For more than a decade, this blog has covered the topic of patentable subject matter. Over the years, we’ve addressed various issues regarding business methods, abstract ideas and other various topics. The “laws of nature” exception has presented itself from time to time, but never before have we seen as dramatic a juxtaposition of two remarkably different cases in this area that both call for the same end result. Among these two cases include: (1) a petition for certiorari submitted by automotive parts manufacturer American Axle on December 28, 2020; and (2) another petition submitted by prenatal testing provider Ariosa Diagnostics on December 30, 2020.
Prior to American Axle’s petition, the company was disappointed by a six-to-six split in the Federal Circuit that invalidated one if its patents—which created a method for manufacturing quieter automobile driveshafts—and stated that the patent was found directed to a nonpatentable natural law. In its recent petition for certiorari, American Axle recites a broad range of reasons why the U.S. Supreme Court should revisit Section 101 jurisprudence. From the opposite perspective (that of an accused infringer), Ariosa urges the Court to reverse—on this same doctrine and for a different but equally broad set of reasons—the Federal Circuit’s determination upholding a patent claiming separation of human DNA based on size.
Though these cases involve extremely different subject matter, in both cases, the petitioners see it as the Court’s unshakable duty to address once again the laws of nature exception to patentability. We’ll detail Ariosa’s petition first.
Ariosa’s Petition: An Accused Infringer’s Perspective
As its primary focus, Ariosa’s petition argues that in the 2013 Myriad case, the Supreme Court laid down the clear rule that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” Ariosa leads off its introduction section with an entire paragraph devoted to the teaching of Myriad:
Seven years ago, this Court held that isolated DNA is not patent eligible under 35 U.S.C. § 101. Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580 (2013). The Myriad Court explained that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” Id. at 580. This principle cannot be evaded by claiming routine and conventional methods to isolate a given DNA segment. As the Myriad Court explained, “separating [a] gene from its surrounding genetic material is not an act of invention.” Id. at 591 (emphasis added).
Ariosa argues that this excerpt from Myriad compels reversal in its case, and notes that the passage presents a question regarding “a patent that claims nothing more than a method for separating smaller DNA fragments from larger ones, and analyzing the separated DNA for diagnostic purposes, using well-known laboratory techniques.”
Far from suggesting that the Supreme Court has been wrong to put its gloss onto Section 101, Ariosa explains that it is enshrined in our patent law:
For nearly 170 years, this Court has held that “[l]aws of nature, natural phenomena, and abstract ideas are not patentable.” Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 216 (2014); see also Le Roy v. Tatham, 55 U.S. (14 How.) 156, 174-175 (1853). These categories of subject matter comprise “the basic tools of scientific and technological work,” Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589 (2013) (internal quotation marks omitted), and “monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it,” Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71 (2012).
Ariosa’s petition faults the Federal Circuit for producing a holding that “cannot be reconciled with Myriad.” Further, Ariosa takes fault with the Federal Circuit for “concluding that the patent at issue was not even ‘directed to’ unpatentable subject matter,” focusing on a much-discussed phrase in this area of law. Ariosa specifically faults the majority for distinguishing “Myriad on the ground that the claims there recited compositions of isolated DNA, whereas the claims here recite methods for isolating DNA.”
Ariosa also repeatedly emphasizes a distinction between “invention” and “discovery” in its petition. For instance, it criticizes an approach taken in an original ruling by the Federal Circuit (it was later modified) that the patent’s “inventors discovered” fetal DNA characteristics, i.e., size distribution, that “is dictated by nature, not by humans.” Although the Ariosa petition recites in full the statutory provision involved—namely Section 101’s text that begins “Whoever invents or discovers any new and useful process…”—Ariosa does not expressly explain why “discovery” (or variants) suggests ineligibility.
Zooming out to a broader perspective, Ariosa also warns about issues of “profound national importance” including, for example, stating that the decision below “brings the law one step closer to effectively permitting the patenting of DNA.” In addition, Ariosa provides a collection of complaints about the state of Section 101 law, citing the Federal Circuit’s recent observation in Realtime Data LLC v. Reduxio Systems, Inc. that “district courts might be tempted to opt for an effective coin toss rather than a reasoned analysis when faced with a challenge under § 101.” Ariosa provides a parade of other snippets from the Federal Circuit regarding Section 101, including characterizing it “as among ‘the most baffling concepts in...
