The Supreme Court and Patent Protection for Medical Diagnostics: A Closer Look at CareDx and Stanford U v. Eurofins

by Dennis Crouch

The recently filed petition for certiorari in CareDx and Stanford University v. Eurofins Viracor, Inc. (Supreme Court 2023) offers an opportunity to examine the patent eligibility doctrine in the context of an important health diagnostics innovation. The inventions at issue relate to early detection of organ transplant failure, which obviously hold significant potential to save lives and reduce reliance on invasive exploratory surgical procedures. The detection method involves identifying DNA fragments from the transplant within the bloodstream, a challenge that had stumped scientists for over a decade.  Although various scientists had proposed mechanisms for using this information, the evidence shows more than a decade of failed ideas, and at least one article reported that the process is “difficult and impractical.”  The breakthrough came when Stanford researchers successfully applied high-throughput multiplex sequencing (“shotgun sequencing”) to detect single nucleotide polymorphisms (SNPs) unique to donor organs.  Of potential importance, the Stanford researchers did not create these new sequencing techniques, but they were the first to take advantage of them in this particular context and, as the claim language below shows, the scientists focuses on creating thresholds as part of a method that particularly work in this situation.

Three patents are central to this case: U.S. Patent Nos. 8,703,652, 9,845,497, and 10,329,607. Claim 1 of the ‘607 patent exemplifies the claimed method, which includes the following steps:

  1. Providing a plasma sample from the recipient;
  2. extracting cell-free DNA from the sample;
  3. performing “selective amplification” of target DNA sequences, wherein that amplification “amplifies a plurality of genomic regions comprising at least 1,000 [SNPs]” using PCR;
  4. performing “high throughput sequencing” comprising a “sequencing-by-synthesis reaction” with an error rate of less than 1.5%;
  5. providing sequences comprising “at least 1,000 [SNPs]”; and
  6. quantifying the proportion of donor-derived DNA, using distinguishing biomarkers drawn from those at least 1,000 SNPs, and wherein the donor’s cell-free DNA comprises at least 0.03% of the total in the sample.

The Infringement Lawsuit: The Delaware District Court initially denied defendants’ motions to dismiss and for summary judgment of ineligibility. However, Chief Judge Connolly later reconsidered the summary judgment motion and ultimately ruled that the claims were ineligible under the two-step analysis set forth in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012). The Federal Circuit affirmed this decision.

The petition to the Supreme Court raises the following simple question: Is a new and useful method for measuring a natural phenomenon, which improves upon prior methods for measuring the same phenomenon, eligible for patent protection under Section 101? The petition emphasizes the importance of this case compared to Tropp and Interactive Wearables, and it underscores the need for the Supreme Court to review its application of eligibility exceptions to medical diagnostics.

This case has potentially significant implications for US patent law doctrine as well as potential impact on investment in medical diagnostics. We’ll be following the case closely and talking more about its potential effects.

36 thoughts on “The Supreme Court and Patent Protection for Medical Diagnostics: A Closer Look at CareDx and Stanford U v. Eurofins

  1. 5

    “the Stanford researchers did not create these new sequencing techniques, but they were the first to take advantage of them in this particular context”

    LOL

    I was the first to use a drone to rapidly identify which of my neighbors have plaster gnomes in their gardens, wherein the gnomes have forked beards.

    Can I has patent now?

    Seriously, these claims are junk. Every time a detection method is invented or improved it’s inevitable that a tiny army of free riders will try to claim the use of the method to detect the exact thing that the method was designed to detect (e.g., DNA sequences) in “this particular context or for this particular reason that wasn’t expressly identified before.”

    Excellent work by the district court and the defendants here quickly identifying the abuse and putting the hammer down. The point of the patent system is to reward the inventors of the better detection methods and thereby encourage the development of better methods. It’s not supposed to be a game where latecomers pile on and make the invention impossible to use for its intended purpose without risk of a multiple lawsuits filed by disparate latecomers.

    1. 5.1

      While I understand what you’re talking about with the drone analogy, I’m not even sure that it 100% fits with the situation at hand. If there was some actually needed utility in finding out whether the gnomes had forked beards or not (like someone’s life might depend on it), then perhaps I could even look the other way on your drone flying patent. While you are correct that they are using the old testing/seq method they appear to have come up with, and I’m guessing put in the claims, the actual specifics on how to use that testing in a meaningful way with real utility which apparently was long needed. Idk bro, 10 years seems like a long timeish. I think there could be room made for such things being put down as legit tech advances. But I do understand the counter args.

      1. 5.1.1

        Also I’d just add, I kinda doubt that this patent created a “minefield” (tho that may be what patenting such leads to I do not know in actual reality), or even one “mine”. Seems like they came up with their own little niche use with other people unlikely to just accidentally stumble into doing the same thing without having already read that person’s work and copied it more or less directly. Tho again I will agree there may be some such similar patents that might.

