Myriad: Isolated DNA out, cDNA in

By Jason Rantanen

Association for Molecular Pathology v. Myriad (2013)  Download 12-398_8njq

In an unanimous opinion, this morning the Supreme Court drew a sharp line between isolated DNA (not patentable subject matter) and cDNA [synthetic versions of DNA that omit non-coding portions] (patentable). There is a curious concurrence by Justice Scalia that I'll post about separately.

The Court's basic rationale is similar to Judge Bryson's dissent in the Federal Circuit opinion. DNA is really about information, Myriad's patent claim treats it as if it's about information, and that's how the Court treats it as well.  Because the minor chemical differences between naturally occurring DNA and isolated DNA don't change the informational component of DNA relative to its naturally ocurring state, isolated DNA is not patentable.  However, the creation of cDNA in the laboratory does affect this informational component by removing the non-expressing portion of the DNA sequence, thus producing a non-naturally ocurring DNA sequence.  This change in the informational content is sufficient to render the cDNA sequence patentable.

The 101 Standard: The court applied an incentive/preemption framework for analyzing the patentable subject matter issue:

As we have recognized before, patent protection strikes a delicate balance between creating “incentives that lead to creation, invention, and discovery” and “imped[ing] the flow of information that might permit, indeed spur, invention.” (quoting Mayo v. Prometheus, at 23)

Isolated DNA: Simlar to its approach in other patentable subject matter cases, the Court first looked to the essence of what Myriad had done.  "Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13. The question is whether this renders the genes patentable….In this case, [] Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention."  Slip Op. at 12.

In reaching its conclusion as to the unpatentability of isolated DNA, the Court adopted an information-centric view of DNA as opposed to a chemical-structural approach: 

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 focuson 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 withthe information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.

Slip Op. at 14-15.

cDNA Patentable: The Court reached a different result for cDNA:  

cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. As already explained, creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring. Petitioners concede that cDNA differs from natural DNA in that “the non-coding regions have been removed.” Brief for Petitioners 49. They nevertheless argue that cDNA is not patent eligible because “[t]he nucleotide sequence of cDNA is dictated by nature, not by the lab technician.” Id., at 51. That may be so, but the lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a “product of nature” and is patent eligible 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.

Slip Op. at 16-17 (emphasis added).  Note that under the last bit, a cDNA sequence may not be patent eligible subject matter in some circumstances.

What are the consequences?  My immediate reaction is that for most practical applications, the Court's holding means that even though the broadest possible biotechnology product claims (to the isolated DNA itself) aren't going to be patentable, the key elements in making and using a biotechnology-based invention are still going to be protectable via patents (Part III of the Court's opinion makes this especially clear).  This will allow researchers and competitors a little bit of wiggle room to design around biotechnology patents because they can use the basic isolated sequence but there will still be substantial limitations on what they can do with that isolated sequence.  For this reason, I'm skeptical that the Court's opinion will have a negative effect on the incentives for creating biotechnology-based applications.  To the contrary: by affirming that cDNA can be patented, it may strengthen the incentives for investing in research in this area.

In terms of the effects on my friends here at the University, I can see at least two consequences. First, it may allow researchers more freedom to engage in whole-genome sequencing because they won't need to deal with a multitude of isolated DNA patents for individual sequences.  On the other hand, because early-stage research on newly discovered DNA sequences cannot be patented, it may encourage companies – and perhaps universities – to pursue greater secrecy over those early stage discoveries.  Social research norms may cut against this – particularly in universities – but there may be some increased pressure, particularly at the margins, towards secrecy of potentially valuable inventions.

Update: In the short term, this case may have an immediate impact on BRCA testing.  Via Brian Love at Santa Clara, Hank Greely just tweeted that: "Ambry announces its own BRCA 1/2 sequence test. $2200, a 30%+ cut from Myriad. They'll do deletes/dups for $500. Price hemorrhaging begins!" 

259 thoughts on “Myriad: Isolated DNA out, cDNA in

  1. Let the record show that Malcolm has failed.

    Failed to find the nuts to admit he was wrong and I was right.
    Failed to defend his pet theory that he tossed on a bonfire of his own making in his first substantive attempt to square Prometheus with the precedent case most on point.
    Failed to deny his own 1ying svckpuppetry (that he had previously sworn he did not do when he was QQng up a storm).

    And my intern just came in with this: Malcolm has posted nearly 21,000 words in one week on something ‘that he doesn’t care about.’

    LOL – nearly 21,000 words of mewling QQ and not word to show he has the nuts to admit the plain FACT that I got the decision and reasoning right and that he was wrong.

    So ends this chapter on Myriad, with a wonderful bookmark to the torching admission by Malcolm and a whole lot said that amounts to nothing.

    Life is good.

  2. That’s pretty funny.

    Thank you. That means a lot, coming from you – Your keen sense of humor is well known, especially since yesterday’s “joke.”

  3. That was an excellent analysis and break down of Diehr. You should publish it in a, Diehr for Dummies book! Seriously.

  4. That’s pretty funny.

    Almost as funny as the occasional crybaby’s veto attempt, and the ‘stop picking on MM’ mewling.

    Almost.

  5. NWPA:” But, converting numbers to different bases is not a scientific truth. But,the big picture is right. Where is that line of what is math of a scientific truth and what is application?”

    I agree with you and that is an excellent question. Hmm… it makes me wonder if the astronomer(s) that proved Einstein’s General Theory of Relativity by using their telescopes to take a picture of the sun light bending around the moon, and doing the necessary math would cross that line. My intuitive analysis and best educated guess would be, yes.

    Under the statute the process would be eligible, as the math is applied and does not pre-empt the underlying concept ( General Theory of Relativity). It would not even pre-empt Einstein’s equations for the theory. There would be a new use of the astronomers old math, telescopes and other apparatus in an ordered combination; fully integrated and fully patent eligible. But of course, today such a process would involve software and computers and so be pre-ordained an abstract idea. It’s scary when you realize how far we have regressed. At some point the madness has to stop. I am counting on that day at the Court.

  6. Leopold Bloom.

    For some strange and (I am sure) purely coincidental reason, several member of the little circle club all changed their monikers to two letter initials.

    Malcolm Mooney went to MM
    Leopold Bloom went to LB
    MaxDrei went to MD

    Hmmmmm.

  7. But, that is what I mean by iron age thinking. They only find concrete objects eligible.

    Doesn’t that make it “concrete age thinking”?

  8. Actually, it would be instructive to get that Fish attorney’s analysis of Diehr since he used it to defeat the claims in Prometheus. I remember that the basis was what was considered new and he had an argument that the only reason in Diehr it was held eligible is that it was the first time a process had included a interactive checking. He had two theories of why it was held eligible (both wrong or should be wrong and both essentially trying to hold Benson as good law).

    But, his arguments are no doubt going to be used again in the great software case that will go to the SCOTUS soon.

  9. Well, anon, the analysis of Diehr is complicated. I took the CLE where the Fish attorney who did Prometheus analyzed Diehr. I seem to recall his arguments were so convoluted as to be beyond remembering, but he won Prometheus.

    My point was simply that because there was that rubber is why they held it eligible. The SCOTUS has completely discounted information in patent eligibility–outrageously.

    But, that is what I mean by iron age thinking. They only find concrete objects eligible.

  10. The thing about Diehr was that the physical object being made was not new.

    The only thing new in Diehr was the computer program that took the (old) thermocouple data, applied the (old) Arrhenius equation, and opened the (old) door to produce an (old) mold. The new was the ability to apply the computer program with a GREAT COMPUTER BRAIN, and thus do a better job of opening the (old) door.

  11. The whole thing is bizarre the way the SCOTUS has systematically used 101 to try and remove all modern inventions that are not a physical object. (Really, save for Diehr and you have to wonder if that was saved because it was making a physical object.)

  12. Well, 101, I agree with your statements above regarding the math for scientific truths. But, converting numbers to different bases is not a scientific truth.

    But,the big picture is right. Where is that line of what is math of a scientific truth and what is application. The other problem is Haliburton where they extended the exception to essentially applied math methods for the public policy reason that they didn’t want to stop other companies from building iron machines in a different way.

    So, it is a slippery slope the SCOTUS has taken step after step of excluding everything but iron.

    And, Lemley functional claiming nonsense is the other line of what is abstract. Lemley completely misrepresents functional claiming—to an extent he should have to resign from Stanford.

  13. Fish scales: “Any thoughts as to how this opinion may effect the patent eligibility of business methods, software and “abstract ideas” (whatever they heck they are)?”

    101 Integration Expert: I do not believe this will effect business methods or software because it appears to be a cut and dried product of nature exception. (Oh, and BTW, congratulations anon. That was a very impressive prediction not only on the outcome, but on the rationale as well.) The Court has been clear on what it believes is abstract, such as a fundamental truth; an original cause or a motive. Business methods and software per se do not meet that definition. Some have confused mathematical equations and formulas with abstract ideas but such reasoning is incorrect. Mathematical equations are not eligible when they represent laws of nature, physical phenomenon, or some other scientific truth. If that other scientific truth is a product of nature, and the claims present nothing beyond the math equation and formula, then the claims would be ineligible under the product of nature exception. Which would have nothing to do with business methods, software or abstract ideas.

  14. PART V

    But I ask, what use is a sat dish, TV Set, Cell Phone, or even a computer without the processes and systems for using them? Maybe the honorable Judge Lourie, or the esteemed members of the Versata Board can answer this question for us. If not the Supreme Court surely will!

  15. PART IV
    The irony is the lower courts have gone to the extreme to the point that not only the intellectual concept and any math that may represent it is excepted, but the information processing inventions such concepts have made possible are also excluded! Thus ALL progress is r-e-t-a-r-d-e-d! Theses judges think, yes it’s fine to get a patent on a satellite dish, thats an iron object, or maybe even a television set itself. But a patent on just the system and process for using or improving the use of such objects is forbidden!

  16. PART III

    I tend to agree with the Court’s thinking. Imagine if I invented or discovered the Photo Electric Effect or Einstein’s General Theory of Relativity and had a patent on the concept and the math equations? I would then be able to prevent all applications beyond the math. That would remove the basic tools of scientific work from the public domain. The inventors of systems and processes for satellites, cell phones, television networks, and all modern information processing would have to pay me a royalty.

  17. NWPA: “Of course you are right 101 about the “preempt an abstract idea” being the most intellectually dishonest part. That is so farcical. Abstract idea was meant to prevent patents on things like a stitch in time saves nine. But, you know even this is wrong. ”

    PART I

    Also, I seem to recall reading in Supreme Court case law they were concerned someone might patent an idea like Einstein’s General Theory of Relativity. Thus the proscription for patenting abstract intellectual concepts. But Alice and even Versata come no where close to claiming an intellectual concept like a theory of General Relativity. The Court then reasoned that someone might also come up with the mathematical calculations for such a theory, as Einstein did. And even though the math equations are not abstract, the Court reasoned that such equations would represent “scientific truths” and would in effect be the same as patenting intellectual concepts like the general theory of relativity itself. So once again the proscription against patenting disembodied math equations, like e= mc square.

  18. Try reading what I actually said Malcolm. There is a clear comparison between what instigates the ‘need’ for Leopold to speak up (and it is the little red cape of ‘anon said’).

    Keep up son.

  19. LOL.

    Did you have a point with that post, Malcolm? Other than displaying the inability to read my post as suggested, or to realize just how much of a hypocrite you are with your own use of the N word?

