CareDx v. Natera: A Response To Professor Holman

Guest Post by Edward Reines.  Reines Co-Chairs the nationwide Patent Litigation practice at Weil Gotshal. He represents CareDx and Stanford in the pending patent lawsuits.

Professor Holman’s recent post on the Federal Circuit’s CareDx v. Natera opinion is a thoughtful addition to Professor Crouch’s review of that decision.  Professor Holman concludes that the Stanford inventions were doomed from the start because they can be labelled as “molecular diagnostics methods” and are thus patent ineligible under Federal Circuit law.  Professor Holman’s conclusion is troubling.  It would limit the patentability of new inventions in an entire scientific discipline merely based on a label.

This labelling mode of analysis is fundamentally flawed because the Supreme Court’s Alice decision mandates a two-step test focused on the claimed advance of the patent, no matter the field of invention.  The test is designed to “distinguish between patents” that would pre-empt a field by broadly claiming “[l]aws of nature, natural phenomena, and abstract ideas” and patents that do not pose this risk because they add to these concepts with “human ingenuity.” There is thus nothing inherent about molecular diagnostics that precludes their patentability and merely labelling a method as “molecular diagnostics” should not be a kiss of death.

Take the Stanford patents.  Those patents document that the natural correlation between organ rejection and elevated levels of cell-free DNA of the organ donor was known for almost a decade before the inventions.   The patents then explain that numerous scientists motivated to measure that increase in cell-free DNA failed to come up with the patented measurement methods.   The patents cite an article published right before the Stanford patent filing that concluded that it was altogether “impractical” to measure cell-free DNA to monitor organ rejection.

The Stanford patents distinguish the failed prior art measurement efforts and describe new inventions on how to better measure cell-free DNA using advanced DNA analysis techniques.  The claimed inventions are better measurement methods that previously eluded the field – not the discovery of the natural correlation itself.  And there was no claim that they posed the pre-emption risk that animated Alice.

Federal Circuit law places at the heart of Alice step one whether the “claimed advance” is the natural law.  In CareDx, as Magistrate Judge Burke had originally concluded, the claimed advance of the Stanford patents is an improved human-devised measurement method.  The Federal Circuit’s opinion failed to properly focus on the “claimed advance” analysis and failed to squarely address that the patents describe numerous prior art failures. This prior art history is irreconcilable with the panel’s conclusion that the patented measurement methods are so conventional as applied to the natural correlation that they could not possibly qualify as patent-eligible human invention.

Instead, the Federal Circuit imported the “conventionality” analysis from step two into step one in lieu of a proper “claimed advance” analysis of Federal Circuit precedent.  As originally contemplated in Mayo, the “conventionality” analysis was akin to determining if the claims included mere trivial additions on top of discovery of a natural law.   Here, the conventionality analysis instead became a short-cut obviousness analysis.  Yet, even that fails because the decade of prior failures at measuring the cell-free DNA for a good organ rejection test proves that it was not conventional to use the patented measurement methods for this purpose – otherwise the many groups working on the problem would have arrived at that solution ultimately invented by the Stanford team.  And the supposed disclaimers in the patents never even suggest that applying the claimed measurement techniques to the tough context of cell-free DNA somehow was not an invention.  Everything about the description of the inventions is inconsistent with that conclusion.

The Federal Circuit cannot blame the Supreme Court for this latest constriction of molecular diagnostic patenting even though many Federal Circuit judges have bemoaned the stinginess of the Supreme Court’s Alice test in this area.  As explained long ago in Diamond v. Diehr, and as repeated in Bilski and Mayo, the Supreme Court recognizes that: “It is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.”  Even if the Stanford measurement methods were known (and the prior art history calls that into serious doubt) their application to a natural law can certainly be patent eligible if it is the product of human innovation, as claimed by the patents.

