Mayo v. Prometheus: Natural Process + Known Elements = Normally No Patent

by Dennis Crouch

Mayo Collaborative Services v. Prometheus Labs., Inc. (Supreme Court 2012)

A unanimous (9–0) Supreme Court has held that the personalized medicine dosing process invented by Prometheus is not eligible for patent protection because the process is effectively an unpatentable law of nature. This decision reverses the Court of Appeals for the Federal Circuit’s holding that the claims were patentable because they included substantial physical limitations.

The Prometheus invention identifies a “relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove [either] 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 8×10(8) red blood cells, then the administered dose is likely to produce toxic side effects.”  In addition to claiming the boundaries between over and under dosage of thiopurine based upon measuring 6–TG in the blood, some of the Prometheus claims include additional limitations such as (1) administering thiopurine to a patient and (2) determining the blood level of 6–TG.

Law of Nature: In its decision, the Supreme Court first identified the correlation between 6–TG blood levels and over/under thiopurine dosage as an unpatentable law of nature.

The relation is a consequence of the ways in which thiopurine compounds are metabolized by the body—entirely natural processes. And so a patent that simply describes that relation sets forth a natural law.

As is usual in these cases, the Court referenced the groundbreaking discoveries by Einstein and Newton and noted that neither “E=mc²” nor the “law of gravity” would have been subject matter eligible.  Taking that as a premise, the court jumped to the conclusion that, therefore, the discovery that the blood level of 6–TG in a human correlates with either an overdose or underdose of thiopurine is also subject matter ineligible.

Additional Elements: The Supreme Court then considered the additional limitations and held them insufficient to transform the identified natural law into a patentable process.  The opinion repeatedly and favorably cites Parker v. Flook, 437 U. S. 584 (1978) in finding that the physical and transformative elements of the invention were not “genuine applications of those laws[, but] rather .. drafting efforts designed to monopolize the correlations.”  As to the claimed application of the law of nature, court here found it relevant and important that the additional steps were already known in the art.

Because methods for making such determinations were well known in the art, this step simply tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists in the field. Such activity is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law.

The conclusion here is that (1) a newly discovered law of nature is itself unpatentable and (2) the application of that newly discovered law is also normally unpatentable if the application merely relies upon elements already known in the art.  To be clear, the court still maintains the law of Diehr that “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.”  On the other hand, the “application” must be “significant,” not “too broadly preempt” use of the law, and include other elements that constitute an “inventive concept” that is significant and separate from the natural law itself.  Of note, it is likely important that in this decision the court unfavorably cites the limitation of Flook found in Diehr that eligibility under §  101 “must be” based on claims “considered as a whole.”

Process and Presumption: In addition to the legal elements, the decision can be read to create a process for determining patent eligibility for patent claims that include a law of nature.  The court wrote that the “additional features” that show an application of the law must “provide practical assurance that the [claimed] process is more than a drafting effort.”  This language suggests that the burden will be on the patentee to prove that its limitations are more than patent attorney tricks. 

Whither Myriad: Although no action has been taken yet, I presume that the Supreme Court will now vacate and remand the pending Myriad case with instructions to the Federal Circuit to reconsider its holding that isolated human DNA is patentable.  Following Mayo, the court could logically find that the information in the DNA represents a law of nature, that the DNA itself is a natural phenomenon,  that the isolation of the DNA simply employs an isolation process already well known and expected at the time of the invention, and ultimately that the isolated DNA is unpatentable because it effectively claims a law of nature or natural phenomenon.  One distinguishing point is that Prometheus claimed a process while Myriad claims a composition of matter.  As we have seen in recent cases, the Federal Circuit already largely rejects formalistic distinctions between process and composition claims. Here, that distinction is further minimized by the reality that the claimed DNA is functionally characterized by the already well known process of isolating human DNA.

Read the opinion by Justice Breyer hereLINK.

The following is the text of the now invalidated Claim 1 of the Prometheus U.S. Patent No. 6,355,623.

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 8×108 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 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently ad­ ministered to said subject.

374 thoughts on “Mayo v. Prometheus: Natural Process + Known Elements = Normally No Patent

  1. Next, your strawman argument is impeccable.  

    What I actually said is this:

    1) Bilski claims were directed to a business method.
    2) They were held not eligible.
    Arguendo
    3) Business methods are not categorically eligible for patenting. 

    Only after endless semantic debates did I get AI to agree that every method claim (and even some that are deemed methods), even his precious business method claims, are still subject to the traditional exclusions relating to laws of nature, mental steps and abstract ideas and for that reason are not categorically eligible.  Yet even with this concession, AI will immediately say, "Business methods are eligible.'

    It makes one gag.

  2. Welcome to the new dissection.

    Take any claim and dissect it into pre-, post-, and extra-solution steps as well as law of nature steps.

    law of nature steps = gone.
    pre- post- and extra-solution steps = gone.

    The patent ship has sailed.

  3. +1.

    Useful simply does not mean patent utility.

    Any patent utility dependent on a law of nature means the patent should not exist.

  4. EG, I have the exact same concern.  Breyer never came out and actually said that had there been an post-test treatment step the claims would have been saved.  His rhetoric is repleat with admonishments about insignificant post solution activity.  The fact that treatment was an otherwise old step gives one pause.  Malcolm, in this thread, has also insisted that the application step be new and novel.  I don't know what he means by that.

    But with that additional step, the claims here would have been exactly like those in Diehr.  The process would have been a specific application of the otherwise unpatentable law of nature.  Administering the drug with a different dosage is just like opening the mold.  It is a physical step that is modified by the new information.

  5. (i.e., patent-eligible) utility

    Dissect away.

    What is the utility of any pharmaceutical compound?

    Per this decision, that utility is intimately interwoven with the natural law of body processes.

    Unless you actually invent a new body process, it’s off to the 101 guillotine with you.

  6. I think Breyer also suggested that if post solution activity were routine or obvious, they could be ignored.

    Breyer most definitely conflated “old” with 101.

    Proudly so. Dangerously so.

    The real question is how did the rest of the court let this slip by?

  7. I think you are focusing on what Prometheus did and not what the claims cover.

    So how are those “precise correlations” identified by humans (not nature) “laws of nature”?

    The correlation was true even before it was discovered by Prometheus. The claims don’t cover discovering the correlation. The claims cover the correlation itself. The correlation wasn’t man-made.

    Your comment appears to be based on the premise that Prometheus deserves a patent because it discovered the correlation.

    identification of what “concentrations” are “ineffective or cause harm” is what humans do, not “nature.”

    it is patent-ineligible, even if the correlation identified is previously unknown.

    I’m not disputing that Prometheus did something useful, but that doesn’t necessarily mean that it should get a patent.

  8. No. Plenty upon plenty of Ned Heller arguments clearly stating that business method patents are categorically denied because Bilski was a business method.

    Ergo,

    Bilski = business method.
    Supreme Court says Bilski not patent eligible.
    Ned says all business methods are not patent eligible.

    Prometheus = medical method.
    Supreme Court says Prometheus not patent eligible.
    Ned
    should be saying all medical methods are not patent eligible.

  9. JEB, I would agree with you had the Court held that the claims would have been unpatentable even if they had required that an adjusted does be administered.

    Why do you think the claims stop at the diagnosis step and do not include the final treatment step?

  10. because there is no proof that the DNA was prior art.

    Proof of such would be rather easy to provide.

    It’s rather like the chicken and the egg…

  11. merely becomes someone subsequently discovers the same sequence in the gonad cells of an Antarctic sea urchin.

    That’s more than “merely” enough. If that were to happen then there could be no denying that same sequence is a natural phenomenom (as opposed to a law of nature). The patent would in effect cover something not made by the hands of man.

    It would be just as non-patent eligible. Period. End. Of. Analysis.

  12. “Had the claims simply required the doctor or some machine to adjust the dosage according to the recommendation, there would have been no problem.”

