Patentable Subject Matter: Federal Circuit Upholds Patentability of Drug Dosage Method Claim

Prometheus Labs. v. Mayo Clinic (Fed. Cir. 2009)

In a unanimous panel opinion, the Federal Circuit has rejected Mayo’s patentable subject matter challenge under 35 U.S.C. 101 – holding that the claimed methods for calibrating a drug dosage were properly the subject of patent protection. The lower court had found the claims invalid under Section 101.

In its decision, the Federal Circuit applied its recent Bilski precedent.

The proper inquiry under § 101 is whether these methods meet the Supreme Court’s machine or transformation test articulated in Benson and Diehr, and applied in Bilski, and, if so, whether the machine or the transformation is central to the purpose of the claims.

Of course, Bilski is now on appeal at the Supreme Court.

The claimed method is essentially an iterative testing mechanism where the treatment drug is injected in the patient and the patient’s subsequent metabolic response is measured. The next dosage is then re-calibrated based upon the measured metabolic response.

Holding: Following Bilski, the Federal Circuit ruled that the required administration of a drug “transforms an article into a different state or thing” and that the transformation was an “integral” part of the calibration method. As such, the claims satisfy the patentable subject matter test of Bilski.

To be patentable, the claim must not wholly preempt the use of a natural process. Here, the court only weakly rebutted Mayo’s argument:

The claims cover a particular application of natural processes to treat various diseases, but transformative steps utilizing natural processes are not unpatentable subject matter. Moreover, the claims do not preemptnatural processes; they utilize them in a series of specific steps.

Method of Diagnosis: The court was clear to distinguish the Prometheus claims from diagnosis claims that merely requiring data gathering and correlation rather than an injection of drugs.

The asserted claims are in effect claims to methods of treatment, which are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition. . . .

The crucial error the district court made in reaching the opposite conclusion was failing to recognize that the first two steps of the asserted claims are not merely data-gathering steps. . . . [T]he administering and determining steps are part of a treatment protocol, and they are transformative.

Thus, this decision at least suggests that the asserted diagnosis claim in LabCorp v. Metabolite would not be patentable. That claim involved only two steps: (1) assaying a body fluid for its homocysteine level; and (2) correlating high homocysteine with a vitamin deficiency.

Despite the stated distinctions, this case could be seen as a muted challenge to the Supreme Court and especially to Justice Breyer’s dissent from the Court’s late dismissal of its grant of certiorari. In its one sentence reflection on Breyer’s dissent, the Federal Circuit opinion merely indicates that opinion’s lack of precedential value and that the claims are “different.”

In reaching its conclusion, the district court relied heavily on the opinion of three justices dissenting from the dismissal of the grant of certiorari in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., 548 U.S. 124 (2006) (Breyer, J., dissenting). . . . That dissent is not controlling law and also involved different claims from the ones at issue here.

The court was clear the parties did not dispute other validity issues such as obviousness or novelty, but rather focused solely on the question of patentable subject matter.

Chances for Supreme Court Review: The setup of this case makes is a good candidate for Supreme Court review especially if the Court is not fully satisfied by its Bilski decision. The Supreme Court has regularly used case clustering in the past when considering patent issues: Nonobviousness (John Deere (1966), Adams (1966), & Anderson’s-Black Rock (1969)); Patentable subject matter (Flook (1978), Charkabarty (1980), Diehr (1980)); Prosecution history estoppel (Warner-Jenkinson (1995) & Festo (2000)).

Notes: Judge Lourie drafted the opinion which was joined by Chief Judge Michel. District Court Judge Clark (E.D.Tex.) joined the panel sitting by designation.

94 thoughts on “Patentable Subject Matter: Federal Circuit Upholds Patentability of Drug Dosage Method Claim

  1. I agree this patent should never have been allowed based on the following:

    1. 6-TGN>230 pmol/8x10e8 have been associated with 6-MP efficacy in 1990. See Lynn Lennard’s work
    2. Confirmation in Crohn’s by Cuffari in 1995. Patent was not even filed.
    3. hplc assay not proprietary..

  2. Good grief.

    Remind me why the Federal Circuit is allowed to rule on patent cases at all? They’re obviously either incompetent or owned. This patent should never have been allowed by any government ever.

  3. The only infringement proved was a one time offer of sale — that is the point. Mayo is litigating here without substantial exposure for liability.

    As to the claims, it seems clear that the real invention is the method of treating the patient by administering the drug and adjusting the dosage depending on the level of metabolites. Adding the test to the claim is an attempt to extend liability to the lab that performs the test. But, from my point of view, the lab should not be involved at all in the infringement except if they induce infringement in some manner. I don’t see how they could be direct infringers, as the novelty is in the treatment. A claim centric on the test would be devoid of any novelty, as the test itself appears to be conventional.

  4. Ned, so what you are saying is that if the patentee had wanted to prevent others from performing the test at all, then it should have also had claims where the administering step was omitted. I guess you’re right, given that the CAFC found the determining step to be sufficiently transformative so as to satisfy Bilski. I think the CAFC was wrong on this point, but I also think the whole opinion is problematic. The claims lack utility because altering a person’s thinking (“indicates a need”) is not a substantial utility.

    Oh, and I do understand that one cannot infringe a method claim by offering for sale (to perform) one element of a method claim. But it’s kind of a technical point: once Mayo starts performing, it infringes, so what’s the big deal?

  5. And, Hans, you still do not seem to get that one cannot literally infringe a method claim by offering for sale (to perform) one element of a method claim. Perhaps this “offer” might induce infringement, but it is not itself direct infringement.

  6. Hans, the problem is a claim drafting issue according to the Federal Circuit. One could draft claims involving only the lab, only the physician, or both. The fact that one doesn’t have such claims in his patent is attorney error, plain and simple.

  7. Ned, I must admit that if the physician who administers the drug and the lab that performs the test are each employed by, or otherwise under the control of Mayo, then there is no “single actor” problem, and the court’s finding of infringement of claim 7 in this case is legitimate (assuming the patent is valid, of course). But think about that for a minute: it’s infringement if the physician is employed by Mayo, but not infringement if the physician is not employed by Mayo. I mean, what is going on here?

  8. Well I agree w/ Bob in so far as adding mental steps (as opposed to making the whole claim a mental step as MM’s example did) shouldn’t make the claim 101 ineligable. They should simply be treated as art issues, allowing for liberal use of implicit knowledge when interpreting the prior art.

    That’s my take on it, and I’ve applied this methodology to many cases pending before me already. I have one currently pending.

