Mayo v. Prometheus Labs: Bilski and Medical Methods

Mayo v. Prometheus Labs (On Remand to the Federal Circuit 2010)

The Federal Circuit’s first full post-Bilski decision may come in the case of Mayo v. Prometheus Labs. That case had been pending on a petition for a writ of certiorari to the Supreme Court. In a June 29 order, the Court granted the petition and then summarily vacated the decision with a remand to the Federal Circuit to reconsider the case “in light of Bilski v. Kappos, 561 U.S. ___ (2010).”  The Supreme Court regularly uses this grant-vacate-remand (“GVR”) proceeding for pending cases are impacted by a decision.

In the case, the Mayo Clinic has challenging the validity of two Prometheus patents based upon suspect patentable subject matter. (U.S. Patents 6,355,623 and 6,680,302). 

The Prometheus patents claims an iterative approach to dosing that involves three steps: (1) first administer a drug to a subject; (2) then determine the level of drug in the subject; and (3) finally decide whether the next dose should be the same, higher, or lower. The decision on the next dose is made by comparing the the level of the drug in the subject against predetermined thresholds. Claim 1 of the '302 patent adds additional detail including identifying the active ingredient (6-thioguanine), the diagnosis (a GI disorder), and the predetermined thresholds (e.g., 230 pmol of drug per 8108 red blood cells). Claim 46 of the '623 is a broad claim in that it does not not require the administration step (step 1 from above).

The Federal Circuit held the method patentable under its Bilski test by finding that the required administration of the drug transformed an article into a different state or thing — essentially creating a per se rule that a method requiring administration of a drug will be deemed patentable subject matter under Section 101. The court also held that the "determining the level" step was necessarily transformative since "those levels cannot be determined by mere inspection." 

On remand, the focus will shift from the machine-or-transformation test to the broader question of whether the claims are directed to a statutory “process” and/or whether the claim scope is impermissibly abstract. Of course, the machine-or-transformation test may still be instructive in answering these question.

Abstract Idea and Broad Functional Language: The claims are written in broad functional language without tying the the claimed methods to any particular technology. Thus, the "administering" step could potentially be accomplished by any effective method (that has or will be invented) of getting the drug into the subject. Likewise, the patent offers potential methods of "determining the level" of drug in the body (e.g., liquid chromatography) but the claim is broadly written to seemingly cover any mechanism that fulfills that method. 

Novelty Involves the Mental Step: Of course, the general iterative process is well known, what makes the Prometheus claims novel is that they identify the particular thresholds that are important (e.g., 230 pmol). In practice, the process of comparing the thresholds to the subject's drug level is done in the mind of a physician. As Mayo explains, this merely involves the physician's mental recognition of a natural correlation between metabolite levels and patient condition.

The case also represents a growing trend of pitting patient advocates (who want cheaper access to medicine) against innovators (who create better treatments).

Note: In the same Post-Bilski order, the Supreme Court also issued a GVR in the case of Classen Immunotherapies, Inc. v. Biogen IDEC.  On remand, the Federal Circuit will be asked to decide whether the following claim fits within the scope of 35 USC 101:

Claim: A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

45 thoughts on “Mayo v. Prometheus Labs: Bilski and Medical Methods

  1. “The case also represents a growing trend of allying patient advocates (who want cheaper access to medicine) and innovators (who create better treatments) against
    patent lawyers, who do neither”

    Fixed that for you.

    What Hans said. The number 290 pmol is the only non-obvious, original thing in the entire patent, and that’s a discovery of a law of nature.

  2. IANAE, you are correct. A new and non-obvious method to detect the presence/absence/amount of a biomolecule is and should be patent-eligible, provided, of course, that such detection is useful (e.g., the presence/absence/amount of the biomolecule is correlated with some trait or condition about whose existence it is important for people to know). But that’s not where the battle is being waged. The battle is being waged over the actual correlations. The problem is, correlations are not made, they are discovered (or not). They are laws of nature, just like F=ma or E=mc2. They can be utilized in a process patent claim, but they can’t BE the claim.

  3. Malcolm, I will tentatively agree as I cannot think of an exception.

    ping, I think Steven was right that the majority simply stated Bilski’s claims to be abstract without explaining why. However, they did say their prior precedent were valid and explained them. Taken as a whole, I think the Bilski claims were abstract because they did not pass the MOT. They were not directed to a machine. They were not directed to a law of nature. They were not transformative. Merely by the process of elimination, the only thing left was that they were an abstraction.

