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Supreme Court Throws Out Human Gene Patents

Posted by Soulskill on from the klingon-gene-patents-still-ok dept.

thomst sends this quote from an Associated Press report: "The Supreme Court on Monday threw out a lower court ruling allowing human genes to be patented, a topic of enormous interest to cancer researchers, patients and drug makers. The court overturned patents belonging to Myriad Genetics Inc. of Salt Lake City on two genes linked to increased risk of breast and ovarian cancer. The justices' decision sends the case back down to the federal appeals court in Washington that handles patent cases. The high court said it sent the case back for rehearing because of its decision in another case last week saying that the laws of nature are unpatentable. In that case, the court unanimously threw out patents on a Prometheus Laboratories, Inc., test that could help doctors set drug doses for autoimmune diseases like Crohn's disease."

32 of 91 comments (clear)

  1. Not exactly... by Theaetetus · · Score: 5, Informative

    "The Supreme Court on Monday threw out a lower court ruling allowing human genes to be patented, a topic of enormous interest to cancer researchers, patients and drug makers. The court overturned patents belonging to Myriad Genetics Inc. of Salt Lake City on two genes linked to increased risk of breast and ovarian cancer.

    Not quite. The Supreme Court overturned the Federal Circuit ruling that the patents were valid and infringed, and remanded back for reconsideration based on the recent Prometheus v. Mayo case. Basically saying, "take another look." They did not however "overturn patents" nor did they "throw out human gene patents" as the headline states.

    We can make predictions and argue about what the Federal Circuit will likely decide on remand, and what the Supreme Court might then do if re-appealed, but it's not nearly as over as the headline or summary say.

    1. Re:Not exactly... by YodasEvilTwin · · Score: 4, Insightful

      Thank you for fighting the good fight on irresponsible journalism, good sir.

    2. Re:Not exactly... by Anonymous Coward · · Score: 4, Insightful

      The headline gave me hope. Patenting human genes or any naturally occurring genes is insane. You might as well patent blue eyes. Just because you are the first one to see it and identify it doesn't make it personal property especially when most of us have it in our bodies already. This was always about controlling whole lines of research. We have people dying from breast cancer, and yes men die from it too, while a corporation pisses all over the gene that causes it to prevent others from working on a cure that involves the very gene that causes it. Who cares if thousands and potentially millions die when there are corporate profits at stake! The whole system is insane.

    3. Re:Not exactly... by viperidaenz · · Score: 2, Insightful
      First off, I agree with you, patenting genes is stupid.

      Who cares if thousands and potentially millions die when there are corporate profits at stake!

      However, just because something can save the lives of millions is not a reason to not allow it to be patented. Pretty much every safety feature in cars is covered by numerous patents. Many may have expired by now but ABS, Traction Control, Seat belts... were all covered by patents at some point.

    4. Re:Not exactly... by Sique · · Score: 4, Insightful

      But why should the gene be patented? The patent seeker in question didn't invent the gene, nor did he invent the way it expresses into proteins, nor did he invented the proteins synthesized. Someone discovered what role the gene plays in the metabolism, but that's a discovery, not an invention.

      --
      .sig: Sique *sigh*
    5. Re:Not exactly... by pepty · · Score: 4, Informative

      But why should the gene be patented? The patent seeker in question didn't invent the gene, nor did he invent the way it expresses into proteins, nor did he invented the proteins synthesized. Someone discovered what role the gene plays in the metabolism, but that's a discovery, not an invention.

      That's not what the patents cover.

      They usually cover:

      1. Adding or removing genes from an organism to give the organism a useful new phenotype (corn that makes bt toxin).

      2. A process for manufacturing a protein that includes taking it out of the original organism and expressing it in a different one so that you get a higher yield.

      3. A diagnostic based on the presence of a particular version of a gene or protein (what this case was about)

      4. A new version of a protein that is more useful than the natural one.

      Some are still pretty obnoxious though.