    Did you really need to draw the attention to your own failings even more?

  20. Clearly, I am impugning the Robes – not the race.

    Uh … what?

    the one of two people to have ever used the N word on this blog.

    God, you’re one f—ed up a–h0le.

  21. LOL – coming from the one of two people to have ever used the N word on this blog.

    Hypocrite, why don’t you read my post at 9:45.

  22. Especially on the day that another Hit1er video makes an appearance on the blog – and you are quiet about that.

    Your cheerleader skirt is showing.

  23. Leopold – you are taking offense much too easily. Clearly, I am impugning the Robes – not the race.

    Let’s not start shooting arrows at the wrong target (again). Let’s not aim for another version of the crybaby’s veto.

  24. “We will not let our implicit reading become a dead letter – even if that means that someone will have to challenge the constitutionality of our actions. The constitution is what we say it is and we are never ever ever wrong”

    rumored to be overheard from the GroupofNineBlackRobedTr011s – or is it the GroupofEightandThreeFifthsBlackRobedTr011s.

  25. Sad really that the federal circuit is so deficient in their love of patent law that these arguments don’t even occur to them. They are robots that paid their dues to get on the fed. cir. and could care a less what happens to the patent system (save for a few–Rader, Newman, maybe Moore, and O’Malley.)

  26. I think this point should be pushed much harder. That the SCOTUS is simply refusing to follow the 1952 act. They don’t even seem to reference the statute, but only their own precedent. Outrageous behavior on their part.

    The other thing about this is that all these judges that Obama is appointing seem to have no experience (in general) with patent law and don’t even seem to have any appreciation for this giant issue.

    It is after all the response the federal circuit should be giving the SCOTUS—you guys are NOT following the statutes but common law that was meant to be over ruled by the 1952 act. (Certainly 101 flash of genius was and I think all of it was meant to be over ruled.)

  27. Quick 6, grab that time machine – the notion of the Supreme Court not following the 1952 act and the taking away of the common law path to defining invention (and codifying such in 103) as opposed to the atom bomb of 101 was an original thought at some point in time. We need to run to that time machine and make sure that Rader and Quinn say it first.

  28. Of course you are right 101 about the “preempt an abstract idea” being the most intellectually dishonest part. That is so farcical. Abstract idea was meant to prevent patents on things like a stick in time saves nine. But, you know even this is wrong. As there initial fear was that patents would be granted on an abstract idea as such—meaning that no art could be applied as this was a new abstract idea. But, that is not the modern patent system. A stick in time saves nine would easily be dealt with 102 and 103 now. But, you see they were afraid that a species couldn’t be applied to the claim as it was an abstract idea. Now the logic of the abstract idea abstract is no needed at all with 102, 103, and 112. THIS IS ANOTHER EXAMPLE OF THE SCOTUS REFUSING TO COMPLY WITH THE 1952 PATENT ACT.

  29. I agree mainly with your analysis 101. And it is a Kangaroo court. And, I have read that they are talking about extending the covered business method review to all patents. So, all patents may come under this type of Kangaroo analysis. (And to be clear if the PTO can get its act together and reduce the backlog then this could be the primary litigation route for patents—be afraid.)

    Seems to me the problem is that if any claim that involves any computation is classified as a law of nature, then it is hard to fight this type of “logic.” It is ridiculous to say that all these heuristic methods are laws of nature. Haliburton is the case that breaks this logic as in Haliburton the SCOTUS explains that the “logic” of putting all of these in laws of nature is so that other people can build other types of lab equipment to implement the “mathematical method.” You see the public policy reason for this vast grab no longer exists.

    Their logic breaks down too at the hardware/software boundary and at the list of exceptions such as doing computations on an image of a real object is a type of transformation. I think the way forward is to push on these breaking points of their logic. The “other ways of doing” it is another breaking point that does not hold water in other areas of patent law. I mean you don’t say well, you can claim fiber optic cable as long as you can also show there are three other ways of sending light over a glass cable. Now do you?

    And, consistently that is what happens with these types of arguments. If they break down and seem ridiculous in other areas of patent law, then it is a good indication that they are Kangaroo logic.

    We do need to amplify our voices, though. Lemley needs to challenged publicly for academic dishonesty, for example.

    You know, this abstract thing came about after they lost their battle for all numbers to be a law of nature and now they seem to be winning on both fronts.

    The biggest problem we have now is that Obama is singing their songs–what a dope that guy is. I voted for him twice but you can see he has turned into a bubble person that has no clue what reality is.

  30. Overall, of course, this is excellent 101. We need to amplify our voices and confront Lemley, Lourie, Stern, etc.

    One problem: the law of nature from Benson if often taken by the anti’s to mean any mathematical algorithm which results in a mathematical computation.

  31. NWPA said “He will see instantly that if the covered business method review is expanded then all patents to do with software can be funneled into the kangaroo court. And, now we do not appear to have the Fed. Cir. to stop the burning.”

    Please tell me the law offers some recourse to an applicant or patentee that has their invention invalidated under the covered business method review!?!?!?

  32. The proceeding was Part Four. This is Part Five.

    WARNING. Now we are entering the height of intellectual dishonesty by the Board.

    “Versata contends that there are many ways to practice the abstract concept of determining a price through arranging customer and product data hierarchies that fall outside the scope of the claims. PO Resp. 26-27. Yet, the fact that the claims could be drafted differently does not demonstrate that the additional limitations are meaningful. Flook,  437  U.S.  at  590  (“A  competent  draftsman  could  attach  some   form of post-solution  activity  to  almost  any  mathematical  formula  .  .  .  .”), 593

    ( Flook is referring to claiming a mathematic formula that represents a scientific truth. Versata claims no such formula so there are no steps that are appended, and therefore no post-solution activity to any formula. The case law is misapplied. Again, Versata is claiming an “integrated” process that also includes technology, although there is no requirement by statute or case law even for that inclusion. )

    “We conclude that  Versata’s  claims  do not add meaningful limitations beyond the recited abstract idea and, in practical effect, preempt the abstract idea.”

    The Board’s conclusion loses considerable credibility because it ignores Versata’s contention that the concept is not pre-emtpted then concludes without evidence, that the claims “preempt the abstract idea”. If this was an intellectually honest board they would have fully considered any examples of Versata’s that demonstrated for a fact the claims did not pre-empt the Board’s alleged concept and abstract idea of the invention. In effect this Kangaroo Review Board convicts without even considering evidence that could prove they are wrong. A sad day for Patent Law and Inventor rights.

  33. SAP  contends  that  Versata’s  claims  do  not  add  anything  beyond  routine,  conventional activities to the unpatentable abstract concepts. Pet. 18. The abstract nature of the claims is said to be confirmed by the fact that the claimed data arrangements and pricing calculations can be performed manually. Id.

    (SAP is incorrect because a process that can be performed manually is neither abstract by the statute, or by any case law from the Supreme Court of the United States of America.)

    Versata contends that patent eligibility must be evaluated considering each of the claim elements in [combination], and that the challenged claims include specific separate and distinct steps that are not general or abstract in any way. See, e.g., PO Resp., 15. For  example,  Versata  states  that  SAP  has  failed  “to  address  the  storing, retrieving, sorting, eliminating and determining steps required by claim 17 and  their   [interrelations]  with  one  another  and  with  the  arranging  steps.”    Id. at 16. Emphasis added.

    ( Versata is correct in that the claims must be evaluated as a whole. Furthermore, evaluating Versata’s claims in combination and the interrelation of the elements with one another is called “integration” and is doing no more that what the Supreme Court has set forth as the example of what “is” patent eligible subject matter. See the oft cited and always ignored instruction from Prometheus as follows.

    ” In Diehr, the overall process was patent eligible because of the way the additional steps of the process “integrated” the equation into the process as a [whole.] 450 U. S., at 187. These additional steps transformed the process into an inventive application of the formula. ) [MAYO COLLABORATIVE SERVICES v. PROMETHEUS LABORATORIES, INC 566 U. S. (2012) 3 Syllabus] (Emphasis Added)

    (The absence of the forgoing passage from Prometheus by the review Board is quite conspicuous. Especially when relying on Prometheus for authority to determine what is and is not patent eligible subject matter.)

  34. Part Three

    “SAP contends that Versata’s  claims  are  unpatentable  under  §  101  as  they  are   centered on abstract ideas. Pet. 17. at 18. SAP further states that the claims  merely  recite  “abstract  ideas  with  nothing  more  than  ‘well-understood, routine,  conventional  activity’  added.”    Id., citing Mayo, 132 S. Ct. at 1294.”

    ( Sap is incorrect. The Supreme Court has so stated that an abstract intellectual concept is a fundlemental truth, an original cause or motive. Versata makes no such claims. Furthermore Mayo is referring to steps added to a claim of a mathematical equation or formula that represent a LoN, Natural Phenomenon, or “scientific” truth. Again Versata makes no such claim(s) and therefore SAP has missapplied the law)

    “SAP states the abstract nature of the claims is demonstrated by the fact that the method steps can be performed in the human mind or by a human using a pencil and paper. Id.”

    (Again, SAP is incorrect, the example of method steps that can be performed in the human mind or by a human using a pencil and paper are only used by the Supreme Court for a claimed mathematical equation, formula, or other scientific truth. Versata does not makes no such claims of a mathematical equation, formula, or other scientific truth, therefore the analogy is misapplied)

  35. Part Two:

    In Benson…..The Court concluded that the claims sought  to  “pre-empt the mathematical formula and  in  practical  effect  would  be  a  patent  on  the  algorithm  itself.”    Id. at 71-72. Accordingly, the claims were held unpatentable under § 101.

    ( There is no mathematical equation being claimed by Versata. Therefore the analysis is misapplied with no legal authority. )

    “The Court further recognized that  purely  “conventional  or  obvious”  limitations  are  “normally  not  sufficient  to   transform an unpatentable law of nature into a patent-eligible application of such a law.”

    (Again, there is no law of nature claimed. The analysis is misapplied with no legal authority

  36. NWPA:This opinion from the PTAB is big.

    101 Integration Expert: Yes, one big misapplication of the law. Here is part one of my dismantling of this opinion. Part one.

    “A claim is not patent-eligible where it merely recites a law of nature and adds additional steps that merely reflect routine, conventional activity of those who work in the field. Id. at 1298.”

    (There is no law of nature claimed. The analysis is misapplied with no legal authority.)

    “Further, the  “prohibition  against  patenting  abstract  ideas  ‘cannot  be  circumvented  by   attempting to limit the use of the formula to a particular technological environment’  or  adding  ‘insignificant  postsolution  activity.’”    Bilski, 130 S. Ct. at 3230 (quoting Diehr, 450 U.S. at 191-92).

    ( There is no formula being claimed. The analysis is misapplied with no legal authority. )

  37. NWPA said : “J. Lourie: There are no other steps besides 101. The procedure is as follows. Look over the invention. If it looks like it shouldn’t be permitted to be a patent, then say it is abstract and not eligible.”

    However, the Supreme Court says abstract intellectual concepts are recitations of a fundamental truth; an original cause or a motive. What Judge Lourie did in Alice is take an “integrated” process and disintegrate it, also called dissection. Clearly an illegal act.

    And even after Lourie disintegrated Alice claims he STILL could not identify a single abstract concept of a fundamental truth; original cause or a motive. Yet he still declared all Alice claims as abstract.

    A blatant violation of the law right in front of our faces. Yet very few have called him out it.

