CareDx v. Natera: Some Further Thoughts on the Patent Eligibility of Molecular Diagnostics

By Chris Holman

A couple days ago Dennis posted a nice review of the Federal Circuit’s recent decision in CareDx v. Natera, in which he emphasized the fact that the court characterized a number of boilerplate statements in the patent document as “admissions” that the various DNA analysis technologies recited in the claims, e.g., next-generation sequencing (“NGS”) and digital PCR, were “conventional” for purposes of step two of the Alice/Mayo framework. I decided to write this follow-up post to explain why, in my view, these “admissions” in the patent document did not affect the outcome in the case, and that these claims were doomed irrespective of the patent’s characterization of the technologies.

The reason these claims were deemed patent ineligible, in my view, is that they are directed towards a molecular diagnostic method, and, as Judge Moore bemoaned in her dissent from the Federal Circuit’s denial of en banc rehearing of Athena Diagnostics v. Mayo, 927 F.3d 1333 (Fed. Cir. 2019), the Federal Circuit’s current interpretation of the Supreme Court’s decision in Mayo v. Prometheus has “resulted in a per se rule that excludes all diagnostics from eligibility.”  She notes that ‘[s]ince Mayo, we have held every single diagnostic claim in every case before us ineligible.” As such, the outcome in CareDx was, in my opinion, preordained. In fact, it would have been quite unexpected if the Federal Circuit had upheld the eligibility of the claims, given that in Athena Diagnostics all 12 of the judges that heard the case appeared to agree with Judge Moore’s assessment of the current state of affairs at the Federal Circuit regarding the eligibility of diagnostic claims of this type.

Athena Diagnostics is a very interesting decision for those of us concerned about the patent eligibility of molecular diagnostics. It resulted in eight separate opinions, in which all 12 of the judges who decided the case joined, in various combinations. Interestingly, as Judge Moore pointed out, ‘”[n]one of [her] colleagues defend[ed] the conclusion that claims to diagnostic kits and diagnostic techniques, like those at issue, should be ineligible.” In fact, my reading of the decisions is that all of the judges agreed that molecular diagnostics should generally be eligible for patent protection, and that the fact that they currently are not is a significant cause for concern.

There is a split of the court, however, with respect to whether the Federal Circuit has the ability to address the problem without an intervention by the Supreme Court or Congress. A seven judge majority (Lourie, Reyna, Chen, Hughes, Prost, Taranto, and Dyk) believes that the court’s hands are tied, and that Mayo dictates that diagnostic methods are patent ineligible. Judge Lourie, for example, wrote that the court could “accomplish little in [rehearing this case], as we are bound by the Supreme Court’s decision in Mayo.”  Judge Hughes “agree[d] that the language in Mayo, as later reinforced in Alice, forecloses this court from adopting an approach or reaching a result different from the panel majority’s.”

In light of this interpretation of Supreme Court precedent, these judges thought it would be futile to take up the case en banc. For example, Judge Hughes wrote that, while he “agree[d] that the bottom line for diagnostics patents is problematic[,] this is not a problem that we can solve. As an inferior appellate court, we are bound by the Supreme Court.”

The five dissenting judges (Moore, O’Malley, Wallach, Stoll, and Newman), on the other hand, expressed the view that, in fact, Mayo had not rendered all molecular diagnostics patent ineligible per se, and that the Federal Circuit had erred in interpreting Mayo in this restrictive manner. Judge Newman, for example, found the “majority’s position [to be] a flawed interpretation of the Court’s decision in [Mayo].  The Court did not hold that methods of diagnosis are subject to unique patent-eligibility rules. We have mistakenly enlarged the Court’s holding, in substance and in application.”  These five judges would have reheard the case en banc, allowing the Federal Circuit an opportunity to correct this perceived error, and opening up the door for the patenting of at least some molecular diagnostics.

Notably, two of the judges that decided CareDx, Lourie and Hughes, were part of the Athena Diagnostics majority that interpreted Mayo as requiring a finding of patent ineligibility for diagnostic claims of this type. The third judge on the CareDx panel, Judge Bryson, was a senior judge at the time Athena Diagnostics was decided, and did not participate in that decision.

In CareDx, the patent owner tried unsuccessfully to convince the court that the DNA analysis techniques specifically recited in the claims were “unconventional” enough to avoid the strictures of Mayo. While implicitly acknowledging that techniques such as PCR and DNA sequencing are conventional, CareDx basically argued that digital PCR and next-generation sequencing were sufficiently cutting edge at the time of the purported invention as to be not “conventional” for purposes of the Mayo two-part framework. But these techniques were apparently known to those of skill in the art at the time, and under the Federal Circuit’s current interpretation of Mayo I think the court would have found the use of any known method of DNA analysis to be lacking in the “inventiveness” required to meet the standard. While the “admissions” in the patent document provided a convenient route for the court to conclude that the methods were conventional, I think it would have arrived at the same conclusion regardless of any statements made in the patent, given that these techniques were presumably not novel at the time of invention.

