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Oral Argument in Mayo v. Prometheus – Why Mayo Will Lose

On December 7th at 10:05 a.m., the Supreme Court heard oral arguments (transcript at end of this post) in the “Prometheus case,” presented by Stephen M. Shapiro of Meyer Brown (Mayo) and Richard P. Bess of Latham & Watkins. Solicitor General Verrilli also argued.  In earlier posts on this appeal, e.g., on November 7th, I noted that Mayo’s brief de facto asks the Court to follow the “LabCorp dissent” (548 U.S. 132, 136). In this dissent from a dismissal of cert. as improvidently granted, Justice Breyer, joined by Souter and Stevens, urged the Court to consider that all simple diagnostic tests that correlate a level of a chemical marker (like homocysteine) to a pathology (like a vitamin deficiency) are no more than impermissible attempts to patent natural phenomena: “[T]he process is no more than an instruction to read some numbers in light of medical knowledge.”

Mr. Shapiro was asked by Justice Breyer what further limitations were necessary in a claim arguably reciting a natural phenomenon, so that all uses of the natural phenomenon were not preempted (“What do you have to add? And it can’t be that you take the law of nature out and look to whether the rest of it meets the patent criteria….But look, what do you want to say the rest of it has to add up to?”) Mr. Shaprio answered that “the rest of it has to add up to some step that limits the natural phenomenon, so that you have a concrete, specific…[interrupted at this point].” The questioning then focused on the breadth of the claims.  Justice Scalia suggested that a solution to the problem might be to recite individual diseases, rather than to recite all autoimmune diseases, Mr. Shapiro interrupted and tried to invoke the claim at issue in LabCorp:

“No it wouldn’t [be sufficient to recite individual diseases]. That would be LabCorp, where there was just one malady in the patent; it was a vitamin deficiency with a natural correlation. And Justice Breyer’s opinion explained that – that is too preemptive of the natural phenomenon.”

However, here the roof on this shaky construct collapses. Justice Breyer has apparently had second thoughts about the “LabCorp dissent”:

“Yeah, but what my opinion lacked, and frankly, and sometimes that’s the virtue of a dissent in such a case, it lacked – and Novartis points this out very well in their brief—it lacked an explanation as to why what I thought was a patent just said, observe the correlation – [Mr. Shapiro, “Yes.”] –why isn’t that an application of a law of nature? And if you look to LabCorp’s dissent to find an answer to that question, you are better than I because I couldn’t find it.”

Turning to Novartis’ amicus brief, one finds the arguments that Justice Breyer is referencing at pages 9-10:

“[O]ne may not patent a law of nature itself, but may patent an application of it for ‘new and useful’ ends. This should not be viewed as an unusual balance to strike; virtually any useful patent claim must ultimately rely on laws of nature to generate useful results.”

“[D]iagnostic-process claims, like the therapeutic-process claims at issue here, are not simply directed to the law of nature itself, but to a practical application of a law. They invariable require the detection of a biomarker and take advantage of a natural correlation between that bio-marker and a disease to make a diagnosis and thereby inform a course of treatment, if needed or desired. Hence they to not offend s. 101.”

While Justice Breyer continued to question Mr. Bress about “what has to be added to a law of nature to make it a patentable process,” the relative lack of questions posed to Mr. Bess indicates to me that, at least most of the Justices “get” Prometheus’s position. In fact, during Mr. Shapiro’s rebuttal, which mostly attacked the utility of the patent claims, Justice Sotomayor pretty much nailed the flaw in Mayo’s arguments:

“I guess my problem is, if we call this just simply an application of natural phenomenon or of a natural process, why are treatment patents at all [Mr. Shapiro attempts to interrupt] permissible, meaning if someone finds out that at level 300 it’s bad, and tells doctors to stop, that’s natural, too.”

Earlier, the Solicitor General had argued, in an answer to a question from Justice Alito about natural phenomena:

“[T]he difference here is that there is a conversion of the natural body chemistry. The metabolites wouldn’t be in the body but for the administration of these drugs. And I do think if one were to say that this is a natural phenomenon –and this is what I mean about the destabilizing risk of thinking about this as a 101 issue rather than 102 or 103—you’re going to call into question lots and lots, thousands in fact, of medical use patents where the patent is: Administer a therapeutically effective dosage of this drug in order to treat this disease.”

Game-set-match. The Court is not going to risk this. I see no worse than a 7-2 decision for Prometheus, with Roberts, and perhaps Kagan, dissenting. How’s that for going out on a limb?



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