    Good point, Ned, but my concern is that the “collateral damage” caused by Breyer’s unfortunate statements that “routine, conventional activity” won’t save a claimed method that otherwise is deemed to cover just a “law of nature” could make even such an adjusitng step problematic. As I said upthread, Breyer’s opinion is replete with nonsensical stuff that will simply burden the patent-eligibility question further on such methods

  13. patent laws have always

    The new “have always.”

    Out of fifteen million Ned Heller posts, today is the first day of the new MONT.

  14. Malcolm, I will agree that you have successfully pointed out that the subsequent discovery of wild DNA will not anticipate a DNA claim because there is no proof that the DNA was prior art.

    However, the facts I propose are not that.  I propose that the wild DNA is known.  It is known once the researcher has discovered it, not so?  How can one isolate DNA from wild DNA that is not known to exist, albeit that its exact chemical structure is not known until one does isolate it?

    Logically,

    Isolated DNA = Wild DNA subjected to a known process.

    One cannot have Isolated DNA without preexisting Wild DNA.  

    So when you say you have invented a new and unobvious Isolated DNA compound, I have a hard time understanding your logic. You are basically saying as well that the Wild DNA is new and unobvious when that Wild DNA is not new, but old.

  15. The result depends on how you look at the claim. If you start with the discovery, which is the therapeutic range of the metabolites, then the administering and determining steps are insignificant post-solution activity. If you start with the administering and determining steps, then you conclude that a transformation takes place and the rest of the claim is irrelevant for 101 purposes. Apparently, the Supreme Court likes the former approach.

  16. arbitrage, I think so too.  But see Malcolm pointing out elsewhere that the "application" of the  law of nature has to be new and non obvious.  I think Breyer also suggested that if post solution activity were routine or obvious,  they could be ignored.  Here, the administering of the drug in response to metabolite tests was old.  The only thing new was the correlation.  It seems a rather artificial line to draw to require what the claims recommends. 

    Had they actually said that using the correlations would have been enough we wouldn't even be asking these questions.  But, as far as I can tell, the opinion did not go this far.

  17. Ned: if wild DNA is old or deemed old, the process for isolating that DNA known, the I would suggest the isolated DNA might be considered structurally known from the old or deemed old wild DNA.

    The isolated DNA can’t be “structurally known” if neither the nucleic acid sequence nor a substantial utility for the nucleic acid sequence was unknown. As I’ve already discussed ad nauseum, any other outcome leads to absurd situations where a completely synthetic, highly engineered nucleic acid with profound anti-cancer properties becomes “ineligible subject matter” merely becomes someone subsequently discovers the same sequence in the gonad cells of an Antarctic sea urchin. That’s frxckin rxtxrded and that’s why the Supremes would never uphold that result. Period. End. Of. Analysis.

    The real discovery here is the correlation between the wild DNA and a specific disease.

    The correlation claims are already dead, Ned, and their eligibility is not being appealed to the Supreme Court. The composition claims, in contrast, are a crystal clear example of statutorily eligible, novel subject matter that can be used to exploit/apply a law of nature.

  18. EG, I will agree that the discovery of the correlations is the act of a human. But the correlations themselves are a product of nature. I think there is a difference.

    I think the patent laws have always demanded that patents be awarded to those who apply laws of nature to new applications. I think, therefore, that the Prometheus claims would have been held patentable had they gone one step further and had actually applied the new information in some practical manner and not have simply stopped at reciting the correlations in the report. Had the claims simply required the doctor or some machine to adjust the dosage according to the recommendation, there would have been no problem.

    Assuming this is correct, where is the problem?

    Let me suggest an answer to my own question. Do you have any concern with 35 USC 287(c)?

    (c)

    (1) With respect to a medical practitioner’s performance of a medical activity that constitutes an infringement under section 271(a) or (b) of this title, the provisions of sections 281, 283, 284, and 285 of this title shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.

  19. I don’t think I “admitted” to anything, I just helped the guy above draft something.

    Whether or not I, any given examiner, or the BPAI/CAFC/USSC will give you “credit” or “weight” for this supposed “function” is an entirely different matter and would be done ivo specific prior art. And we could discuss that to death in these hypothetical claims. I’m not game today. Sorry brosensky this 101 case is quite enough for me.

  20. “That’s what “design around” is for.”

    The entire point of this decision and those like it is that designing around is not possible and that is a problem. It isn’t just “tough sniff sniff” or “tough” it is unpossible. Which is exactly what these kinds of claims aim to do, make designing around impossible.

    Funny how you tards can keep on missing that forever.

  21. I think that if the following step (c) had been present in the claim, the whole issue of patentable utility might never have arisen:

    (c) continuously monitoring the level of thioguanine and adjusting the quantity of drug administered so as to maintain a level of thioguanine within the range of 230-400 picomole per 800 million RBC’s.

  22. The examiner should have rejected the claims (in USP ‘623) as obvious, by simply ignoring everything in the claims after step (b). Everything after step (b) can be ignored, because they are just “mental steps”.

    You might run into a little difficulty with the fact that mental steps are allowed in claims.

    You might also run into a lilttle difficulty with MPEP § 2143.03 which clearly states that “All Claim Limitations Must Be Considered” and the body of §2143.03 which requires that:

    “All words in a claim must be considered in judging the patentability of that claim against the prior art.” In re Wilson, 424 F.2d 1382, 1385, 165 USPQ 494, 496 (CCPA 1970).

  23. Max, in Euro-land, can the first discoverer of a use for an known compound authorize that first discoverer to patent the known compound?

    Perhaps the question makes sense only in the US as we require a composition to have a use before we can patent it. In Euro-land, if I understand this correctly, lack of a known utility is no obstacle for patenting a new compound. This implies that the first discoverer of a use could not get a compound patent where the compound was known.

  24. there is a danger that the grant of patents that tie up their use will inhibit future innovation premised upon them

    ANY patent inhibits short term use, but NO patent inhibits future innovation premised upon them.

    That’s what “design around” is for.

    And even for argument’s sake, if that “design around” is too tough (sniff-sniff wah wah), you are still free to enjoy the bounty of the discovery by paying the small price that serves the great end of promotion. If the design around is too tough, that tells you that getting to that very valuable point is even more worth the cost.

    After all, per the very same Supreme Court (See Golan) there is more than one way to promotion, and paying something to someone for something old (and previously in the public domain) can still serve that “promotion.”

  25. MM, again, if wild DNA is old or deemed old, the process for isolating that DNA known, the I would suggest the isolated DNA might be considered structurally known from the old or deemed old wild DNA.

    The real discovery here is the correlation between the wild DNA and a specific disease. Might I politely suggest that Prometheus may have some bearing on Myriad for this reason?

  26. The examiner should have rejected the claims (in USP ‘623) as obvious, by simply ignoring everything in the claims after step (b). Everything after step (b) can be ignored, because they are just “mental steps”.

    A 103 rejection could have been imposed on the ground that a biochemist would have had reason to perform pharmacokinetic studies for any of several reasons.

    ………………………….

    I would not be particularly disturbed by the SCOTUS decision, if it could be taken in isolation. But I am very concerned about what it will mean for the diagnostic industry. The industry as a whole provides immensely valuable products, and I would not want to see investment capital leave that space.

    (I’m an examiner…who shall remain anonymous).

  27. There you have it.

    All medical methods are categorically not patent eligible.

    Why isn’t Ned applying his famous logic here?

  28. Well it was a dissent and Rader’s opinion in Bilski largely prevailed at the Supreme Court over a dissent in which Breyer joined. Moreover, Breyer’s concurring opinion in Bilski indicated that he really liked the MOT, albeit, not as an exclusive test. Taking that clue as a possible way around Breyer’s dissent in Metabolite, Rader relied on the MOT just to divert Breyer’s attention.

    The problem was, all along it appears, that the MOT requires a new transformation. See my discussion above with Malcolm for more on this.

  29. OK, old.

    I don’t think the MOT section of the opinion said that

    I don’t think any section of MOT says anything about “old.”

