Tuesday, December 10, 2019

US Solicitor General Calls for Reconsideration of Mayo v Prometheus

Hikma Pharmaceuticals v. Vanda Pharmaceuticals, 16-2707, 1887 F3d 1117 (Fed Cir 2018) petition for certiorari No 18-817
            US 8,586,610

The patentable subject-matter jurisprudence of the Supreme Court of the United States is a train wreck of historic proportions. In the brief of the United States recommending that the Supreme Court of the United States deny certiorari in Hikma Pharmaceuticals v. Vanda Pharmaceuticals, 16-2707, 1887 F3d 1117 (Fed Cir 2018). the US Solicitor General has joined the chorus of voices calling for reconsideration of SCOTUS’s framework for assessing patentable subject-matter, especially as set out in Mayo v Prometheus 566 US 66 (2012) (hat tip to Patent Docs).

The 610 patent relates to the use of iloperidone to treat schizophrenia. The drug was already known for that use, but the inventors had discovered that people with a specific genetic variant, the “CYP2D6 genotype,” did not tolerate it well. The representative claim 1, in effect claimed testing a patient for the CYP2D6 genotype and administering a reduced dose to those who did not tolerate the drug. As pointed out by Patently-O, the claim at issue in Hikma v Vanda is substantively very difficult to distinguish from the diagnostic method claim at issue in Mayo. However, in Hikma it was framed as a method of treatment claim—”A method for treating a patient” comprising testing and then administering iloperidone at a low or high dose according to the results—while in Mayo the claim was to “A method of optimizing therapeutic efficacy for treatment” of the disorder at issue, comprising a step of “determining the level” of the relevant analyte, such that the result “indicates a need” to increase or decrease the drug. In the Fed Cir, the majority in Hikma nonetheless held the claim to be patentable subject matter, distinguishing Mayo on the basis that in Hikma the claims include specific treatment steps rather than merely directing the physician to consider the test results. Prost CJ, in dissent, was of the view that Mayo was not distinguishable.

In its brief, the Solicitor General has now argued that cert should be denied, on the basis that the majority had gotten the right result on the facts (21). However, the Solicitor General (12-13, 15) acknowledged the force of Prost CJ’s logic. More importantly, the Solicitor General did not confine itself to the particular claim at hand. Throughout the brief, the Solicitor General emphasized that the logic of Mayo calling into question the patentability of many types of inventions that have long been considered to be unquestionably good subject matter:

Nevertheless, as evidenced by the dissenting opinion below, it is arguably unclear how the longstanding and entirely correct rule that method-of-treatment claims are patent-eligible can be reconciled with mechanical application of Mayo’s two-step framework. (10)

Indeed, it is arguably unclear whether even a method of treating disease with a newly created drug would be deemed patent-eligible under a mechanical application of Mayo’s two-part test. (14, original emphasis).

The brief as a whole is a sustained critique of Mayo. The question is not if Mayo should be reviewed, but when; the brief argues that this is not the right case to address the “confusion” caused by the recent SCOTUS jurisprudence: “instead should provide additional guidance in a case where the current confusion has a material effect on the outcome,” in particular a diagnostic method case such as several where the Fed Cir has indicated that it might have gone the other way but for Mayo.

I wonder if the Solicitor General has another motive in recommending that cert be denied in Hikma. While the Solicitor General is of the view that Mayo needs to be rolled back, it’s not evident that SCOTUS will agree. If they take a diagnostic methods case and affirm that diagnostic methods are unpatentable, this would be bad, but only in the same way that the status quo is bad. If they took Hikma and reversed it, holding Mayo really does apply, the situation would be even worse than it is already.

I won’t say more than that: Patent Docs provides a longer review, and the brief itself is well worth reading for those with a real interest. (I might quibble with the analysis a little bit; the brief suggests that the root of the problem is Bilski, which marked a sharp departure from prior SCOTUS jurisprudence when it added expressly non-statutory exceptions to patentability (4, 8). In my view, the roots of the problem go deeper, back to Funk Bros: see The Rule Against Abstract Claims: A Critical Perspective on US Jurisprudence, (2011) 27 CIPR 3. But this is a minor point: I do agree that Bilski was a turning point and turning the clock back that far would be an improvement.)

Unfortunately, this debate remains relevant in Canadian law. The modern SCOTUS approach is clearly inconsistent with Shell Oil [1982] 2 SCR 536, the leading SCC decision on patentable subject matter. Unfortunately, CIPO has gone its own way on the issue of patentable subject matter, and diagnostic methods in particular, apparently inspired by US case law. It seems inevitable that the issue will be litigated in Canada, and when it does, the Solicitor General’s brief should give Canadian courts fair warning that the SCOTUS jurisprudence should not be followed.

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