  38. Are you sure you are banned and the odd filter isn’t just catching you? I get a lot of posts that don’t work because of words that you would think would be fine. Try just one word posts to see if you are really banned. Did Dennis send you email banning you?

  39. anon: “….appreciate the work you have done in making the 101 analysis accessible and understandable at a simple level. And make no mistake, there are those with vested interests in NOT understanding. And make no mistake, there are those with such interests willing to make sure that others do not come to that understanding.”

    Thank you very much anon. And trust me, I am under no illusions about the lengths they will go to do just that! Why else would I now have had two IP addresses blocked in a row?

    It certainly seems more than suspicious that shortly after I make a post on “Integration Analysis” suddenly IP addresses no longer work on Patently o

    Obviously the powers that be do not want this information to get out or be discussed. While commenters like MM, Ned and 6 are allowed to run roughshod over the blog, and completely misrepresent the law at will.

    I have grown tired of having to jump thru hoops and use different machines, ISP’s and screen names just to make a simple honest post on the current state of the law. So I will be taking my fight to the real world. I may be banned from posting but I am not going away. You, NWPA, and E.G. keep up the great work here. And to the Anti Patent crowd. See you at the Supreme Court!

  40. People who wish not to see, who run around with their eyes tightly clenched, will not appreciate the work you have done in making the 101 analysis accessible and understandable at a simple level.

    And make no mistake, there are those with vested interests in NOT understanding.

    And make no mistake, there are those with such interests willing to make sure that others do not come to that understanding.

    These are not constrained by intellectual honesty, or honesty of any sort.

  41. >
    > LB  said: Hey 101 Integration Expert, can you do us a favor and
    > perform integration analysis on this claim:
    >
    > 101 Integration Expert said: LB, now that I have read the
    > specification, studied the drawings and all claims, I would be glad to apply “Integration Analysis” to the claims in question, in order to establish 101 statutory subject matter. We begin with the clear and unambiguous letter of the law, 35 USC 101, and ask; Are the claims a process?  The answer is, yes.  Since the claims are a process under 35 U.S.C. § 101 and meet the definition of Process under 35 U.S.C. § 100(b) the claims are physical, and are legally not abstract. However, this does not mean the claims pass 101 and are statutory subject
    > matter. The Supreme Court has created exceptions, derived implicitly from the statute.  Therefore, we must ask 3 more questions as required
    > by the Court.  Are the claims a Law of Nature?  The answer is, no.
    > Are the claims a physical phenomenon? The answer is, no.  Are the claims a mathematical equation or formula representative of a Law of
    > Nature,  Physical Phenomenon, or other “scientific” truth?  The answer is, no. In such a special case as when the answer is yes, in addition to the mathematical equation or formula, the claim would need at least one additional step that limited the process so that the claims as a
    whole did not pre-empt the LoN, Natural Phenomenon, or “scientific” truth. Furthermore, if the additional step(s) were present, or added and the LoN, Natural Phenomenon, or “scientific” truth itself were
    > still pre-empted by the claims as a whole, the additional steps would be counted as extra-solution activity, and the claims would still fail 101. Next we ask; Do the claims recite an intellectual concept such as
    > a fundamental truth; an original cause or a motive?  The answer is,
    > no. In which case we are now required by law to take the claims as an inseparable whole( integrated ) and determine if they are new and useful, if so they pass 101 and we proceed to the other sections of the statute to see if they meet those conditions and requirements. And that my friends is an example of “Integration Analysis” A clean,
    > clear, concise and accurate application of the law.
    >
    > Any questions?

  42. ” act of violence against patent law. ”

    o noes! an act of violence agin patent lawl! The horror! The humanity!

    On a more serious note, is an act of violence agin patent lawl more or less serious than a normal act of violence? Than domestic violence?

    Hey NWPA, when are you going to stop beating your patent system?

  43. “But they punted”

    They didn’t punt Ned, Je sus Chris t on sale, I just got done telling you exactly how they’d rule, a thousand times, and explained why. They did, with the exact same rationale. And you come back and say that “following the law” is somehow “punting”?

    You’re a ta rd Ned. There’s little else to be said.

  44. With all due respect to Michael Stipes:

    I thought that I heard Malcolm sing

    Trying to keep up with you
    And I don’t know if I can do it
    Oh no, I’ve said too much
    I haven’t said enough

  45. Yes, JD. Maybe one the of bio experts can disabuse me here, but my take away is: Client – i have discovered a break thru compound that cures cancer. It cost us 1 billion in testing and exploration of the most obscure life forms on the planet. IP Attorney – under Myraid – you need to keep the compound a trade secret because it is found in nature – and is therefore has an absolute bar to patent – not even patent eligible. – but you are free to patent all kinds of applications of the discovery. Under the AIA you can keep the best mode from disclosure – because failure to disclose the best mode (in our example the break thru discovery of the naturally occurring compound) is not a defense to a patent.

    Back to me: On reading Myraid, sounds like you bio and chemical guys and can work around it. Tis, breathtaking, however, to see that every compound that can be ‘isolated’ from nature is going to NEVER EVER be eligible for patent. I would have thought our society would want to encourage this type of exploration, discovery and DISCLOSURE. Meh, guess SCOTUS has got it all figured out for us.

  46. I need to get the time machine back to 6, since I had to use it to copy Rader and Quinn to get this ‘unoriginal thought’…

  47. You really should be more afraid of the power grab.

    While they only address a small reason for the use of the power grab in this decision, the logic they use is open-ended.

    This is literally an Article 1 court, subservient to a pure executive branch, (well, the fourth branch of the government… – but the head of the PTAB is still the head of the USPTO), with no apparent check to the law it can write, it can decide what it means and what it can enforce. ZERO checks and balances.

    Perhaps there are some serious constitutional separation of powers issues here…

  48. J. Lourie: There are no other steps besides 101. The procedure is as follows. Look over the invention. If it looks like it shouldn’t be permitted to be a patent, then say it is abstract and not eligible, otherwise go ahead and give them a patent.

  49. This part of Benson is ignored:

    (funny, just as you have always ignored it Ned, as you have NEVER answered my request for you to address this quote – EVER)

      It is said that the decision precludes a patent for any program servicing a computer. We do not so hold.
  50. You see they keep morphing. They are very clever. Lemley has hits this at every angle possible. He will be all over this. He will see instantly that if the covered business method review is expanded then all patents to do with software can be funneled into the kangaroo court. And, now we do not appear to have the Fed. Cir. to stop the burning.

    If you read the opinion it is just like Benson. I till cannot for the life of me understand how anyone can with a straight face recite the Benson “logic.”

    I suppose 101 is right that it is possible that the SCOTUS might fix this. Possible. If you have to rely on the SCOTUS to get something done, though, you are desperate.

  51. I agree anon. Actually, with a little thought everyone should be very afraid of this decision. We see the nonsensical logic of Benson being applied (if you can use that word) and a Puppet Court. All, they need now do is expand the covered business method patent to all software/hardware and there go all the patents. It will only cost you about $100-$200K now to burn down a patent.

  52. Benson is controlled by Diehr

    As is Flook.

    See Bilski.

    P1sspoor jurisprudence from this Article 1, Super Examiner, Puppet Court.

  53. The results of basic scientific research should be considered a “public good” (in the economic sense), and direct compensation – if any – should be provided under a “liability rule” rather than a ‘property rule’.

    Not sure how logically you made that jump – such is unconnected to anything in this case. Quite in fact, the model you advocate has been a dismal failure from the historical record.

    Your inclusion of ‘ethics’ is likewise misguided, one-sided, and without support. Please do not assume a (false) moral position based on your ideology.

    Thanks.

  54. This opinion implicitly but solidly rejects the idea voiced recently by CAFC members (notably Newman and Rader) that patents are needed to foster private basic scientific research. In that respect, it can have far-reaching consequences.

    But the SCOTUS is right. if only because patents are not for facts but for acts (that can be carried out by a PHOSITA).

    The results of basic scientific research should be considered a “public good” (in the economic sense), and direct compensation – if any – should be provided under a “liability rule” rather than a “property rule”. Because the latter type of rule gives too much power to its owner (as Calabresi and Melamed explained in 1972). And Myriad indeed has shown to abuse this power, perhaps legally permissible, bit not ethically.

  55. Learn the different rules, roles and meanings of the patent law sections.

    Timing is not a 101 issue. “Routine,” and hence timing, is a 102/103 issue.

    Thanks.

  56. Patents law must keep itself in step with the recent advancements. In today’s world, isolation of DNA is a routine technique. Way back in 1980s and 90s it was a miraculous thing to do. Therefore, I should think, claims reciting isolated DNA do not merit patent protection. Any comments?

  57. Leopold Bloom: “Hey 101 Integration Expert, can you do us a favor and perform integration analysis on this claim”

    Hello Leo:

    This is not an integration problem. It’s a broadest reasonable interpretation (BRI) problem. The Board, in it’s broadest reasonable interpretation, has read out all all significant limitations, and statutory elements in the claim to the point there is only an abstract concept left with no physical process the concept can be integrated into. But I ask you Leo, does that sound reasonable?

    If it’s legally possible, this inventor needs to appeal and at least get to the CAFC where the claims can be interpreted in light of the specification. But even then it is a roll of the dice depending on which panel you get. And with more Obama appointees getting on the bench and judges like Linn leaving that gamble is getting greater everyday. Ultimately what needs to happen is another case like Diehr in which an inventor or patentee goes all the way to the Supreme Court and explicitly argues the following:

    If it pleases the Court, in Prometheus this Court said Diehr was the case most on point for what is patent eligible subject matter, then proceeded to instruct that: “in Diehr, the overall process was patent eligible because of the way the additional steps of the process [integrated] the equation into the process as a whole. 450 U. S., at 187. These additional steps transformed the process into an inventive application of the formula. ) [MAYO COLLABORATIVE SERVICES v. PROMETHEUS LABORATORIES, INC 566 U. S. (2012) 3 Syllabus] (Emphasis Added)

    From there the inventor should be prepared to show how their process precisely conforms to the Court’s rationale and analysis for integration. I believe once this happens you and the rest of the anti’s will be shut down for another 30 years, just like after the Diehr.

  58. “Help me with this, why would CLS make it to the Supremes? Assuming Alice is a rational actor, and that they see that the case has a potentially negative outlook at the Supremes, why would they petition for cert?”

    First of all Diehr challenged the PTO in the wake of Flook and won it’s case. And I think most would agree that Diehr had a potentially negative outlook with Flook and Benson before it being the reigning precedent. So one should never be cowed and simply give up because a lower court rules against you.

    Second, your assumption is wrong because Alice has a very positive outlook at the Supreme Court when viewed thru the lens of the Court’s use of “integration” to determine what “is” statutory subject matter.

    If Alice had claimed a math equation that represented a law of nature, or natural phenomenon, and the equation was limited to use on a computer, then I would agree, the potential for the Court to affirm would be significant; since that is precisely what the Court has said is non statutory subject matter regarding computers and software.

    However, Alice has made no such claim. The concept of Alice’s invention is not disembodied at all, but is instead “integrated” into a physical process and a system utilizing machines, which according to the Supreme Court, transforms the process as a whole into an inventive application of the concept, and thus makes the claims statutory subject matter. See Prometheus, Diehr, and CLS Bank v Alice, Rader dissenting.

    A sharp, learned, and gutsy patent attorney would challenge the CAFC decision using the Courts “Integration Analysis” as the template and foundational core of his/her argument, and win! Hope that helped.

