Vanda on Rehearing: Will the Federal Circuit Defy SCOTUS?

by Dennis Crouch

Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018) offers an example of a claim on the cusp of eligibility.  In a 2-1 decision, Vanda’s schizophrenia treatment claim was found eligible with Judge Lourie penning the majority and Chief Judge Prost in dissent. Judge Hughes was the swing vote here.

I have several thoughts on the patents at issue here, but they boil down to the following (1) Vanda’s claims should be patent eligible; (2) but the claims are not patent eligible under Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012) and Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014).

Now, West-Ward has filed its petition for rehearing en banc on the following question*:

1. Whether adjusting a dose of an old drug based on a patient’s genetic risk of poorly metabolizing it is eligible for patenting under 35 U.S.C. § 101.

A brief in support has been filed by Inventia and Mylan.

I previously wrote that “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.”

The claim in Vanda is directed toward a method of treating a patient suffering from schizophrenia with the drug iloperidone. The drug was already known as a schizophrenia treatment prior to the invention here, but some individuals did not tolerate the drug well (risk of “QTc prolongation”). The major discovery of the inventors here was that a genetic difference (the “CYP2D6 genotype”) led to those folks likely being poor metabolizers of iloperiodon.  The patent then has two basic steps:

  1. Determining whether the patient is genetically a poor metabolizer of the drug (i.e., has the CYP2D6 genotype)
  2. Administering iloperidone to the patient (<12 mg per day if express CYP2D6 genotype; otherwise 12-24 mg per day) in order to reduce the risk of “QTc prolongation” for poor metabolizers.

The basics here is that the inventors discovered the relationship between the genetic expression, a potential risk, and a safe drug level. That discovery itself is clearly not patentable and so the patentee added

The Supreme Court’s Mayo decision also involved a personalized treatment approach  (this time for IBD) based upon metabolization rate with the following two steps:

  1. Administering the drug (6-thioguanine) to treat the GI disorder; and
  2. Measure (“determine”) the level of the drug (6-thioguanine) in the blood — with low levels (<230 pmol per 8×108 red blood cells) indicating a need to increase the next drug dosage and high levels (>400 pmol per 8×108 red blood cells) indicating a need to decrease the next drug dosage.

In distinguishing these claims the majority explained that

Mayo was a diagnostic method while Vanda is a treatment method.  The reality is though that both are diagnostic and treatment oriented.  What the majority suggests, but does not say, is that Mayo’s claims would be patent eligible if they added one more step of injecting the new dosage. To me added injection sounds like the type of non-inventive post-solution activity that cannot transform an ineligible law of nature into a patent eligible invention.

Stepping back a little bit — One way to think about this case is as the flip side of Sequenom. In that case, the Federal Circuit followed Mayo, but expressly called for the Supreme Court to revisit its eligibility doctrine.  In his en banc denial concurring opinion, Judge Lourie wrote: “I find no principled basis to distinguish this case from Mayo, by which we are bound.”  However, the Supreme Court did not grant certiorari in Sequenom.  Rather than following that same approach — asking for help from the Supreme Court — The court in Vanda decided to make it happen themselves.  In my view, an en banc denial here will be a high flaunting of Supreme Court precedent — the question then will be what – if anything – will the Supreme Court do about it?

Eligibility: Preamble Does the Trick for Federal Circuit

 

 

82 thoughts on “Vanda on Rehearing: Will the Federal Circuit Defy SCOTUS?

  1. 12

    Before the inventors’ discovery, some patients were serious side effects with no known way (1) to identify which patients would suffer the side effects (with the possibility that such identification would not be possible) and (2) to alter the treatment for those patients that might have serious side effects so that the patients could get the benefit of the treatment without the side effects (again, with the possibility that this would not be possible). The inventors discovered biological characteristic of patients at risk of the serious side effects (thus solving the first problem) and then determined how that discovery could be applied to alter the treatment for those patients that might have serious side effects so that the patients could get the benefit of the treatment without the side effects (thus solving the second problem). The inventors then claimed a method of treatment that applies their discoveries to achieve results that could not have been achieved before their discoveries and invention. If this is not patent eligible, we are in big trouble.

    Regarding comparison to the Mayo decision, there the claim merely called for the doctor to think about the correlation. The claim did not even require a treatment. And, as the Supreme Court noted, the adjustment of dosages and treatment of the same conditions with the adjusted dosages was already being done before the patentees there filed their patent application. This seems quite distinguishable from the claim and the facts here.

    For these reasons I disagree that the Federal Circuit panel here was flouting the Supreme Court’s decision in Mayo

    1. 12.1

      [The facts in Mayo were that] the adjustment of dosages and treatment of the same conditions with the adjusted dosages was already being done before the patentees there filed their patent application

      True here as well. Dosages of drugs get adjusted all the time, for all kinds of reasons. Doctors don’t want to harm their patients, generally speaking, so if they see an unpleasant side effect or some sign of intolerance in a particular patient, then the dosage will be lowered. Conversely, if they see that the patient isn’t responding at all, the dosage may be increased.

      Of course in every instance there is a “reason” (a fact; some information) underlying the patient’s particular responsiveness to the drug.

      The inventors discovered biological characteristic of patients

      And so they are entitled to “own” those patients, right? At least to the extent that those patients want to be able to control the dosages of an otherwise public domain drug so they don’t suffer or die. Sure, that seems fair.

  2. 11

    “Determining whether the patient is genetically a poor metabolizer of the drug”

    OMG! Logics and stuff. Ineligible!

    1. 11.1

      It really does help your credibility if you can demonstrate a tiny bit if understanding of the actual issues and arguments. Try harder.

  3. 10

    The basics here is that the inventors discovered the relationship between the genetic expression, a potential risk, and a safe drug level. That discovery itself is clearly not patentable

    Is it? How can you square that statement with the notion that you find this “invention” eligible?

    This is just another patent on an item of information. Need I say more?

    1. 10.1

      But the patent does not claim mere information. One cannot infringe these claims merely by knowing something, or thinking something. One must take tangible action in the world outside one’s head to infringe these claims.

