Source: http://tidge.com/archive/Mayo_01.html
Timestamp: 2019-04-21 08:33:27+00:00

Document:
CLS Bank Int'l v. Alice Corp. Pty. Ltd.
I have decidedly mixed feelings about the Supreme Court's March 20, 2012 decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U. S. ___ (2012) ("Mayo II") concerning subject matter patentability.
On the one hand, I strongly believe that it is time for the pendulum to start swinging back against patent validity, and that this country would be a whole lot better off if more patents were invalidated in court (as well as having fewer patents issue in the first place). Mayo II may prove a powerful tool in that regard, and that's good.
In the final analysis, because it is bad law, this decision bodes ill for inventors, patentees/assignees, patent lawyers, and, most importantly, all of the judges who have to traverse the murky maze of metaphysical jargon that masquerades as a "legal test" for subject matter patentability.
After letting the Fed. Cir. try a second time to apply §101 to the claims at issue (in Prometheus II, see sidebar for links), the Supreme Court finally said enough is enough and, in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U. S. ___ (2012) ("Mayo II"), told the Fed. Cir. that it is still not applying Bilski correctly.
Nevertheless, there is some sweeping language in Mayo II that could effectively invalidate a slew of patents, although it remains to be seen if the apparent scope of the language will be so wide-ranging in practice (more likely the scope will vary from court to court, and from Fed. Cir. panel to Fed. Cir. panel).
wherein the level of 6-thioguanine greater than about 400 pmol per 8x10^6 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
Despite citing all of the right cases in all the right ways (Chakrabarty, Diehr, Parker v. Flook, Benson, Bilski, etc.) and providing an explanation of the differences between the patentable claims in Diehr and the unpatentable claims in Flook, as well as a historical exegesis of a Supremes' 1845 patent case involving Morse's patents (which, in turn, discusses an 1841 English patent case), when the Supremes actually dissect the individual steps of the claim at issue, they seem to be making things up as they go along.
Administering Step Does Not Add Enough, as It Refers to a "Pre-Existing Audience," i.e., "a Particular Technological Environment"
Determining Step Does Not Add Enough, as It Merely Adds "Conventional ... Pre-Solution Activity"
Prometheus' patents set forth laws of nature—namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm. Claim 1, for example, states that if the levels of 6-TG in the blood (of a patient who has taken a dose of a thiopurine drug) exceed about 400 pmol per 8x10^6 red blood cells, then the administered dose is likely to produce toxic side effects. ... The relation [between metabolite levels and likely harm] is a consequence of the ways in which thiopurine compounds are metabolized in the body--entirely natural processes. And so a patent that simply describes that relation sets forth a natural law.
Disregarding the Supremes' imprecise paraphrase of what Claim 1 actually says, their definition of what is an unpatentable natural phenomenon or natural law appears to open the door for subject matter patentability attacks on almost any patent involving the natural processes of the human body, regardless of the "unnatural" original cause or mechanism for initiating that natural process (like the introduction of a human-made drug).
People had been experimenting for years to find the right material for constructing vascular grafts, tubes that fit inside veins/arteries that need repair. People knew the problem was the hole-y nature of the material, as it needed to be porous enough to let materials through (such as, e.g., red blood cells), but the internal passages had to be small enough to prevent too much flow and clotting. The trick was "tissue ingrowth," the process by which the living walls of the artery literally grow through and around the material forming the artificial tube, effectively creating an inner skin (inside the tube) and making the tube part of the body, so to speak. Gore's Gore-Tex had just the right internal structure—like Goldilocks finally finding the perfect bear bed, Gore-Tex internal structure had through-passages which were not too big and not too small.
Not too big and not small for what? Tissue ingrowth, a natural phenomenon, a process the inner arterial walls engage in naturally when material is next to it. To use the words of the Supremes: "the relation [between the size of the internal passages in a graft material and whether it would be a successful graft] is a consequence of the way in which [inner arterial walls behave] in the body—entirely natural processes." Did Bard/Goldfarb's patent add enough to that natural relation to qualify for patent protection?No, a million times NO.
This is only one example, of course; based on the logic of the Supremes' Mayo II decision, a creative lawyer can make non-trival arguments attacking almost any patent relying on natural processes.