  9. Hans Blix wrote: “Les, I agree that it would still be very difficult to make a case for inducement against the company that markets 6-TG to physicians (after all, the physician does not have to order/perform the test upon administering the drug), but to me, this opinion opens the door at least a crack, provided that the standard of care is to perform the test each time the drug is administered, and provided that whoever is performing the test is the agent of, or under the control of, the physician. We know that Prometheus has already “won” on the issue of infringement, at least with respect to claim 7, meaning that the district court has at least implicitly found Mayo to be the agent of, or under the control of, the physician. I mean, how else could Mayo be found to have infringed claim 7? Personally I think that is totally ridiculous, and I wonder why Mayo did not argue this point more forcefully at trial and/or appeal. I am telling you, if Mayo infringes claim 7, then it is not that crazy to suggest that the party which markets the drug also infringes.”

    Hans, I believe I mentioned earlier in this thread that the district court held that a “published” offer of sale of the “test” was an infringement of the method claims. I think this is legally incorrect regardless of the two-party issue.

    A possible reason that Mayo may not be contesting this issue is that they also intended to conduct the tests in their clinics with “employed” physicians.

    However, in the earlier Metabolite case,the doctors were found to have “directly” infringed, meaning they were deemed to have themselves perform all steps in the claimed method, when they gathered the data, ordered the test, and mentally assessed the results of the test. It apparently was assumed that proof of simply ordering the test was sufficient proof that the doctor conducted the test. But as we have observed in here, the law not only requires that the lab be associated with the doctors orders when it conducts the test, but also that the lab be an employee or the agent of the doctor at the time.

  10. Bob,

    I want very much to agree with you. But, in terms of being able to say that the law completely accords with your view, I think that the Classen case stands in the way. In effect, it seems we have the Fed Circuit issuing conficting case law, with Classen on one side, and Metabolite and Prometheus on the other. It boosts your credibility that Classen was non-precedential, but I am disconcerted that Newman was on the panel that basically said you can read a known immunization step out of the claim for 101 analysis. Moore made it clear in oral arguments that that was what the Court did in that case.

    Playing devil’s advocate, I think it is correct that 100(b) and 101, taken together, make it clear that the 1952 Congress wanted new uses of old devices/processes/etc. to be eligible for patentable subject matter. However, unless I am misinformed, the Courts carved out or renewed the mental step exception case law in the early 1970s, and Congress took no action to countermand that case law. Further, even without that exception, it is not entirely clear that Congress wanted a new use of an old device/process to be eligible for patentable subject matter without that new use satisfying 101 on its own merits. Moreover, even if Congress wanted the new use to be eligible for patentable subject, it is not the Court’s fault that Congress failed to alter the legal requirement for identification of a direct infringer.

    In other words, taking the Metabolite claim for example, Applicants would have no problem adding the steps of diagnosing a patient or performing another test towards daignosing the patient or treating the patient, except for that pesky direct infringer requirement. In effect, Congress said to let people patent new uses for known devices/processes, but failed to provide a mechanism whereby applicants can obtain the types of claims they want. Why should the Court’s twist the 101 case law into a pretzel trying to accomodate the needs of Applicants when Congress failed to do so?

    Personally, I hope SCOTUS and the CAFC give the 101 case law a purple nurple if that’s what it takes to give Patentees claims they can enforce against their competitors. The direct infringer requirement is the true culprit, but we can’t expect Congress to do what needs to be done here. I’m somewhat encouraged to see the CAFC delaing with the issue thoughtfully, even if it seems that the court is divided within. Still, we can’t afford to be blind to these issues.

  11. BHodges: “Consider this hypothetical situation: at some point in the past, a method consisting of the steps of administering 6-TG to a patient and of subsequently measuring the levels of 6-TG in the patient’s blood was discovered. If the inventor of this method filed a patent application on this method, there is no question that it is patent-eligible subject matter. Given that, it does not make sense that later adding a step to this method transforms the whole new method into patent-ineligible subject matter.”

    I disagree that it does not “make sense.” It is entirely possible to add a limitation to a claim that turns it from statutory subject matter to non-statutory subject matter. Consider: “An apparatus comprising wheels and a handlebar,” versus, “An apparatus comprising wheels and a handlebar, wherein said apparatus exists only in the mind of a human.”

    BHodges: “If such methods are objectionable, it should be for art reasons, not by twisting 101 law into pretzel logic”

    I don’t see any “pretzel logic.” You want “pretzel logic”, then watch someone here try to defend Beauregard claims sometime.

  12. Malcolm Mooney wrote:

    “NAL’s Hero: ‘use of a known determination step in a new combination method such as the one here is a new use of a known method, which is clearly made patent-eligible subject matter in 35 U.S.C. 100(b). It is a new application of a known determination step.’
    Except that according to the claim as written, Bob, the only “new application” is thinking about the data in a “new” way.
    You think that new uses of processes including new methods of thinking about the process?”

    and also wrote:

    “Indeed, the statutory subject matter here is a method of treating a patient, comprising: dosing, taking a measurement within time period X, and admistering a higher dose if the measurement is below Y, or administering a lower dose if the measurement is above Z.

    The “wherein X indicates a need” either tunrs the claim into non-statutory mental stepping garbage that claims a doctor’s thoughts, or it should be ignored in which the claim is (if I’ve got the facts right) anticipated or obvious. Pick your favorite, doesn’t matter to me.”

    I do think that making a new determination/inference can be a new use under 35 U.S.C. 100(b). However, your second post quoted above gets to another heart of the patent-eligible subject matter debate. Addition of only mental steps to other steps that are already known in the art might make a claim unpatentable as lacking novelty or as being obvious. That this is so is not a reason to decide the claims are not patentable subject matter. I do not think there should be your choice here.

    Consider this hypothetical situation: at some point in the past, a method consisting of the steps of administering 6-TG to a patient and of subsequently measuring the levels of 6-TG in the patient’s blood was discovered. If the inventor of this method filed a patent application on this method, there is no question that it is patent-eligible subject matter. For example, it is at least a patentable-eligible method of treating a patient. Given that, it does not make sense that later adding a step to this method transforms the whole new method into patent-ineligible subject matter. For example, a method of vulcanizing rubber should not become patent-ineligible merely because the vulcanizer reads a measurement and thinks something about the measurement. If such methods are objectionable, it should be for art reasons, not by twisting 101 law into pretzel logic that the debate here shows is unworkable and philosophically inconsistent.

  13. Not so obvious:

    The discussion was in the context of whether or not this opinion opens the door to a possible claim of inducement to infringe against the party which markets the drug that is administered in the claim. If a lab that performs/sells the test is the only lab which does so, and if the lab is legally considered to be under the control of the physician who requested the test on behalf of his/her patient (such that it is inducing the physician to infringe), then what is to stop Prometheus from claiming that the company which markets the drug is also inducing the physician to infringe? This all assumes, of course, that every time a physician administers the drug to a patient, he/she orders the test.