    Which Book of MOT are you reading from?

  30. we adults often discussed what “standard 101 analysis calims as a whole” actually meant in practice.

    Let me guess: What-Ev?

    I don’t think those are the types of “adults” that should be allowed to play with the law.

  31. Hey Malcolm, that wasn’t me that made that post. Notice the moniker “Not Ned?”

    I made the post asking the question about whether an administering step would have save the claims here. The claims then would have been just like Diehr and unlike Flook. I presume the Supremes would have had no problem with them then, but I am not sure. The reason I am not sure is that they seem to place great emphasis on the law of nature aspect of the discovery. This may have lead them to hold that an administering step, without more, would have been “insignificant” post solution activity because it was, in itself, old and obvious.

  32. “Discoveries” are not one of the recited statutory classes. Nor are “facts”, “laws of nature”, “poetical musings” or “feelings.”

    Technically speaking, neither are “Inventions” one of the recited statutory classes.

    It must be the right type of invention.

  33. Per the court, simply interpreting (or even applying, without specificity) a new fact doesn’t count as a new process.

    No. It says more than that. It says even applying old things with the new fact doesn’t count as a new process.

    Newsflash. There is nothing new under the sun.

  34. Not the right type of discovery.

    You didn’t read the decision did you?

  35. “configured to” in your claims, that is nothing more than a functional recitation.

    Are you admitting to a functional relationship?

  36. Generally, no structure = no apparatus claim.

    No.

    Generally, no structure = means plus function claims. MM got this one: what does the spec say?

  37. There’s no “mess” at all, provided you read the case with the intention of misunderstanding it.

    Fixed. Here try my “What-Ev” glasses in order to see the (non-haha) mess.

  38. If it’s an old drug administered by an old method, the method is invalid under 102/103. No 101 problem

    You didn’t read the Supreme Court decision.

  39. So – where’s the line?… the natural phenomena that occurs when the drug comes in contact with the human body?

    The line is behind your patent. Hand it over.

  40. Why would that matter? The transformation is neither new (bodies have not developed a new way of transforming chemicals), nor, now with this decision, should they be treated as anything but laws of nature.

    What’s left after you dissect the claim and take out that which is not patentable?

    With comments such as these, Ned, where I can barely understand what you are asking, or what you are talking about, and it’s completely unclear to me what your concerns are, I’ve learned that it’s best to ask for a do-ever. Please try again. Maybe start by explaining what “they” refers to.

    I will say this: if you think that this decision has some terrible unforseen or forseeable consequences for patent law or for developers of new drugs and new treatments, you’re certainly wrong. In any event, any such consequences pale miserably compared to the litigation nightmare that would have flowed from the opposite holding, a holding that garned no support from any Justice.

  41. I have seen litigators twist language and make arguments that bordered on illogical

    Way past that border here, my first timer.

  42. So novel, non-obvious compositions that are obtained by “well known processes” are now considered to be “laws of nature”? Please

    You are welcome. Welcome to the land of dissection and What-Ev.

    Enjoy your stay.

  43. , the proper, and pretty much standard, 101 analysis was calims as a whole.

    Yes, young sockie, except we adults often discussed what “standard 101 analysis calims as a whole” actually meant in practice.

    By doing so, we avoided relying on claims for our clients that were just blown into smithereens by a 9-0 Supreme Court opinion.

  44. Take the player piano with new music on the old roll.

    Wouldn’t that (new music) make the piano roll a new roll?

  45. Every invention in the history of the world is a combination of known elements/steps and “laws of nature”- it is called Conservation of Matter and Energy. The standard put forth by the Supreme Court in this decision means that only black magic is patentable. Get out your cauldrons-

  46. Typically that would mean that the drug itself is new

    Why would that matter? The transformation is neither new (bodies have not developed a new way of transforming chemicals), nor, now with this decision, should they be treated as anything but laws of nature.

    What’s left after you dissect the claim and take out that which is not patentable?

  47. It is well known that the “academics” have an agenda rooted in anti-property anythingism. Please return to Techdirt.

  48. Nice. Now move the goalposts back.

    There are other doctrines, Mr. What-Ev to cover claims elements that are not related. No matter what those claim elements are, be they “new thoughts” or otherwise. IT’s clear that you are not a “serious educated patent prosecutor,” otherwise you would run as far and as fast as possible from the What-Ev fantasy you indulge in.

    Regardless, the proper, and pretty much standard, 101 analysis was calims as a whole.

  49. On a different note, I am still trying to reconcile the Supreme Court’s exclusion of patents on laws of nature with the statute’s express inclusion of “discover[ies].”

    Steve, the statute doesn’t expressly incorporate all discoveries, but only the discovery of new and useful processes, machines, etc. Per the court, simply interpreting (or even applying, without specificity) a new fact doesn’t count as a new process.

    No, the statutory recitation of “discovers” is not superfluous. Not every invention is “discovered,” but I dare say that Teflon was discovered, in the sense that it was a fortuitous (accidental) result as opposed to something developed from some previous flash of insight. I expect that there a number of chemical processes that are discovered, rather than “invented” in the usual semse of that term.

  50. Malcolm, in your opinion, does the following indicate that an administering step would have saved the claims?

    “The laws of nature at issue here are narrow laws that may have limited applications, but the patent claims that embody them nonetheless implicate this concern. They tell a treating doctor to measure metabolite levels and to consider the resulting measurements in light of the statistical relationships they describe. In doing so, they tie upthe doctor’s subsequent treatment decision whether that treatment does, or does not, change in light of the inference he has drawn using the correlations. And they 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. The “determining” step too is set forth in highly general language covering all processes that make use of the correlations after measuring metabolites, including later discovered processes that measure metabolite levels in new ways.

    We need not, and do not, now decide whether were the steps at issue here less conventional, these features of the claims would prove sufficient to invalidate them. For here, as we have said, the steps add nothing of significance to the natural laws themselves. Unlike, say, a typical patent on a new drug or a new way of using an existing drug, the patent claims do not confine their reach to particular applications of those laws.” (Emphasis supplied.)

  51. The statute says that if you discover something you can get a patent on it.

    “Discoveries” are not one of the recited statutory classes. Nor are “facts”, “laws of nature”, “poetical musings” or “feelings.”

    And what this case is about is what happens when you attempt to capture ineligible subject matter (i.e., a “law of nature”) by sloppily tacking some eligible subject matter onto it. What happens is you get the ring finger across the lips. Nine times.

  52. Try using the structure of the kit and the specific steps you take in the “diagnostic test”. Oh, what’s that you say? Your patent is worthless because other tests and kits that do the same thing are easy to invent? Tough sht. Maybe you should design those other tests and kits too and patent them as well.

    That might actually labor. Too scary to contemplate in the information age.

  53. Was this too easy of a case for SCotUS? What if the two “wherein” clauses were written as actual steps? Something like this:

       if the level of 6-thioguanine is less than about 230 pmol per 8×108 red blood cells, then increasing the amount of said drug subsequently admin­istered to said subject, and

       if the level of 6-thioguanine is greater than about 400 pmol per 8×108 red blood cells, then decreasing the amount of said drug subsequently ad­ ministered to said subject.

    The ‘623 patent has dependent claims, but none provide “post-solution” activity. That’s why the claims look so much like the BCD converter in Benson.

    On a different note, I am still trying to reconcile the Supreme Court’s exclusion of patents on laws of nature with the statute’s express inclusion of “discover[ies].” The statute says that if you discovery something you can get a patent on it. Besides laws of nature and natural phenomena, what else is there to discover? Is the statutory recitation of “discovers” superfluous?

  54. I develop a simple diagnostic test and kit and try to patent it, yet denied because the method involves a “law of nature”?

