Natera Responds to Sequenom's Petition for Rehearing En Banc

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.

Comments

[EG]

"Myriad establishes that cffDNA itself is not patent eligible."

Don,

How can Natera's counsel say that with a straight face? Didn't Myriad say that cDNA could be patent-eligible?

Also, the concluding comment by Natera that you quote ("Congress struck a delicate balance in Section 101, and the Supreme Court has maintained that balance in its recent trilogy of eligibility decisions") is not even close to being accurate; the Royal Nine haven't followed what Congress enacted in 35 USC 101 on patent-eligibility in 1952, much less "maintained" any degree of "balance" what is patent-eligible that is other than disingenuous rhetorical nonsense and judicial activism at its worst.

[Shahid Hasan]

I posted my thoughts on the 101 issue ( with the Sequenom issue in mind) on linkedin. please feel free to share with your readers if you wish.
https://www.linkedin.com/pulse/patent-eligibility-dilemma-under-35-usc-101-shahid-hasan?trk=hp-feed-article-title-publish

[Shahid Hasan]

cffDNA=cell-free fetal DNA
cDNA= complimentary DNA

Two entirely different elements. cell-free fetal DNA = genomic DNA