        1. 5.1.1.2

          I kinda doubt that this patent created a “minefield”

          I do too. Do you know what a “minefield” is and how it’s gets created.

    2. 5.2

      will try to claim the use of the method to detect the exact thing that the method was designed to detect

      You are – or should be – well aware that laws already exist for the purpose that you are attempting to use for some other point.

    3. 5.3

      Unreal that we have to walk people through the basics again but if I invent a new detection technology for detecting things and sell it, you don’t get to re-patent methods of using my invention to detect “new” things (“new” in this case meaning both “known things that haven’t been looked at before with this particular invention” and “newly discovered things”). If you don’t understand why this is the case, well …

      Note that there is still lots of room for innovation in the “detect things” space. You could even improve my detector or develop a non-obvious process of using it. But the “invention” can’t be just naming or identifying some pre-existing or natural thing.

      1. 5.3.1

        I mean bro I would tend to agree with you in general if it’s JUST detect new thing x. If however, using your old method/device in its ordinary usage manner takes like a year or two to figure out how to use to “detect new thing x” and “people’s lives depend on detecting new thing x”, I just have to tell you I would be generous enough to give a patent for how to do it with the new sub-method. Flying the drone copter likely cannot be newly patented. ESPECIALLY if you can be nudged into including what you actually did that makes the detection possible beyond the basics of the prior method/device. Flying the drone copter and setting up a computerized system to detect gnome faces that actually works to a decent degree and takes awhile to develop and detecting gnome faces is important (people’s lives depend on it) then I mean bro, you gotta be willing to give patents to get people to do the work and DISCLOSE their sauce.

        I get that in your art people will be constantly pushing the line and trying to just patent “detect x with old method”. And sure, maybe that should be banned as an abstract idea. But when they start putting in the things that they needed to develop, generally at great cost, I mean bro, it’s kinda what patents are for.

        “But the “invention” can’t be just naming or identifying some pre-existing or natural thing.”

        That’s literally not what happened in this case tho was it?

        1. 5.3.1.1

          Flying the drone copter and setting up a computerized system to detect gnome faces that actually works to a decent degree and takes awhile to develop and detecting gnome faces is important (people’s lives depend on it) then I mean bro, you gotta be willing to give patents to get people to do the work and DISCLOSE their sauce

          This is the “long felt need” prong of the 103 “secondary factors” on steroids, which is its natural state. When something is referred to as “impractical” that is an admission that the “technology” exists to carry it out but nobody is going to pay for it. In other words, there is no invention or discovery, unless what’s really happening is not rewarding inventors but … investors and gamblers.

          The lowest form on inventing once again is …

  2. 4

    Unless four SCOTUS judges have relatives whose bodies have rejected organ transplants and who would have been helped by this technology, I don’t see this case going anywhere. Which stinks, because the invention in this case is just the kind of thing that *should* get patent protection. But then so was the invention in Sequenom, and SCOTUS screwed that up too.

  3. 3

    Between Mayo and Sequenom and over 60 denials of cert (as well as the arguments from the ACLU and AMP, it seems unlikely that the Court will grant cert. And we may regret it if they do, on their track record (including Funk Bros so not an entirely recent phenomenon)

      1. 3.2.1

        funkybros – back in the time when the Supreme Court self-identified as:
        “The only valid patent is one that has not yet appeared before us.”

        Hmmm – something about not learning from history comes to mind….

    1. 3.3

      [I]t seems unlikely that the Court will grant cert. And we may regret it if they do…

      Once upon a time, I used to hope that the Court would see how adversely the Mayo/Myriad/Alice regime is affecting technology and would backtrack (as they did in Diehr and Chackrabarty, following their Benson and Flook debacles). If I am honest, however, I have to admit that there have not been any evident detriments to technology. New drugs, new devices, new software (etc) is coming out just as quickly or even more quickly now than it did pre-Bilski. I expected a parade of horribles that never did show up.

      Nevertheless, I am still hopeful that Mayo and Alice will be retrenched. Senators Coons & Tillis have shown durable interest on this point, and that is all it takes to achieve new legislation—a patient Congress member who keeps trying.

      So far, they have tried for a total reversal of both Mayo & Alice (with a §112(f) reform as the sweetener), and that failed. Next they tried to repeal Mayo (with a partial codification of Alice as the sweetener), and that failed. Presumably the next attempt will feature a repeal of Alice (with who knows what as the sweetener), and we can see how that goes.

      The important thing is that—just like Sen. Leahy’s repeated attempts to pass the AIA—if Sen. Tillis & Sen. Coons keep trying long enough, they will surely get something through eventually. I look forward to seeing that something.