      1. 10.1.1

        The problem (one of the problems) is that the “tangible action” required by the claim includes doing nothing (administering zero amount of drug). Another problem is that the “tangible action” is in the prior art.

        So what’s being added? Information. Information obtained using prior art methods.

        Again: don’t fall into the trap of believing that because something is useful, it must be eligible for patenting. There’s more to it than that.

    2. 10.2

      This is just another patent on an item of information.

      No, it is not.

      Need I say more?

      No, you need to say less. Or, conversely, actually know more about the topic that you want to say anything about.

        1. 10.2.1.1

          Or, do as I suggest and play better.

          You can always do as you have always done – parrot your nonsense incessantly.

          That just does not make it any less to be nonsense.

    3. 10.3

      Why does a ‘discovery’ not pass the 101 test per se? A discovery – in which has been reduced to practice in a method or device – most certainly should be. Almost all patents, contain a sort of ‘discovery’ in the inventive concept. But the claim is the means in which the claim ‘reduced to practice’ the ‘discovery’ to the claimed invention.

  4. 9

    Rather than… asking for help from the Supreme Court… [t]he court in Vanda decided to make it happen themselves.

    Exactly correct. After years of being slapped down by the SCotUS, the CAFC had timidly begun to ape their masters and deem ineligible claims that clearly should be regarded as eligible. Now, however, they (like we) see that the SCotUS has lost interest in §101, they realize that they are free to start nudging the equilibrium back to its status quo ante.

    I was very disappointed when the SCotUS decided to take a pass on Sequenom, but now I am starting to think that the denial of cert. was the best thing to happen since Alice. If the Court would deny cert. in that case, they clearly have no interest in tackling the §101 subject again any time soon. That is the signal that the sane contingent on the CAFC (which is larger than one might expect) needed to start the process of “distinguishing” Mayo/Alice into well merited oblivion.

  5. 8

    SCOTUS and counsel under Myriad, Mayo and Alice created so much confusion around so simple a concept under 101.
    “To me added injection sounds like the type of NON-INVENTIVE post-solution activity that cannot transform an ineligible law of nature into a patent eligible invention.”
    As soon as you rely upon “inventiveness”, you are no longer in the realm of 101.
    Vanda’s patentability should be a simple obviousness analysis. It is subject matter eligible (four tangible steps) but not necessarily patentable. The only contribution to the art was “determining whether…”
    It does not matter that such determination necessarily requires some sort of calculation, because the claim is not simply directed to such calculation. The “determining” requires tangible underlying steps. But, even if the “determining” were purely a calculation (an abstract step), the claim would still be subject matter eligible because of the other tangible steps required and their inherently.tangible results.

  6. 7

    Again, the basic problem is that we can’t have tests of is X a Y when Y is not defined and when the test based on a subjective feeling of the fact finder.

    Right now, the test for 101, is basically, is the claim a witch.

  7. 6

    Protons,
    Neutrons,
    Electrons.

    Once again we see the (same) ones parading “Logic” that would make any and all “hard goods” not eligible through what amounts to a parsing and dissection to apply eligibility on a piece part level.

    1. 6.1

      No idea what you’re talking about , “anon”. Do you have an argument? Then make it using complete sentences in English. State your assumptions and show us your logic, if there is any. Good luck.

        1. 6.1.1.1

          Your accusing someone of pretending not to know what you likely believe they do not in fact understand is paradoxically, incoherently, yet appropriately, hilarious. :)

          1. 6.1.1.1.1

            Oh, Anon2, it is not that Malcolm really does not understand – I have explained to him the “Big Box of Protons, Neutrons, and Electrons” “logic” often enough, and with enough particularity (and, as he asks for here, enough simple complete sentences in English), to be quite clear the point of the phrase. ALL that he is doing here is his typical dissembling and accusations in order to pretend that he does not understand – since his current meme (and it IS his current meme) reflects the “logic” of the Big Box – yet again.

            He wants to recycle his tripe and pretend that the cogent counter to his tripe has never been provided.

            1. 6.1.1.1.1.1

              I have explained to him the “Big Box of Protons, Neutrons, and Electrons” “logic” often enough

              No, you’ve never explained it. Your imaginary “big box” makes no sense whatsoever in the context of the chemical patent claims that you want to pretend are analogous to functional claiming of logic processing machinery. Stringing together a bunch of words isn’t an “explanation”, Humpty. We’ve been through all that before.

              What’s hilarious is that you can’t just admit the existence of an exception carved out by jurists in your favor. That would be baby step for you. Granted, it would make you a hypocrite but you already own that a thousand times over.

              1. 6.1.1.1.1.1.1

                false accusations (“you’ve never explained it“) coupled with the typical Accuse Others meme (“make you a hypocrite“)

                …and what is this “admit the existence of an exception carved out by jurists in your favor” notion that you are sliding in here? Could that be the exceptions to the Judicial doctrine of printed matter? Shall we (yet again) revisit the fact that I provided a direct, easy to understand Simple Set Theory on that, invited your participation on a dialogue on the explication – MANY times – and yet, we ALL saw that you only ran away repeatedly?

                1. false accusations (“you’ve never explained it“)

                  You still haven’t explained it. This is what you do every time: you pretend that you explained it but you haven’t.

                  What is the significance of this imaginary “big box of protons”? What on earth does it mean? How does this imaginary “box of protons” in any way address or fix the problems presented by functionally claimed boxes that perform logic processing tasks?

                  In every other endeavor, structural claims that don’t recite new configurations in structural terms (directly or indirectly by reference to structures in the specification) are not patentable. How does waving your hands around and squawking about “boxes of protons” constitute anything other than nonsense? You’ve never explained this.

                2. This is what you do every time: you pretend that you explained it but you haven’t.

                  Simply not true.

                  You just want to play the brier patch game – old trick that is not going to be fallen for.

                  Besides, the concept is relatively simple – but like most anything else put to you, you have selective amnesia for anything that does not fit your rather trite script.

                  As to your own immediate confusion – as I noted in my reply above, you seem intent on slipping in some other concept – and that concept is one that you have refused to engage upon (after getting roasted with an admission against your interests by engaging another poster on when you admitted to knowing and understanding the exceptions to the judicial doctrine of printed matter).