As It Refers to "Pre-existing Audience,"
i.e., "a Particular Technological Environment"
The Supremes pronounce that the "administering" step "simply refers to the relevant audience, namely doctors," which "is a pre-existing audience" and, since the step merely refers to a pre-existing audience, the step is an impermissible attempt to circumvent the prohibition against patenting abstract ideas by limiting the claim to "a particular technological environment." Mayo II, p. 9. While sounding agreeable enough in the abstract (like all case law on subject matter patentability), using this concept of a pre-existing audience to specifically strike down the "administering" step as merely limiting the claim "to a particular technological environment" is ... , well, a little weird.
It would be far easier to use the logic regarding "pre-existing" (that "doctors used thiopurine drugs to treat patients suffering from autoimmune disorders long before anyone asserted these claims") to strike down the "administering" step as clearly disclosed in the prior art. In fact one might even interpret the Supremes as having implicitly used the §102 novelty requirement in its logic rejecting the administering step, except that the Supremes' reasoning is explicitly pure §101, and only §101 (e.g., rejecting the government's suggestion to use §§102/103: "relevant cases rest their holdings on §101, not later sections").
As an aside, I find the Supremes' references to the "audience" of the patent claim and/or the administering step forced, imprecise, and annoying. See, e.g., pp. 9, 11, 13. I realize they want to emphasize the notion that the claims merely "inform" an audience of natural laws, but I think they will regret binding the term "audience" so closely with the individual step-by-step analysis if a creative attorney realizes an argument concerning what the relevant audience is will help her/his case. Another tangential and fundamentally unimportant analysis is not what pseudo-§101 pseudo-jurisprudence needs.
"[T]his step tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists who work in the field," and thus does not add enough, as "purely 'conventional or obvious' '[pre]-solution activity' is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law" Mayo II, p. 10. "Normally not sufficient?" What are the ab-normal conditions under which a well-known conventional activity can transform an unpatentable law of nature into a patent-eligible application of such a law?
Anyway, although this sounds like the §102 novelty requirement, it really is the §101 test for when added activity is enough to transform a law of nature into a patent-eligible application of that law. I hope that clears things up for you.
Stepping back for a moment from the Supremes' philosophizin' (as Huck Finn would say), I am troubled by the underlying reality of this lawsuit. Both Prometheus and Mayo sell testing kits that perform this determining step, and only this determining step. A step which the Supremes say is clearly conventional, obvious, and well-known. Forgetting §101, why should anyone be able to sue a manufacturer for patent infringement for making and selling a product which only performs a conventional, obvious, and well-known metabolite test? Now, I know some legal reasoning involving indirect infringement that may justify it, but I think most people on the street (including businesspeople) will never understand how that could possibly make sense. And I'm on their side. No one should be able to use the patent system to bootstrap "ownership rights" that effectively force someone selling a well-known, conventional, and obvious product to pay ransom. I don't care how many think-tank studies, economics books and articles, law professor's blather, etc., you can cite otherwise, allowing such a thing operates as a drag on the economy.
Could the new prior user rights provisions in the AIA provide some protection in this instance? I'd have to re-read that section again to be sure, but I would bet not. My guess is that you would have to show you performed all of the steps of the asserted patent claim, not merely show you've been selling the same accused product for 20 years, to get protection under AIA prior user rights. Of course, you may be able to show that a consumer performed the steps with your product, or that your own internal quality testing sometimes performed the steps, etc., (all arguments which existed long before the AIA) but that's ridiculous. A well-crafted prior use/user law should simply say if you've been selling the same product since at least a year before the effective filing date, no one can sue you with any type of patent for continuing the same practice, regardless of how their lawyers tie that practice into the wording of the patent claims. This would likely mean some patentees with valid claims would not be able to sue you in some cases. But my law would more than pay for itself by providing business certainty at the price of legal consistency.
Since these clauses essentially re-state what the Supremes are calling a natural law, it is not surprising the Supremes do not find enough here, but rather "at most [the] add[ition of] a suggestion that [the doctor] should take those laws into account when treating his patient" Mayo II, p. 10.
I also find the Supremes' repeated references to the wherein clauses as a "step" irksome. See, e.g., pp. 9, 10 ("... the three steps ...").
Considering "the three steps as an ordered combination adds nothing to the laws of nature that is not already present when the steps are considered separately. ... Anyone who wants to make use of these laws must first administer a thiopurine drug and measure the resulting metabolite concentrations, and so the combination amounts to nothing significantly more than an instruction to doctors to apply the applicable laws when treating their patients." Mayo II, p. 10.