    Prometheus was not denied a claim to a kit. Moreover, Prometheus did not “design a diagnostic test.” The test for metabolite was old in the art and admitted as such by Prometheus. Prometheus discovered an (alleged) FACT (law of nature) about the correlation between optimal drug dosage and metabolite levels. Rather than claim a method of administering certain novel drug dosages, Prometheus chose to instead claim and assert a method that recited old steps and thinking about the FACT (law of nature). By doing so, they effectively claimed the FACT (law of nature) itself.

    the review of additional limitations should be an obviousness determination. Namely, was it obvious to use the law of nature in the claimed manner.

    The specific metabolite levels recited in the “thinking” step of the claim were arguably non-obvious. The Court reasoned that there was no clear legal justification for ignoring laws of nature (or thinking about laws of nature) in a 103 analysis. Therefore, 101 is the preferred method for destroying claims such as Prometheus (i.e., [oldstep]+[newthought] claims).

  55. “I develop a simple diagnostic test and kit and try to patent it, yet denied because the method involves a “law of nature”?”

    There is a simple way around this, claim your diagnostic test and kit in terms that have nothing to do with the lawl of nature. Try using the structure of the kit and the specific steps you take in the “diagnostic test”. Oh, what’s that you say? Your patent is worthless because other tests and kits that do the same thing are easy to invent? Tough sht. Maybe you should design those other tests and kits too and patent them as well.

  56. “An apparatus for determining an amount of 6-thioguanine, comprising:
    (a) a drug administering unit configurable to do some stuff,
    (b) a 6-thioguanine level determining unit configurable to do some stuff.

    Again, watch out for your intended uses. And when you finally get around to putting “configured to” in your claims, that is nothing more than a functional recitation. There is likely no 101 issue, but you will likely run head first into prior art and/or have a worthless claim since nobody makes such a machine or even has a desire to make such a machine.

  57. It is only gobbledygook if you refuse to read and understand the very simple concepts they are setting forth. They even took their time to hold your hand in this decision.

  58. Let me get this straight.

    I discover a previously unknown metabolite that is generated during most chemotherapies.

    I also discover that if the metabolite is kept in a very tight window during the treatment, the effectiveness of the chemotherapy skyrockets. I develop a simple diagnostic test and kit and try to patent it, yet denied because the method involves a “law of nature”?

    I wonder if the patentee would have had better luck with additional claim limitions (“administering the next dose at a higher level or lower level depending on the determination”).

    I think correct for the Court to identified the “law of nature” elements of a claim but the review of additional limitations should be an obviousness determination. Namely, was it obvious to use the law of nature in the claimed manner.

  59. Ned By allowing an old transformation to count in this case, the Federal Circuit essentially allowed a patent on the new correlation. This analysis has broad implications for 101 analysis.
    Take the player piano with new music on the old roll. Using the Prometheus analysis, because everything else is old, the claims really is to the new music itself, something I would presume is not the subject matter of a patent.

    Agreed, although there is an interesting passage in the opinion where Breyer refers to the lack of any new utility in the invention as claimed beyond the recognition of the law of nature. So, if the new piano roll had some identified non-musical (i.e., patent-eligible) utility, it might escape the 101 guillotine.

  60. re: 2, Perhaps not, but the applicant did DISCOVER them:

    35 U.S.C. 101 Inventions patentable.

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

  61. I agree entirely with EG that the opinion is rhetorical nonsense.

    The court did reach my preferred outcome, but it is rhetorical gobbledygook.

    One step forward, three steps backward.

  62. Huh? How is that claim any different from what was ruled unpatentable in Prometheus?

    Also, how in the world could the US claims have been enforced against a generic drug company that simply made and sold the drug?

  63. MM, "What does it mean that the transformation of an existing drug in a body is new?Typically that would mean that the drug itself is new, Ned. Nothing in this decision would suggest to a reasonable person that a method of administering a new drug is patent ineligible."
    My question was directed to your assertion that because the transformation in the body was old, the transformation did not count under the MOT.  Your response effectively states that an old drug produces an old transformation.  It takes a new drug, or at least some new administration protocol of an old drug, to produce a new transformation.  With such a claim, the claim is directed to new compositions or protocols, things of man, not things of nature.  The fact that they produce new transformations in the body actually is a reason they are patent eligible.
    By allowing an old transformation to count in this case, the Federal Circuit essentially allowed a patent on the new correlation.  This analysis has broad implications for 101 analysis.
    Take the player piano with new music on the old roll.  Using the Prometheus analysis, because everything else is old, the claims really is to the new music itself, something I would presume is not the subject matter of a patent.

    I would add here, that the music does not modify the functional operation of the piano. If it did, that might make the piano new.

     

  64. I notice that in the granted EP counterpart, there is the following claim:

    “An in vitro method for determining efficacy of treatment of a subject having an immune-mediated [g.i.] disorder or a non-IBD autoimmune disease by administration of a 6-mercaptopurine drug, comprising determining in vitro level of 6-thioguanine in a sample from said subject having immune-mediated g.i. disorder or said non-IBD autoimmune disease, wherein said treatment is considered efficient if the level of 6-thioguanine is in the range of about 230 pmol per 8×108 red blood cells to about 400 pmol per 8×108 red blood cells.”

    Would such a claim be patentable under Prometheus?

    I don’t think so.

    The US claims appear to be open to enforcement against a generic company for simply making and selling the generic drug.

    Huh?

  65. In other words, the Court clearly characterizes a new medical use of an old pharmaceutical compound as implicating a “law of nature”–namely, how that drug affects some bodily function. So while I agree with the ulimate conclusion, how the Court got there is an absolute mess.

    There’s no “mess” at all, provided you read the case with the intention of understanding it. The Court recognizes that one or more “laws of nature” are imnplicated by all patent claims. The 101 issue arises in circumstances such as in Prometheus when the “law of nature” itself is effectively being claimed, as opposed to a specific novel application or composition that merely implicates or relies on the law of nature for its efficacy.

    Again, as I’ve pointed out in comment threads here over the many years five billion times already, the easiest way to see the difference between these types of claims is to look at how the claims affect individuals who are practicing the prior art. Do the claims turn such individuals who think about the new “law of nature” into infringers? If so, you’ve surely crossed the line into 101 ineligibility. It remains that simple, friends.

  66. I notice that in the granted EP counterpart, there is the following claim:

    “An in vitro method for determining efficacy of treatment of a subject having an immune-mediated [g.i.] disorder or a non-IBD autoimmune disease by administration of a 6-mercaptopurine drug, comprising determining in vitro level of 6-thioguanine in a sample from said subject having immune-mediated g.i. disorder or said non-IBD autoimmune disease, wherein said treatment is considered efficient if the level of 6-thioguanine is in the range of about 230 pmol per 8×108 red blood cells to about 400 pmol per 8×108 red blood cells.”

    Would such a claim be patentable under Prometheus? The US claims appear to be open to enforcement against a generic company for simply making and selling the generic drug. Possibly that’s why it runs afoul. Any thoughts? Is the EP claim a way to protect the diagnostic tool manufacturers without allowing for ever-greening or trolling?

  67. As to the last point, the opinion states that in a “typical” patent for a “new drug or a new way of unsing an existing drug”, the patent claims “confine their reach to particular applications of those laws.” In other words, the Court clearly characterizes a new medical use of an old pharmaceutical compound as implicating a “law of nature”–namely, how that drug affects some bodily function. So while I agree with the ulimate conclusion, how the Court got there is an absolute mess.

    It’s the equivalent of a guy in Milwaukee deciding to stop on the way home from work to buy a 6-pack of beer, but not arriving home until a week later. Why? Because you flew to Nome, hopped on a freighter which took you to Seattle, bought a bike which you rode to Portland, and then hitchiked back to Milwaukee to the store around the corner from your house. Sure you got your 6-pack, but you decide to give up beer because it costs too much $ to get to the store to buy it.

