Eligibility: Preamble Does the Trick for Federal Circuit

by Dennis Crouch

Vanda is an important patent eligibility case drawing a fine line between the the eligible personalized medicine treatment claims and the ineligible methods of Mayo and Ariosa

Vanda Pharma v. West-Ward Pharma (Fed. Cir. 2018)

In a split decision, the Federal Circuit has affirmed the validity/infringement of Vanda’s U.S. Patent No. 8,586,610 covering a schizophrenia treatment using iloperidone. The claims require personalized dosage — depending upon the patient’s metabolization rate of iloperidone (“CYP2D6 activity”).

West-Ward filed an Abbreviated New Drug Application (ANDA) that substantially copied Vanda’s FANPAT application — Vanda then sued for infringement.

ANDA-Filing infringement is an oddity – filing of an FDA application to make a generic version of a patented drug is the act of infringement.

It shall be an act of infringement to submit— (A) an application … for a drug claimed in a patent or the use of which is claimed in a patent.

35 U.S.C. 271(e)(2).  Infringement was straightforward here because the proposed package label recommends personalized dosage based upon the aforementioned metabolic activity (and thus would induce infringement).

Eligible Subject Matter: The primary dispute is whether the claims survive the Mayo and Ariosa — i.e,. are they eligible or are they instead directed to an unpatentable law of nature.

The claims at issue in Vanda were roughly parallel to those found unpatentable in Mayo v. Prometheus.  In Mayo, representative claim 1 of the challenged Patent No. 6,355,623 was directed to treatment method that involved (a) administering a drug (6-thioguanine); and then (b) determining blood level of the drug.  A low blood level (less than about 230 pmol per 8×108 red blood cells) indicates a lack of effectiveness and a need for a higher subsequent dose while a high blood level (greater than about 400 pmol per 8×108 red blood cells) indicates potential for toxicity and that the next dose should be reduced.

In finding the claim invalid, the Supreme Court unanimously held that the correlation between blood level, efficacy and toxicity was an unpatentable law of nature and that the administration and determination steps were already well known in the art and thus insufficient to transform the claim to a patent eligible invention.

In Vanda, representative claim 1 is directed to a method of treating a patient suffering from schitzophrenia by (a) determining whether the patient is genetically a poor metabolizer of the drug (CYP2D6 genotype) then (b) administering iloperidone to the patient (12-24 mg per day if good metabolizer; <12 mg per day if poor metabolizer) in order to reduce the risk of “QTc prolongation” for poor metabolizers.

First the dissent — Chief Judge Prost identified the similarity here and explained her position that “the asserted patent claims [are] directed to a law of nature.”  At its crux, the invention began with the discovery of the health problems created by treating folks with lower CYP2D6 activity and recognition that a lower dose would be appropriate.

Importance of the preamble: The majority (Judges Lourie and Hughes) took the other side – and argued that the claiming differences were important between Mayo and Vanda.  Importantly, for them, the preamble in Mayo directed the claims toward “a method of optimizing therapeutic efficacy” while the Vanda claims are directed to “a method for treating a patient.”

This case, however, is not Mayo. First, the claims in Mayo were not directed to a novel method of treating a disease. Instead, the claims were directed to a diagnostic method based on the “relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.” Id. This “relation is a consequence of the ways in which thiopurine compounds are metabolized by the body—entirely natural processes. And so a patent that simply describes that relation sets forth a natural law.”

Although the representative claim in Mayo recited administering a thiopurine drug to a patient, the claim as a whole was not directed to the application of a drug to treat a particular disease. See id. at 74, 87. Importantly, the Supreme Court explained that the administering step was akin to a limitation that tells engineers to apply a known natural relationship or to apply an abstract idea with computers. See id. at 78 (comparing the claim in Mayo to “Einstein telling linear accelerator operators about his basic law and then trusting them to use it
where relevant”). To further underscore the distinction between method of treatment claims and those in Mayo, the Supreme Court noted that “[u]nlike, say, a typical patent on a new drug or a new way of using an existing drug, the patent claims do not confine their reach to particular applications of those laws.” Id. at 87.

In this case, the ’610 patent claims are directed to a method of using iloperidone to treat schizophrenia. The inventors recognized the relationships between iloperidone, CYP2D6 metabolism, and QTc prolongation, but that is not what they claimed. They claimed an application of that relationship. Unlike the claim at issue in Mayo, the claims here require a treating doctor to administer iloperidone in the amount of either (1) 12 mg/day or less or (2) between 12 mg/day to 24 mg/day, depending on the result of a genotyping assay. The specification further highlights the significance of the specific dosages by explaining how certain ranges of administered iloperidone correlate with the risk of QTc prolongation. See, e.g., ’610 patent at col. 4 ll. 1–15. Thus, the ’610 patent claims are “a new way of using an existing drug” that is safer for patients because it reduces the risk of QTc prolongation. Mayo, 566 U.S. at 87

Very important case here. Although I believe that the invention should be patent eligible, the majority’s approach appears to latch onto simple patent drafting tricks as the basis for distinguishing Mayo — an approach directly rejected by the Supreme Court in Mayo.

Vanda

A method for treating a patient with iloperidone, wherein the patient is suffering from schizophrenia, the method comprising the steps of:

determining whether the patient is a CYP2D6 poor metabolizer by: obtaining or having obtained a biological sample from the patient; and performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype; and

if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day, wherein a risk of QTc prolongation for a patient having a CYP2D6 poor metabolizer genotype is lower following the internal administration of 12 mg/day or less than it would be if the iloperidone were administered in an amount of greater than 12 mg/day, up to 24 mg/day.

