Mayo Collaborative Services v. Prometheus Laboratories -- What the Supreme Court Said

By Kevin E. Noonan --

In a decision he has waited six years to write (having dissented from the Court's decision not to decide similar issues in Laboratory Corp. v. Metabolite Labs., Inc. in 2006), Justice Breyer (and a unanimous Court) overturned the Federal Circuit's decision that diagnostic method claims are eligible for patenting under 35 U.S.C. § 101.  Before discussing the reasons for the Court's decision and its possible impact, it is best to attempt to discern the reason why the Court believes its judgment on patent-eligibility is superior to the court specifically created by Congress to make patent law its particular area of expertise.

As a reminder, the case involves claims directed to methods for determining whether an effective amount of a drug is being administered to a patient.  The claims of the patents-in-suit (U.S. Patent Nos. 6,355,623 and 6,680,302) were held invalid by the District Court as being outside the scope of patent-eligible subject matter under 35 U.S.C. § 101, based on its application of the "machine or transformation" test enunciated in In re Bilski.  These claims included claims that affirmatively recited an "administrative" step, exemplified by Claim 1 of the '623 patent:

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

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


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


    wherein the level of 6-thioguanine less than about 230 pmol per 8x10⁸ red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and


    wherein the level of 6-thioguanine greater than about 400 pmol per 8x10⁸ red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

And claims that did not recite such a step, exemplified by Claim 46 of the '302 patent:

46.  A method of optimizing therapeutic efficacy and reducing toxicity associated with treatment of an immune-mediated gastrointestinal disorder, comprising:

    (a)  determining the level of 6-thioguanine or 6-methylmercaptopurine in a subject administered a drug selected from the group consisting of 6-mercaptopurine, azathiop[u]rine, 6-thioguanine, and 6-methyl-mercaptoriboside, said subject having said immune-mediated gastrointestinal disorder,
    wherein the level of 6-thioguanine less than about 230 pmol per 8x10⁸ red blood cells indicates a need to increase the[] amount of said drug subsequently administered to said subject, and

    wherein the level of 6-thioguanine greater than about 400 pmol per 8x10⁸ red blood cells or a level of 6-methylmercaptopurine greater than about 7000 pmol per 8x10⁸ red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The Federal Circuit reversed, finding that the claims recited sufficiently transformative steps that they satisfied the Bilski "machine or transformation" test.  The Federal Circuit interpreted the entirety of Supreme Court precedent on patent eligibility to construe patent-eligibility broadly, limiting eligibility to exclude only laws of nature, physical phenomena, and abstract idea (based, the panel suggested, on historical precedent extending back to the 19th century; Le Roy v. Tatham, 55 U.S. (14 How.) 156, 174-75 (1853), continuing in the Court's most recent opinion on this issue (Bilski v. Kappos).  In the appellate court's opinion, the Prometheus claims are merely a particular application of a natural phenomon, alá Diehr, rather than an attempt to preempt a natural phenomenon, alá Benson and Flook.

The Supreme Court disagreed.  Beginning with its decision in Diamond v. Diehr, the Court's opinion set out the terms of the debate:  to pass Constitutional muster, 35 U.S.C. § 101 must contain an "implicit exception":  laws of nature, natural phenomena, and abstract ideas.  Citations of the Court's prior precedent (bolstered by citation of English law, curiously post-independence) are followed in the opinion by the overriding policy assumption behind the Court's decision:  that "monopolization of [the basic tools of scientific and technological work] through the grant of a patent might tend to impede innovation more than it would tend to promote it."  In this context, of course, the Court recognizes the uncertainty of the policy conundrum, and suggests that evidence that "monopolization" would not impede innovation should be important in deciding that such claims would or would not transgress the Court's policy imperatives.

Fortunately, the Court also recognizes that there must be a balance, since "too broad an interpretation of this exclusionary principle could eviscerate patent law [because] all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas."  That balance is appropriately struck, accordingly, by determining whether a claim embodies an application of a natural phenomenon or a law of nature; however, the Court warns that transforming a law of nature into a "patent-eligible application of such a law [requires that] one . . . do more than simply state the law of nature while adding the words 'apply it.'"

This case, the Court says, is at the "intersection of these basic principles."  How the Court frames the issue goes a long way towards understanding their decision:  according to the opinion, the case is about "claims covering processes that help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage level is too low or too high," illustrating another issue central to Justice Breyer's concerns:  interference by patents with the practice of medicine.  The Court then announces the fundamental reason it decided that the Prometheus claims are not patent-eligible:  the "claimed processes have [not] transformed these unpatentable natural laws into patent-­eligible applications of those laws."

