Supreme Court has Granted Cert in the Myriad Case, Question: Are Human Genes Patentable

by Dennis Crouch

From the get-go, case of AMP v. Myriad appeared to be on its way to the Supreme Court. That fate was furthered by District Court Judge Sweet’s sweeping 2010 ruling in the case. As written, that ruling would have invalidated essentially all gene patents. As predicted, the Federal Circuit reversed and followed its own prior precedent that isolated genes are patentable.

Now, the Supreme Court has granted the petition for writ of certiorari and will hear the case — limited to the single question: “Are human genes patentable?”

I’m sure there will be significant amicus support on both sides.  A decision will probably not arrive until the end of the spring term.

Read more on the case.

 

92 thoughts on “Supreme Court has Granted Cert in the Myriad Case, Question: Are Human Genes Patentable

  1. Interesting thoughts from Tim Roberts in the PatLit blog:

    Consider a claim directed to Human Gene X. What is the scope of that claim? I mean, what about a particular “Gene X” that is present in both the human genome and in those of one or more non-human living beings? Suppose that the stuff accused of infringement was isolated from a non-human source. Does it infringe?

    Long ago, when I first started to draft claims, my teacher was keen to bring it home to me how problematic adjectives in claims can be. He was right, wasn’t he?

  2. Let me know if you still don’t understand this. I’ll break it down for you even further.

    Was this a false offer? I don’t see your breakdown (well I do, just not the one you thought you were offering) in response to my several follow-up questions.

    Why are you running away MM?

  3. Warehouse of nature is not nonsense. Obviously you have yet to re-read the Supreme Court Chakrabarty decision, have you?

    Try doing so before your next comment.

  4. I’ve said it before and I’ll say it again: this is the strangest aspect of the trollery around this issue. The same folks who never ever shut up about how 103 was the proper tool and not 101 are suddenly clamoring for 101 to be applied here, even though as a matter of law 103 is perfectly suitable to handle claims which do nothing more than take a known “product of nature” and isolate it or otherwise change it in an (allegedly) insubstantial matter.

    LOL – completely untrue and see your dancing-in-the-streets self-defeating beloved 9-0 Prometheus decision why.

  5. Suppose Dr Murrell had claimed a pharmaceutical composition for the treatment of angina or other heart conditions comprising nitroglycerin and a pharmaceutically acceptable carrier or diluent.

    Surely that’s a novel composition, and not controversial under Prometheus. The problem with Prometheus is that it was a two-”step” method of (1) doing a thing, and (2) noticing a feature of the thing you just did. It’s a method claim problem.

    Absolutely correct analysis. It really is that easy.

    PC: formulation into tablets or other forms for convenient administration to the patient could be regarded as an insignificant post-solution activity

    If nitroglycerin was previously known, the legal tool for removing such composition claims is tried and true and used every day. It’s called “obviousness.” If you recall the Prometheus decision, a fair number of paragraphs was devoted to answering the pleas from certain parties that 103 was the proper tool for removing Prometheus’ claims as well. The Supreme Court noted (correctly) that 103 wouldn’t work absent a doctrine that permitted the PTO and/or the Court to ignore a novel, non-obvious mental step during the obviousness analysis.

    The Supreme Court declined to create or approve of such a doctrine. But recognize a key fact, Paul: this issue regarding what to do with the mental step in an obviousness analysis is completely irrelevant to composition claims reciting novel structure. That means that the key facts which led the Prometheus court to find the claims ineligible under 101 (as opposed to some other statute) in that case do not apply when discussing properly claimed novel compositions of matter.

    I’ve said it before and I’ll say it again: this is the strangest aspect of the trollery around this issue. The same folks who never ever shut up about how 103 was the proper tool and not 101 are suddenly clamoring for 101 to be applied here, even though as a matter of law 103 is perfectly suitable to handle claims which do nothing more than take a known “product of nature” and isolate it or otherwise change it in an (allegedly) insubstantial matter.

    Literally NONE of the issues which drove the decision in Prometheus (e.g., effectively claiming merely thinking about a natural phenomenon) are relevant in the context of properly claimed novel compositions.

  6. A claim to novel structure is almost inherently 101-eligible, subject to utility concerns

    Agreed, although I would throw in “non-obvious” as well. And so the usual mouthbreathing trolls around here don’t get too excited, we should note again that the structure being referred to is recited in the claim rather than merely (and usually incorrectly) inferred to exist because the claimed composition “does something new.”

  7. Paul, I’ll let IANAE’s comment speak for me. It’s accurate enough. You never answered the question I asked you. Waving your hands around and saying “it might be said this”, “it might be said that” is not very compelling when “this” and “that” are quite silly. Your premise is that Prometheus somehow blasted a giant hole through all of patent law. Breyer was careful to point out that the mere fact that a claim implicated a “law of nature” or a “phenomenon” of nature was absolutely NOT the reason why the claim was deemed ineligible.

    A rule of law cannot be correctly stated if it covers unintended situations where inappropriate consequences follow.

    LOL! Funny, then, that you choose to attack an allegedly “broad formulation” of mine (without stating what it is, exactly), implicitly endorsed by the Supreme Court 9-0 (and more recently the Federal Circuit), and yet you fail to provide a single compelling example of an “inappropriate consequence.”

    Meanwhile, anon and others run around spewing nonsense about the “Warehouse of Nature” and you just sit there. Give me a break, Paul.

  8. anon” I guess it takes a 101 Integration Expert to show you how to do that”

    I have tried to help MM numerous times. As he certainly helped me by posting the link to the Official Office Guidance on Integration. But I think his obsession for his theory has blinded him to all reason and sanity. I recall someone posting an analogy about dead horses laying next to perfectly good drinking ponds?

  9. Paul Cole Wrote: Did the opinion in Bilski leave the law in a clearer or a more uncertain state?

    101 Integration Expert: In terms of 101 controlling case law it left the law in a much clearer state.

    We know for example that 101 is a broad and open gate when it comes to statutory subject matter, thus the Court refusing to limited 101 eligibility for processes tied to machines, transformations or technology.

    We know that there is no Constitutional or statutory grounds for banning business methods as patent eligible subject matter, thus the Court refusing to do so.

    We know that Diehr is controlling precedent and the Courts previous cases stand for no more than the principles in Diehr, ( Claims as a whole, Integration, No Dissection )

    Paul Cole: Can anyone determine what the rule of law underlying Prometheus actually was?

    101 Integration Expert: Yes, the rule of law for 101 statutory subject matter is : “Integration”.

    As I previously contributed;

    Integration has been defined explicitly through the Supreme Court’s line of 101 statutory subject matter cases, most notably in Benson, Flook, Diehr, Bilski and Prometheus. In fact,the reconciling of the Court’s precedents on “Integration” accumulated in a 9-0 ruling in Prometheus which explained:,

    “Diehr and Flook, the cases most directly on point, both addressed processes using mathematical formulas that, like laws of nature, are not themselves patentable. 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. But in Flook, the additional steps of the process did not limit the claim to a particular application..” ) [Cite as: 566 U. S. ____ (2012) 3 Syllabus] ( Prometheus referencing Diehr)

    Using the Courts line of 101 cases as the lens thru which to determine when claims are “integrated” it is apparent that a new and useful process claim in general has a clear presumption of “Integration” and the presumption remains valid, and requires no further analysis under 101 unless the claims as a whole recite;

    1. A bare Court created Judicial Exception, (derived implicitly from the Congressional Statute of 101) or

    2. The first element of the claim is a bare Court created Judicial Exception, (derived implicitly from the Congressional Statute of 101) followed by additional steps that apply the Judicial Exception. In the case of the latter, extra-solution analysis, (pre or post ) occurs to determine if the claims are integrated.

