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« Legislators Support Labeling of Genetically Engineered Foods | Main | Mayo Collaborative Services v. Prometheus Laboratories -- What the Court's Decision Means »

March 21, 2012


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

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.

This is insane.

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.


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.

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.

"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.

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.

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

"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.

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.

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?

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.

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.

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.

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.

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.


Don't be such a hater.

Peace :)

"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."


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

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.

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