                3. Go ahead and explain it, “anon”, if it’s so “simple.”

                  I mean it’s not as if you appear to be evasive or anything.

                  ROTFLMAO

  8. 5

    The clear message to the pioneers in the medical goods and services industry which they seem unable to hear is:

    “STOP investigating, researching, discovering, analyzing and perfecting techniques which make possible the values of improved health and welfare of potential patients/consumers if those techniques rely upon a discovery of a principle of nature.

    Whatever the effort, time, and money spent to make the discoveries surrounding the CYP2D6 genotype, and its practical application to improve the health of patients/consumers, they will not be recognized, or rewarded BECAUSE they rely on a discovery of a principle of nature, i.e. how reality works (and necessarily how reality always worked)…

    i.e. stay away from trying to make fundamental discoveries, that is going too far, content yourself with innovation limited to combinations of what are, more or less, individually already known…

    If you want something in return for a discovery which is too fundamental or important, don’t bother, we don’t want your solution… or at least we don’t want to exchange anything for it.

    Don’t stray too close to the sun, you will be burned.”

    Seriously, they have to stop working for a society which clearly does not want to pay for what they have to offer. Society does not deserve their appropriated effort, and it’s just plain stupid to work for nothing.

      1. 5.1.1

        Ah, Salk and his statement. The fact that Salk didn’t care about profiting from his vaccine doesn’t mean that’s how other think, or should think.

        More importantly, Salk did his work before the FDA required much in the way of clinical testing. If he were to try to get his vaccine approved today, it would cost far more in inflation-adjusted dollars than it did in the 1950’s. Who’s going to pay for that without promise of recompense – the federal government?

      2. 5.1.2

        Slashdot Reader:

        Yes all inventors need is a pizza ’cause they naturally just do these things. Salk had a lot of support structure already in place.

        Probably you are a Google shill anyway.

      3. 5.1.3

        Jonas Salk – like any inventor – is free to choose to NOT partake in the patent system.

        Jonas Salk – nor anyone else is not free to impose their choice on others and make it so that no one may choose to partake in the patent system.

        Therein, Slashdot Reader is the fallacy of your contribution.

    1. 5.2

      The clear message to the pioneers in the medical goods and services industry which they seem unable to hear is

      I think that it is too soon to say whether they are deaf to this message. There is a long lag time in the pharma business between R&D and product launch. The fact that we are still seeing new products arrive at an essentially average rate consistent with pre-Mayo history does not really tell us much. After all, the R&D necessary to bring today‘s new products to market was invested back before Mayo. The real tell will not arrive until ~2025 or so.

      I hope that the biotech and pharma industries did not take the message of Mayo/Myriad to heart, but I will not say that we can know whether they did or did not for at least another seven years. In any event, if they did scale back investment in response to Mayo, hopefully they will ramp back up again soon, as it becomes increasingly clear that Mayo is being distinguished into an increasingly narrow corner.

    2. 5.3

      It’s a problem with eligibility law (if it can even be called “law”). The problem is that, in trying to draw admittedly difficult lines, the outcomes are not given enough weight. When those lines are drawn in a way that results in loss of ownership for things that we clearly want to encourage, then the line-drawing has failed. Time for Congress to erase this ugly slate and remove the doubt about when desirable innovation is to be rewarded.

    3. 5.4

      Lots of us spent years of our lives discovering correlations and dedicating them to the public. No regrets. Stop projecting your greedy selfish tendencies into others.

      1. 5.4.1

        What is greedy, selfish (in its own way), and projecting is your very own admonition, Malcolm. You want to discount choice solely on your own choice while vilifying the choice that others may make.

        You elevate your feelings (and your feelings about yourself for being “altruistic”) and denigrate the legal possibility of a different choice.

        The cognitive dissonance for you must be truly overwhelming if – as you claim – you obtain patents all the time for such greedy people who do not choose as you have chosen and simply give their inventions away for free.

        How do you live with yourself by being the one that supplies such greedy people with patents that run so against your “altruistic” nature?

  9. 4

    Dennis,

    What is the basis for this statement:

    I have several thoughts on the patents at issue here, but they boil down to the following (1) Vanda’s claims should be patent eligible;

    Vanda didn’t invent genotype assaying. It didn’t invent the drug. It didn’t invent the means for delivering the drug. All Vanda did was discover the fact that a particular genotype has some bearing on one’s ability to metabolize a drug. That is the only salient disclosure in the entire specification, that’s the quid of the quid pro quo.

    Do you view discoveries about the world as something that has traditionally been within the realm of patent law?

    For example, if I discover a new cave on someone else’s land, should I be entitled to the cave under federal patent law for a term that Congress chooses to set, in derogation of state-controlled land grant to the owner? Similarly, if I discover a new, naturally growing plant or animal should I be entitled to a monopoly on making or using it?

    If not, why am I more entitled to the discovery of the natural relationship than the cave, the plant, or the animal, when I didn’t put either the relationship nor the cave nor the others into the world?

    Was Einstein a fool for not patenting E=mc^2?

    1. 4.1

      The invention in this case is a process that involves applying a particular law of nature (selected by the inventor) that influences the metabolism of a drug to solve the problem of treating schizophrenia in human.
      I think you need to start with that before discussing eligibility.

      1. 4.1.1

        applying a particular law of nature (selected by the inventor)

        Particularity has no bearing on laws of nature. This isn’t an abstract/concrete dichotomy, a law of nature is ineligible no matter how particular you get in describing it. Also the number of laws of nature do not change, so it doesn’t make a lot of sense that the Supremes could categorically say that Einstein couldn’t have patented e=mc^2 (a particular law of nature selected by the inventor which has applications) and distinguish this.

        that influences the metabolism of a drug to solve the problem of treating schizophrenia in human.

        The application doesn’t influence the metabolism, the metabolism is what it is. The law of nature is what it is. The “invention” in this case is the disclosure of the law, the cause-effect knowledge that particular genotype = poor metabolism.

        The fact that disclosing the law has utility has no bearing on anything. Disclosure of any law will always have utility. But disclosure of any FACT will also always have utility to someone. Journalists make non-public facts public every day. Journalism is an art. Are you suggesting that journalists are inventors and can patent their disclosures? Does that seem like the kind of disclosure congress was given the power to regulate?

