Did the Federal Circuit Misapply the Transformative Standard in Bilski in Prometheus Labs v. Mayo?

I had been meaning for quite some time to comment on what appears in this quarter to be a clearly erroneous holding on the law in the Federal Circuit’s ruling in the Prometheus case (Prometheus Laboratories, Inc. v. Mayo Collaborative Services), currently on petition for certiorari as follows:

No. 09-
In the Supreme Court of the United States


Petition for a Writ of Certiorari to the United
States Court of Appeals for the Federal Circuit


Fish & Richardson P.C.
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Counsel of Record

Mayer Brown LLP
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Chicago, IL 60606
(312) 782-0600

Counsel for Petitioners


The Federal Circuit, reversing the district court, upheld Prometheus’s patent claims covering a process for correlating the level of certain chemicals in a patient’s blood with the patient’s health. By those claims, Prometheus seeks to monopolize the use of blood tests in the research, diagnosis, and treatment of disease, such that a physician violates the patent merely by thinking about the correlation between the test results and the patient’s health or treatment. This Court granted certiorari to determine whether basic scientific relationships may be monopolized in this way in Laboratory Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124, 135 (2006) (“LabCorp”), but dismissed the writ for lack of adequate issue preservation. Dissenting from dismissal, Justices Breyer, Stevens, and Souter explained that such patents are invalid under this Court’s precedents, and that resolving the issue presented in LabCorp was of great importance to innovative scientific inquiry and effective medical research and treatment.

The question presented is as follows:

Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between patient test results and patient health, so that the claim effectively preempts all uses of these naturally occurring correlations.

Eugene Vokokh writes at the Volokh Conspiracy:

As we argue in the petition,

Prometheus’s claims … attempt to exclude the public from using the results of basic human metabolic testing in the research, diagnosis, and treatment of disease. They do so by claiming protection for the process of recognizing a correlation between the level of certain chemicals in the patient’s blood and the patient’s health…. [T]he claims are silent as to what should be done with such correlations and as a result purport to cover and thus preempt all possible uses of the biological correlations….

Prometheus’s broad patent claims attempt to turn a physician’s thought processes into infringement…. Importantly, Prometheus’s claims do not recite what is to be done once the physician recognizes the correlation [based on blood test results]. As a result, the claims cover and preempt all such uses. They begin and end with observation of the test results. What the physician might do with that observation is irrelevant because simply thinking about the subject suffices to infringe the patent. As Prometheus’s expert testified, if the physician reads an email with the test results, it would not matter if she “crumples it up, throws it away, reads it, acts on it, doesn’t act on it, any assumptions you want to come up with.” The physician infringes the moment she recognizes the correlation.

As previously noted, I wanted to comment this case already before the petition for certiorari, but I did not get to it. However, I was once again jogged into action recently when I ran across the following posting by Eric W. Guttag at CAFC: Method for Calibrating Drug Dosage Is Transformative | IPWatchdog.com | Patents & Patent Law where he writes inter alia:

“In reversing the district court’s ruling in Prometheus, Judge Lourie, writing for the Federal Circuit panel, was faced with the unenviable task of trying to reconcile the “natural phenomena” prohibition with the Bilski “machine or transformation” test. First, Judge Lourie concluded that the “administering” and “determining” steps of the patented drug dosage calibration method were “transformative.” Specifically, the “transformation is of the human body following administration of a drug and the various chemical and physical changes of the drug’s metabolites that enable their concentrations to be determined….

With all due respect, Judge Lourie’s opinion in Prometheus is clear evidence of how tortuous it is to apply the Bilski “machine or transformation” test objectively to drug dosage calibration methods like those in Prometheus. In fact, the earlier non-precedential 2008 per curiam decision in Classen Immunotherapies, Inc. v. Biogen Idec presaged how arbitrary the Bilski test can be when applied to such drug/medical dosage calibration techniques. Classen, which came out not long after Bilski, is astounding for its brevity (one paragraph of 69 words), or as Kevin Noonan poignantly observed, the claimed method for essentially calibrating an immunization schedule for a treatment group, relative to a control group, was longer than the opinion by 20 words. But more significantly and as I commented when it came out, Classen is ghastly for completely failing to explain how this “new” Bilski test was applied to the claimed immunization schedule calibration method. And while Prometheus does far more than Classen to explain how Bilski should be applied to such drug/medical dosage calibration methods, I still see much “straining” in Judge Lourie’s opinion in trying to reconcile the “natural phenomena” prohibition with the “machine or transformation” test.”

Read Guttag’s full posting here.

We agree that the Federal Circuit opinion is “strained”, to put it mildly. Judge Lourie’s patent decisions do not bear the good seal of the future in our book.

Guttag’s reasoning reminded us of the core logic in Lab Corp v. Metabolite Labs, where certiorari was dismissed as improvidently granted. The Fire of Genius wrote about that:

“Reviewing LabCorp’s brief on the merits, as well as a number of amicus briefs, Crouch reported in December 2005 that “[a]ccording to LabCorp, the claim involves ‘no actual invention beyond the scientific discovery it recites.’ The claimed correlation is a scientific principle or law of nature, and its discovery alone cannot be patentable,” according to LabCorp.”

