Myriad: Justice Scalia’s Concurrence

By Jason Rantanen

Concurring in part and concurring in the judgment in Myriad, Justice Scalia wrote:

I join the judgment of the Court, and all of its opinion except Part I–A and some portions of the rest of the opinion going into fine details of molecular biology. I am unable to affirm those details on my own knowledge or even my own belief. It suffices for me to affirm, having studied the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA (cDNA) is a synthetic creation not normally present in nature.

What are your thoughts?  Is the level of detail in the Court's opinion too great, too little, or just right? 

98 thoughts on “Myriad: Justice Scalia’s Concurrence

  1. I took this very differently than most people it seems. Note the use of “my belief” in the opinion and remember what is the basis of molecular biology indeed all of modern biology, evolution. It looks to me like he is saying that he can’t believe in molecular biology since to do so he would have to believe in evolution.

  2. For this analogy to hold Myriad would have to be able to isolate BRCA2 from any chromosome, just as a sculptor can (within reason) carve any shape into a block of marble. Myriad would have to actually create the sequence of BRCA2 by chipping atoms off of individual nucleotides until the proper sequence is revealed, not just clipped out.

    A better analogy than carving a statue would be popping out the pieces of a toy model of a car from a flat frame of injection molded plastic. The shapes of the pieces of the model, like genes, are predetermined and readily apparent to a child – er, PHOSITA -, as are the points at which the pieces connect to the frame. The child’s contribution is in identifying which piece of the model to pop out next, actually popping it out, and then doing something with it. No one would consider the child to be Mike -er Michelangelo – for his efforts though.

  3. Mea culpa, hydrolysis is not the right word. Let’s use the example of ‘isolating’ water (H2O) from saltwater. Same point.

  4. Les,

    It was your use of the statues example that was wrong.

    Put. The. Shovel. Down.

    “Made by man” is not enough. It has never been enough. Man can make water through hydrolysis. Do you think water should be patented? (and please do not attempt to move the goalpost by switching to a 102/103 response).

  5. This issue is MADE BY MAN. NOT Usefulness. Are you arguing that the ISOLATED BRCA genes are not useful?

    Anyway, whether statues are patentable is not even a side issue. It was just something else you were wrong about.

  6. The science is cartoonish, and that’s the problem. It tries to make a simple decision by simplifying the picture, and in the end creates uncertainty and complexity because of the implications in the real world of the language used that Thomas probably didn’t realize. In that sense, Scalia is wiser than Thomas on this.

    Consider what happens when people who are still anti-GMO post-Mark Lynas (link to marklynas.org), figure out that medications are now incentivized to be “non-natural.”

  7. LOL – that works for me, seeing how wrong you are.

    Thanks !

    Tell me again who nailed the result AND the rationale?

    Speak up Les, Who? Who?

    That’s right – who’s your daddy?

  8. any more than I think the result of the work of a chain gain hitting stones with hammers to make smaller stones is a work of art.

    LOL – That’s at least one reason why you are wrong – someone will consider such a work of art.

    And that was the first of threee reasons I provided to you: non-useful art = p1sspoor analogy

    Your not accepting my reasons is a ‘you’ problem. And frankly, its a problem that I care for – not at all.

  9. The issue is not carving or cutting. I don’t think the result of randomly hacking at a chromosome is patentable any more than I think the result of the work of a chain gain hitting stones with hammers to make smaller stones is a work of art.

    However, the result of cutting or carving a chromosome with skill and finesse to arrive at an isolated gene based on ones discovery of the gene or technique for cutting….. that, like carving or cutting stone to free David, is the work of man, not nature.

  10. When you come back, bring a design patent on a process (unless you think a process under 101 and a design patent are not applicable – in which case, come back with your tail between your legs)

  11. Les,

    You came back way too soon.

    Are you saying 101 doesn’t apply to design patents?

    Not in any meaningful way that you think it does.

    I suggest that you brush up on design patents – start with MPEP 1500.

  12. If you think the process for isolating genes is closer to carving than it is to cutting, we will just have to agree to disagree.  Honestly, all this demonstrates to me is that all of the analogizing going on in this case is not only useless, but misleading.  

