Guest Posts: Preparing for Mayo v. Prometheus Labs

By Professor John Golden, Professor in Law, The University of Texas at Austin

Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (S. Ct.)

Scheduled for oral argument on Wednesday, December 7, 2011

In Mayo Collaborative Services v. Prometheus Laboratories, Inc., the U.S. Supreme Court looks to address questions of whether and when certain types of medical methods are patentable subject matter. Prometheus specifically involves methods for optimizing patient treatment in which the level of a drug metabolite is measured and a measured level above or below a recited amount "indicates a need" to decrease or increase dosage levels. In 2005, the Court granted certiorari on related issues in Laboratory Corp. of America v. Metabolite Laboratories, Inc., but the Court later dismissed LabCorp as improvidently granted. In 2010, the Court reaffirmed the existence of meaningful limitations on patentable subject matter in Bilski v. Kappos, but the Court but did little to clarify the scope of those limitations.

Will Prometheus bring light where Bilski failed? Arguments to the Court invite it to further clarify the status of the machine-or-transformation test for process claims. Bilski indicated that this test is relevant but not necessarily decisive, and the Federal Circuit relied heavily on the test in upholding the subject-matter eligibility of Prometheus's claims. In the circuit's view, "asserted claims are in effect claims to methods of treatment, which are always transformative when one of a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition." Likewise, a metabolite-level measurement step was found to "necessarily involv[e] a transformation." Although Prometheus's claims include "mental steps," the circuit emphasized that the inclusion of such steps "does not, by itself, negate the transformative nature of prior steps."

Prior posts provide additional background on the Prometheus case. The first wave of merits briefs have been filed. These include the opening brief for the petitioners, briefs in support of the petitioners, and briefs in support of neither party. The respondent-patentee's brief as well as supporting amicus briefs will be due in the upcoming weeks.

BRIEF FOR PETITIONERS (Stephen Shapiro, Mayer Brown): Prometheus's patent claims violate Supreme Court precedent forbidding claims that "preemp[t] all practical use of an abstract idea, natural phenomenon, or mathematical formula." Prometheus's claims "recite a natural phenomenon—the biological correlation between metabolite levels and health—without describing what is to be done with that phenomenon beyond considering whether a dosage adjustment may be necessary." The claims' drug-administration and metabolite-measurement steps are merely "'token' and 'conventional' data-gathering steps" that cannot establish subject-matter eligibility. Patent protection is unnecessary to promote the development of diagnostic methods like those claimed and will in fact interfere with both their development and actual medical practice.


AARP & PUBLIC PATENT FOUNDATION (Daniel Ravicher, Public Patent & Cardozo School of Law): "Allowing patents on pure medical correlations … threatens doctors with claims of patent infringement" and "burdens the public with excessive health care costs, and dulls incentives for real innovation." "The Federal Circuit has latched on to trivial steps beyond mental processes, such as the 'administering' step in this case, to uphold patents that effectively preempt all uses of laws of nature." Prometheus's recitation of an "administering" step stands "in stark contrast to most pharmaceutical patents that require a 'therapeutically effective amount' of a drug be administered."

ACLU (Sandra Park, ACLU): In assessing subject matter eligibility, the Supreme Court "has focused on the essence of the claim," using a "pragmatic approach [that] allows the Court to see through clever drafting." Prometheus's insertion of drug-administration and/or measurement steps into a claim "does not alter the fact that the essence of the claim is the correlation between thiopurine drugs and metabolite levels in the blood." Further, the First Amendment bars Prometheus's claims. "What Prometheus seeks to monopolize … is the right to think about the correlation between thiopurine drugs and metabolite levels, and the therapeutic consequences of that correlation."

AMERICAN COLLEGE OF MEDICAL GENETICS ET AL. (Katherine Strandburg, NYU School of Law): The patents at issue "grant exclusive rights over the mere observation of natural, statistical correlations." They "convert routine, sound medical practice into prohibited infringement" and generate burdens and conflicts for patient care and follow-on innovation. "The machine or transformation test is inapposite … to determining whether a claim preempts a natural phenomenon." It can be too trivially satisfied without shedding sufficient light on whether claims "reflect inventive activity" or "improperly preempt downstream uses of the phenomenon."

ARUP & LABCORP (Kathleen Sullivan, Quinn Emanuel): "The patents assert exclusive rights over the process of administering a drug and observing the results…. This not only blocks the mental work of doctors advising patients, but also impedes the progress of research by seeking to own a basic law of nature concerning the human body's reaction to drugs." "Patents on measurements of nature" raise constitutional concerns by removing factual information from the public domain, thereby conflicting with patents' constitutional purpose to "promote the Progress of Science and useful Arts" and threatening to chill "scientific and commercial publication."