Professor Holman’s conclusion that the Federal Circuit labelling method may have controlled the CareDx outcome should give real pause to the patent law community.   Such labelling might be useful to describe the inventions at issue in prior decisions, but it is not a basis to proscribe whether an invention is eligible for patenting.   The Stanford patents are plainly directed to a better measurement method that evaded many motivated prior artists.  Such human innovation is the claimed advance and is patent eligible under Alice even if it can be labelled as a molecular diagnostic method.

67 thoughts on “CareDx v. Natera: A Response To Professor Holman

  1. 8

    I guess it makes the fundamental ‘,information’ nature of the innovation (i.e., the biomarker) just too plain to see??

    No sheet Sherlock.

    The major problem is one of information.

    My suggestion is to look at the nature of the utility of the information.

    Useful in a human mind? Not eligible.

    Useful toward a non-human actor’s proximate goals? Eligible.

    It’s so simple that anon can almost understand it.

    1. 8.1

      LOL – it has never been a question of whether I can understand your claptrap.

      It has always been a matter of you not understanding the terrain of patent law and what utility means in the patent sense.

      That sense is ALWAYS judging usefulness as per a human mind. Here, you seem to want to tweak your phrasing, but “Useful toward a non-human actor’s proximate goals?” just does not work.

      Yet again: traffic light. A very simple example that absolutely wrecks your nonsense.

    2. 8.2

      It’s so simple that anon can almost understand it.

      [Citation needed]

    3. 8.3

      I largely agree with you. I’m think* I’m just more supportive of the patentability of diagnostic methods, both textually and from a public-policy standpoint.

      *you view Mayo as correct, right? No patents on new/nonobvious biomarkers?

      1. 8.3.1

        *you view Mayo as correct, right? No patents on new/nonobvious biomarkers?

        If the utility of the new, non obvious and useful information arises in a human mind, its fundamentally and fully abstract. Mayo is correct so far as thinking about a correlation- which cannot and must not be an infringing act.

        However, no human mind, no abstraction in the utility. If a nanobot uses a correlation to control a process that it is performing, the utility is non-abstract and should be eligible- subject to 112, 103 etc.

        Judges should construe the result of a process patent as a matter of law.

        1. 8.3.1.1

          More gobbedlygook with “However, no human mind, no abstraction in the utility.

          No human mind to judge utility (in the patent sense), no utility at all.

          You just don’t seem to even want to come close to understanding the terrain here marty.

          1. 8.3.1.1.1

            The word abstract has major meaning in your so-called “terrain”.

            The Supreme Court, unhelpfully, won’t tell us exactly what it means- but judges know it when they see it.

            Since the latin root of the word abstract means to “draw away” and clearly there can’t be abstraction without a human mind, its hardly an illogical jump to conclude that humans making use of information is a pure abstraction.

            It’s also a handy test and a natural border for policy purposes.

            Meanwhile, all you got is that “abstract” should be ignored because it’s not in the Act of 1952.

            One of us knows the terrain and it ain’t you sister.

            1. 8.3.1.1.1.1

              Lol – you have zero clue as to the terrain, “sister.”

          2. 8.3.1.1.2

            PS Curmudgeon – per their own words- is yet another person who generally sees it my way.

            Slowly, then suddenly.

            1. 8.3.1.1.2.1

              Do not dislocate your shoulder there marty as that was no “general agreement,” but was much less a ‘polite’ nod to a minor point.

              On that minor point, C is clearly mistaken.

              1. 8.3.1.1.2.1.1

                … this is yet another reason why “politeness” is vastly overrated.

    4. 8.4

      “The major problem is one of information.”

      Could be. I see it more as a “group management” issue as the pain problem. The Group is the Congress, and those few who manage the group are doing a terrific dis-service to the advancement of the art in cancer et al. research by seemingly turning a shoulder to new diagnostic methods.

      A huge part of various charities and even a gov or two (collectively “leeches”) keep touting the necessity of further cancer research, b/c … a cure is just around the corner……

      At the same time, the System IP Machine seems to be not wanting to promote progress in the medical diagnostics area, by frowning on new developments. It is become, a neuroticism-generator.