  13. No, the Isolated BRCA2 gene is carved out of the chromosome as David was carved out of the block of marble (not that he couldn’t have been carved directly out of your alleged mountainside).

    In both cases material was removed until all that bits that were not the target item were separated from the target item.

  14. The analogy does not work for the following reasons.  

    In order to carve the David, first a block of marble is cut from the mountainside, then it is altered by carving.

    Isolating DNA is equivalent to cutting the marble from the mountainside, it is only that first step – there is no subsequent carving going on – the nucleotide sequence is not changed.

    Additionally, in your analogy the part being cut away (analogous to the isolated sequence) are the chips of marble on the ground (not at all like an isolated sequence), and the David would be the rest of the sequence left behind that it was cut from (this also makes no sense at all).

  15. Thanks Leopold, I was wondering why you have been so quiet of late and then I realize that Myriad shut down the cheer leading sessions for awhile.

    If you are going to attempt to hijack my phrases, you need to at least wield them appropriately.

  16. Or you don’t confuse the line and maintain the line like you do across all patent law and require an application.

  17. The line I believe should not be nature vs. non-nature

    There you are going to have a problem with the Supreme Court and their implicit reading into 101 of the warehouse of nature belonging to all men.

  18. Almost everything we patent in biology (drugs, genes) is a product of nature of some sort.

    I most certainly hope (and believe) not.

    Product of nature does not mean that a product that you make from components from nature is a product of nature.

  19. Wow, that is truly an awful patent. On top of that, it’s really, really creepy. Electrically conductive nails? LOL.

    But I note that the doll has “moveable” parts and it’s not just a statute per se. I think it’s a ridiculous distinction to draw between art and utility but it’s certainly one of the distinctions the PTO seems to regularly “rely on” when handing out j–ky patents. Likewise, if you can shove the object into an orifice for pleasure or therapy, that seems to also “lubricate” the process of obtaining a utility patent. Have any utility patents granted on objects that just sit there, with no moving parts, whose sole utility is to “promote feelings” (or suppress them)?

    The only one I can think of is Dembiczak’s orange g-rb-ge bag.

  20. Do the justices or the applicants or the examiners understand the difference between the process invented to separate the gene or gene fragments even though what is extracted is naturally occuring.

  21. For arguments sake, let’s assume we can distinguish discovery (finding out about nature) vs. invention (doing something clever to make nature work the way we want). Can we draw the line in biological innovations such as that with genes here? The innovation involves learning about nature. Once you know how genes work, what pathways are involved, the solution would appear obvious, even straightforward right? If so, then distinguishing between discovery vs. invention – or nature vs. manmade – is pointless. Either we allow everything discovery to be patentable or none … or we need another line…

  22. If you want a utility patent, all you need to do is put a lubricious coating on it.

    Why narrow the claim? Simply assert a utility that it promotes feelings of liberty and goodness, and discourages bad people from visiting the country.

    Can’t be any less ridiculous than the asserted utility of “inspiring, educating and entertaining children” in patent 5,456,625. It has “all the advantages of the prior art and none of the disadvantages”.

  23. I think you may have misundestood me a little. I fundamentally do not think genes are patentable – but where do we draw the line. The product of nature line is really when you go down the biological route. Almost everything we patent in biology (drugs, genes) is a product of nature of some sort. We figure out what target to attack, because the target works a certain way in health vs. diseased individuals. So it is… The line I believe should not be nature vs. non-nature. It should be more honestly on whether something is a basic tool of science. That’s what I was trying to say. Wrote a law review article on this specific point a few years ago…

  24. What I claim as my invention is—

    The herein-described design of a statue representing Liberty enlightening the world, the same consisting, essentially, of the draped female figure, with one arm upraised, bearing a torch, while the other holds an inscribed tablet, and having upon the head a diadem substantially as set forth.”

    If you want a utility patent, all you need to do is put a lubricious coating on it.

  25. Oh, I understand the question that you presented.

    Do you understand how the decision treats that question?

  26. LOL

    You trot out a design patent.

    Priceless.

    Taking lessons from the Malcolm School of Self-Defeat Without Self-Awareness now?

