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Justice Breyer to Diagnostic Test Patentees - “Abandon Hope All Ye Who Enter Here.”

Kevin Noonan recently posted an article entitled “The Fantastical World of Justice Stephen Breyer” that demonstrates, via Breyer’s quotes during various oral arguments, his suspicion that the patent system is, for example, issuing broad, hard to understand, claims that lead to “national monopolies” and encourage trolls to  harass “small businessmen.” Breyer certainly appears to be leading the court in this area – he authored Mayo after all. No matter what Dr. Noonan thinks about his rhetoric, his anti-patent bias is clear, and has been for some time.

Noonan’s article encouraged me to re-read Breyer’s dissent from the Court’s refusal to decide whether or not the diagnostic claim at issue in Laboratory Corp. of Amer. Holdings v. Metabolite Labs., Inc. was patent-eligible under s. 101. (Breyer’s “Metabolite Labs. Dissent.”) (A copy can be found at the end of this post.) This remand occurred in 2006. The Fed. Cir. was still using the “useful, concrete and tangible result” test of State Street Bank, which morphed into the machine or transformation test by the time Bilski was decided. Both “tests” were urged to be applicable to the diagnostic claim at issue, but Breyer found no transformation recited in the claims and no precedent in the u-c-t test.

Claim 13 read as follows:

“A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of:

assaying a body fluid for an elevated level of total homocysteine; and

correlating an elevated level to total homocysteine in said body fluid with a  deficiency of cobalamin or folate.”

You cannot write a simpler “If A, then B” diagnostic test than that—no sampling step and no method-of-treatment step. Unlike, Mayo, no reference level for HCys is given, it simply ends with a mental step.

Apart from the policy issues which bothered – and still bother “the Breyer IP Court,” Breyer simply seems unable to see the difference between an in vivo natural correlation (a noun), such as “a body fluid having x ug/ml HCys and y ug/ml cobalamin,” or simply “having elevated HCys and depressed cobalmin” and the mental step where the tester or doctor correlates (a verb) the levels found in a particular patient with normal or depressed cobalamin. It is this inability to separate the natural phenomenon from the practical result of using it in a diagnostic assay that is causing the chaotic jurisprudence and patent examination that we are all living with today. Also please read my post on GCG (4/26/16) – Judge Dyk explicitly said that the discovery/application of the correlation cannot provide the “inventive step” needed to impart patentability under the Mayo/Alice test. The PTO Examination Guidelines have taken the same position about “simple” biomarker-based assays. The analytics I have seen on rejections in art areas handling these applications prompted the use of the Dante quote in the title – that sign was posted at the entrance to Hell.

If a judge, defendant or anyone else with standing wants to limit the reach of the patent system by excluding diagnostic claims and method of medical treatment claims, the Metabolite dissent is the place to start. If you ignore the mental step based on the discovery of the correlation, it is easy to agree with LabCorp, just as Breyer did:

“There can be little doubt that the correlation between homocysteine and vitamin deficiency set forth in claim 13 is a ‘natural phenomenon.’ That is what the petitioners argue. It is what the Solicitor General has told us…..Indeed it is close to what the respondents concede….(‘The correlation between total homocysteine and deficiencies in cobalamin and folate that the Inventors discovered could be considered, standing alone, a ‘natural phenomenon’ in the literal sense: It is an observable aspect of biochemistry in at least some human populations.’)” [Ed. Note: ‘next time’ omit observable.]

But Metabolite Labs. needed to argue that the correlation, standing alone, is not the only element in the claim. It argued that there are discrete testing and correlating steps. But now the natural in vivo correlation (noun) sounds like the mental step. Met. Labs. did argue that claim 13 is a patentable “application of a law of nature.”

A few more sentences on that topic might have been difficult to rebut, but it defined “application of a law of nature” as requiring a physical transformation and a useful, concrete, and tangible result. This let Breyer skip having to discuss the key point and simply to express his dissatisfaction with these soon to be discarded tests: “And here, aside from the unpatented test [for HCys], they embody only the correlation between homocysteine and vitamin deficiency that the researchers uncovered. In my view, that correlation is an unpatentable ‘natural phenomenon’ and I can find nothing in claim 13 that adds anything more of significance.”

Shades of Mayo! Justice Breyer has seen his relatively brief dissent mushroom into one more “rigid test” that, in any case, nobody can apply with any logical consistency. Like the waifs in Oliver!, everyone is left wanting the elusive “more” required to get a claim to a diagnostic test that uses a natural phenomenon and/or natural product. If the Sequenom petition for cert. is granted (which I hope it is not, since there is only one very broad diagnostic claim), he will again have his chance to rail against monopolies, trolls and other evils of the patent system. I hope he tells us how to apply the Mayo/Alice test in a way that can result in patentable subject matter. Until then, this version of the Divine Comedy rules.



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