    Everyone has been focusing on whether the Federal Circuit was correct in finding the patent valid, but to me the bigger issue is infringement. There is no possible way that Mayo is infringing this patent, and yet in this case, the district court found Mayo to be infringing claim 7.

  14. Hans -
    I’m not a legal scholar. But, under those circumstances, I would have to believe that the only reason the doctor would be aware that the test is available is because the infringer advertised or publicized it. Therefore it would seem to me to totally be the infringers responsibility.

  15. “if…Mayo was the only lab that performed the test?”

    Hans, your point is immaterial – infringment does not depend on the actions of others. The test is not Mayo’s to sell.

  16. Les, I think I know where you are going with your last question. You are suggesting that the physician need not order the test from Mayo, but rather could just order it from Prometheus. In this particular case, I agree, since Prometheus does offer its own test. But what if Prometheus did not offer its own test, and Mayo was the only lab that performed the test?

  17. Hans -

    Does the doctor of your concern specifically order the infringing test or is the lab free to purchase the test kit of the patentee?

  18. Les, I agree that it would still be very difficult to make a case for inducement against the company that markets 6-TG to physicians (after all, the physician does not have to order/perform the test upon administering the drug), but to me, this opinion opens the door at least a crack, provided that the standard of care is to perform the test each time the drug is administered, and provided that whoever is performing the test is the agent of, or under the control of, the physician. We know that Prometheus has already “won” on the issue of infringement, at least with respect to claim 7, meaning that the district court has at least implicitly found Mayo to be the agent of, or under the control of, the physician. I mean, how else could Mayo be found to have infringed claim 7? Personally I think that is totally ridiculous, and I wonder why Mayo did not argue this point more forcefully at trial and/or appeal. I am telling you, if Mayo infringes claim 7, then it is not that crazy to suggest that the party which markets the drug also infringes.

  19. Wow! Wow! Wow!

    I went back and reviewed the Fed. Cir. decision in Metabolite, which has the very same infringement issues posed here. The Feds. noted that the only issue on “direct infringement” of the doctors was whether they performed the “mental association” step. It apparently was assumed they were responsible for the actions of the otherwise independent labs when they ordered the tests.

    But such is not the law. In order to directly infringe through the actions of a third party, the doctors have to “control” the lab, as if the lab were an “employee” of the doctor. It appears time and again a basic fundamental of infringement of method claims has been ignored by defense counsel and not raised sua sponte by the courts.

  20. The administering and/or determining steps bring the claim within Bilski.

    But if I were the examiner I would argue that the two wherein clauses do not further limit the steps of the METHOD and therefore are given no patentable weight.

  21. Hans, I read the district court opinion on infringement. While Mayo did raise the objection that the PO had to prove that “someone” performed the method, the DC brushed that aside. Instead it held that Mayo’s “offer for sale” of the “test” by itself literally infringed the claim, focusing solely on the disputed claim terms which were exclusively associated with the test. Personally, I have no idea just how an “offer for sale” of a test could literally infringe a method claim regardless of “the single-actor” rule. The only legal support the court cited was to a case involving an offer for sale of an apparatus.

    Does anyone here know of any case were an offer of sale of a “test” could literally infringe a method claim?

    Claim 7 is similar to claim 1 for the purposes of this issue.

  22. And here we have evidence of it being known in ’89:

    Latest bibliographic data on file with the International Bureau

    * Link
    o Permanent Link
    o Bookmark this page

    Pub. No.: WO/1989/009778 International Application No.: PCT/US1989/001531
    Publication Date: 19.10.1989 International Filing Date: 12.04.1989
    IPC: C07H 19/20 (2006.01), C07H 21/00 (2006.01)
    Applicant: CHEMICAL INDUSTRY INSTITUTE OF TOXICOLOGY [US/US]; P.O. Box 12137, Research Triangle Park, NC 27709 (US).
    Inventors: RICHARDSON, Frank, Charles; (US).
    BRONSTEIN, Seymour, Maynard; (US).
    Agent: BARBER, Lynn, E.; Olive & Olive, P.O. Box 2049, Durham, NC 27702 (US).
    Priority Data:
    182,177 15.04.1988 US
    Title: OLIGONUCLEOTIDE CONTAINING 6-THIOGUANINE AT A PREDETERMINED SITE
    Abstract: A 6-thioguanine containing phosphoramidite has been synthesized and subsequently utilized in the preparation of an oligonucleotide containing 6-thiodeoxyguanosine. The method includes steps of acylation, alkylation and phosphitylation of 6-thiodeoxyguanosine and incorporation of the resulting phosphoramidite into an oligonucleotide at a specific site. The new oligonucleotide may be used to study the effects of 6-thioguanine on replication, and on alkylation of 6-thioguanine by anticancer agents, and the possible repair of those alkylations.

  23. 6-thioguanine has been mainly used for intensification courses. Since preliminary data have shown that 6-thioguanine is more effective than 6-mercaptopurine, we compared the efficacy and toxicity of the two drugs for childhood lymphoblastic leukaemia. METHODS: Consecutive children with lymphoblastic leukaemia diagnosed in the UK and Ireland between April, 1997, and June, 2002, were randomly assigned either 6-thioguanine (750 patients) or 6-mercaptopurine (748 patients)

    So…. the drug has been around since at least ’97… and the patent at issue was filed in ’99…

    link to ncbi.nlm.nih.gov

  24. Locke: “I also disagree when you contend the treatment hasn’t been optimized unless there is a concluding action (I presume the concluding action you want is adjustment of the dose if the metabolite levels are high or low).”

    Indeed, the statutory subject matter here is a method of treating a patient, comprising: dosing, taking a measurement within time period X, and admistering a higher dose if the measurement is below Y, or administering a lower dose if the measurement is above Z.

    The “wherein X indicates a need” either tunrs the claim into non-statutory mental stepping garbage that claims a doctor’s thoughts, or it should be ignored in which the claim is (if I’ve got the facts right) anticipated or obvious. Pick your favorite, doesn’t matter to me.

    But the well-drafted claim should have just recited the steps. “Wherein X indicates Y” is either not a step or its a mental step which, in this instance, renders the claim unpatentable under 101 because, in spite of some commenters have said, the other steps are not central to the purpose of the claim. They are ancillary. The only transformation in the claim that effects the “optimization” is the thinking step.

  25. Mooney,

    You make a pretty good point and I agree that a concluding action puts the claim on BETTER s.101 footing, though I disagree when you contend it is necessary in order show a utility.