      If you just today invent electrophoresis or paper chromatography, and can use it to separate a complex mixture of lipid substance extracted from a living subject’s spine and make more-efficacious medical practice based on the quantity of say, ratio of arachidonic to clupadonic acid present, that seems fair game to easily win a patent for. Stuff like that is genius oft.

      The true criteria are mainly new, useful, non-obv. Section 101 only contains a reference to conditions and requirements found elsewhere in the Title.

      I can’t see the group management getting any better, so the battle is on the Lawyers.

  2. 7

    Following up on Ben’s comment below it is more than a bit odd that the recent complainers on the front page aren’t explaining to everyone exactly where in the claims these “improved detection methods” are described.

    One reference stating that a known detection method is “impractical” for purpose X is hardly a teaching away from the utility of a prior art detection method that is known to be incredibly powerful when the correct conditions for achieving that power are identified. Are those conditions in the claims, along with a description of the limits of the claims (upper and lower bounds of detection that are possible under those conditions)? That’s the start of a fix for securing patent rights to this alleged invention.

    At some point it was “impractical” to use a plane to fly public passengers across the pacific ocean but once it became clear to anyone in the art that it was theoretically possible to do it (even if “impractical”) all subsequent claims to “use a plane to fly to X” were d.o.a. UNLESS they recite a specific non-obvious improvement in the plane. It doesn’t matter how specifically you describe X or if nobody knew about the existence of X. What matters is that the actual solution to the problem is laid out in the claim itself and was never taught or suggested before.

    1. 7.1

      I’m disappointed, Prophet, that nobody has replied to your assertion that the claim has to do more than state the problem, namely, it has to recite the solution. Forty years of EPO practice reveals that toggling between problem and solution is a remarkably potent way to tease out, with guaranteed fairness to both inventors and the public, what is patentable from what is not.

      Where is Greg on this? What does he say?

  3. 6

    Greg >>the feedback that the CAFC is getting is that their jurisprudence is on the right track.

    Nope. What is happening is the Scotus doesn’t really care right now. The Scotus made some really broad cases and is letting the CAFC do what they will with them.

    The CAFC could easily cabin these cases and I’d bet that the Scotus would ignore them too.

    1. 6.1

      Fair enough. Neither of us can really know the counterfactual, so I cannot meaningfully say that you are wrong, any more than you can meaningfully say that I am wrong.

      1. 6.1.1

        Fair enough Greg.

  4. 5

    > The test is designed to “distinguish between patents” that would pre-empt a field by broadly claiming “[l]aws of nature, natural phenomena, and abstract ideas”

    As I explained last thread, SCOTUS isn’t even consistent on that point. The big problem with bioinformatics isn’t that it revolves around discovering new “natural phenomena.” The ‘test tube’ exception to Alice that SCOTUS announced in Myraid remains good law i.e., you’ll have a valid claim if you create a new molecule *even if the new molecule is just a trivial variation of the biomarker and all the steps in its creation are ‘conventional’*

    Instead, the big problem with bioinformatics at the Fed Cir seems to be that the field primarily uses computer processing (vs. chemicals). I guess it makes the fundamental ‘information’ nature of the innovation (i.e., the biomarker) just too plain to see??

    Semi-related: I’m expecting that all “applied machine learning” patents will be declared invalid in the next few years, because they too only discover natural correlations hidden in large data sets. And worse, 99% of them can’t even describe those correlations for 112 purposes as well as the bioinformatics folks do.

    1. 5.1

      I’m expecting that all “applied machine learning” patents will be declared invalid in the next few years, because they too only discover natural correlations hidden in large data sets. And worse, 99% of them can’t even describe those correlations for 112 purposes as well as the bioinformatics folks do.