87 thoughts on “CareDx v. Natera: Some Further Thoughts on the Patent Eligibility of Molecular Diagnostics

  1. 7

    Reportedly another legal article describes this as holding the “..inventions were unpatentable “[b]ecause the ‘patents are directed to a natural law together with conventional steps to detect or quantify the manifestation of that law.’” That dual requirement is far from killing all diagnostic patents.

    1. 7.1

      That dual requirement is far from ki ll ing all diagnostic patents.

      You seem to relish in missing the point, Paul.

      One needs not arrive at a “all” to understand WHY the legal treatment is in plain error.

  2. 6

    OT, but I find it appalling [pun intended] that so much of the recent comments on this blog are political discourse unrelated to patents by attorneys arguing about “facts” and their sources. Especially, not a single reference, even from attorneys, for the really effective source of facts, which is testimony under oath under penalty of perjury and subject to effective cross-examination, and equally tested rebuttal evidence. Or, alleged facts presented in lawsuit complaints which are later admitted or judicially determined to be baseless or unprovable.
    Also, an insufficient discussion of the relative un-importance to our legal system or government of many of such alleged or reported non-governmental disputed scandals or other such facts. Fed by extremists of various different political biases, many media sources, and widespread ignorance of the Constitution and how our legal system [slowly] operates.

    1. 6.1

      Er, o.k. You are laying yourself out for disappointment if you are hanging around here, waiting for a discussion of “testimony under oath under penalty of perjury and subject to effective cross-examination, and equally tested rebuttal evidence.” I am sure that there is somewhere on the internet that you could find such a conversation if you want it, but it is not likely to happen around these parts.

    2. 6.2

      Egan told me he signed an NDA. Just found out hiding in South Haven MS for the time necessary to claim residency as long as he had an atty licensed in MS he was able to hide the business bankruptcy and sneak me in it, and hold me captive from DUE PROCESS by using my son in Memphis where Egan filed for the business. THIS IS CALLED WHITE COLLAR CRIME

    3. 6.3

      Actually, Paul most of what you said is wrong. I’ve provided references and would be happy to provide more if there was an agreement to actually engage with the facts. I will find a video that is typical where they go through how the NY Tx reports half the facts and misrepresents the facts they report. This is typical.

      As to your point about not mattering much. This is patently ridiculous. Hunter’s Laptop not being reported changed the outcome of the election along with the lies to the FBI approved by HRC that there was a connection between Trump and a Russian Bank. And the Hunter Laptop was not reported based on 100 former intelligence agents saying it was Russian disinformation and yet they keep their security clearances. So here we have lies to the FBI, the FBI lying, and the news media exploiting this to burn down Trump.

      With the Stormy Daniels payments we have 70 former prosecutors lying that it was an illegal payment and the news media using it to burn down Trump. Note that there is no consequences to the 70 former prosecutors lying. Probably an ethics violation to their respective state bars. Plus the DOJ then used a jailhouse snitch scheme to get Cohen to confess to the payment being illegal, which enabled the NY AG to investigate the Trump organization. We know this was not an illegal payment or the lawyer for the Trump organization would have been tried but he wasn’t and Trump would be charged. But it was not illegal.

      So there is this intersectionality of the press, former government people, and the government. What we are missing is that the newspapers used to be on the side of truth and would investigate these issues. Now the newspapers are part of the scams.

      I can back up all that I have written but I am not going to spend a lot of time for snide replies. And that is just a couple of cases. There worse things going on.

      I note that you as the far left always does start off with your feelings, Paul.

      1. 6.3.1

        I note that you as the far left always does start off with your feelings, Paul.

        That’s part of the playbook.

        By basing this on one’s “feelings” (or ‘lived experiences’), one then glides into having their own truth.

        Truth – and facts – are no match for the Liberal Left 1984 machine.

        1. 6.3.1.1

          “By basing this on one’s “feelings” (or ‘lived experiences’), one then glides into having their own truth.”

          Truly, the best way. I’m surprised we don’t see it as standard practice in office actions by now with all the leftism in the upper ranks of the PTO. I like ol kathi, but she is either leftist captured, or leftist herself.

          1. 6.3.1.1.1

            Pardon potential repeat…

            Truly, the best way.

            The best way? At what exactly?

            I’m surprised we don’t see it as standard practice in office actions by now with all the leftism in the upper ranks of the PTO.

            Stop mouthing the signaling, 6.

            How exactly would this “personal truth” thing work as standard practice in Office Actions?

            You do realize that this “personal truth” annihilates objectivity and any actual resolution path, right?

            For example, in regards to your “standard practice in Office Actions,” the applicant’s “personal truth” will be every bit as valid as ANY “truth” provided by the Office – including any actual objective indicia or any prior art.