  27. Think? I know you can patent a statue. For example: It ain’t David, but its a statue.

    link to google.com

    “This design may be carried out in any manner known to the glyptic art in the form of a statue or statuette, or in alto-relievo or bass-relief, in metal, stone, terra-cotta, plaster-of-paris or other plastic composition. It may also be carried out pictorially in print from engravings on metal, wood, or stone, or by photographing or otherwise.

    What I claim as my invention is—

    The herein-described design of a statue representing Liberty enlightening the world, the same consisting, essentially, of the draped female figure, with one arm upraised, bearing a torch, while the other holds an inscribed tablet, and having upon the head a diadem substantially as set forth.”

  28. Les,

    I am left ‘speechless’ only so far as you want to ignore my post of 9:12 inwhich I gave you three reasons.

    Persuading you is not something I need to do. The fact that You think you can patent a Statute of David as an article of manufacture tells me that no one is likely to be able to persuade you.

    Come back when you figure out why.

  29. I think you are and Forbes are over-reacting here. The science isn’t perfect, but I wouldn’t go so far as to call it “wrong.” There are some semantics which could certainly be improved, but beyond that I’m curious to see what you think is so egregious.

  30. Just saying your sorry and that I’m wrong is not a very persuasive argument.

    Your analogy is the one that is lacking. The claim to David would not be a claim of marble from marble and the claim of Myriad is not generic DNA from generic DNA. It is a claim of a BRCA2 gene from a chromosome.

    The David from Marble analogy is very apt. So much so that it has left you speechless. …only able to utter sorry wrong. no no no no

  31. Sarah cDNA will get stuck on obviousness

    Only if the natural gene sequence or mRNA sequence was previously disclosed. If the applicant is the first to have sequenced the genome of the organism and demonstrate a utility for the gene or the encoded protein, then the applicant should get the patent on the cDNA (assuming the gene has introns…). It seems highly unlikely that such a claim could be deemed obvious.

  32. Yes, it is.

    If you think otherwise, then you do not understand.

    There was no blanket pass for cDNA’s that you may think there was in the decision.

  33. Sarah: They punted anything else and didn’t say that all cDNA were per se patentable. They only said that cDNA could be patentable as it is not a product of nature. That is not to say that all cDNA will be patenable.

    I know the difference between “eligibility” and “patentability”, even if the Court is routinely sloppy about it. My point has nothing to do with the obviousness of any given cDNA in view of the prior art, whether or not that prior art is deemed to include previously unknown genomic sequences.

    I think that SCOTUS does have an understanding of the genetic code, transcription, and translation. I don’t think there is a conflict between Thomas’s statements that you pointed to.

    I can’t put it more clearly than I did in my original comment. But you should read it again because I’m not talking about a conflict between 101 and obviousness. I’m talking about a conflict between saying, on one hand, “we aren’t saying anything about nucleic acid sequences that are different from naturally occurring sequences” and on the other hand saying “you can’t patent natural genes and the information they encode.” Again, that’s a conflict because the genetic code is inherently redundant (i.e., in some cases, several different codons correspond to the same amino acid), therefore different nucleic acid sequences can encode the same information, and therefore the Court (contrary to its own assertion) is certainly saying something about claims to polynucleic acids with sequences that differ from “natural” sequence.

    And it’s not a trivial thing. Two different sequences may encode the same protein but the differences in the sequences can have profound effects on the ability of, say, a transformed cell to express that protein in a useful manner.

  34. Tim,

    Legal error here for you: 101 has no such time element – you are conflating the time aspect of 102.

    See Prometheus (9-0 dance a jig baby)

  35. Mere isolation did not effect a change in kind and you are simply – to use your analogy, claiming marble from marble.

    Sorry Les, you are simply wrong here.

    You are also wrong about the statute of David falling intot he useful arts because it is an article of manufacture.

    Scary wrong there.

  36. I think you’re missing the mark. This pretty clearly goes to the “on information or belief” typically used in sworn declarations filed in court, i.e., you know a fact yourself or have been given reason to believe that fact. Not religious at all.

  37. The problem with this logic is that there is no effort in removing the introns. The cell does that itself, through natural processes, to form mRNA. You make cDNA from that by just doing the reverse process that turns DNA into RNA.