Mayo

A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

 

 

 

 

 

 

95 thoughts on “Eligibility: Preamble Does the Trick for Federal Circuit

  1. 12

    Vanda obtained approval for the marketing of iloperidone in 2009 after it disclosed to the FDA the need to reduce the dose for slow metabolisers of the drug (in order to prevent QT elongation). This disclosure would have been in the form of trial data analyses and, possibly, a published report. In other words, doctors using this drug would have known about this relationship and modified their use of this drug right from the get-go.

    In 2013, the patent in issue – a patent covering a method of preventing QT elongation using this drug – was granted. How? I must be missing something.

    If this patent is allowed to stand, drugs with similar pharmacodynamics as iloperidone will be at risk of being tied up in similar, ridiculous, “method” patents.

    1. 12.1

      Two thoughts:

      (1) It is possible to know that dosage needs to be adjusted for slow metabolizers without knowing that the CYP2D6 allele is diagnostic for slow metabolism. In other words, it is not entirely clear from what you say that the present claims are anticipated and/or obvious in view of the state of the art at filing.

      (2) IF these claims are anticipated/obvious, then they deserve to fail. They deserve, however, to fail under §§ 102 or 103. This judgment still reached the right result—i.e., that the claims do not deserve to fail under §101.

      1. 12.1.1

        It is possible to know that dosage needs to be adjusted for slow metabolizers without knowing that the CYP2D6 allele is diagnostic for slow metabolism

        Greg, you’re a patent attorney, right? Connect the dots here instead of just letting your statement hang out there in the wind.

        “Knowing” a fact about nature can not turn an invalid claim into a valid claim for the same reason that “knowing” a fact about nature can not turn a method in the public domain into an infringing act.

        Step up the game, people. You’re a couple steps behind.

        1. 12.1.1.1

          Connect the dots here instead of just letting your statement hang out there in the wind.

          Accuse Others much?

          (like, ALL the freaking time?)

      2. 12.1.2

        IF these claims are anticipated/obvious, then they deserve to fail. They deserve, however, to fail under §§ 102 or 103. This judgment still reached the right result—i.e., that the claims do not deserve to fail under §101.

        Good lorb, the zombies just keep coming. Too flipping funny.

        The claims absolutely deserve to fail under 101 if they rely on non-obvious but ineligible subject matter to overcome 103. The only other solution (which has been tried and for some mysterious reason the usual suspects never complain about it) is to inject 101 issues into the 103 analysis. And what is the magical difference between that and addressing the 101 issues directly, pray tell?

        1. 12.1.2.1

          Greg, you’re a patent attorney, right?

          STOP conflating 101 and 103.

        2. 12.1.2.2

          “The only other solution”

          The only other solution to what problem? Your desire to eliminate patents?

          Other “solutions” include acknowledging that Methods are eligible subject matter and that the patent is valid.

    2. 12.2

      Your question seems to be, at least in part about dates. The application has a priority date of September 30, 2004, which is well ahead of the 2009 date you seem to assert at which the method was common knowledge.

      THAT is how and why the patent issued. The method was invented 5 years earlier.

  2. 11

    Thank goodness this case has clarified the law!

    1. 11.1

      Care to explain?

      1. 11.1.1

        anon, what has happened to you? He is being ironic.

        1. 11.1.1.1

          Not always evident (just take a look at Malcolm’s posts on this very thread).

          Does it hurt to ask for 6 to add a bit more meat to the bones of his post?

          1. 11.1.1.1.1

            “Not always evident”

            It depends, perhaps, on where one is on the spectrum.

            I had no trouble with either post.

  3. 10

    I’m not a chem person, so can someone confirm for me if this is the case:

    Patentee claims – Determine status of quality A. If A is true, then 12B. If A is false, then 24B.

    Determining A was previously known. Administering B was previously known.

    The non-obvious contribution is the if-then causal relationship A -> 12 or !A -> 24, yes?

    If so, 9-0 reversal based on Mayo. The majority forgets the simple maxim that eligibility is not like a nose of wax which may be twisted and turned. If repetition of known data gathering and repetition of known treatment were sufficient to prevent the law of nature exception, there would be no law of nature exception.

    The idea that the Mayo patentees failed because they didn’t explicitly limit the treatment to, e.g., taking it internally is ridiculous. The Supreme Court didn’t take Mayo because the patentee needed to limit his implementation to a particular known implementation. If that were true, Sequenom would have been taken.

    The second step is a search for something inventive beyond the improper disclosure – the fact of nature. Contrary to the majority’s opinion, if you tell a doctor that a person with quality A is safer with 12mg and !A should be 24mg, every doctor knows what to do with that information. There’s nothing inventive in the test and nothing inventive in the application. Something doesn’t become eligible because it is applied. Alice itself was construed by the Supremes as “applying it on a computer.” The application requires an inventive step to be significantly more.

    1. 10.1

      Just read the dissent and it’s entirely correct, most notably at Footnote 1. That’s the only reasonable view of the claims – they are non-obvious because they trade upon the discovery of a natural law.

      1. 10.1.1

        this reminds me of the dialogue on the notion that “unpredictability” is nothing more than “gee, we really do not know what is going on right now.”

        The “logic” played out here is that some want to give patents for that “gee we don’t really know/therefore we call it unpredictability” while withholding patents for the putting together (in a purposeful manner) configurations that will do as desired, i.e., being able to predict that if such and such configuration is so designed, we are able to obtain this (new) utility.

        bass ackwards to a certain degree, eh?

        1. 10.1.1.1

          bass ackwards to a certain degree, eh?

          Not really. I don’t think they said they knew why this happens, and I don’t think that if they threw up their hands and said “we don’t know why, just give us a patent” that they would have gotten one.