            You may be thinking that this “personal truth” would ONLY used by the side of the Office, but that would just not be so. Quite in fact, as the Office is (to co-opt the 60’s) The Man, use by the Office would carry LESS impact.

            That “Leftism” higher up would be confounded — and is likely why you have NOT seen this implemented.

            1. 6.3.1.1.1.1

              “The best way? At what exactly?”

              Fact finding/establishin derp. The topic of discussion.

              “How exactly would this “personal truth” thing work as standard practice in Office Actions?”

              You simply find facts based on how you feeeeeeel about a claim, derp.

              “You do realize that this “personal truth” annihilates objectivity”

              Obviously.

              “and any actual resolution path”

              Not sure what you’re talking about.

              ” the applicant’s “personal truth” will be every bit as valid as ANY “truth” provided by the Office”

              Yes, but they don’t have the POWA. The gov does.

              1. 6.3.1.1.1.1.1

                Fact finding/establishin derp.

                LOL – you derp at your own expense, as the rest of the post explains just how “fact-finding” is rent asunder – you are so focused on YOUR path of ease that you neglect to recognize that this “facts by feeling” is a TWO WAY street, and the applicant’s feelings cannot be ‘wrong’.

                Your view of POWA is simply false – you have not thought this through.

                The removal of any ACTUAL objectivity means that the ONUS (rather than POWA) that YOU have means:
                you L O S E (remember – the patentee is ENTITLED – how can you forget one of your favorite words?)

                1. “you are so focused on YOUR path of ease”

                  Not at all, I, personally would of course use my feeeeelings to benefit the POC/female/trans etc. IDers. As is appropriate.

                  “and the applicant’s feelings cannot be ‘wrong’.”

                  But their feelings being right or wrong is irrelevant as they have no power. Derp. Just as in Soviet Russia.

                  “you have not thought this through.”

                  Sure I did, we will overthrow the white cis hetero christian capitalist patriarchial system comrade.

                  “the patentee is ENTITLED – how can you forget one of your favorite words”

                  They only get a notice of allowance if it ApPeArS that they are entitled (under 151). If it does not ApPeAr (to the PTO) to be the case (because of, for instance, an issue under 102/103 on account of facts found based on an examiner’s, or later district court judge’s feeeeelings) then they are not entitled. Derp derp. Control the fact finding and you control all. Control the basis for the fact finding and you control all.

                2. LOL – you still miss the fact that the complete LACK of an objective standard dooms the process, as it certainly would appear to THEIR feelings that they are IN FACT entitled. You do NOT get to rest ONLY on your Feelings-facts – in ANY further processing, and the arbiter above you will NOT be able to give you that POWA that you think that you have. That judge will HAVE TO give ALL the same weight, and YOU need even just a smidge more for your view to prevail.

                  You will not have that – you do NOT get the dead even 50-50 split.

                  Bottom line here 6, is that this ‘feelings’ notion obliviates the rational processing.

                3. “LACK of an objective standard dooms the process”

                  That’s how we’re going to tear down the white cis hetero christian capitalist patriarchy comrade. And that’s why it’s the best fact finding process.

                  “as it certainly would appear to THEIR feelings that they are IN FACT entitled.”

                  Yes but they’re not an issuing agency or court and have no power in this better system. I still don’t understand how you’re not understanding that.

                  “You do NOT get to rest ONLY on your Feelings-facts”

                  Under the newly proposed system we do.

                  “and the arbiter above you will NOT be able to give you that POWA”

                  Sure they will. That will obviously need to be changed as well to accommodate the new fact finding paradigm.

                  “That judge will HAVE TO give ALL the same weight,”

                  Not at all, under the new system the judge will either have to defer to the office’s feeeeeeeling found facts, or perhaps be allowed to make a new factual finding solely based on his feeeeeeelings. And that’s assuming that the judicial branch even is allowed to persist in existing, as it is obviously white supremacist anyway. Abolition of judiciary with all powers to be brought under the executive in committee form for great soc justice may be necessary. In either event, they certainly will not be allowed to continue trying to be “objective” as that is a feature of white supremacist patriarchy.

                  “You will not have that – you do NOT get the dead even 50-50 split.”

                  Its not going to be 50/50. It’s going to be 100/0 in the gov’s favor. Always.

                  “Bottom line here 6, is that this ‘feelings’ notion obliviates the rational processing.”

                  Of course, that’s how we’ll get rid of the evils of the white cis hetero christian capitalist patriarchy.

                4. “Check this out 6:”

                  Tiny smol cute asian girls are white supremacist if their rhetoric is white supremacist bro

                5. ????? Why the “R” card here 6? There is absolutely ZERO in her “rhetoric” that supports that reply by you.