CATO INSTITUTE ET AL. (Ilya Shapiro, Cato Institute): This case provides the Supreme Court with an opportunity to strike a blow against the "thousands of abstract process patents which have been improvidently granted since the 1990s" and that are already adversely affecting software and financial innovation. Historically, patentable "processes" "aimed to produce an effect on matter, and these patents do not." The "indicat[ing] a need" clauses in Prometheus's claims do not even form part of a process because they do "not describe an action." Patent claims such as these, "whose final step is mental," impermissibly tread on the public domain and "freedom of thought."

NINE LAW PROFESSORS (Joshua Sarnoff, DePaul College of Law): The Supreme Court "should expressly recognize" that the Constitution requires that "laws of nature, physical phenomena, and abstract ideas" be treated as prior art for purposes of determining patentability. "Allowing patents for uncreative applications would effectively provide exclusive rights in and impermissibly reward the ineligible discovery itself." Barring claims like Prometheus's under section 101, as opposed to relying on patentability requirements such as novelty and nonobviousness, promotes "efficient gate-keeping" and "sends important signals."

VERIZON & HP (Michael Kellogg, Kellogg Huber): "It is longstanding law that a claim is non-patentable if it recites a prior art process and adds only the mental recognition of a newly discovered property of that process." See Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242 (1945). "This principle is soundly based on Section 101's limitation to processes and products that are not only 'useful' but 'new.'" "[A]dding to the old process in Prometheus's patent claims nothing more than a mental step of recognizing the possible health (toxicity or efficacy) significance of the result of the process does not define a 'new and useful process.'"


UNITED STATES (Solicitor General Donald Verrilli, Jr.): The claimed methods recite "patent-eligible subject matter," and petitioners' objections to patentability are properly understood as challenges to the claimed methods' novelty and nonobviousness. By analogy with "patent law's 'printed matter' doctrine," the claims should ultimately be found invalid because, as construed by the district court, they "merely … appen[d] a purely mental step or inference to a process that is otherwise known in (or obvious in light of) the prior art." But the Supreme Court should affirm the Federal Circuit's holding on subject matter eligibility.

AIPPI (Peter Schechter, Edwards Wildman): AIPPI "encourages all member countries to allow medical personnel the freedom to provide medical treatment of patients without the authorization of any patentee." Unlike the U.S. and Australia, most countries "exclud[e] methods of medical treatment of patients from patent eligibility." When the medical-practitioner exemption of 35 U.S.C. § 287(c)(1) applies, "the courts lack subject matter jurisdiction." The exemption applies to the defendants, who "are plainly 'related health care entities.'" Thus, "the case should be dismissed for lack of federal subject matter jurisdiction."

MICROSOFT (Matthew McGill, Gibson Dunn): Subject-matter eligibility tests should not involve "pars[ing] the claimed invention into the 'underlying invention' and those aspects that are 'conventional' or 'obvious' or insignificant 'extra- or post-solution activity.'" Such parsing lacks any guiding principle that can make its application predictable. Petitioners seek an improperly "expansive application of the mental steps doctrine." "[I]f every step of a process claim can be performed in the human mind, that process is unpatentable." But the Federal Circuit has improperly "extended th[is] principle to apply to machines or manufactures that replicate mental steps."

NYIPLA (Ronald Daignault, Robins Kaplan): Innovation's "bewildering pace" argues against "rigid categorization of patent-eligible subject matter." "[T]here is no basis for excluding processes directed to analyzing the chemicals in a patient's body from patent eligibility." When satisfied, the machine-or-transformation test should decisively establish eligibility. But failure of the test should not necessarily establish ineligibility. Preemption analysis "must incorporate a critical assessment of whether the claim at issue actually claims a fundamental principle as a fundamental principle in contrast to an application of that principle."

ROCHE & ABBOTT (Seth Waxman, WilmerHale): Patents are crucial for innovation in personalized medicine and more particularly for the continued development diagnostic tests that can enable such medicine's practice. Arguments "that patents on diagnostic tests stifle innovation and basic scientific research" are "largely based on speculation, rather than sound evidence." Generally speaking, "market-driven business practices and self-enforcing market norms correct for any perceived limitations on the accessibility of patented diagnostic technologies." Congress should be trusted to provide appropriate patent-law exemptions for medical practice and research.

333 thoughts on “Guest Posts: Preparing for Mayo v. Prometheus Labs

  1. 333

    Readers must be at a loss to understand the reason for such convoluted claims.

    A possible US claim might read:

    A method for treating a subject suffering from ulcerative colitis, Crohn’s disease or another immune-mediated gastrointestinal disorder, which comprises administering to said subject a drug providing 6-thioguanidine (6-TG) at a predetermined therapeutically effective and non-toxic dose individualised for said subject such that the level of 6-TG in 8 x 10^ 8 red blood cells is between 230 and 400 pmol.