Citing Parker v. Flook, the Court immediately takes its decision outside Judge Rich's adage about how to interpret patent law:  while that eminent jurist realized that "the name of the game is the claim," the Court here states that its precedent "warn us against interpreting patent statutes in ways that make patent eligibility 'depend simply on the draftsman's art' without reference to the 'principles underlying the prohibition against patents for [natural laws].'"  Doing so requires that claims to "a process that focuses upon the use of a natural law also contain other elements or a combination of elements, sometimes referred to as an 'inventive concept,' sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself."  In this the Court continues its historical tendency to conflate patent-eligibility under § 101 with patentability under, inter alia, § 103.  (Because this is a tendency apparently incapable of correction, it is perhaps best to accept it.)  This does lead to another quirk of the Court's interpretation of patent law:  rather than consider the claims as a whole (which, after all, is mandated by § 103), the Court then arrives at its decision by considering that "the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field" (albeit not applied to this method), and that "at the same time, upholding the patents would risk dis­proportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries" (seemingly ignoring the portion of the patent statute that limits patent term to 20 years from the earliest effective filing date).

Having set forth the grounds for its decision, the Court then directed its attention to the claims at issue.  In its opinion, "scientists already understood that the levels in a patient's blood of certain metabolites, including, in particular, 6-thioguanine and its nucleotides (6–TG) and 6-methyl-mercaptopurine (6–MMP), were correlated with the likelihood that a particular dosage of a thiopurine drug could cause harm or prove ineffective" (taking this understanding from the '623 patent specification).  The opinion acknowledges that the patentees determined the "precise correlations between metabolite levels and likely harm or ineffectiveness."  But the Court also noted (in agreement with the Federal Circuit) that "the claim's language, 'indicates a need to decrease' (or 'to increase'), as not limited to instances in which the doctor actually de­creases (or increases) the dosage level where the test results suggest that such an adjustment is advisable."

The Court disagreed with the Federal Circuit, however, that the recited steps of the claim involved a transformation sufficient to render the claims patent-eligible.  The Court starts with its interpretation that the Prometheus claims "set forth laws of nature," and then determines that the claims do not "so significantly more that simply describe these natural relations."  Specifically, the Court says that the patent claims do not do "enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws."

The Court next explicates why it comes to this conclusion.  The opinion returns to its concerns over the efforts of the artful claim drafter seeking to "monopolize the law of nature itself."  The Court illustrates situations where such efforts should be unavailing (interestingly, taking its examples from the physical rather than the chemical or biological/medical arts):

Einstein, we assume, could not have patented his famous law by claiming a process consisting of simply telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced (or vice versa).  Nor could Archimedes have secured a patent for his famous principle of flotation by claiming a process consisting of simply telling boat builders to refer to that principle in order to determine whether an object will float.

For the Court, the Prometheus claims provide no more than in these hypothetical situations.  The claims "administering" steps "simply refer[] to the relevant audience, namely doctors who treat patients" with thiopurine drugs.  But this audience is "preexisting" since these drugs have been used to treat certain diseases (and impliedly to be subject to the same limitations on ascertaining the proper dose of a drug for a particular patient) before the patented invention.  The "determining" step is indeterminate:  no particular method for making the determination is specified, and thus the entirety of prior art methods for making the determination is encompassed by the claim, in the Court's opinion.  This is the basis for the Court's opinion that the step embodies "well-understood, routine, conventional activity previously engaged in by scientists who work in the field."  Hieing back to Flook, the Court states that such "pre-solution activity" is "not enough to transform an unpatentable law of nature into a patent-eligible application of such a law."  And the Court does not believe that these claims embody the "exception to the exception" recognized in Diehr that "a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made" because "[a]nyone who wants to make use of these laws must first administer a thiopurine drug and measure the resulting metabolite concentrations."

For the Court, "[t]he upshot is that the three steps simply tell doctors to gather data from which they may draw an inference in light of the correlations," merely "inform[ing] a relevent audience of certain laws of nature."

