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The Courts Biotech Medicine Patents

Supreme Court: No Patents For Natural DNA Sequences 214

Posted by timothy
from the finer-distinction-than-I'd-like dept.
ColdWetDog writes "The ongoing story of Myriad Genetics versus the rest of the world has come to an end. In a 9-0 decision, the US Supreme Court has decided that human genes cannot be patented. From a brief Bloomberg article: 'Writing for the court, Justice Clarence Thomas said isolated DNA is a "product of nature and not patent eligible merely because it has been isolated." At the same time, Thomas said synthetic molecules known as complementary DNA, or cDNA, can be patented because they require a significant amount of human manipulation to create.' Seems perfectly sane. Raw genes, the ones you find in nature are, wait for it — natural. Other bits of manipulated DNA / RNA / protein which take skill and time to create are potentially patentable. Oddly, Myriad Genetics stock actually rose on that information." Adds reader the eric conspiracy: "The result for Myriad is that they still have protection for their test, however the decision also allows researchers to work with the DNA sequences that are predecessors to the cDNA used in the test." Here's an AP report on the ruling, as carried by the Washington Post.
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Supreme Court: No Patents For Natural DNA Sequences

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  • Why is it odd? (Score:5, Interesting)

    by Eskarel (565631) on Thursday June 13, 2013 @12:12PM (#43997023)

    The court case is over and the result wasn't actually all that bad. Sure Myriad and their stock holders would much rather have complete patent rights to the whole thing, but they kept the protections on their actual asset and the court case is now final and decided. Hell even if they'd lost completely their stock probably would have gone up because at least the risk was gone.

  • by sjbe (173966) on Thursday June 13, 2013 @12:15PM (#43997079)

    Oddly, Myriad Genetics stock actually rose on that information.

    That's not really surprising. All that means is that the market expected the news to be worse than it actually was. Once the ruling was handed down and the uncertainty removed, the stock rebounds based on the new information. You'll see this all the time where a company has a terrible quarter and their stock price goes up because while it was indeed terrible, it wasn't as terrible as expected.

  • by Anonymous Coward on Thursday June 13, 2013 @12:31PM (#43997339)

    A breath of IP sanity from SCOTUS? And unanimously at that?

    Indeed.

    Even the good recent decisions are uncomfortably often a 5-4 split (meaning that we could be one retirement away from flipping them). That thought disturbs me...

  • A thought experiment (Score:5, Interesting)

    by wbr1 (2538558) on Thursday June 13, 2013 @12:37PM (#43997447)
    What if a company makes and patents a cDNA that is later found to also exist naturally?

    Have we sequenced every variant of every species?

    Case in point, Monsato make GM crops that resist herbicides. What if the parts they are patenting, have analouges in some other plant in the wild?

  • by ankhank (756164) * on Thursday June 13, 2013 @01:10PM (#43997853) Journal

    ! yep

    We already know that's the case for antibiotics. And we know plants compete with one another by suppressing competitors' growth.

    Seems to me Thomas's comment is intended to add a loophole -- "we created this cDNA and patented it, so we have the patent, so if you claim you found the exact same thing out there in nature somewhere, it must be you stole it from us." Betcha.

    http://www.nejm.org/doi/full/10.1056/NEJMp1215093 [nejm.org]
    The Future of Antibiotics and Resistance
    Brad Spellberg, M.D., John G. Bartlett, M.D., and David N. Gilbert, M.D.
    N Engl J Med 2013; 368:299-302January 24, 2013DOI: 10.1056/NEJMp1215093
    ----------------
    "... after billions of years of evolution, microbes have most likely invented antibiotics against every biochemical target that can be attacked — and, of necessity, developed resistance mechanisms to protect all those biochemical targets. Indeed, widespread antibiotic resistance was recently discovered among bacteria found in underground caves that had been geologically isolated from the surface of the planet for 4 million years.2 Remarkably, resistance was found even to synthetic antibiotics that did not exist on earth until the 20th century. These results underscore a critical reality: antibiotic resistance already exists, widely disseminated in nature, to drugs we have not yet invented.

    "Thus, from the microbial perspective, all antibiotic targets are “old” targets...."
    -----------------

  • Re: Why is it odd? (Score:5, Interesting)

    by Samantha Wright (1324923) on Thursday June 13, 2013 @01:32PM (#43998055) Homepage Journal
    The only time cDNA occurs naturally is in the reproduction of a retrovirus or the replication of a retrotransposon. Myriad is still using the natural human sequence in their tests. This is like getting ownership of a quote from a book because you copied it into a Notepad window and then into Google, instead of just pasting it directly into Google in the first place, and then claiming it's a good way to find a certain rare edition of the e-book because it contains a typo made by the original author. It's completely and utterly intellectually dishonest.
  • by Rob Y. (110975) on Thursday June 13, 2013 @01:46PM (#43998155)

    Right. The process for making a cDNA copy of a particular sequence is probably patentable. But I'm betting Myriad didn't invent that process. Whoever did should be able to patent it, and Myriad should have to pay them royalties for applying the process to the BRCA gene. And maybe something as general as cDNA construction should be a FRAND-type patent, so that it's owner can't 'own' all DNA by owning the standard testing methodology. Just like Motorola isn't allowed to own the cellphone industry by virtue of having come up with the standard communications protocol used by cellphones.