                  (Your emulation of the “D” ‘when-all-else- F A 1 L S -call-them-names is futile here)

                6. “There is absolutely ZERO in her “rhetoric” that supports that reply by you.”

                  Her post containing rhetoric supporting the current white supremacist way of doing things (the supposedly objective fact finding paradigm) obviously supports me making my post above.

                  Look anon I’m obviously be somewhat parodying, but yes, there are quite a few actual irl leftists that believe that there is no such thing as “objectivity” and that all attempts to claim that there is, or claim that a person making a decision (about anything, including a fact finding) is being “objective” in their decision, is just them upholding a power structure of one sort or other. And in this country that power structure being upheld is what they call the white supremacist patriarchal capitalist power structure. Thus, her supporting people participating in the current fact finding regime is, quite literally to those leftists, supporting exactly the white supremacist patriarchal capitalist power structure and thus makes her a white supremacist (someone who supports the aforementioned power structure, like MM). Not lying bruh.

                7. Hahahahaha – 6, if the point of your reply here carries – you lose the war.

                  You can only “carry this charade” so far before it crashes and burns — as it must.

      2. 6.3.2

        Night Wiper: “ I will find a video”

        He’s going to find a video, folks!

        Dennis and Jason’s favorite son. Heckuva job, MBHB!

        1. 6.3.2.1

          “He’s going to find a video, folks!

          Dennis and Jason’s favorite son. Heckuva job, MBHB!”

          Because the leftists at the NYT are liek tots trustworthy n sheet as they literally openly acknowledge that they, as a collection of journos, have an agenda.

          1. 6.3.2.1.1

            liek tots trustworthy n sheet

            Why bother with this “effect?”

  3. 5

    Day zero: I file my application on a new non-obvious telescope and publish it.

    Day five: Mr. X files a patent on using my telescope to look at a newly discovered non-obvious object in derp space (discovered by Mr X using a different telescope).

    Is Mr X’s patent eligible? According to the ridiculous CAFC precedent made up out of vapor, the answer is “yes” but only because my telescope is “not conventional”. A claim to the use of every other telescope to view the newly discovered object would, of course, be ineligible as protecting a natural phenomenon (ie., the object).

    So it’s absolutely the case that the CAFC’s exception based on the “non-conventionality” of the detection method is absurd and wrong. But there’s nothing at all wrong with the fundamental principle that you can’t protect a diagnostically relevant fact (e.g., a correlation) merely by reciting existing technology for detecting that fact. The only reason some patent lawyers complain about this is because they want the income. It’s pure greed. No normal person who spends more than a minute thinking about the ramifications of letting entities use patents to effectively own correlations (?!) thinks this is a good idea. It’s not a good idea. It’s sick and disgusting.

    1. 5.1

      According to the ridiculous CAFC precedent made up out of vapor, the answer is “yes”…

      Thinking of things that are made up out of vapor, you will want to include this so-called “precedent” in that list. There is no such CAFC precedent.

      The case at issue in Prof. Holman’s essay holds that this claim is not eligible. There is no precedent holding for eligibility as you postulate. You are just imagining such.

      1. 5.1.1

        Presumably the party trying to rely on the “unconventionality” of detection methods here believes differently than you, Greg, for some mysterious reason. Berkheimer is precedential, no? Or at least “controlling”? You’re the pedant avoiding the issue (as usual) so you tell everybody what the heck you are talking about.

        I’m perfectly aware of the (correct) result in this case and why that result was reached, by the way.

        1. 5.1.1.1

          I believe that we both consider Prof. Kevin Collins “Knowledge/Embodiment Dichotomy” to be a good summary of what the law presently is. Prof. Collins illustrates this dichotomy with the example of a book. If the novel aspect of the book is the writing on the pages, then the book is not patentable, regardless of how novel and non-obvious might be the ideas expressed in that writing. If the novel aspect is the binding, however, then the book is patentable.

          Notably, however, Prof. Collins explains that if the book is novel in both the writing and the binding, then this is still patentable. The fact that the claim might recite ineligible subject matter (the writing) does not take away from the patentability of the claim as it rests on the structural recitations of the features of the binding.

          Returning to the case at hand, the DNA in the bloodstream is analogous to the writing. If there had been a novel detection technology here (“next, next generation sequencing,” if you will), then the novel detection technology would have been analogous to the novel book binding structure in Prof. Collins analogy. The putative NNGS could have saved the claim, even if the claim also recited the correlation that proved insufficient to save the claim. That is the sort of “non-conventional” element that the court wanted to see.

          Whether a telescope—invented by someone else and not yet disclosed in a non-confidential setting as of the filing date—counts as a “non-conventional” (in a manner analogous to Prof. Collins’ book binding) will be an issue of first impression when it first arises. Nothing about this precedent compels the conclusion that the telescope would qualify as the “non-conventional” element.