The Court also states that the cases "most directly on point" to their decision are Flook and Diehr; this choice suggests philosophical as well as practical possibilities that will be discussed elsewhere.  In the opinion, the Court found the "way the additional steps of the process [recited in Diehr] integrated the equation into the process as a whole" rendered those claims patent-eligible, while in Flook all that was provided by the claim was the patent-ineligible algorithm to calculate alarm limits in pre-existing processes.  (While this portion of the opinion also [re]introduces language concerning whether these additional steps, in both Flook and Diehr, were "obvious, already in use or purely conventional," this conflation is an invariant part of any § 101 analysis by the Court.)  Applying this precedent, the Court finds that the Prometheus claims present a case for patent-eligibility that is "weaker than the (patent-eligible) claim in Diehr and no stronger than the (patent-ineligible) claim in Flook."

The Court then takes a brief excursion beyond the boundaries of its own precedent, considering a 19th Century English case regarding blast furnaces (which the Court must have considered the closest other precedent raising "a legal problem very similar to the problem now before [the Court])" and to its own Bilski and Benson opinions before arriving at a concern raised in Benson:  that "patent law not inhibit further discovery by improperly tying up the future use of laws of nature" (citing Benson, Flook, Bilski, and O'Reilly v. Morse).  Curiously, in view of the Chief Justice's recent statements on the general lack of usefulness provided by the legal academy, the opinion cites law review articles by Mark Lemley, Bohannan & Hovencamp, and Rebecca Eisenberg (whose "tragedy of the anticommons" is still anticipated 14 years after its possibility was perceived).  The Court recognizes that the laws of nature encompassed by the Prometheus claims are "narrow laws," but their transgression is that they "tie up the doctor's subsequent treatment decision whether that treatment does, or does not, change in light of the inference he has drawn using the correlations" as well as "threaten to inhibit the development of more refined treatment recommendations (like that embodied in Mayo's test), that combine Prometheus' correlations with later discovered features of metabolites, human physiology or individual patient characteristics."  While these concerns seem to implicate claim scope as much as subject-matter eligibility, the Court seems content with making its decision on § 101 grounds.

The opinion does leave some room for hope (or for more artful patent claim drafting), stating that the Justices do not "now decide whether were the steps at issue here less conventional, these features of the claims would prove sufficient to invalidate them."  The "basic underlying concern" is that "these patents tie up too much future use of laws of nature."

Finally, the opinion considers and rejects the views of the Federal Circuit, Prometheus, the U.S. government, and relevant (and informed) amici such as the Biotechnology Industry Organization.  Regarding the Federal Circuit, any transformation associated with the "administering" step is "irrelevant" according to the opinion, since this step merely selects the group of patients "who are likely interested in applying the law of nature."  The Court also finds no transformation in the determining step, because such a step "could be satisfied without transforming the blood, should science develop a totally different system for determining metabolite levels that did not involve such a transformation."  In rejecting Prometheus' argument that the narrowness of the laws of nature encompassed by the claims argues in favor of patent-eligibility, the opinion states that "[c]ourts and judges are not institutionally well suited to making the kinds of judgments needed to distinguish among different laws of nature, . . . the cases have endorsed a bright-line prohibition" against patenting such laws per se.

The government's position is rejected by the Court because relying on the other sections of the patent statute to invalidate claims such as the Prometheus claim would turn § 101 into a "dead letter" and is inconsistent with the Court's prior precedent (which perhaps the government was trying to modify).  The Court also explicates its reasons why the other sections are not up to the task of policing the patent-eligibility question regarding laws of nature.

The last group of advocates whose views are rejected by the Court, amici with relevant experience, are counterbalanced by other amici, like the AMA and other medical groups, who advocate little or no patent protection to avoid "a vast thicket of exclusive rights over the use of critical scientific data that must remain widely available if physicians are to provide sound medical care."  In doing so, the Court finds more persuasive the opinions of consumers of this technology rather than its providers.  The Court also sees these differences of opinion as reflecting the "double-edged sword" of patent protection, reiterating Justice Breyer's long-standing opinion that too much patent protection is as bad as too little.

In the end, the Court suggests that those who disagree with their decision have recourse elsewhere:

[W]e must recognize the role of Congress in crafting more finely tailored rules where necessary.  Cf. 35 U.S.C. §§161–164 (special rules for plant patents).  We need not determine here whether, from a policy perspective, increased protection for discoveries of diagnostic laws of nature is desirable.

Clearly suggesting little chance of a change of heart from the Court.

Comments

[David Koepsell]

Logic prevails over crafty rhetoric! Score one for the good guys! ;)

[EG]

Kevin,
A very nice and thoughtful summary of Breyer’s opinion. I also detect that you, like I, are very disturbed by the reasoning in this opinion.