        1. 4.1.1.1

          applying a particular law of nature (selected by the inventor)

          Particularity has no bearing on laws of nature.

          It is hornbook law that laws of nature are not patentable, but applications of natural laws are patentable. Diamond v. Diehr, 450 U.S. 175, 187 (1981) (“[A]n application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection”).

          The point in Vanda is that the inventors not only identified a natural law, but they recognized a particular circumstance in which one could apply this natural law to achieve a useful-to-humans outcome, and limited their claims to that useful-to-humans circumstance. That is exactly the sort of claim that is supposed to be eligible, notwithstanding the fact that the claim involves a law of nature.

          The application doesn’t influence the metabolism, the metabolism is what it is.

          That is one way of looking at it, but it really is not the only way of looking at it. It is just as sensible to say that treating physician does something—as a result of the Vanda disclosure—that treating physicians did not do before the Vanda disclosure, and that the different course of treatment results in a different metabolic outcome for patients.

          Your argument depends on getting very abstract about what is going on pre- and post-Vanda disclosure, as if we are somehow indifferent ot the fact that physicians are taking a different course of action before and after. Given that patents are directed to the useful arts, I am hard pressed to see why we should evaluate them from this distant and abstract perspective, rather than from the useful and practical perspective of what the relevant actors actually do in view of Vanda’s invention.

          1. 4.1.1.1.1

            Lowering a drug dose exactly as was done in the prior art because you have some (ineligible) information that “tells you” to lower the drug dose is not an “application of a natural law” that is worthy of patent protection. On the contrary, it’s the sort of claim that will corrode the system and lead to more reforms that the same footstamping maximalists here will also complain about.

            Also, it doesn’t matter that the Koch brothers would pay $1 billion for the information. Facts like that work against the patent reward, not in favor of them.

            1. 4.1.1.1.1.1

              Working “in favor” or “against” the patent reward is NOT dependent on your feelings towards people with wealth.

              There is NO part of US patent law that dictates eligibility based on the “wealth” of the inventor.

              But speaking of wealth, why is it that you have never addressed the dichotomy that the one single form of innovation MOST accessible to the non-wealthy is also the form of innovation that riles your feelings up the most? It’s as if you wear this sheepskin of “anti-wealthy” while being the wolf attempting to deprive the most poor innovators… (or at a minimum, the area of innovation most accessible by those with the most limited means)

            2. 4.1.1.1.1.2

              Even if what you say is true, having one limitation of a claim that is not new is not the test for ineligibility.

                1. It is in Malcolm’s parse and apply eligibility only to the piece parts view (or “logic”)….

              1. 4.1.1.1.1.2.2

                having one limitation of a claim that is not new is not the test for ineligibility.

                I never said otherwise. Any other strawmen you want to attack?

                1. I never said otherwise.

                  and yet you constantly argue otherwise (as you constantly attempt to parse claims and apply eligibility at a per element level…

          2. 4.1.1.1.2

            Seems more than a bit “abstract” to ignore the practical consequences that a tidal wave of “determine and inject” type claims will have on the ability of doctors to treat patients without fear of a a lawsuit.

          3. 4.1.1.1.3

            but applications of natural laws are patentable.

            Sure, but the only way to square “applications” with Alice is that the additional features is that additional concrete acts by themselves are not sufficient, they have to be significant, inventive additional acts. If thinking about the distinction in Mayo isn’t sufficient, I fail to see how performing the rote, uninventive act of delivering the medication pushes it over the edge into significance.

            but they recognized a particular circumstance in which one could apply this natural law to achieve a useful-to-humans outcome,

            Again, you could say the same thing about Alice, or Mayo for that matter. A doctor thinking about the proper dosage is a useful-to-humans outcome for the same reason as the doctor giving the proper dosage is a useful-to-humans outcome, if for no other reason that doctors never proscribe something before thinking about the proper dosage.

            Don’t you think that when *delivering* the correct dosage is so close to *determining* the correct dosage that your attempt to distinguish them exalts form over substance, which is exactly what the Supremes explicitly say not to do in Alice? It’s the epitome of making eligibility be “like a nose of wax.” If Mayo was so easily overcome by such an easily discernable act, why didn’t the Supremes say in Mayo “You know, he could have fixed this by adding a step to deliver the medication”?

            I mean why take Mayo at all in that case? How many times is a doctor going to think about the right dosage but not provide the right dosage? How many people are they protecting by invalidating a claim that would have been followed by the missing, validating step in 99.99% of cases?

            All signs seem to point to the distinction you’re making, which I agree is a factual difference, not being a relevant one. Obviously no one will ever get a patent for the Mayo claims again, but in terms of precedent, this claim can hardly be more factually similar.

            It is just as sensible to say that treating physician does something—as a result of the Vanda disclosure—that treating physicians did not do before the Vanda disclosure,

            This is true of literally every patent that has utility. Every patent claims to cause someone to do something different. If they did the same thing, it wouldn’t be novel. If they do something different, they’re doing it for some sort of benefit. The Alice test does not merge with the utility test.

            Your argument depends on getting very abstract about what is going on pre- and post-Vanda disclosure, as if we are somehow indifferent ot the fact that physicians are taking a different course of action before and after.

            But the reason the doctors are doing something different is because of the, as you call it, disclosure of thing that is hornbook law ineligible.

            If you wrote a disclosure that explained the genotype/metabolism relationship and mentioned not one single word about delivering the dosage (i.e. it completely ignored the “application” of the law) the end result would be the same: physicians would be taking the exact same “different course of action.” It’s hard to conclude that the delivery step is “significant” when you could entirely eliminate it from the disclosure and one of skill in the art would act in the same way as if you left it in. That leads me to believe that the claim is an attempt to get exactly what is ineligible rather than some significant application of it.

            How do you square this analysis with the Parker v. Flook analysis that “Respondent’s process is unpatentable under § 101, not because it contains a mathematical algorithm as one component, but because once that algorithm is assumed to be within the prior art, the application, considered as a whole, contains no patentable invention.” Doesn’t that suggest to you that in order for something to be significant you would have to have an inventive combination assuming the ineligible act was already in the prior art? When it comes to biochem this is obviously true – the gene and its anti-metabolism effect have been “in use” to every member of the public with the genotype every time they took the medication.