          My understanding is that these people didn’t figure out WHY the natural law functions as it does here, they simply ran a bunch of tests and found a correlation between cutting the dosage and safe outcomes when a certain variable was present.

          In other words – this IS the “gee we don’t really know” bucket. And even if it isn’t, it’s clear that bucket wouldn’t work anyway – in order to get past utility and obviousness you’re going to have to have to have that correlation data anyway, and regardless of whether you name that relationship or not, it can be inferred.

          So you can’t do less than what these guys did and still get a patent, and you can’t do more than what these guys did and still get a patent. That’s because this type of discovery is simply not eligible.

          1. 10.1.1.1.1

            Your last sentence reminds me of 35 US 100 (a): (a) The term “invention” means invention or discovery.

          2. 10.1.1.1.2

            RG: Something doesn’t become eligible because it is applied. Alice itself was construed by the Supremes as “applying it on a computer.” The application requires an inventive step to be significantly more.

            BUT INVENTING IS TEH HARD AND MOST PEOPLE DONT HAVE ALL DAY ALSO CLEARLY YOU NEVER HAD A ILLNESS IF WE DONT GRANT CLAIMS LIKE THIS WE WILL NEVER FIND OUT WHAT UNKNOWN THAREAPEUTIC METHOD WILL NEVER BE UNCOVERED BECAUSE ITS IMPOSSIBLE ALL WE KNOW IS THAT THERE WILL BE LESS WORK FOR PATENT ATTORNEYS WHO ARE TEH REAL CANARIES IN TEH COAL MIND OF THE ECONOMY OR QUITE IN FACT THE INVISIBLE HANDS

            1. 10.1.1.1.2.1



    2. 10.2

      The majority forgets the simple maxim that eligibility is not like a nose of wax which may be twisted and turned

      What planet are you from?

      1. 10.2.1

        The one when people have read Alice and Flook?

        This Court has long “warn[ed] … against” interpreting § 101 “in ways that make patent eligibility `depend simply on the draftsman’s art.'” Mayo, supra, at ___, 132 S.Ct., at 1294 (quoting Flook, 437 U.S., at 593, 98 S.Ct. 2522); see id., at 590, 98 S.Ct. 2522 (“The concept of patentable subject matter under § 101 is not `like a nose of wax which may be turned and twisted in any direction …'”). Holding that the system claims are patent eligible would have exactly that result. Alice at 2360

        You should try reading cases sometimes. It enhances your ability to predict what will be done in a future case.

        1. 10.2.1.1

          You completely miss the point that the Supreme Court themselves has mashed the nose of wax (even as they tell others not to do what they are doing.

          THAT is why I asked the question.

          YOU should try reading the cases sometimes, and do a little critical thinking as to how those cases fit into the bigger picture. DO more than swallow what the Court is spoon feeding you. Apply some thinking all on your own.

          Then take note that “what happens in the future” very much as changed from 101 case to 101 case – look at the players involved and where they stood in the pantheon of cases over time (and how – for example – Stevens was set to bookend his career with an assigned majority view in Bilski but LOST that majority writing position and ended up with a concurrence which was really a dissent.

          You may want to be able to understand law, the structure of the Supreme Court and the ongoing battles throughout history in order to pick these things up. I suggest that you do that instead of trying to give advice to your betters.

          1. 10.2.1.1.1

            This would be a smart challenge if not for the fact that I’m doing so much better than you on the scoreboard.

            We’ll see if this case goes en banc, then we’ll see if the Supremes take it. I’ll bet you $20 right now that when litigation ends these claims will not be valid.

            1. 10.2.1.1.1.1

              I doubt that Prof. Crouch would care for us to use his site to violate the online gaming law of various states (especially given that it is not clear who is located where on this board), but were it not for considerations of law and etiquette, I would cheerfully take the other end of that wager.

              1. 10.2.1.1.1.1.1

                I’m with RG so you’re in for $40, Greg.

            2. 10.2.1.1.1.2

              This would be a smart challenge if not for the fact that I’m doing so much better than you on the scoreboard.

              Except for the fact that the issue you keep on missing (and rather the point here) is that the scoreboard is broken.

              Celebrating a broken scoreboard is the epitome of ignorance.

    3. 10.3

      I don’t agree with Mayo, but random guy I think your analysis of the law is basically correct.

    4. 10.4

      If repetition of known data gathering and repetition of known treatment were sufficient to prevent the law of nature exception, there would be no law of nature exception.

      This is just not true. It is perfectly possible to maintain a patent system that would prohibit claims to law of nature per se, but permit claims that use known measuring techniques to apply law of nature. That is to say, if you say that it is permissible to claim

      A method of diagnosing sickle cell trait in a patient, the method comprising amplifying hemoglobin allele AS by polymerase chain reaction from a sample taken from the patient.

      this does not ipso facto imply that you must also allow

      A method of diagnosing sickle cell trait in a patient, the method comprising identifying hemoglobin allele AS in the patient genome.

      It is entirely sustainable to say that the recitation of a known measurement technique is enough to separate an unpatentable law of nature per se from a patentable application of the law of nature. The Supreme Court did not choose to draw the line at that point of demarcation, but there is no reason that they could not have done so. Such a distinction would not, as you contend, have swallowed up the rule against patenting laws of nature.

      1. 10.4.1

        It is entirely sustainable to say that the recitation of a known measurement technique is enough to separate an unpatentable law of nature per se from a patentable application of the law of nature.

        No, it’s not. You’re arguing to do away with the law of nature exception, which is a valid position, just not one the court took and just not one that will be taken.

        The starting point for the Supremes is to always determine what was the contribution to the sum of knowledge that this inventor put forward. Alice is simply a framework which allows a fact finder to filter out certain “improper” disclosures and ask if the claim should be sustained because there is something additional beyond that disclosure.