  68. An apparatus for determining an amount of 6-thioguanine, comprising:
    (a) a drug administering unit configurable to adjust an amount of 6-thioguanine in response to an indication provided by a 6-thioguanine level determining unit; and
    (b) a 6-thioguanine level determining unit configurable to determine a level of 6-thioguanine in a subject having an immune-mediated gastrointestinal disorder,
    wherein said 6-thioguanine level determining unit indicates a higher amount of 6-thioguanine when a level of 6-thioguanine is less than about 230 pmol per 8×10^8 red blood cells, and
    wherein said 6-thioguanine level determining unit indicates a lower amount of 6-thioguanine when a level of 6-thioguanine is greater than about 400 pmol per 8×10^8 red blood cells.

  69. It’s an indisputable fact that Prometheus sued Mayo because Mayo’s doctors were practicing the prior art and thinking about an unpatentable fact that had been disclosed and dedicated to the public by Prometheus. Same deal with Classen.

    That was probably enough for the Supreme Court to realize that the law reviews were more than “just a bunch of arguments.”

  70. Ned: OK, old. I don’t think the MOT section of the opinion said that.

    I don’t think it said that either. But it did say something to the effect that the “transformations in the claim are old, insignificant transformations that amount to nothing more than a draftsperson’s efforts to capture the law of nature.”

    if you are right, the Prometheus claims could have been patentable even if everything in the claim were old but one thing, and that being the transformation of the old drug in the body was new.

    You’re not making sense Ned. Please familiarize yourself with the facts of Prometheus. If there’s something you don’t understanda about the facts of Prometheus, please go ahead and ask. I’m not going to address nonsensical hypotheticals.

    What does it mean that the transformation of an existing drug in a body is new?

    Typically that would mean that the drug itself is new, Ned. Nothing in this decision would suggest to a reasonable person that a method of administering a new drug is patent ineligible.

  71. I would prefer the Court to read the statute broadly without imposing convoluted exceptions to the plain meaning, and then allow Congress to do the narrowing if they so choose. Law review articles on these subjects are by and large just a bunch of argument, but the Court cites them as though they present economic facts.

  72. OK, old.

    I don’t think the MOT section of the opinion said that. I will agree that that section also did not say that the transformations were excluded because they were natural phenomena.

    So, if you are right, the Prometheus claims could have been patentable even if everything in the claim were old but one thing, and that being the transformation of the old drug in the body was new.

    I must admit, I need some help here in understanding your meaning. What does it mean that the transformation of an existing drug in a body is new? I have an idea of what you might mean. But please, spell it out. Give us an example claim.

  73. “2. They shouldn’t be patentable because the applicant did not invent them.”

    Will this still be a bar for applications falling under the AIA?

  74. yes comrade, the collective is more important than individuals.

    How does that philosophy end every time?

    The constitution exists and men far smarter than you thought about these issues. Deal with it.

  75. You’re an employee who has been paid for developing things. Maybe your salary expense is the drag instead of the IP assets your company has generated for itself?

    Dennis, why are you attracting all of these techdirt types lately?

  76. I would be semi-not-uninterested to hear how this decision cannot be “squared” with Bilski according to NWPA. Especially in light of the fact that it starts off squared with Bilski with no additional squaring required.

  77. An apparatus for optimizing therapeutic efficacy for treatment of an immune-mediated gastronintestinal disorder, comprising:
    (a) a drug administering unit to do some stuff; and
    (b) a level determining unit to do some other stuff.

    That’s all you claimed in apparatus terms brosensky. Watch out for intended uses.

  78. “Usually an examiner will boil out all the method type language and leave you with:”

    That is correct. Although in this guy’s case it isn’t so much “method steps” that are taken out as it is intended use.

  79. “An apparatus for optimizing therapeutic efficacy for treatment of an immune-mediated gastronintestinal disorder, comprising:
    [No structure in this "unit"...] (a) a drug administering unit to provide 6-thioguanine to a subject having said immune-mediated gastronintestinal disorder; and
    [No structure in this "unit", either...] (b) a level determining unit to determine the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
    [No structure here...] wherein an indicated level of 6-thioguanine less than about 230 pmol per 8×10^8 red blood cells as determined by said level determining unit indicates a need to increase the amount of said drug subsequently administered to said subject and
    [And no structure to be found, here...] wherein an indicated level of 6-thioguanine greater than about 400 pmol per 8×10^8 red blood cells as determined by said level determining unit indicates a need to decrease the amount of said drug subsequently administered to said subject.”

    Generally, no structure = no apparatus claim. But I’ve not seen it expressed as a 101. Usually an examiner will boil out all the method type language and leave you with:

    “An apparatus for optimizing therapeutic efficacy for treatment of an immune-mediated gastronintestinal disorder, comprising:
    (a) a drug administering unit; and
    (b) a level determining unit.”

    If these two are both known and known in combination, you’re not novel. All the rest of the language in an apparatus claim is just hand-waving.

  80. I mailed each justice on the Supreme Court a copy of the following two books:

    1. “Against Intellectual Monopoly” by Boldrin and Levine.

    2. “Against Intellectual Property” by N. Stephan Kinsella.

    They must have read these two books – I’m glad it’s having an effect in changing people’s views on the detrimental effects of IP law and the need to just abolish these bad legal policies which cause great harm to innovation and society.

  81. And where in the statute or constitution does it say newly discovered laws of nature are not patentable, and why shouldn’t they be patentable?

  82. An apparatus for optimizing therapeutic efficacy for treatment of an immune-mediated gastronintestinal disorder,

    It could fall under 101 without alarming me. But it also seems like a very likely FAIL under 112 and/or 102/103.

    Of course, it all depends on what structures are disclosed in the specification. Welcome to Patent Law for Grown Ups.

  83. >>Don’t focus too much on the individual words or >>you’ll miss the poetry.

    Yes, don’t bother with reality or the facts, we have an agenda we have to implement.

    $$$$$$$$$$$$$MM$$$$$$$$$$$$$$$$$$$

  84. I suppose since the petitioner was harping on natural phenom the USSC just went ahead and threw them that bone.

    Ding! Ding! Ding! Ding!

    Abstractions. Mental steps. Thinking about “laws of nature.”

    It’s pretty much the same bullxhxt and should be treated similarly. Don’t focus too much on the individual words or you’ll miss the poetry.

  85. 101?
    An apparatus for optimizing therapeutic efficacy for treatment of an immune-mediated gastronintestinal disorder, comprising:
    (a) a drug administering unit to provide 6-thioguanine to a subject having said immune-mediated gastronintestinal disorder; and
    (b) a level determining unit to determine the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
    wherein an indicated level of 6-thioguanine less than about 230 pmol per 8×10^8 red blood cells as determined by said level determining unit indicates a need to increase the amount of said drug subsequently administered to said subject and
    wherein an indicated level of 6-thioguanine greater than about 400 pmol per 8×10^8 red blood cells as determined by said level determining unit indicates a need to decrease the amount of said drug subsequently administered to said subject.

  86. What I suggest is that the reason the MOT transformation does not prevail here is that the transformation itself is a natural phenomena.

    If you disagree, please explain why the MOT did not prevail here.

    Because the “transformations” in the claim are old, insignificant transformations that amount to nothing more than an draftsperson’s efforts to capture the law of nature and/or remove the fact of the correlation from the public domain in the only context where it matters. In other words: what I’ve been saying here for years.

  87. It’s not a reach at all, sockie. In the context of claims like Prometheus, I’m quite certain that a “law of nature” is indistinguishable from “a fact” for patent law purposes.

    Obviously if you claim a method reciting old steps and thinking about a “non-fact” then you will run into utility and/or 112 issues so it’s truly moot point.

    Let me know if you have difficulty understanding why this must be the case. I’m more than happy to explain it to you.

  88. “all the patent birthers out there.”

    Are “patent birthers” persons attempting to file a US patent application, claiming its priority is in the Kenya Patent Office?

  89. “Would apparatus claims directed to the same method yield the same result?”

    Apparatus claims directed to a method get 101’d every time for mixing stat categories.

  90. “Great point, EG. Next thing you know they’ll be telling us that embryonic stem cells are “scared.” [evil laugh] ”

    It is Fun With Transposition hour.