  59. My scribe just came in with the stats for the three Myriad threads:

    Number one for quantity of posts: Malcolm (aside from me – but I do care and I am gloating).

    Better yet, Malcolm has more than three times the average words per post than I (with quotes and requotes removed).

    Yep – shows just how much he doesn’t care.

    /eyeroll

    LOL – and still he does not have the nuts to admit that I was right and he was wrong.

  60. I’ll add based on MM’s “we merely hold that genes and the information they encode are ineligible simply when isolated” comment above, what does this do to the 100+ antibodies in clinical trials? There may be some screening involved but antibodies basically come from naturally occurring sequences do they not?

  61. Wasn’t “isolated” using definitions and embodiments typically essentially a claim about a degree of purification and therein was the novelty? Beyond that Thomas says isolation is necessary to do genetic testing, but it isn’t is it unless he changed the definition?

    In any event, I think this further decreases the likelihood companies will try and enter the markets (OTC or lab) for gene-based diagnostics, including for emergent viruses & bacteria. Such diagnostic products were already considered by many not worth the risk and the margin. That would leave MDs open to set the frequency and cost of such tests (and wasn’t that what this case was about – a doctor running his own version of the test and charging for it vs. paying for the patented test?). Myriad’s test was a aberration in terms of its cost, so to me this means test costs will rise as will the use of such tests since it’s an additional revenue stream for MDs.

    Further this means new genomes are more likely to go trade secret now rather than enter public databases via patents, as anyone who has used, for example, BLAST via NCBI and the “pat” database will be aware. I’d consider that a negative for research.

  62. So, IANAE, you told me that I didn’t understand the science of Myriad and yet I understood it well enough to predict the outcome and the reasoning and the case they would cite.

    You really an ignorant p$g. I challenged you to make a prediction on Myriad, but you didn’t. You see IANAE your lame little games are pretty transparent when you have to actually perform real legal analysis. Then you come off as the p$g that you are.

    So, why the LOL? You sound like some twirp in a gang of laborers trying to insult the local lawyers.

  63. And just think IANAE, I accurately predicted the outcome of your chem case. I understood the science and correctly predicted the case they would most prominently cite.

    You see, some of us care about patent law and take the time to make reasoned arguments and remedy our ignorance.

    You should reflect on this.

  64. Really, IANAE, is it silly? What do you think I meant then? Can you figure that out?

    You are right in that “Turing complete” is a bit of a slang term. But, “barely even nonsense”? Not really.

    You know, IANAE, you come off as a p$g. A person that is intentionally ignorant and wants to use the ignorance to commit an act of violence against patent law. You seem to wallow in your ignorance and think you are cute or clever. You are neither. You come off as a sociopathic p$g.

  65. you have told me you don’t even know what the Church Turing Thesis is.

    Pretty sure I’ve never told you that. Also, pretty sure you did tell me that “software is Turing complete”, which is so silly it’s barely even nonsense.

  66. INANE’s specialty is trying to be a smart-@$$, and leaving out the smart.

    It’s only become worse over time as the cumulative effects of Calvinball face sp1kes present themselves.

  67. Sorry INANE, “instructions to do math” is applied math.

    Applied math is statutory subject matter in all fields.

  68. IANAE: you have told me you don’t even know what the Church Turing Thesis is. Perhaps, given how annoyed you and the other chem people are regarding this SCOTUS opinion, you should consider trying to educate yourself on information processing.

    You may find that there is merit in our arguments. And, you may find it more rewarding to actually contribute to the conversation rather than being one of the p$gs who make outrageously ignorant statements.

  69. You know IANAE, you should use this time to reflect that perhaps you are ignorant regarding these matters.

    Consider how to tell the difference between software/hardware.

    And what is the difference between “instructions” and method steps? Aren’t all your chemical methods really just a set of instructions?

    Allapat is still good law.

  70. software is instructions and math is not instructions?

    The basic idea is that software is instructions to do math. Neither instructions nor math are statutory subject matter, except (for the time being) in one particular field.

  71. Well, sounds like Gene tried to be fair about it. In fairness, MM, how do you answer Gene’s argument that software is instructions and math is not instructions?

  72. It appears to me that this decision along with Prometheus also kill method of use claims that do not involve a non-obvious step.

  73. Wondering whether the outcome will apply to genes isolated from plants? Would anybody please comment on that. Thank you.

    I think that the caselaw is limited to genes isolated from humans only.

  74. The footnote very clearly tells everyone

    nutball spewage

    The actual footnote language:

      The possibility that an unusual and rare phenomenon might randomly create a molecule similar to one created synthetically through human ingenuity does not render a composition of matter nonpatentable.

    Malcolm’s reading ‘difficulty’ (is it a reading difficulty or purposeful misrepresentation… hmm):

    Possibility (conjecture – future based)
    might create (conjecture – future based)

    If after the grant of a patent, an item is ACTUALLY found to be a product of nature – as in then “[t]hus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter” – because the conjecture has been removed.

    So is Malcolm ready yet to remove his nose from his own CRP?

    LOL – extremely doubtful, as he just does not have the nuts to admit how right I was and how wrong he was.

  75. Why would it not?

    Any product of nature, ranging for example from simple minerals to complex living things such as plants, all fall to the Judicial Exception.

  76. Wondering whether the outcome will apply to genes isolated from plants? Would anybody please comment on that. Thank you. I think that the caselaw is limited to genes isolated from humans only.

  77. All I read from this foolish decision is that the Court is making a policy based exception to patent eligible (“isolated”) subject matter without wanting to admit that it’s a policy-based decision.

  78. ??? countless drugs, toxins, and other agents are “natural products” isolated from nature too. The key word “ISOLATED”.

  79. Looks like the court made the correct decision.

    Can’t believe all the sour grapes here with the “iron age thinking” and such.

    How any one could delude themselves into thinking isolated DNA could (and more importantly should) be patentable is beyond me.

  80. Actually, is the question whether “removal of those introns be obvious to and within the skillset, etc”?

    Or is it instead that whether it would be obvious to read off the cDNA sequence from the mRNA coded from the DNA?

    Although one does not get this from all the reporting about this decision, the only valid reading is that while nucleic base sequences that don’t occur in nature are patentable subject matter under 101, under 103 they are only patentable if they are not sequences which can be inferred by someone with the requisite skill-in-art from sequences which do occur in nature. In other words, the decision forces the 103 argument as a necessary consequence.

  81. So how could Myriad have drafted the claim now? Isolated DNA is unpatentable, diagnostic test relying only on natural phenom is unpatentable under Prometheus. So is “existence of BRCA and BRCA1 gene leads to high risk of breast and ovarian cancer” a law of nature?

  82. “Just the other day you reacted to my definition of “technological” to declare that a programmed computer was “transformed” under the test I proposed. Now Quinn says in his hysterical response to SAP v. Versata”

    Anon doesn’t have an original idea in his head. He just copies and emulates others, such as Eugene, Rader, etc.

  83. I wouldn’t say that it necessarily does, but I will say that in my subjective view, yes, the judicial exceptions were rather arbitrary when they were dreamed up. Or at least they are nowadays as the real world has developed around them such that they are not all that they should be. Just as a for instance, were we back in the olden days when the judicial exceptions were being formulated, they’d go ahead and tack software on explicitly for good measure. They’d probably also be more clear about the natural phenom and nat. law exceptions.

  84. “So P is the probability that the supremes would give a negative decision ”

    These tar ds probably have the patent religion world view that this probability is 0 or near 0. This is pretty blatant since they believe the law at least was, if indeed it still isn’t, on their side.

    “But we know that P is non-zero”

    “We” do, as in you and me. “We” are not quite as ta rded as the people asserting these claims.

  85. The problem, it seems, with the Myriad claims is that the claim was not structural, but to an active “sequence” or combinations of sequences that encode for a protein. Claimed that way, the sequence or sequences are found in nature.

    It doesn’t matter how they are claimed. Either the sequences are found in nature or they aren’t. Again, Myriad’s claims were certainly “structural” in that one need only know the structure of a given composition to know whether that composition infringed Myriad’s claims. Similarly, it’s the structure of the claimed compositions that permitted the Court to state that the claimed compositions were “non-natural.”

    To a biologist or, more accurately, to any person who understands really basic and easy-to-understand scientific facts, there is no meaningful difference between

    “a polynucleotide encoding protein with amino acid sequence [insert amino acid sequence here]” and

    “a polynucleotide with sequence [insert reverse-translated nucleic acid sequence here]”.

    That is because the genetic code, although redundant, is universal. See, e.g., link to en.wikipedia.org

    a claim to a molecular compound that was, as Lourie stated, different from that found in nature would be eligible regardless that portions of the compounds exist in nature

    Well, sure, because “portions” of every molecule exist “in nature.” They are called “atoms.” Again, the difficult question is: if I claim a new, non-obvious composition of matter, does it become ineligible merely because that composition is a portion of some larger naturally occurring composition? At least with respect to non-intron containing polynucleotides where the recited sequence is identical to a sequence in a human being, we know the answer to that question is YES. As to whether I could get a claim to a single, specified polynucleotide with a sequence “possessing the same information content” (i.e., coding the same protein) as a different sequence that is found in a human cell, that’s still a bit up in the air until Thomas corrects the last part of his opinion. Right now it doesn’t make any sense, from a basic biology point of view.

  86. You do not have this correct.

    Malcolm is on record as there being definite structural differences in the claims.

    It is humorous to see you bend over backwards in an attempt to help Malcolm find some storm shelter for Malcolm, with none to be found for the non-repentant BS-tu rd.

  87. As I read your answer, it depends on whether the claimed molecule is structurally different from that in nature.

    Lourie already said the isolated DNA was a different molecule structurally. So if one simply claims that "different" structure, it should be eligible.

    The problem, it seems, with the Myriad claims is that the claim was not structural, but to an active "sequence" or combinations of sequences that encode for a protein. Claimed that way, the sequence or sequences are found in nature. The sequences claimed were not different structurally from what was in nature.

    So, if I do have this correct, a claim to a molecular compound that was, as Lourie stated, different from that found in nature would be eligible regardless that portions of the compounds exist in nature.

    But, I think, the PTO will no longer grant such patents if the result is simply another way of claiming isolated DNA.

  88. Ned,

    First I am Rader, now I am Quinn?

    Sorry, I am neither.

    I haven’t gotten to the Article 1 case yet. I am enjoying my gloat day over Malcolm way too much.

  89. Anon, are you Quinn? Just the other day you reacted to my definition of “technological” to declare that a programmed computer was “transformed” under the test I proposed. Now Quinn says in his hysterical response to SAP v. Versata,

    “Software is transformative. It takes a machine, any machine, that is otherwise wholly incapable of operating to perform a particular function and transforms it into a machine that is capable of offering the specific functionality defined by the code. Thus, if we are going to be perfectly honest and acknowledge undeniable objective reality, software is patentable under the machine-or-transformation test despite being tethered to a machine and because it is transformative.”

    You and he are certainly communicating.

  90. The first person to do it did indeed ‘invent.’

    How to separate…

    4runner – this was covered long long ago. You got a new way of obtaining the product of nature? great – you get a patent on the method. You still do not get a patent on the product of nature.

    Patent Law 101.

  91. I wonder if, in the Supreme Court’s “mind”, the “information content” of a nucleic acid includes any other property except the relationship of the nucleic acid to the protein sequence it encodes. It’s certainly true (and not at all unusual) for various human-made modifications to a nucleotide sequence to leave the protein-coding property of DNA absolutely unchanged while other properties of the DNA can be radically changed. What then? Does the “information content” prong of Thomas’ eligibility test trump all other considerations (as appears to be the case)? Or was the Court simply ignorant of these issues?