    6. Re:Not exactly... by pepty · · Score: 2

      Not necessarily, or at least, I wouldn't hold my breath... They can gloss against Prometheus by saying that isolated DNA doesn't exist in nature and therefore is not a "law of nature" itself, same as the Supreme Court found vulcanized rubber to be patentable in Diehr, even though rubber itself existed.

      But if "isolated DNA" is the anchor they're holding onto, they're also screwed. There are plenty of ways of running the test without creating Myriad's version of isolated DNA, some of them have the benefit of being useful for running hundreds of DNA tests at once. Even worse, the price of sequencing your genome is expected to drop to 1/3 of the cost of Myriad's test. Once you have that data, there is already free software out there that will score the test for you (or your doctor).

      Cheap sequencing is basically the ball game when it comes to charging for individual DNA diagnostics. They can't charge the sequencing company a licensing fee if all they do is give you your genome. They can go after someone who distributes software that does the analysis ... but not in the EU (if the software is free), and probably not after the Prometheus decision.

      Basically, after ~2014 you will be able to pay $1K for your genome and after that every DNA test you ever want or need is free*..

      *So long as your doctor accepts them.

    7. Re:Not exactly... by __aaltlg1547 · · Score: 3, Informative

      No, it's not a reason not to patent it. The reason is that the gene existed and did what it did before you discovered what it did. It doesn't matter that you just discovered the gene that makes me able to regulate the insulin in my blood. I've been using that gene for that purpose and so has almost everybody else. If you now use that new knowledge to make a drug that helps diabetics, good for you. You can patent THAT DRUG. But you shouldn't be able to patent the gene or the mechanisms by which it operates. Those are simply facts of nature. Those facts belong to nobody even though you discovered them.

      Now if somebody else figures out how to make the same thing happen with a different drug (that works better than yours or is easier to produce) THAT person should own the rights to their drug. I consider every drug to be non-obvious, because it's never obvious that a novel substance when introduced into the body will be safe and effective. Often all the indications are that a candidate drug will work, only it proves to have unsafe side effects or doesn't work because of some factor that the inventors couldn't know about without trying it in real patients.

      As for patenting genes in living organisms, it shouldn't be allowed unless all of the organisms are to be contained in a secure environment under your physical control. Once it escapes control, only the original maker should be held liable for its propagation and any economic damages that it caused.

    8. Re:Not exactly... by __aaltlg1547 · · Score: 2

      No, you could also specific non-obvious applications of the knowledge.

      A drug that mimics the action of the gene would be a non-obvious application. (All drugs being non-obvious.)

      A test that measures an enzyme regulated by the gene would be an obvious application, unless there was something novel about how the test works.

    9. Re:Not exactly... by Anonymous Coward · · Score: 4, Interesting

      But why should the gene be patented? The patent seeker in question didn't invent the gene, nor did he invent the way it expresses into proteins, nor did he invented the proteins synthesized. Someone discovered what role the gene plays in the metabolism, but that's a discovery, not an invention.

      That's not what the patents cover.

      They usually cover:

      1. Adding or removing genes from an organism to give the organism a useful new phenotype (corn that makes bt toxin).

      2. A process for manufacturing a protein that includes taking it out of the original organism and expressing it in a different one so that you get a higher yield.

      3. A diagnostic based on the presence of a particular version of a gene or protein (what this case was about)

      4. A new version of a protein that is more useful than the natural one.

      Some are still pretty obnoxious though.

      Please mod the parent up, these are crucial details here, and as always, the devil is in the details.

      To clarify some more, in the pharmaceutical world, the simplest standard for patent-ability of a novel chemical compound is that it does not exist in nature. So penicillin itself, for example, cannot be patented because it occurs naturally in mold. A process for purifying it from mold, however, is quite patentable. Or, if you chemically modified penicillin slightly by adding a doohickey bit to one end such that it even works on penicillin-resistant bacteria, that would also be patentable since penicillin doesn't exist in nature with the doohickey bit. Sure, that may seem like cheating, slightly, but there is undeniably much value added in figuring out exactly how many ways you can tinker with penicillin and make new antibiotics.

