By Donald Zuhn –-

Last week, Appellee Natera, Inc. filed its response to the petition for rehearing en banc filed by Appellants Sequenom, Inc. and Sequenom Center for Molecular Medicine, LLC in August (see "Sequenom Requests Rehearing En Banc") (a summary of the response filed by Appellee Ariosa Diagnostics, Inc. can be found here).  In its response, Natera argues that in affirming 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)"), the Ariosa panel "faithfully applied Mayo, Myriad, and Alice to conclude that the asserted claims are ineligible for patenting."  Natera suggests that "[a]t bottom, Sequenom and its amici disagree with the Supreme Court's jurisprudence on patent-eligibility," but contends that the Federal Circuit is "constrained to follow precedent" and therefore asserts that Sequenom's petition should be denied.

Arguing that the Federal Circuit panel correctly found the asserted claims to be patent ineligible, Natera explains that:

The asserted claims are drawn to the discovery that cell-free fetal DNA (cffDNA) circulates organically in maternal plasma, which is an ineligible natural phenomenon under Myriad, 133 S. Ct. at 2111.  The claims apply only routine analytical methods (such as amplification and detection) to that natural phenomenon, which is insufficient to confer patent-eligibility under Mayo, 132 S. Ct. at 1297–98.

As for the doctrinal and policy objections raised by Sequenom and its amici, Natera contends that:

The very same arguments were presented, often by the same amici, to the Supreme Court in the Mayo–Myriad–Alice trilogy.  The Supreme Court rejected those arguments, expressly or implicitly, in adopting its eligibility framework.  Since this Court does not sit to check the Supreme Court's work, the recycled objections to that framework now presented by Sequenom and its amici cannot support review or revision, much less reversal, of the panel decision.

Natera points out that "[n]ovelty and non-obviousness are necessary, but not sufficient, preconditions to patentability," adding that these requirements "do not substitute for the independent (and antecedent) requirement of patent-eligibility."  According to Natera, "[i]f novelty and non-obviousness were all that is required, patentees would be able to monopolize natural phenomena where, as here, the existence or utility of the phenomenon was not known or obvious before the discovery."  Natera argues, however, that "[t]he proper Section 101 eligibility inquiry, by contrast, assumes that knowledge of the phenomenon is in the public domain, where it rightfully belongs," and suggests that the instant case "illustrate[s] the wisdom of this dichotomy," because "[o]nce it was discovered that maternal plasma contains cffDNA, the application of routine analytical methods to that plasma and its contents was a simple step."

As for the argument made by Sequenom and its amici that the asserted claims recite an eligible application of the natural phenomenon that fetal DNA exists in maternal plasma, Natera counters that the asserted claims "amount to prototypical 'apply it' instructions, which Mayo squarely forecloses."

With respect to the issue of complete preemption, Natera states that:

Contrary to amici's suggestion, . . . complete preemption has never been required to hold claims ineligible.  See Flook, 437 U.S. at 597; Diehr, 450 U.S. at 204; Mayo, 132 S. Ct. at 1303.  Rather, "the underlying functional concern here is a relative one: how much future innovation is foreclosed relative to the contribution of the inventor."  Mayo, 132 S. Ct. at 1303.  In this case, the patent contributes no invention: the newly discovered natural phenomenon is in the public domain, and the asserted methods were well-known in the prior art.  Thus, any preemption would be too much preemption. [emphasis in response]

Natera also argues that the instant case "would be a particularly bad vehicle for rethinking preemption analysis, even if that path were not foreclosed by Mayo and Alice, because the claims asserted here, in fact, broadly preempt all known methods for detecting cffDNA in maternal plasma and making diagnoses therefrom."

In response to the concerns expressed by Sequenom and its amici that the panel decision will deter investment and innovation in the biotechnology industry, Natera counters that "they do not address the deleterious effects of over-expansive patent monopolies covering natural phenomena, including the economic and social costs to the health care system in general, and pregnant women and their families in particular."

In concluding that Sequenom's petition for rehearing en banc should be denied, Natera suggests that:

Congress struck a delicate balance in Section 101, and the Supreme Court has maintained that balance in its recent trilogy of eligibility decisions.  As with their doctrinal arguments, the policy arguments advanced by Sequenom and its amici reflect no more than their disagreement with the Supreme Court's precedents in this area.  They are free to take up their differences (once again) with the Supreme Court, or they may use these arguments to urge legislative change, but under the extant statute as authoritatively construed by the Supreme Court, the panel could not — and this Court cannot — adopt their policy agenda.