    A reasonable EPO claim might read:

    A drug providing 6-thioguanidine (6-TG) for administration to a subject suffering from ulcerative colitis, Crohn’s disease or another immune-mediated gastrointestinal disorder at a predetermined therapeutically effective and non-toxic dose individualised for said subject such that the level of 6-TG in 8 x 10^8 red blood cells is between 230 and 400 pmol.

    The novelty of both claims is that the dose is predetermined and individualised for the patient such that it falls within the narrow therapeutic window where it is neither ineffective nor toxic.

    The problem in this case is that a perfectly legitimate invention is disguised by unduly convoluted and arguably not very apt claim drafting.

  2. 332

    Listen, sockie,  both the Supreme Court and Congress seem to want to distinguish between technological and non technological business methods.  If a claim passes the MOT, it clearly is technological.  The claim at bar in Bilski did not pass the MOT and was found wanting.  

    So we have the universe fairly well divided.  BMPs that pass the MOT are patent eligible.  Those that do not are not.

    I think that just about describes it.  

    Regarding Section 18 of the AIA, Congress may want to fix it to clearly extend the subject matter for the post grant review to Section

  3. 331

    A little reverse logic:

    Ned: Medical method patents are NOT categorically EXCLUDED. (Yes, I know, Ned has never actually gotten around to saying this – he tucks his manhood under his skirt and runs away every time someone tries to get him to look at this extension of his position).

    The double negative implies a positive: that Medical method patents are patent eligible.

    That is what you and other sockpuppets actually said, and repeatedly so. Medical method patents are patent eligible.

    Since we know that this cannot be, the only logical recourse is that ALL Medical method patents MUST be patent ineligible.


  4. 330

    Feel free to ignore the actual point (as is your custom) in order to focus on the messenger.


    I did not intend to comment on the substance of the comments — just AI’s attitude.




    Way to call out the bogus response nearly four hours before it hit the boards.

  5. 329

    Total BS what Ned said. But rather than give him an out to answering the Simple Question above, I will join in the holding of the feet to the fire.

    Ned, Can you please answer the question??????

  6. 328

    Anon, you are fricken jerk. Here is the sequence:

    Ned: “And finally note, the former definition [of business methods] in section 273 has been repealed.”

    Anon: “Not repealed — expanded.”

    Ned: “Not on the point I made.”

    Anon, don’t bother to respond. You are officially on ignore once more.

    Anon: “Expressly on the point you attempted to make.”

    How the hades you can make even a short time in this world without someone leveling you for being the biggest A-hole on the planet is beyond me.

  7. 327

    His questions relate to substance of law – both legislative and case law at the highest levels of our system – he has asked. You have said you will respond. You now play more games with more strings, and then say you will respond.

    You sir, are an unmitigated l_iar.

    I love how posting in your own name provides for the type of control that we most desparately need.
    /off sarcasm

  8. 326

    Expressly on the point you attempted to make.

  9. 325

    (a) IN GENERAL.—Section 273 of title 35, United States Code,
    is amended to read as follows:"

    The as follows is the new 273, prior user rights section.  This new section has no mention of business methods.

  10. 324

    Ned, I asked, “If this was an act of Congress please provide the statute, and quote the text.”

    Yet you did not quote the text.

    I also asked, ” please do not cite the AIA without first addressing the substantive points made by Simple Questions above at Oct 21, 2011 at 11:26 AM”

    You did not address those substantive points.

    You have failed to redeem yourself.

  11. 323

    Notice the sustained ad hominem attack.

    I ask, is this not the mark of a true subversive?

    This despite your gentlemanly effort to offer a face saving out and debate on the issue and not the person.

    Still Ned refuses to do so.

    He desperately wants to negate the truth.

    He does not want to see a discussion that leads to the reason our PTO is situated under the Commerce Department.

    He knows it will further cast light on his real agenda and expose the shameless shilling his presence on this blog stands for.

  12. 322

    Okay, let’s end this:

    Whether there is any complex programming, be it technical, a machine or otherwise is irrelevant.

    There is no MOT or technology requirement. That is a irrefutable FACT.

    So your ability to prove or disprove “extensive” computer interface” and/or whether the steps required intricate or complex computer programming is irrelevant to 101 subject matter eligibility . See ( Diamond V Diehr).

    While the computer interface, programming Et al. might be a helpful clue,this case was ultimately decided on the DCAT, Diehr’s Concept and Application Test as are all post Bilksi 101 cases. (See Diamond V Diehr) ( Research Corp).

    Case Closed

    ::Bangs Gavel::

  13. 321

    I said I would respond to his questions related to substance.  If he makes points or asks, I'll respond.

    Sent from iPhone

  14. 319

    Anon, I did not intend to comment on the substance of the comments — just AI's attitude.