  91. Yeah EG there’s one thing I still find a bit odd in this decision and that is that the court has insisted on going down the natural phenom road rather than the abstract idea road. They play it fast and loose with calling a correlation etc. a natural phenom rather than simply an abstract idea. It technically could go either way, because it is both, but I suppose since the petitioner was harping on natural phenom the USSC just went ahead and threw them that bone.

  92. Would apparatus claims directed to the same method yield the same result?

  93. Man this mo comes out swingin’ don’t he?

    “Those cases warn us against interpreting patent statutes
    in ways that make patent eligibility “depend simply on the
    draftsman’s art” without reference to the “principles un­
    derlying the prohibition against patents for [natural
    laws].””

    “Still, as the Court has also made clear, to transform an
    unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the
    law of nature while adding the words “apply it.”

  94. sockie Up till now the standard 101 analysis was claims as a whole, including law of nature.

    Your statement is nearly incoherent but to the extent it is coherent, it is inaccurate. Except for a few sockpuppets/trolls, no serious educated patent prosecutor believed that a method of thinking about a newly discovered law of nature could be rendered eligible for patenting merely by tacking on a patent eligible step (e.g., “drinking coffee”).

  95. sockette: So – where’s the line? All therapeutic treatments involve natural phenomena, i.e. the natural phenomena that occurs when the drug comes in contact with the human body?

    If it’s an old drug administered by an old method, the method is invalid under 102/103. No 101 problem, however, unless a step is added which recites thinking about the natural result of the administration (as in this case). If it’s a new nonobvious drug, it’s eligible and valid under 102/103.

    Are diagnostic methods OK if the test itself is novel and unobvious and not OK if the test itself is old or obvious?

    If the diagnostic “test itself” is novel and non-obvious (by virtue of the recitation of a new and non-obvious transformative step or series of transformative steps), it is extremely unlikely that the test will be found ineligible.

    What about a new use for an old pharmaceutical composition? No longer patentable because the old composition has shown a “natural phenomena”?

    There is absolutely nothing in this case that suggests the result you contemplate. You should read the case more carefully and talk to some experience patent prosecutors before you do your clients a disservice.

  96. MM, to an extent you are right. The transformation in a human body is a natural phenomena. The correlation of metabolites is a law of nature, the direct result of the natural phenomena.

    What I suggest is that the reason the MOT transformation does not prevail here is that the transformation itself is a natural phenomena.

    If you disagree, please explain why the MOT did not prevail here.

  97. what can you expect from technologically-challenged bunch of Justices who are completely ignorant of biochemistry

    Great point, EG. Next thing you know they’ll be telling us that embryonic stem cells are “sacred.”

    BWAHAHAHAHAHHAHAHAHAHA!!!!!!!!

  98. So – where’s the line? All therapeutic treatments involve natural phenomena, i.e. the natural phenomena that occurs when the drug comes in contact with the human body? Are diagnostic methods OK if the test itself is novel and unobvious and not OK if the test itself is old or obvious? What about a new use for an old pharmaceutical composition? No longer patentable because the old composition has shown a “natural phenomena”? SC says “To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws?” How much is enough?

  99. We need not determine here whether, from a policy perspective, increased protection for discoveries of diagnostic laws of nature is desirable.

    “But we’re happy to go on at great length about why it’s undesirable, supported by the greatest minds in legal academia.”

  100. Breyer’s opinion is as disastrous, as it is nonsensical for determining patent-eligibility of drug testing methods. For example, Breyer’s opinion states “those in the field did not know the precise correlations between metabolite levels andlikely harm or ineffectiveness.” So how are those “precise correlations” identified by humans (not nature) “laws of nature”?

    It gets even worse with this statement: “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.” That statement is mind-boggling; the generation of the metaolite levels is what “nature” does, but the identification of what “concentrations” are “ineffective or cause harm” is what humans do, not “nature.” But then again, what can you expect from technologically-challenged bunch of Justices who are completely ignorant of biochemistry and what drug testing requires?

    Another “gem” is this one: “To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sumof their parts taken separately.” In other words, if the drug testing involves “routine, conventional activity” (which is probably true of most drug testing methods), it is patent-ineligible, even if the correlation identified is previously unknown. What rhetorical nonsense.

    My final specimen of rhetorical nonsense: “there is a danger that the grant of patents that tie up their use [i.e., discovery of new laws of nature” 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 morefuture invention than the underlying discovery could reasonably justify.” What a gross mischaracterization of the claimed drug dosage calibration method. The fact that Breyer cites to no data or evidence to support the “will inhibit future innovation” statement, but simply to journal articles (Lemley’s being the first) just makes it worse.

    The bottom line is that SCOTUS and especially Breyer are firmly anti-patent. This nonsensical decision simply proves the point.

  101. Is there a problem with using law review articles as persuasive support for a legal position? Can you explain why using law review articles would not be prudent here? What would you prefer?

  102. NWPA you’ve always been the bad guy. Seriously you went your whole life without knowing that? Seriously? I mean, talk about oblivious.

  103. I agree with the decision – This is a good start in getting rid of the “patent drag” on innovation.

  104. Hmmm… how many CAFC judges count as “people who held themselves out as patent attorneys”?

  105. An advocate may do that, but a good advocate will understand the implications of the decision and understand how the other side is going to use it.

    I am afraid this is not good.

    Quiz: Which movie did this line come from?

    “When did I become the bad guy?”

  106. I have seen litigators twist language and make arguments that bordered on illogical. There are tens of thousands of patent prosecutors. We all need to start writing and arguing every single argument that has potential to put this genie back in the bottle. One of my favorite sayings is “The future you see is the future you get.”

    Do we want this case interpreted our way or not? Blogging about how terrible this is for us won’t help. Let’s start blogging about what it could mean. (see my recent post below). I don’t have all the answers right now. I just know that collectively we can undue most of this. That’s the future I see.

  107. I haven’t even read the decision, but here’s one way I may try and interpret this case: It is not patentable to take an assay that is known in the art and modify it by correlating it with a natural phenomenon. However, if there is anything different about what is assayed or how it is assayed, then it would be patentable. The take home message should be to avoid using “correlating” in a patent claim or at least make sure it is patentable without the “correlating” clause.

    Since I have never written a patent claim using “correlating” and I don’t know anyone personally that has (at least that I’m aware of), this decision will have essentially no impact on my practice.

    When I read the case, I’ll see if the result I want can be supported by the facts. That’s what an advocate does. If it can’t, I’ll come up with a different result that is acceptable and see if I can support that.

  108. Ned: But the bottom line: transformations in a human are now to be considered laws of nature and not the kind of transformation the MOT is talking about.

    That is just about the wackiest possible take-away from this case that I can imagine.

    Please, everyone: ignore the italicized text above. It’s simply wrong.

  109. You could probably substitute “mental step” for “law of nature” in this case and it would read just as persuasively.

    That’s some over exurbatant reach

  110. Andrew Hansen, you can’t hide in a hole about this either. We have to dig into the parts that are going to be used and figure out how to get around them and minimize the damage.

    But, let’s not kid ourselves. The following quote will be gushing from the mouths of the Cybersource 3 and Moore:

    The ignorant 9 summarizing Benson;

    “But it held that simply implementing a mathematicalprinciple on a physical machine, namely a computer, wasnot a patentable application of that principle.”

  111. transformations in a human are now to be considered laws of nature

    Careful there Big Ned, you sound awfully lot likethat guy who thought the AIA was going to outlaw pharma because it dealt with the human body.

    So if transformation in a human body are laws of nature, then all pharma is kaput because there is no utiliy outside of the improper transformation.

    Add that to the claim dissection and hit the road Pharma. You will be lucky to even get what India ia handing out.

  112. Does anyone want to know what Judge Dyk’s “happy dance” looks like? If you were in his office now, you’d know.

  113. AH Are you going to advocate for a narrow reading or not?

    Pretening that this case should be read “narrowly” would not be doing a service to my clients. But go ahead and advocate for it.