Frankly, Breyer’s reasoning is nonsensical, illogical, and very obviously, result driven. (I would also characterize it as “patent hostile,” even though I know others would disagree.) What I’m most critical of is that Breyer’s opinion leaves you with no understandable guidance on how to craft a “patent-eligible” method claim in this context. For most analytical methods, which is what Prometheus’ claimed drug dosage calibration method is part of, the results (e.g., numbers) is what they do and why they’re important. If you take the reasoning in Breyer’s opinion to its even more illogical extreme, I don’t see how many (if any) analytical methods will survive a “patent-eligibility” challenge under 35 U.S.C. § 101.
What Breyer’s opinion does is try to determine the “patent-eligibility” question under 35 U.S.C. § 101 in a vacuum, divorced from any consideration of the other relevant patent statutes such as 35 U.S.C. § 102, and especially 35 U.S.C. §§ 112 and 103. That’s what Breyer’s opinion essentially does when he dismisses the approach suggested by the U.S. Solicitor General which I, Michael Risch, Chief Judge Rader, and many others believe is the only way you can make rational, logical, and objective determinations what is or is not “patent-eligible” under 35 U.S.C. § 101. That’s also why the Flook case that Breyer’s opinion so heavily relies upon for precedential support is so logically flawed: (1) it forces you to treat previously unknown “laws” (or relationships) as if they’re part of the prior art; (2) it dissects the claim language to try to separate out the supposed “law of nature” from the rest of the claim context. When you do either of these techniques with the claim, you do so in contravention of what 35 U.S.C. § 103 explicitly says (especially that the claimed invention should be considered “as a whole”), as well as what is implicit in 35 U.S.C. § 112, second paragraph (that claim defines what the invention is). Unless you’re willingly to address the claimed invention in the context of all of the relevant patent statutes (which Breyer and his 8 cohorts appear to be unwilling to do), determinations of patent-eligibility under 35 U.S.C. § 101 are no more objectively based than using a Ouji board.

I frankly find the whole “law of nature” reference in Breyer’s opinion to be completely inappropriate for evaluating Prometheus’ claimed method. We’re not talking about Einstein’s “theory of relativity” or Newton’s discovery of the “law of gravity.” Instead, we’re talking about administering a specific man-made (thiopurine) drug, measuring the levels of measured metabolites (which only humans can do, even if they use instruments), and evaluating the measured level metabolites to decide whether the drug dosage needs to be adjusted because it’s too high or too low. You may fault how Prometheus’ drug dosage calibration method was claimed (the “draftsman’s art” as Breyer calls it). But doing so on the basis of this claimed method being essentially nothing more than a “law nature” in the guise of “routine, conventional activity” is totally unpersuasive and illogical reasoning.

Where Prometheus’ claimed method needs to be “transformative” to survive “patent-eligibility” under 35 U.S.C. § 101 is after the “determining step.” That’s the conclusion my patent attorney brother Mark and I’ve come to in trying to sort out cases like this case, Bilski, and others. In other words, what the claimed method must do is either convert physical (e.g., compounds, reactants, etc.) or tangible (e.g., data) elements into something different, or cause that “conversion” to achieve a useful result (e.g., adjust the drug dosage, or at least an “active” instruction to adjust the drug dosage). That “transformative” step also has to be at least partially at the crux of why the claimed method is unique. The “wherein clauses” in Prometheus’ claimed method that simply inform you that the drug dosage is too low or too high are just too “passive” to make this “transformative” jump to patent-eligibility under 35 U.S.C. § 101.

But if Breyer’s opinion prohibits consideration of such “transformative” steps if they’re judged to be “routine, conventional activity” (which is true of many analytical methods which often use a combination standard techniques or steps but in a unique way), we’re going to have difficulty making that “transformative” jump. Frankly, the whole, illogical line of Supreme Court “patent-eligibility” reasoning that starts with Gottschalk v. Benson and ends with Diamond v. Diehr needs to be “torched” and replaced with the now discarded “tangible, concrete, and useful results” (TCU) test of State Street. (What my brother Mark and I suggest for modifying Prometheus’ claimed method complies with the TCU test.) All other proposed standards for judging “patent-eligibility” under 35 U.S.C. § 101, especially those proposed by the Supreme Court, pale to subjectivity, and simply lead to nonsensical and illogical results. And the approach proposed by the U.S. Solicitor General which examines the “patent-eligibility” issue in the context of the other relevant patent statutes is also likely the only one that will get you there.

