Hikma Case Set for Supreme Court Consideration

by Dennis Crouch

Hikma Pharmaceuticals USA Inc. v. Vanda Pharmaceuticals Inc. (Supreme Court 2019)

Briefing is now complete in this important eligibility case pending before the Supreme Court. Hikma’s petition presents the following question:

Whether patents that claim a method of medically treating a patient automatically satisfy Section 101 of the Patent Act, even if they apply a natural law using only routine and conventional steps

Hickma’s question clearly mischaracterizes the Federal Circuit opinion – a common approach these days.  In its opposition brief, the patentee Vanda calls-out the intentional error:

Hikma’s Petition wrongly asserts that the Federal Circuit declared all method-of-treatment claims to be “automatically” patent-eligible under Section 101. . . [Hickma’s] Question is not presented by the decision
below or any other decision.

Although Hickma does a good job of nit-picking, the underlying reality is important — the Federal Circuit’s decision in Vanda is not easily reconciled with its Ariosa decision or the Supreme Court’s decision in Mayo v. Prometheus.  And, the Federal Circuit and USPTO have effectively green-lighted patents on methods of treatment that would be ineligible if recharacterized as methods of diagnosis or creating a treatment plan.

The amicus briefs in this case all focus on the same issue — arguing that the Federal Circuit’s Vanda decision conflicts with Mayo and Flook. The Law Prof brief explains:  “The Federal Circuit’s decision effectively overturns this court’s precedents, thwarts the proper development of patent eligibility law, and will lead to countless improperly issued patents.”  The Law Professor Brief was filed by Stanford’s IP Clinic – although neither Mark Lemley nor Lisa Larrimore Ouellette signed-on.  Professors Josh Sarnoff (DePaul) and Katherine Strandburg (NYU) substantially drafted the brief.  Top pharma-patent litigator Douglass Hochstetler (KelleyDrye) filed the AAM brief.

= = =

In a previous post, I explained that Vanda’s drug dosage claims that have two basic steps:

  1. Determining whether a patient is likely a poor metabolizer of the drug iloperidone based upon DNA analysis (i.e., determine if the patient has has the CYP2D6 genotype)
  2. Administering iloperidone at a lower dose to predicted poor metabolizers in order to reduce the risk of “QTc prolongation” for poor metabolizers.

In the case, iloperidone was already known as a drug treatment and it was also known that some folks were poor metabolizers in a way that created the particular health risk and that a lower dosage is still effective for poor metabolizers (since the drug stays in the body longer).  A remaining problem solved by the inventors was how to predict who should get the low dosage.  The core discovery here is that a genetic difference substantially explains the risk.  The inventors made that important discovery and then implemented it with straightforward administration steps.  The question then is whether this approach is patent eligible.

39 thoughts on “Hikma Case Set for Supreme Court Consideration

  1. 5

    Below, starting at 3.1.2, there is an exchange between two of the regular (even non-pseudonym) regulars) that bear some critical notations for both accurate statements, inaccurate statements, and further – critically – omissions of understanding of how the Rule of Law is intended to work under the US Sovereign:
    Comments worth noting as accurate :
    this is NOT an issue of “statutory construction of §101.” These are long-standing Sup. Ct. judicial definitions of unpatentable subject matter called “exceptions” that are NOT based on the language of 101, as demonstrated many times with Sup. Ct. citations on this blog. (PM)
    In any event, to the extent that the exceptions are not a function of statutory construction, that does not make the word “slipshod” any less apposite. There is a statute in place. The SCotUS really should apply the statute, or declare it unconstitutional. (GDL)
    No one should be comforted by the idea that the SCotUS is just making up the patent law on its own hook, when—by the SCotUS’s own acknowledgment—“the powers of Congress to legislate upon the subject of patents is plenary by the terms of the Constitution…” (McClurg v. Kingsland, 42 U.S. 202, 206 (1843)). (GDL)
    Comments worth noting as inaccurate:
    are they Sup. Ct. judicially created limitations for which there is insufficient evidence that the existing §101 was clearly intended by Congress to overrule them? (PM)
    a bit difficult to say with certainty whether or not the exceptions are a matter of (1) statutory construction [sic]; (2) common law; or (3) constitutional necessity. There is authority aplenty to support each possibility. (GDL)
    Let’s see some support for:
    “authority aplenty for constitutional necessity” – which would mean that the Court is explicitly noting that what it is doing is not some “implicit interpretation of statutory law,” but instead is itself placing itself in the shoes of the legislative body and declaring that ANY statutory law necessarily includes the scrivining of the Court itself (thereby usurping the role of Congress).

