Sequenom’s Fetal DNA Diagnostic Method Not Patent Eligible Subject Matter

Author: Alex Kwan-Ho Chung
Editor: Aaron Gleaton Clay

In Ariosa Diagnostics, Inc. v. Sequenom, Inc., Nos. 2014-1139, -1144 (Fed. Cir. June 12, 2015), the Federal Circuit affirmed the district court’s determination that the asserted method claims are invalid because they are not directed to patent eligible subject matter under 35 U.S.C. § 101.

Sequenom’s U.S. Patent No. 6,258,540 involves methods of amplifying and detecting cell-free fetal DNA (“cffDNA”) in the plasma of pregnant women. The methods allow for non-invasive prenatal diagnosis of a fetus’s gender or genetic defects. The invention was made possible by the discovery that maternal plasma—a portion of the mother’s blood sample typically discarded as medical waste—harbored a small fraction of non-cellular DNA that the fetus inherited from its father.

On appeal, the Federal Circuit evaluated patent eligibility of the asserted claims, applying the two-step framework established in Mayo Collaborative Services. v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012).  Specifically, the Court determined: (i) “whether the claims at issue [were] directed to a patent ineligible concept”; and if so, (ii) “whether additional elements transform[ed] the nature of the claim into a patent-eligible application” by providing an “inventive concept.”

First, the Court held that the asserted claims were directed to a patent ineligible concept because they were generally directed to detecting the presence of a naturally occurring phenomenon. The Court stated that the claimed methods started with cffDNA taken from maternal plasma and ended with paternally inherited cffDNA. The Court concluded that the claimed methods began and ended with natural phenomenon and were therefore directed to matter that is naturally occurring.

Second, the Court found that the additional elements of the claimed methods did not amount to “an inventive concept that transform[ed] the natural phenomenon of cffDNA into a patentable invention.” The Court held that “[w]here claims of a method patent are directed to an application that starts and ends with a naturally occurring phenomenon, the patent fails to disclose patent eligible subject matter if the methods themselves are conventional, routine and well understood applications in the art.” The Court concluded that the asserted method claims’ steps of preparing, amplifying, and detecting paternally-derived cffDNA, including polymerase chain reaction (PCR) techniques, were “well-understood, conventional and routine” steps, appended to a natural phenomenon. Thus, the Court concluded that the second step was not met and that the claims were therefore invalid as not directed to patent eligible subject matter.

In a concurrence, Judge Linn noted that he joined the decision “only because” he was “bound by the sweeping language of the test set out in Mayo,” without which he “see[s] no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible.” Judge Linn stated that the Supreme Court’s “blanket dismissal of conventional post-solution steps” left no room to factually distinguish Mayo, noting that unlike Sequenom’s methods, the conventional steps involved in Mayo were already being performed in the art at the time, whereas in this case, no one in the art at the time amplified and detected paternally-inherited cffDNA.

In a concurrence, Judge Linn noted that he joined the decision “only because” he was “bound by the sweeping language of the test set out in Mayo,” without which he “see[s] no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible.” Judge Linn stated that the Supreme Court’s “blanket dismissal of conventional post-solution steps” left no room to factually distinguish Mayo, noting that unlike Sequenom’s methods, the conventional steps involved in Mayowere already being performed in the art at the time, whereas in this case, no one in the art at the time amplified and detected paternally-inherited cffDNA.

For additional, expanded coverage of this case, see Finnegan’s IP Update: Federal Circuit Decision in Ariosa v. Sequenom Offers Further Clarification on the Scope of Patent-Eligible Subject Matter.

 

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