Another beef I have with Breyer’s opinion is his overstated “concern that patent law not inhibit further discovery by improperly tying up the future use of laws of nature.” But the claimed drug dosage calibration method, which is specific to thiopurine drugs, in no way “[ties] up the future use of laws of nature.” Indeed, his citation to O’Reilly v. Morse (where Samuel Morse discovered the electrical telegraph but then tried to claim any means for electrical communication) is “overkill” in the extreme with respect to this claimed drug dosage calibration method.

Breyer raises a similar “horror story” by arguing that “the grant of patents that tie up [the use of discoveries, laws of nature, etc.] will inhibit future innovation premised upon them, a danger that becomes acute when a patented process amounts to no more than an instruction to ‘apply the natural law’, or otherwise forecloses more future invention than the underlying discovery could reasonably justify.” But Breyer presents no data or evidence to support this supposed “horror story.” Instead Breyer cites two law review articles. So much for actual “facts” to support this supposed “horror story.” This supposed “horror story” raised by Breyer is also pretty flimsy given that Mayo Collaborative Services didn’t “innovate” the claimed method in the first place (and contrary to what some amici disingenuously suggested, was a “for-profit” competitor of Prometheus, the patentee).
Far more troubling to me than this supposed “horror story” is the potential reaction by those researching, developing (and funding) such drug dosage calibration or related analytical or diagnostic methods if the patent-eligibility bar is perceived as being raised too high by Mayo Collaborative Services. Two potential reactions are possible, both of which would be a far greater impediment to innovation, as well as increasing the storehouse of scientific and technical knowledge for such analytical methods. One is that research, development (and funding) of analytical methods will simply decrease if the investment in such testing cannot be protected (or is perceived to unprotectable) by patents. (And as you know, without patents, there is no “disclosure to the public” of the analytical methods being claimed.) The other is that such research, development (and funding) of such analytical methods will continue to the extent that such methods can be viably protected as “trade secrets.” And for universities engaged in researching such analytical methods, and where “trade secrets” are not a viable option, making the patent-eligibility bar too high could be the “death knell” for such university research.

Running throughout Breyer’s opinion is another bothersome theme raised by several of the amici which is completely bogus: the claimed method is trying to “patent thought.” See, for example, Breyer’s assertion that the claimed method would “tie up the doctor’s subsequent treatment decision whether that treatment does, or does not, change in light of the inference he has drawn using the correlations.” The trouble with this assertion is that it doesn’t reflect medical reality or what the claimed method actually covers. The doctor is very unlikely to be the one determining the level of metabolites. Instead, that doctor, after administering the drug, would most likely need a separate lab to determine the level of metabolites present in the blood sample supplied by that doctor. And here’s the real kicker: whatever the doctor does with (or thinks about) the metabolite levels determined by the lab doesn’t infringe the claimed method. See also 35 U.S.C. §287(c) which immunizes a medical practitioner (and its related health care entity) from patent infringement for performance by the medical practitioner of a “medical activity.”

Like you, I’m particularly irked by Breyer’s snide remark early in his opinion that Supreme Court precedent “warns us against interpreting patent statutes in ways that make patent eligibility ‘depend simply on the draftman’s art’ without reference to the “principles underlying the prohibition against patents for [natural laws],” once more citing the logically flawed Flook case. But that remark is a non-sequitur, given that 35 U.S.C. § 112, second paragraph, says that the invention is to be described (and defined) by “one or more claims” at the end of the patent specification. If the “draftman’s art” cannot be used to turn a patent-ineligible “law of nature” into a patent-eligible application of that “law,” then what, pray tell, can be used? Breyer’s further comment that such precedent “insist that a process that focuses upon the use of a natural law also contain other elements or a combination of elements” (which he says is sometimes referred as the “inventive concept”) is completely unhelpful. After all, Breyer later in his opinion says “routine, conventional activity” won’t save a claimed process (or method) that otherwise is deemed to cover just a “law of nature.” (One the several “conflicting” statements in Breyer’s opinion.)