    So the only artificial steps involved are isolating the mRNA which already has its introns removed, and reverse transcribing it into DNA.

  38. Seems to me the big picture here is that the SCOTUS should try to understand modern science and technology if they want to control it. We can dance around them and probably make this opinion not very meaningful, but isn’t that just a waste.

  39. 35 USC 101 only authorizes discoveries to “new” manufactures, compositions of matter, etc. The isolated DNA here already existed in nature, so it was hardly new.

  40. I agree. And had he signed onto the majority opinion in Bilski most of the issues regarding information processing and 101 would have been resolved.

    In chem we have this principle that discoveries are worthless to 101 and we have the ominous Funk Brothers that mixtures don’t count.

    In electrical we have Benson returning, which is the most twisted contradictory opinion in patent law I have ever read.

  41. Statues are articles of manufacture and are patentable subject matter.

    The David here is the isolated BRCA2 gene. Myriad, like Mike, carved it out of the marble of a chromosome.

    It could be said that David’s structural similarity with the stone from which it was carved could be said to dwarf the significance of the structural differences between statue and naturally occurring stone, especially where the structural differences are merely ancillary to chipping away of parts that were not David.

    However, the speaker would be a…. errrr… wrong.
    However

  42. First, your analogy dwells in the non-useful arts.

    You seriously think that is an apt analogy?

    Second, you quite ignore ‘the facts’ of what was involved in this case. Mere isolation of snipped ends simply does not compare to the rest of what still remains. From the decision, quoting Bryson: “that genetic “structural similarity dwarfs the significance of the structural differences between isolated DNA and naturally occurring DNA, especially where the structural differences are merely ancillary to the breaking of covalent bonds

    Third, there is no “David” in this fact pattern. Rather, to use your analogy, Myriad is claiming ‘marble’ in the block of marble. “The location and order of the nucleotides existed in nature before Myriad found them… In this case, by contrast, Myriad did not create anything.

    Les – this is pathetic and I expcet better from you. Cripes, even 6 can do better than this.

  43. No. The SCOTUS discounting “discoveries” is madness.

    The problem is that they have iron age hats on. You can frame “discovery” as discovering that hinges are helpful for a door.

    Oh well…don’t feel like writting this down right now. But, come on! Think! Is figuring out the relationship between some sequence of DNA and a disease and how to predict it not worth a patent? Does that make sense in the modern world? Isn’t this a form of distilling? What is a discovery? Is it possible that they need to rethink what a discovery is?

  44. Sorry Les, you are quite simply wrong, and your analogy, although picturesque does not fit the facts of this case – as noted by the Justices as they did evaluate the snips taken.

  45. Scalia is a buffoon. He was before penning that silly concurrence and he will remain so on all future decisions he writes.

  46. But, its not a product of nature. Not any more than David is a product of nature because it was carved out of Marble.

  47. I think If a justice can’t understand the case and form his own opinion, maybe he should recuse himself, or bother to pick up a book and learn a little bit about the subject. I’m pretty sure I learned about DNA in Junior High.

  48. The cDNA that retroviruses do produce – like the short chain cDNA’s – are not patent eligible.

    This cannot be that difficult to understand.

  49. If retroviruses produce cDNA, why is it considered that cDNA is not normally present in the nature?

  50. Or not.

    You reach way too hard here Allen. At the same time that you say the Court should have brought up Funk (which they did, btw), you say “free to patent… collections” – which is the exact opposite of what Funk tells you: the mere collection of microbes in Funk was rejected.

    Plus, you are going in the opposite direction of this case – this case was not dealing so much with additions as it was with subtractions (you know, snip here, snip there).

    Bottom line, more honestly: the snips did not do enough to change the claim from what is ‘freely available to all men,” that is, a product of nature which is part of the judicial exclusion of phenomena of nature. Mere structural changes may not be enough.

    And just as the Court does recognize that not all cDNA is eligible (they provided the example of short chains) – other long chains will not be eligible either if, as you posit, they too are products of nature.

    There is nothing wrong or dishonest about the holding in that regard. The holding is direct, simple, and straightforward. Only those wanting to be confused will find a way to be confused.