    This decision was not the ultimate effup I was fearing, but it is pretty effed up …

  92. As Orwell said

    Funny – that’s what you are famous for attempting with your revisionist and selective recollections of history, Ned. But look which cases the Court cited – exactly the ones I kept telling you to look at.

    It appears that you just did not have the control.

  93. There will be no further responses from me

    translation: I don’t even have the ba11s to say ‘No mas.’

    LOL – it’s Malcolm nose full of his own CRP day.

  94. Thanks for the schooling, but, and I’m sorry to have to ask this, where does the pre-mRNA come from?

    So I didn’t get full methodology, but, and correct me if I’m wrong, irrespective of the plurality of different steps inbetween, you go from the DNA to eventually get the cDNA, do you not?

    Are the steps inbetween always (roughly) the same?

    Isn’t cDNA anticipated?

    If pre-mRNA is from DNA, and mRNA is from pre-mRNA and cDNA is from mRNA then i think your answer to my question is wrong.

  95. Malcolm, do you think a claim to a specific chemical compound would be “eligible” if the applicant described isolating DNA from a specific gene was the way to make the compound?

    I’m not sure I follow you. My initial thought is that it would “depend” on the specific chemical compound that was claimed. It’s entirely possible to engineer a cDNA (i.e., protein encoding DNA without introns) by isolating natural DNA from an organism, sequencing the DNA, “guessing” where the introns are, and deleting them. And we know that cDNA is eligible. So, in that limited sense, you have the Supreme Court’s answer and you don’t need mine.

  96. By the way, here’s the fantastic “punt” at the end of the case:

    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.

    Is it possible that Thomas et al does 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.

    Curiouser and curiouser …

  97. Try taxing the footnote again Malcolm. Pay attention to the words of conjecture and the verb tense.

    You know, basic reading skills.

    Still do not have the nuts to admit how wrong you were and how right I was – I am loving your cowardice.

  98. Nice strawman, but winning the case has nothing to do with my post.

    You do know that Farmer Bowman was an 70+ year old independent farmer whose counsel was contingent based and who was basically judgement proof, right?

    You certainly are not showing such awareness. Definitely a sign of too many Calvinball face sp1kes.

  99. EG: In other words, Myriad’s claimed “isolated” DNA sequences didn’t look enough like a chemical molecule divorced from the native DNA. Those sentences also somewhat of a “jab” at Breyer’s derogatory comment in Mayo about not letting patent-eligibility under 35 USC 101 depend on the “draftsman’s art.”

    I don’t think there is any such “jab,” EG. Moreover, I don’t see how it’s possible to draft a claim to a “new” DNA polynucleotide with a sequence that is identical to a pre-existing sequene in a chromosome and get a patent.

    But here’s a question for you: Let’s say you discover a new protein in a cell whose genome was unsequenced prior to your patent application. You sequenced the protein and you want to claim all the novel DNA sequences which encode that protein. So you type out and separately claim every possible nucleotide sequence encoding for a that protein (easy to do, given the genetic code).

    Under the reasoning of this case, the claim to the nucleotide polymer that is identical to the “natural” sequence in the genome is ineligible UNLESS the natural gene encoding that protein comprises introns. That much is crystal clear.

    But what about the other non-identical sequences that have very little nucleotide similarity to the natural sequence but have the same “information content” (because of the redundancy in the genetic code)? What if, due to the particularities of codon usage, one of those novel, non-obvious sequences functions surprisingly well for over-expressing the protein in a particularly microbe? Patent still denied? That seems ridiculous. This is where Thomas’ decision fails miserably, in my view. It’s incredibly weak on the science, to the point of being a caricature of the science. And this is very, very simple stuff, where the ramifications are obvious.

  100. Agreed.

    I was surprised by the revision of Funk Bros. as well.

    As Orwell said, “He who controls the present, controls the past. He who controls the past, controls the future.”

  101. In re: “separating the gene from the surrounding genetic material is not an act of invention.”

    Once upon a time, no one knew how to separate a gene from its surrounding genetic material.

    The first person to do it did indeed “invent.”

    Further, if the separation process were patentable subject matter, it would seem that the product(s) of this patentable process were also patentable since the product is physically distinctive from that which is found in nature.

    Apparently, patentable subject matter rejections should now consider the prior art.

  102. Malcolm, do you think a claim to a specific chemical compound would be “eligible” if the applicant described isolating DNA from a specific gene was the way to make the compound?

  103. Does anyone know of case law where the SC addressed the meaning of “discovers” in 101?

    I suppose the glib answer would be: this case.

    But I think the Court here would argue that an “invention” needs to be “new” and “DNA encoding sequence X” is not “new” if the cell’s DNA was doing the exact same thing. Now, if only the cell’s spliced messenger RNA was doing that (because there were introns in the DNA sequence), then it’s a completely different story …

  104. James, I agree, and I thought there really was no product of nature exception. I thought, though, that there was a law of nature case here in that the patent fairly covered the correlation between certain genetic mutations and a disease. Prometheus has gone out of its way to hold that such correlations could not be patented.

    The holding here is odd, because if the information content of the DNA claimed is the reason for the holding, they should have banned patenting cDNA as well. But they punted, and seem to come up with a very firm product of nature exception. The sequence cannot be patented because it exists in nature.

    I still have to think about this some more. But we seem to have our very first product of nature case — all prior cases being dicta.

  105. 6: it is how the law, as it has stood for idk, 100+ years, breaks things down.

    Not sure I understand you. You mean to say that the law, as it has stood for 100+ years, breaks things down arbitrarily?

  106. As was expected and it could have been far, far worse. At least Justice Thomas wrote it in a way that kept the patent-ineligible part of the holding pretty much cabined, more so than you might think.

    Also, besides saying that cDNA was patent-eligible (versus “isolated” DNA that wasn’t) are these sentences at pages 14-15 of the slip opinion: “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.” In other words, Myriad’s claimed “isolated” DNA sequences didn’t look enough like a chemical molecule divorced from the native DNA. Those sentences also somewhat of a “jab” at Breyer’s derogatory comment in Mayo about not letting patent-eligibility under 35 USC 101 depend on the “draftsman’s art.”

    Further, as I and others know, the Myriad opinion is essentially applicable only to that 2% of the human genome that follows the pre-ENCODE approach to genetics. That means that the Myriad opinion is really inapplicable (i.e., not on point) as to 98% of the human genome that doesn’t follow the pre-ENCODE approach to genetics. So the “game” isn’t over yet by a long shot.

  107. the “isolated” DNA was structurully indistinguishable from a product of nature

    I disagree. Thomas expressly acknowledges the difference and the fact that the claimed subject matter is “non-natural.”

    “isolated” was given zero patentable weight.

    Oh boy, not this again. I agree that the term was deemed insufficient to rescue the claimed DNA polymers from ineligibility in this case.

    I can envision plenty of situations in which the recitation of “separate” would structurally distinguish a claim from the prior art, and maybe even products of nature.

    So can I. I was trying to confirm your agreement on that point with my “non-sequitur.” I succeeded.

    I don’t think this case would have turned out any differently if the patentee had claimed/argued that it’s claimed DNA was separated, rather than isolated, from a product of nature.

    Well, the patentee would likely have been required to state what the polymers were “separated” from, which might have led to a far more narrow claim and avoided much of the brouhaha. When you rely on a term like “isolated” (or any other term) to get your patent, you should strive to be as clear as possible about what is and is not excluded by the term. I’ve said that from day one and the failure of Myriad to fix this problem early on (and the failure of certain pundits to acknowledge the problem) was a major error on their part.

  108. This will be funny, check out part d as if it is distinct from part c near the end.

    The revised form paragraph 7.05.01 shown below will be added to the
    custom form paragraphs in OACS shortly.

    ¶ 7.05 Rejection, 35 U.S.C. 101, -Heading Only- (Utility, Non-Statutory, Inoperative)
    Claim [1] rejected under 35 U.S.C. 101 because
    Examiner Note:
    1. This form paragraph must be followed by one or more of form paragraphs – 7.05.01, 7.05.011, 7.05.012, 7.05.013, 7.05.02, 7.05.03, or another appropriate reason.
    2. Explain the rejection following the recitation of the statute and the use of form paragraph(s) or other reason.
    3. See MPEP §§ 706.03(a) and 2105- 2107.03 for other situations.
    4. This form paragraph must be preceded by form paragraph 7.04 in first actions and final rejections.

    ¶ 7.05.01 Rejection, 35 U.S.C. 101, Non-Statutory [REVISED]
    the claimed invention is directed to non-statutory subject matter because [1]
    Examiner Note:
    1. In bracket 1, explain why the claimed invention is not patent eligible subject matter, e.g.,
    (a) why the claimed invention does not fall within at least one of the four categories of patent eligible subject matter recited in 35 U.S.C. 101 (process, machine, manufacture, or composition of matter), e.g., the claim is directed to a signal per se, a contract between two parties, or a human being; or
    (b) why the claimed invention, although nominally falling within at least one of the four eligible categories, is directed to a judicial exception to 35 U.S.C. 101 (i.e., an abstract idea, natural phenomenon, or law of nature); or
    (c) why the claimed invention would impermissibly cover every substantial practical application of, and thereby preempt all use of, an abstract idea, natural phenomenon, or law of nature; or
    (d) why the claimed invention is directed to a naturally-occurring nucleic acid or fragment thereof, whether isolated or not, that is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., — U.S. — (June 13, 2013).
    2. For a claim that is directed to an abstract idea and is non-statutory, use form paragraph 7.05.011.

  109. The SC said that isolating a “gene from its surrounding genetic material is not an act of invention.”

    101 states that “Whoever invents or discovers any new and useful…”. Why is an “act of invention” required under 101? Shouldn’t an “act of discovery” suffice?

    Does anyone know of case law where the SC addressed the meaning of “discovers” in 101?

  110. Today in Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad), the
    Supreme Court held that claims to isolated DNA are not patent-eligible under 35 U.S.C.
    § 101. Myriad significantly changes the Office’s examination policy regarding nucleic
    acid-related technology. The purpose of this memorandum is to provide preliminary
    guidance to the Patent Examining Corps.
    As of today, naturally occurring nucleic acids are not patent eligible merely because they
    have been isolated. Examiners should now reject product claims drawn solely to naturally
    occuning nucleic acids or fragments thereof, whether isolated or not, as being ineligible
    subject matter under 35 U.S.C. § 101. Claims clearly limited to non-naturally-occurring
    nucleic acids, such as a cDNA or a nucleic acid in which the order of the naturallyoccuning
    nucleotides has been altered (e.g., a man-made variant sequence), remain
    eligible. Other claims, including method claims, that involve naturally occurring nucleic
    acids may give rise to eligibility issues and should be examined under the existing guidance
    in MPEP 2106, Patent Subject Matter Eligibility.
    In Myriad, the Supreme Court considered the patent eligibility of several claims directed to
    isolated DNA related to the human BRCAI and BRCA2 Cancer susceptibility genes. The
    Supreme Court held that certain of Myriad Genetics’ claims to isolated DNA are not
    patent-eligible, because they read on isolated naturally-occuning DNA that is a “product of
    nature.” The Court held that isolating a “gene from its surrounding genetic material is not
    an act of invention.” The Supreme Court held that other claims are patent-eligible, because
    they are limited to cDNA, which is a type of man-made DNA composition that is not
    naturally-occuning. The Court held that “cDNA is not a ‘product of nature’ and is patent
    eligible under § 10 1.”
    The USPTO is closely reviewing the decision in Myriad and will issue more
    comprehensive guidance on patent subject matter eligibility determinations, including the
    role isolation plays in those determinations.