      +1

      1. 5.1.1

        I actually see pretty much anything with a processor as being invalid. These are by definition “abstract”, as they have software that can be explained on paper. And it only “sometimes” matters what’s wrapped around them. Garage door openers, cameras, video transcoding equipment, power grid equipment, all invalid. Based on that logic, anything with a processor can be invalid, you just need certain judges on the panel.

        1. 5.1.1.1

          I think BobM is right that anything with a process can be proclaimed abstract.

          That has been known almost since Alice.

          Just a giant shxt show.

          1. 5.1.1.1.1

            “ anything with a process can be proclaimed abstract.”

            Anything can be “proclaimed” to be anything. So what? There are no Federal judges out there “proclaiming” that all process claims are ineligible under the current law. None. And any judge who does “proclaim” that can and will be mocked as a low intelligence mewling dirtbag, just like the mindless crying commenters here who “proclaim” such things.

            What you maximalists never seem to grasp is that people are patenting process claims all the time, and asserting them, and those claims are not being declared eligible. Maybe it’s you and your greedy intellectually stunted clients who are the problem?

            1. 5.1.1.1.1.1

              “declared INeligible”

              Darn auto-correct.

            2. 5.1.1.1.1.2

              Likewise, there are no judges out there “proclaiming” that any claim “with a processor” is ineligible.

              Are SOME claims reciting a processor ineligible? Definitely. If the processor in the claim is ineligible on its own terms, will reciting some traditionally eligible but old element rescue the claim? Nope. If the claim recites non-obvious eligible subject matter (i.e., an eligible invention), will the addition of an element describing a processor make the claim ineligible. Hardly ever.

              Do you patent lawyers here have the intelligence to deal with these constraints and discuss them like normal intellectually honest reasonable people? The answer for most of you is “no.” Look in the mirror and do some reflecting.

              1. 5.1.1.1.1.2.1

                That is just not how the law is, Malcolm (and you well know it).

                See Diehr.

        2. 5.1.1.2

          I actually see pretty much anything with a processor as being invalid.

          The frustrating thing about Mayo/Alice is that we have seen a long parade of claims that do not deserve to fail under §101 going down on §101 grounds. However, to say that they do not deserve to fail §101 is not to say that they really were valid and enforceable. For the most part, §101 is being substituted (rather arbitrarily) to do the work that §§ 103 or 112 should be doing in a given instance.

          Obviously, there have been plenty of cases where claims to physical objects that can include a processor (Enplas Display v. Seoul Semiconductor, 909 F.3d 398 (Fed. Cir. 2018), Apple Inc. v. Wi-LAN Inc., 25 F.4th 960 (Fed. Cir. 2022), Kaufman v. Microsoft Corp., Federal Circuit 2022, etc) have been held valid and infringed. In other words, there certainly is no per se rule that if there is a processor, the claims will not hold good.

          What I have taken away from the case law is that §101 is being used in place of §§ 103 & 112. If you write a claim that should survive a §103 challenge and a §112 challenge, it will probably survive the §101 challenge. If the claim should fail for §103 or §112, however, then it will probably go down (bizarrely) for §101. This is an unsatisfactory result, to be sure, but it is the sort of thing on which a lawyer can be of use to the client in deciding whether and how to protect the invention.

          1. 5.1.1.2.1

            and the filter kicks in…

            Your comment is awaiting moderation.

            July 28, 2022 at 4:09 pm

            Greg “Dozens” gets it wrong.

            Again.

            The fact that certain cases show passing of 101 is NOT ANY type of ‘salvation.’

            As I have long noted, it is a Gordian Knot, and the fact that a case COULD pass and that same case COULD ALSO NOT pass IS very much a major part of that problem of the Gordian Knot.

          2. 5.1.1.2.2

            Greg, that makes sense but raises another question, namely, how to those working for the inventor best help the PTO and the courts to categorize the subject matter as new and inventive, even before the Examiner issues the first Action on the Merits, so that the claims have at least a sporting chance of surviving the 101 enquiry.