  51. This DNA sequences found in nature is not patentable vs. cDNA is patentable because the cDNA sequence is not found in nature is clearly erroneous.

    cDNA contains exons, sequences that are expressed. By definition, they exist in nature, even if not on DNA chromosomes. That is, while DNA expression typically involves the cutting out of introns (which include regulatory and other info), the eventual DNA that is expressed (i.e. cDNA) is found in nature – as the target is expressed. To make a protein A, the exons for protein A are excised and combined to a mRNA that contains the same info as the cDNA. So the sequence in cDNA is found in nature.

    This is a not a level of details question. It is where in the body do you look for the cDNA sequence.

    The level of detail question posed in this post concerns something like the following.

    What if the cDNA contains the DNA sequence not just protein A but protein A and B, and protein A and B are usually not expressed together in nature?

    This is a slightly different question than that posed to the court here – although it’s related (multiple genes are sometimes expressed together, can you patent specific patterns of expression, i.e. genes related to specific diseases?). But then we go the question of Funk – the level of details question.

    Can you patent a bacteria? A bacteria mixture? A soil mixture made up of naturally occurring bacteria but in a mixture that is not naturally occurring?

    If we go down this route, the question should not be whether cDNA is patentable vs. DNA – but whether DNA libraries are patentable, when the individual genes are not.

    The Court should have brought up Funk – which in my view is clearly relevant to when genes are patentable and when they are not.

    Unfortunately, FUNK itself doesn’t provide much guidance.

    And biology makes things more complicated. How do we know whether some sets of genes are expressed or not expressed in nature? Even under normal conditions, some group of things are always expressed somewhere, under some condition, in nature. In fact, that’s what research is about – to find out about what groups are expressed in healthy individuals, and hopefully to utilize that for sick individuals.

    Still it’s a guidance.

    What the court is really worried about is pre-emption. Supposedly people should not be able to patent basic gene elements, but they are free to patent gene libraries (collections of genes). But collections of genes can be just as elemental – basic – to future research.

    A better way to frame the preemption question is not with nature, or abstractness, but with whether something is a “basic tool of nature.” With this criterion, basic gene elements would not be patentable, but so would not be some gene libraries, depending … on whether the patenting would block important research.

    Kind of roundabout – but at least we are framing the core question more honestly…

  52. The simple question deserves a simple answer:

    The Supreme Court cannot keep their fingers out of the patent nose of wax.

  53. In case you have trouble finding the holding:

    Held: A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.

    Worth repeating: is a product of nature

    No need to try to make this more complicated by kicking up the dust of ‘information.’

  54. Someone please explain to me how this squares with the fact that 35 USC 101 expressly authorizes patents to “discoveries”?

  55. Ned,

    There you go again misreading law.

    1) Scalia’s “identically” get’s a vote of one Justice. That is not the holding of the case.

    2) Quite to the point, “identical” is not required, because the claim was not identical. This was stridently put forth by Malcolm, and was his raison d’etre that the Court would decide that the ‘product of nature’ exception did not apply.

    3) It’s still amusing how hard you are trying to find some port of call for Malcolm from this Myriad storm. Almost touching, really.

    Nah.

  56. Malcolm, thanks. 
     
    This does make it a lot clearer.  This is a very simple product of nature case.  If the claimed subject matter is “identically,” in the words of Scalia, in nature, it is unpatentable.   That bit on the end in Thomas’ opinion about “information” was pure dicta.

     
     
     

  57. The ‘policy’ basis is what they used. And Thomas should not be singled out – he merely wrote this opinion, which was signed by pretty much everyone, and the Court’s other 101 decisions are no less policy based.

    ‘Policy’ is what the Judicial Exceptions are. It is merely legal sophistry that the Court needs to borrow authority from somewhere in order to write patent law. And since 1952, they have (largely) chosen to use the ‘implicit’ reading of 101 as the preferred vehicle for the implantation of their nose-of-wax policies.

    Perhaps this decision will wake the NIMBY’s from their slumber…

  58. No.

    No.

    No.