One thing I do agree with in Breyer’s opinion (and which is a major weakness in both Federal Circuit decisions in this case) is that the “administering step” being “transformative” in terms of the drug being converted by the human body into the metabolites is essentially irrelevant to the patent-eligibility question under 35 U.S.C. § 101. As I note above, the claimed drug dosage calibration method is problematical in relying upon a final “determining step” followed by “wherein clauses” that essentially provide the results of that “determining step,” as well as some “what ifs” about what those results mean. After the Supreme Court’s ruling in Bilski, I was already concerned that such data-gathering “determining steps” might not push such drug dosage calibration methods, as well as other related diagnostic methods, into the “patent-eligible zone.” In fact, in the companion case of Classen Immunotherapies, Inc. v. Biogen Idec, the claimed method which essentially calibrates an immunization schedule for a treatment group (relative to a control group) is now likely to be deemed patent-ineligible, especially in view of the Supreme Court’s ruling in Mayo Collaborative Services.

That’s my thoughts.

Dave: You may believe the “good guys” won, but I beg to differ. Breyer’s opinion may make for a good “philosophical” discussion, but it’s very flawed “legal” reasoning as I’ve discussed above. That’s why I’ve got very little respect for this opinion. As also I point out above, and contrary to what several amici supporting Mayo Collaborative Service’s position disingenuously suggested, we’re not talking about a “not-for-profit” research institution being accused of infringement, but instead a “for-profit” competitor of the patentee, Prometheus. You’re free to disagree with what I’ve said, and believe what you want, but I’m not backing away from anything I’ve said here.

[lxf001]

This is insane.

[David Koepsell]

EG: "If the 'draftman’s art' cannot be used to turn a patent-ineligible “law of nature” into a patent-eligible application of that “law,” then what, pray tell, can be used?"

The answer is, as I've always claimed, something more than crafty language, or the addition of some magical clauses. Rather, the dividing line between nature and artifice is where some creation occurs through man's intention, and something new is created which could not exist but-for that intention and action. Go back and read anything I've written on the subject and this is what I have consistently claimed. Merely identifying some natural phenomenon doesn't suffice, changing it in some way, bringing it to bear on some process or product to make something that would not exist but for human intention, is what should count. The good news is, 9 Supreme Court justices appear to be leaning in that direction.

[Gary Johnston]

Kevin:

Excellent summary, although, as expected, brimming with contempt. You knew this day was coming. As did I, having predicted precisely this outcome many times on this board. All of these claims seek to make infringers out of people who generically determine a biological or chemical profile of a person using old techniques, and then think about the "significance" of that determination. It is the applicant itself that discloses in the specification the significance of the determination.

This was an amazingly easy decision for the Court. It is shocking that anyone thinks this is the wrong result. As for how the Court came to its conclusion, all I have to say is, yaaawwwwnnnn.

[David Koepsell]

Of course, I think it will be even easier in the Myriad case. In Mayo, at least there was some "method" attached to the claim for the naturally-occurring correlation. In Myriad, two of the challenged claims are merely naturally-occuring strings of nucleotides. Slam dunk, it seems, after this decision.

[EG]

"Merely identifying some natural phenomenon doesn't suffice."

David, sorry but you're reasoning like a "philosopher," not like a "lawyer." Contrary to what Breyer's opinion suggests, Prometheus' claimed method has nothing to do with "laws of nature" or "natural phenomena." Determining the metabolites generated by administration of a man-made drug is "natural phenomena"? Oh please don't hide such sophistry under that fig leaf.

Instead, the patent-eligibilty of Prometheus' claimed has EVERYTHING to do with how the claim was written ("crafted"). That you don't understand that basic concept tells me that you, like Breyer (and his 8 cohorts) are completely clueless as to how the patent claims work. (Some of us patent practitioners got a real giggle when Breyer's opinion didn't even recognize what those "wherein clauses" really mean).

Again, David, as I said above, Prometheus' claimed method has trouble reaching the "patent-eligibilty zone," but not for the reasons you (or Breyer) suggest.

Gary: I'm not going to disagree with you that Prometheus' claimed method is problematical is reaching the "patent-eligibility zone." But if you think this was an "easy decision" based on the warped reasoning expressed in Breyer's opinion, you are as clueless as is David Koepsell as to how how the patent claims work. And don't give me that nonsense that Prometheus' claimed method someone "patents thought" like some of the amici supporting Mayo's position disingenuously suggested. That argument doesn't even pass the "smell test" in my book.

[David Koepsell]

The problem is that patent-claims and interpretation don't track reality closely. The natural correlation between drugs and metabolites is a naturally-occurring phenomena, no matter how you decide to word it all. The drug may well be an artifact, however, if it took human intention to bring it into the universe. It's time patent-practitioners came back to earth, left the post-modernity behind, and started to act like they aren't smarter than everyone else. It's good to see SCOTUS putting you back in your place.