  4. Malcolm Mooney joins the crowd of one with a different twist – Bilski 14

    The transformation you seek need not be there at all. Your misguided attempt to parse claims into old steps and new steps need not be challenged for the illegality it presents.

    Bilski 14

    Diehr Lives! Inventors Win!

  5. Ned Again, in light of Bilski, all I think Benson stood for is that reciting a GP computer to calculate a mathematical algorithm is insignificant extra solution activity. Something has to be transformed as well.

    And the “something” that is transformed needs to be transformed by combined steps of the invented process, not by an old step (or series of old steps) that happen to be recited in the claimed method.

  6. but Bilski clearly seems to suggest that a claim that does not pass the MOT is presumptively abstract.

    Actually Ned, the majority, while ruling that Bilski’s particular claims are abstract, definitively stated that not passing the MOT cannot be held to be abstract (without more). The nuance here is that your presumptively abstract is equal to MOT being “The” test, which the all Supremes said a big fat NO to.

  7. IANAE, any new lab test might still be patentable, but using an old lab test in a new treatment regime will not be patentable as a lab test, but only as a treatment regime.

    I think the Feds will not get into “wholly” preempt. 6 seems focused on this to an obsession, but Bilski clearly seems to suggest that a claim that does not pass the MOT is presumptively abstract. That is what the new guidelines seem to say as well.

    Again, in light of Bilski, all I think Benson stood for is that reciting a GP computer to calculate a mathematical algorithm is insignificant extra solution activity. Something has to be transformed as well.

    To 6, “transformation” is the sine quo non of traditionally patentable processes. So when you talk about Diehr and traditional processes, what you are really saying is that the “object” of a traditional process is the transformation of a machine, manufacture or composition (the other three classes) from one state into another state.

  8. “Would someone undertake the research required to arrive at the method, validate the method and obtain FDA approval without the promise of a patent? ”

    You need FDA approval to administer an already (i assume) approved drug in the manner instantly claimed?

    I think not sir.

    The answer to Stevens would be of course they would, as MM mentioned.

  9. I think the outcome of the Prometheus case on remand is going to be that the claims are going to be held unpatentable unless they include the nuanced administering step in response to the lab test.

    I think that’s the proper outcome. The information isn’t patentable unless you claim doing something conditionally on the information.

    What implications do you think this will have for diagnostic methods generally? Perhaps they won’t be statutory unless the actual testing step is transformative (as opposed to simply observing the presence of a gene or metabolite), or a treatment is administered conditionally on the test result.

    I would think that a claim along the lines of “noticing that someone has the BRCA1 gene, and telling them about it” pre-empts the abstract idea/natural phenomenon that “BRCA1 correlates with increased risk of breast cancer”.

  10. “In the present case, I assume you will say the Prometheus claims do not define a traditional process, but they would if they included the nuanced administering step in response to the blood test. If so, we end up in the same place.”

    If they included the nuanced administering step they may or may not still preempt all uses of aforementioned abstract idea. If they still do, then they still fail.

    As to whether or not they are a “traditional” method they certainly don’t seem to have manufactured anything, so no, they aren’t.

  11. I think the outcome of the Prometheus case on remand is going to be that the claims are going to be held unpatentable unless they include the nuanced administering step in response to the lab test.

    So I assume in the future, the claims will have to actually include the administering step. But doctors, and those acting under their direction, appear to be immune from infringement for actually treating a patient. See, section 287(c). So the question will arise, can anybody be successfully sued for infringement with respect to these kinds of advancements in medicine?

    Obviously, section 287(c) was a mistake.

  12. The question Justice Stevens would ask is whether the availability of patents in this field promotes progress. Would someone undertake the research required to arrive at the method, validate the method and obtain FDA approval without the promise of a patent?

    Of course they would, so they could control the market of the properly labeled drug, i.e., the old drug labeled for its “novel non-obvious” use. FDA approval is relatively trivial for the old drugs, unless the dosage is exceptionally different for the previously approved dosage.

  13. 6, I merely compare Flook to Diehr to see what is different.

    In the present case, I assume you will say the Prometheus claims do not define a traditional process, but they would if they included the nuanced administering step in response to the blood test. If so, we end up in the same place.

  14. “Diehr was different. It added the step of actually doing something with the calculation, opening the mold.”

    You have it backwards Ned, just as the court noted explicitly in Diehr, Diehr was a traditional manufacturing process that just so happened to have the abstract idea used. They did not “add” a step of actually doing something with the calculation to come up with the claim. Instead, they merely “added” the calculation to steps of actually doing something.