    First ABCD must be patentable. And SC rulled that DNA is not patentable (cDNA is DNA stripped of NON-CODING combinations).

    So its clear here.

    Its like with any “law of nature” by limiting DNA to only coding sequences.

    And ofc. SC rulled only on 101 of cDNA..

  59. Unless you do “How correct SC was in its rullings regarding *high* tech in xx-yy years, after 5, 10, 20y”

    That could be funny :D

  60. Such a bad opinion. They should have just ruled it unpatentable on a policy basis, instead of trying to justify “isolated DNA” vs, cDNA and the notion of “information”. I am not at all impressed with Thomas.

  61. I wanted to edit my comment, but I can’t.

    The “effort” to remove the introns is made by the cell machinery. The introns are lost during transcription. The company then used a reverse transcriptase to make the cDNA, which is what retroviruses (e.g. HIV) do all the time.

    I’m a scientist, not a lawyer, let alone a judge. To me, the judgement seems unreasonable and flawed, but might stand the test of law.

  62. I think the point is that it takes effort to remove the introns. That effort gets out of the product of nature exception. The effort to isolate a gene is not enough and keeps DNA within product of nature. The effort to remove the introns is enough to get it past the product of nature exception. cDNA will get stuck on obviousness, but the Court didn’t rule on that because it wasn’t raised.

    I think that the logic would be along these lines. Plucking a leaf from a tree isn’t patentable – that’s just nature and still looks almost identical to nature. Plucking a leaf, taking the veins out, and putting it back together isn’t nature and could be patentable. It probably won’t be on other grounds, but it’s not going to fall under the product of nature exception.

    The genes and the information they encode language isn’t from Thomas, it’s from the amicus briefs/lower court opinions. This opinion seems to be cut-and-paste from various amicus.

  63. I was responding to your last paragraph. I should have written a longer post. Thomas’ information content analysis make sense when viewed in a particular light.

    I think that SCOTUS does have an understanding of the genetic code, transcription, and translation. I don’t think there is a conflict between Thomas’s statements that you pointed to. Yes, isolating a gene does take some manipulation that changes a sequence. However, isolating a gene is not fundamentally altering that gene or the sequence within that isolated segment of DNA. cDNA is different in that there is some other step involved – some scientist had to do something to get the cDNA. cDNA is based on nature, but it’s not typically found in nature. The cDNA sequence is different from the DNA sequence with the introns still there.

    The SCOTUS position on the distinction between cDNA and isolated genes makes sense when you look at precisely what they were ruling. They were only ruling on if isolated genes are products of nature. They punted anything else and didn’t say that all cDNA were per se patentable. They only said that cDNA could be patentable as it is not a product of nature. That is not to say that all cDNA will be patenable.

    And they’re not saying that all cDNA would live up to any other legal challenges that someone could come up with – like say, a challenge claiming that any particularly cDNA is an obvious invention. I’d guess that cDNA wouldn’t live up to an obviousness challene if it ever went up to SCOTUS that way. Recombinant DNA would be another issue.

    You initially wrote that the information content of cDNA is identical to the information content of the natural intron-including DNA, at least for protein expression. I just misinterpreseted what you wrote about that.

  64. The issue isn’t a molecule containing A,B,C,D. It is a molecule chain A-B-C-D. My understanding is that B-C-D wouldn’t be patentable, because it would be a per-existing subset of A-B-C-D, which itself was a subset of something else.

    However, A-C-D might be patentable.

  65. I agree with you, not only on this point but aso with respect to the “punt” you referred to above. That one makes absolutely no sense at all, as it is completely inconsistent with the rest of the decision.

  66. I have to say I was a bit repudiated by the latter part of his statement. It is a dangerous thing to order based on a belief, especially when there is evidence available to counter any “beliefs”.

  67. Only some DNA nucleotides, however, code for amino acids; these nucleotides are known as “exons”. Nucleotides that do not code for amino acids, in contrast, are known as “introns”.

    Scalia did good by acknowledging his own ignorance. The others expressed theirs in passages such as the one above.