        In this case (assuming my characterization is right) the thing that this person added was the natural relationship. He didn’t teach the art you could use a test to find a quality of a person (which would be eligible), he didn’t teach the art a means and method allowing you to inject someone (which would be eligible), and he didn’t teach the art that before you go randomly injecting people you should perform a test to determine if they have a quality (i.e. the claim as a whole).

        His ONLY substantial contribution was the discovery of the relationship. If you are going to disavow that discovery, the claim MUST fall, because the alternative is that you can allow the discovery, the inventor would simply have to submit a lot of claims which particularly name all of the known things you can do with that knowledge. i.e. A first claim which performs discovery means X to determine if quality A exists, a second claim which performs discovery means Y to determine if quality A exists…a N-th claim that delivers the treatment through known treatment means X, and N+1 which delivers the treatment through known means Y… That may be great for people like you, who would probably get paid more money for more work, and it would certainly be great for someone like me, who would definitely get paid despite doing no further work beyond the first claim, but that doesn’t change the fact that the person is receiving a monopoly when his only contribution to the art was the disclosure of a natural law.

        It is entirely sustainable to say that the recitation of a known measurement technique is enough to separate an unpatentable law of nature per se from a patentable application of the law of nature.

        It’s entirely sustainable to allow for monopoly of old things too – simply have tradable licenses from the federal government like they do with radio frequencies. But that’s not the *patent* system we have. This isn’t a function of the Supremes drawing a random line, this is a function of the words “promote the progress” excluding mathematical logic, inductive abstract leaps and discoveries about the natural state of the world which were never intended to be within Congress’ purview to regulate with the power.

        1. 10.4.1.1

          [A] [H]e didn’t teach the art that before you go randomly injecting people you should perform a test to determine if they have a quality (i.e. the claim as a whole).

          [B] His ONLY substantial contribution was the discovery of the relationship.

          I am not clear on the distinction between A & B in the above. The Vanda inventors’ contribution is the discovery of the correlation, but they also (having made that discovery) taught the field that “before you go randomly injecting people you should perform a test to determine if they have [the CYP2D6 allele].” These are just two ways of describing the same invention.

          It’s entirely sustainable to allow for monopoly of old things too…

          O.k., if you wish to be silly about it, yes, that is “sustainable.” Elizabethan England had such a legal arrangement, and it was a drag on the economy, but it did not totally tank the whole show.

          To present my point more specifically, granting monopolies on old goods is sustainable but inconsistent with the idea of promoting progress of the art. By contrast, granting patents on claims to using old techniques to measure newly discovered correlations is entirely consistent with promoting the art. Before the patent, one has a given level of casualties because people who cannot tolerate iloperidone are administered an unsafe dose. After the patent, one has a lower level of casualties, because physicians know to lower the dose for a critical (but identifiable) subpopulation among patients. This decrease in casualties is an advance. You have not in any wise compromised the advance of the art by granting that patent.

          1. 10.4.1.1.1

            I am not clear on the distinction between A & B in the above. The Vanda inventors’ contribution is the discovery of the correlation, but they also (having made that discovery) taught the field that “before you go randomly injecting people you should perform a test to determine if they have [the CYP2D6 allele].”

            [A] is simply pointing out that the art understood that you should diagnose before treating. In a world where the art simply treated randomly, the claims would be eligible because they teach the art to diagnose before treating. Similarly, in a world without a means for detecting the allele, the detection device would render the claims eligible. Similarly, in a world without a means for delivering the treatment, that means would render the claims eligible. We don’t live in any of those worlds, and the sole contribution was the relationship. Once you agree, as you seem to, that the discovery is the correllation, you’re conceding the claims are ineligible, because the only other thing described by the claims is the routine use of the detection and treatment means in view of the natural relationship. That is not significantly more.

            “before you go randomly injecting people you should perform a test to determine if they have [the CYP2D6 allele]”

            Both of our statements are true because your quote is not coextensive with mine. I specifically did not nominate the quality because the quality is part of the natural law (existence of A controls amount of B treatment). They did not teach that before you treat people you should test to determine a relevant diagnosis.

            Putting the allele into it certainly makes your statement true (that they taught this sentence). But you can’t put that allele into it, because that is not asking if the claim has “other features” under Alice Step 2 that make it significantly more than the exception. That is considering *the exception itself* under the second step, which is simply not the focus of the second step. The exception is to be considered under the first step. If you consider the exception itself under the second step then there would be no 101 test, as all non-obvious exception disclosures (i.e. everything that passes 103) would inherently pass 101.

            That’s why I point out Footnote 1 in the dissent, as that points out that the reason the claim was non-obvious was because of the exception. That’s always going to be the case: If the claim doesn’t include something not previously known it’s not going to pass 103. But just because it passes 103 doesn’t mean it passes 101. You have to ask if the reason it is passing 103 is because it’s simply taking conventional things and adding a judicial exception.

            By contrast, granting patents on claims to using old techniques to measure newly discovered correlations is entirely consistent with promoting the art. Before the patent, one has a given level of casualties because people who cannot tolerate iloperidone are administered an unsafe dose. After the patent, one has a lower level of casualties, because physicians know to lower the dose for a critical (but identifiable) subpopulation among patients.

            Except before the patent, the person who actually developed a machine to measure something (you know, what patents are supposed to be used for) could license the machine to measure any qualities of nature it was capable of measuring. Now their patent has been devalued by a person discovering something that is outside the boundaries of patent law. That devaluation doesn’t promote the progress either, because it disincentivizes the next measurement machine.

            1. 10.4.1.1.1.1

              Huh? Did the inventor of the rocking chair devalue the IP of the chair inventor? The inventor of [improvement patent] technology builds a more extensive market for [base patent] technology, which enhances the value of the base patent.