By Donald Zuhn —

On Monday, Appellee Ariosa Diagnostics, Inc. filed its response to the petition for rehearing en banc filed by Appellants Sequenom, Inc. and Sequenom Center for Molecular Medicine, LLC in August (see "Sequenom Requests Rehearing En Banc").  In its response, Ariosa argues that in affirming 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)"), the Federal Circuit "faithfully applied Supreme Court precedent."

Characterizing claim 1 of the '540 patent as "purport[ing] to broadly cover using routine laboratory methods to detect naturally-occurring paternally-inherited nucleic acid of fetal origin in maternal serum or plasma," Ariosa argues that the panel's analysis of this claim "is exactly what the Supreme Court has mandated and its conclusion is controlled by the Supreme Court's directive that a 'process that focuses upon the use of a natural law' must 'also contain other elements or a combination of elements, sometimes referred to as an 'inventive concept,' sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself,'" quoting Mayo Collaborative Services v. Prometheus Laboratories, Inc.  Ariosa also criticizes the language of claim 1 as being "circular and devoid of content," explaining that:

The claim recites a method for detecting naturally-occurring paternally inherited nucleic acid whose only step (aside from making more copies of the nucleic acid) is detecting the naturally-occurring paternally inherited nucleic acid.  This is little more than a claim to the natural phenomenon itself — and thus it is hardly surprising that the panel found this claim fails to recite anything "sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself" [quoting Mayo].

In particular, Ariosa points out that claim 1 recites:  "A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises . . . detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample" (emphasis in brief).

Noting that Sequenom argued in its petition that the panel misinterpreted Mayo and that the panel decision is contrary to the Supreme Court's decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. and Diamond v. Diehr, Ariosa counters that "[t]o the contrary, it is Appellants — not the panel — that misinterpret Mayo, misapply Myriad, and misread Diehr."  In support of this position, Ariosa argues that:

Appellants' only legal argument (as opposed to their dire policy-based prognostications) in favor of rehearing en banc is that Mayo, Myriad and Diehr must be read as teaching that "a combination of known steps that incorporates or is motivated by an unpatentable natural phenomenon is nonetheless patentable if that combination 'considered as a whole' was not routine before the patent disclosed it."  Yet Appellants' misreading of those precedents amounts to nothing short of a wholesale revision of the Supreme Court's two-part test for determining whether a claim recites patent-eligible subject matter [cite omitted].

With respect to Mayo and Myriad, Ariosa argues that "Appellants propose a rule under which the first person to claim a process in which any steps are added to a newly discovered natural phenomenon can obtain a patent because, 'considered as a whole,' combining the new discovery with those steps was not 'routine' — because no one had done it before."  Ariosa suggests, however, that:

Appellants fail to recognize that the patentability of the claims in Mayo did not turn on whether the natural phenomenon recited in the claims was newly discovered.  Rather, Mayo held that the prohibition on patenting a natural phenomenon cannot be overcome by combining that phenomenon with additional steps that "consist of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately." [quoting Mayo].  Nowhere did Mayo suggest, let alone hold, that this rule does not apply to a newly discovered natural phenomenon.

As for Myriad, Ariosa notes that in relying on "Myriad's statement that 'the first person with knowledge' of a natural phenomenon is in a better position to claim applications of that knowledge," Sequenom cites no other language from that opinion.  Moreover, according to Ariosa:

[T]he language adds nothing to their argument.  Even if Drs. Lo and Wainscoat were "in an excellent position" to claim an application of their discovery of cffDNA in maternal serum and plasma, they did not do so.  Instead, they procured broad claims that merely point to that discovery and instruct one to "copy" the DNA and "detect" the DNA.

Ariosa concludes its response by asserting that Sequenom's argument is also contrary to Diehr.  Although "Diehr . . . lies at the heart of Appellants' contention that simply adding any method steps to a newly discovered natural phenomenon renders that discovery patentable," Ariosa contends that "Diehr says no such thing."  According to Ariosa, "[t]he asserted claims of the '540 patent are fundamentally different [from those in Diehr].  They 'start and end with a naturally occurring phenomenon' and the method steps between those end points are 'conventional, routine, and well understood applications in the art.'"

Asserting that "there is no reason for this appeal to be reheard en banc and, moreover, no basis on which this Court should disturb the panel's conclusion," Ariosa concludes that Sequenom's petition should be denied.