    I don’t think this was a clear judgement. The following was most troublesome to me:

    Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule. Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes. If the patents depended upon the creation of a unique molecule, then a would-be infringer could arguably avoid at least Myriad’s patent claims on entire genes (such as claims 1 and 2 of the ’282 patent) by isolating a DNA sequence that included both the BRCA1 or BRCA2 gene and one additional nucleotide pair. Such a molecule would not be chemically identical to the molecule “invented” by Myriad. But Myriad obviously would resist that outcome because its claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.

    Why doesn’t it apply to cDNA? Granted, it takes effort to remove the introns from the bulk DNA,

    But extensive effort alone is insufficient to satisfy the demands of §101.

    The modifications do not pass the test of obviousness. This is just like you can’t patent the enantiomer of an already patented drug.

    Nor do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Scientific alteration of the genetic code presents a different inquiry, and we express no opinion about the application of §101 to such endeavors. We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated
    from the surrounding genetic material.

    This is pure confusion. What Myriad did is exactly to modify genetic information by removing stuff it didn’t need. Again, is the information content important, or the structure?

    Confusion, confusion, confusion.

  68. Sarah: kes sense when you look at what they were ruling on. They were just ruling on deterimining if isolated genes are a product of nature; they’re not saying anything about any obviousness challenge

    What makes sense? Obviousness challenge? Not sure who or what you are responding to.

    cDNA is not necessarily the same as the intron-containing gene.

    The cDNA is different from the intron-containing gene by definition. Again, not sure here if you are trying to repeat points already made or address a perceived error …?

  69. Maybe Scalia simply can’t believe that cells and biomolecules work in the way they do. It is pretty amazing and, when it comes to the details (where most of the patenting occurs), it’s not exactly intuitive.

    As for this part of the concurrence:

    “the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA (cDNA) is a synthetic creation not normally present in nature”

    it’s sort of accurate. The isolated DNA has different ends than the naturally occuring DNA. And generally speaking, the nucleotide sequence of a “cDNA” is unlikely to be found in a “natural” DNA but, as Thomas notes, it could certainly happen if the “cDNA” is really short. It’s also true that some organisms have introns in a given gene while a related organism “naturally” lacks the intron in its corresponding “homologous” gene.

  70. It makes sense when you look at what they were ruling on. They were just ruling on deterimining if isolated genes are a product of nature; they’re not saying anything about any obviousness challenge. That would be a different inquiry.

    And cDNA is not necessarily the same as the intron-containing gene. Introns may contain information about how to ustilize the gene, which gene segments to use, etc. (See – antibody production).

  71. “unable to affirm those details on my own knowledge or even my own belief”

    Does anyone else think there is a religious undertone here? Scalia could have stopped with “knowledge.” Further mentioning “beliefs” suggests Scalia might be unwilling to buy into the science here because of a conflict between genetics and faith.

  72. I think the level of detail was definitely too little with respect to why cDNA is not naturally occurring.

    The court previously viewed isolated DNA as not naturally occurring because of the fact that it was snipped from the chain. Without a better understanding of cDNA I am not sure that cDNA is not minimally altered, much in the same way that isolated DNA is minimally altered.

  73. If isolated DNA and cDNA encode for the same protein, the “information” they encode must be the same.

    Yes … but only if by “information” you are referring soley to the “identity of one encoded protein.” The “natural genes” with the introns intact actually encode more “information” (if we’re using the term loosely) because, at least in some cases, the introns themselves contain “information” about how/when they are to be removed inside a cell. Unless I’m remembering wrong, in some cases an intron can encode a separate protein. Or a natural gene can be spliced in two different ways, yielding two different proteins, depending on how various intracellular factors interact with the cell.

    That’s the other thing that’s weird about this decision when looked at from the “product of nature” angle. The cDNA is just a reverse-transcribed naturally occurring RNA. The naturally occuring mRNA has the same “information content” as the cDNA, and no introns, but somehow the cDNA remains eligible. It’s arguably even easier to pull out a cDNA than a naturally occurring gene. Remember those expressed sequence tags in In re Fisher that were found ineligible as lacking utility under 101? Those were cDNA molecules (or portions of them). At the time of filing, what more did Myriad know about the function of the cDNA it patented other than the fact that it was expressed and “valuable” (serious question — I don’t know the answer)?