    omissions of understanding
    Greg here alights on an important factor: no one should be comforted with how the Court has imposed itself. If the law is unconstitutional, it is not an option for the Court to redraft the law (and in so doing, make policy decisions). The law would be unconstitutional of itself and ALL that passes through the unconstitutional law would thus be void (every single patent). To this end, Paul presupposes the legitimacy of the Court rewriting what Congress has done, and implicitly states that for any such ultra vires action, it would be up to Congress to affirmatively rebut the ultra vires act. Such is simply not a correct legal view.
    IF the Court had acted properly and interpreted law in a manner contrary to the will of Congress (and contrasting with the portion correctly put by Paul, IF the Court had a proper statutory basis), THEN a follow on move by Congress would fall within the Rule of Law as to how the various branches of the government provide checks and balances.
    The plain bottom line here since the Court is not acting within that sphere, and thus there is NO NEED for “evidence of intention” of Congress “overruling anything” as Paul presupposes.

    Further, the Act of 1952 itself is not being recognized by Paul as the domain of that Act provides.
    As been explicated by myself in great detail previously, touching upon the words of Judge Rich, the jurist most knowledgeable of what Congress did (because Judge Rich was instrumental in WRITING what Congress did), and how Congress was reacting against a far too anti-patent Court of the 30’s and 40’s.
    Congress had acted to remove the Common Law law writing power of the Court and had acted to REMOVE the Court’s ability to set the meaning of the word “invention” and instead opted to carve up the prior single paragraph into new, separate sections of law and use (rather than the NOT settling Common Law variants of “Gist of the Invention,” “Invention,” “Inventive Step,” and the multitude of other phrase) the different notion of “Non-obviousness.”

    In other words, Even as Paul clamors for some counter evidence, the plain Act of Congress itself already proves the point.

    To also add to Greg’s notion of plenary power is – let me again post the Coined Phrase – the Kavanaugh Scissors (and the possible “out” for the Court to extract itself from its own making of the mess of the Gordian Knot of 101).
    And to Greg, who alights that “(2) common law [has] authority aplenty to support…” PROPER Common Law is interstitial and NOT a rewriting to insert the Court’s desired policy Ends. There is NO authority for the type of Common Law applied by the Court in the arena of 35 USC 101. Such is simply egregiously wrong – from a Rule of Law point of view.

    Bottom line here is that what the Court has done cannot be called “statutory construction,” is not a proper interstitial or interpretation of the statutes, and there is NO sense of proper “Constitutional necessity” that permits the judicial branch to rewrite statutory law in order to impose the desired policy Ends of the judicial branch.

    ON TOP OF the foundational infirmity of what the Court has done, there are several Constitutional infirmities with how they have done what they have done (and as noted in relation to the three prongs discussed by Justice Kavanaugh in the oral arguments of California Franchise Tax Board v. Hyatt, ALL three prongs are easily met).
    Lastly, I will (proudly) note that there has note been a single cogent legal argument provided against my views anywhere.

    Not a one!

    Hence there is every reason why everyone should care what I think. ( )

  2. 4

    There is no reason why anyone should care what I think. Nevertheless, just to put down my marker so that I can receive my plaudits or opprobrium when the eventual cert. decision is announced, I predict that the Court will not take cert. on this one.

  3. 3

    “Although Hickma does a good job of nit-picking, the underlying reality is important — the Federal Circuit’s decision in Vanda is not easily reconciled with its Ariosa decision or the Supreme Court’s decision in Mayo v. Prometheus. And, the Federal Circuit and USPTO have effectively green-lighted patents on methods of treatment that would be ineligible if recharacterized as methods of diagnosis or creating a treatment plan.”

    So what’s the problem? Mayo was wrongly decided, and Ariosa was wrongly decided, even under Mayo. About time the CAFC started to regrow a pair and limit the scope of these wrong SCOTUS decisions to the specific facts of those cases. You want to attack the claims at issue here? Use 102, 103 or 112.

    1. 3.1

      I have two cheers for this post. It is not ideal that the lower courts take an openly antagonistic approach to the Supreme Court, but it is equally not ideal for the Supreme Court to take such a slipshod approach to statutory construction of §101.

      I would prefer that the solution to the problem posed by Mayo come from Congress. Congress does not seem super eager to act, however. Absent Congress, the CAFC distinguishing Mayo in a manner that minimizes Mayo‘s harm to industry is a second best solution.

      1. 3.1.1

        Greg, what do you believe is “the problem posed by Mayo” (which is more accurately “the problem posed by Promtheus’s claims”).

