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<a href="https://healthlawupdate.bakerhostetlerblogs.com/wp-content/uploads/sites/19/2015/07/science-iStock_000017058897_Large.jpg"><img class=" size-medium wp-image-3234 alignright" src="https://healthlawupdate.bakerhostetlerblogs.com/wp-content/uploads/sites/19/2015/07/science-iStock_000017058897_Large-300x225.jpg" alt="Genetic research at the laboratory" width="300" height="225" /></a>With its recent (June 12, 2015) decision in Ariosa v. Sequenom, the Court of Appeals for the Federal Circuit affirmed the Northern District of California’s broad interpretation of the U.S. Supreme Court’s Prometheus v. Mayo holding that claims directed to the mere application of naturally occurring products and phenomena constitute unpatentable subject matter.

Sequenom’s U.S. Patent No. 6,258,540 derives from the discovery that cell-free fetal DNA (cffDNA) may be found in maternal plasma and serum. Applying a combination of known laboratory techniques to their discovery, the inventors implemented a method for detecting and amplifying the small fraction of paternally inherited cffDNA in maternal plasma or serum to determine certain fetal characteristics, such as gender and/or the presence or absence of various genetic defects. Independent claim 1, which reads as follows, is representative of the type of application of the discovery that the ‘540 patent purports to protect:
<blockquote>1. 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 amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.</blockquote>


Writing for the majority, Judge Reyna noted that the claims at issue are generally directed to detecting the presence of a naturally occurring thing or a natural phenomenon, cffDNA in maternal plasma or serum. Using the framework for analyzing claims of this type set forth by the Supreme Court in Prometheus, in a second step, the panel examined the elements of the claim to determine whether it contains an inventive concept sufficient to “transform” the claimed naturally occurring phenomenon into a patent eligible application. Finding nothing more than the straightforward application of the discovery using known techniques, the panel found the claims to be directed to unpatentable subject matter and therefore invalid under 35 U.S.C. Section 101.

Notably, the claims at issue were not directed to either the naturally occurring product (i.e., the cffDNA) or naturally occurring phenomenon (i.e., that cffDNA is present in maternal plasma or serum) per se, and indeed, the claims made no attempt to claim either. Nonetheless, the court found that since the invention relies upon these naturally occurring features, the claimed method does nothing more than simply apply the natural phenomenon in a manner that would be readily apparent to those of ordinary skill in the art once they were made aware of the phenomenon. And while the minority did not dispute the patentee’s assertion that the inventors combined and utilized man-made tools of biotechnology in a new way that revolutionized prenatal care, the court quoted another recent Supreme Court decision on Section 101: “[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry” (quoting Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 210, 2117 (2013)).

Judge Linn provided a concurrence agreeing that the majority’s decision was inescapable because the “Supreme Court’s blanket dismissal of conventional post-solution steps leaves no room to distinguish Mayo from this case, even though [ ] no one [in the prior art] was amplifying and detecting paternally inherited cffDNA using the plasma or serum of pregnant mothers.” However, in voicing his clear disapproval of this result, he all but expressly invited the Supreme Court to reevaluate its prior broad holdings to provide means for distinguishing inventions of the type being claimed in this patent from those at issue in the Mayo case. Whether the Supreme Court elects to accept this invitation remains to be seen.

What Constitutes Patentable Subject Matter in Biotechnology?