    Although an official Guidance has been issued by the Office here, link to uspto.gov

    I have previously posted a brief synopsis of how the Court has applied “Integration Analysis” in each of the 101 cases, which Patent Attorneys and Examiners can use as a guide post for applying Integration Analysis to claims.

    The Supreme Courts Integration Analysis

    Synopsis

    Benson = (Non Integrated)

    Reason/Analysis: Begins with a bare Court Created Judicial Exception of an algorithm followed by additional steps that apply the the Judicial Exception.

    Flook = (Non Integrated)

    Reason/Analysis: Begins with a Bare Court Created Judicial Exception of math followed by additional steps that apply the the Judicial Exception. Extra solution ( pre or post ) analysis required.

    Diehr = (Integrated)

    Reason/Analysis: Claims as a whole are not a bare Court created judicial exception, nor does the first element of the claims begin with a bare Court created judicial exception followed by additional steps that apply it. The claims maintains their presumption of “Integration” and are therefore integrated and statutory subject matter.

    Bilski = (Non Integrated)

    Reason/Analysis: Claims as a whole are a Bare Court Created Judicial Exception of a math formula. No extra solution (pre or post ) analysis required.

    Prometheus = (Non Integrated)

    Reason/Analysis: Claims begins with a Bare Court Created Judicial Exception of a Law of Nature followed by additional steps that apply the the Judicial Exception. Extra solution ( pre or post ) analysis required.

    Interestingly enough, when a claim does begin with a bare Court created judicial exception, e.g. Prometheus, and the Court has had to engage in an analysis for extra solution activity, historically the claims have been held to be invalid under 101. Whether that happens in the Human Gene patent case(s) remains to be seen. But in any case the law of “integration” is clear, and it’s Court sanctioned, which means it’s here to stay.

  10. A claim to novel structure is almost inherently 101-eligible, subject to utility concerns

    Not true. ALL of the judicial exceptions apply no matter which statutory class the invention is portrayed in (see the SC comments on this).

  11. Suppose Dr Murrell had claimed a pharmaceutical composition for the treatment of angina or other heart conditions comprising nitroglycerin and a pharmaceutically acceptable carrier or diluent.

    Surely that’s a novel composition, and not controversial under Prometheus. The problem with Prometheus is that it was a two-”step” method of (1) doing a thing, and (2) noticing a feature of the thing you just did. It’s a method claim problem.

    Even if you tried really hard to apply Prometheus to non-method claims, you’d instantly run into difficulty as soon as the claim recited novel structure. A claim to novel structure is almost inherently 101-eligible, subject to utility concerns.

    The anti-angina activity of nitroglycerin could be regarded as a mere phenomenon of nature “though just discovered”,

    The utility of any substance for its purpose could be regarded as a mere phenomenon of nature. And that would be a real problem if you were claiming the use of a known substance in a known way plus noticing whether or not it has been useful in that instance. However, actually using the known substance in a new way to actually achieve that utility for the first time has to be patent-eligible, or we are forced to invalidate all non-method claims on the basis that they have utility.

    formulation into tablets or other forms for convenient administration to the patient could be regarded as an insignificant post-solution activity

    I wouldn’t go that far, if the actual invention is that the stuff is pharmaceutically useful in the first place. Making it a usable drug is the solution. Also, the standard formulation is a good way to structurally distinguish the inventive compound (the drug nitroglycerin) from the old compound (nitroglycerin for explosives or other uses), while still covering the whole of the patentee’s invention.

    The pharmaceutical composition claim which is in standard form for a first medical indication would block research into further formulations and further medical indications for nitroglycerin.

    I don’t think that claim would block further research. The Prometheus claim actually blocked doing a prior art test and noticing the result. The nitro claim would only block the use of composition itself, which is an inherent tension in the patent system.

    blocking further development was an objection raised in the 1790′s to James Watt’s patent for a steam engine.

    Presumably that was only because his improvement (he didn’t invent the steam engine) was so significant that it obsoleted all previous designs. It wasn’t the only way to design or build a steam engine. Whether it was the only way to build a steam engine that good, I couldn’t say. But it certainly didn’t block further development in the way we normally understand the expression.

    Thanks, Paul. Glad someone is teasing out these distinctions between Prometheus and well-claimed inventions, in a sensible and rational discussion.

  12. Paul,

    Careful – it sounds like you are trying to get MM to square the Prometheus decision with the law it rests upon.

    You should be aware that MM has always run away when people have asked him to provide that answer.

  13. Malcolm:

    Here is what I said in a guest posting on Prometheus in this blog:

    “It is, however, less than clear by what logic new drugs escape the rule in Mayo but the Prometheus test is caught by that rule. For example, nitroglycerin was first synthesized in 1847 and was used as an explosive. In 1878 it was introduced as a treatment for angina by Dr William Murrell. Suppose Dr Murrell had claimed a pharmaceutical composition for the treatment of angina or other heart conditions comprising nitroglycerin and a pharmaceutically acceptable carrier or diluent. The anti-angina activity of nitroglycerin could be regarded as a mere phenomenon of nature “though just discovered”, the reference to treatment of cardiac disorder could be a mere limitation to a particular technological environment and formulation into tablets or other forms for convenient administration to the patient could be regarded as an insignificant post-solution activity since the incorporation of active ingredients into tablets or other dosage forms was well known long before 1878. The pharmaceutical composition claim which is in standard form for a first medical indication would block research into further formulations and further medical indications for nitroglycerin. Indeed, blocking further development was an objection raised in the 1790′s to James Watt’s patent for a steam engine. It might be said that the hypothetical Murrell claim confines the reach of what has been discovered to the particular application of pharmaceuticals but it might equally be said that the Prometheus claim confines the reach of what has discovered to the particular application of a blood test for metabolites of drugs of a particular family. If there is a distinction, arguably it is no more than pragmatism.”

    A rule of law cannot be correctly stated if it covers unintended situations where inappropriate consequences follow.

  14. Over the longer term we are all dead, and science is actually subjugated to a new generation of politics.

    One has to look no further than Prof. Crouch’s 50-year old software patent letter post (and my comments therein).

  15. Science be da–ed, political mileage is better.

    Over the short term, yes. Over the longer term, no. Science wins, every time, and ideological lunacy end up kicked to the gutter where it belongs.

  16. Paul Cole: The difficulty is that the broad formulation that you have sugggested vitiates most claims to pharmaceutical compositions where the active ingredient is a known compound

    Prometheus concerned a process claim with a method step. How does my “broad formulation” (?) to assessing the eligibilty of method claims comprising mental steps “vitiate” claims to pharmaceutical compositions?

    the Prometheus decision lays down no new rule of law but was mere pragmatism.

    Wow! You might be “getting it”, Paul. Congratulations. That’s why it was a short 9-0 decision.

    And for the record, it’s also exactly why the alleged “settled expectations” didn’t amount to a hill of beans. Prometheus’ claims should never have been granted in the first place. The same will hold true for B-claims, eventually. It’s all a big game played by PTO and its favorite “customers.”