  111. The footnote merely speaks as to a conjecture about what MAY happen.

    No, Dumpty. The footnote very clearly tells everyone that merely finding a composition “in nature” will not suffice, as a per se matter, to render ineligible a previously granted patent on that composition.

    This was a major concern of mine (as you would recall if you weren’t a s0ci0path and a l i a r) and I’m very glad it was addressed point blank by Thomas.

  112. The passage highlighted by Jason upthread is certainly “important” but it’s also very oddly written:

    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.

    Okay, so the Court admits that it’s a fact that “isolated DNA” is structurally distinct from the DNA in the human genome. But then there’s this:

    Myriad’s claims are simply not expressed in terms of chemical composition,

    That’s false. Show me the structure of a chemical and I’ll tell you if it’s covered by Myriad’s claims. I don’t need to know what the chemical does. I just need to see the structure. The Court seems unable to deal with the fact all possible encoding nucleotides for a given protein are ascertainable by knowledge of the protein sequence. The PTO understands this, certainly. It’s basic biology.

    nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA.

    This is a very strange sentence. Who is “they”? Is “they” referring to Myriad’s claims, or Myriad the company? Either way the statement, as written, doesn’t make much sense. The claims were granted only because they recited the “isolation” limitation so they certainly did rely on the “chemical changes”. And Myriad and everybody else that manipulates DNA polymers certainly relies on the fact that the DNA is isolated from the cell and further from an unwieldly chromosome.

    Whatever point Thomas was trying to make here, he failed. He does a little better in this section but it’s still terribly written:

    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. …. Myriad’s patents would, if valid [sic], give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes (or any strand of 15 or more nucleotides within the genes) by breaking the covalent bonds that connect the DNA to the rest of the individual’s genome.

    This is about as close as the Court gets to a claim construction and it appears to have correctly construed the claims incredibly broadly. As has been pointed out here and elsewhere, the claims which cover 15 nucleotide sequences, regardless of how long the DNA containing those sequences is or whether that DNA has any function other than to recognize it’s complementary sequence, are surely invalid in view of sequences in the prior art. There’s also a likely 101 utility issue with claims covering such sequences.

    But the Court does seem to have construed Myriad’s claims to cover, at least, a nearly full-length human chromosome comprising the BRCA1 or BRCA2 genes, where even the tiniest bit of that chromosome has been broken off. That construction of “isolated” seems essential to the Court’s other critical finding, which is that “isolation is necessary to conduct genetic testing”. Given a more narrower construction, that finding can not be reached and the reasoning of the case begins to unravel. Of course, given that construction, this patent could have been put in re-exam and tanked as anticipated in two seconds by the reams of prior art showing isolated human chromosomes …

    Oh well. A shamelessly greedy company gets its comeuppance and takes down a few other patent estates with it. So it goes. At least we got a little bit of clarity injected into limits of the still very fuzzy “product of nature” doctrine.

  113. Don’t you love the first stage of denial that Malcolm is going through?

    His haphazard, mad scrambling for ANY spin is just so yummy.

  114. How many sacks of cash did Monsanto get out of that?

    That’s right: zero.

    Would that be because Bowman paid them by certified check? Because the cash was actually in a briefcase?

    Only cartoon villains pay in sacks of cash. Doesn’t change the fact Monsanto won the case.

  115. Good thing then that software does not exist in nature and the “configure to” is structure won’t have this same problem, then, eh 6?

  116. in quantity for profit

    LOL – you mean like Farmer Bowman?

    How many sacks of cash did Monsanto get out of that?

    That’s right: zero.

  117. “That remains true.”

    Not in this case. A few weeks/months ago you provided me with an explanation of what “structure” you thought “isolated” added/brought to the claims, but the Court didn’t see it that way apparently. To them, the “isolated” DNA was structurully indistinguishable from a product of nature. In other words, “isolated” was given zero patentable weight.

    “Do you also believe that ‘separate’ is not a structural limitation in a composition or article of manufacture claim? e.g., ‘wherein said second doohickey is attached to X, but in a region of X separate from said first doohickey’?”

    I’m not sure what this non sequitur has to do with anything, but I can envision plenty of situations in which the recitation of “separate” would structurally distinguish a claim from the prior art, and maybe even products of nature. But I don’t think this case would have turned out any differently if the patentee had claimed/argued that it’s claimed DNA was separated, rather than isolated, from a product of nature.

  118. And your 2:02 reading is precisely the wrong reading – at that point in time (after the meteor HAS crashed), it no longer would be a conjecture of IF – it would be an actual fact and POOF – the patent is gone as claiming ineligible material.

    And this MUST be the way – else you allow a patent on a Product of Nature which this Court says is forbidden.

    You know – theis is related to the Simple Question you NEVER got the nuts to actually answer…

    As they say: svcks to be you.

  119. Grandchildren?

    They’d have to have an awful lot of PTA.

    Also, unless you’re selling your genetically modified children in quantity for profit, I doubt you’ll be worth suing even if they theoretically could.

  120. LOL – I laugh at your feeble grasp at any type of port to crawl into with this Myriad storm, and answered this footnote below.

    I am 100% Correct in EXACTLY why the Court held that a Product of Nature exception exists in this case.

    But please, Malcolm, keep FLAILING.

  121. So… They would decide to file cert if the expected value of doing so exceeds the expected value of not doing so. I assume that is what you meant by “greed.”

    Ok, so the expected value (EV) is equal to the probability adjusted potential return of the choice. So P is the probability that the supremes would give a negative decision that would affect their portfolio; further, EV1 must be greater than or equal to EV2 to constitute a reasonable business decision. Where EV1 is (1-(probability of bad decision by supremes))*(value of winning). And EV2 is (value of future business less the instant invalidated patents).

    So, if EV2 is assumed static, then a “greedy” actor would seem to either suppose a small probability of a bad decision or that the value of winning is much greater than the value of future business less the instant invalidated patents.

    But we know that P is non-zero. We can also guess that P is large given other supreme court cases. So, the “greedy” actor has placed (the value of winning) to be much larger than the (value of future business less the instant invalidated patents)? Huh?

  122. ok… so viewing this alongside Bowman v Monsanto, if I receive gene therapy for a disease using cDNA, would I have to pay Myriad license fees on my children? Grandchildren?

  123. LOL – sure 6 – just like I busted you on another matter that you ‘claimed’ you had spone on – but I checked every record on the case and you had not.

    Love this type of implicit weasaling you are trying to do when the court uses my EXPLICIT reasoning.

    But hey, keep on struggling not to give credit where credit is due.

  124. LOL

    Massive Malcolm FAIL.

    Ii knew you would jump at the footnote wihtout recognizing what it actually says. (btw, did you get to th enext page yet?)

    The footnote merely speaks as to a conjecture about what MAY happen. Eligibility is not affected by what MAY happen – but will most definitely be affected by what would in fact happen – even in the future – as per the case this court uses: Chakrabarty.

    LOL – your ‘pet’ misunderstanding about discovering a product of nature after patent grant is gone. Waive bye bye. Eventhough just discovered, such an item covered by a patent would lose it eligibility becuase it would EFFECTIVELY a patent on a product of nature – and this Court will not allow that.

    EXACTLY like I told you countless of times. – You remember, the Simple Question you refuesed to answer, but tried to co-opt as a question of your own?

    LOL – Massive Malcolm FLAIL

  125. I had once hoped that advances in genetic testing would allow my children to be free from numerous diseases as a result of early detection and diagnosis,

    Genetic testing won’t keep your children free of diseases. You’d have to get their genes changed if they tested positive.

    As for other diseases and conditions, anybody who develops a patented treatment will have a strong economic incentive to diagnose as many clients as possible, even if the test itself isn’t patentable. Heck, you might even get the test for free, as long as you’re willing to pay freemium prices for the patented drug.

  126. Why is Prometheus poorly reasoned?

    LOL – more “answers” as questions…

    You (and ‘associated cohorts’) were asked many many many times to square the Prometheus

  127. LOL – nothing arbitrary about the Product of Nature reasoning.

    But please, keep that frenetic scramble going on.

    The board is out of popcorn again.

  128. So, then, all patents to proteins already used in therapy that are substantially similar to the endogenous protein are per se invalid? Such as insulin, growth hormone, and erythropoietin (at least some of these molecules’ patents have already expired)

  129. Sure, it’s standard now, but Scalia would have graduated high school at around the time the double helix was discovered.

    Right, the point is that it’s easy for a typical 14-16 year old kid to understand this stuff after a couple hours of instruction. I suppose you do have to “try” to understand it. That’s probably the harder part for these Justices, most of whom probably have much less interest in science, generally, compared to other subjects.

  130. way below Prometheus for that title.

    Why is Prometheus poorly reasoned? Do you believe people should be entitled to protect a new thought (or any other abstractions) merely by appending an old conventional step prior to that thought?

  131. “And notwithstanding what Prof. Crouch says above, the Court did not use pre-emption (in the 6 sense”

    Um, the “6 sense” is exactly what they used. You don’t have to call it out by the name preemption every time. If your claim covers a judicial exception STRAIGHT UP AS IN THIS CASE, it preempts. It may also preempt INDIRECTLY AS IN OTHER CASES.

    Why you have such a hard time understanding this is quite beyond me. The second type, the indirect type, is not the only “6 type” of preemption.

  132. I had once hoped that advances in genetic testing would allow my children to be free from numerous diseases as a result of early detection and diagnosis, the way my generation benfitted from antibiotics and vaccines. I guess not.

    Uh … the Supreme Court in Prometheus held that you can’t patent methods of thinking about old test results. Here, the Supreme Court is saying that you can’t get a patent on an isolated DNA polymer that you identified in a cell and then isolated, unless the claimed polymer has a different sequence (or at least, different “information content”).

    It’s still perfectly legal to develop such tests as the ones you describe. Researchers did so in the past without patent incentives and they will continue to do so in the future.

  133. ” allowing claims to isolated cDNA molecules to remain eligible is completely arbitrary”

    I agree, but it is how the law, as it has stood for idk, 100+ years, breaks things down.

  134. Big picture: something about the SCOTUS that makes it want to destroy our patent system. This isn’t the first time they have gone into this mode.

  135. Exactly. Just like Stevens had no clue regarding information processing. He graduated back when math was associated with laws of nature (and Douglas before him).

  136. “isolated” is structure

    That remains true. The Court here is just saying that, because the “information content” of the DNA molecule is unchanged, the mere isolated nature of the claimed molecule is insufficient to distinguish it from the longer molecule from which it was derived. See, e.g., page 15: “separating the gene from the surrounding genetic material is not an act of invention.”

    Do you also believe that “separate” is not a structural limitation in a composition or article of manufacture claim? e.g., “wherein said second doohickey is attached to X, but in a region of X separate from said first doohickey”?

  137. Combined with Prometheus, this is probably the end of early-detection diagnostic tests and personalized medicine. You can’t claim the method (Prometheus), and you can’t claim the tools (Myriad). I had once hoped that advances in genetic testing would allow my children to be free from numerous diseases as a result of early detection and diagnosis, the way my generation benfitted from antibiotics and vaccines. I guess not.

