Supreme Court Shows its Interest in New Eligibility Case

by Dennis Crouch

Hikma Pharmaceuticals USA Inc., et al. v. Vanda Pharmaceuticals Inc., No. 18-817 (Supreme Court 2019)

In this case, the Supreme Court has requested input from the U.S. Government — requesting the views of the U.S. Solicitor General (CVSG).  The SG’s office will likely submit its brief in December 2019 — so we have a nice wait on this question presented:

The question presented is 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.

Although Hikma did not declare all method-of-treatment claims automatically patent eligible. It appears that the court has doubled-down in Natural Alternatives Int’l. Inc. v. Creative Compounds, LLC (Fed. Cir. 2019) (“These are treatment claims and as such they are patent eligible.”).

The court is also awaiting the views of the SG in HP v. Berkheimer on the question of the extent that eligibility is based upon a questions of fact. Berkheimer has become standard Federal Circuit law — as the court explained recently in Natural Alternatives: “Eligibility under § 101 is a question of law based on underlying facts.”

41 thoughts on “Supreme Court Shows its Interest in New Eligibility Case

  1. 7

    Untouched (so far) is the view here in regards to Berkheimer…

    Given the nature of examination as occurring outside of the Article III judicial bodies, the nature of the APA, and even the nature of the specific Office limitations on Official Notice (for example, may not be used for an indication of the state of the art, nor may be used for anything but limited “gap filling”), the designation of 101 as containing underlying factual matters is NOT a small matter, and cannot be ignored as it remains a pivotal point (even as the new protocol provides a number of off-ramps in the eligibility analysis prior to the point of engaging what Berkheimer dictates).

  2. 6

    I wonder if anything claimed as a “dietary supplement” should properly be characterized as a method of “treatment”.

    Additionally, in my narrow mind, the only way we should allow new uses for old drugs to obtain patent protection should be a doctrine that treats them as new compositions when combined with the pharmakinetically involved structures in the body.

    As methods claims, the only novelty is the information that they would work for a certain purpose, and information used by doctors (or any persons) should not be eligible subject matter.

    1. 6.1

      in my narrow mind, the only way we should allow new uses for old drugs to obtain patent protection should be a doctrine that treats them as new…

      The problem IS your narrow mind.
      See 35 USC 100(b). Then try to get out of your own way and understand the terrain of patent law to which understanding of 35 USC 100(b) necessarily takes you.

      1. 6.1.1

        The problem is greedy entitled patent maximalists and trolls like you, B i l l y.

        The beatings will continue.


          To your lack of understanding of the terrain, it only appears to be a defective tautology.

          You need to stop looking for “something else” and pay better attention to those in the know that reach out to help you.


            It only appears that way? To those who can’t read the words on the page or the cases that have attempted to deal with it?

            When the statue says “The term [process] means process” it’s not a tautology, because some patent blogt roll says so. Please.

            Bilski was a punt, and everyone knows it. They admit Process could be a manner of doing ANYTHING, and we know that ANYTHING is not eligible for patenting. QED, they did not want to deal with it then. Sooner or later, they will have to.

            Section 101 similarly precludes the broad contention that the term “process” categorically excludes business methods. The term “method,” which is within §100(b)’s definition of “process,” at least as a textual matter and before consulting other limitations in the Patent Act and this Court’s precedents, may include at least some methods of doing business. See, e.g., Webster’s New International Dictionary 1548 (2d ed. 1954) (defining “method” as “[a]n orderly procedure or process . . . regular way or manner of doing anything; hence, a set form of procedure adopted in investigation or instruction”


              You continue to want to ignore the plain fact that you need to recognize the terrain.

              Go back to one of my first comments to you vis a vis Sun Tzu.


              … and there can be little doubt about my views as to the Charley Foxtrot rendered by the Supreme Court in regards to patent law (concerns of “any” process already being taken care of by the other prong of 101:utility within the Useful Arts).

              Part and parcel of your problem is the eagerness to dismiss that which you disagree with (and dip to the mindless ad hominem of ‘Tr011’).


              Martin, your a programmer aren’t you. Do you really not understand the concept of overloading an operator?

              100(b) is very similar. It says, look, we are not going to write this long string of words every time we mean to refer to this list. Instead, we are overloading the word process here to mean process and/or any of these other things.

              Its not defective. Its efficient.

  3. 5

    Years before Alice, I predicted on this blog that the SCOTUS would come up with a case that would permit judges to invalidate claims at the SJ stage. And once I read Rader’s dissent in Bilski I said the SCOTUS would adopt this. And I was right.

    How did I do that? The short answer is that I know that the SCOTUS doesn’t care much about the Constitution or the Patent Act. They are primarily driven by policy when they come across issues they think they need to fix.

    So the real question is not the law but what are the justices thinking now about patents? We need to get some intel into what their corr upt little minds are thinking about patents. From Oil States, I’d say there are two or three that might be thinking that patents have been crushed enough, but there are still the four liberal justices that don’t even want any patents and they have Thomas.