    I’ve been prosecuting for many years now and I can remember the first time I saw an [oldstep]+[newthought] claim. I could not believe that such cr-p made it through the system. And I couldn’t believe how long I had to wait until the Supreme Court issued the smackdown. It should have been fixed during the Metabolite Labs dust-up but it wasn’t.

    Heckuva job, Dudas. And heckuva job, Kappos. Massive failures, both of them.

  17. I think, with the Scientific American article that I quoted, that this was a point I was making. Science be da–ed, political mileage is better. P.S. Evolution is nonsense too, and global warming is not a problem. Shame that fluorocarbons were banned – they were so inexpensive and useful as refrigerants and for cleaning PCBs.

  18. The difficulty is that the broad formulation that you have sugggested vitiates most claims to pharmaceutical compositions where the active ingredient is a known compound, but the Prometheus opinion expressly stated that the patentability of such claims was not to be disturbed. You may recall the nitroglycerin example I gave from a previous posting. The suggestion, therefore, is that the Prometheus decision lays down no new rule of law but was mere pragmatism.

  19. Please tell me what my “agenda” is and explain how my “agenda” squares with my well-known views about the subject matter eligibility of (1) [oldstep]+[newthought] claims

    Still trying to find that anywhere else but YOUR postings MM.

    Maybe if you provide the link to the Office implementation guidance for the Prometheus decision again, this time theory will be there.

  20. Your attempt at humor notwithstanding, the SC is not guided by general public opinion, it is guided by political opinion. In Myriad it will be presented with interest groups vs business, politically speaking. They will vote whichever way will get them the most political mileage with their constituencies, in which members of “the public” are most certainly not included.

    The “USA” is perhaps one of the best branding jobs in history. It’s a dying joke, but many around the world still buy into the marketing strategy and believe the ad copy–but they’re starting to catch on to the reality, if only slowly.

  21. it is utterly irrelevant in the US system of representative democracy whether or not your general “public” understands the terms of the investments

    Interesting. I wonder if the Supreme Court agrees with you.

    LOL.

  22. LOL–”the public”. Up here in MN, I have encountered baby-boomer members of “the public”–even those with legitimate post-secondary degrees from reputable US institutions–who are not exactly certain where “Canada” is.

    Possibly worse than that, they don’t know where Detroit is. Possibly worse than that, they have no idea what is in the direction “north”.

    “The public” doesn’t understand ANYTHING except their immediate environment, spatially and temporally–and sometimes not even that.

    And THAT, my friend, is the essential national character upon which current US governance relies.

  23. This time, I didn’t even get past the first line.

    It is up to the public to inform itself of the terms. As long as the specific parties negotiating the terms and performing the contracts understand them, it is utterly irrelevant in the US system of representative democracy whether or not your general “public” understands the terms of the investments, which terms are essentially dictated by agencies under the direct control of the “public’s” duly-elected representatives.

    Give me a break. Your moral relativism is utterly boring.

  24. That’s pretty easy

    Funny that, neither you nor your friends ever squared the Prometheus decision with the decisions it not only rests on, but say are closest on point.

    I guess it takes a 101 Integration Expert to show you how to do that (but hey, at least you can say that you were the first to post a link to how the Office viewed Prometheus, even if you didn’t bother to read (or understand) it before you posted it.

  25. How do you account for (valid) process claims composed entirely of steps “old in the art?”

    (and not even getting to your new mental step addition?)

  26. results in a claim that is effectively a claim to the ineligible process

    What does “effectively” mean?

  27. IBP “The public” “invests” “billions of dollars” on terms it sets. If those terms include a temporary grant of IP rights to someone else, so be it.

    Does the “public” understand that the investments are made on those terms? I’ve talked to a lot of members of the “public”, IBP. You know, those people who aren’t directly invested in our awesome patent system because they are members of the 99.999% of the population who never has and never will file a patent themselves or on behalf of anyone else. Pretty much invariably those people expect that if they pay for researh into X that when X is discovered it can’t be held hostage for twenty years at the whim of the employee whose salary was paid for by the public.

    That’s what I meant by “non-controversial and rational.” Maybe step outside your office sometime and meet some normal people. Try to avoid blowing your patent sunshine up their bhehinds and just listen to them.

    Maybe “the public should have free access”, but it DOESN’T.

    That’s what Prometheus and the patent t–b—gers so desperately wanted to believe. How did that work out?

    it appears that in my absence you have continued pushing your agenda.

    LOL. Please tell me what my “agenda” is and explain how my “agenda” squares with my well-known views about the subject matter eligibility of (1) [oldstep]+[newthought] claims and (2) novel, non-obvious nucleic acid compositions. Seriously. Let me know.

  28. Mooney–

    Give me a break. I couldn’t even get past the first part of the first paragraph this time.

    “The public” “invests” “billions of dollars” on terms it sets. If those terms include a temporary grant of IP rights to someone else, so be it.

    Wanting to re-write what are now characterized as unfavorable terms, that “the public” itself imposed, is HARDLY “non-controversial and rational”.

    Maybe “the public should have free access”, but it DOESN’T. If you are in support of re-writing agreed-upon contracts after performance has occurred, then I suggest that all the bloated public-sector pension and benefits contracts be rolled-back, or just eliminated.

    Give me a break. I have been too busy of late to read this blog, but it appears that in my absence you have continued pushing your agenda. Fair enough, and we both know why it is fair enough…but it has really gotten old.

  29. In appearing to support the wish of The Association for Molecular Pathology, Breast Cancer Action and Boston Women’s Health Book Collective, amongst others, that the public should have free access to the fruits of difficult and costly research

    Just so the point is not lost, it’s a non-controversial and quite rational proposition that the public SHOULD have free access to the fruits of difficult and costly research where (1) the public has invested billions of dollars in the foundational research in the form of government grants and/or (2) the fruits of that research are unpatentable, publicly disclosed scientific facts (e.g., “genetic marker X is correlated with disease Y”).

    What’s happening here is the result of a “race to the bottom” where patent applicants first attempted to seize control of the facts themselves (they were hammered by the Prometheus Supreme Court decision, and rightfully so) and, in addition, the applicants sought to broadly claim the most inexpensive, fundamental and obvious tool for obtaining the data necessary to apply that fact (i.e., a polynucleotide complementary to the genetic marker of interest).

    Did you (or do you) have an opinion about Incyte’s failed patents, Paul? Myriad’s nucleic acid composition claims seem to rest on a foundation only a tiny degree removed from Incyte’s nucleic acid composition claims. Somehow the Courts managed to take (most of? all of?) Incyte’s nucleic acid compositions down without getting into this “product of nature” nonsense (at least, that’s how I remember it).

  30. Can anyone determine what the rule of law underlying Prometheus actually was?

    That’s pretty easy: mental processes are ineligible subject matter and appending old, conventional non-mental steps prior to a novel step of thinking about a new “idea” (whether it be a law of nature or any other fact) results in a claim that is effectively a claim to the ineligible process (because practitioners of the prior art can’t think about the new fact while they are practicing) so: no patent.

    Let me know if you still don’t understand this. I’ll break it down for you even further.

  31. What should be the criteria for the intervention of a non-specialist court of final appeal in a specialist legal area?

