Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (see "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)").  Last month, Sequenom filed a petition for rehearing en banc, arguing that the panel's decision in June was inconsistent with the Supreme Court's decisions in Diamond v. Diehr, 450 U.S. 175 (1981), Mayo v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), and that the panel's decision poses a threat to patent protection in multiple fields of invention.  On August 27, twelve amicus curiae briefs were filed in support of Sequenom's petition for rehearing en banc.  Over the next few weeks, Patent Docs will examine these amicus briefs.  Here, we review the brief submitted by Professors Jeffrey A. Lefstin and Peter S. Menell.

The authors of the brief are professors of law at the University of California who teach intellectual property law.  In addition to their law degrees, Prof. Lefstin holds a doctorate degree in biochemistry and Prof. Menell holds a doctorate degree in economics.

The amici offer four arguments justifying the grant of Sequenom's petition for rehearing en banc.  First, the amici argue that the case presents vitally important issues at a critical juncture in the development of patent-eligibility law.  Noting that "[t]he past 40 years have witnessed the most rapid period of technological change in our nation's history," the brief states that "Congress has been reluctant to weigh in on the scope of patentable subject matter, and the Supreme Court stood on sidelines for much of this critical period."  However, the brief points out that since 2010, the Supreme Court has decided four patent-eligibility cases:  Bilski v. Kappos, 561 U.S. 593 (2010); Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012); Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013); and Alice Corp. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014).

In discussing these cases, the amici note that "Mayo explained that the distinction between an unpatentable law of nature and a patentable invention lay in the patentee's application: whether it evinced an 'inventive concept' beyond the underlying law of nature.'"  However, the brief suggests that Mayo "glossed over several key issues, including how to reconcile prior discordant decisions (Flook and Diehr), and whether the requirement of 'inventive concept' demands an unconventional application, or merely more than the generic instruction to 'apply the law.'"  The brief also notes that "Justice Breyer, the architect of Mayo, later commented [during oral argument in Alice Corp.] that Mayo did no more than 'sketch an outer shell of the content' of the patent-eligibility test, leaving the content to be developed by the patent bar in conjunction with the Federal Circuit."  The brief further notes that the Myriad Court "upheld the eligibility of claims to cDNAs -- DNA molecules derived from naturally occurring RNA by known, conventional, and routine laboratory procedures," and in Alice, the Court "confirmed that Mayo's framework governs all patent-eligibility determinations under § 101."

While stating that "[t]he primary responsibility for developing patent-eligibility doctrine now rests with this Circuit,"  the amici contend that "[t]he panel's decision uncritically accepts an expansive reading of Mayo that conflicts with insights from Myriad and Alice," and argue that, as a result, "[t]here is serious risk that failure to engage this issue at this juncture could set the patent system on a dire course."  The brief declares that "given Congress's reluctance to take on these critical questions [about the patentability of diagnostic testing] and the Supreme Court's less than lucid articulation of standards, the Federal Circuit has an especially important role in ensuring that this controversy receives thorough evaluation."

The amici next argue that Mayo does not require that a new discovery be applied by unconventional means in order to be patent-eligible, and contend that "the [Ariosa] panel was incorrect to conclude that Mayo dictates a test of unconventional application."  The brief notes instead that "Mayo suggests two other possibilities for an 'inventive concept': non-preemptive application; and non-generic application."  Looking to Myriad, the brief explains that:

There was no pretense in the case that the act of reverse-transcribing natural mRNA into cDNA was inventive, and indeed the production of cDNA was known, routine, and conventional when the Myriad patents were filed in 1994.  Had the Court required unconventional application over the natural phenomenon of mRNA, the Court could not have sustained the eligibility of the cDNA claims.

As for Alice, the brief states that this case "clarified that the § 101 inquiry asks not whether a claim represents an unconventional application of a fundamental principle, but whether a claim does more than state a fundamental principle, plus a generic instruction to 'apply it.'"

According to the amici, while the Supreme Court's interest in unconventional activity "is best understood as a sufficient condition for patent-eligibility: claims are patent-eligible if they implement a fundamental principle by unconventional means," the Ariosa panel "goes well beyond that test by elevating unconventional activity to a sufficient and necessary condition for patent-eligibility: claims are patent-eligible if and only if they implement a fundamental principle by unconventional means."

The third argument presented by amici for granting Sequenom's petition for rehearing en banc is the prohibition in Mayo and Alice against dissecting the claims into old and new components.  The brief suggests that Diamond v. Diehr, 450 U.S. 175, 188 (1981), "made clear that even processes consisting of previously known steps could be patent-eligible."  The brief also contends that "it is surely clear that Diehr's prohibition against dissecting claims has not been set aside by the Court's more recent decisions," including both Mayo and Alice.  The amici argue, however, that "under the panel opinion's statement of the law, any process claim based on a natural phenomenon is ineligible for a patent unless the individual steps of the process are novel."

The amici conclude by arguing that the Ariosa panel's rule would invalidate claims that the Mayo Court deemed to be patent-eligible.  The brief sets forth two examples: Nielsen's hot-blast smelting process, which disclosed the heating of air prior to its introduction into the blast furnace, and the new use of an existing drug, both of which the amici note the Mayo Court deemed to be patent-eligible.  As for the first, because both the heating of air and the introduction of air into the blast furnace were well-known, "[u]nder the panel opinion's analysis, because Neilson implemented his discovery by old and known means, his patent would be invalid."  As for the second example, the amici contend that "under the panel opinion's statement of the law, a claim to administering a known drug to treat a new condition would be ineligible, because the steps of administering the drug to a patient would be known and conventional at the time of filing."