  74. Steve, long ago, Learned Hand expressed misgivings in his ruling on Adrenalin that he really didn’t understand the chemistry involved.

    Scalia was honest to point out that he voted the way the did because he thought the evidence showed the claimed subject matter to be

    identical

    to that found in nature.

    Note also that he limited his view to “the portion” claimed. I read this to suggest that the “portion” he is talking about is the sequence that encodes proteins, which brings up the problem that Malcolm identified.

    What is he talking about, really?

    As I read Malcolm’s posts, I see that portions of the DNA that encode for the identified proteins does not include the introns. As such, the claimed active portions are identical for both isolated and cDNA.

    But I too do not understand the chemistry here, and what I just said may be incorrect.

  75. Malcolm, I begin to see your point about “information.” If isolated DNA and cDNA encode for the same protein, the “information” they encode must be the same.

    This seems to be what cause Quinn some angst as well.

  76. They just did everything in their power (intentionally or not) to avoid sharing their knowledge effectively.

    Corrected.

  77. things can go terribly wrong when you mix science and the law without anyone around who knows what the heck is going on.

    This much is true. In this case, however, there were plenty of people “around” who certainly knew exactly “what the heck” was going on. They just did everything in their power (intentionally or not) to share their knowledge effectively. I mean, if I’ve got some defender of Myriad’s claims (names withheld) debating me on public TV, I’m going to make him defend the validity of those claims under 102 and 103 or look like a f00l trying to do it.

    The good news, at least, is that the worst of Myriad’s claims are toast. They were going to go down one way or the other. Good riddance.

  78. Jason, it’s not so much the level of detail that bugs but the lack of focus on the key facts (especially disputed facts) and the lack of a clear resolution/explanation of issues that would seem obvious and important to anyone with a rudimentary knowledge of biology (e.g., anyone trying to patent in this area).

    I’ll restate something I put at the very bottom of the previous thread regarding the remarkable “punt” at the end of the decision:

    Nor do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Scientific alteration of the genetic code presents a different inquiry, and we express no opinion about the application of §101 to such endeavors. We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.

    Myriad lost its battle to protect the “information content” of certain parts of the human genome when it (rightfully) lost its diagnostic method claims. Myriad’s compositions do not protect “information” encoded by nucleic acids any more than a claim describing a novel anvil protects “information” about the anvil-filled space it creates in water when it’s dropped into a pool.

    Is it possible that Thomas et al do not understand the genetic code and the straightforward (albeit redundant) relationship between codon triplets in DNA and the corresponding amino acids in the resultant protein? It certainly seems so from this paragraph. How can the court state on one hand that “we merely hold that genes and the information they encode are ineligible simply when isolated”, and at the same time state that it is “expressing no opinion about altering the naturally occuring sequence of nucleotides”? It seems to me that the first statement is clearly and inherently expressing an opinion about such an alteration. It’s saying that alterations in a nucleic acid which do not change the amino sequence of a protein encoded by the nucleic acid relative to the non-natural sequence will not suffice to confer eligibility to that claim. The second statemet also clearly contradicts the Court’s holding that cDNA is patentable. The “information content” of cDNA is identical to the information content of the natural intron-containing gene, at least from the perspective of protein expression.

  79. I think it’s an admission that things can go terribly wrong when you mix science and the law without anyone around who knows what the heck is going on.

    “I am unable to affirm those details on my own knowledge or even my own belief.” Seems to me that Scalia recognizes the fatal flaw with the product of nature doctrine, which is that it presumes there’s nothing left to be discovered.

  80. Apparently they worked hard to take something away from the molecule in order to make cDNA. Thus the original molecule may contains A, B, C and D and the cNDA contains only B, C, and D.
    Under normal claim construction, if I have a claim covering the combination of B,C and D. There would be infringement by something that has A, B, C and D.

  81. It depends on whether or not these “fine details” were undisputed. I think the Court provided more detail than necessary, but it wasn’t making factual findings.

    Anyway, I agree with Scalia that the Supreme Court shouldn’t be ruling on the nature of DNA, but I don’t think anyone in their right mind would cite the Supreme Court for its scientific knowledge.

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