    I also disagree when you contend the treatment hasn’t been optimized unless there is a concluding action (I presume the concluding action you want is adjustment of the dose if the metabolite levels are high or low). I think the treatment IS optimized whether the doctor ultimately adjusts the dosage because metabolic levels (and any other molecular diagnostic result) are likely to be one factor considered by the doctor in coming to his ultimate conclusion. Anything that weighs in the doctor’s final decision has helped the doctor make a more informed, comprehensive decision (thus resulting in better care for the patient). In other words, if there is clinical utility (i.e., the doctor will actually consider the information gained) then there is utility under s.101. By the way, if there is no clinical utility no one will develop the test.

    And with that, lunch hour’s well over…

  26. Locke -
    Hans’ question was in regard to manufactures of the drug, which presumably was manufactured, available and used prior to the invention of the test. I assume it was prescribed on a Take one pill and see if that works …if not, call me and I prescribe taking two, basis, rather than the fancy inventive taking an actual measurement basis of the claim.

    Accordingly, my analogy is not strained in the least.

  27. Locke: “And Noonan’s point about no one suing doctors is NOT trivial or academic but intensely practical (and true, by the way).”

    I have no idea what “intensely practical” is supposed to mean in that context. But if the kit for determining 6-TG levels is old and Mayo supplies the kits to doctors who can do whatever they want with it (surely including thinking about the results), then where is the infringement?

  28. NAL’s Hero: “use of a known determination step in a new combination method such as the one here is a new use of a known method, which is clearly made patent-eligible subject matter in 35 U.S.C. 100(b). It is a new application of a known determination step.”

    Except that according to the claim as written, Bob, the only “new application” is thinking about the data in a “new” way.

    You think that new uses of processes including new methods of thinking about the process?

    I think you’re wrong. In fact, I know you’re wrong.

  29. Locke: “Bilski says nothing about the method consisting entirely of the transformation (Mooney et al.), only that the transformation must be central to the PURPOSE.”

    The purpose of the claim is to optimize a patient’s therapy. However, if the *steps* set forth in the claim are followed, nothing whatsoever is optimized.

    The proper way for the Federal Circuit to have dealt with this case would have been simply to find the claims, as drafted, lack utility under 101. The entire transformation test should simply be merged with the utility test. Changing a thought in a person’s mind is not a substantial utility for patentability purposes. It’s the actions that result from that thought that are transformative, and those reactions must be recited in the claim.

  30. Les,

    I think your analogy is strained. Sticks, cables and cloth are commodity items and have a million substantial non-infringing uses so… no, people selling these would not induce infringement.

    As for Hans”s question, I think the answer is likely “yes.” Doctors induce the lab’s infringement by ordering the test (for lab-centric claims) and the lab induces the doctor to infringe by marketing the test as capable of diagnosing a particular condition (for doctor-centric claims). And Noonan’s point about no one suing doctors is NOT trivial or academic but intensely practical (and true, by the way).

  31. Hans:

    Re:

    “If the lab running the test (Mayo, in this case) is deemed to be the agent of, or under the control of, the physician ordering the test, then doesn’t this opinion create the possibility that anyone who markets 6-thioguanine infringes the patent by inducing the physician to infringe?”

    Since the Wright brothers got a patent on a plane made of sticks, cables and cloth, did that create the possibility that anyone who marketed sticks or cables or cloth infringes the patent by inducing the people who wanted to fly to infringe?

  32. Max, survival always trumps status quo, i. e., capital investors really don’t care about esoteric discussions.

    The whole idea in establishing a “patent court” in 1982 was to impose stability in patent law.

    That effort was driven by the management of large U. S. manufacturers telling their patent guys (I was one) that they would cease R&D funding and shift their investment capital into the service sector, especially so-called “financial services”.

    You see, by the beginning of the 1980s, patents were being invalidated at will and without rhyme or reason by scientifically illiterate judges and my colleagues and I were thus unable to give any reliable predictions as to patent portfolios. About all one could say is the 5th circuit was better for patent owners than the 9th.

    Well, the DC Bar got Congress to remove our language in the bill establishing the CAFC which required that patent cases before the new court be decided only by judges of that court who actually were Registered Patent Attorneys with litigation experience.

    So now the CAFC is actuallly now less predictable than the old 9th Circuit. And since the AIPLA is now controlled by non-patent attorneys (so-called “IP” lawyers), forget about reforming the CAFC.

    That the CAFC no longer can function as a predictive tool is a central reason why capital for innovations in manufacturing has dried up in the USA.

    Ironically, in a few years, the PRC and other nations that are now the leaders in technical and scientific innovation probably will muscle Congress to re-establish a more predictive patent system, including a reform of the CAFC and–quite possibly–deleting the impossibly subjective 103 or at least revising it to require the use of real POSHITA in trials as opposed to PhDs.

    Anyway, Max, in the end, it doesn’t matter what is said by the Mandarin scholars here. Money follows results, not syllogistic arguments about fuzzy decisions.

  33. If the lab running the test (Mayo, in this case) is deemed to be the agent of, or under the control of, the physician ordering the test, then doesn’t this opinion create the possibility that anyone who markets 6-thioguanine infringes the patent by inducing the physician to infringe?

  34. Curious -

    I agree with you. But, they do mention the concept, and the Bilski court twisted what they said to justify the non-sense the Bilski court came up with…

    For example, I believe it was in one of those cases where the Supremes said a transformation included in the claims before them was “the clue” to the method claim reciting patentable subject matter.

  35. Continuing with my earlier example, if the claim were drawn to a method of drawing blood, treating the arm with antiseptic would be central to the purpose of the method (as would having the patient pump their fist, etc.).

    I think Prometheus goes part of the way toward (properly in my mind) burying the unfortunate “mere data-gathering” concept. This phrase crept into the case law seemingly by accident (or at least in cases whose reasoning and facts are inapplicable to medical diagnostics) and should be consigned to the dustbin of legal catchphrases.

    In diagnostics, data-gathering will never be merely insignificant extra-solution activity. When trying to discover some fact that is heretofore unknown, examination of preliminary facts (i.e., facts potentially probative of the ultimate fact) is necessary. In fact, note the prominence of “examination” in the following definitions of :diagnosis” found on dictionary.com:
    a. the process of determining by examination the nature and circumstances of a diseased condition.
    b. the decision reached from such an examination.

  36. Locke,

    I agree with you that Breyer’s dissent in LabCorp is inane. On par with his comments about “racoon thwarting inventions” during oral argument in KSR.

  37. By the way, I do not mean the court explicitly discusses an example akin to the one I gave. I only mean the court’s discussion of “central to the purpose” shows how the transformation must have more than a passing or tangential relationship to the purpose of the method.