            1. 4.1.1.1.3.1

              Your problem is trying to square with a broken scoreboard (all the while clenching tight your eyes to the fact that the scoreboard is broken).

              Heck, one cannot even “square” all of the Court’s OWN “writings” each with each other!

    2. 4.2

      “For example, if I discover a new cave on someone else’s land, should I be entitled to the cave under federal patent law for a term that Congress chooses to set, in derogation of state-controlled land grant to the owner?”

      No, but if you find a clever way to create a new cave on someone else’s land, especially on land which was thought to be completely unsuitable for maintaining a cave structure, you might feel entitled to some compensation for providing that information that allows them to create and maintain the new cave.

      The situation pre-invention was that some people, when given the lowest normal dose of a drug, had severe enough side-effects that treatment was discontinued. Clinical trials had already established that there was little effectiveness of the drug in a normal population at lower doses.

      The patentees invented a protocol for treating a population of the drug that could not be treated under the normal protocol, but could surprisingly be treated safely and effectively by much lower doses of the drug – doses that the prevailing wisdom held would be ineffective. There is nothing natural about the compound, and there is nothing natural about giving the compound to a person. By using this novel, non-obvious protocol, they were able to effectively treat people for whom previous treatments had been found ineffective.

      In any other field, they would have the option of keeping this all a trade secret, walking up to people who found they had terrible side-effects from normal treatment, and saying, “hey, I have this little pill that might treat your problem without those nasty side-effects – give me a DNA sample, and if I think you’re a good candidate, I’ll let you have the pill for a mere $5000.” I guess they could still do that. I can see the Facebook ads now – “Suffering terrible side effects from iloperidone? Send us a DNA sample – we may be able to help you! Our secret treatment will make iloperidone effective for you!!! Only $10,000 for the secret to treating your schizophrenia safely and effectively!!!!!” And of course, the secret is cutting the pills in half. Because everyone knows that taking less of a drug is more effective, right?

      1. 4.2.1

        There is nothing natural about the compound, and there is nothing natural about giving the compound to a person.

        There is a lot that is old and in the public domain about that, however. Also old is giving the drug to people with the genotype “disclosed” in this specification. Also old is lowering the dose when those people prove to be intolerant of the drug.

        And what’s “natural” is the genotype that is being “determined” using an old determining method.

        Lots of room for innovating in this space, of course. And obtaining a patent on that innovation. But it would require a fair amount of work and there wouldn’t be as much work going around to patent attorneys. Oops! I’m not supposed to talk about that.

        1. 4.2.1.1

          You are conflating – at an element by element parsing – that which is old and that which is “natural.”

        2. 4.2.1.2

          “There is a lot that is old and in the public domain about that, however. Also old is giving the drug to people with the genotype “disclosed” in this specification. Also old is lowering the dose when those people prove to be intolerant of the drug.”

          Which speaks to 102 and 103, but not to 101. And no, lowering the dose when the people prove to be intolerant was not old, because it was thought that if the dose were lowered below the minimum then given, there would be no clinical effect. The person having skill in the art before the invention would have determined that the patient was exhibiting unacceptable side effects caused by the drug at the lowest dose, and discontinued treatment. The discovery of a population of people who exhibited side effects at low therapeutic doses of the drug was prior art; the fact that they also exhibited beneficial effects of the treatment at what was thought to be sub-therapeutic levels was not discovered until the researchers had put in years of work trying to determine what the population exhibiting unacceptable side-effects had in common. Once it was determined that they were poor metabolizers of the drug (a natural phenomenon), that discovery was used to invent an entirely new drug protocol based on the counterintuitive notion that in a certain population that could now be effectively predicted, otherwise clinically sub-therapeutic doses could be applied effectively according to a newly invented protocol.

          1. 4.2.1.2.1

            good point mike – and your point also speaks against the attempt by Random to paint this merely as a situation of “extension” (as if the treatment protocols were exactly the same).

  10. 3

    To me added injection sounds like the type of non-inventive post-solution activity that cannot transform an ineligible law of nature into a patent eligible invention.

    There’s no need to hedge your bet with “to me.” It’s true “to everyone.” This isn’t a case where there is reasonable debate about whether Mayo controls, if “injection” is the kind of activity that survived Alice Step Two, there is no Alice case. If only someone could divine a motivation here…

    One way to think about this case is as the flip side of Sequenom. In that case, the Federal Circuit followed Mayo, but expressly called for the Supreme Court to revisit its eligibility doctrine. In his en banc denial concurring opinion, Judge Lourie wrote: “I find no principled basis to distinguish this case from Mayo, by which we are bound.” However, the Supreme Court did not grant certiorari in Sequenom. Rather than following that same approach — asking for help from the Supreme Court — The court in Vanda decided to make it happen themselves.

    Bingo. They asked the Supremes to do something, the Supremes said no. Alice was FOUR YEARS ago and Congress has done nothing. At some point you might want to – I don’t know – maybe admit that Alice is the law. Or you could go the opposite route and decide that you are the law.

    To all the people who think that the Supremes overstepped by deciding Alice (and really they did not, but assuming they did) you simply MUST call out the Federal Circuit here for also overstepping their bounds. It isn’t their function to attempt to overrule the Supreme Court just because they don’t like the outcomes of precedent application. Anyone who supports the outcome of this case really isn’t in favor of the rule of law, they just want their own subjective views to control.

    1. 3.1

      You speak of “rule of law” while celebrating a broken score board…

      Which branch of the government (the only branch of the government) has been allocated authority to write patent law?

      1. 3.1.1

        Which branch of the government (the only branch of the government) has been allocated authority to write patent law?

        Assuming the Supreme Court is acting poorly, to whom does the Constitution give the authority to check and balance it? Hint: It’s not the court that the Constitution explicitly calls “inferior.”