    Heck, there was a bunch of confused patent prosecutors out there saying that there was no way that the Supremes would find the claims ineligible. And then you had guys like Kevin Noonan and his lil sychopant EG who simply refused to talk about the issues, as if that would somehow make them disappear. LOL. They’ll be puking up crow for weeks.

  114. RE: reading the tea-leaves for possible impact on Myriad

    Myriad claims isolated BRCA DNA of SEQ ID X/Y/Z and methods based on said isolated BRCA DNA. The act of isolating a chemical compound (i.e. DNA) from nature AND determining the sequence which would otherwise be unknown sans the “hand of man” leads me to think that the SCOTUS (or the Fed Cir upon remand) would likely follow Diehr and find isolated DNA patentable. If “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection,” isolated BRCA 1/2 DNA and methods requiring said isolated BRCA sequence (and its various mutants) should be patentable. Please let me know if I am missing something here.

  115. Andrew Hansen; I agree. We need to try to minimize this. But, we do need to figure out how it will be used by Moore and the Cybersource 3. We can’t hide from the fact that it did not adopt Rader’s recommended method of dealing with 101. It was a slap to Rader and the Kappos.

    But, I do think that one line is that there are principles described in the opinion that go against 150 years of SCOTUS precedent.

    What about the other claims? What about the administering step after determining?
    What about those claims?

  116. What makes you think I wasn’t advocating against the decision that we got in Prometheus? Your response perpetuates the problem that I see in patent prosecution…. you, like many of the other prosecutors I know, are focused on the past. Are you going to advocate for a narrow reading or not?

  117. The future we see is the future we will get. Patent drafters need to start thinking about how to limit the damage rather than point out how bad the damage is. Patent drafters are the kind of people that show up to a car accident and start screeming, “Oh no, you’re all going to die.”

    If someone knows how to start a thread on this Blog, why don’t we start a thread about how Prometheus doesn’t change anything. Let’s choose our own destiny.

  118. Yes, should be handled under 102/103

    That ship has sailed. Bye-bye! Bye, ship. So long!

    Nobody could have predicted, etc.

  119. Patent prosecutors need to think more like advocates for their clients when an adverse decision is rendered.

    I would recommend advocating for your clients before the adverse decision is rendered. Years before.

    That’s what I did.

  120. sockie: To me, the determining step alone makes this a method claim that could be patented assuming the remaining legal requirements are met.

    That’s nice. You do realize that the Supreme Court just told you to sxck it?

    This wherein clause is not a limitation.

    It’s identical to the clause in this case, where the Supreme Court just told you to sxck it.

  121. The important thing here is for the patent community to respond correctly to the Supreme Court decision. We need to limit Prometheus to its facts. We need to promote the idea that this isn’t a significant decision. It merely stands for the proposition that the use of the word “correlating” won’t create patentability if the only novel feature is the discovery of a law of nature.

    Patent prosecutors need to think more like advocates for their clients when an adverse decision is rendered. I see litigators do this all the time. Why is that when something adverse comes out in patent prosecution, we have a slew of patent attorney’s that want to give a seminar at the next AIPLA or ABA meeting discussing how we are all screwed.

    We should all protest any attorney that gives a “sky is falling” seminar at the next ABA or AIPLA meeting. We’re lawyers and we should be advocating for our clients. Only a terrible lawyer would interpret this decision broadly.

  122. From this thread I’m getting the impression that patent drafters see this as a black day for patent drafters.

    I guess it’s like GM? You know, what’s bad for patent drafters is real bad for the USA.

    I see SCOTUS references English cases. On isolated DNA, Malcolm, there is a recent blockbuster from the UK Supreme Court, Human Genome Sciences, reversing the first and second instances in order to confer breathtakingly wide scope of protection. Lobbying from the biotech industry assocn seems to have helped. I envisage a not dissimilar outcome in the pending Myriad case.

  123. MM: wherein a rate slower than 9.8 m/s^2 indicates a need to decrease the air resistance of said object.

    This wherein clause is not a limitation. It simply states a relationship between the measured rate and the need. How does one perform this relationship? The wherein clause is not a step of a process, nor is it at all clear how it further limits the only step requiring any real physical action or transformation, i.e., the determining step. To me, the determining step alone makes this a method claim that could be patented assuming the remaining legal requirements are met.

    The issue with your example is not whether the claim presents patentable subject matter, but whether the subject matter is novel, nonobviousness, etc.

  124. Actually the “remove the law of nature” and see if anything else remains is pretty standard 101 analysis.

  125. Regarding the Myriad remand, Dennis writes

    As we have seen in recent cases, the Federal Circuit already largely rejects formalistic distinctions between process and composition claims. Here, that distinction is further minimized by the reality that the claimed DNA is functionally characterized by the already well known process of isolating human DNA.

    So novel, non-obvious compositions that are obtained by “well known processes” are now considered to be “laws of nature”? Please. The term “isolated” is a limitation on the physical properties of the DNA composition. It is not “functional.” You seem to be suggesting that isolated nucleic acid composition claims are product-by-process claims. Not true. Isolated nucleic acid composition claims include within their scope nucleic acids that are synthesized by purely chemical means, in the laboratory, having never seen the inside of a cell.

    Also, correct me if I’m wrong, but the en banc Federal Circuit has already addressed in detail the (frankly ridiculous and incomprehensible) arguments about whether a novel, non-obvious nucleic acid composition is a “law of nature.” If I’m the Federal Circuit, I write a one paragraph opinion stating, essentially, that nothing in Mayo contradicts or changes any of the analysis in the earlier opinion.

    Done.

  126. Strawman

    However, I always thought the transformation in a human was something natural and linking the MOT to this transformation was going to be a problem.

    I did not expect this result. I thought the Government position the better position: handle it under 102.

    But the opinion does address the government position, but mistates it, I believe.

    But the bottom line: transformations in a human are now to be considered laws of nature and not the kind of transformation the MOT is talking about.

  127. Now advising all clients to maintain all “laws of nature” they discover for use in diagnosis/personalized medicine as trade secrets. Nothing like promoting the useful arts.

  128. Let’s try that again.

    Dennis: [T]he Court referenced the groundbreaking discoveries by Einstein and Newton and noted that neither “E=mc²” nor the “law of gravity” could be patentable. Truthfully it is a bit of a jump to then conclude that, therefore, the discovery that the blood level of 6–TG in a human correlates with either an overdose or underdose of thiopurine.

    I don’t understand your point, Dennis.

    The Court’s point is that Newton (or Galileo) could not have patented “A method of optimizing the use of Earth’s gravitation field, comprising determining the rate of a falling object near the surface of the Earth, wherein a rate slower than 9.8 m/s^2 indicates a need to decrease the air resistance of said object.”

  129. The Supremes seem to have punted on the broader issue you and the government supported that any new information added to an old method was not patentable either under 101 or 102.

    The Supremes actually went further and suggested that there was no basis in patent law for ignoring the recitation of a law of nature in a 102 or 103 analysis. Hence, 101 was preferred. Of course, being the Supreme Court, they could simply have stated the basis based on first principles. Whatever. As I’ve always said, I don’t care how claims in the form [oldstep]+[new thought] are crushed.

    There is no express discussion of mental steps in the Supreme Court’s decision, which I’ll admit is a disappointment. Instead, they treat the step of “thinking about the law of nature” as equivalent to the “law of nature” itself. That’s not unreasonable. You could probably substitute “mental step” for “law of nature” in this case and it would read just as persuasively.

  130. I don’t understand your point, Dennis.

    The Court’s point is that Newton (or Galileo) could not have patented “A method of optimizing the use of Earth’s gravitation field, comprising determining the rate of a falling object near the surface of the Earth, wherein a rate slower than 9.8 m/s^2 indicates a need to decrease the air resistance of said object.”