        1. 3.1.1.1

          You mean besides an “Ends justifies the Means” ultra vires and Constitutionally infirm legislating from the Bench…?

          1. 3.1.1.1.1

            As explained numerous times, the decision will never be reversed because it’s essential to the functioning of a sane patent system. Greg appears to understand this but I was curious to see how he would choose to articulate the “problem” presented by Prometheus’ claims in his own words.

            1. 3.1.1.1.1.1

              Your feelings are NOT an explanation.

              Instead, try some cogent legal reasoning.

              (in other words, you really need to be able to treat the counter points already on the table in an inte11ectually honest manner — something that you have never even attempted)

              1. 3.1.1.1.1.1.1

                Sure they are anon. Just like his feelings are an explanation, in his mind, as to why he would vote for the literal raci st party when he is supposedly wanting to stand up to ra cism.

                link to news.yahoo.com

                1. Тогда, обязательно надень свое тяжелое пальто.

            2. 3.1.1.1.1.2

              in his own words.

              Greg tends more and more not to do that. Maybe he picked up this habit from you.

      2. 3.1.2

        Greg, et al, I agree with your cert denial bet, but this is NOT an issue of “statutory construction of §101.” These are long-standing Sup. Ct. judicial definitions of unpatentable subject matter called “exceptions” that are NOT based on the language of 101, as demonstrated many times with Sup. Ct. citations on this blog.
        Better questions might be: are all of these “exceptions” Constitutionally-based limitations [that are not amenable to overruling by Congress], or are they Sup. Ct. judicially created limitations for which there is insufficient evidence that the existing §101 was clearly intended by Congress to overrule them?

        1. 3.1.2.1

          [T]his is NOT an issue of “statutory construction of §101.” These are long-standing Sup. Ct. judicial definitions of unpatentable subject matter called “exceptions” that are NOT based on the language of 101, as demonstrated many times with Sup. Ct. citations on this blog.

          Honestly, I think that it is a bit difficult to say with certainty whether or not the exceptions are a matter of (1) statutory constructoin; (2) common law; or (3) constitutional necessity. There is authority aplenty to support each possibility.

          In any event, to the extent that the exceptions are not a function of statutory construction, that does not make the word “slipshod” any less apposite. There is a statute in place. The SCotUS really should apply the statute, or declare it unconstitutional. No one should be comforted by the idea that the SCotUS is just making up the patent law on its own hook, when—by the SCotUS’s own acknowledgment—“the powers of Congress to legislate upon the subject of patents is plenary by the terms of the Constitution…” (McClurg v. Kingsland, 42 U.S. 202, 206 (1843)).

          1. 3.1.2.1.1

            translation: the Supreme Court scrivining is ultra vires.

            as noted by yours truly L O N G ago….

      3. 3.1.3

        Absent Congress, the CAFC distinguishing Mayo in a manner that minimizes Mayo‘s harm to industry is a second best solution.

        I beg to differ and posit that the second best solution would be the application of the Kavanaugh Scissors (the coined term for the application of the holding of the Schein case coupled with the pronouncements in the oral arguments of California Franchise Tax Board v. Hyatt).

        In other words, the Court itself sua sponte recognizing that it may NOT legislate from the Bench with its own added exceptions to pure statutory law, and that a reversal of its own scrivinings is justified because the three conditions of:
        1) the Court has been egregiously wrong
        2) the Court finds that their prior decisions have had severe practical consequences, and
        3) the Court finds that there can be NO real reliance in the “Gist/Abstract” sword that they have unleashed onto patent law,

        ALL are met with the muckery of their 101 scrivinings.

  4. 2

    “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” 35 U.S. Code s101

    Accordingly, these claims are eligible.

    Now move on to 102, 103, and 112.

    ’nuff said.

    1. 2.1

      As written, section 101 must either be interpreted with the so called judicial exceptions or it’s worthless (and unconstitutional). So it’s been interpreted with the exceptions. Over and done with. The other sections can not pick up the slack of a 101 literally interpreted unless those other sections, too, are interpreted to comprise the judicial exceptions.

      The easiest way to understand this (for some) is to recognize that mental processes are … processes. Nobody believes that Congress intended to make mental processes (e.g., the application of logic to data) eligible for patenting. But how would 102, 103, or 112 prevent a well drafted claim to a non-obvious mental process being patented? The answer is: they can’t do it. Oh but wait! It’s a “utility issue”, you say. Well, okay, but this non-obvious mental process happens to be incredibly useful. So what exactly did you have in mind (and be exact, since the alleged problem with the Supreme Court’s interpretation of 101 is that it’s oh so difficult to understand)?