      In the biotech world, this simple and commonsense criteria has been ridiculously abused. The argument, summarized briefly, is that when you isolate a gene you have to snip it out of the rest of the DNA before you can run a test on it, and that isolated snippet doesn't naturally occur in the universe (only the whole honking genome does). Semi-magically, the gene is not patentable inside a genome as it naturally exists, but if you cut it out, it's a "different molecule" that is now patentable.

      What about the whole test aspect, you say?

      There is some language in the patent law that the details of your innovation must be "non-obvious to a person skilled in the art".

      Once you know the sequence of the gene involved, the mechanics of doing a test is pretty much something you could do yourself in a high school biology lab. The principles are taught in intro biology textbooks, you can order all the reagents you need and use a mail order sequencing lab for probably under 50$ a pop. So there's really no value added in providing the details of how to make a test for a gene once you've isolated it. Any idiot could teach themselves how to do it over the weekend, it requires no particular expertise whatsoever once you know the sequence of the gene. So defending the process of designing a test once the gene is known clearly does not pass that test for patentable in and of itself.

      Proponents of gene patents argue that it would be the most equitable mechanism to help recoup the massive expenses involved in figuring out exactly what genes are involved with disease and how to design a treatment plan based on the results of specific, targeted gene tests. Which would be great if there was anything in the patent code that ensured the people who figured out how a gene works and why you would care to test for it end up with the patent for it. But as it stands now, there are no standards on what level of detail must be provided for the "how" and "why" aspects in a gene-test patent application, just the raw sequence itself.

      In the Myriad Genetics case, for example, the company with a monopoly on test for a major breast cancer gene was not the same group of people who first isolated the gene and figured out what it did. Academi

  2. Patent links by CapitalR · · Score: 5, Informative

    Here's links to a few of the patents in question:
    http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=5747282.PN.&OS=PN/5747282&RS=PN/5747282
    http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=5837492.PN.&OS=PN/5837492&RS=PN/5837492
    http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=5693473.PN.&OS=PN/5693473&RS=PN/5693473
    And here's the Federal Appeals Court case, which lists the rest of the patents:
    http://www.bloomberglaw.com/public/document/Assn_for_Molecular_Pathology_v_US_Patent__Trademark_Office_653_F3

  3. WOW... by El+Fantasmo · · Score: 5, Insightful

    Nature is unpatentable, something everyone knows and understands until you get a law degree.
    Please, please, please let this ruling stick!

    These same justices also need to decide that Monsanto's GMO crop products are WILLFULLY contaminating other people's property. If Monsanto can stop their GMOs' pollen from being carried by the wind, then they can lay claim to all plants with Monsanto genes, until then...

    1. Re:WOW... by garyebickford · · Score: 4, Interesting

      Yes. Someone should prosecute Monsanto for criminal trespass. (No joke, it's a valid legal principle - companies and people have been prosecuted criminally and also sued for damages for allowing their critters, fumes, liquids, waste etc. to escape their property and cause damage on others' property. With respect to Monsanto, it's a bit more complicated because Monsanto is essentially allowing, encouraging and forcing their customers to do the trespassing. I suppose that could be considered conspiracy?

