | Permalink

      From this article.

      “If one of these companies had been allowed to patent a gene for the enzyme the statins block, the others would have likely been asked to look elsewhere for drugs. “Blocking another biotech or a pharmaceutical company from trying to come up with a cure for disease really does block research,” says Venter, “and the public loses. Why should one company say that’s their unique source of biology?”

      A patent on Epogen is one thing; a patent on a target for a drug is another. Luckily, however, it seems that the vast web of patented gene sequences is not stopping anyone from trying to discover new drugs. “There were a couple of gene patents that were worth a lot of money, so all of a sudden every university and every biotech company spent a fortune on patenting genes,” says Venter. “I think only the patent lawyers got rich.”

  11. Posted June 13, 2013 at 9:09 am | Permalink

    Didn’t Supreme Court allow Monsanto to patent seed DNA?. I know they’ve manipulated them, but then nature reproduces and the court ruled natures ‘work’ also belonged to Monsanto. Am confused, seems arbitrary and dependent on ?? Not sure

    • Notagod
      Posted June 13, 2013 at 10:03 am | Permalink

      From above (meaning up in the original post zone, not intending to mean the freaky christian zone):

      The Supreme Court ruled unanimously Thursday that natural human genes cannot be patented by companies

      Human exceptionalism at work, brought to us by apparently by the christian.

      I would like to see the whole mess of the patents laws rewritten. Like that will ever happen as long as the repuglican has a seat.

      • Karl Withakay
        Posted June 13, 2013 at 10:38 am | Permalink

        “The Supreme Court ruled unanimously Thursday that natural human genes cannot be patented by companies”

        I think the key term regarding this ruling is “natural”, more than it is “human”.

        • Notagod
          Posted June 13, 2013 at 6:03 pm | Permalink

          Having now read part of the ruling I think you are correct. The the word “human” probably shouldn’t be in the reporter’s statement.

          But, that leaves Telthescavenge’s question unresolved.

  12. Posted June 13, 2013 at 9:12 am | Permalink

    I wonder why the patent office couldn’t have figured this out for itself and denied the patent application.

    • neil
      Posted June 13, 2013 at 10:05 am | Permalink

      The US Patent Office is overwhelmed and overmatched. Legitimate applications pile up and illegitimate ones get rubber stamped. US patent policy is a mess, unable to deal with the conceptual issues associated with so-called intellectual properties.

  13. Notagod
    Posted June 13, 2013 at 9:50 am | Permalink

    “Why shouldn’t we worry that Myriad or companies like it will just say, well, you know, we’re not going to do this work anymore?”

    Yeah, in the good mormonized christian state of Zootah, who would give a damn about doing anything just for the purpose of helping without obtaining a sizable monetary reward?

    Wanting a sizable reward for doing anything is christianity at its best. Hopefully, we’ll never see another round of christianity at its worst.

  14. neil
    Posted June 13, 2013 at 10:01 am | Permalink

    To make matters worse, Myriad did not find BRCA1. Mary-Claire King, an academic researcher at the University of Washington identified it.

    • Diana MacPherson
      Posted June 13, 2013 at 10:06 am | Permalink

      Oh snap!

  15. Andrew van der Merwe
    Posted June 13, 2013 at 10:09 am | Permalink

    I’m keen to know what this would mean for companies like Monsanto and Burke International. The latter is the one that tried to patent Rooibos tea (made from a wild South African bush).

  16. Posted June 13, 2013 at 10:43 am | Permalink

    Definitely a step in the right direction. I’m left wondering what this means for the fuzzy line between “natural” and presumably “unnatural” genes. Is it unnatural to incorporate a plasmid from a firefly’s butt into a strain of bacteria using various restriction endonucleases, but natural to allow the bacteria to do so on its own given enough raw material and time?

    Good thing we have armies of highly scientifically-competent lawyers, judges and juries to adjudicate such matters, or this could turn into a mess.

  17. neil
    Posted June 13, 2013 at 11:03 am | Permalink

    Interesting. Myriad’s stock price well up today. Maybe it didn’t really lose the case, at least what was important.

    • tomh
      Posted June 13, 2013 at 2:20 pm | Permalink

      This was a very narrow ruling and many of Myriad’s patents survive. There’s plenty of money still to be made. The opinion does not involve methodclaims, patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Pp. 17–18 http://t.co/VZVWgb0y6Q

  18. Posted June 13, 2013 at 2:48 pm | Permalink

    Who cares what Myriad gets out of the deal? If Myriad hadn’t rushed to find the gene and sequence it, it would certainly have been done by medical researchers. It’s simply a natural thing to do, and the technology for mapping and sequencing disease genes does not require the financial strength of companies like Myriad.

    This.

    I have never understood the argument from innovation for giving companies a license to print money. Now admittedly I am not a medical researcher or engineer but I, for example, research not for profit but for a moderate stable income and the respect of my peers.

    Heck, just look at the Soviet Union. They had excellent scientists and engineers. First man in space, at the cutting edge of many areas of research, etc. (Not saying that I would want to live under communism, or that capitalism isn’t more dynamic overall, but the point is that the idea of rapid innovation depending on patents is completely blown out of the water by a casual glance at history.)

    • Filippo
      Posted June 14, 2013 at 3:36 pm | Permalink

      ” . . . I, for example, research not for profit but for a moderate stable income and the respect of my peers.”

      That seems to be the motive for most STEM types and, if I may say so, STEM subject school teachers who enter the education profession not for the money but for an enthusiasm for STEM in particular and learning in general.

      Certainly not the motive for scientifically uncurious Romneyesque MBA/JD types.

  19. Sean
    Posted June 13, 2013 at 8:18 pm | Permalink

    The surgeon who discovered the liver does not have the right to patent it. Bizarre and sick that this corp would even consider this remotely ethical.

    I think similar patents for g.m. soy & corn have been vigorously enforced which is entirely unfair on farmers.

  20. Posted June 13, 2013 at 10:43 pm | Permalink

    Here’s an informative posting about the Supreme Court opinion on the Patently-O blog: http://www.patentlyo.com/patent/2013/06/myriad-isolated-dna-out-cdna-in.html

  21. Paul
    Posted June 14, 2013 at 6:49 am | Permalink

    the problem with allowing ANY patenting of simple sequence is that we have ABSOLUTELY NO IDEA of the diversity of naturally occurring variants. this is true for all but a minuscule fraction of organisms. so if some biotech outfit gets to patent something they have assembled and then we eventually find this same (naturally-occurring) sequence in a rice field in Nagaland …


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