  • Re:Why is it odd? (Score:5, Interesting)

    by PRMan (959735) on Thursday June 13, 2013 @01:55PM (#43998271)
    Yes. But you can't patent a new species of plant or animal just because you are the first to find it. Those are "natural" ie found in nature. Taking those building blocks and making a discovery with them (a tungsten wire will glow when electricity is applied to it) is worthy of patent protection, not "hey, I found this new thing called tungsten and nobody else can use it".
  • Re:Why is it odd? (Score:4, Interesting)

    by Samantha Wright (1324923) on Thursday June 13, 2013 @02:19PM (#43998607) Homepage Journal

    Yes, it's relatively easy to PCR up the sequence from the genome once you know what you're looking for.

    Let me make an extended computer metaphor to explain this properly.

    The human genome is comprised of many different types of information, which we can liken to pieces of text in different languages. Consider a case where we have a long document written in Russian that discusses source code for a program that was heavily commented—but in Greek. (For those of you following along in the lab, Russian is the untranscribed DNA, Greek is transcribed but noncoding, and the ASCII program itself is the coding sequence.) All of this is in UTF-32.

    When the cell functions normally, it uses the program's source as a build script: it copies the code out of the document into CP-1253 (the Windows Greek code page), and then cuts out any remaining "??????" left by the transcription, as well as all of the Greek comments in the middle of the code. There are some comments at the start of the code and at the end, but most of the copy is the code itself.

    In the Myriad case, they've found a program that works the other way, called reverse transcriptase. It turns the 8-bit Greek/ASCII mixture back into UTF-32, but the Russian and the intragenic comments are still gone, leaving us with a usable sequence that we can do a bitwise search comparison with. This is very convenient to do because there's already a complete set of such sequences available. These are called cDNA libraries, and we rely on them everyday to tell us where the Greek comments are.

    What researchers will be forced to instead is to cut the sequences out by hand directly from the wide Unicode source, using a lab technique called PCR splicing. The stupid thing is that there's no chemical difference between the two—it would be impossible to prove one way or the other where the diagnostic sequence came from, unless you knew the sequence's history. It just means that researchers now have to fumble around with splicing a bit more. Presumably the only reason Myriad isn't crapping their pants is because they think they can litigate based on intent in such cases.

  • by sanchom (1681398) on Thursday June 13, 2013 @04:37PM (#44000525)

    "the US Supreme Court has decided that human genes cannot be patented."

    Does it means animals and plants DNA can be patented?

    "Human genes cannot be patented" is an overly broad interpretation of the ruling.

    To say that these "isolated segments of naturally occurring human genes cannot be patented" would be more correct.

    In the case where an inventor creates nonnaturally occurring gene sequence with markedly different characteristics from anything occurring in nature, it is left open whether or not those are patentable.

    Plant genes meeting these criteria have been held to be patentable. See Monsanto, for example. It is possible that animal genes, or even human genes that meet this criteria would be patentable.

  • by AthanasiusKircher (1333179) on Thursday June 13, 2013 @05:06PM (#44000913)

    Is anything actually achieved by oral arguments? It seems mainly an opportunity for lawyers to get flustered, choose the wrong tack while thinking on their feet, be manipulated by the justices, and oversimplify.

    These days, oral arguments tend to be a place for the justices to prod attorneys with particular questions. Often, it seems they do this with the intention of bringing up a point that might influence or accentuate an idea that could sway one of the other justices, rather than necessarily to clarify a question for themselves -- though, if they are really curious about a particular issue themselves, you can tell. They will keep cutting through the BS spouted by the attorney and hammer the same question until they get an answer. Maybe this is to prove a point to the other justices, but it can also be to assure themselves that they've gotten all possible perspectives on the question. Another common tactic in oral arguments is for the justices to pose interesting hypotheticals that they think may clarify the case, but which may not have been adequately addressed in briefs.

    Is Thomas' silence really a comment on the fact that this is a waste of his, and everybody else's, time?

    Actually, he's explicitly said why he doesn't talk. Oral arguments tend to be a lot of banter among the justices these days, but they used to let lawyers at least speak a little more. Thomas has said that he thinks his colleagues should give a little more room for attorneys to try to make points and bring up what they think is important.

    I think he'd like to hear a little more and perhaps then ask questions relevant to the lawyers' points. But in the current court, we rarely ever get to hear a lawyer talk for more than 30 seconds on his/her own material before being interrupted. Thomas thinks this makes oral arguments more about the justices' preoccupations rather than what the lawyers think is important.

    I can see his point. The justices get to debate each other and their clerks for hours on end about their preoccupations. Oral argument could be a place to get a few insights into the major concerns of the litigants, if we could ever hear them talk.

    On the other hand, the justices will be the ones who ultimately decide things, so maybe it's best if they stick to the stuff that actually concerns them. It's just unfortunate when they start using lawyers as legal "punching bags," clearly only to drive home a point to one of the other justices.

  • by sanchom (1681398) on Friday June 14, 2013 @02:17AM (#44004415)

    When a researcher makes cDNA from mRNA, is the result only "not found in nature" if the original genomic DNA had introns.

    So as a result should all prokaryote-derived cDNA be unpatentable? Perhaps only certain cDNA from humans are patentable (from genes with introns)?

    Yes, this is correct. Justice Thomas writes (at page 17 of the slip opinion): "As a result, cDNA is not a “product of nature” and is patent eligible under 101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA."

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