        Again, there actually isn’t a problem. Ineligibility decisions date back at least to Morse, and the Supremes interpreted a statute to not erase their prior jurisprudence. There’s no “broken” situation here – there’s an entirely normal way for Congress to reassert itself if the Supremes made a mistake. The fact that Congress has not means there is nothing broken.

        I knew you’d be the one to argue that there’s nothing wrong with what the Federal Circuit did.

        1. 3.1.1.1

          Again, there actually isn’t a problem.

          Wrong.

          There very much is a problem with a broken scoreboard.

          That was NOT “interpretation” to preserve – especially if you actually understood what happened in 1952 and the fact that Congress took away the common law ability to reshape the word “invention” and in its place created the law of obviousness.

          Yes, Congress CAN “reassert itself.” But the fact that Congress CAN do that – even the fact that Congress HAS NOT done that – does NOT change the fact that the scoreboard IS broken. You are absolutely wrong to think that because Congress has not fixed the broken scoreboard that the scoreboard must not be broken. You only display your inability to understand law with such a mindless statement.

          As to “you’d be the one to argue that there’s nothing wrong with what the Federal Circuit did.” – did I actually provide any such argument?

          No. I have made no comment as to whether or not there was nothing (or anything) wrong with what the Federal Circuit did.

  11. 2

    The claim is eligible: it recites a process that includes an administering step. The administering step involves a real person ingesting a physical substance. There’s nothing abstract about that. If the Supremes try to say otherwise, they were wrong, as any 5-year-old can tell you, so they should be ignored. Besides, if the Supremes want to weigh in again on this matter, they will.

    What surprises me a bit – but only a bit – is the claim not being invalidated under 102/103: if the patient doesn’t have the gene, then the administering step is the same as it always was. So in effect Vanda is claiming the already-known method, but now with the knowledge that the patient doesn’t have a particular gene. But that issue doesn’t appear to have been raised on appeal. (And yes, I can make out a case for why the claim as worded is ok under 103, but it still doesn’t sit quite right.)

    1. 2.1

      “The claim is eligible: it recites a processor that makes physical changes to magnetic stored memory and sends out signals which control remote devices. There’s nothing abstract about that.” Look I can make it work with Alice too.

      This kind of logic is not only wrong but laughable. Abstraction has nothing to do with this claim, and even if the claim was an abstract idea claim the analysis still doesn’t turn on whether there is any concrete step.

      The claim is an attempt to monopolize the pre-existing natural relationship that is a product of nature this person didn’t invent. The only thing the claim adds is a command to perform an injection that the art already knew how to do, and in fact routinely did. The question isn’t whether administering an injection is a concrete act, it’s obviously a concrete act. The question is whether the injection is an inventive act such that the claim is more than a tarted-up attempt to claim the natural relationship. It’s not an inventive act, and the administering step is just lipstick on a pig.

      The only question is whether there is a necessary technological teaching
      to provide an advancement in assaying for CYP2D6 as opposed to any other genotype. There is not. The only advancement is the command to look for CYP2D6 because it controls a natural relationship. That disclosure is not an eligible disclosure.

      What surprises me a bit – but only a bit – is the claim not being invalidated under 102/103: if the patient doesn’t have the gene, then the administering step is the same as it always was.

      And if the claim only had one step, the administering step, it would be anticipated. But the claim includes testing for the gene: “performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype.” That step is not anticipated by traditional administrations, and even if assaying the sample for the genotype were previously done, there was no motivation to apply it to this scenario. It’s clearly non-obvious.

      So in effect Vanda is claiming the already-known method, but now with the knowledge that the patient doesn’t have a particular gene.

      No, Vanda is claiming a well-known step as the final step in a method that included a determination step that never existed before.

      You’re perfectly backward. The fact that has no bearing on a 102/103 rejection (that at least one step was extremely well known in the art) is the very fact why it is a 101 rejection (that step, rather than some sort of important “concrete”ness is instead not significantly more). The ineligible act under 101 (the relationship between the genotype and the effectiveness) is the very thing you’re ignoring that makes something novel and non-obvious under 103. The backward logic is a perfect example of why 103 doesn’t solve the problem and why 101 is necessary.

      1. 2.1.1

        Um, no.

        If the claim claims something that’s already known, or is obvious in view of what’s already known, that’s a 102/103 issue.

        The claim at issue here recites a physical process. So it’s eligible under 101.

        102/103 don’t enter into picture in a proper 101 analysis. As I already said, to the extent SCOTUS says otherwise, SCOTUS should be ignored (or, in polite legalese, the case should be “distinguished” from SCOTUS cases). If the Supremes think the lower court got it wrong, they will step in and say so.

        And FWIW, it’s pity it’s not Justice Stephen “I hate patents” Breyer who’s retiring.

        1. 2.1.1.1

          Agree Atari Man. What I find disturbing emanates from statements like this: “The claim is an attempt to monopolize the pre-existing natural relationship that is a product of nature this person didn’t invent.”

          Lets apply this to another type of claimed invention in medicine – a new use for an old drug. Using an old drug (product of nature) to treat a different, but known disease (natural relationship, the inventor just “discovered” this use) would not survive this test.

          I don’t have the answer for our conundrum, but I am sure I don’t want the above to be the guiding principle in bio/pharma inventions.

          1. 2.1.1.1.1

            I agree Atari Man and xtian.

            What is the difference between this and a person making an alloy? All they did was add metal, which is known. The metal was known. It is just a mental step with the addition of something that is already known.

            Basically, people like RandomGuy are just so ignorant of what inventions are and science that there is no talking to them. The Federal Circuit speaks of information in its “ethereal form.” Right out of medieval Europe.

          2. 2.1.1.1.2

            There is also a certain psychotic component to RandonGuy’s statements in that they are just these strange declarative statements that X is some general thing Y. It is very similar to saying that woman X is a witch (Y). There is no bounds on the Y or clear definition of what Y is and there is no rational reason given (or usually possible) or consistent way of testing if X is a Y.

            It is psychotic. And certainly has no rigor. I have noticed too that the people that speak like RandonGuy tend to have signs of mental illness or they have obvious signs that they know they just fabricating nonsense to get their way.

            In all cases, the type of stuff spewed out by RandomGuy is the enemy of a rational society and the scientific method.