            Could it be that this is why clients based in the USA are pushing their cases at the EPO, to get early allowance of commercially useful claims?

            Could it be though, that the most important way is to draft the specification in a way that presents the claimed subject matter as an ingenious and effective solution to a real problem in a technical field, reflecting what a properly functioning patent system is supposed to do, namely, positively to promote progress more than enough to counter-balance the inevitable, and negative, restraint of trade caused by the grant of exclusive rights.

            You know, the way everybody drafts, these days, except for drafters within the USA.

            1. 5.1.1.2.2.1

              if I might butt in…

              “… best help the PTO and the courts to categorize the subject matter as new and inventive…”

              In the US, we don’t. The laws are different in EU as they are based on what is permissible is tht which is specified as permissible, whereas in the US, all is permissible except that which is not expressly verboten. So, we do not need to help the “system” of courts and PTO to make any determinations, the burden is on them to specify instead, why not is the invention patentable.

              It is a fundamental difference, jurisdictions where all is permitted excepting that which is expressly forbidden vs. others where alles ist verboten excepting that which is expressly permissible.

              1. 5.1.1.2.2.1.1

                Thanks Chrissy,

                You may be unaware that for forever and a day MaxDrei has been an EPO Uber Alles shill, and routinely 1g n0res that different Sovereigns have made different choices.

              2. 5.1.1.2.2.1.2

                “ we do not need to help the “system” of courts and PTO to make any determinations”

                Meet the world’s st0 0pi dest and most toxic patent attorneys right here folks.

                1. Malcolm, right there you made my day. I laughed out loud. With great gusto.

                  You set me wondering though, how clients are faring, whose patent applications are written by “C.Whewell” and “anon”. Not sure these individuals are “toxic”. I prefer to think of them as misguided. For their clients though, it is irrelevant. The bottom line is that they fail to get a full scope of protection for their clients’ meritorious contributions to the art.

                2. Aww, I was just repeating what two Eu and two UK lawyers each tole me independently, on four separate occasions 20 years ago, on their turf, la la la, maybe things have changed.

                  We used to compare and contrast UK law and Deutschland all the time at the pub, and likewise in Munchen, once at Augustiner and another time on Pettenkoffer strasse. la la la, maybe things are different now, did they merge UK law with Germany ? doubt it. Have fun ya’all, stay safe.

                3. A clear sign that MaxDrei is DEEP into the weeds:

                  Malcolm, right there you made my day. I laughed out loud. With great gusto.

                  When was the last time that Malcolm was actually correct about how the legislated US patent law is to be properly understood?

                  Ever?

                  And here, Malcolm mouthes a simple base insult and MaxDrei becomes giddy….

              3. 5.1.1.2.2.1.3

                And so? In the real world?

    2. 5.2

      Correlations aren’t eligible subject matter for protecting with a patent. You can’t “claim around” this barrier. An eligibility requirement that always you to protect a correlation because “a computer found it” or because “it was found using a calculator” is worthless.

      Correlations aren’t eligible for patent protection. They’ve NEVER been eligible for patent protection. This is a good thing! Normal people who aren’t high on patent crack understand this.

      Is there a theoretically possible way to give the “discoverers” of correlations and other “valuable facts” some sort of compensation? Sure. But the answer is definitely not “use the utility patent system.” That’s absurd, I’m addition to being disgusting and harmful to both the system and whatever field of endeavor is associated with the correlations.

      Consider that the people who are designing and building (not programming) non-obvious improved computers — the computers that can carry out this data mining — are already being paid and can also obtain patents on their inventive tools. The programmers of those machines get paid well. Seems like perfectly fine incentives and lo and behold tons of new (and unpatentable -yay!) correlations are being discovered (and disclosed!) every day.

      1. 5.2.1

        Correlations aren’t eligible subject matter for protecting with a patent. You can’t “claim around” this barrier.