[Kevin E. Noonan]

Dear Gary:

Contempt may be a bit strong; intellectual disdain, perhaps.

I don't care at all about the Prometheus claims; anyone competent can come up with better ones. I do care about the Court ignoring the law, and how the law has been interpreted, to arrive at a result, no matter what policies they think that result promotes.

I also think that the Court imposed a "bright line rule" of no value regarding laws of nature, and then reverted to its traditional "totality of the circumstances" regarding what more needs to be claimed to be a valid application of such laws rather than a pre-emption (although I don't recall them using that term).

My worry is that the Court has once again made it less, not more, certain where to properly draw the line on patent-eligible subject matter, and that this decision will counsel clients to keep as much as possible as a trade secret. Which will retard rather than promote progress, the opposite of what the Court should be trying to do.

Finally, it is more than a little anachronistic for the Court to be playing judicial Goldilocks in cases like this.

Thanks for the comment

[EG]

"The problem is that patent-claims and interpretation don't track reality closely."

Only in your "philosophical" world, David. Also we "patent-practitioners' do work in the real world, not in some abstract "vacuum" that Breyer's opinion suggests patent claims operate in.

"The natural correlation between drugs and metabolites is a naturally-occurring phenomena, no matter how you decide to word it all."

You can believe that, David, but that's, still a nonsequitur. Again, how can metabolites from a man-made drug be deemed simply a "naturally-occurring phenomena"? Did "nature" administer those drugs? Of course not. Besides, as I've stated above, that's not the problem with Breyer's opinion characterizing Prometheus' claimed method as being a "law of nature" issue.

The comment about being "smarter than everyone else" only applies to us patent practitioner's perhaps understanding better than others (like you) how patent claims work and what the patent law actually is. After all, I've been drafting patent claims now for over 34 years. How long have you been drafting patent claims? If you and SCOTUS want to "play on our turf," I would suggest using the correct rules, i.e., the patent statutes. Put it this way: would like me to apply my patent rules to your "philosophical" world?

And please don't obfuscate and "spin" the discussion by suggesting SCOTUS "put us back in our place." The fact is that the Federal Circuit, probably led by Chief Judge Rader, will likely "cabin" this decision, as it should, or else all analytical and diagnostic methods will never surive the illogical standard set out in Breyer's opinion. The "reality" (if you want to know) is that the Federal Circuit can outlast SCOTUS on this issue; SCOTUS can't (and won't) take every single case that potentially involves a patent-eligibility question.

Peace David, let's move on as neither of us is going to change our minds about this. You've said your piece and I've said mine.

[David Koepsell]

Eric, I'm at utter peace right now. I think you give "philosophy" too little credit. Distinctions between things like nature and artifice are indeed philosophical, ontological issues, not legal issues. The law could say that 2+2=5, but the fact of 2+2=4 is a matter of mathematics and logic no matter what laws might say. In this case, and in the Myriad case, claim-drafters and the federal circuit attempted to say that X does not equal X, which is logically wrong. (e.g., in the Myriad case that the string of nucleotides [X] made through natural evolution somehow becomes man-made [X] when the natural boundaries of the gene are discovered). Attempts to paint such products and phenomena of nature as artifice violate the law of identity, and this is something that philosophers have something definite to add to the debate. While my attempts have been scorned in the past, it is no small vindication to see the highest court in the land drift in my direction. The laws of thought remain immutable and correct, even in light of rhetorical and political attempts to to ignore them. The occasional correction from logically-minded justices is warranted and welcome. We shall see what happens next. Meanwhile, peace to you too.

[6]

It is rather funny to see Kevin's jaundiced view of the decision.

This decision says nothing which was already not said in other decisions. This decision does nothing more than slap you in the face with the thing which people have been telling you for quite some time now.

Yet still Kev hopes for creative drafting etc. Will these charlatans never cease in their working of evil? Do we have to impose a steep penalty on the officers of the court expressing these views to get them to stop routinely disrespecting the law of their land?