  131. Closer to the truth: the big dogs’ legs can be raised higher:

    Federal Circuit refusal to address Supreme Court concerns of Metabolite: Prometheus went through two cycles at the Federal Circuit before a final resolution at the Supreme Court, in each case refusing to address the argument of the patent challenger to consider the arguments of Justice Breyer in the Metabolite case.
    In the second case, the Federal Circuit noted that “Mayo, as did the district court, points to the opinion of three Justices dissenting from the dismissal of the grant of certiorari in [Metabolite], 548 U.S. 124 (Breyer, J., dissenting from dismissal of certiorari as improvidently granted). * * * Again, with respect, we decline to discuss a dissent; it is not controlling law, and it involved different claims from the ones at issue here.” Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347, 1356 n.2 (Fed. Cir. 2010)(Lourie, J.)

  132. It’s worth stating again: had the Supremes decided this case the other way, the tracks would have been cleared for patenting new facts and new information per se, merely by limiting the application of those facts (i.e., thinking about those facts) to generalized contexts in which some arbitary or insubstantial “transformation” is taking place.

    This was the only correct result.

  133. Laugh! Exactly. And, how in the world can one tell what a natural law is or scientific truth? The SCOTUS is essentially favoring not quantifying anything or else it becomes a law of nature.

    It is really right out of the pre-1930’s thinking.

  134. Bilski – MOT is but one of several choices. Remand Prometheus

    Prometheus on remand – Hmmm. Let’s look at our choices. Yes, MOT seems the best, and, yes, MOT is met.

    Prometheus at SCOTUS – Yes, Bilski does say MOT is an option, but one among many. MOT seems the way to go, so here is what we have to say about what you (CAFC) decided. We are going to enrich MOT analysis (no need to talk about anything else since MOT seems OK here) by deciding that changing something is not good enough if the change is what results from a naturally occuring process. That’s not a transformation. That’s just a law of nature. OK, we are done here. Next case, please.

  135. GREAT day for patent law! To think , there were people who held themselves out as patent attorneys that thought the CAFC got it right. Uh-oh.

  136. This has been a paid commercial advertisement. The views expressed here may not reflect the views of rational people.

  137. Malcolm, haven’t read the decision yet, but based on Dennis’ post, not exactly your view, but close. The problem is that the new information has to be a law of nature to render the claim invalid. The Supremes seem to have punted on the broader issue you and the government supported that any new information added to an old method was not patentable either under 101 or 102.

  138. Below is the crux of the matter. What is the unknown use of a conversion algorithm on a computer implemented with shift registers? And, how is converting a number a scientific truth or natural law? And, how is the policy used in Morse and Haliburton present here to allow people to build new machines using the method of operation? I think that in Morse the court was probably right when the focus was on the machine. But, in Benson the focus is not another machine but the methods of processing information.

    Can’t believe this.

    “Similarly, in Benson the Court said that the claims before it were “so abstract and sweeping as to cover bothknown and unknown uses of the [mathematical formula].”409 U. S., at 67, 68.”

  139. If 6-TG and 6-MMP are novel, synthetic pharmaceuticals (are they?)

    Nope.

    Except for the method of thinking about the correlation, all steps in the claim are admitted to be old and conventional in the application itself.

  140. I just can’t believe that someone like Lemley has won a battle. It shows one just how low this country is sinking.

  141. Apologies in advance if this was covered by one of the lower courts; or if the answer is obvious; I’m not asking rhetorically:

    Is there a reason why these claims aren’t covered by the “improvements” prong of S. 101? If 6-TG and 6-MMP are novel, synthetic pharmaceuticals (are they?) that fall under the first prong of S. 101, then it seems like the claims in Prometheus would only need to be “new and useful improvements thereof” to satisfy S. 101. (SS. 102 & 103 would obviously become dispositive then.)

    Thanks

  142. And the rest of us that understand the economic consequences of this type of analysis and decision.

    And you, whether you’re smart enough to realize it or not.

  143. The following is just not the way patent law is supposed to work. The SCOTUS and bozos like Moore and the Cybersource 3 are going to make patents so expensive as we will have to put everything in the patent application including all that is known.

    The “determining” steptoo is set forth in highly general language covering all processes that make use of the correlations after measuring metabolites, including later discovered processes that measure metabolite levels in new ways.

  144. The other thing here is that Morse and Benson are not alike. And the public policy for Morse is not present in Benson. In Morse, the idea is that someone could come up with a new machine to implement the principle. OK. That is probably right. In Benson they are saying that someone might need to use the Benson machine in another machine.

    Just such bozos. The $$$$ people are winning with nonsense. The swift boaters. The simians. The $MM$’s.

  145. This summary of Benson is not good. How bizarre that somehow an information processing method is a law of nature. I can’t believe that we are back to that. Such ignorance.

    The public policy for this does not even exist anymore. Read Haliburton where the public policy is clearly stated so that other can build other machines that use the same principle, but here that would not be the case as the invention is information procesesing, which is now classified as a scientific truth. What bozos!!!!

    A heuristic algorithm for face detection is a scientific truth? Bozos do not seem to understand that these mathematical algorithms are only a result of how refined the engineering is and what notation is most convient. That is it. Their blast oven could be represented as a mathematical algorithm too iwth the pre-heater. Would that transform an engineering invention into a scientific truth?

    Finally, in Benson the Court considered the patentability of a mathematical process for converting binary-coded decimal numerals into pure binary numbers on a generalpurpose digital computer. The claims “purported to coverany use of the claimed method in a general-purpose digitalcomputer of any type.” 409 U. S., at 64, 65. The Court recognized that “‘a novel and useful structure created with the aid of knowledge of scientific truth’” might be patentable. Id., at 67 (quoting Mackay Radio, 306 U. S., at 94).But it held that simply implementing a mathematicalprinciple on a physical machine, namely a computer, wasnot a patentable application of that principle. For the mathematical formula had “no substantial practical application except in connection with a digital computer.” Benson, supra, at 71. Hence the claim (like the claims before us) was overly broad; it did not differ significantly from a claim that just said “apply the algorithm.”

  146. SC, you have to realize that on this board are likely many paid people that work for the lobby groups. Money has corrupted our entire system. The $$$ have won–and lost, but their plans are to get their $50 million and run to New Zealand.

  147. I like how Breyer explains that these claims would impede, not foster, innovation, and then cites a bunch of law review articles. Nice analysis, thanks.

  148. SCOTUS has completely disincentivized private investment in personalized medicine R&D

    LOL. Because pharmaceutical companies have no interest in identifying applications for their drugs.

    potentially just killed off numerous existing start-ups that are based on pending applications claiming this type of subject matter

    Poor investment choice. Some of us have been aware of this problem for years. You roll the dice, you take your chances.

  149. Is anyone concerned that SCOTUS has completely disincentivized private investment in personalized medicine R&D, and potentially just killed off numerous existing start-ups that are based on pending applications claiming this type of subject matter?

  150. sockie: (aren’t we supposed to consider the claim as a whole

    As this decision makes crystal clear (although many of us understood this already), the alleged prohibition against claim dissection articulated in Diehr was intended to prevent claims from being declared ineligible merely because one limitation recited or implicated ineligible subject matter.

    Thanks for playing.

  151. When was the last time there was no dissent, a unanimous Decision?

    Perhaps readers can agree too: a genuine No Brainer.

  152. $MM, here all day and getting paid by the word. Little doubt that the lobbyist have swift boated methods of therapty and diagnoses.

  153. Prometheus 9-0:

    To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, whenviewed as a whole, add nothing significant beyond the sumof their parts taken separately.

    I love the smell of claim dissection in the morning.

    Thank you, SCOTUS, for doing the right thing.

    Great decision, extremeley well-written. If anyone has any questions, I’m here all day.

  154. Exactly Morse. And, you better not figure out exactly what is going on in a method of treatment or it becomes a natural law.

    The witch hunt has reached the SCOTUS. Bozos.

  155. “Because methods for making such determinations were well known in the art.”

    Oh I see, first we figure out which limitation are not novel (aren’t we supposed to consider the claim as a whole), remove those limitations, then consider whether the dissected claim is patentable subject matter under 101. Grotesque.

Comments are closed.