              1. 10.4.1.1.1.1.1

                The inventor of [improvement patent] technology builds a more extensive market for [base patent] technology, which enhances the value of the base patent.

                Only true if the improvement is patent-eligible technology and not some abstraction like “look at this and realize the meaning while you sit in the rocking chair.”

                That’s the whole point of having a subject matter eligibility screen. Why is this always forgotten? Fundamentals, people.

                1. Define technology – in non-circular terms – and then show where that definition is in the patent law.

        2. 10.4.1.2

          You’re arguing to do away with the law of nature exception…

          Naturally, I do not agree with this characterization. I will stipulate that I am arguing to do away with a version of the law of nature exception. I am, however, totally on board with the idea that e=mc^2 per se should not have been eligible, even back when it was a novel and non-obvious assertion.

  4. 9

    Okay, where to begin. First, I’ll admit: I haven’t read the case yet. But I will.

    Second, taking this case at face value, it changes nothing and — if anything — it just solidifies the reasoning and the holding of Mayo (which is an untouchable case that will be with us forever). By this I mean that a claim which recites non-obvious physically transformative steps is not a Mayo-type claim in the first place. It was the lack of such steps which doomed Prometheus.

    Third, this is a horrible and misleading title for this article and the write-up is opaque. The preamble is not the key here. As I just noted, the key is the presence (allegedly) of non-obvious physically transformative steps (e.g., novel steps which lead to a physical transformation of matter which was unexpected). If there is any doubt about the un-importance of the preamble, just read the majority’s own opinion: Although the representative claim in Mayo recited administering a thiopurine drug to a patient, the claim as a whole was not directed to the application of a drug to treat a particular disease.

    Dennis you kind of messed up the analysis because when you listed the steps in Mayo’s claim you omitted the final step which is that somebody (or something) needs to determine the “meaning” of the measured drug level, i.e., does the drug level “mean” that you administer more drug? or does the measured drug level “mean” that you do nothing? Crucially, Prometheus admitted during trial that this last step (i.e., thinking about the meaning of the measurement) was all that was necessary to infringe the claim after the prior art was practiced. You didn’t actually have to treat the patient, even if the measured level “meant” that you should. You could just pick your behind. You still infringed. THAT WAS WHY THE CLAIM WAS INELIGIBLE.

    The sole question that I have (before reading the case) is whether a schizophrenic patient with this particular genotype was ever administered iloperidone “in an amount that is greater than 12 mg/day, up to 24 mg/day.” If so, then there is still a glaring ineligibility problem because determining the presence or absence of a gene sequence using prior art techniques is ineligible subject matter. In that scenario, the big legal question is: what difference should it make whether an ineligible detection step with some special “meaning” occurs before or after a prior art drug administration step? The argument for “no difference” would be that the fundamental policy concern that drove the result in Prometheus v. Mayo is still front and center, i.e., because correlations are so easy to draw (particularly in the era of “Big Data”) granting such claims has a chilling effect on the medical profession. On any given day, there are all kinds of different reasons to adjust a patients dose of a particular drug. If the gates are opened to “correlate then adjust” claims, before a doctor (or a patient) can “legally” adjust a dose based on his/her own experience, the doctor (or patient) will need to check to see whether he/she has ever been informed of some genetic sequence in the patient’s genome. In other words, the more you know about your own genome the more likely it is that you will infringe one of these cr @p patents. And don’t think that Kevin N 00 nan and his cronies aren’t aware of this.

    Speaking of which — for the love of decency — please do not pretend that N00nan or any of the “experrts” over at Patent Cr0cks was somehow “on top of this.” They weren’t. And they never will be. They’ve never been able to discuss Prometheus v. Mayo in honestly. All that N00 nan cares about is more patents and if he could figure out a way for he and his rich buddies to own your (or your doctor’s) thoughts about your health based on some “correlation”, he would do it. He’s admitted that much.

    1. 9.1

      You are clearly wrong in at least that Bilski stating that MoT was NOT required (by a 9-0 vote).

    2. 9.2

      “And don’t think that Kevin N 00 nan and his cronies aren’t aware of this.”

      Kev has cronies?

  5. 8

    I don’t know guys.

    What is the relationship between iloperidone and CYP2D6 poor metabolizer?

  6. 7

    If anybody out there thinks this case “clarifies the law”, raise your hand.

    Because that’s the more important thing, right? The clarity?

    LOL

    Just kidding, folks. We all know that clarity is the least important thing.

    1. 7.1

      I cannot understand the point that you are attempting to make Malcolm – the level of snideness is so great that I cannot tell what your position actually is.

      1. 7.1.1

        Do you think that this case clarifies the law regarding ineligibility, “anon”?

        Simple question.

        I would assume it’s the first question on a lot of people’s minds because a lot of people never ever ever stop whining about how oh-so-confusing this stuff is (when it really isn’t … until the CAFC starts making “exceptions” without any rational legal basis).

        1. 7.1.1.1

          Do you think that this case clarifies the law regarding ineligibility, “anon”?

          No. It does not. That is clear from my various posts here.

          This is nothing more than a “ping” that will be met with a “pong” from another panel.

          I answered your simple question – now will you state your views in such a way that clarity of your views can be ascertained? (you are not there yet).

    2. 7.2

      It clarifies the law in the sense that its shows that the pendulum is swinging back toward sanity.

      Its a bit ironic, I suppose, that the road back to sanity goes through schizophrenia… But, maybe it had to, since it was Alice that took us through the looking glass.

      Tea anyone?