  138. That’s definitely standard high school biology. An advanced 8th grade biology class probably covers mRNA and cDNA.

    Sure, it’s standard now, but Scalia would have graduated high school at around the time the double helix was discovered.

  139. “Assuming Alice is a rational actor, and that they see that the case has a potentially negative outlook at the Supremes, why would they petition for cert?”

    Greed?

  140. Scalia’s opinion is remarkable. He does not join Part 1-A because it is beyond his “information or belief.” Huh? I think I learned that stuff in high school biology (and I wasn’t even in AP) or at the very least in my college bio class for non-science majors.

    That’s definitely standard high school biology. An advanced 8th grade biology class probably covers mRNA and cDNA. I don’t blame, Scalia, though when both Myriad’s and the ACLU’s lawyers were kicking dust into everybody’s eyes at every opportunity.

  141. it’s more than just being right- it’s why I was right:

    You seem to have been dead wrong about this, though:

    “The possibility that an unusual and rare phenomenon might randomly create a molecule similar to one created synthetically through human ingenuity does not render a composition of matter nonpatentable.”

    However you imagined your handwavey “product of nature” test to work, anon, you never answered this simply question in that straightforward way, although it was put to you at least twenty times.

    Anyway, now we know what happens when that meteor crashes in the yard and a creates trace amounts of a chemical that was patented ten years earlier: the composition remains eligible. And that’s a good thing.

  142. Oh, and on the same grounds that they decided.

    LOL – that would be wrong.

    Nice try. But don’t worry, I threw you a bone below(well, a fragment of a bone anyway)

  143. You have to put on your caveman hat to understand the SCOTUS. Ugg, me see same sequence. Can’t patent that. Ugg, me see different sequence. Can patent that.

    Ugg, where is our brandy and literature.

  144. He did ask me if I was predicting a use of pre-emption.

    And notwithstanding what Prof. Crouch says above, the Court did not use pre-emption (in the 6 sense).

    C’mon 6 – let’s hear you announce who nailed this decision (and for all the right reasons).

  145. Footnote, bottom of page 19. Awesome that the Court addressed this, point blank. Thank you.

    “The possibility that an unusual and rare phenomenon might randomly create a molecule similar to one created synthetically through human ingenuity does not render a composition of matter nonpatentable.”

    Fascinating. We can quibble about “unusual and rare” but that’s a very interesting (and sensible) limit on the “product of nature” exception.

  146. On this blog and repeating the EXACT same nonsense at Patent Docs under the various svckie names lilsted (LOL but Malcolm doesn’t use svckpuppets…

    /major eyeroll

    And funny thing, you see him scrambling all over – and he just does not have the nuts to say he was wrong.

  147. no matter what section

    LOL – talk about FLAILING – Just say “WHATEV”

    What a grasp of legal reasoning

    /eyeroll

  148. There is something internally contradictory about the Court’s reasoning. To the extent it relies on the “information content” aspect of DNA to minimize the importance of changes made by Myriad relative to the naturally occuring DNA (i.e., the human chromosome in a human cell), allowing claims to isolated cDNA molecules to remain eligible is completely arbitrary. If we’re focusing solely on the useful product (or function, I suppose, in the case of functional nucleotide sequences that do not encode proteins) that is “encoded” by a DNA segement, then the natural gene and the cDNA are identical. The same “natural” “information” corresponding to the expressed protein is in the cDNA (also the mRNA from which the cDNA is made). That’s the entire point of making cDNA, which is analogous (from the crude perspective of, say, a Supreme Court judge) to ripping out the blank pages in a book prior to reading it.

  149. No need to read the threads Malcolm – I noted your frenetic dancing post-oral arguments and made note of your duplicity and shiftiness.

    It’s all archived.

    B-b-b-but keep on trying to spin it that the Court did not faltly use a Product of Nature rationale.

    Let me repeat what they said:

    Held: A naturally occurring DNA segment is a product of nature and not patent eligible

    LOL – hey we need more popcorn already.

  150. does that mean that these isolated and expressed proteins per se are no longer patentable subject matter?

    No “seems to indicate” – it’s a flat out NO, they are not patent eligible.

    And that’s not patentable (under a 102/103/112 rationale), that’s a “Don’t even come in at the front gate.”

  151. properly (structurally) claimed, novel chemical mixtures are ineligible because the individual components are not ‘modified in any way’

    No – but if they are EFFECTIVELY products of nature, even though they be “properly (structurally) claimed, novel chemical mixtures” they are not patent elligible.

    LOL

  152. most poorly written and reasoned cases in the history of Supreme Court’s patent case law

    LOL – way below Prometheus for that title.

  153. cDNA is created from RNA, NOT DNA. RNA polymerase creates a long RNA molecule which contains the whole gene (introns + exons). This is called a pre-mRNA and is a copy of the DNA sequence.

    The cell then splices this pre-mRNA- that is, the introns are removed, and the exons are joined to create a messenger RNA- or mRNA. So a scientist creates a cDNA by using reverse transcriptase, which is an enzyme that creates a DNA copy of the mRNA. This DNA copy is a cDNA.

    So to answer your first question, yes, a cDNA can be- and always is- created without reference or use of the gene’s DNA.

  154. Incredulous at the way judges are interpreting the invention.

    In the case of Myriad’s claims, I can see the argument the Court is making at least. I don’t find it convincing or necessary (because the claims are invalid for other reasons).

    But the Funk Brothers “analysis” in Thomas’ decision is nonsense, maybe even worse than the analysis in Funk Brothers itself, which is saying something because that’s one of the most poorly written and reasoned cases in the history of Supreme Court’s patent case law.

  155. Can cDNA of a gene be created without reference or use of the DNA of the gene?

    If it can only be created from the original DNA then does that not mean that once you know what the DNA is, then you know what the cDNA is?

    Does the scientist, knowing the sequence of the DNA, know what the cDNA sequence will be?

    Does the scientist just take some DNA then add
    the reverse transcriptase and produce cDNA?

    I’m not a lawyer, nor a molecular biologist, but applying a known method or substance to another substance to produce an anticipated but new substance appears to fall under the description of obvious.

    I’m asking because I don’t have the experience or knowledge and you guys possibly do (well, i’m not sure in some cases).

  156. “For the record (and as I’ve been saying all along), I never cared about the outcome one way or the other”

    For the record, this is total B$.

    Uh … no. Go back and read the threads. I made that point probably a dozen times, maybe twenty, over the course of the last several years. Myriad’s claims were invalid, even if they are ineligible.

    My concern was with a vaguely pronounced all-encompassing “product of nature” test like the hand-wavey g-rb-ge you spewed here. The holding seems very much focused on DNA’s “information content” and the methods Myriad used to make its discovery.

    I’m not sure this decision would apply (with the same result) to, say, a previously unknown chemical isolated from an Amazonian bee’s stinger and purified so that it was useful for treating childhood leukemia … but I haven’t finished reading the case yet. Nor is it clear to me that if I synthetised such a chemical de novo in a lab, would the subsequent discovery ten years later of an identical chemical in microscopic amounts in, say, a bee’s stinger render my claim to a purified version of that chemical ineligible? Let me know if you believe otherwise. These were my concerns before and they remain my concerns now. Myriad’s compositions claims and claims like them? I could care less. They were awful, no matter what section of 35 USC you used to tank them. Good riddance.

  157. 2. a.If the claim was for a simple, obvious , widely useful solution ( e.g.: 10ug/ ml cDNA, 50mM Tris buffer) then I think it would be disallowed for just being isolated DNA.

    2.b. If they make the solution functional enough to avoid that (e.g.: 10ug/ml cDNA, reagent x, buffer 1, enzyme A) the claim will be much narrower in scope. Plus wouldn’t there be issues with prior art that had claims on solutions of “any” cDNA mixed with reagent x, buffer 1, and enzyme A?

  158. >>novel chemical mixtures are ineligible because the >>individual components are not “modified in any way”!

    Gee, you are sounding like the information processing folks. Incredulous at the way judges are interpreting the invention.

  159. Help me with this, why would CLS make it to the Supremes? Assuming Alice is a rational actor, and that they see that the case has a potentially negative outlook at the Supremes, why would they petition for cert? The CAFC may have invalidated a small set of their patents, but did not release a decision that could potentially invalidate more of their portfolio. The Supremes do not look to be so kind (or at least there appears to be a slightly negative outlook). So, on the one hand, you have the loss of a battle and on the other you are rolling the dice (that appear to be loaded) on the war. It would appear that a rational actor would take his losses and play this situation out for as long as possible, leaving the Supremes out.

  160. Scalia’s opinion is remarkable. He does not join Part 1-A because it is beyond his “information or belief.” Huh? I think I learned that stuff in high school biology (and I wasn’t even in AP) or at the very least in my college bio class for non-science majors. Pretty basic stuff here. Perhaps the clue is “belief” — maybe it is some weird Xtian thing about not believing in DNA. Bizarre.

  161. “Truth be told: who really called it?”

    Um me? Pretty dam sure I said isolated = invalid, cDNA = valid about a 1000 times. Oh, and on the same grounds that they decided.

  162. Thomas’ discussion of Funk Brothers is very odd:

    Upon learning that several nitrogen-fixing bacteria
    did not inhibit each other, however, the patent applicant
    combined them into a single inoculant and obtained a patent. The Court held that the composition was not patent eligible because the patent holder did not alter the bacteria in any way. Id.,at 132 (“There is noway in which we could call [the bacteria mixture a product of invention] unless we borrowed invention from the discovery of the natural principle itself”). His patent claim thus fell squarely within the law of nature exception.

    Unless I’m mistaken, there was no dispute in Funk Brothers that the claimed mixture of bacteria was a new and non-obvious mixture. Yes, each individual strain of bacterium recited in the mixture was old and “found in nature” but (unless I’m mistaken) the claimed mixture was not found in the nature, nor was it obvious. The difficulty in Funk was that the claims were drafted functionally, such that the natural principle itself (“some strains don’t inhibit each other”) was being protected. The problem was certainly not that the bacteria recited in the mixture were not “modified in any way.”

    Thankfully this is just some cr-ppy dicta. Pretty sure the last thing anybody wants is a Supreme Court declaring that properly (structurally) claimed, novel chemical mixtures are ineligible because the individual components are not “modified in any way”!

  163. Actually, anon, if you search for it you can find MM ripping me apart for my prediction (re-posted above.) With lots of insults directed towards you.

  164. It is a concurrence in judgement and in reasoning, limited to the one section (and that section’s reasoning) that is explicitly segregated.

    Try again (you are closer)

  165. I think there was an excellent point made above regarding isolated and or expressed human proteins, that indistinguishable from naturally occurring ones in the body. So if you engineer cells in cell culture or bacteria to produce an exact identical human protein (such as Amgen’s EPO), does that mean that these isolated and expressed proteins per se are no longer patentable subject matter? The reasoning from this opinion seems to indicate that they would not be.

  166. At this rate I’ll finish reading the case tomorrow

    Translation: its going to take forever to spin something out of this that I can claim as victory without a nose full of my own CRP.

    Very much loving the show, Malcolm. Thanks for bringing the popcorn.

  167. For the record (and as I’ve been saying all along), I never cared about the outcome one way or the other

    For the record, this is total B$.

    For someone who ‘didn’t care’ you sure spent a lot of time trying to year me down.

    Epic FAIL for you, Malcolm.

    As far as the ‘spillover’ you quite miss the fact that it is your NIMBY ways that took a hit here: hence the they came for you line.