If the range of amounts of thiopurine metabolites in the blood which are both effective and safe is based on natural processes, and thus constitute an unpatentable law of nature, wouldn't a compound consisting of well-known chemicals in a new precise mix of specific amounts which is surprisingly safe and effective (in fact, let's say the mix is an unexpected quantum leap in safety and efficacy over previous mixes of the same or similar chemicals), also be based on natural processes, and thus also be an unpatentable law of nature? What about a new chemical?
Does it make sense to allow an indirect patent infringement claim against someone selling a conventional, obvious, well-known testing product? See discussion here.
Is this ruling limited to method patents? That is, can such a test for subject matter patentability be used to invalidate patents on devices and compositions?
What if a computer patch did the steps? [tidgenote: I saw a flexible computer patch on TV which you simply stick on your body like a band-aid and it would monitor blood flow, etc.] Can you have a patent claim to a patch which recites the specific structural components in the patch performing the steps (and nothing more)?
What if an implant did the steps? Completely chemically, i.e., no electronic parts, but rather the right combination of materials and structure to react to its environment in such a way as to maintain the metabolite levels in the safety zone. Can you have a patent claim to an implant whose materials and/or structure perform the steps (and nothing more)?
Hell yeah, I agree with all that! But, using the Fed. Cir.'s MySpace analogy below, these hypotheticals are equivalent to stating that wine which has turned to vinegar does not taste good (at least as wine per se), the problem is at the other end of the spectrum, where reasonable people/oenologists can come to completely opposite (and fundamentally unprovable) opinions as to what wine tastes "best" with fish.
The particular pleasant sounding platitudes above actually merge with an extremely unrealistic hypothetical at the end. But any thinking person will soon discover that, while s/he agrees with these platitudes, they provide no guidance for determining when a real world patent claim recites the application of an idea that is so metaphysically "close" to the idea itself as to be impermissible (beyond the single absurd wine=vinegar example of "apply it" which is completely bereft of the metaphysical nuances that make analyzing real world patent claims so terribly difficult).
Any in-depth study of real world examples from the case law shows that these statements provide no guidance whatsoever, and are little more than agreeable-sounding abstract principles.
We are no longer practicing law, my friends, but are rather engaged in philosophy. And while we all agree one can't patent f=m•a, this "example" should not mislead one into believing it is possible to formulate a bright-line test for when a patent impermissibly claims an abstract concept. Similarly, while we all have the gut feeling when looking at certain claims that they are "wrong" and should not be patentable, this is not equivalent to (and should not be mistaken for) the possibility of a PRACTICAL and consistently APPLICABLE test for determining the metaphysical line separating improper and proper applications of abstract ideas.
Indeed, as anyone who has thought deeply enough about these matters knows, it can be maddeningly difficult (if not impossible) to come up with definitions or even understandings of concepts like "abstract idea," "law of nature," "natural phenomena" (vs. unnatural phenomena?), and "mathematical algorithm" that can be consistently applied across all of the real world examples that come your way.
Our opinions spend page after page revisiting our cases and those of the Supreme Court, and still we continue to disagree vigorously over what is or is not patentable subject matter. ... [citing cases] ... .
This effort to descriptively cabin §101 jurisprudence is reminiscent of the oenologists trying to describe a new wine. They have an abundance of adjectives — earthy, fruity, grassy, nutty, tart, woody, to name just a few — but picking and choosing in a given circumstance which ones apply and in what combination depends less on the assumed content of the words than on the taste of the tongue pronouncing them.
- p. 15, MySpace v. Graphon (Fed. Cir. March 2, 2012).
But the Fed. Cir.'s suggestion that "courts could avoid the swamp of verbiage that is §101 by exercising their inherent power to control the processes of litigation" (p. 17) and decide all other issues first (particularly §§102/103) is not an effective long-term solution. First, not all of the Fed. Cir. agrees with the solution (see MySpace dissent). Second, the District Court judges can do whatever they want, and now the Supremes' Mayo II decision will egg those so inclined to render decisions on philosophy. Third, Pandora's box has been opened, and litigants will continue making §101 arguments until and unless the Supremes overturn or at least "refine" their old case law.
Although the Fed. Cir. MySpace majority correctly identified the difficulty of establishing a clear criteria for what is an unpatentable "abstract idea," they also incorrectly opined that the case law, "[t]hough hardly brightline," established "reasonable guidance" for the other two unpatentables ("laws of nature" and "physical phenomena"). As the Supremes amply demonstrate for "laws of nature" in Mayo II, the Fed. Cir. MySpace majority is wrong. At the least, to the extent there was "reasonable guidance" concerning how to determine when a patent claims an unpatentable "law of nature" before Mayo II (which I don't think is possible), the Supremes have successfully sabotaged it. In that regard, Mayo II was a step in the exact wrong direction, although I do not fault the Supremes for it, but rather the lawyers not explaining (or, in some instances, not understanding) the situation and the law clearly enough.