  7. 6

    It is important to note that this was not an appeal merely from a preliminary 101 motion only decision below. The important specific patient administration claim step here in the form of: “if X>A, administer Dose [1]; if X<A, administer Dose [2]" also apparently passed muster under a 103 challenge below to the claim. That might not be the case for some other pharmaceuticals where the need for a major dosage difference for patients depending on their body fluid test for "A" would have been obvious to a POSITA?
    This case does seem to eliminate the previously widespread "the sky is falling" prognostications that ALL medical diagnostic tests are unpatentable under Mayo.

    1. 6.1

      This case does seem to eliminate the previously widespread “the sky is falling” prognostications that ALL medical diagnostic tests are unpatentable under Mayo.

      Well, yes, it does, but mostly because it distinguishes Mayo so aggressively as to essentially limit Mayo to its facts. This is a good thing, in my book, but it was hardly clear before Friday that the CAFC was going to take so aggressive a line of resistance against Mayo. I think that the sky-is-falling line was not inappropriate before last Thursday.

      1. 6.1.1

        ..and may also be “back in vogue” depending on the next panel decision.

        The parallel to other types of 101 decisions seems to be being closed over here…

        1. 6.1.1.1

          “closed” == “glossed”

      2. 6.1.2

        I think that the sky-is-falling line was not inappropriate before last Thursday.

        ROTFLMAO

        There have been plenty of diagnostic patents granted since Mayo, Greg.

        Give us a break, please.

        1. 6.1.2.1

          But has it not been your position Malcolm that ALL such diagnostic patents have been improper based on the Mayo case?

          It is not possible here to tell if you think that such claims (now) were proper and that this case is no cause for alarm, or if this case is simply a travesty and even more a cause for alarm.

          1. 6.1.2.1.1

            has it not been your position Malcolm that ALL such diagnostic patents have been improper based on the Mayo case?

            LOLOLOLOLOLOLOLOLOOLOL

            My goodness some people have a really hard time with reality.

            No wonder you can’t tell the difference between a Repu k k k e and a Democr@t.

            1. 6.1.2.1.1.1

              Your reply sheds no light on the topic.

              Try less dust-kicking and try more being direct.

              Use that “great” handle of the English language that you are always on about.

              1. 6.1.2.1.1.1.1

                Your reply sheds no light on the topic.

                But isn’t your position that all such crack dealing should be legal?

          2. 6.1.2.1.2

            ALL such diagnostic patents

            As opposed to the kind that are not “such”?

            What the heck are you trying to say?

      3. 6.1.3

        Well, yes, it does, but mostly because it distinguishes Mayo so aggressively as to essentially limit Mayo to its facts. This is a good thing, in my book, but it was hardly clear before Friday that the CAFC was going to take so aggressive a line of resistance against Mayo.

        I agree with this assessment. Now, given the history of what the Supremes have done with 101 both before and after Mayo, do you think it was the Supreme’s intention to limit Mayo to its facts?

        1. 6.1.3.1

          I don’t give @#$% what “the supremes” intended to do with Mayo. It should be limited to its facts, as should Myriad and Alice. And the CAFC, and the PTO, should have been doing that since the day each of those decisions were given. If that’s not to the liking of Mr. Roberts & Co., SCOTUS has not been shy about expressing its views in the patent sphere.

          Anyway, one panel does not a trend make. I can, unfortunately, think of other groupings of CAFC judges that would have decided the 101 aspects this case differently.

          1. 6.1.3.1.1

            [O]ne panel does not a trend make. I can, unfortunately, think of other groupings of CAFC judges that would have decided the 101 aspects this case differently.

            Sure. This is a perfectly reasonable (albeit depressing) counterpoint to my giddy hope that this really is tangible reason to hope that the pendulum is swinging back.

          2. 6.1.3.1.2

            I don’t give @#$% what “the supremes” intended to do with Mayo. It should be limited to its facts, as should Myriad and Alice.

            What about McWrong?

        2. 6.1.3.2

          [G]iven the history of what the Supremes have done with 101 both before and after Mayo, do you think it was the Supreme’s intention to limit Mayo to its facts?

          Your mention of “before and after” Mayo is interesting. Remember that it was almost exactly the same Court that took away with Diehr that which it had given with Flook. Consistency is not their strong suit.

          Besides, they did four 101 cases in as many years. They are grown tired of the subject. I would bet against their taking certiorari to this one, no matter how flagrantly it flouts Mayo.

          1. 6.1.3.2.1

            “Remember that it was almost exactly the same Court…”

            Should have checked Oyez before I hit submit.

          2. 6.1.3.2.2

            Assuming there is no en banc (which would seem unlikely) they wouldn’t need argument, they could summarily reverse and adopt the dissent’s holding. You could do it with one sentence.

            But the most likely outcome is that there is an en banc which adheres to Mayo. If the en banc were to affirm, there’s a significantly stronger reason for the Supremes to take it.

  8. 5

    This is PRECISELY the kind of claim that I considered from the outset (and advised colleagues shortly after the Prometheus v Mayo decision issued) should be patentable, and the distinctions from Prometheus are precisely what would be expected.

    The claimed method involves:
    (a) a test on the patient performed by the hand of man;
    (b) selection of an appropriate dose of iloperidone for the patient based on the outcome of the test; and
    (c) administration of iloperidone to the patient by the hand of man to effectively and safely treat schizophrenia.

    It is plain that the claimed method has sufficient human intervention to fall within the eligible process category of section 101, although this rational and necessary test required by law does not appear to trouble the Federal Circuit unduly. Overall, though a very sensible and welcome decision.

    1. 5.1

      Hi, Paul.

      But could one characterize Mayo similarly as:

      (a) a test on a patient being dosed with 6-thioguanine, performed by the hand of man;
      (b) selection of an appropriate dose of 6-thioguanine for continued administration to the patient based on the outcome of the test; and
      (c) continued administration of 6-thioguanine to the patient by the hand of man to effectively and safely treat the GI disorder.