        Well, sometimes you cannot claim around that prohibition, and sometimes you can. Diagnostic method claims have failed every time they have been asserted post-Mayo. However, if the diagnostic outcome affects the course of treatment, then you can instead claim a “method of treatment” instead of a “method of diagnosing,” and Vanda Pharma. v. West-Ward Pharma., 887 F.3d 1117 (Fed. Cir. 2018) tells us that the “method of treatment” claims can still hold good. The trick is that you have to have a different course of treatment to be administered in view of the different diagnostic outcomes—even if all of those courses of treatment are old in the art.

        1. 5.2.1.1

          >even if all of those courses of treatment are old in the art.

          That sound awfully close to a “well-understood, routine, and conventional” course of treatment (once the hard part has been accomplished i.e., the correct diagnosis). Another loophole in the Mayo/Alice framework?

          My conspiracy theory is that SCOTUS and the FedCir are secretly just applying the old State Street Bank test. Test tubes and methods of treatment seem more ‘tangible and concrete’ than does data processing.

          1. 5.2.1.1.1

            your prior comment about the resurrected “Gist” comes to mind as well….

          2. 5.2.1.1.2

            “ Test tubes and methods of treatment seem more ‘tangible and concrete’ than does data processing.”

            They ARE more concrete than data processing. Data and data processing are abstractions. Test tubes are not abstractions.

            Vanda is itself a terrible decision and the “confusion” created by the CAFC in that case os, as Greg notes, the result of the CAFC trying to create a loophole and failing miserably.

            Consider a claim to a method for “reducing risk of dehydration” based on my “discovery” of an “important” temperature parameter. The first step is that you determine whether the temperature in your environment is greater or less than 82.454 degrees. If it’s greater, you drink two sips of water within ten seconds, if it’s less you drink one sip of water and wait more than ten seconds for the next sip.

            Is this an eligible claim? Of course not. Allowing claims like this turns DECISION MAKING BASED ON A CORRELATION into an infringing act which is utterly insane. Beyond that, if you open the gates wide to this kind of stuff neither the PTO nor doctors or anybody else will be able to keep up with the disclosure of “infringement liability creating information” that might be used for decision-making.

            The claims at issue in Mayo were WORSE than this claim, by the way. Consider that next time you whine about the case.

            The properly drafted claim, by the way, is the claim that describes just the actual “inventive” step without any “choice” to practice a non-inventive method. In other words, it’s a method treatment where the step is the non-obvious administration of a chemical or combination of chemicals. The non-obviousness can flow from the chemical (if it’s new) or from the particularly described subject (if that type of subject has never before been treated with the chemical before) or both (if you really want a “strong” claim).

            1. 5.2.1.1.2.1

              Yet again ploying your desire to exclude methods from including decision making AS A PART OF a process is nothing more than a BAD attempt at moving the goal post and making a part of a claim TO BE the entire claim.

              You’ve attempted this like forever – even back to the slapped-down “entirely-in-the-mind” misadventures of yours in the computing arts.

              Sorry Malcolm, you are just going to have to recognize that innovation protection is meant even for the Fifth Kondratiev wave.

      2. 5.2.2

        Correlations aren’t eligible subject matter

        Are you moving the goalposts again?

        Taking an element and pretending that such is the claim as a whole?

        Much like you used to do with “Entirely In The Mind?”

  5. 4

    Sorry, MaxDrei, I don’t remember seeing this argument–how is US patent law currently violating GATT-TRIPS?

  6. 3

    “The claimed inventions are better measurement methods that previously eluded the field – not the discovery of the natural correlation itself.”

    Where are these better measurement methods in the claims?

  7. 2

    Ed got it right. The claims of these patents were — and remain — unquestionably eligibility valid.

    But the problem, you see, is that the CAFC just does not give a d.a.m.n.

    Congress could fix this, but . . . Congress.

  8. 1

    Professor Holman’s conclusion is troubling. It would limit the patentability of new inventions in an entire scientific discipline merely based on a label.