In view of the upcoming Supreme Court decision in the Bilski case, it is most certainly instructive to look at the Federal Circuit’s confused decision in Prometheus, where the holding, to again quote Guttag, was as follows:

[T]hat the “administering” and “determining” steps of the patented drug dosage calibration method were “transformative.” Specifically, the “transformation is of the human body following administration of a drug and the various chemical and physical changes of the drug’s metabolites that enable their concentrations to be determined….

EVERY legitimate medication or diagnostic test – patentable or not – will in some manner affect the human body, so that the impact of any medication or diagnostic test on the human body is, in our view, NOT the transformative element required by Bilski. All medicines and diagnostic tests by their very nature are intended to cause changes or measure changes in the human body, but the human body is not thereby “transformed” but remains the fundamental human body that it is. Standard blood tests are not a “transformation”. Nor can it be that any medication or test is transformative simply because the patent claimant claims that it affects the human body.

Rather, the medication or the diagnostic test must itself involve a physical transformation of the invention vis-a-vis prior art. A needle that takes human blood for blood testing can be improved in form and function – THAT is an invention, but such a needle can not claim a monopoly on blood-taking. Similarly, a well-calibrated thermometer can be improved in its physical technology to measure the not always constant human temperature by various means and at various locations on or in the body, but it can not thereby claim a monopoly on calibrated thermometers to measure human temperature or reserve certain areas of the body as monopoly zones. Similarly, radioisotopes or – less effective – dyes are injected into the human body as aids in finding lymph nodes nearest to tumors, but no one should be able to claim an exclusive monopoly on using these methods for diagnosis. Particularly the latter example is closely analogous to Prometheus because the injected material is used for diagnosis and the human body is “affected”, i.e. “marked”, by the injection. That is not the transformation that Bilski is talking about.

On petition for certiorari, Mayo correctly asks the Supreme Court, as noted at Patently-O:

Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between patient test results and patient health, so that the claim effectively preempts all uses of these naturally occurring correlations.”

Obviously, the answer is no, and we hope that the SCOTUS is wise enough to so find.

As the Federal Circuit wrote – without, however, holding accordingly – this is an attempt to patent methods – rather than a physically transformed invention:

“Prometheus is the sole and exclusive licensee of the ’623 patent and the ’302 patent. The patents claim methods for calibrating the proper dosage of thiopurine drugs….”

Naturally occurring correlations viz. processes in the human body – if the Supreme Court of the U.S. (SCOTUS) correctly decides the matter – can never serve as the basis for a transformative patent claim. Otherwise, this would grant ANY medication or diagnostic test monopoly rights on the respective affected naturally occurring correlation in the human body that is being medicated or diagnosed, and no other medication or diagnostic test would be able to impact or test those correlations or processes without violating somebody’s patent.

Medical devices or diagnostic test kits that test naturally occurring correlations or processes can be patented, but the correlations or processes themselves can not be subject to patentable monopoly claims. That seems so elementary as to defy legal rebuttal.

As the – wrongly over-ruled District Court – had already correctly decided (we quote from the Federal Circuit opinion):

“The court stated that the inventors did not “invent” the claimed correlation; rather, “6-TG and 6-MMP are products of the natural metabolizing of thiopurine drugs, and the inventors merely observed the relationship between these naturally produced metabolites and therapeutic efficacy and toxicity.” Invalidity Opinion, 2008 WL 878910, at *7.”

Hence, the Prometheus case must be reversed and the Bilski standard must be clarified to point out that the transformative test must apply to the physical invention – here a diagnostic test – itself, not to its impact on human beings. Nearly EVERYTHING we make impacts human beings, one way or another. That is not the transformation Bilski is talking about.

In the instant case, Invention A – let us say Test Kit A – can test the metabolites X and Y and Invention B – a completely different Test Kit B – can test the metabolites X and Y, but Invention A can not bar any other inventions that test metabolites X and Y just because they test them. Rather, the physical test kit itself – if it is an invention – must be infringed for patent infringement to be present. Conversely, Test Kit B, if later in time to Test Kit A, must involve a physical transformation – which it does in this case – as the Mayo Kit – as opposed to previously existing Prometheus Kit – is intended to use different – and we presume, improved – calibration levels to determine toxicity. That’s progress. As the Federal Circuit wrote:

“Prometheus marketed a PROMETHEUS Thiopurine Metabolites test (formerly known as the PRO-PredictRx® Metabolites test) that used the technology covered by the patents in suit. Mayo Collaborative Services and Mayo Clinic Rochester (together, “Mayo”) formerly purchased and used Prometheus’s test, but in 2004, Mayo announced that it intended to begin using internally at its clinics and selling to other hospitals its 2008-1403 own test. Mayo’s test measured the same metabolites as Prometheus’s test, but Mayo’s test used different levels to determine toxicity of 6-TG and 6-MMP…. Mayo rescinded its announcement shortly after the lawsuit was filed and still has not launched its test.”

As it stands, there is no transformative difference between the Prometheus calibration test and the hedge fund method that was found non-patentable in Bilski. Prometheus is not trying to get a monopoly on an invented medical device or to protect a patent on a particular invented Test Kit – it is trying to get a monopoly on a diagnostic method and is trying to prevent others from using that method anywhere, in any way and in any form, to the detriment of the health of everyone, and only for the sake of their own pocketbook.


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