          1. 5.1.1.1.1

            Greg, Malcolm, analogies are good as far as they go, but I’m not sure that they match perfectly the situation where a patent application contributes to the useful arts a new, useful and enabled method for revealing a correlation which facilitates a diagnosis of disease. A method is neither an “object in deep space” nor a book binding.

            Still and all, I’m glad I don’t have to advise clients in this field, or draft claims that are eligible, proportionate to the contribution to the art and thereby promote progress in diagnostic methods, to the benefit of us all.

            1. 5.1.1.1.1.1

              In this case, isn’t the discovery the existence of the correlation–not the method of revealing the correlation?

            2. 5.1.1.1.1.2

              [A]nalogies are good as far as they go, but I’m not sure that they match perfectly th[is] situation…

              Agreed, Max. I was trying to meet Malcom half-way with an analogy that I believe that he finds compelling. If you distrust the analogy, I will not hang on it. My real point is that if your claim does not extend beyond the bounds of a patentable (useful, novel, & non-obvious) invention, then it is patentable—full stop. Even if the claim includes other limitations that would not themselves impart patentability, the limitations that confine the claim to useful-novel-non-obvious scope continue to make the claim patentable.

              Whether those useful-novel-non-obvious limitations would make the claim patentable, however, when they are part of the secret prior art (Malcolm’s hypo) is an open legal question. In practice, secret prior art issues do not actually arise all that often, and this particular secret prior art hypo is extremely far-fetched. I am dubious that we will ever get an answer to Malcolm’s question. My real point, however, is that—contrary to the huffing of post #5—there is nothing in CareDx v. Natera that actually compels any particular answer to Malcolm’s hypo.

              1. 5.1.1.1.1.2.1

                There is no “secret prior art” in my hypothetical. There is published prior art disclosing the telescope but the telescope is not “conventional” (it’s too new) as of the date that the second application is filed.

                1. My apologies. There is nothing in CareDx to say that the published application would be regarded as “non-conventional.” You are reading such a conclusion into the text, but it nowhere says that. Besides, even if the decision did say such a thing, it would be dictum relative to the actual facts at issue in CareDx. No future court would be bound to hold that a five-day-published document’s contents are “non-conventional.”

                2. Greg and his strawman: “There is nothing in CareDx to say that the published application would be regarded as “non-conventional.”

                  That’s nice. I never suggested otherwise.

                  The point is that a non-obvious telescope that is freshly disclosed and has never been used by anyone in the art except for one person is by definition “non-conventional”. On the other hand, once that telescope is disclosed it’s prior art and for the purposes of determining eligibility of a claim reciting the use of that telescope for its intended purpose, it’s “unconventionality” is irrelevant. Get it, Greg? This isn’t difficult.

                  If you’re having difficulty, imagine the same hypo but instead of a telescope it’s a book, and instead of looking at a new object it’s “storing” non-obvious text.

                  You think the “non-conventionality” of that prior art book makes a difference? If so, why?

                3. Fair enough. If it pleases you to catastrophize about distantly unlikely hypos, I will not try to stop you. Chacun à son goût.

                4. Just noticing the loaded phrase that Malcolm inserts:

                  and for the purposes of determining eligibility of a claim reciting the use of that telescope for its intended purpose

                  How did that go in Diehr?

                  (and yes that same case serves as a reply to some of your other comments today)

                5. If you’re having difficulty, imagine the same hypo but instead of a telescope it’s a book, and instead of looking at a new object it’s “storing” non-obvious text.

                  Oh, by all means DO venture closer to an actual discussion on the Written Matter Doctrine – and its critical exceptions.

                  As if you have not been thoroughly OWNED on this for at least the last dozen years or so.

          2. 5.1.1.1.2

            Anyone believing that anything written by Prof. Collins is anything other than schlock has zero credibility.

          3. 5.1.1.1.3

            I had a much longer comment that is lost in the ether but the bottom line is that the correct standard for whether a physical element or elements can rescue a claim that recites ineligible subject matter (like non-obvious writing) is whether the physical elements (e.g., the book or the telescope) are inventive (i.e., non-obvious, at a minimum, as of the critical date). Whether the physical elements are “non-conventional” is irrelevant.

            1. 5.1.1.1.3.1

              Where are you getting this “has to be physical” thing that you are inserting as a necessity?

              Shall we replay Alappat along those lines?

              1. 5.1.1.1.3.1.1

                “ Where are you getting this “has to be physical” thing ”

                Where? I have a brain. That’s where. Brain + logic + reason, and a refusal to bury my head in the sand and pretend I was born yesterday.

                On what planet can you rescue a claim protecting an ineligible abstraction (e.g., written text) or a natural phenomenon (e.g., object in space) by additionally reciting only an abstraction? The answer is “there is no such planet.”