      1. 3.3.1

        “&” Smith (as is typical with Greg’s hidden links) misses yet again attempting to blame “R’s” for debt ceiling games…

        As to the “patent message,” what Greg views as “Sweeteners” were correctly identified as Trojan Horses.

  4. 2

    To put a fine point on it, can one patent a method for “measuring” a law of nature (assume that the measuring method is itself new and there are non-infringing ways to measure the law of nature). This seems to be quite distinct from USING the law of nature to do something. Here, if one is just “measuring” and that is all the claim requires, I don’t think the Supreme Court will take it up. But, I can be wrong.

    1. 2.1

      I don’t think the Supreme Court will take it up. But, I can be wrong.

      One is always on safe ground in predicting that the Court will not take a §101 case. The math just is not there.

      Only four seats have turned over since Mayo was unanimously decided, and it requires four votes to grant cert. Therefore, to see a cert. grant on this issue one must believe either that all four of the new justices repudiate the bipartisan consensus around Mayo, or else that one of the other five has changed his/her mind since Mayo.

      I would be delighted to discover that either of those possibilities is true, but they both seem unlikely. “Cert. denied” is much the likelier outcome here.

      1. 2.1.2

        As to Greg’s comments (about patent matters), certainly the Court not taking cert is an easy prediction, but just as certainly, patent practitioners being all meek and “we must accept” will NOT change anything.

        We are advocates.

        Advocate.

  5. 1

    Sure, but is the method for measuring old, and the use of the measurements what is new?

    If so, the question is more about a method to gain certain utility from measurements

    Distinction without a difference? Or very different?

    1. 1.1

      35 U.S. Code § 100 – Definitions (emphasis added)

      When used in this title unless the context otherwise indicates—
      (a) The term “invention” means invention or discovery.
      (b) The term “process” means process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.

      1. 1.1.1

        The statute doesn’t by itself totally answer the question because laws of nature are exceptions to the statute. So the question is not about “new” vs. “old” but, rather, about patenting laws of nature.

        1. 1.1.1.1

          What part of my response is lacking for an answer?

          If you venture into an ultra vires writing from the Bench, you will of course understand the natural loss of validity for such a position.

      2. 1.1.2

        As used in the term “new use”, the term “new” presumably does not mean simply ANY “use” that has not taken place before.

        It means an inventive use or at least a previously uncontemplated categorically different use beyond what was originally contemplated for the process, article, etc. Otherwise the term “new use” would be just a bad joke. “Hey I’m using this eraser to erase a word I just made up! Give me my patent as mandated by the statute as interpreted by this glibertarian patent huffer on the Internet!”

        Get it? I hope so because this is easy.

        1. 1.1.2.1

          It means an inventive use or at least [?] a previously uncontemplated categorically different use beyond what was originally contemplated for the process, article, etc.

          LOL – I am going to need cites for your twisted view there Malcolm.

          Of course, everyone know that you will not (cannot) produce them.

        2. 1.1.2.2

          As used in the term “new use”, the term “new” presumably does not mean simply ANY “use” that has not taken place before.

          Why not?

          Otherwise the term “new use” would be just a bad joke. “Hey I’m using this eraser to erase a word I just made up! Give me my patent as mandated by the statute as interpreted by this glibertarian patent huffer on the Internet!”

          The phrase “new use” occurs in (and only in) the §100(b) definition of “process.” Aside from the instance in which it is defined in §100, “process” occurs in (and only in) the §101 list of categories of “inventions patentable.” It is not really all that crazy to suppose that the framers of Title 35 were content to let §103 deal with the problem that you suggest. In other words, it is facially plausible that “new use” really does mean any “use” that has not taken place before, because Title 35 is structured in such a way that the one section of the statute for which the definition of “process” is relevant is not the section intended to weed out the claims to which you (rightly) are objecting here.

          We do not need §101 to do all the work of removing claims that the patent system is not meant to sustain. Some of the work can be done by the other sections of Title 35.

          1. 1.1.2.2.1

            The question mark (Greg’s latest hidden link) is a bit more fitting than he realizes, even as Yglesias is nothing more than another Liberl Left hack.

            As to Greg’s meandering into patent law, the codification at §100(b) does need to be understood in the light of THAT day and the purposeful intent to expand “process” into what we understand on a more vernacular basis today (as opposed to the more strict basis prior to the Act).

            This was previously pointed out to marty (who cannot bother with the terrain of law) who wanted to claim that §100(b) was unrecoverably circular.

        3. 1.1.2.3

          … and as you have already admitted, your argument is not with me, but with Congress and the law they passed in 1952.

    2. 1.2

      >Distinction without a difference? Or very different?

      I guess under current precedent, I’d worry that a mere “method for measuring” would be abstract, as the output is just a number (plus the “insignificant post solution activity” line of cases). I’d feel more confident about a method of use b/c I can argue the number has been integrated into a practical application.

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