    Prof. Holman’s conclusion is troubling because the law is troubling. The law ought not to exclude molecular diagnostic methods, but for all intents and purposes it does. It is not Prof. Holman’s conclusion that is doing the limiting, but rather the law that Prof. Holman summarizes with regrettable accuracy.

    1. 1.1

      The issue that interests me is why none of the Fed Ct judges is showing any interest in distinguishing all these meritorious diagnostics cases from the Supreme Court’s ratio in Alice. Is it perhaps that they are motivated to resist what they vaguely perceive to be an ever-accelerating “creep” of eligibility into fields of technology outside the useful arts?

      Or is it that they simply lack a scientific education at a level high enough for them to understand the difference between i) natural philosophy as such and ii) new, useful and inventive advances in the useful arts that are made available by advances in natural science?

      Or is there some other reason? Perhaps the trial judges are still waiting for a trial lawyer who i) is perfectly briefed on both the underlying science and on the meaning of the claim, ii) has a high enough scientific education to understand the matter exactly, and ii) is rhetorically talented enough, to help the judges through to the same exact scientific understanding, without which they will not be in a position to write a correct decision?

      Or is it that the courts are still dealing exclusively with patents drafted before Alice gave the drafters a new drafting roadmap?

      Meanwhile, in this regard, the law of the USA continues to offend its international obligations under GATT-TRIPS. Regrettable, for sure.

      1. 1.1.1

        Sorry, MaxDrei, I don’t remember seeing this argument–how is US patent law currently violating GATT-TRIPS?

        1. 1.1.1.1

          Signatory States must provide patent protection in “all fields of technology”. Who says that methods of diagnosis are not within a field of technology?

          1. 1.1.1.1.1

            Please define “technology” (in a non-circular manner).

            Or are you going to fall back again on that cop-out “remain hazy for future thingies?”

          2. 1.1.1.1.2

            Thank you. I guess the counterargument would be that patents for methods of diagnosis are not officially excluded (not per se forbidden) and therefore the US does not violate this rule. It seems like achieving the same result through a variety of changes in the law should also violate this rule and must have been addressed at some point (generally, under GATT-TRIPS). Seems like it would be a difficult suit to bring and win though–there would have to be a complaint brought to the WTO, right? So another country would have to bring a dispute against the US on behalf of its citizens….

      2. 1.1.2

        As to: “The issue that interests me is why none of the Fed Ct judges is showing any interest in distinguishing

        You sure do not like to listen, do you MaxDrei?

        I have explained this quite plainly, even using the colorful analogy of the putative psychological experiment of training simians in a cage with a fire hose.

      3. 1.1.3

        … and what exactly is this “an ever-accelerating “creep” of eligibility into fields of technology outside the useful arts?

        Why do you insist on ignor 1ng the fact that the US term of Useful Arts is wider than “technology” (however loosely you may choose to define that term?)

      4. 1.1.4

        “Or is there some other reason? ”

        Ja, kein wissenschaft lehrnen ! Kurzsichtiger !!

        link to amgreatness.com

        1. 1.1.4.1

          Prager U is just not going to register with many here, my pal.

      5. 1.1.5

        Max, you are not the only one confusing the rationale and line of Sup. Ct. decisions applied to some diagnostic tests with the different rationale and line of Sup. Ct. decisions applied to quite a few software-related end-result claims, and misleadingly calling them all “101” decisions or “Alice” decisions.
        The Supreme Court in Diamond v. Chakrabarty, as reconfirmed in more recent decisions, made clear that there are three different grounds for such “unpatentable subject matter” decisions. Stating that: “The laws of nature, physical phenomena, and abstract ideas have been held not patentable.* See Parker v. Flook, 437 U.S. 584, 98 S.Ct. 2522, 57 L.Ed.2d 451 (1978); Gottschalk v. Benson, 409 U.S. 63, 67, 93 S.Ct. 253, 255, 34 L.Ed.2d 273 (1972); Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 68 S.Ct. 440, 441, 92 L.Ed. 588 (1948); O’Reilly v. Morse, 15 How. 62, 112-121, 14 L.Ed. 601 (1854); Le Roy v. Tatham, 14 How. 156, 175, 14 L.Ed. 367 (1853).”
        *Of these three different grounds the former are applied in Mayo-type decisions and the latter is applied in Alice-type decisions.