      In other words, let’s hear your idea for a working eligibility statute now that you understand why 102, 103 and 112 don’t work.

      1. 2.1.1

        Because machines are mental processing things…

        Oh wait, anthropomorphication

        ()

        1. 2.1.1.1

          We needn’t discuss the issues presented by computing machines to appreciate the incredible Constitutional failure of a literally interpreted 101.

          There’s nothing controversial about this, by the way. Dennis knows it. Jason knows it. Heck, even David Hricek knows it.

          1. 2.1.1.1.1

            Your feelings are noted – as is the rather empty proclamation that “anyone” knows it.

            Your “running away” from the actual discussion of computing machines (and such STILL being machines) is also noted.

        2. 2.1.1.2

          Sounds like MM is trying to have a civil conversation, anon.

          Please try to help. Little faces that jeer at people are not helpful.

          1. 2.1.1.2.1

            I care not at all about EMPTY civility, Night Writer.

            He stepped directly into the anthropomorphication point – and that is NOT a new point (meaning, that he invites the criticism that I have provided).

            Let him actually address — in a cogent and inte11ectaully honest manner — that which he avoids, and then we can celebrate any attempt at civility.

          2. 2.1.1.2.2

            I think Dennis or David H. must have given him a timeout last week. His tone and substance has improved.

            1. 2.1.1.2.2.1

              Tone, yes.
              Substance? – well if you count lack of downright offensive blight, perhaps; but if you count actual legal substance (including any type of inte11ectually honest treatment of counter pointe presented – to his same old vapid retreads, then NO, there has not been an improvement in substance.

      2. 2.1.2

        …and let’s be inte11ectually honest about this whole “interpretation” thing: the judicial exceptions are entirely extra-statutory and have NO interpretative aspect.

        Where is my Schein case holding quote…

      3. 2.1.3

        “As written, section 101 must either be interpreted with the so called judicial exceptions or it’s worthless (and unconstitutional). ”

        Nonsense.

        1. 2.1.3.1

          Yup.

          It is an empty proclamation with zero cognitive, legal, or inte11ectually honest support provided.

          Supposedly, he is an attorney, but he uses the legal words with no support for his usage – and this is nothing more than a thin veneer for his feelings.

  5. 1

    The discovery here (a naturally occurring DNA mutation) is ineligible for patent protection. The claim is an attempt to perform an end-around that fundamental (and important) prohibition.

    Some kind of non-obvious detection kit could have been claimed but you can’t claim an obvious use of the ineligible information. People have a right (absent rational criminal statutes) to administer known drugs for their known purposes in whatever quantity is helpful to them. And they have a right to gather information for that purpose using public domain methods.

    That’s what Mayo was about and that’s what this case is about.

    1. 1.1

      Adding: note the bizarre result that, if these claims are granted, a patient with the mutation could be forced to pay more money to lower his dose of the drug. Greed is endless in certain circles.

      1. 1.1.1

        (meant to say “found valid and eligible” instead of “granted”)

    2. 1.2

      ” And they have a right to gather information for that purpose using public domain methods.”

      But they wouldn’t have known what information to gather without the public disclosure of the DISCOVERY of the inventors.

      “Who ever invents or DISCOVERS…”

      There is nothing TO discover but laws and products of nature. Clearly discoveries are meant to be patent eligible.

      Would you rather a system that encourages these inventors to keep their technique a trade secret leading to other doctors prescribing over doses to some of their patients?

      1. 1.2.1

        Those are hardly the only two options here.

        We already have a “system” that encourages clinicians to treat patients carefully and to share life-saving information with other caregivers. It’s staffed with human beings with consciences.

        Turning medical information into a commodity (or a liability) is a rotten idea and the idea that without doing so nobody will share or create information is both absurd and also the product of spending way too much time in the patent bubble. Only a certain class of patent attorneys obsess about “not enough patents covering medical information.”

        1. 1.2.1.1

          Commodity or liability…?

          Your argument goes too far (and WELL past any patent aspects).

          Your view can be translated such that all medicine should be free. All doctors should work for free. All medical devices should be developed, proven out, and distributed for free.

          The minute you insert the real world notion of costs, someone being paid (making a living), and any sense of “non-free” your argument evaporates.

          You engage in your typical “Accuse Others” with words like “absurd” and “bubble.”

          Wake the F up.

        2. 1.2.1.2

          Do you think we would have the life saving medicines we have now without patents to protect new drugs?

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