            1. 2.1.1.1.2.1

              There is also a certain psychotic component to RandonGuy’s statements in that they are just these strange declarative statements that X is some general thing Y.

              I guess the ability to associate and group things is limited to some tiny portion of the population to which you don’t belong.

              It is very similar to saying that woman X is a witch (Y).

              It is also very similar to saying that a male X is a type of human Y, but you’d disparage that statement too if it meant getting more patents.

              There is no bounds on the Y or clear definition of what Y is and there is no rational reason given (or usually possible) or consistent way of testing if X is a Y.

              Sure, I mean, you could actually ask the inventor whether he invented the relationship or not, or you could maybe duplicate the experiment to see if people who aren’t the inventor also see the relationship, or you could peer review to question the relationship, but beyond that it’s entirely unknowable how that effect got there.

              It is psychotic. And certainly has no rigor.

              Don’t tell the scientists that, they’re very touchy on the issue.

              I have noticed too that the people that speak like RandonGuy tend to have signs of mental illness or they have obvious signs that they know they just fabricating nonsense to get their way.

              And the worst part of all is that this RandonGuy has convinced some people to let him argue cases and other people to let him examine patents. He’s a menace. If he keeps going around applying the law to things, next thing you know we’ll have an ordered society!

              1. 2.1.1.1.2.1.1

                A fluff response Random.

                All you did was repeat what I said and then repeat what you had said before. Not a single substantive response.

                Again, your game is no different than saying woman X is a witch Y. Who knows what a witch is. And who knows how to tell if she is a witch. The fact finder will tell you if she is a witch.

          3. 2.1.1.1.3

            Lets apply this to another type of claimed invention in medicine – a new use for an old drug. Using an old drug (product of nature) to treat a different, but known disease (natural relationship, the inventor just “discovered” this use) would not survive this test.

            An old drug is not a product of nature, but that’s ultimately irrelevant. Whether you’re talking about an already-dedicated-to-the-public man-made combination drug, an entirely novel man-made combination or even a naturally occurring plant, a method that involves use of the item to treat a disease is eligible. Mayo explicitly states that.

            What is not eligible is once the drug or plant is already being used to treat the disease, to explain exactly how nature works to extend the statutory term. Its an entirely different situation requiring an entirely different analysis about whether the extension is even a type of thing we should be endorsing.

            The alternative is ridiculous – imagine patenting a method of using a bow to shoot an arrow and then getting a further patent based upon disclosure of gravity changing the flight of the arrow and compensating for that, and then a third patent based on disclosure of the parabola equation and compensating for that.

        2. 2.1.1.2

          If the claim claims something that’s already known, or is obvious in view of what’s already known, that’s a 102/103 issue.

          The fact that ONE element is known doesn’t make the claim anticipated or obvious. The claim has a determining step. Was that step performed in the prior art method?

          102/103 don’t enter into picture in a proper 101 analysis.

          A 101 analysis requires a question of what is an “invention” under the law. You can’t give patents for things that aren’t inventions. Not everything you put after the words “I/We Claim” constitute inventions.

          And FWIW, it’s pity it’s not Justice Stephen “I hate patents” Breyer who’s retiring.

          You’d need a lot more retirements to reverse Alice or Mayo.

  12. 1

    DC I have several thoughts on the patents at issue here, but they boil down to the following (1) Vanda’s claims should be patent eligible

    They “should be patent eligible” because … why? Because without 20 year monopolies on correlations nobody will be motivated to discover why certain drugs don’t work as well on every individual?

    Please address the second question in your answer to the first and also address the fact that granting patents on “non-obvious” “useful correlations” between (a) an identiable variation in X and (b) the relationship between that identifiable variation and X’s reaction to event Y is going to lead, first, to a meltdown at a patent office that is barely equipped to handle what is already being presented to it and, second, to an absurd effective tax on a multitude of different technologies (not just medicine) as the “correlation” claims pile up around every endeavor under the sun. Finally, consider the fact that pretty much everyone involved in making a substantive rule here is relatively wealthy compared to the people who the rule will affect (i.e., they can afford to pay, relatively speaking, the added costs).

    Surely you must have thought about this stuff already in the course of forming your “belief” about what “should” be the result.

    To me added injection sounds like the type of non-inventive post-solution activity that cannot transform an ineligible law of nature into a patent eligible invention.

    The answer to whether a claim with a step of determining genetic identity and then administering a drug is “patent eligible” should depend on the specifics of the claim. “Injecting a drug or not as indicated by the correlation” does indeed sound non-inventive.

    Of course, what also sounds “non-inventive” is when you are treating a patient for schizophrenia and they obviously are not tolerating the drug being adminstered so … you administer less or you stop administering the drug. We can be 100% certain that in the prior art some patients were being administered the drug, identified as intolerant based on any number of criteria, and as a result had their dosage decreased or stopped. What is being added to THAT prior art (public domain) method is an *ineligible* step of “determining” an inherent fact about the patient using prior art detection methods. This means that doctors who are merely aware of the patients genotype (a freedom that can’t be taken away) and aware of the patented correlation in the “correlate and adjust” claim (another freedom that can’t be taken away) will be at risk of infringing the claim and hauled into court should they dare to adjust the dosage for some other reason. Those “some other reasons” will be easy to come by, as anyone can imagine. “Intolerance” to a drug usually comes with identifiable side effects, after all.

    If you want to “promote progress” in the art of treating diseases, what you want are better drugs (patented or not) and better methods (patented or not) for detecting genetic variances (pretty much all of which can be “correlated” with something or the other). Patenting correlations, directly or indirectly, isn’t going to “promote progress”. It promotes patenting and it promotes higher costs for everyone. Maybe, Dennis, you are banking on some wonderful universal health care being offered to every citizen in this country in the near future. I’m sure the Supreme Court will gladly uphold the constitutionality of that legislation, whatever it looks like LOLOLOLOL

    1. 1.1

      One more additional effort to illustrate the problems presented by this particular claim:

      DC the inventors discovered the relationship between the genetic expression, a potential risk, and a safe drug level. That discovery itself is clearly not patentable

      This is correct, with the clarification that correlations themselves are ineligible for protecting with a patent.