    If cert is granted, I’ll figure out what the outcome will be. It takes me 5 or 6 hours of work to do that as I need to read a bunch of the briefs and case law and (/sarcasm on) discern what the court feels it must do to guard the large international corporations from ruin (/sarcasm off).

    1. 5.1

      To your views, there may well be a mixed reaction to the “changing of the guard” currently underway in the Court’s make-up.

      Those on the fence may well choose to NOT be so “anti-patent” in order to conserve their energy for more Liberal fights.

      And those already deeply “anti-patent” AND Liberal (think: Breyer, Notorious G, and Sotomayor), may realize that their days are numbered (both personally and philosophically).

      It is no small matter then, that my own coined term of “Kavanaugh Scissors” may come into play as a mechanism for the Court to extract itself from what is very much turning into a “no-win” scenario, given the incredible level of Constitutional infirmities that their legislating from the Bench has created.


          Innovation flourishes.

          As is to be expected with a strong patent system (and as also expected, will exacerbate your cognitive dissonance immensely).

  4. 4

    It looks like we are going to get some more 101 cases. I doubt much will change, though.

    1. 4.1

      One of the possible “battle lines” shaping up — and something that the Court may weigh in on — is the distinction between “inventive concept” and “practical application.”

      One of these was expressly rejected by Congress in the Act of 1952, while the other may be seen as an “interpretation” of one of the two baseline requirements of 35 USC 101 (those baseline requirements are: fitting into at least one of the statutory categories, and having a utility within the Useful Arts).

      Of course, IF the Court were to “man up” and somehow find some humility, we could also see the application of the Kavanaugh Scissors.

      1. 4.1.1

        I imagine Thomas writing some obtuse opinion that ignores the issue you describe and then proclaims that nothing has changed.


          Anything that the Court writes that does not admit their own screwup will be — by definition — obtuse.

          What is a necessary step in any addiction recovery plan? Why would you think treating the addiction of the Court’s policy insertions in patent law be any different?

    2. 4.2

      Ding. Ding. Ding.

      And you can start getting ready for the bubble to pop. That’s going to have a larger impact on “investment” than 101.

    3. 4.3

      To the contrary, with a changing of the guard as to the Court’s composition, the Gordian Knot is primed to be cut.

      There is — of course — no guarantee, as the Court has long done whatever they want to do without regard (in part, because of the sheeple of attorneys that hold some unholy allegiance and continue to pretend that the nA ked emperor has such fine clothes).

      But those vocal among us that do NOT accept such are gaining headway in pointing out the Constitutional infirmities that have been accompanying the legislating from the Bench, and now with Kavanaugh, have a clear pathway to emphasize the three points that will “allow” the Court to extradite itself with minimal “loss of face.”

  5. 2

    Between recent positive changes at the CAFC, Dist. Cts., the Patent Office, and soon SCOTUS and Congress, the red tide of 101 foolishness has indeed turned.

    While a handful of misguided, agenda-based folks like the EFF and MM don’t like it, they’d better get used to it.

    American innovation leadership is on its way back.

    1. 2.1

      As opinionated as EFF is, you would think it would have a presence on this blog.

      1. 2.1.1

        Are you sure that they do not?

        (sorry, but best icon for the “eye roll” effect for the Efficient InFringer Front — not your comment).

    2. 2.2

      There is no “swinging back”. The PTO may unleash more junk but that’s not going to change anything except (soon enough) to make things even worse for the bO ttom feeders who are trying to protect abstractions.

      Cleaning up the edges around Myriad is actually a positive development but changes very little because very little was affected in the first place.


      I know it’s hard for you true believers to believe as you sit in your echo chamber but, by and large, most patent attorneys think you s u c k.

      1. 2.2.1

        Your projecting is — of course — 180 from actuality, Malcolm, as most patent attorneys think quite the opposite.


          … and I would add, that most do NOT suffer from the extreme cognitive dissonance that you routinely display in your anti-patent zeitgeist.

          Most of us quite believe in patents.
          Most of us quite believe in protecting the innovation that our clients develop.
          Most of us quite understand the Kondratiev Fifth Wave and don’t whine about the form of innovation most prevalent (and most prevalent to the non-wealthy at that).

  6. 1

    It appears that the court has doubled-down in Natural Alternatives Int’l. Inc. v. Creative Compounds, LLC (Fed. Cir. 2019) (“These are treatment claims and as such they are patent eligible.”).

    As I wrote in the previous thread, given the manner in which claims in the US are permitted to be scrivened, there is no “automatic eligibility” conferred upon any class of claims where that class is described broadly in terms of its art field (e.g., “method of treatment”).

    What’s really silly about the CAFC’s statement is that the issue was already dealt with in Mayo. Prometheus certainly considered its claims to be “methods of treatment” (and the claims definitely covered methods of treatment; they also required that a patient at some point be treated with the drug that was metabolized according to the claim — that treatment step, of course, was in the prior art).