    There is an important difference. Which you don’t seem to grasp. Still.

  15. 6, Hans seems to get it.

    On Benson, I think that case is like the extra-solution activity mentioned in Flook and Bilski. A math algorithm is abstract. Simply reciting its execution on a computer is insignificant extra solution activity. The claim effectively monopolized the abstract idea.

    Diehr was different. It added the step of actually doing something with the calculation, opening the mold. I think that is what the Supreme have in mind here on remand.

  16. Nothing in Bilski lends credence to the idea that the claims at issue in Prometheus are valid. Very simply, you can’t stop with the correlating step. There has to be an additional step. This was true before Bilski, and it’s true after Bilski. The original CAFC panel (which included a district judge) did not grasp this. As Dennis said, Mayo will not go away quietly. I fully expect the claims at issue to be invalidated.

  17. Ned, you still do not understand the basis for the B/F/D line of cases and you apparently do not understand the reasoning behind Diehr. I don’t know how you could possibly be missing it by now.

    The question that must be asked Ned, for every claim, is whether or not that claim preempts (or even “substantially” preempts, the caselaw isn’t too clear here) an abstract idea or algorithm. If the answer is yes, the the claim falls. The current claim appears as though it preempts the abstract idea I just put forth, since this is the case it doesn’t matter whether or not it passes MoT, or whether or not an “administering” step is claimed, it still falls.

    Diehr was not decided the way it was merely because the abstract idea was being used to open a mold “was enough”. There is no “measurement stick” that one must “get over” by providing “enough”. It was decided that way because that limitation amongst others caused the claim to not preempt the use of any abstract ideas.

    It is easy to come up with another use for the abstract idea/algorithm in Diehr. Child’s play. Thus, it passes. The same cannot be said for B/F. Likewise, it cannot be said for the instant claim.

    Unless you think you’re up to the task. Go ahead Ned, provide me with another use of the abstract idea that appears to be preempt in this case. Just one. If you can, I’d give it a pass.

  18. Dennis, without the administering step actually being claimed, the Prometheus claims are abstract in the same way as the claims in Flook and Bilski. Contrast Diehr, where the use of the abstract idea to open a mold was enough. Here, the use of the data from the test must also be claimed.

    I don’t think this is a Benson case.

  19. Indeed, I would like to see the court consider such. Thank you Mr. Crouch. I hope this winds it’s way to the proper attorneys.

  20. “Prometheus MUST come out the same way on remand.”

    DDC Responds: I don’t believe that you will see Mayo give up so easily. Rather, Exr.6 presents a potentially credible argument that the claim improperly preempts use of a natural phenomenon. The challenged claims cover an iterative method of dosing 6-thioguanine (6-TG) for the treatment of an immune-mediated gastrointestinal disorder. The invention is based on a discovery that a properly treated patient should have a 6-TG body-concentration of between 283 and 493 pmol per 10,000 red blood cells and the claims are written in a way that arguably preempts all uses of that newly discovered natural phenomenon.

  21. dissent will get cited and mislead a court at least one more time

    Happens all the time per Andrew Kline.

  22. I think SCOTUS just looked into its cert petitions and said “Hmmm, this case is decided under Bilski and is not a business method, let’s GVR it.” That’s the only way to explain Prometheus and Classen getting GVR’d. Prometheus MUST come out the same way on remand.

    Actually, there is one alternative explanation for the Prometheus GVR: Breyer instigating more mischief. Maybe he wasn’t satisfied with having the most cited dissent from a reversal of cert (LabCorp) and was bitter about the majority opinion in Bilski. So he decided to push to get Prometheus GVR’d in the slim hope his LabCorp dissent will get cited and mislead a court at least one more time. And that’s my paranoid theory of the day.

  23. (Most methods that involve taking a sample from a patient (blood, saliva, etc.) and measuring the presence or level of some agent in that sample require some type of transformation of the sample in order to get the result.)

    That may well be the case, but you’re still not actually claiming a transformation. You’re claiming achieving the result by any means now known or later discovered, and asserting that any such means would probably involve some unspecified transformation or other.

    How about this claim:

    1. A method of optimizing transportational efficiency of an object, comprising:

    (a) administering a vehicle providing fastness to said object; and
    (b) determining the level of fastness of said object;
    wherein a fastness level less than 60 mph indicates a need to increase the amount of fastness subsequently administered to said object and
    wherein a fastness level greater than 70 mph indicates a need to decrease the amount of fastness subsequently administered to said object.