  38. As to whether the determining step is merely insignificant extra-solution activity, I think the decision explains pretty well how these determining steps are central to (i.e., central to accomplishing) the purpose of the claimed method. The court also does a pretty good job of explaining that does not mean merely practically necessary to carry out the method. For example, preparing the patient’s arm with antiseptic before injection or blood draw might be practically indispensable for the method, but it is not central to the PURPOSE of the method.

    Bilski says nothing about the method consisting entirely of the transformation (Mooney et al.), only that the transformation must be central to the PURPOSE. The distinction with Grams should have been explained in terms of Grams’s laughable paucity of specificity. Those claims essentially claimed a method of discovering a diagnostic test, without any specific field or marker. In other words, Grams was claiming the abstract idea principle statistical correlation of ANY marker with ANY phenotype. NOW THAT’S WHAT I CALL PATENT INELIGIBLE (coming to music stores this Fall).

  39. This decision is correct on all the law and the right outcome on all points, though at times some of the reasoning bogs down (see especially the discussion of In re Grams). I definitely cringed when the opinion said “Regardless, because the claims meet the machine-or-transformation test, they do not preempt a fundamental principle.” This kind of seemingly mechanical application of a bright-line test is likely to raise the ire of SCOTUS.

    That said, Prometheus gives a good peek at what two CAFC judges think of Breyer’s inane dissent in LabCorp and, thus, is reassuring to me. Further, these are lifesaving technologies that deserve protection (thus distinguishing them from virtually all business method patents, which I believe are what Bilski was really aiming at).

  40. But Stuart, the threads rather suggest that some classes of “user” of the patent system can make good money from:

    “a patent statute which has become essentially impossible to function as a predictive tool.”

    When some vociferous people like the sophisticated status quo, it is nigh on impossible to change it. That is because neither the law-givers nor the law-makers are competent to distinguish the good arguments from the bad. Abolish democracy, perhaps?

  41. “Method of Diagnosis: The court was clear to distinguish the Prometheus claims from diagnosis claims that merely requiring data gathering and correlation rather than an injection of drugs. [...] Thus, this decision at least suggests that the asserted diagnosis claim in LabCorp v. Metabolite would not be patentable. That claim involved only two steps: (1) assaying a body fluid for its homocysteine level; and (2) correlating high homocysteine with a vitamin deficiency.”

    Actually, the court explicitly says that the administration step is unnecessary and the determination step is sufficient for the method to be patent-eligible. See the very bottom of page 16:
    “Mayo is correct that not all of the asserted claims contain the administering step. That omission, which occurs in claims 46 and 53 of the ’623 patent, does not diminish the patentability of the claimed methods because the determining step, which is present in each of the asserted claims, is also transformative and central to the claimed methods. Determining the levels of 6-TG or 6-MMP in a subject necessarily involves a transformation, for those levels cannot be determined by mere inspection.”

  42. Kevin Noonan said:
    “I think, but I would have to check, that the statute defines “biotechnology” with regard to 103(b) or 271(e).”

    Section 271 doesn’t appear to be what you were thinking of. However, in relevant part, section 103 says:

    “(b)

    (1) Notwithstanding subsection (a), and upon timely election by the applicant for patent to proceed under this subsection, a biotechnological process using or resulting in a composition of matter that is novel under section 102 and nonobvious under subsection (a) of this section shall be considered nonobvious if-

    (A) claims to the process and the composition of matter are contained in either the same application for patent or in separate applications having the same effective filing date; and

    (B) the composition of matter, and the process at the time it was invented, were owned by the same person or subject to an obligation of assignment to the same person.

    (2) A patent issued on a process under paragraph (1)-

    (A) shall also contain the claims to the composition of matter used in or made by that process, or

    (B) shall, if such composition of matter is claimed in another patent, be set to expire on the same date as such other patent, notwithstanding section 154.

    (3) For purposes of paragraph (1), the term “biotechnological process” means-

    (A) a process of genetically altering or otherwise inducing a single- or multi-celled organism to-

    (i) express an exogenous nucleotide sequence,

    (ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence, or

    (iii) express a specific physiological characteristic not naturally associated with said organism;

    (B) cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody; and

    (C) a method of using a product produced by a process defined by subparagraph (A) or (B), or a combination of subparagraphs (A) and (B).”

    I don’t see how this applies to the issue we discussed earlier. For one thing, the patentee has the option whether to proceed under subsection (b) (and presumably that’s during prosecution, not litigation), and furthermore, subsection (b) appears to be geared towards a novel and nonobvious product produced by a biotechnological process, whereas here, the product(s) that result from the process are unpatentable (because they are already well-known). In other words, the claims at issue here pretty clearly are not product-by-process claims.

  43. OK, kids: Everybody’s sooooo smart! As such, consider the following non-hypothetical:

    Your JOB depends on your ability to provide your clients with ACCURATE predictions about patentability, validity, enfoceability, infringement, (etc).

    Assume those clients are “Management”–humorless types who have zero interest in arcane lectures from their patent counsel and simply want to know: “do we win or lose?”

    Our economy is dying from the sharply reduced flow of capital for R&D. That loss of blood is a direct consequence of a patent statute which has become essentially impossible to function as a predictive tool.

    Until Congress re-writes 101 (and 102-103) and requires CAFC judges to have scientific training
    there will be more endless blogs by squabbling patent lawyers posting hair-splitting assessments about the latest ramblings of judges who really need to find another day job.

    Oh, there is one predictive outcome: You get fired for failure to provide a meaningful economic function.

  44. Regarding the determination step, the Federal Circuit here found that this step involved a transformation (transformation of the blood sample) that takes place in the manipulations needed to make the determination. This is correct; assays to determine the levels of metabolites involve physical transformation of patient samples. Such physical transformations are central to the determination of the level of the metabolite. So such steps should clearly meet the transformation prong of the Bilski test.

    The discussion of such determination steps often turns (in cases and in blog posts) to the fact that nothing in the determination step is new (conventional techniques and known assays). I do not think that focus on the lack of novelty of individual steps or components should have a place in determining patent-eligible subject matter. Patentability determinations should not be made by dissecting a claim; patentability should be determined for the claim as a whole (I have always been aghast at how causually this well-established principle has been violated in various decisions on patent-eligible subject matter). Also, use of a known determination step in a new combination method such as the one here is a new use of a known method, which is clearly made patent-eligible subject matter in 35 U.S.C. 100(b). It is a new application of a known determination step. That should be patent-eligible.