[JOB]

This is one the best reasoned, clear and concise decisions ever delivered by SCOTUS. It is consistent with over 50 years of jurisprudence. Together with KSR, it will stand the test of time and bring patent law practice back from the dark ages and the mess that the CAFC had brought on the field since State Street with the useless TCU test, the even worse TSM test and finally their insane interpretation of the MOT test. The bar had been set so low that anything became patentable. No wonder that entire industries such as software have been fundamentally opposed to patents as the field was becoming ruled by con artists such as Myhrvold.
But one day, like a long dormant volcano, SCOTUS woke up with KSR, put their foot down with Bilski and slammed the door with Prometheus. This trifecta of cases will become the new classics for future generations of law students studying patent law.
It is amusing to see how many sore losers are attacking SCOTUS for lack of understanding of patent law. The real mental midgets are the CAFC judges led by Judge Rader and Newman who repeatedly and deliberately failed to accept the preemption principle articulated by SCOTUS since Flook and Diehr and reestablished with total unanimity with this decision. Only Judge Kimberly Moore on the CAFC had fully understood the importance of the preemption principle and had been consistent in her oppostion to the wild overreach of Judges Rader and Newman(not suprising as Judge Moore is the only scientifically trained member of the CAFC with an MIT engineering degree). I would not be surprised at all if she eventually pens the decision for the CAFC nailing the coffin on Myriad after the case gets remanded by SCOTUS. Judge Rader has simply lost any credibility on 101 issues (if he ever had any) after this decision.
Frankly, some of the patent practitioners who advised their clients to file such misguided claims have only themselves to blame and should turn in their licenses for incompetence.
I am not worried for a second about future research and IP protection in personalized medicine. I pretty much exclusively deal in diagnostic method patents and never in my wildest dreams would I have suggested or written such ridiculously broad claims as in Prometheus, Classen or Myriad. The true innovators in the Prometheus case were the scientists at Mayo Clinic ho had a better method than the one proposed by Prometheus, but could not practice it. The real tragedy would have been if the decision had gone the other way.
My only hope is that SCOTUS takes it one step further and completely eliminates most software patents. I would not be surprised at all if business methods were next on the chopping block. They have zero utility, do not promote innovation (ask Facebook) and are a drag on small companies which can't defend against frivolous infringement suits.
This decision is a victory for true innovators, patients and physicians. The only losers are the scam artists and patent trolls such as Prometheus and the idiots at Nestle who bought the Company for $500 million.

[James Demers]

I think the howls of dismay here are unwarranted. The Prometheus inventors did not invent anything. The prior art provided the drugs, identified the metabolites, provided the analytical methods, identified the side effects, and even disclosed that metabolite levels correlated with side effect toxicity. (The specification of the '623 patent admits all of this.) All that was missing was the routine task of finding the numbers, and that's why the only novel element in the claims was the numbers.

Nine Supreme Court justices say you need more than just the numbers to have a patent-eligible claim, and we can live with that. I submit that it will be very rare that a newly-invented, non-obvious clinical test has nothing new to it but the numbers themselves, so that broad Prometheus-like claims (determining X, wherein the results mean Y) are the only option available to the draftsman. Narrower claims will leave room for other inventors to come up with improved methods of obtaining and/or using the numbers -- which is as it should be.

[Skeptical]

When someone writes "This is one the best reasoned, clear and concise decisions ever delivered by SCOTUS," all credibility is lost.

As for the howls of dismay, the dismay is not aimed at the claims themselves (for the most part); but rather, the howls are directed to the extremely poor legal writing (including the often incomplete reasoning)involved in the decision. Far, far too many of those celebrating this decision cannot see that a "whatever" mentality makes for poor, ambiguous, and more difficult (not less) law.

[Kevin E. Noonan]

I must say I agree with Skeptical: the issue isn't the patent-eligibility of the Prometheus/Classen/Myriad claims per se; indeed, if the Court had said that the claims were overbroad so that they unfairly precluded use of the natural law by others I might agree. Indeed, I think that is the best interpretation that can be hoped even from the Prometheus opinion.

Unfortunately the Court went much further, and that is the problem: they created a "bright line rule" against patenting laws of nature, supported by a subjective analyis of when you know when your claim is doing just that. Which can lead to mischief.

[Kevin E. Noonan]

Dear James:

I hope you are correct. If that is the only effect of Prometheus I will be the first to celebrate.

Thanks for the perspective.

[Kevin E. Noonan]

6:

Don't be such a hater.

Peace :)

[EG]

"Unfortunately the Court went much further, and that is the problem: they created a 'bright line rule' against patenting laws of nature, supported by a subjective analysis of when you know when your claim is doing just that. Which can lead to mischief."

Kevin,

How true. As I've said, get out that Ouija board, you couldn't do any worse than SCOTUS did in this case.

[lorac]

I'm a little late to this party, but wanted to say that your sarcasm was wonderfully crafted. Thanks as always for your well written commentary.