    Now, it so happened that Prometheus’ claims admittedly did not require any new treatment to take place. All that needed to happen to infringe the claim, according to Prometheus, was for someone to follow the prior art steps and then “make a determination” about whether to administer more or less drug, where that determination was made by reliance upon the correlation (two threshold values) that Prometheus “discovered” and dedicated to the public in their patent specification (dedicated to the public because, of course, you can’t protect information with a patent).

    In other words, the claims at issue in Mayo were indeed “ineligible method of treatment” claims. Yes, the recited treatment step and the post-treatment step of identifying the rate of metabolism of the drug were in the prior art. Yes, the eligibility problem arose because the claim attempted to protect a correlation in a particular context and did not recite any new physically transformative treatment steps. It’s worth noting that while Mayo may have slowed the attempt to try to claim such ineligible subject matter, it did not prevent it and we can bet everything under the sun that the PTO let some ineligible claims that are indistinguishable from Mayo fly out the door.

    As I wrote in the other thread, another very simply (and very easy to understand) circumstance in which a method of treatment claim is going to be ineligible is where the claim recites physically transformative treatment steps that are in the prior art (exactly as claimed) but where the claim also recites an abstraction or some “limitation” that, by itself, is also ineligible for patent protection. For example, one can’t obtain an eligible claim by reciting, say, “treating a headache by taking two aspirin in the morning and, if one has the [non-obvious] Mutation X, taking one aspirin in the afternoon”. That’s because taking two aspirin in the morning and one in the afternoon is in the prior art and “observing the existence of mutation X” is ineligible. The same result (ineligibility) is reached of course if, in response to the observation that the [non-obvious] mutation exists, no aspirin is taken in the afternoon. And the same result is reached if the failure to follow the recited steps results in instant d e a th for those individuals with the mutation.

    I realize there are practitioners who will reflexively feel their blood boil when they read this (because they identify very strongly with their oh-so-deserving clients seeking to monetize such claims). Those practitioners should take a deep breath and understand the (obvious) implications of granting [non-obvious] claims like these. What ends up happening is that people (including chem/bio patent attorneys like me, and my family members) are turned into patent infringers when we (1) take aspirin for a headache, just as people have done for eons, provided that we (2) are aware of a fact about our bodies.

    Not everything revolves around patents, folks. I know this is extremely difficult for some patent attorneys (and law professors) to understand, and ever more difficult for those that do understand to admit and discuss intelligently.

    1. 1.1

      I think you’re describing an instance of inherent anticipation. People having that mutation have presumably been around for a long time, and so has aspirin.

      1. 1.1.1

        Moo: I think you’re describing an instance of inherent anticipation.

        I think “inherent anticipation” more accurately applies to the circumstance where a composition or method is being claimed that is identical to a prior art method or composition *except* for the recitation in the claim of a previously unrealized inherent property or result.

        [Note that the “inherent properties” and “inherent results” (as such) are ineligible subject matter (regardless of how stunningly non-obvious they are/were) so the analysis under 101 or 102 is virtually identical, i.e., identify the prior art and determine whether there is anything eligible and inventive (i.e., not “inherent”) recited in the claim beyond that prior art. Thus, in this particular context anyway (i.e., the context of protecting “new” inherent results as described in the above paragraph) the issue can arguably be thought of as an anticipation or eligibility problem.]

        More importantly, however, in the example I provided in comment 1, the additional limitation is not an inherent property or result but rather an ineligible and non-obvious mental step. There is nothing “inherent” in the prior art about observing that a subject has a previously undiscovered non-obvious mutation. The problem, therefore, is not “inherency”. The problem is a claim that grants ownership to an INELIGIBLE method of thinking about something in the context of another method that is indisputably in the prior art. That’s not an anticipation problem. That’s not a utility problem (at least not unless we’re allowing *gasp* some court to tell us what “utility” means). That’s not a 112 problem. It’s a straight up subject matter eligibility problem, and it’s in the context of a “treatment claim.” The CAFC should have realized this sort of issue when it made its ill-considered statement.


            Whole Why is it that you refuse to recognize that aspect?

            1) We’re discussing 101 and not 103. I do welcome your very very serious criticism of the judicial activist decisions which have allowed courts to eliminate limitations from claims in the course of performing a 103 analysis, in direct violation of the plain words of the statute.

            2) Merely reciting the vapid phrase “claims as a whole” is not an argument, nor is it a response to anything I’ve written. If you’ve got a point to make regarding this vapid phrase, go ahead and make it. Use direct statements, logic, and create an argument with your own words. Otherwise, kindly S T F U. Thank you in advance, Bi lly, for your civil and serious second attempt to fashion a “cogent” (LOL) response to my comment.


              1) We’re discussing 101 and not 103.

              So what? Claims as a whole is fully in line with a discussion of 101.

              Quite in fact, it is paramount.

              2) Merely reciting

              is NEITHER vapid, nor lacks as a response to what you have written. To the extent that you continue to attempt a parsing of claims or applying eligibility in only a piece part manner, YOU are not applying the law correctly.

              Use direct statements, logic, and create an argument with your own words

              Asked and answered – that you run away from such from me does NOT mean that I have not provided same. It just means that you are not inte11ectually honest.

              No surprise there.

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