      --
      It's easier to be a result of the past, but more fun to be a cause of the future! http://www.spacefinancegroup.com/
    2. Re:WOW... by andydread · · Score: 2

      The fact that you can take a gene from one life form, insert it into another life form and patent the result, and sue others when your genetic combination contaminates their property is totally ludicrous. However it is the law as Monsanto has purchased it and we all have to live by the law. Unless we the people lobby to get the law changed Monsanto will continue unabated until all food staples become Monsanto's "intellectual Property" and you wont be able to plant anything useful without paying a license fee to plant and purchase seeds that bring a risk of you getting sued for re-using them. Did you know that when you "license" Monsanto seeds you must allow the Monsanto police force on your property for up to 3 years after ceasing using their seeds? That's one gem from their "Round-UP Ready " EULA. The Monsanto EULA is ridiculously comical but its dead serious and their lawyers are brutal. Fun times ahead. Lets hope the "You can't patent nature" rule sticks and this applies to Monsanto and other litigation happy patent abusers that try to own life.

  4. Genes have been patented for years by ozduo · · Score: 4, Funny

    didn't Levi patent Genes years ago or did he just invent them?

    --
    I got to the chocolate box before you, that's why the hard ones have teeth marks.
  5. I'll take "Let's corner the market" for $900 Alex by schrodingersGato · · Score: 2

    It just seems like they have set up new ground rules by which an army of lawyers will translate into a high-cost-of-entry market (jn a market with an already bloated cost of entry). I would not hold my breath in hoping that corporations will change their practices...

  6. /. car analogy by vlm · · Score: 2, Interesting

    Please rate my standard /. car analogy:

    Last week they overturned a patent on painting a car such that it reflects light with a spectral peak at 650 nm, in other words, its painted red, with the justification that red being a certain wavelength is a fairly obvious natural fact rather than a patentable invention. Today they kicked a patent on "a car cooling system that cools by accepting cool air at the radiator intake, heating it, and exhausting the heated air thus cooling the engine" back for further review based on last weeks overturning because the laws of thermodynamics are also mere laws of nature.

    --
    "Science flies us to the moon. Religion flies us into buildings." - Victor Stenger
    1. Re:/. car analogy by mellon · · Score: 3, Insightful

      So basically what you're saying is that there's no obvious distinction to draw between things being red and things being hot, and so either both should be patentable, or neither should. This is entirely correct. Patents are a bad idea. We should just get rid of them entirely. Okay, now, back to the real world. In the real world, we aren't abandoning patents altogether, so courts have to litigate these stupid angel-dancing-on-the-head-of-a-pin questions, and they have to come up with plausible-seeming justifications for invalidating patents that are clearly bogus, while still pretending that these same justifications don't apply to less glaring cases to which, as you have pointed out, they really do apply. Sux2bus.

  7. ABOUT TIME! by quixote9 · · Score: 5, Interesting

    I'm a biologist and I watched the whole evolution of PCR and the mad scramble to patent every bit of human DNA with stunned disbelief. Did the legal beagles not understand that they were allowing the equivalent of patenting somebody else's books in a library?

    Apparently, they didn't.

    But, after a generation or so, and a festering swamp of patents, the truth seems to be dawning on them. I shall watch our future progress with considerable interest.

    1. Re:ABOUT TIME! by rahvin112 · · Score: 4, Interesting

      Well Myriad's been making a TON of money charging people $3500 for a $200 test all because they patented the gene in question (not the test which is standard DNA profiling).

  8. Whatta world, whatta world by Cazekiel · · Score: 5, Insightful

    Love this from the article... The justices' decision sends the case back down for a continuation of the battle between the scientists who believe that genes carrying the secrets of life should not be exploited for commercial gain and companies that argue that a patent is a reward for years of expensive research that moves science forward.

    A reward for doing their jobs, what they're paid to do. Isn't that what their paycheck is for, the money they get from the medications/equipment/etc. they develop? Would they seriously stand in the way of a group of lower-on-the-totem-pole scientists for actually coming up with a cure, claiming "No, you can't cure this strain of ovarian cancer, since it involves such-and-such gene--we own that."? The fact that I lean toward 'yea, they would, wouldn't they?' makes me feel ill. We live in a world where we can be sued for posting a kid's birthday party on youtube with the 'Happy Birthday' song in it, and screw us all if we get cancer and can't rely on different, smaller companies that were on the brink of discovering cures but didn't have the dough to fight the C&D orders.