  45. I am not sure I see the basis of believing that a claim such as the one here should not be patentable subject matter (looking at it from an economic and policy point of view, leaving aside the legal tests of patentable subject matter currently in flux). It is clearly based on a discovery of something that had not been known. That discovery clearly has real world value when applied as claimed, otherwise Mayo would not have commercialized an infringing test. One of the purposes of the patent system is to encourage disclosure and commercialization of such valuable discoveries. And consider, the valuable test (valuable both to the test seller and to patients) might not have been developed unless patent protection was available. For all of these reasons, I do not see a valid basis for the opinion by some that such claims/inventions are ridiculous plagues on business, the public, and the patent system.

    Regarding whether a determination of the level of a metabolite (present here, in the Metabolite claim, and in many diagnostic methods) is an insignificant data gathering step, I think the purpose of the determination (that is, the discovery of valuable information to be gained from the determination) is more than enough. The diagnosis of a condition or adjustment of treatment based on a determination is a valuable technological result and represents a useful and valuable application of the discovered correlation.

  46. “Do you think think that the statutory language of 101 is ill-adapted for filtering duty?”

    MD,

    I do. Part of the problem is that current language in 101 on what the statutory classes are still resides in the 19th Century. But more significantly is that 101 uses the class “processes” as the catch all to include “improvements” which suggests, at least to me, an effort by Congress not to use 101 as anything other than a coarse screen (i.e,. no patenting of discoveries, natural phenomena or abstract ideas).

    The Federal Circuit has now turned the “statutory subject matter” determination into an entirely arbitrary and subjective standard that no one (including the Federal Circuit) can apply in a rational and consistent matter. The Prometheus case is just the most recent glaring example of the unworkability of the Bilski test.

    But the primary culprit in this 101 mess is SCOTUS. The decisions in Gottschalk v. Benson, Parker v. Flook, Diamond v Diehr, as well as Justice Breyer’s dissenting opinion in Metabolite, show SCOTUS’s penchant for misapplying or simply ignoring the patent statutes, and simply applying their own rules pulled out of thin air. For example, Flook makes the nonsensical statement that a previously unknown and unrecognized algorithm is to be treated as “prior art”. How does that statement square with 35 USC 102, much less 35 USC 103?

    Instead, SCOTUS, as well as the Federal Circuit, should go back to the doctrine wisely set forth in O’Reilly v. Morse which is often miscited as a 101 case, but is really the forerunner of 35 USC 112, 1st paragraph. What O’Reilly v. Morse says is you get the claim scope you enable, no more, no less. I’m fine with that as you can factually ascertain from the patent spec whether or not the claim scope is enabled. The Federal Circuit, as well as SCOTUS, has sadly shown they can’t do this with 35 USC 101.

  47. Since this was merely a CAFC decision to not sustain a summary judgment based on 101, it leaves the defendants and the district court free to seek summary judgment or trial on 103 obviousness or any other unpatentability basis.
    This is the only decision here:
    “CONCLUSION
    For the foregoing reasons, we reverse the judgment of the district court and remand to the court with instructions to deny Mayo’s motion for summary judgment that the asserted claims are invalid under §101.”

  48. The timing of this ruling is suspicious IMHO. It tends to take Biotec out of the fight in the Bilski case…at least where drug administration is involved.

    I suppose if you made the same determinations without first administering the drug, they would say there was no transformation…

  49. EG. Do you think think that the statutory language of 101 is ill-adapted for filtering duty? Is 101 nevertheless being used for filtering because it’s self-evident to ordinary intelligent lay people that some sort of patent-eligibility filter is needed, and the only one available is 101?

    Or is it OK to permit enabling clear written descriptions of new and non-obvious mental processes to be patented (perhaps because of the difficulty of proving infringement)?

  50. Prometheus is a huge improvement over the ghastly opinion (if you can call it that) in Classen. But this case also highlights how unworkable and subjective the “machine or transformation” test of Bilski is.

    I also don’t envy Judge Lourie trying to reconcile the “natural phenomena” prohibition with the Bilski test. (And I don’t mind at all him taking a backhanded swipe at Justice Breyer’s dissenting opinion in Metabolite).

    Frankly, Prometheus wastes a huge amount of judicial verbiage on what should have been an easy ruling (the claimed method is statutory subject matter under 35 USC 101 without blinking an eye). The Federal Circuit, as well as SCOTUS need to drop 35 USC 101 as the primary screen, and focus instead on 35 USC 112, followed by 35 USC 102/103. That’s essentially what Professor Risch of West Virginia said, and he’s right.

  51. I think, but I would have to check, that the statute defines “biotechnology” with regard to 103(b) or 271(e).

  52. Good question Smash. Would you say that the presence of a claim to, say, a new and improved bio-absorbable suture makes it “a biotechnology patent” that is “violated” by a “healthcare entity” whenever such a suture is used by an employee to close a life-threatening wound?

  53. Why wouldn’t the applicant have written the claims in terms of actions taken? Instead of simply indicating a change should be made, couldn’t the claims simply read “administering an increased amount of said drug if…” and “decreasing an amount of said drug if….” I forget whether there is some prohibition on having either/or type situations in claims, but if there is, couldn’t they simply be written as two claims?

  54. From 35 U.S.C. 287:
    “For the purposes of this subsection . . . the term “medical activity” means the performance of a medical or surgical procedure on a body, but shall not include . . . the practice of a process in violation of a biotechnology patent.”

    I don’t see a statutory definition of “biotechnology” in the statute or in nearby statutes. Did I miss it? If there is none, what’s to prevent some district court (say, for instance, EDTX or EDVA) from construing this process patent as involving “biotechnology”?

  55. I’m not saying it, Malcolm, 35 U.S.C. 287(c) says it:

    (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.

    (2) For the purposes of this subsection:

    (A) the term “medical activity” means the performance of a medical or surgical procedure on a body, but shall not include (i) the use of a patented machine, manufacture, or composition of matter in violation of such patent, (ii) the practice of a patented use of a composition of matter in violation of such patent, or (iii) the practice of a process in violation of a biotechnology patent.

    And remember, according to the facts Mayo was going to practice “its” test internally and sell it to other hospitals.

  56. Ned, you are correct. Obviously I had not read the opinion very carefully. It is interesting that the district court granted Prometheus’ motion for summary judgment of infringement of claim 7, but not of, for example, claim 1, which is practically identical to claim 7. This assumes, of course, that Prometheus did in fact move for summary judgment of infringement of claim 1 (I am not familiar with the procedural history of the case). I am not a litigator, but it may well be too late for Mayo to argue that it does not infringe claim 7 on the ground that there is no direct infringement by a single actor. That would be too bad for Mayo, because I think it’s pretty clear that it does not infringe, directly or indirectly. It will be interesting to see what happens on remand.