    Firstly that the non-specialist court has the skills to resolve the matter in dispute. Secondly that the existing state of the law amounts to a serious wrong. Thirdly that the non-specialist court has a reasonable chance of truly understanding the underlying technical facts and legal principles and of producing an opinion that is both correct in outcome and correctly reasoned (the Kalo case, for example, being a clear instance of a correct outcome based on reasoning that it is difficult to support). Fourthly that there is a reasonable chance of arriving at a new rule of law which is preferable to that which existed formerly. Fifthly that there is a reasonable chance that the new rule of law can be expressed in a way that meets the needs of those closely connected with the subject matter in dispute without major but unintended colateral damage in situations unforeseen when the opinion was written, especially by ill-advised and over-broad dicta.

    Although there have been outstanding decisions from the Supreme Court e.g. in Festo, its recent record in our field could most charitably be described as patchy. Did the opinion in Bilski leave the law in a clearer or a more uncertain state? Can anyone determine what the rule of law underlying Prometheus actually was?

    Is Myriad a case where intervention was justified? Two concurrent Federal Circuit decisions were well reasoned, have been generally welcomed in the profession and compelling reasons for disturbing them are difficult to discern. If it was a matter of legal certainty then refusing certiorari would have been the wiser course. An ill thought-out decision could be profoundly damaging to the chemical, pharmaceutical and biotechnology indistries at least, could cut US law off from a century of legal thought concerning the patenting of new chemical entities and from international standard practice on this topic. In the present case, the decision to grant certiorari is not grounds for confidence but for the reverse.

    Coincidentally, the current edition of Scientific American carries a lengthy article by Shawn Otto warning of the dangers of science denial when carried into politics, warning that “When facts become opinions, the collective policymaking process of democracy begins to break down.” There appear to be real dangers of science denial being carried into law also, and the decision for certiorari in this case highlights the dangers of this happening. In appearing to support the wish of The Association for Molecular Pathology, Breast Cancer Action and Boston Women’s Health Book Collective, amongst others, that the public should have free access to the fruits of difficult and costly research, the Court has the appearence of embracing populism rather than rationality.

  32. This is the same reason why the hard-core propents of the “product of nature” tests refuse to engage your questions in a meaningful way. They can’t do so because (1) they don’t understand the science or (2) they do understand the science but they need to pretend that they don’t in order to “win.”

    MM, may I remind you that lies are not allowed on the new Patently-o.

    Your only escape from the quote above is that you reference Robert’s questions as having not been answered by the hard-core “propents” of the “product of nature test.”

    First, Robert has only now asked his questions, second, what is a “propent” and third, what is this test you speak of? Do you mean the Judicial Exception?

  33. What I want to know is why the question is framed as only human genes.

    To get the Supreme Court to grant cert without laughing outright.

    If this case were about the eligiblity of nuclec acid compositions with a sequence of nucleic acids identical to those in brine shrimp, it would never have gotten off the ground.

    This is the same reason why the hard-core propents of the “product of nature” tests refuse to engage your questions in a meaningful way. They can’t do so because (1) they don’t understand the science or (2) they do understand the science but they need to pretend that they don’t in order to “win.”

  34. What I want to know is why the question is framed as only human genes. What about the poor little archebacteria and HCV and the corn plants? Is their DNA/RNA patentable or not? Nobody is advocating on their behalf . . .

    If the Supremes say “human genes aren’t patentable”, where the heck does that leave us in terms of other genes? Still the same chemical compound. Do emotions run as high when it’s an infectious disease?

    Consider: Novartis might not have a lock on HCV blood screening . . .

  35. Are you now beginning to understand why I have been stressing the importance of SS&C when it comes to utility, and why I have been stressing the importance of utility in general, for YEARS now?

    I’ve been dealing with utility rejections under 101 in practice for my entire career, IBP, so I never doubted its importance. It’s always an issue, as far as I’m concerned, although not a terribly difficult to overcome.

    I don’t know what “SS&C” is.

  36. Wasn’t it you who was of the opinion that utility was not a “condition” of patentability? If not, you have my apologies.

    That wasn’t me. I have the opposite opinion. I even recognized a utility argument in the Prometheus case, although I thought it was a clear loser and far less effective then the approach of acknowledging the ineligible subject matter (mental step) then looking to see if there are any novel/non-obvious transforming steps in the claim which could save it.

    Clearly, in your hypos, by my logic the 2 pieces are not “identical”, nor could they be described “identically” in a disclosure.

    Thank you for recognizing this obvious fact. The same obvious fact is true in the Myriad case: the claimed nucleic compositions are not identical to any “natural” molecule.

    if 2 different utilities were disclosed for the 2 pieces you describe–one useful for law enforcement, the other perhaps useful for detecting gravity waves–the larger would still anticipate the smaller, UNLESS a specific limitation was added as to extent, and unless said magnitude limitation was deemed limiting.

    That’s nice. Please understand that the hypo you are now suggesting is a completely different set of facts from the facts at issue in this case. There is no known practical, patentable utility for an unisolated human genome. You could swing from a tree branch or wipe your behind with a leaf. What do you do with a chromosome in a living cell?

    Please also understand that you didn’t ask originally about “anticipation”. My understanding is that the polynucleotide composition taught and claimed by Myriad was not previously disclosed prior to Myriad, even as a part of a molecule 10,000 times longer than the claimed composition. Happy to be wrong about that. It’s another relevant fact.

    Lastly, you seem to be mostly concerned with an issue of claim construction: does Myriad’s broadest composition claim literally cover an entire human chromosome containing the recited sequence? That’s a very different question from the quesstion being asked by the Supreme Court. And I’m not sure that anyone is suggesting that either party is proposing this as the proper claim construction. Do you know otherwise?

  37. You treat DNA as the finite sequence that it is, but you do not treat the polynucleic acid composition

    I have no idea what you are talking about. DNA and polynucleic acid are generic terms for the same class of chemical compound.

    I have been on top of this issue for a decade, at least. It’s not me that lacks precision.

    is it your opinion that the magnitude or extent of an invention, dictated by its practicality insofar as use by humans is concerned, can alone impart patentability

    No, that’s no my opinion. For example, one could discover an incredibly useful fact but one can not patent that fact or a method of thinking about, no matter how practical that method may appear to human beings.

  38. MM–

    Are you now beginning to understand why I have been stressing the importance of SS&C when it comes to utility, and why I have been stressing the importance of utility in general, for YEARS now?

  39. MM–

    See my post above. I hope that you are starting to understand more about the utility criterion, by investigating this issue. Wasn’t it you who was of the opinion that utility was not a “condition” of patentability? If not, you have my apologies.

    Clearly, in your hypos, by my logic the 2 pieces are not “identical”, nor could they be described “identically” in a disclosure. Notice that you have referred to them as “pieces”, which implies finite extent, which implies that extent is an essential descriptor.

    Both you and I have been big on structural recitations. Consider instead the case where the piece that is found in nature is just slightly too big to be wieldy in a particular application, but which has identical structural properties, except for extent–say, a piece that was perfectly scaled, but weighed a ton.

    Is the new piece patentable based upon a consideration of its utility? That would seem to depend upon precisely how the utility was described, and whether or not the concept of utility is treated as a “condition” of patentability.

    This type of consideration–whether utility alone can impart patentability to an invention–is a sort of “corollary” way of thinking about whether or not a lack of utility can preclude patentability–because if it can, it is clearly a condition of patentability, as patentability is conditioned upon the disclosure of utility.