                But go ahead and pretend otherwise. [shrugs]

                1. And the filter nabs another…

                  Your comment is awaiting moderation.
                  July 21, 2022 at 5:27 pm
                  You do notice the irony as to “in my brain” for discussions of physicality and abstract ness, eh?

                  Pssst – we’ve covered this many times now: think “Diehr.

    2. 5.2

      So long as there are ten million other designs of telescopes that you can use to do the detection who cares tho?

      1. 5.2.1

        But, the date of 04/25/06 only comes around once. So why pray tell did he sign 04/25/06 on the front page of a File that has no 04/25/06 anywhere else on the other Documents. Doesn’t that date infer not only intent, but if we only were in Smith’s Office only once it also infers that maybe you are saying I was there another day filing. No wonder Wingo now Reynolds left. WHY HASN’T THE US BANKRUPTCY ATTYS. OFFICE OR THE BANKRUPTCY COURT QUESTIONED HER ABOUT THE LOGISTICAL NIGHTMARE THAT WILL HAVE TO BE EXPLAINED TO THEM?

  4. 4

    Greg DeLassus, an intellectually bankrupt hack: “ It is the discoveries in which known machines and known compositions of matter are used to achieve previously unattainable diagnostic results that have proven unpatentable per se.”

    Those “discoveries” are biological facts. That’s why they are ineligible for patent protection.

    This isn’t complicated. It’s the correct result. The fact that some patent attorneys can’t admit basic truths about patent law and how claims work (and how they don’t work) is a stain on the profession.

    If these whining patent attorneys get their way and diagnostically relevant facts become weaponized against doctors and patients, then patent law will truly have crossed the rubicon. At least we’ll know who to blame.

    1. 4.1

      I don’t think that anon would appreciate you summarily passing off their title of “intellectually bankrupt hack” to someone else.

      1. 4.1.1

        No doubt it is a great responsibility taking over the mantle of “intellectually bankrupt hack” from anon, but I know from experience that anything s/he can do, I can do better. I feel that I am up to the task.

        1. 4.1.1.1

          >>Greg DeLassus, an intellectually bankrupt hack

          Now you know what it is like to blog with MM for 17 years.

          >>anything s/he can do, I can do better. I feel that I am up to the task.

          Funniest comment I’ve read on here in a long time!

          1. 4.1.1.1.1

            + 1,000,000

          2. 4.1.1.1.2

            Funniest comment I’ve read on here in a long time!

            It was intended in jest, so I am glad to see that it had that effect.

            1. 4.1.1.1.2.1

              Laughing AT you Greg – not with you.

              Most likely just not the effect that you were aiming for.

            2. 4.1.1.1.2.2

              No anon. I was laughing with Greg.

            3. 4.1.1.1.2.3

              Laughing AT you Greg – not with you.

              Most likely just not the effect that you were aiming for.

      2. 4.1.2

        As usual, my friend NS II, you pick the oddest moments to attempt to jump in and slam me.

        Yes another massive
        F
        A
        I
        L
        for you.

        1. 4.1.2.1

          Slam you? I’m defending you and all your hard work. I just want you to know that your contributions have not gone unrecognized.

          1. 4.1.2.1.1

            Lol – with friends like that…

            Sorry but no, your opinion is as errant as ever.

    2. 4.2

      As a frequent patient, I’d much prefer a fact be “weaponized” than “undiscovered.”

      Doubly so if its only “weaponized for 20 years.”

      1. 4.2.1

        “As a frequent patient, I’d much prefer a fact be “weaponized” than “undiscovered.”

        False dichotomy. Put down the patent crack pipe.

        Patenting correlations and facts is an absolutely terrible idea that has been rejected soundly for eons by every jurisdiction in the universe, for good reasons.

        1. 4.2.1.1

          What does “patenting facts” even mean?

          Are you playing your old goal-post moving game making a part of a claim to somehow BE the claim as a whole?

          (Analogous to your goal-post moving of making a claim to be TOTALLY in the mind, when the claim just is not)

          1. 4.2.1.1.1

            “ What does “patenting facts” even mean?”

            For starters it means using the patent system to claim ownership over correlations that can be drawn between data (e.g., biological data obtained using pre-existing methods) and the likelihood of disease.

            If you can’t keep up, maybe try shutting up. Further obvious attempts to derail the discussion with inanity will be ignored or I’ll just point out the plain truth: a sack of diseased snail feces is a better excuse for a human being than you.

            1. 4.2.1.1.1.1

              Ownership over correlations….

              Um no.

              Much aside from your insistence on a supposed “you infringe just by thinking” – NO such thing ever existed.

  5. 3

    “ Go back and re-read Prof. Holman’s essay. He did not say that all “diagnostic patents” are ineligible. He said that all “molecular diagnostic methods” (emphasis added) are ineligible.”

    Holman is a liar because that’s not true. Greg DeLassus, of course, has been promoting myths about Mayo for years, as has Kevin Noonsn, one of the worst hacks in this field.