      Now consider this step recited in the claim:

      Administering iloperidone to the patient (<12 mg per day

      That step is anticipated. Anticipated subject matter (administer zero amount of this drug) plus ineligible subject matter (look at patient’s DNA using prior art methods) = g@r bage.

      Now, if the claim is directed to an old drug is administered in a non-obvious dose that’s never been administered to a patient before, that’s a different story. Or if claim is directed to an old drug that is administered in an old dose to a “non-obvious” type of patient who’s never been administered the drug before, that’s also a different story than the one before us in Vanda.

      Be very very wary of falling into the trap of believing that just because a “discovery” is beneficial to a particular type of person in a particular circumstance that someone must be rewarded for that “discovery” with a patent. That is a slippery slope that will throw the system down another hole that benefits a tiny tiny fraction of people at the expense of everyone else (and at the expense of progress). Friendly reminder: there are other ways to reward people. Don’t forget about them.

    2. 1.2

      I admit this is outside the scope of this discussion, but it is tangentially relevant to the topic of correlations and genetic/biomarkers of patients.

      If a pharma company can identify that a subset of a diseased population will respond to a treatment statistically better than the entire disease population in general, wouldn’t this advance the science? Wouldn’t this advancement lead to better treatment paradigms? No longer would a patient have to try each and every treatment for their disease before they “found” the one that works for them. Don’t we want personalized medicine?

      The flip side, is that by doing this, pharma companies are in a sense decreasing their own market share. If there is a genetic test that allows one to determine treatment response to a sub-population, the treatment won’t be used in the greater population. This means less sales, and conversely, the price for personalized treatment actually increases. However, your treatment success-rate also increases.

      Why correlation patent claims like these are useful to pharma companies, given the above, is that a generic company may “carve out” the genetic treatment step in their label. MD’s and insurance companies will still require the genetic testing so that the patient will be put on the “right” drug. The result is that the generic company doesn’t have the label, isn’t infringing the patent, but still is prescribed to the patient. The result is that there is no incentive for the brand pharma to discover the personalized medicine.

      1. 1.2.1

        The result is that there is no incentive for the brand pharma to discover the personalized medicine.

        I do not agree with this at all. Assume the following:

        Pfizer is the brand sponsor of CELEBREX (celecoxib). Suppose that Pfizer discovers that loose bowels (a side effect of celecoxib) correlate with allele 1 of the ptbK gene, and that patients with allele 2 rarely experience loose bowels in association with celecoxib. Pfizer can patent that discovery (under Vanda, one could get a claim to the effect of “a method of treating pain in a patient in need thereof, the method comprising: determining that the patient carries ptbK gene allele 2; and administering a pharmaceutically effective dose of celecoxib to the patient”).

        When Pfizer submits this information to the FDA, however, the FDA will revise the label to require that physicians genotype patient ptbK genes, and instruct that celecoxib be prescribed only if the patient carries allele 2. Under Hatch-Waxman, generic companies must copy the brand label exactly, so the generic companies will be required to label their drugs in a way that constitutes induced infringment of Pfizer’s new patent. In other words, this discovery is a very useful way for Pfizer to extend the market exclusivity that it enjoys as the branded NDA sponsor.

        Admittedly, this strategy works best if no ANDAs have yet been approved, and also works better for prescription than for non-prescription drugs. Still and all, it is a great incentive for branded NDA sponsors to continue investigating their own drugs for strategies (such a personalized medicine gene correlations) that improve patient safety. Given that we want to incentivize such research, this just goes to show that Vanda is an example of the right way to do patent law.

        1. 1.2.1.1

          Greg,

          I agree Vanda is good law. But I want to continue our other dialogue.

          If Pfizer found out about the allele/loose bowel correlation after the CELEBREX was on the market (i.e., publicly used), then your claimed invention would be inherent. (Subject matter eligible under Vanda, but inherent under 102/103 grounds.)

          Label v generic label: Whether the FDA would require prior generic testing for the allele and only allow the sub-population to the treated, would be in my opinion, only required if the AE was something more serious then loose bowels. So, unless the agency requires prior generic testing (and the indication statement is something like: Celebrex is indicated for moderate to severe pain in patients with allele 2 of ptbK), Absent that clear indication statement, the generic could just list the AE and not require testing, thus avoiding patent infringement.

          Thanks for the discussion.

          1. 1.2.1.1.1

            Likewise, thank you for the discussion. Taking your points in order:

            1) Look at my hypothetical claim. There is an allele “determining” step in there. How is that determining step inherent in the prior art merely because celecoxib was already on the market?

            2) I have seen the FDA revise labels to minimize loose bowel side effects before. I agree that they would revise the label for something really serious, like the effects at stake in Vanda’s invention, but I stand by the contention that the FDA would require a label change even for less serious side effects, so long as the intervention required to prevent the side effects is not especially hard on the patient (and genotyping a single gene is not).

      2. 1.2.2

        If a pharma company can identify that a subset of a diseased population will respond to a treatment statistically better than the entire disease population in general, wouldn’t this advance the science?

        No need to be so limited. Disclosure of any fact is an advancement. A journalist discovering some unpublished fact and publishing it is useful. We don’t give them patents, and yet somehow they still disclose things.

        If a pharma company discovers a benefit they have a motivation to disclose it – selling more of their drug.

        No longer would a patient have to try each and every treatment for their disease before they “found” the one that works for them.

        As an aside, statistically sampling patients to “try and find what works for them” doesn’t seem very inventive, does it? It seems like their ought to be a doctrine that would keep a patent award from someone doing what a lay person can do. Either it’s obviousness or its eligibility.

        The flip side, is that by doing this, pharma companies are in a sense decreasing their own market share. If there is a genetic test that allows one to determine treatment response to a sub-population, the treatment won’t be used in the greater population.

        Not really. If the drug doesn’t actually treat, it will not sell.

    3. 1.3

      “Because without 20 year monopolies on correlations nobody will be motivated to discover why certain drugs don’t work as well on every individual?”

      Let’s go with that. Yes. Now explain to me why that is unworthy. After all, why put effort into understanding why pharmacology does or does not work when you can simply continue to treat the individual as a black box.

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