    Sent from iPhone

  15. 318

    anon, I am referring to In re Bilski's express overruling all of its prior cases to the extent that they depended on any test other than the MOT.  

    Now, that does leave the Federal Circuit wide open to develop new precedent other than the MOT, as you suggest.  I was simply advising Night that if he is relying on pre-Bilski authority, that authority is not reliable.

  16. 317

    “Also, given the express direction from the Supreme Court to “redevelop” the 101 jurisprudence, the recent Federal Circuit case on 101 after Bilski, most notably Research Corp Technologies and Ultramercial (with Ultramercial severely limiting the wayward and aberrant Cyborsource) are most likely the cases that are to be use and are being used by NWPA (and are being avoided by Ned).”

    Sounds about right.

  17. 316

    Just to make sure I understand what Ned has actually written (as opposed to what he may have thought that he has written), The recent Federal Circuit cases on 101, released after the Bilski decision, cannot be expressly overruled by Bilski. That wold be a procedural and logical impossibility (notwithstanding Michael R. Thomas’ time traveling invention).

    Also, given the express direction from the Supreme Court to “redevelop” the 101 jurisprudence, the recent Federal Circuit case on 101 after Bilski, most notably Research Corp Technologies and Ultramercial (with Ultramercial severely limiting the wayward and aberrant Cyborsource) are most likely the cases that are to be use and are being used by NWPA (and are being avoided by Ned).

  18. 315


    But that clearly is not the question.

    Can you please answer the question as you have said that you would?

  19. 314

    The thinking is, you do not need a “defense” to something that is not patent eligible to begin with.

  20. 313

    the real problem is that we need and “ingore” button that works.

    No. That is decidely not what we need. People already ignore the call for substance far too easily on this blog.

  21. 312


    What you call “constant harassment” is what others call a search for substance – exactly because there are no substance checks on this blog (like the aforementioned and denigrated blog).

    If you would pay half the attention you do to your “hurt feelings,” and half the effort you dole out to your constant evasions, there would not be any “constant harassment” because you would actually address those points necessary to support your constant agenda-driven posts.

    It really is that simple – answer the questions to you when the questions are asked and we all can move forward in the debates. Play the games (as you constantly decide to do) and people will keep on asking you to support the foundations of your position with correct statements of law.

    Not too hard to figure out.

  22. 311

    Ned, you seem to want to spread doubt about my postions without really addressing them. A pretty clear sign that your motives are not good.

    Benson unravels into vapor with just a little bit of thinking that isn’t based on 1920’s physics. I’ve shown you several ways of unraveling the psychotic mess of Benson and to date you haven’t address any of them, but rather made little snippet comments as if you are superior to me and that my comments should be viewed with caution.

    The Cybersource three should be removed for extending the holding Benson.

  23. 310

    This appears to be a meaningless requirement given that simple questions’ simple questions were repeats of questions put to you many times by many people and there can be no doubt that you are fully aware of just what the questions are.

    Yet another game from you, yet another evasion.

  24. 309

    Not repealed – expanded. There is a mighty difference.

  25. 308

    The lecture fits.

    MaxDrei needs the lecture.

    You still have not provided an actual substantive rebuttal to the points of the lecture.

    Whether or not he was “simply making a point,” the fact remains that he was making a point – and a good one.

    Feel free to ignore the actual point (as is your custom) in order to focus on the messenger.

  26. 307

    IANAE, I too am very tired of the constant harrassment by a few posters here.

    Malcolm and I have repeatedly called for Dennis to do something about it. Nothing has happened.

    So, if you don’t seem me for awhile, you know why.

  27. 306


  28. 305

    Night, back for section 112 paragraph 6, the Supreme Court really had a problem with inventors claiming all ways of achieving a result having invented only one machine for doing so.

    They viewed method claims involving machines and and around the general rule.

    Since the 1952 act however, judge Rich has done his best to put these cases into the ashcan of history with a rule of construction that limits the claims to the machines or steps disclosed in the specification and their equivalents.

  29. 304

    Night, you have to be careful about what cases you rely on. Most of the recent Federal Circuit cases on 101 were expressly overruled by Bilski.

  30. 303

    anon, the Federal Circuit premised its holding in Prometheus on the fact that the claims at issue passed MOT.  My comment was directed to Prometheus case and this holding.

    If you followed this thread in any detail, you will notice that I believe that the MOT operates on claims as a whole.  What the Federal Circuit did in Prometheus was to dissect the claim, determine that the MOT operated on claim elements, rather than on the claim as a whole, and then stated that the claim was patentable subject matter.  Such is not, in my opinion, the MOT test, at least not when MOT is operating on the claim as a whole.

  31. 302

    when?  When he addresses the question to me in a post that shows up on my e-mail.

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