    Grow up, liars.

    1. 3.1

      I am flattered to achieve mention alongside Prof. Holman and Dr. Noonan. I am not sure that I deserve to share the spotlight with such esteemed luminaries.

      1. 3.1.1

        There is no “esteem” to be had in maintaining the mythology that Mayo was wrongly decided and steadfastly refusing to discuss what the patentee in that case admitted was an act of infringement: merely THINKING about the “new meaning” of the results of a pre-existing metabolic test.

        That’s on you and your little culty club of (gag)“esteemed” patent attorneys on the Internets. Most of us don’t have a problem with Mayo, because it was correctly decided.

  6. 2

    There is no valid basis for bad advice to inventors by a Fed. Cir. judge that all diagnostics patents [much less all unobvious new medical uses of known drugs for other uses, as is even in a preceding blog here] are unpatentable just because the few challenged diagnostic patents the Fed. Cir. has taken since Mayo involved only using conventional detection means or methods to discover naturally occurring substances. There are many novel blood or urine diagnostic machines with unchallenged patents. They are not merely discovering something that was already there only because new and better test equipment which they did not invent became readily available.

    1. 2.1

      There is no valid basis for bad advice to inventors by a Fed. Cir. judge that all diagnostics patents… are unpatentable… There are many novel blood or urine diagnostic machines with unchallenged patents.

      Go back and re-read Prof. Holman’s essay. He did not say that all “diagnostic patents” are ineligible. He said that all “molecular diagnostic methods” (emphasis added) are ineligible.

      This is an accurate summary of the law as it stands. You are correct that “there are… diagnostic machines” (emphasis added) that can survive an eligibility challenge, but this is not what Prof. Holman was discussing. Machines are not methods. It is the discoveries in which known machines and known compositions of matter are used to achieve previously unattainable diagnostic results that have proven unpatentable per se.

      1. 2.1.1

        > “molecular diagnostic methods” (emphasis added) are ineligible.

        I agree. Bioinformatics inventions are basically ineligible per se nowadays. Interestingly, one quirk of section 101 is that this ineligibility occurs because the field relies on computers, *not* because the field is primarily discovering new natural phenomena and then saying “apply it” (i.e., the Mayo rule)

        That is, Myriad is still good law. Thus, even though the BCRA marker was a natural phenomena, and converting that marker into cDNA was very, very “conventional” at the time, Myriad still had a valid patent.

        But…NGS is computer based, not test-tube based, so no ‘new molecule’ is ever created…which means the same basic innovation (i.e., a specific genetic marker) is now ineligible.

      2. 2.1.2

        Re: “.. known compositions of matter are used to achieve previously unattainable diagnostic results that have proven unpatentable per se.” Check that against common commercially successful non-machine diagnostic tests like urine test strips for pregnancy. Was that not patented?

        1. 2.1.2.1

          At the time that urine test strips were still patented, laminar flow materials were still novel and thus patentable. Once again, no one doubts that one can still patent a machine, or a composition of matter whose utility is diagnostic. The point of contention is that new diagnostic methods—uses of old machines and old compositions of matter to achieve new diagnostic outcomes—have become unpatentable per se. You are talking past the point at issue.

        2. 2.1.2.2

          At the time that urine test strips were still patented, laminar flow materials were still novel and thus patentable. Once again, no one doubts that one can still patent a machine, or a composition of matter whose utility is diagnostic. The point of contention is that new diagnostic methods—uses of old machines and old compositions of matter to achieve new diagnostic outcomes—have become unpatentable per se. You are talking past the point at issue.

  7. 1

    [T]he outcome in CareDx was… preordained. In fact, it would have been shocking if the Federal Circuit had upheld the eligibility of the claims, given that in Athena Diagnostics all 12 of the judges that decided against rehearing the case appeared to agree… regarding the eligibility of diagnostic claims of this type.

    Exactly. There was nothing that that the patentee could have done differently—during draft, prosecution, or litigation—that would have affected the outcome for these claims. These claims were never going to survive an eligibility challenge under the law as it currently stands.

    I do not like the law as it stands for precisely that reason. Nevertheless, the law is what it is, and our likes and dislikes do not affect that state of affairs.

    1. 1.1

      When I went to law school – not that long ago – a ‘discovery’ was eligible for patent protection. Remember that rain forest movie where the researchers were to discover the cure for cancer in a rare rain forest orchid? In other words they discovered the naturally occurring molecule in an orchid. And cured cancer. But today that is a per se bar. This SCOTUS is clueless, just the worst. Goodby Breyer.

      1. 1.1.1

        It still should be patentable: “Whoever invents or DISCOVERS any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”

        To the extent it’s not, the courts are misreading the law.

        1. 1.1.1.1

          To the extent it’s not, the courts are misreading the law.