  57. Hans Blix said, “Um, how does Mayo infringe this claim? Mayo isn’t administering the drug, it’s merely performing the assay. And last I checked, indirect infringement requires an underlying direct infringement by a single actor. Who is the single actor in this case? The physician who orders the test on behalf of his/her patient? Does anyone really believe that Mayo is the agent of, or under the control of, the physician?

    Prometheus may have won on the issue of patent validity (at least for now), but it is a long ways from winning the case.”

    After reading your post I read the opinion. Apparently, the district court has already held Mayo to have literally infringed claim 7, which, I presume, also has a involving a physician and not Mayo. If this is correct, it appears that Mayo “had” an excellent defense against infringement; but may have not asserted it. I wonder if Mayo still has an opportunity to raise this issue on remand wrt to the other claims.

  58. Assuming that the machine or transformation test is a proper test, claim 1 meets the test because of the administering a drug to a subject step.

    Now whether the claim meets 102, 103 and 112 are different tests.

  59. 6: “What on earth would make you say such a thing? Have you been readin’ on their specification?”

    No, on their claims. That’s where Phillips tells us to start, after all …

    But I also agree with you regarding the mathematical/intuitive argument for “determining” that we’ve both proposed. No reason it could apply to the upper bound as well, provided that the determination is made soon after administration of the drug (note that the claims, of course, fail to recite any limitation in this regard, and therefore literally cover administering and determining over any time period).

  60. OL “Is the difference between Prometheus claims 46, 53 and the Metabolite claim 13 that the preamble in the Prometheus claims talk about “treatment” (ie transforming the patient) while Metabolite talks about “detecting a deficiency” (ie only changing knowledge)?”

    Sadly, it would appear to be so, which is very odd given that there is no “treating” step in thoes particular Prometheus claims, making it difficult to see how the preamble could be used in that manner. Talk about breathing life into a claim: the preamble says the invention will do this, therefore it must be so even if carrying out the recited steps verbatim fails to transform anything that wasn’t transformed exactly the same way in the prior art.

    Your comment and Hans Blix comment raise another troubling issue that arises from these mental inventions: what is required for infringement exactly? Do I have to ask someone for information about the 6-TG levels in order to have “determine” it? What if someone hands me a piece of paper with the patient’s 6-TG levels apparent from the information on the paper? Can I treat the patient without infringing?

    By the way, this is the cue for Noonan to come here and say that nobody is ever going to sue any physicians for treating patients with this knowledge so we are wasting our time.

  61. “I think the limitation “determining the level” is different than “thinking that there is a level.”"

    Depending on the specification it may be. But when I look at my buddy that I just gave a flu shot to and think “there is some flu shot in my buddy” I just determined “the level” of the flu shot in my buddy. The level I determined is “above 0″.

    “I think the level must be measured with at least the accuracy to distinguish between 230 and 400 pmol of 6TG/8×10*8 blood cells. ”

    What on earth would make you say such a thing? Have you been readin’ on their specification?

    “Or is it the Federal Circuit’s position that it wouldn’t anticipate because we can’t read the mind of the technician?”

    Implicit information to the skilled worker reading the reference is implicit. I don’t think the CAFC will take a position otherwise should the issue be brought to them thus.

    Nonlimiting wherein clause is nonlimiting.

  62. Plurality of threseholding units-

    Are you saying that you can administer a drug without AN amount of the drug being inherently administered?

  63. 6 – I”M saying there is a consistency problem. I was being sarcastic. Fortunately, the decisions are moving in the right directly. But if the decision in this case is reasonable, then Metabolite should have gone the other way A Fortiori.

  64. The proper way for the Federal Circuit to have dealt with this case would have been simply to find the claims, as drafted, lack utility under 101. The entire transformation test should simply be merged with the utility test. Changing a thought in a person’s mind is not a substantial utility for patentability purposes. It’s the actions that result from that thought that are transformative, and those reactions must be recited in the claim.

  65. I wonder if this case really says that a Metabolite-like claim is not patentable subject matter. Would a Metabolite claim fail because its assaying step is only a data-gathering step or would it survive because its assaying step neceasrily requires some manipulation? Prometheus inconsistently seems to support both of these outcomes. The opinion in Prometheus states at 16-17 that
    “Mayo is correct that not all of the asserted claims contain the administering step. That … does not diminish the patentability of the claimed methods because the determining step, which is present in each of the asserted claims, is also transformative and central to the claimed methods. Determining the levels … necessarily involves a transformation, for those levels cannot be determined by mere inspection. Some form of manipulation, such as the high pressure liquid chromatography method specified in several of the asserted dependent claims or other modification of the substances to be measured, is necessary to extract the metabolites from a bodily sample and determine their concentration.”
    In Metabolite there were also more specific claims that outline a particular method for the assaying step. I presume that any assaying claimed in Metabolite would require some form of manipulation and thus Prometheus suggests that Metabolite’s claims would be patentable subject matter. But the opinion later argues that data gathering won’t be enough. Which side then wins in Metabolite? Is the difference between Prometheus claims 46, 53 and the Metabolite claim 13 that the preamble in the Prometheus claims talk about “treatment” (ie transforming the patient) while Metabolite talks about “detecting a deficiency” (ie only changing knowledge)?

  66. 6, I disagree with your 5:27 post. I think the limitation “determining the level” is different than “thinking that there is a level.” I think the level must be measured with at least the accuracy to distinguish between 230 and 400 pmol of 6TG/8×10*8 blood cells. The court seemed to construe the claim to *require* that tissue be transformed to take the measurement.

    Interesting, though, to consider whether a mathematical determination of the level would suffice: if in the prior art 6-TG was administered at a dose that, mathematically, would necessarily lead to less than 230 pmol 6TG/8×10*8 blood cells, would the claim then be anticipated (the only remaining step is mental and should be ignored)? What if the dose was subsequently increased? Or is it the Federal Circuit’s position that it wouldn’t anticipate because we can’t read the mind of the technician? I’m feeling queazy …

  67. “How does one decide what is “insignificant” and “mere” data gathering”

    Simple. You decide whether or not you wish to invalidate the claims and then assign lables as needed. If you are a SC justice, you’re always right. If you are one of billions of other people, you will be second guessed incessantly.

  68. 6 echoes Paul Cole, in suggesting that 103 will deal with much mess under 101. Now me, I’m struck by MM’s “transformation” of a fact into a thought, and thinking that those who in 1973 barred “mental acts” from patentability, in the EPC equivalent of 101, were on to a good idea.

  69. Um, how does Mayo infringe this claim? Mayo isn’t administering the drug, it’s merely performing the assay. And last I checked, indirect infringement requires an underlying direct infringement by a single actor. Who is the single actor in this case? The physician who orders the test on behalf of his/her patient? Does anyone really believe that Mayo is the agent of, or under the control of, the physician?