    Your attempted spin is as weak as ever.

    Now ‘bow.’ (You and your ‘friends’ Francis, Robert, Keeping It Real, left hand, right hand, etc)

  168. First line in the decision would be graded zero in a high school biology exam:

    Each human gene is encoded as deoxyribonucleic acid (DNA), which takes the shape of a “double helix.” Each “cross-bar” in that helix consists of two chemically joined nucleotides.

    The two molecules across from each other in the helix are not chemically “joined” but rather pair with each other due to hydrogen bonding interactions. It’s extremely important to all of biology, in fact, that the two molecules are not joined. Anyway …. onward. At this rate I’ll finish reading the case tomorrow …

  169. I did make a mistake. It is: “concurring in part and concurring in the judgment.” So, he was not concurring in part of the opinion (which is not a dissent, but is also not a concurrence).

  170. Ha – based on your comment I went and read IPWatchdog. A bit hysterical, isn’t it? And it appears that Gene is not going to brook any dissension over there…

  171. MM and IAEAE (the good Germans), they came for you.

    For the record (and as I’ve been saying all along), I never cared about the outcome one way or the other, as long as we didn’t get some hand-wavey “product of nature” test that would expand ineligibility beyond simple truncations of existing, longer sequences (which is how they treat these molecules) into other modified chemicals (including DNA that has been chemically so that it is different, chemically and therefore “informationally” from a pre-existing subsequence in a larger molecule). At first glance at the decision, that particular result seems to have been avoided by the Court expressly pointing out that adding a single nucleotide to the sequence that is otherwise identical to a natural sequence gets one out of the 101 problem.

    It’s also interesting that, while they were asked to opine on “human genes” they seem to have gone ahead and destroyed the eligibility of isolated genes from any non-intronic organism (those organisms are, by far, the most prevalant forms of life on earth). Although it was a pretty “used up” space already, patents on novel, non-obvious short oligomeric (and otherwise unmodified) nucleotides will now also be impossible to obtain because of the strong likelihood that an identical sequence can be found in a much longer natural (or synthetic) molecule.

    As others have noted above, the “logic” of this decision is likely to spill over into other tech areas. That’s probably the best part about this decision, which was otherwise completely unnecessary (because the claims are invalid anyway).

    Lastly, I wonder what happens now to the “research method” claims upheld as eligible by the Federal Circuit and (apparently) approved of by the Supreme Court prior to this decision? Some of those methods recite nothing but using these ineligible molecules to create research tools according to old conventional steps. If those claims remain valid, then the impact of this decision is much more limited than it seems.

  172. 1) it is a concurrence and not a dissent.
    2) he is basically admitting his limitation and simplifying his reasoning: it is a product of nature, and not enough is ‘applied.’

    Your blue sky is falling is that this does not hinge on ‘information’ as much as you think. Any ‘information’ already there is there regardless and nothing is really being done with it other than saying, “hey, that is information.”

  173. While cDNA may be patent eligible under 101, would it be obvious as a derivative of the DNA? I don’t know enough about gene splitting but it looks possible to me that the argument is there that, as seemingly accepted by SCOTUS,
    “[t]he nucleotide sequence of cDNA is dictated by nature, not by the lab technician.” Id., at 51. That may be so, but the lab technician unquestionably creates something new

  174. I don’t see anything about products of nature in the language of the statute. And that’s the point. I want the Court to be honest about the fact that it’s simply ignoring the statute and inventing its own set of rules about what is and isn’t patentable.

    Well, I say “rules.” That term is probably too generous. “An ever-growing pile of subjective policy considerations that seem to inform the Court’s decision as to whether a given invention is or is not patentable” is more like it.

  175. Can you explain your last paragraph?
    1) how does this ‘throw another question mark?’
    2) what do you mean by ‘narrow?’
    3) what is the unstated qualifier that accompanies ‘as it should be?’

  176. “3. CAFC should make decisions the opposite of what they want so that when the Supreme Court reverses them they’ll get the actual decision they want.”

    Truth

  177. “anon, I think it is sad. It bodes ill for CLS Bank v. Alice at the SCOTUS or whichever software case makes it way up there.

    We are now in the Iron Age.”

    Welcome to the IRON AGE! And yes, it bodes very well for CLS bank!

  178. Keep in mind that Myriad concerns only patent eligibility of cDNA. There’s another step: Obviousness. The existing obviousness analysis assumed that the extracted-DNA material was itself patentable material. So, the real obviousness question becomes this:

    For a particular set of cDNA (which is patent-eligible subject matter because it actually does remove introns), would the removal of those introns be obvious to and within the skillset of one who is skilled in the art of DNA-based diagnosis/therapy?

    I think that Myriad loses on these facts. I can imagine circumstances in which choosing which introns to remove, so as to (hypothetically) improve yields/avoid toxicity/avoid false positives, could make a particular cDNA composition nonobvious and original. By analogy to Feist, “removing all the typos” isn’t originality; “removing the typos that get in the way of understanding the passage, but leaving in the typos that don’t get in the way of understanding the passage and allow the reader to see the overall context of the passage” is, and is not original. This patent application fails that reasoning.

  179. Genetic testing wouldn’t have been patent-eligible under Bilski (as the CAFC and SDNY noted) or really easily patentable today (likely obvious). I’m not concerned about the availability of them, because this is a place where quality and accuracy are key, and Myriad’s tests were not so accurate or high-quality and too expensive.

    The biggest thing is how this applies to recombinant protein products and any other patented biologics. That’s where the big money and big risk are right now, not in genetic testing (even if you think therapeutic antisense therapy might work in the long-term, you can get a process patent on that kind of thing and get a lot of exclusivity even without a patent).

    There are just so many reasons I think this decisions is overblown. Yes, it throws another question mark into what is a “product of nature,” but I don’t think the decision really adds much to that category. It’s incredibly narrow, as it needed to be.

  180. Thank you patent-o for a much more reasonable and less ridiculously hysterical (and thus more likely to be realistic) analysis of this case.

    Glad I found this blog, fast becoming the only one I will visit.

  181. So we should allow natural products to be patentable? Seriously? That is incredibly against section 101 and history…

  182. “Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention”

    Hmm…”found.” One might even say that Myriad “discovered” an important and useful gene. The Patent Act says that “The term “invention” means invention or discovery.” So how, according to the plain language of the statute, was Myriad’s important and useful discovery not an act of invention?

  183. Any thoughts as to how this opinion may effect the patent eligibility of business methods, software and “abstract ideas” (whatever they heck they are)?

  184. “claim 2 asserts a patent on” Do you think an Ivy League-educated Supreme Court Justice could get the verbiage right?

  185. This one is ugly. Under this decision there isn’t much that would still be eligible and certainly nothing that had to do with setting a price of anything.

  186. “separating that gene from its surrounding genetic material is not an act of invention”

    How does this bode for therapeutic biologics?

  187. Hey 101 Integration Expert, can you do us a favor and perform integration analysis on this claim:

    17. A method for determining a price of a product offered to a purchasing organization comprising:
    – arranging a hierarchy of organizational groups comprising a plurality of branches such that an organizational group below a higher organizational group in each of the branches is a subset of the higher organizational group;
    – arranging a hierarchy of product groups comprising a plurality of branches such that a product group below a higher product group in each of the branches in a subset of the higher product group;
    – storing pricing information in a data source, wherein the pricing information is associated, with (i) a pricing type, (ii) the organizational groups, and (iii) the product groups;
    – retrieving applicable pricing information corresponding to the product, the purchasing organization, each product group above the product group in each branch of the hierarchy of product groups in which the product is a member, and each organizational group above the purchasing organization in each branch of the hierarchy of organizational groups in which the purchasing organization is a member;
    – sorting the pricing information according to the pricing types, the product, the purchasing organization, the hierarchy of product groups, and the hierarchy of organizational groups;
    – eliminating any of the pricing information that is less restrictive; and
    – determining the product price using the sorted pricing information.

  188. Good comment Guest, but what if this is just the start. Do you see more important areas being help ineligible?

    I guess the genetic tests will be cheaper now, but where will the new ones come from?

  189. Feels like the public perception of the impact of this is going to be worse than the actual impact – aside from cheaper BRCA testing, which is huge. It was pretty hard to get any DNA patents, whether genes, cDNA, or otherwise. The decision seems limited to DNA, and probably won’t effect recombinant proteins (which are the bigger issue). I don’t even think it affects researchers that much, since I doubt many had their research chilled by these kinds of patents.

    Sure, this feels like a big case, but in terms of its actual effect I don’t see any huge impact.

  190. The “DNA in a solution” idea may or may not fly, as it may not be that different from the “unisolated” version of the DNA in the cell…information etc. is unchanged.

    Not having studied the rest of the Myriad claims at issue, I wonder what the rest looked like? probes as part of an array, labled with a marker?

  191. Scalia’s dissent is perfect Iron Age thinking. It illustrates perfectly the opinion of the Justices despite it being a dissent.

  192. Thanks Ned.

    But it’s more than just being right- it’s why I was right.

    Note the use of those cases I asked you to look at (and that you tried to ignore): Chakrabarty, Funk

    Note the reasoning, even thought Malcolm (and Francis and… well you get the picture) tried ‘their’ rhetorical game of feigned and then projected ignorance…

    But thank you.

    (perhaps later today I will have a short snippet for you on the Rader Bilski dissent – re-reading that dissent in light of Prometheus, given how much Prometheus parallels Lab Corp. speaks to a larger issue than the mere question of ‘what does abstract mean?’) – but in the meantime, I have much gloating to do.

  193. Interesting dissent by Scalia…unable to understand the details of biology but still willing to draw a fine line between isolated DNA and cDNA. Not sure what other people think about this, but I believe it’s hard to apply the law to the facts when (1) you don’t understand the facts, and (2) the evolution of the law seems intertwined with the evolution of technology.

  194. Malcolm, I think you owe me the wager.

    “Phenomena of nature” == “Product of Nature”

    Really?

    The real clue was the genetic sequence. That is information and that, not the chemicals, is the subject matter that cannot be patented.

  195. Some thoughts:

    1. What about Prokaryotic DNA which lacks introns? How can it’s isolated DNA be distinguished from cDNA

    2. Claim an isolated DNA as part of a solution. A solution of the DNA at a certain concentration is a new product.
    A solution comprising an isolated DNA of sequence X at a concentration from >XX%.

    3. CAFC should make decisions the opposite of what they want so that when the Supreme Court reverses them they’ll get the actual decision they want.

  196. anon, I think it is sad. It bodes ill for CLS Bank v. Alice at the SCOTUS or whichever software case makes it way up there.

    We are now in the Iron Age.

  197. as opposed to a chemical-structural approach

    LOL – the material for gloating is deep in this decision.

    When will Malcolm come out to play?

    (ps: who’s your Daddy?)

  198. This is what I posted —-

    If had to bet, I’d say they are going to hold it ineligible. I think that anon’s analysis is basically right. They have gone into a something more mode and discount information such as in Funk brothers. They want something from the iron age–not the information age as counting as new.

    So, they are going to say that what is isolated is just what is already there in the DNA and all the techniques to isolate it are old. The sequences are there in DNA. So, what have you got in iron age thinking? Nothing. You have something outside of the DNA that looks just like the DNA in its important parts and the parts that don’t are old. Ineligible. All the predictive power won’t count–information age. All the finding the sequence in the DNA won’t count–information.

    Going to be ugly. That’s my predication. 6-3 decision.

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