    Under conventional thinking, it is sufficient if ANY SS&C utility is disclosed, and the statement of utility is not considered limiting. Extending this conventional thinking to your hypo, it would not matter if 2 different utilities were disclosed for the 2 pieces you describe–one useful for law enforcement, the other perhaps useful for detecting gravity waves–the larger would still anticipate the smaller, UNLESS a specific limitation was added as to extent, and unless said magnitude limitation was deemed limiting.

    I’ll end there for now, and await your response before continuing.

  40. Mooney–

    I know it’s only a blog, but you must be more precise.

    Your condition was that it be an “identical sequence”.

    Since you use DNA as a basis of comparison, and DNA represents a finite sequence, the polynucleic acid composition is logically also a finite sequence, and the logic behind my question remains sound.

    Your question, OTOH, is inconsistent. You treat DNA as the finite sequence that it is, but you do not treat the polynucleic acid composition in the same manner.

    You might instead refer to the polynucleic acid composition as a subsequence, or something similar, that puts your question on a sound footing.

    Concerning your further post, is it your opinion that the magnitude or extent of an invention, dictated by its practicality insofar as use by humans is concerned, can alone impart patentability? I await your response before posting my own opinion.

  41. The answer to the question “are human genes patentable?” is no. If the Sup. Ct. thinks that is the question, and given its recent track record and confusion it might well do, then Myriad are out of luck. However, if Myriad can actaully get the Ct. to consider whether what they have claimed is patentable – then they have some hope of a reasonable hearing. But when the NYTimes and even this Patent Blog subscribes to the mischaracterization – the odds don’t look good..
    Its become political, hence all nuance and precision goes out the window, soundbites and vagueness are weclomed in.

  42. the sole purpose of this strawman is to not provide an answer to the question you asked. Run with it at your own risk.

    Corrected – LOL.

    IBP, don’t worry, MM provided no answers on the afore mentioned Prometheus threads either. The incredibly simple fact is that novelty for MM is indeed from an alternate universe, one in which insults and empty nebulous “I explained a bajizillion times already” statements (when no cogent explanation has ever been given) are actually believed to be substantial.

  43. One quick follow-up question: if you do believe that the two pieces of iron alloy are “identical”, why is it that law enforcement officers always reach for the 12 inch piece when they want to get into a locked car? The piece inside Jupiter isn’t patented, after all. If the 12 long piece and the ten billion inch long piece were “identical”, then shouldn’t they both be equally useful?

    Lastly, just so there is no confusion, the sole purpose of this hypothetical is to provide an answer to the question you asked. Run with it at your own risk.

  44. IBP,

    Imagine a piece of iron alloy ten billion inches long buried in the center of Jupiter, unusuable in that form and with some details of it as yet not understood or described. This ten billion inch long piece of iron alloy also includes billions of tiny pieces of poisonous arsenic integrated into its structure. Now imagine a previously undescribed piece of iron alloy that is only 12 inches long and which exists outside of the center of Jupiter and which is free of arsenic. Although unknown at the time that the 12 inch long piece of iron alloy was first disclosed, the ten billion inch long piece of iron alloy comprises a series of unusual impressions (along one tiny tiny fraction of its 10 billion inch total length) that are identical to those found along 10 inches of the 12 inch long piece of iron alloy. On the 12 inch long piece of iron alloy, these impressions make the piece incredibly useful for opening locked car doors. Law enforcement officers everywhere agree that the 12 inch long piece of iron alloy is incredibly useful.

    Is it your opinion that the 12 inch long piece of iron alloy is “identical” to the 10 billion inch long piece of arsenic-encrusted iron alloy found in the center of Jupiter? If so, you and I need not discuss the case further as your understanding of “anticipation” is so different from mine that you might as well be from another solar system.

  45. IBP: Ignoring the pomposity behind the statement of what the “proper” question “should” be…

    MM, if the identical sequence is found in a human cell, how could it be novel as required by your question?

    Oh boy. I feel like I’m back in the Prometheus threads again explaining incredibly simple facts to people who are determined at all costs not to understand them.

  46. Ignoring the pomposity behind the statement of what the “proper” question “should” be…

    MM, if the identical sequence is found in a human cell, how could it be novel as required by your question?

  47. And, MM, of course I know what the instant issues are. What amazes me is how complicated people want to make this, when it is not.

  48. So, what companies are going to want to do is the following:

    Devise a test for breast cancer. Keep it secret. You send in a sample and they tell you the results.

    Again, you want to probe into how things are done and seem bothered by information processing. Odd mind you have.

  49. NWPA Maybe the answer will be no human DNA is not per se patentable, but when portions are discovered that have a separate utility, then the answer is yes.

    That’s already the test. The novel, non-obvious nucleic acid claimed by Myriad has a “separate utility” of being extremely useful for detecting the presence of a mutation closely linked to breast cancer. That’s the argument, anyway.

    After all, what good is any of this unless scientist figure out how to cut up and slice the information and use it.

    Again, this is exactly what was done in the instant case.

    There is an interesting issue lurking in your statements, however. That issue can be presented as follows:

    Everyone agrees that the general utility “it can be used to detect the presence of its complementary sequence” is not sufficient for a nucleic acid molecule to meet the specific/substantial requirement under 101. Is it enough to meet the utility requirement to simply provide any specific additional information as to why the detection of that particular sequence is “important”? i.e., “the sequence is correlated with a 0.5% increase in Alzheimers in women of Irish descent”. That sounds pretty insubstantial but it might mean a lot to some sick insurance company type. It’s also the type of information that is incredibly easy to pump out ad nauseum provided you have access to a database of people with Alzheimer’s disease. THAT is the level of game-play of the vast majority of “stakeholders” in this kerfuffle.

  50. Maybe the issue is good. Maybe the answer will be no human DNA is not per se patentable, but when portions are discovered that have a separate utility, then the answer is yes. After all, what good is any of this unless scientist figure out how to cut up and slice the information and use it. Kind of a Bilski answer.

    It is odd, in some ways, that the knowledge that the test is looking for a specific sequence of DNA makes people think that they own that and you can’t patent that, but if the test works in some way they don’t understand then they are fine with patenting a test for some disease.

    Before the research–no test.
    After research–here is a test.

    And, people want to look inside it and say depends on how the test works. Why? Whatever is patented it is free in 20 years.

    Odd the way people think. It is kind of like the information processing patents, where we get this odd reaction that somehow a law of nature is inside the computer and you can’t patent that.

  51. “they’ll discover in a very, very short period of time that they’ve made a mistake and they need to reel it back in”

    sounds like squirming to me

  52. Huh? Clearly we are entering in the weak period like under nixon and carter. When patent law was strengthened under the courts improvement act – startups and innovation leaped forward. Weak patents IMHO, only help the entrenched – google, ms, ibm, etc. and hobble funding of startups and dis-incentivize discovery.

    Per the topic, one can only hope the bar does a better job explaining the science than they have in the recent past. After seeing the borderline falsehoods in the microsoft briefing however i would suspect we are in for some whoppers.

  53. LB, with respect to my earlier comment:

    The proper question that should be asked and answered is the one implied by my earlier comment: does an otherwise novel, non-obvious polynucleic acid composition which does NOT read on a whole human body or a cell of a human body [i.e., the sort of sequences claimed by Myriad] become ineligible subject matter when it is demonstrated, either before or after the filing of the application in which the composition is first disclosed, that the identical sequence of nucleic acids in the claimed polynucleic acid composition is (1) found in a human cell and (2) not specifically and willfully placed in that cell.