    Achieving fastness tends to require a transformation, such as combustion of fuel.

  24. Come on, where’s everyone to defend this claim? Does it not appear that the abstract idea I put forth is completely covered by this claim? Is not then this idea improper under the exact rationale of bilski and his fellows B/F/D?

  25. “You can decide that any claim “preempts all uses” if you define the realm of possible uses by the claim language!”

    I did not use the claim’s language. I specifically wrote new language. The language I did use sets forth an abstract idea that appears to be preempt by the claim. Furthermore, even if you want to insist that the abstract idea I typed out is the “language of the claim” then that will plainly mean that claim is directed to an abstract idea.

    Note that I cannot do this type of “abstract idea” analysis with a traditional manufacturing method.

    “I think an important factor here is the the method does not preempt all uses of the drug, or all ways of determining proper dosing. ”

    That is not relevant at all to the inquiry supported by the recent Bilski decision.

    But thanks for playing.

  26. The S. Ct. may want the Fed. Cir. to address the 2006 Breyer dissent to the DIG in Metabolite, where Breyer said that a somewhat similar method was an attempt to patent a natural phenomenon.

    The Fed. Cir. said that the Prometheus methods were transformative b/c (i) administering the drug to the patient necesarily would have a transformative effect on the patient and (2) the “determining” step inherently requires physical transformations of blood samples, etc.

    (Most methods that involve taking a sample from a patient (blood, saliva, etc.) and measuring the presence or level of some agent in that sample require some type of transformation of the sample in order to get the result.)

    You’d be equally hard pressed to show that issuing patents on which patients to treat leads to cheaper or more effective treatments.

    You could say this about any patent. The act of granting the patent per se does not make the invention cheaper. The question Justice Stevens would ask is whether the availability of patents in this field promotes progress. Would someone undertake the research required to arrive at the method, validate the method and obtain FDA approval without the promise of a patent?

    And no, determining medicine dosage is not usually a matter of “Do you feel better yet? No? Lets pump in more drugs.”

    6: You can decide that any claim “preempts all uses” if you define the realm of possible uses by the claim language! I think an important factor here is the the method does not preempt all uses of the drug, or all ways of determining proper dosing.

    I think the Federal Circuit may find a way to draw a line bewtween Prometheus (patentable) and Classen (not patentable). It also may weigh in on this issue when it decides the ACLU v. Myriad (BRAC I) case.

    link to pharmapatentsblog.com

  27. SORRY

    It preempts all uses of the abstract idea that A level of 6-thioguanine greater than about 400 pmol per 8.times.10.sup.8 red blood cells indicates a need to decrease the amount of a drug that provides 6-thioguanine in doses administerd subsequent to a first dose administered to said subject doesn’t it?

    Are there other uses of that particular abstract idea?

    Corrected my typo/antecedent basis.

  28. It preempts all uses of the abstract idea that the level of 6-thioguanine greater than about 400 pmol per 8.times.10.sup.8 red blood cells indicates a need to decrease the amount of a drug that provides 6-thioguanine in doses administerd subsequent to a first dose administered to said subject doesn’t it?

    Are there other uses of that particular abstract idea?

  29. “Does anyone think that the claimed method in Prometheus preempts all uses of it?”

    All uses of what?

    Here’s the claim:
    1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
    (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
    (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
    wherein the level of 6-thioguanine less than about 230 pmol per 8.times.10.sup.8 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.times.10.sup.8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

    Are you suggesting it preempts all uses of 6-thioguanine? Or all uses of methods of optimizing treatment? Or what?

  30. I agree with Chisum:

    “The claimed subject matter may have been very obvious in view of the state of the art or possibly unduly vague but, to characterize them as “abstract ideas” stretches the meaning of “abstract” and “idea” beyond recognition.”

  31. I don’t buy the Circuit’s holding that administering a drug is transformative, much less that determining a level is. Claim 1 doesn’t recite any particular machines or transformations, and it’s broad enough to encompass hypothetical future methods that don’t require a transformation to determine the level. The human’s metabolic reaction doesn’t count as a transformation, because the human is not recited, much less claimed, and the invention appears to be all about dealing with humans that are insufficiently “transformed”. This is a round-about way of claiming the correlation between a metabolite and the effect of a drug, which is more of a discovery than an invention.

    I simply take issue with the procedural aspects of remanding to a court whose original holding is already apparently consistent with the new precedent.