      1. 5.1.1

        (Of course, the main claim in Mayo didn’t explicitly require my imaginary (c) “continued administration”, as writ it was just information)

      2. 5.1.2

        Definitely. One could characterize Mayo that way. That is why it is so encouraging to see that the CAFC chose not to characterize Mayo that way. It is a good sign that the CAFC are working so aggressively to distinguish Mayo and limit it to the facts of the rather quirky claim at stake in that case.

        I have resisted the urge to think that the pendulum is swinging back, but this case really gives me hope that such is happening.

        1. 5.1.2.1

          It is a good sign that the CAFC are working so aggressively to distinguish Mayo and limit it to the facts of the rather quirky claim at stake in that case.

          That claim was less “quirky” than many claims of similar or identical scope, at least in terms of protecting the “invented” correlation in a particular context.

          I take it that chem/bio practice is not your bread and butter. Unless I’m wrong, please stop digging. I watched this farce play out in real time and chuckled as the firm’s clients hung themselves when they refused to come back to earth.

          1. 5.1.2.1.1

            Your comment is awaiting moderation.
            April 16, 2018 at 9:41 am

            Sadly though Paul – as noted by the dissent (and subject to the same ping-pong effect of a “luck of a panel” draw), this is just NOT as “sensible” as you would hold it out to be.

            1. 5.1.2.1.1.1

              Of course, this is not through any fault of your own. THIS particular panel may match your prior stated view. The next panel may not.

              This is the fault of the judicial m u c k e r y that takes even a “plain that the claimed method has sufficient human intervention to fall within the eligible process category” and wipes away ANY “fitting a category” because the judicial exceptions are allowed to “float” to be pretty much anything that a judge wants to make them to be, and fitting a statutory category has become largely meaningless if a panel does not want you to have a patent.

              THIS is a “gift” of the Supreme Court.

              1. 5.1.2.1.1.1.1

                The Supreme Court simply
                F
                A
                I
                L
                E
                D

                because their gift of the “Gist/Abstract” sword came with NO limits (and with terms simply undefined – i.e., “abstract,” “significantly more”).

                Even as your “a-b-c” rendition here is sufficient to qualify as meeting the statutory category, that is merely part 1 of the two-part “Alice/Mayo” test, and guarantees nothing at the end of the day.

                I think that you celebrate TOO quickly with the comment of “this rational and necessary test required by law does not appear to trouble the Federal Circuit unduly” just because THIS panel happened to have two members willing to let this one slide by. But some other judge with Prost on the next panel and your comment will NOT apply.

                All of this circles back around to my provided view that the Supreme Court (and its b r o w b e a t i n g of the CAFC) have essentially nullified the Act of Congress in the Act of 1952.

                The only meaningful fix must come from Congress.

                1. And that meaningful fix must apply the Constitutional power of jurisdiction s t r 1 p p 1 n g of the non-original jurisdiction of patent appeals from the Supreme Court (while setting up a new Article III court to maintain the satisfying of Marbury which only requires Article III review and not Supreme Court review).

                  All else will only end up back in the Supreme Court and that Court doing whatever it feels like doing.

  9. 4

    The funny thing about ALL Pharma patents: the only utility of the configuration of protons, neutrons and electrons comes from the laws of nature and how those configurations act with the human body.

    The kernel of all (any) anti-patent** argument has a reflection in the Pharma world.

    ** by this, I mean the typical anti-patent positions of either anti-software patent or anti-business method patent. At their core, anti-patent is anti-any patent. This is because at its core, patent law is (largely) agnostic as to the field of innovation. It is when one wants to single out a particular field of innovation that the gamesmanship (read that as spin) is engaged. Critical thinking rips right through such games.

    1. 4.1

      at its core, patent law is (largely) agnostic as to the field of innovation

      Love the parentheses. Too funny.

      1. 4.1.1

        The parentheticals are there because there ARE some aspects of law geared to specifically Pharma matters (i.e., orang book and such).

        Your “too funny” is most odd.

        Are you that confused as to how you feel about this case that you are desperate to Tr011 something?

  10. 3

    How about:

    I claim only subject matter that is patent eligible under 35 USC section 101 for a method comprising…..

    1. 3.1

      Fails 112.

      (and yes, those applying some small amount of critical thinking will quickly realize why the legal concept of Void for Vagueness impugns the entirety of the Justice-written law of 101 and why Jeremiah the Bullfrog’s attempted fix does not work).

      1. 3.1.1

        Anon, I meant of for the substantive steps to follow “comprising…”

        Did you not interpret it that way?

        1. 3.1.1.1

          Does not matter what substantive steps you want to add to follow “comprising” – the 112 fault is in the statement of “only subject matter that is patent eligible

          1. 3.1.1.1.1

            So, are you saying, for example, that those college engineering students that Scotus said could write the Bilski (or was it Alice) software over a weeken could not determine what is meant by “only subject matter that is patent eligible?”

            1. 3.1.1.1.1.1

              I am saying what I have said:

              Your beginning phrase f a 1 l s 112 (that phrase hooked into the notion of you wanting to simply provide a caveat that 101 is passed).

              Since you are having trouble connecting the dots, let me help you: what it means to pass 101 (as a mere phrase – as the type that you want to insert) is simply NOT something that can be determined; hence, 112 cannot be satisfied with your use of the phrase.

              1. 3.1.1.1.1.1.1

                Why not? The Supreme Court has issued an edict that you can’t patent abstract ideas and implies that everyone knows what the metes and bounds of “abstract ideas” are.