    --
    You want to know how to help your kids? LEAVE THEM THE F*&K ALONE. --George Carlin
    1. Re:Whatta world, whatta world by viperidaenz · · Score: 2

      A reward for doing their jobs, what they're paid to do. Isn't that what their paycheck is for, the money they get from the medications/equipment/etc. they develop?

      Their argument is, if they can't get a patent on it, anyone can use their hard-earned research to make their own medication/equiptment and those who paid to do the research are not reembursed. The scientists themselves may have been paid, but the company that paid them will will have essentially thrown the money down the toilet.

      The alternative to patents is not publishing the results of anything that cost you money to produce.

    2. Re:Whatta world, whatta world by dgatwood · · Score: 2

      No, the alternative to patents is public funding grants.

      --

      Check out my sci-fi/humor trilogy at PatriotsBooks.

  9. Re:COOL!!! by 93+Escort+Wagon · · Score: 4, Funny

    Now the patent trolls can't sue me for violating a megacorps' 'patent' because I'm still breathing!

    Crap! I was told to resolve the "jamstar7 is still breathing" problem before the Supreme Court made their decision - now I'm not going to get paid!

    --
    #DeleteChrome
  10. Re:COOL!!! by ackthpt · · Score: 4, Funny

    Now the patent trolls can't sue me for violating a megacorps' 'patent' because I'm still breathing!

    We are now free to mutate without fear of lawsuit. To the Transmogrifier!!!

    --

    A feeling of having made the same mistake before: Deja Foobar
  11. Re:COOL!!! by CanHasDIY · · Score: 3, Funny

    We are now free to mutate without fear of lawsuit. To the Transmogrifier!!!

    Scientific progress goes 'Boink?'

    Or is that only when you turn the Transmogrifier on its side?

    --
    An enigma, wrapped in a riddle, shrouded in bacon and cheese
  12. Wrong Reading of Decision by Blindman · · Score: 2

    The Supreme Court didn't rule on the patentability of genes. The Supreme Court sent the case back down to the Federal Circuit with instructions to try again in light of a different and recent Supreme Court case, Prometheus v. Mayo. Ordinarily, this would be RTFA, but since the article is wrong, it would be RTF(case), but I'm guessing the writer isn't here.

    --
    I don't practice what I preach because I'm not the kind of person that I'm preaching to.
  13. Re:COOL!!! by Endo13 · · Score: 3, Interesting

    I carry my trusty transmogrifier gun with me. That way, should I happen to accidentally get carried several miles into the air by a balloon I'm still safe!

    --
    There is no -1 Disagree mod. Slashdot.org/faq defines mod options. USE IT.
  14. Common Sense Prevails by Anonymous Coward · · Score: 2, Insightful

    Genes were not "invented" or "created" they were only discovered. They should never have been patentable.

    If you could patent a gene then you would be able to patent a river if you discovered it first.

    Doesn't make sense.

    1. Re:Common Sense Prevails by wiredlogic · · Score: 2

      Technically they never have been. Applications of genes are what have been patented. Of course it is easy to create a broadly scoped patent that covers every conceivable application for a specific gene.

      --
      I am becoming gerund, destroyer of verbs.
  15. Re:Finally by registrations_suck · · Score: 2

    I don't often side with the Church, but I would LOOOVVVEE to see some Catholics or Hindus or someone file copyright infringement against medicine companies on behalf of God/Creator Spirit/what-have-you.

    Any such lawsuit would be dismissed on lack of standing to file such a suit. One would need to have some acceptable proof of power attorney provided by said supernatural sky friend.

  16. Re:COOL!!! by erroneus · · Score: 4, Insightful

    We now need to expand on this throwing out any patent on any gene at all. GM foods may or may not be a good idea, but to patent anything alive is definitely a bad and dangerous thing when it puts a tiny minority in control of the world's food supply.