      6. 1.1.6

        [W]hy [are] none of the Fed Ct judges… showing any interest in distinguishing all these meritorious diagnostics cases from the Supreme Court’s ratio in Alice[?]

        Many of these ineligibility decisions have been appealed to the Supreme Court. The Court has repeatedly declined to review these decisions. In other words, the feedback that the CAFC is getting is that their jurisprudence is on the right track. We are getting the law that the Supreme Court wants, and will continue to do so until Congress intervenes.

        1. 1.1.6.1

          Sadly, I must concur with Greg.

          Perhaps the changing make-up of the Court will spur a change (along the lines of the Kavanaugh Scissors – with the Barrett Pivot**)

          ** newly added.

        2. 1.1.6.2

          OK, Greg. Accepted. But that answer somehow begs the next question, namely why are those eminent and self-confident Justices of the Supreme Court so inflexible on this issue. Might it be for one or more of the reasons I set out at 1.1 above?

          1. 1.1.6.2.1

            Different Justices have had different views (while pretty much all still maintain their addiction to sticking their fingers into the wax nose of patent law).

            Many times in the past many different commentators (including me) have pointed out the importance of keeping track of the Justices in their opinions.

            Why then would you be surprised here?

      7. 1.1.7

        [T]he law of the USA continues to offend its international obligations under GATT-TRIPS.

        I used to believe this, but I find myself more and more skeptical of this argument. TRIPS Art. 27(2) provides that “[m]embers may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect… human… health… .” There is a colorable argument for the freedom of doctors to diagnose without fear of patent liability coming within the scope of this 27(2) exception. It is not a sure winner of an argument, but not a sure loser either.

        Meanwhile, TRIPS violations only matter if there is some WTO member out there willing to bring an enforcement action against the U.S., but plenty of other WTO members have had similar provisions in their law for decades now. If this was the sort of thing about which WTO members were inclined to fight, it would have already happened. There just does not seem to be any sort of international appetite to seek a ruling on the extend of the Art. 27(2) exception. Functionally, then, it is hard to say that the U.S. is not in compliance with our TRIPS obligations.

        I wish that the WTO would say that we are out of compliance. That might spur Congress to act. It does not seem a likely development, however.

        1. 1.1.7.1

          Greg, I’m pleased that my provocative GATT-TRIPS question produced such an informative answer, an answer that I find 100% persuasive. After all, the EPC itself excludes from eligibility methods of diagnosis, but only “as such” and only “when practised on the human or animal body”. Thank you.

          It was Paul Cole who was running this GATT-TRIPS point some years ago, but I haven’t read anything from him in recent years on this point. Now I know why.

      8. 1.1.8

        [W]hy [are] none of the Fed C[ir] judges… showing any interest in distinguishing all these meritorious diagnostics cases[?]

        To be fair, they have shown some interest in distinguishing Mayo/Myriad. They have given us Vanda Pharma. v. West-Ward Pharma., 887 F.3d 1117 (Fed. Cir. 2018) and Rapid Litigation Mgt. v. CellzDirect, 827 F.3d 1042 (Fed. Cir. 2016). These are not nothing.

        1. 1.1.8.1

          Poor widdle Greg – there are a host of cases holding contradictory results.

          That is very much part of the problem.

          1. 1.1.8.2.1

            Oh Greg, you might earn the ire of BobM with such a political link.

            (Noting that the majority of “created jobs” are merely in fact COVID-related “pick-ups” to which Biden falsely claims credit to. He happens to do that false credit-claiming quite a lot.)

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