    The reason why changing “identical” to “similar” turns the exercise into madeness is that given the enormous size of the human genome (3 x 10^9 base pairs) and the great variability between individuals which already exists (see wiki entry under “evolution” link to en.wikipedia.org), there is already a decent probability that the sequence of a randomly generated polynucleic acid below a certain length will already match with an identical sequence found in some human being.

    In other words, it’s entirely reasonable to expect that without ever studying a human cell I could design a relatively short nucleic acid of a defined length (i.e., a novel chemical) with all sorts of remarkable properties (i.e., a novel, non-obvious chemical) and be blocked at the 101 gate because the sequence of my very specifically claimed novel, non-obvious polynucleic acid happens to match a sequence of unknown function discovered in the chromosome of a baby born in Chernobyl ten years after my filing date.

    Remember: this is where the sequence is required to be IDENTICAL to find ineligibility. Now if you expand the trap to include “similar” sequences (good luck defining “similar”, by the way) you might as well just state that all patents to isolated nucleic acid compositions (at least to the extent they are claimed by reciting sequences only, and do not include additional modifications, and below a certain length) are per se ineligible.

    I don’t have a problem with that result, frankly. Method claims and claims to engineered cells provide and will continue to provide more than enough progress-promoting. I’d just like to see these issues considered and “dealt with”, rather than ignored. They really are obvious issues, provided one has makes a tiny bit of effort to understand the science — and it’s definitely NOT rocket science. It’s about as simple as science gets.

  54. It is amusing to see you squirm.

    I’m not “squirming.” To the extent the Supreme Court tries to “go broad” with a “product of nature” test for excluding novel, non-obvious chemicals from patent eligibility, they’ll discover in a very, very short period of time that they’ve made a mistake and they need to reel it back in.

    But that’s never going to happen with, say, claims to “new” signals or with claims which recite an old data gathering step followed by a step of “thinking a new thought” about the data. Those are gone forever unless some Congressional m0r0ns decide that such claims are necessary for America to “return to its former greatness” or for some equally inane reason.

  55. Guest: It seems to me like the most important amicus briefs here will be ones that try to explain the science to the Justices, not ones that are trying to explain the law.

    Agreed. And the science is pretty easy, actually.

    the phosphodiester bonds of DNA, which aren’t quite like a conventional covalent bond).

    Huh? What’s a “conventional” covalent bond? And what difference does it make for the purposes of this case whether a phosphodiester bond is “not quite like” one of those?

    Fyi, from Wikipedia: A phosphodiester bond is a group of strong covalent bonds between a phosphate group and two 5-carbon ring carbohydrates (pentoses) over two ester bonds.

  56. The trend of which I speak, that American trade secret law is becoming more protective and that American patent law is becoming less protective, has been analyzed by many commentators in more practical (and less academic) publications. Any practicing IP attorney should have noticed it in his or her practice by now, although the changes in trade secret law are less pronounced in some states than in others.

    I don’t doubt that in some “practical publications” concerned with specific technologies that this “trend” you refer to is detectable. As arts age and fields get crowded, patents are more difficult to obtain. Nothing new there.

    It is not the result of some sinister conspiracy by “moneyed elites,” but is the result of numerous decisions by both state and federal judges at various levels, in combination with the AIA.

    Read my comment more carefully, Nick. I didn’t say anything about a “conspiracy.” There is no “conspiracy.” There is, rather, an open and notorious attempt to own whatever information is perceived to have the most value, to control how that information is obtained, and to control who has access to that information. This isn’t a new phenomenon but the aggression of the stakeholders and wannabe-stakeholders is at a historical extreme, I believe. Maybe I missed the part where Randolph Hearst filed thousands of patents in an effort to control the newspaper industry. Let me know.

    To look at it another way, you surely understand that state and federal judges don’t make up facts and parties out of thin air and decide cases on those made-up facts. They decide the cases that are brought before them. And with the exception of KSR, most of the recent major patent cases relate to the patenting of information, directly (as in Prometheus) or indirectly (e.g., Myriad, where the most valuable use at present for the inventions are determining whether one has the mutation; Nuijten’s failed attemtp to claim a signal). This is the source of the trend: the subject matter.

    We should look to similar periods in the past in determining how to react the current environment.

    From a patent law perspective, there really aren’t any “similar periods” in our history. Although the incessant whining of the patent t–b-gger crowd might imply some great contraction in the patent world, in fact the last twenty years have seen an unprecedented and extraordinary patent bubble being gleefully inflated. That bubble hardly blipped during America’s great recession, something that can be said about very few aspects of our economy other than the wealth and earnings of the top 1%. Go figure.

  57. the Supremes have yet to uphold a method claim involving a mental step as valid under 101 since Bilski.

    There haven’t been that many patent cases since Bilksi. But it should be pointed out that any process claim written with “comprising” language is infringed by someone who carries out the recited steps AND thinks about something immediately before, during, or immediately after carrying out the process. The point here is that is that at least in this one tiny trivial respect, Diehr was absolutely correct: the fact that a claim may include a step that is, by itself, ineligible subject matter does not make the claim ineligible per se.

  58. While I agree with what you are saying, I am not optimistic that the SCOTUS will think of science at this level as the dispositive issue. They might be more receptive to something they can understand, like the explanation that finding an oncogene is akin to collecting leaves from a tree, i.e. just isolating a product of nature. I am not making this up, it was in the Federal Circuit briefs.

    I am not sure that KSR or Kubin have yet been used extensively to reject isolated DNA claims, but I know something else will soon make them obsolete: prior art. Especially for human DNA, you generally need an ancient filing date for priority.

    On a related note, it is ironic that the carrot of patents has spurred Celera into sequencing the human genome a decade before projected, yet some question whether patents stimulate technological progress.

  59. “I remain hopeful that even if they somehow manage (against my prediction) to reach the conclusion that any polynucleotide composition comprising a sequence found in the human genome is ineligible subject matter, it’ll be sufficiently narrow so as not to disturb the eligiblity of ‘nature-similar’ chemical compositions generally.”

    It is amusing to see you squirm. MM has been in the front row cheering on SCOTUS as they have mucked up decision after decision because SCOTUS has a poor handle on both the issues and the underlying facts. Now the chickens have come home to roost.

    My prediction is that SCOTUS will, in its infinite wisdom, completely mess up the science and as a result mess up the law. MM will be on this blog within minutes after the decision is issued tearing apart the decision for all its inaccuracies and omissions.

    Since this deals with a technology that most of us aren’t particular concerned with, odds are that the legal impact of the decision will be cabined. There will be some that will gloating because of MM’s past comments and say that the deserves it. Others, however, will shrug their shoulders and ponder if SCOTUS will ever get a patent case right.

  60. MM — its never too late for a career change. You can always back and get a computer science degree.

    Of course, as you know … all it takes is about 100 baboons and 100 typewriters to prepare software patent application.

    Heck … instead of writing software patent applications for inventors, you can be your own inventor. Haven’t you disclosed dozens of your software patents on this blog the last few years?

    All you need to do is exercise that great computer brain of yours ….