          Ours is a common law system, not a Roman law system. You are confusing the “law” with the “statute.” In a common law system, the law is not the statute itself, but rather the application that a court gives to the statute. It is otherwise in a Roman law system, but ours is not a Roman law system, so that observations scarcely matters to a discussion of U.S. patent law.

          1. 1.1.1.1.1

            > scarcely matters to a discussion of U.S. patent law.

            IDK. In the US system, it’s supposed to be constitutional text > statutory text > judicially made law. To the extent the courts aren’t following that hierarchy, they are acting lawlessly.

            1. 1.1.1.1.1.1

              Greg is (as is typical) overplaying his ‘understanding’ of how law works.

              As a general matter, sure, our system is classified as a ‘common law’ system. But that just does not mean what he implies it to mean (you hit the nail on the head with reference to the Constitution).

            2. 1.1.1.1.1.2

              In the US system, it’s supposed to be constitutional text > statutory text > judicially made law.

              This is true, but only in one sense, and not the sense relevant to the point that I was making.

              It is true that judge-made law is supposed to be the default, but that the legislature is supposed to be able to change (“derogate from,” as the maxim says) the defaults by writing new statutes. It is also true that the legislature is not supposed to be able to make changes that disaccord with provisions of the constitution (whether state constitution or federal constitution, as relevant to the particular context).

              However, how does one know whether a particular statute accords or disaccords with provisions of the constitution? One knows because the courts—in judge-made law—tell you so.

              In that sense, the judge-made law really is the final word, where the “rubber meets road,” so to speak. Similarly, if there is a seeming discrepancy between the straightforward words of the statutory text, and the interpretation that the Supreme Court gives to those statutory text words, the lower courts are supposed to give effect to the Supreme Court’s gloss, not to the district judge’s own reading of the statutory text. Once again, then, where the “rubber meets the road,” it is the court’s interpretation—not the statutory text—that is the actual law, with socially discernible legal effect.

              1. 1.1.1.1.1.2.1

                It is true that judge-made law is supposed to be the default,

                Expressly NOT the case with patent law.

                Greg should know this.

              2. 1.1.1.1.1.2.2

                Hitting a filter

                Your comment is awaiting moderation.

                July 21, 2022 at 1:21 pm

                And a half truth from Greg:

                It is also true that the legislature is not supposed to be able to make changes that disaccord with provisions of the constitution (whether state constitution or federal constitution, as relevant to the particular context).

                While certainly true of legislatures, it is no less true of the judiciary.

                Greg points a finger at one law writing body, neglecting his very own assertions that another branch writes laws, and his “point” on what is essentially ultra vires action is prematurely truncated to fit HIS desired viewpoint.

                Bottom Line: NONE of the three branches are above the law.

        2. 1.1.1.2

          The “OR discover” angle — which is necessarily different than “invent,” has been deeply covered by Sherry Knowles

          See: link to ipwatchdog.com

        3. 1.1.1.3

          BobM, the statute also requires that the discovery be to something “NEW” – read it carefully

      2. 1.1.2

        Why would a claim to a method of administering this compound in a therapeutic amount to treat cancer be per se ineligible?

      3. 1.1.3

        I think you will find that the Sup. Ct. view that scientific discoveries of existing materials are not patentable goes back way before anyone here went to law school. There is even a semantic and original intent argument if you want to rely on Article I, Section 8, Clause 8, of the United States Constitution grant to Congress of the enumerated power “To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.” E.g., the meaning in context at that time of the two different words “science” and “useful arts” plus “inventors” in a phrase that encompasses both copyrights and patents, and is merely a permission for the federal Congress to actually enact such laws.

        1. 1.1.3.1

          Paul, you appear to be inserting a “false flag” of the Constitutional nature of patent law.

          Everyone that I know that is “on my side” is well aware that the Constitutional Clause is a delegation of authority clause.

          But look at “the anti’s” right here on this thread: Greg is making it seem that any judge through common law law writing can make the law BE whatever they want it to be.

          This is an express violation of that specific (and explicit) designation of which branch HAS the authority to write patent law.

          Cross-branch allocations of authority are — as they must be — tightly constrained with ‘control’ firmly in place to avoid Constitutional issues. Now, I realize that you avoid discussing ANY Constitutional issue (which I find still extremely odd), but these things really are important.

      4. 1.1.4

        Under your argument (which has been rejected many times), Einstein could patent the theory of relativity and block anyone from using it. And people could patent human DNA (like they used to), and block all research on it (as opposed to patenting specific uses of DNA or genetically-altered DNA). The law properly does not allow someone to patent things that exist in nature. WERE IT OTHERWISE PATENTS WOULD INHIBIT BASIC RESEARCH

        1. 1.1.4.1

          … or promote it.

          For some reason, people seem to always look at the stick part of the patent as a bad thing.

          It isn’t.

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