    Prometheus may have won on the issue of patent validity (at least for now), but it is a long ways from winning the case.

  70. Prometheous has me further wondering what is going to happen to the case of Ex parte Cynthia Roberts (USPTO BPAI 7/15/08)
    link to des.uspto.gov

    In the latter case, the human eye ball was “perturbed” in order to make diagnositc measurements. Isn’t such perturbance of a human body part, a transformation of the body; just like here in Prometheous?

    ______
    Are we to be cursed by having the Bilski Birds pecking at our innards for all of eternity per the legend of Prometheous?

  71. “The patentee does not believe it should be limited to any particular method.”

    That is correct MM, and that is why any doctor “determining” the level by thinking in his mind “There is a level of drug in this patient” is just fine and will be implicit in any reference showing administration of the drug, and would likely be implicit in any reference simply showing the drug itself.

    But, validity of the claim is a question for the court. I do hope that someone thought to raise a 103 flag for the court to consider though.

  72. More from the slip opinion at 22:
    “Regardless, because the claims meet the machine-or-transformation test, they do not preempt a fundamental principle.”

    Circular reasoning at its finest. What this says is that because the claims (ostensibly) meet the Fed. Circuit’s flawed test, therefore they CANNOT preempt a fundamental principle. The conclusion simply doesn’t follow from the premise.

  73. This (Prometheous, giver of fire) case just goes to show how insane and unworkable the CAFC Bilski decision is.

    How does one decide what is “insignificant” and “mere” data gathering (or post algorithm activity) without engaging in arbitrary and capricious behavior? Aren’t we supposed to have a government run by objective laws and not one run by the whim of men?

    And doesn’t 35 USC 112 give to the inventor the power to decide what he regards as his invention? And if so, isn’t all this ex post facto deciding by the courts as to what is central to the invention and what is not, an activity which is not in accordance with statutory law?

    The CAFC seems to be digging itself deeper and deeper into an unsustainable hole.

  74. Where’s the antecedent basis for “the amount of said drug subsequently administered to said subject”?

  75. 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 administered to said subject.
    ——————————

    DC: “Here, the court only weakly rebutted Mayo’s argument:”

    Agreed. I think the decision is a mess and, assuming it is not overturned (a big assumption), it will create more problems than it purports to solve.

    DC: “Thus, this decision at least suggests that the asserted diagnosis claim in LabCorp v. Metabolite would not be patentable. That claim involved only two steps: (1) assaying a body fluid for its homocysteine level; and (2) correlating high homocysteine with a vitamin deficiency.”

    Not sure I agree with that. As noted in the decision, some of the claims at issue in this case (unlike the claim I copied above) also require only two steps: (1) determining the level of a compound in a human and (2) correlating the level with a need to change the dose of drug. The court held that the “determining step” alone was sufficiently “transforming” because it required that at least some amount of human tissue be transformed into something else in order to determine the level of 6-TG.

    On page 18, the court misleadingly cites Bilski to support its conclusion: “It is virtually self-evident that a process for a chemical or physical transformation of physical objects or substances is patent-eligible subject matter.” See Bilski, 545 F.3d at 962.”

    The problem here is that the invention is not a process “for a chemical or physical transformation of physical objects or substances.” Rather, it’s a process for converting a fact (the level of 6-TG in a tissue) into a thought about that fact (this patient needs a higher dose of drug). That the step of “determining” the fact requires a transformation is insignificant, or should be, to the analysis of the invention for which protection is being sought. Note that a particular method for determining the levels is *not* recited in the claims. There is a reason for that. The patentee does not believe it should be limited to any particular method.

    The court says the claim preambles make it clear that the claims are drawn to methods of “optimizing therapeutic efficacy.” The problem is that if one practices the steps in the claims, no therapy whatsoever is “optimized.” That is because the step of actually administering the drug is missing from the claims.

    At the same time, the court makes sweeping statements such as “The asserted claims are in effect claims to methods of treatment, which are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition.” (page 17). Always transformative? Really? So if I claim, “A method of treating a patient, comprising the old step of administering an old drug to a subject, observing the patient’s face, wherein if the patient appears thirsty thinking about the possibility of giving the patient a cup of tea,” that’s patentable under 101?? Apparently so, as far as the Federal Circuit is concerned. I think the Supreme Court will be suprised.

    In addressing the claims limited to the “determining” step, the court also makes a strange distinction between “determining the levels” of a chemical (i.e., 6-TG) and “determining by mere inspection.” The court seems to imply that the latter sort of determinatino would not be considered sufficiently transformative. It is anybody’s guess as to where “some form of manipulation” ends and “mere inspection” ends. What about opening a mouth to look into the patients throat?

    Anyway, I know Justice Breyer reads this blog every morning so hopefully he’ll express his eagerness to hear the case the next time he’s giving a public lecture somewhere.

  76. 6-
    Maybe I’m reading the wherein clause too broadly, but it says “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” etc.

    On second thought, I think you’re right–you can infringe even without actually increasing/decreasing the dosage in light of the test measurement…

  77. Actually smash, there is no increasing of the drug dosage, and there is no decreasing of the drug dosage that I can find in the claim. Perhaps you could specifically show me where you found these limitations?

  78. From the slip opinion:

    “Claim 1 of the ’623 patent is representative of the independent claims asserted by Prometheus in this case:
    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 administered to said subject.

    Claim 1 of the ’302 patent is substantially the same, with the inclusion of determining 6-MMP levels in addition to 6-TG.”

    So these claims consist essentially of (1) administering a well-known drug (prior art); (2) “determining” the level of a metabolite induced in the patient by administering said drug (arguably a natural phenomenon); and (3) increasing the drug dosage if the measured metabolite concentration is too low, or decreasing the drug dosage if the measured metabolite concentration is too high (obvious in light of (2)).

    Let the verbal brickbats fly, but I’ll say flat out it’s a travesty these claims were upheld. I sincerely hope SCOTUS takes this case and overrules this nonsense.

  79. “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 administered to said subject.”

    Funny enough, some hypothetical wherein clauses are not drafted so as to limit the claim.

  80. Re: “That claim involved only two steps: (1) assaying a body fluid for its homocysteine level; and (2) correlating high homocysteine with a vitamin deficiency.”

    Claim 1 of the present “’623 patent is representative of the independent claims asserted by Prometheus in this case:
    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 administered to said subject.”

    That looks like only 2 steps to me, administering and determining ….with determining being similar to assaying, and correlating being similar to determining, here determing a LOW value of stuff A is correlated to not enough stuff A (duh) and in metabolite too much stuff B was correlated to there being too little stuff C….

    No consistency problem here….

Comments are closed.