  61. MM, I am not a child in a schoolyard and I will not trade insults with you on an otherwise useful web site.

    Nick,

    That’s how he rolls.

    Even after Prof. Crouch has asked the message board to be cleaned up. Even after Prof. Crouch has blocked some of his direct derogatory words (he just posted ‘around’ that type of block). On any substantive exchange, MM just ends up self-defeating. His only recourse is to slink down to his level of insults. Excrement, inappropriate sexual mores, racism, politics, you name it – MM slings it.

    Some here seem to enjoy that type of posting (those that shoot arrows from the low road and STILL do not get what “Terms of Use” signify, for example)

  62. Yeah, the narrow focus of the grant of cert is just as important as the grant of cert. At least we know that the Supremes are not going to invalidate drug screening methods as falling under the abstraction exception to Section 101. That is helpful, because the Supremes have yet to uphold a method claim involving a mental step as valid under 101 since Bilski.

  63. Didn’t the Fed. Circuit kind of smack down ACLU & Co. by assigning costs to Myriad? Maybe I read that wrongly. I thought that was a nice tough.

  64. MM, I am not a child in a schoolyard and I will not trade insults with you on an otherwise useful web site.

    The trend of which I speak, that American trade secret law is becoming more protective and that American patent law is becoming less protective, has been analyzed by many commentators in more practical (and less academic) publications. Any practicing IP attorney should have noticed it in his or her practice by now, although the changes in trade secret law are less pronounced in some states than in others. It is not the result of some sinister conspiracy by “moneyed elites,” but is the result of numerous decisions by both state and federal judges at various levels, in combination with the AIA.

    We’ve been here before, as there have been periods in the history of the Anglo/American jurisprudence when it was not possible to effective protect innovation through patenting. When patents are weak, inventors become more secretive (thus the common law rule that a master can swear an apprentice to 7 years secrecy, and obligate the apprentice to swear his own apprentices to 7 years secrecy during that period). We should look to similar periods in the past in determining how to react the current environment.

  65. “fill my diaper” – another really? My post is accurate and you descend (yet again) into mindless gutter insults.

    If that was a mindless gutter insult then I’d love to see some that he puts some thought into, because that one was awfully funny…

  66. It seems to me like the most important amicus briefs here will be ones that try to explain the science to the Justices, not ones that are trying to explain the law. The three judges on the Federal Circuit focused on the chemical differences between the isolated, purified DNA and native DNA (but unfortunately, didn’t do a perfect job… saying that it’s the breaking of a covalent bond that changes these things reflects a misunderstanding about the nature of the phosphodiester bonds of DNA, which aren’t quite like a conventional covalent bond). How well the Justices understand the chemical and scientific differences will dictate the result. The problem is, unless you just say that human DNA, isolated and purified, is its own patent-eligibility exception, then you have a difficult case to make for isolated, purified proteins (which have traditionally been patent-eligible) and possibly even recombinant proteins.

    The other issue in this case that I think the Justices probably need to be made aware of is that it is now next-to-impossible to get any patent on isolated, purified human DNA (or really isolated, purified DNA of any kind) after KSR, because the PTO is almost certainly going to reject claims to such DNA as obvious (“obvious to try”) and win at the Federal Circuit.

  67. * …If you don’t understand why, then it’s likely you lack the chops to discuss the issues arising from this case in a meaningful way (my apologies to any who take offense).

    That would be me. No offense taken.

  68. A smackdown of the ACLU would be nice, especially given how they ginned up the plaintiff’s in the first place.

    Now, since I know diddly about this area of technology, and since apparently it is an area with which you quite familiar, might you be able to describe the physical/structural difference(s) between DNA that has been isolated and that which exists in its natural state in the body? Is it the physical/structural differences that in my lay eyes permits isolated DNA to properly be catagorized and a chemical compound? BTW, no retort will follow whatever your comment because as noted before this is not my field of expertise.

  69. “Does the Federal Circuit actually bother to read our remand orders?”

    The Federal Circuit majority did a very good job on remand, I thought.

    Note that cert was denied on most of the questions and it remains a very strong possibility that the Court is simply going to issue an ACLU smackdown to clear up some of the worst of the stinking inaccuracies that have been presented (and continue to be presented) by the ACLU and others.

  70. one additional thought…

    who you can’t help but p-ss on every day

    Coming from the number one provider of gratuitous and mindless insults on this blog, this is yet another example of MM’s accuse others of what he does.

    It’s rather sad the combination of self-defeat and hypocrisy you present on a continuous basis MM.

  71. Maybe they should also entertain one more question:

    “Does the Federal Circuit actually bother to read our remand orders?”

  72. If the Myriad isolated DNA claims are ineligible as encompassing products of nature, I cannot see how their human or non-human origin could make a difference. I am always willing to learn from wiser people, but especially on this topic I am not looking forward to learning what the US SC justices think.

  73. The accurate part is that you have employed weasel words as the “start” of your argument, then go off kilter (again) by trying to enlarge that position into one that simply is not supported in law or fact.

    Nice touch by trying to equate business method patents with racial discrimination.

    Really?

    fill my diaper” – another really? My post is accurate and you descend (yet again) into mindless gutter insults. Ever under-impressive you are.

  74. you’ve been informed…what ever that is

    LOLOLOLOLOLOLOLOLOL.

    You crack me up MM.

    Funny, how just a short while ago you had re-found your full appreciation of “effectively,” and now, you cannot seem to understand what the term means.

    As to the other stuff you are posting – what I “appear” to be endorsing – just say no to drugs son.

  75. One additional thought: I note that cert was denied on the (really really broadly claimed) method of using an engineered cell comprising this novel nucleic acid to test things. If the Supreme Court somehow finds this novel nucleic acid composition itself “ineligible”, they’ll have to explain how/why it is possible for method claims which (already do or will) broadly describe all conceivable applications of this “ineligible” composition to remain eligible for patenting.

    That’ll be a very interesting needle to thread!

  76. business method patents have been granted throughout our nation’s patent history

    Black people have been discriminated against throughout our nation’s history.

    Any other super compelling arguments?

    Enough weasel words to avoid being a direct lie

    Translation: “You wrote something accurate again so I am going to sit here and fill my diaper.”

  77. anon, I will say this just once in this thread (you’ve been informed dozens of times in other threads on this topic):

    If Myriad’s composition claims were “effectively” claims to a “product of nature” (whatever that is), then you could identify an object in “nature” (say, a human being) that is “effectively” infringing the claim.

    That object has not been identified. If such a “natural” object had been identified, then this case would never have come this far. If, on the other hand, you believe that a claim to a novel, non-obvious composition of matter becomes ineligible for patenting merely because that claim arguably makes it more difficult for a non-licensee to study a similar but non-identical (and non-infringing) composition found in the human body, then you seem to be advocating for the creation of an entire new legal principle. It’s not necessarily an unsound principle but … coming from you it’s odd, to say the least.

    On a slight tangent, it’s striking to me (and probably others) that you appear to be endorsing rending certain chemical composition claims ineligible by taking the most extreme and irrational view imaginable of a recent Supreme Court case whose reasoning you have unequivocably denounced as nonsense..

    In any case, I’m highly confident that you’ll not have anything sensible to contribute to this thread so consider everything further that you post here to be pre-ignored by yours truly. I do hope you enjoy reading the discussion I’ll be having with the coherent folks who you can’t help but p-ss on every day.

