Solicitor General Weighs in on Section 101, Prompts High Court to Grant Review in Athena Diagnostics v. Mayo Collaborative Services

By Andy Halaby

At the Supreme Court’s request, the Solicitor General on Friday, December 6, weighed in on two pending cert petitions dealing with patent subject matter eligibility under 35 U.S.C. § 101.  Though the Solicitor General urged on behalf the United States that both those cert petitions be denied, he seized the opportunity, in both briefs, to maintain that the Supreme Court should accept review in yet another case, Athena Diagnostics v. Mayo Collaborative Services, and use that opportunity to straighten out what the Solicitor General maintains is a recent, deviant strain of Court decisions interpreting § 101.

In Hikma Pharmaceuticals USA v. Vanda Pharmaceuticals, a 2-1 majority of the Federal Circuit held on April 13, 2016, that Vanda’s claimed iloperidone schizophrenia treatment method was patent-eligible under § 101.  Hikma maintained, in petitioning for cert, that this decision deviated from the high court’s recent precedent (Alice Corp. v. CLS Bank Int’l, Mayo Collaborative Services v. Prometheus Laboratories) in permitting the patenting of what Hikma characterized as “apply[ing] a natural law using only routine and conventional steps.”

In HP Inc. v. Berkheimer, the Federal Circuit held on February 8, 2018, that determining whether some of Berkheimer’s claimed methods for document data storage and edit propagation are patent eligible presented issues of fact precluding summary judgment.  HP maintained, in petitioning for cert, that this decision deviated from the high court’s recent precedent (Alice) that patent eligibility is a question of law and, as such, should not turn on fact issues that might have to be decided by a jury.

The Solicitor General urged the Court to deny review in both cases, but for reasons independent of those cases’ merits.

In Hikma, the Solicitor General argued that the Supreme Court’s § 101 jurisprudence has been flawed in a fundamental way since, and stemming from, its 2010 decision in Bilski v. Kappos, which treated the concepts of “law of nature, natural phenomenon, or abstract idea” as “freestanding, atextual” judicial exceptions to patent eligibility, rather than as embodiments of “Section 101’s statutory and historical context” properly understood and applied.  The Solicitor General argued that, as subsequently applied in Mayo Collaborative Services v. Prometheus Laboratories and other decisions, the Supreme Court’s two-part test for patent eligibility — (1) whether a claim is “directed to” a law of nature, natural phenomenon, or abstract idea, and (2) if so, whether something else (besides well-understood, routine, and conventional activities) transforms the claim into eligible subject matter — is

• internally inconsistent,

• otherwise ambiguous, and

• spills over into other statutory limitations on patentability (e.g., §§ 102 and 103).

The Solicitor General also commented that “[t]he current uncertainty as to the proper application of the Mayo framework has considerable practical consequences for various types of medical innovations,” and quoted Federal Circuit Judge Lourie’s observation concurring in denial of rehearing en banc in Ariosa Diagnostics v. Sequenom, Inc.:  “It is . . . said that a crisis of patent law and medical innovation may be upon us, and there seems to be some truth in that concern.”  The Solicitor General ultimately maintained, however, that the case presented a poor vehicle to “address the confusion stemming from th[e] Court’s recent Section 101 decisions,” since the Federal Circuit had reached the correct result.

In HP, the Solicitor General noted the Federal Circuit’s assertion that “the second Mayo/Alice step ‘is satisfied when the claim limitations involve more than performance of well-understood, routine, and conventional activities previously known to the industry,” and observed that whether that issue presented a legal or fact question “logically depends on the substantive standard for assessing patent-eligibility under Section 101.”  Alluding to his Hikma brief, however, the Solicitor General urged that cert here too be denied; here, because he viewed this case as inadequately raising that standard for review.

The Court has not (as yet) invited the Solicitor General to weigh in on Athena Diagnostics v. Mayo Collaborative Services.  But, as his Hikma brief makes clear, the Solicitor General thinks that is the right § 101 case for the Supreme Court to review:

The Court instead should provide additional guidance in a case where the current confusion has a material effect on the outcome of the Section 101 analysis. For example, Mayo has had particularly significant practical effects with respect to medical-diagnostic methods. See Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 927 F.3d 1333, 1352-1353 (Fed. Cir. 2019) (Moore, J., dissenting from the denial of rehearing en banc) (“Since Mayo, we have held every single diagnostic claim in every case before us ineligible.”), petition for cert. pending, No. 19-430 (filed Oct. 1, 2019). In contrast to this case, where rehearing was denied without recorded dissent, the Federal Circuit’s recent order denying rehearing en banc in Athena was accompanied by multiple separate opinions articulating different understandings of Mayo and seeking clarification from this Court. See id. at 1337 (Hughes, J., concurring in the denial of rehearing en banc) (“welcom[ing] further explication of eligibility standards in the area of diagnostics patents”); id. at 1335 (Lourie, J., concurring in the denial of rehearing en banc); id. at 1339 (Dyk, J., concurring in the denial of rehearing en banc); id. at 1344-1348 (Chen, J., concurring in the denial of rehearing en banc); id. at 1352 (Moore, J., dissenting from the denial of rehearing en banc); id. at 1363-1368 (Newman, J., dissenting from the denial of rehearing en banc); id. at 1370-1371 (Stoll, J., dissenting from the denial of rehearing en banc); id. at 1371 (O’Malley, J., dissenting from the denial of rehearing en banc).

Those various opinions provide substantial grounds for inferring that, if the Federal Circuit were not bound by the current Section 101 framework, that court might have reached different outcomes in Athena itself and in other diagnostic-method cases.  Whether in Athena or in another such case, further guidance from this Court is amply warranted.

In both Hikma and HP, the Solicitor General also argued, in the alternative to cert denial, that the cert petitions should be held in both cases, and disposed of as appropriate, in the event the Court grants review in Athena.

The Solicitor General tacitly having asked whether he too can attend the Athena party, it appears likely the Court will invite him.

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