                So, given the vagaries of language and interpretation, why can’t one address 101 by asserting in their application:

                To the extent that these read upon patent eligible subject matter, and only to that extent, we claim:

  11. 2

    The claim format is one that Kevin Noonan and Don Zuhn at PatentDocs, among others, have noted SHOULD be patent eligible under Mayo. Nevertheless, I am pleasantly surprised to see Judge Lourie draw a distinction between this claim and that that of Mayo, basing himself squarely on the wording of SCOTUS’s own decision. (Conversely, I am not surprised that Judge Prost dissents on the patent eligibility issue.)

    Nevertheless, the claim format here is a panacea: it contains two steps, first determining that the patient has a particular condition, and then administering a drug to treat the condition. The first step need not be carried out by the same party carrying out the second step, and thus, under current US jurisprudence, there’s an easy recipe to avoid infringement.

    Indeed, this being an ANDA case, it appears that West-Ward’s difficulty arose from including statements in its label instructing the physician not only to administer the drug but to first “perform or have performed a genotyping assay to determine whether patients are CYP2D6 poor metabolizers”. I don’t know if inclusion of that statement in the ANDA submission was required under FDA practice, but if it was not, and West-Ward had not included it (or had stated it passively, rather than something the physician would do or direct to have done), there would have been no infringement. Additionally, from the description at page 24 of the court’s opinion, it sounds like the statements in the label regarding testing were not explicit, but that West-Ward did not sufficiently challenge testimony from Vanda on that point at trial. Had that point been better challenged, the outcome could have been no infringement. So the ability to prove infringement of a claim of this structure, while possible (as shown here), is not straightforward.

    Still, we should be thankful for small things, and any decision from the Federal Circuit that circumscribes the ambit of the Mayo/Myriad/Alice cases in the patent eligibility sphere is a welcome one.

    1. 2.1

      I guess this is a good result, but Judge Lourie is just so bad. This case just reminds me of how much Lourie personally has decided in his own private little mind that all information processing is junk. He went with this one because this is his background and he is such a small man that he thinks his area is better than all the rest.

      Please resign Lourie.

    2. 2.3

      [T]he claim format here is [not] a panacea… The first step need not be carried out by the same party carrying out the second step, and thus, under current US jurisprudence, there’s an easy recipe to avoid infringement.

      A couple of thoughts:

      (1) I agree with you that Vanda does not (cannot, really) undo all of the harm done by Mayo. Still and all, this is a step in the right direction.

      (2) I do not read Vanda to suggest that the two steps in this claim are what save it from a death-by-Mayo. I think “providing” steps are a bad idea in any case, and I do not think that the outcome here would have been different if the patentee had not included the “providing” step. In other words, even if this had been a single step (“administering”) method, the case would have come out the same way.

      I don’t know if inclusion of that statement in the ANDA submission was required under FDA practice…

      This is not my area of expertise, so I will defer to others more knowledgeable than myself if they disagree, but I believe that this is the sort of label portion that the FDA will not allow you to omit. That is to say, this is a label portion describing what you need to do to administer the drug safely. The FDA will usually let a generic manufacturer “carve out” a utility from the branded label (i.e., there are two FDA approved utilities for the drug, one on patent and one off, so the FDA lets the generic omit the patented utility, and go to market on the specious theory that the generic will only be prescribed for the off-patent use), but not a safety warning. The patented method here concerns a means to enhance patient safety, not a utility as such. I would be very surprised if the FDA would allow a generic manufacturer to label the drug in a manner that omits critical safety information.

      1. 2.3.1

        For whatever little my opinion is worth, I also think that Vanda took an unnecessary risk by trying to cram two different ideas into one claim. Obviously, Vanda won, so my worry-wartism is a touch misplaced. Still and all, I am pessimistic about the value of choose-your-own-adventure style claims. Instead of one claim with a “if X>A, administer Dose [1]; if X<A, administer Dose [2]" style, I think it would have been safer to write two separate claims.

        1. A method of treating schizophrenia in a patient in need thereof, the method comprising administering 12–24 mg/day of iloperidone to the patient, wherein the patient has been determined not to have a CYP2D6 trait.

        2. A method of treating schizophrenia in a patient in need thereof, the method comprising administering less than 12 mg/day of iloperidone to the patient, wherein the patient has been determined to have a CYP2D6 trait.

        1. 2.3.1.1

          Greg, I agree with you.

          My point about the 2-step claim was simply that it’s a less preferable claim format for enforcement purposes, because if the steps can be split between different entities (where no one party controls both entities), then in the US there’s no infringement (nor inducement to infringe, which is what was found in the present case).

          Nor do I think it was the two steps per se that saved the claim under 101. It was the inclusion of the “administering” step, along with – as Dennis noted – the preamble that recited treating a disease rather than diagnosing (or optimizing, as recited in Mayo). And yes, it would have been worthwhile to try to claim just the administering step, in two different claims as you proposed, although in this case the patentee seems to have done just fine for itself with the two-step claim.

          1. 2.3.1.1.1

            It was the inclusion of the “administering” step, along with – as Dennis noted – the preamble that recited treating a disease rather than diagnosing (or optimizing, as recited in Mayo).

            The preamble was not the problem in Prometheus. Not at all. The problem was the lack of non-obvious physically transformative steps combined with an allegedly non-obvious (and ineligible) step of thinking a “new” thought about the meaning of the data.

            1. 2.3.1.1.1.1

              lack of non-obvious physically transformative steps

              Maybe you missed Bilksi: 9-0, MoT is not a legal requirement.

          2. 2.3.1.1.2

            “Control” is no longer required for induced infringement.

  12. 1

    Malcolm meltdown in 3… 2…

    1. 1.1

      Ha. Maybe he’s on PTO.

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