  78. Patents were never intended to protect information, nor were patents intended to protect abstract methods of characterizing information as a precursor to its monetization (otherwise known as “doing business”).

    Lol – nice. Enough weasel words to avoid being a direct lie (no arguments about pure information or “abstract” methods), but that’s just not quite the same as the stretch to include “otherwise known as “doing business,” now is it MM? See Bilski.

    Also see the guest post right here on Patently-O awhile back that plainly showed that business method patents have been granted throughout our nation’s patent history (Oh, do try to accept that fact).

  79. we might be headed back to an 18th Century economy in which innovations are kept from the public view as trade secrets instead of publicly disclosed in patents.

    What is it about this silly case that causes people to make such bizarre statements?

    The percentage of our economy that is driven by patents to isolated polynucleotide sequences, where those sequences are identical to those in a human being, is microscopically small. Infinitesimally small is more like it.

    Please have a cup of coffee and recognize this basic fact: just because some elites out there are continually pumping the press with information about how genetic diagnostics is going to transform our world into a disease-free utopia does not mean that it is true. Based on prior experience with such proclamations it’s more likely that the exact opposite is true.

    The trend you describe (assuming it is accurate) is not driven by the changing laws of trade secrets and patents but is driven by changes in what the moneyed elites are trying to protect. It’s THAT change that is driving the changes in law that you perceive. Specifically, it’s the increased value that is being placed on information itself and controlling who has access to the most valuable information (i.e., the types of information that are most readily exploited for economic gain by the holder of the information). Patents were never intended to protect information, nor were patents intended to protect abstract methods of characterizing information as a precursor to its monetization (otherwise known as “doing business”). But some greedy attorneys smelled a new “paradigm” and here we are.

  80. Effectively, MM has misplaced his recently re-located understanding of what “effectively” means and somehow misses the Judicial Exception to patent eligibility known as the Product of Nature exception.

  81. I think even you will be willing to acquiesce that if the court has already characterised the issue thus, the outcome is pretty well set

    No doubt the framing makes a difference. On the other hand, I very much disliked the framing of the question in Prometheus but the result was more than a little bit pleasing to me.

    The odd thing about the question for cert here is that it certainly is a very easy question to answer: NO. You can not claim “Human gene X” for the same reason that you can’t claim “Human liver” or “Human blood” or “Human finger.” We can argue about what that “reason” is, I suppose, but I think the simplest answer where we’d find the most agreement is that the claims (1) cover pre-existing subject matter that was not “invented” and (2) they turn every human being into an infringer simply for existing, which means that such claims inherently read on the prior art and are therefore unpatentable per se.

    So obviously the question presented for cert is either sadly wrong (in which case a great deal of time is going to be wasted on irrelevant blawoney) or it’s laughably correct and the Supremes are going to issue another short 9-0 decision explaining some really, really basic concepts to the ACLU.

    The proper question that should be asked and answered is the one implied by my earlier comment: does an otherwise novel, non-obvious polynucleic acid composition which does NOT read on a whole human body or a cell of a human body [i.e., the sort of sequences claimed by Myriad] become ineligible subject matter when it is demonstrated, either before or after the filing of the application in which the composition is first disclosed, that the identical* sequence of nucleic acids in the claimed polynucleic acid composition is (1) found in a human cell and (2) not specifically and willfully placed in that cell.

    I can live with either answer, although I would prefer that the answer to that question is “no.” And I could care less about the impact of the answer to the above question on current or future stakeholders in the area of human diagnostics and medicine. It’s very minimal and anyone who claims otherwise is just trying to avoid discussing the substance of the legal issue. I’m also of the opinion that “settled expectations” is a shorthand for “don’t think! just follow the status quo because otherwise someone’s fee-fees will be hurt!!” It shouldn’t make a hill of beans of difference what anybody has come to “expect” if the rationale for changing the status quo is more sensible than leaving it alone.

    *Note that if you insert “extremely similar” here instead of “identical” the entire analysis turns into an exercise in insanity. If you don’t understand why, then it’s likely you lack the chops to discuss the issues arising from this case in a meaningful way (my apologies to any who take offense).

  82. IANAE is probably right. For at least ten years the Supreme Court has been addicted to vague standards that do no more than muddy the waters in various areas of the law. I think they see themselves as empowering the courts by setting down standards in which there is no predictability whatsoever.

    But, in the mean time, I am going to advise my clients to treat biotechnological innovations as trade secrets, not as patentable subject matter. Seeing as American trade secret law keeps getting more protective, and American patent law keeps getting less protective, we might be headed back to an 18th Century economy in which innovations are kept from the public view as trade secrets instead of publicly disclosed in patents.

  83. even if they somehow manage (against my prediction) to reach the conclusion that any polynucleotide composition comprising a sequence found in the human genome is ineligible subject matter,

    I’ll go out on a limb and say they’ll probably come up with the same unhelpful “we can’t definitively say no on these facts” we got from Bilski. But without the helpful “MOT almost always gives you the answer, which will pretty much always make the answer no” of Bilski.

  84. In other news, water is still wet.

    I know it’s always been extremely difficult for you to make any kind of a positive statement other than “patents are the greatest thing ever,” but maybe you try really really hard this time to let us all know what your comment was supposed to imply.

    Surely you weren’t simply making the trivial point that the law can change over time? That can’t possibly be the sort of “substance” you are always haranguing the rest of us about.

    Do let us know, anon.

    Oh, and for the record: I predicted the Supreme Court’s wouldn’t even bother touching this case. I was wrong about that. Based on the question certified, however, I remain hopeful that even if they somehow manage (against my prediction) to reach the conclusion that any polynucleotide composition comprising a sequence found in the human genome is ineligible subject matter, it’ll be sufficiently narrow so as not to disturb the eligiblity of “nature-similar” chemical compositions generally.

  85. MM sees the writting upon the wall. It is all in the framing of the question, and if they’ve already accepted that the question on appeal is that which D says it is, the case is over my friend. Myriad loses.

    I think even you will be willing to acquiesce that if the court has already characterised the issue thus, the outcome is pretty well set.

  86. can be eligible subject matter when it is filed but can become ineligible later

    In other news, water is still wet.

  87. “Are human genes patentable subject matter?”

    Answer: No.

    Question: Are novel, non-obvious chemicals patentable?

    Answer: That might depend on whether the chemical is a polymeric nucleic acid with a sequence of nucleotides that resembles a sequence in a human.

    Question: Does that include humans in “nature” as well as humans who live or work in hospitals, office buildings, or post offices?

    Answer: Of course. All of those things are part of our natural world.

    Question: What about human cells exposed to man-made chemicals that are known to be mutagens?

    Answer: Yes. Such cells are comprised by human bodies throughout the world and have been since the dawn of mankind. And such cells can also found growing in petri plates in labs throughout the world, just as “naturally” as yeast cells grow on grapes.

    Question: Do human beings comprise DNA sequences that are also found in non-human organisms?

    Answer: Yes, sequences are shared with animals as closely related as monkeys and as distantly related as bacteria.

    Question: So a novel, non-obvious gene in a genetically engineered shrimp can be eligible subject matter when it is filed but can become ineligible later when the same sequence is found in a single human who had been exposed to a chemical mutagen as part of a chemotherapy regime?

    Answer: You’ll have to ask the ACLU. They are the geniuses who created this cluster—k.

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