  32. Does anyone think that the claimed method in Prometheus preempts all uses of it?

    If not, please name a use that it does not preempt.

    If so, does that mean that it passes the MoT test, but is abstract, or does it mean that it doesn’t pass the MoT test because there is no transformation of a particular article?

  33. In 99.9% of the cases, we are talking here about methods that represent the slimmest margin of scientific insight imaginable.

    I was thinking more about medicines, that are more objectively useful, and less likely to have been invented without the patent system.

    Do we need a patent on figuring out when a patient has had enough medicine? Probably not. In any event, I hardly think “is it working yet? No? Up the dosage” is a patentable insight.

  34. Patients always want new and improved treatments, but they’re too expensive. It’s unfortunate that the road from no treatment to inexpensive treatment is 20 years long, but you’d be hard pressed to show that the patent system makes it longer than it would otherwise be.

    You’d be equally hard pressed to show that issuing patents on which patients to treat leads to cheaper or more effective treatments.

    But there’s no doubt that the existence of patents reduces access to methods of treating patients with off-patent drugs, and thereby allows the owners of the patents to charge much higher prices for the drugs than they otherwise would be able to.

    Big Pharma knows this. So do the Li’l Pharmas who dream of being bought out by the Big Pharmas.

    In 99.9% of the cases, we are talking here about methods that represent the slimmest margin of scientific insight imaginable.

  35. I thought the CAFC’s decision in Prometheus was a bad vehicle to try to preserve diagnostic method claims in the wake of the mess of the CAFC’s own making in Bilski. Now that SCOTUS has loosened the reins for them, maybe the CAFC will find a way to preserve diagnostic method claims that’s not as convoluted and forced as its earlier decision in Prometheus.

  36. What will interest me is to see if the CAFC will simply say that anything that satisfies the MoT inquiry also avoids falling afoul of the confusing and elusive “preemption” smelltest just revived by SCOTUS, because preemption concerns are already figured into the “particular machine” or “particular article” components of the MoT inquiry. We could definitely use some more guidance on this whole “premption” thing.

  37. “Abstract Idea and Broad Functional Language: The claims are written in broad functional language without tying the the claimed methods to any particular technology. Thus, the “administering” step could potentially be accomplished by any effective method (that has or will be invented) of getting the drug into the subject. Likewise, the patent offers potential methods of “determining the level” of drug in the body (e.g., liquid chromatography) but the claim is broadly written to seemingly cover any mechanism that fulfills that method.

    Novelty Involves the Mental Step: Of course, the general iterative process is well known, what makes the Prometheus claims novel is that they identify the particular thresholds that are important (e.g., 230 pmol). In practice, the process of comparing the thresholds to the subject’s drug level is done in the mind of a physician. As Mayo explains, this merely involves the physician’s mental recognition of a natural correlation between metabolite levels and patient condition.”

    Sounds 2 me like thar b poast solution activity goin on in this hea poast.

  38. >I guess this means that the MOT test is neither necessary nor sufficient for patentability.

    Not necessarily, I think they’re serving up an opportunity to the CAFC to address the question that SCOTUS didn’t–how do you figure out if something is an abstract idea? I do think it’s a foregone conclusion that patentability will be affirmed, but the SCOTUS is probably more interested in the journey than the outcome. They struggled with 101 for eight months and ultimately took a very minimalist position–they didn’t like MoT, but they have not improved the confusing earlier mental process/natural phenomenon/abstract idea precedent. Now, they want the CAFC to take another crack at it in the post-MoT era.

  39. The Court also GVRed Classen (based on the MoT test), and interestingly flatly denied cert in Ferguson (marketing method that the Fed Cir deemed too abstract). So decisions that take into account abstractness seem to be good.

  40. I guess this means that the MOT test is neither necessary nor sufficient for inpatentability.

    Fixed it for ya.

  41. I guess this means that the MOT test is neither necessary nor sufficient for patentability.

  42. The case also represents a growing trend of pitting patient advocates (who want cheaper access to medicine) against patient advocates (who want better treatments).

    Fixed that for you.

    Isn’t this the central conflict here? Patients always want new and improved treatments, but they’re too expensive. It’s unfortunate that the road from no treatment to inexpensive treatment is 20 years long, but you’d be hard pressed to show that the patent system makes it longer than it would otherwise be.

    What I really don’t get is why this case is worth a remand, if the patents passed the MOT test the first time around, and the MOT test is now (still) sufficient for patentability. What do the Supremes think will turn out differently this time?

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