These forays into philosophy, while entertaining, thought-provoking, and the grist for many a law school professor's career, are completely and utterly inappropriate in a court of law. At least in a Common Law court of law. The Common Law despises philosophy, and it is right to do so.
Now I realize the traditional, but somewhat incorrect, distinction between the Common Law and the Civil Law systems (reasoning from precedent vs. reasoning from civil code) seems fairly meaningless today, as we have as many codes as anyone else, but there is still meaning in the differences between our Anglo-American Common Law and the European Civil Law tradition—much as the differences in analysis and effect between the once-separated but long-united equity and law courts still has meaning and effect today (eBay, for example).
In England, lawyers received their training at the Inns of Court, technical colleges where they learnt their craft like every medieval craftsman, in contact with practising masters, not in universities at the feet of scholars who were apt to lose themselves in controversy. English law worked essentially within the existing feudal framework, whereas continental law incorporated a vast amount of extraneous elements, mainly of Roman origin. Consequently, the feudal law of relation was central in English, and the Roman idea of will in continental law. A final difference is the absence of codification in England. The tradition of case law and empiricism makes very poor soil for codification -- the Romans, who were first and foremost practical jurists, never had a codification -- but with systemic theory and logical deduction from general premises, codes came naturally on the Continent.
The last sentence points out a delicious historical irony: the Romans had a legal system which worked much more like the English Common Law, but since medieval Europe was (re-)introduced to Roman law by means of Justinian's Corpus Juris Civilis (a massive pseudo-codification of Roman law as it lay dying, and indeed guaranteed its death), Europeans "copied" a systematic and abstract approach to the law which the Romans never actually had.
I think it is no coincidence that both the Roman and British empires shared legal systems which were empirical and practical, manned by a guild of craftsmen who learned mostly through apprenticeships, trained problem-solvers rather than the "educated" products of a university education. For, contrary to the confused and disturbing conservative belief that regulation is the cause of all evils, a legal system that regulates and systematizes commercial practices and conceptions of ownership is essential for trade to thrive. And the best possible legal system for such purposes is one that develops slowly and surely, based on the real world problems it confronts, growing in lockstep with the reality it faces, never jumping ahead based on the current fairy tales of philosophy and economics.
Obviously, we have lost our way in that regard. Codification did not destroy the time-worn practical wisdom underlying our legal system (indeed, our "codes" are, for the most part, practical), but rather the rise of the modern law school in the latter part of the 19th century, replacing the ancient system of apprenticeship. Oliver Wendell Holmes, Jr.,'s blistering attack in his review of Christopher Columbus Langdell's book, the first "casebook" in its modern form, was a recognition of what was the beginning of the end of practical jurisprudence. It is no surprise that the top-tier law schools produce graduates utterly incapable of practicing law. See, e.g., 11/20/2011 nytimes.com article, What They Don't Teach Law Students: Lawyering. Such is the natural result of rejecting the apprenticeship system in its entirety, including its notion of a lawyer being a practical craftsman and problem-solver, for a system where students are taught "how to think."
But accepting my heretical views on legal education is not necessary for accepting my argument here. Indeed I think many who completely reject my views on legal education will agree that, in the law of subject matter patentability, we have ventured into a quagmire of metaphysical debate which has yet to be resolved. My argument is that the problem is in fact unresolvable, and that further case law will just get all of us more deeply mired in the mud of deep and incredibly impractical philosophical debate. The only solution is to stop and close the door on this approach to invalidating patents. This could be affected in a number of different ways, which I will explore further in future articles.
Before discussing various possible ways to kill pseudo-§101 pseudo-jurisprudence (or at least to diminish the harm and waste it is causing), I will endeavour to prove that the present legal "test(s)" for subject matter patentability are impractical and incapable of consistent application by comparing the form and substance of the claims which have been rejected with those which have been accepted under that/those test(s). I will also discuss some of the legal history here, to explain how the last 13 years has been so nettlesome in regards to what seemed to be a simple and settled area of patent law.
Part II - What is a Claim?
and the Renegotiation of Royalties?
Implications for Myriad gene case.

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