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 all of patent law,’” and referring to how “’the incoherent body of doctrine’ surrounding Section 101 ‘renders it near impossible to know with any certainty whether [an] invention is or is not patent eligible.’” Ariosa also includes the Federal Circuit’s comment that “Section 101 ‘is indeterminate and often leads to arbitrary results,’” and its conclusion that “Section 101 ‘law needs clarification by higher authority.’”
American Axle’s Petition: A Patentee’s View
Not surprisingly, patentee American Axle urges for a significantly more permissive interpretation of Section 101. The American Axle petition is plain-spoken in its position. For example, in its explanation on why the Court, and not Congress, should address uncertainty regarding patent eligibility, American Axle states:
There is zero confusion about the plain text of Section 101. Only the three non-textual, judicially-created exceptions to the statute have precipitated chaos and uncertainty in our patent system. It is backwards to expect Congress to fix the problems surrounding Section 101 when the statutory text is crystal clear and never in dispute. Our problems are judge-made. The Court should provide the fix.
American Axle’s overall analysis is similarly straightforward. In the questions presented section, American Axle sets the stage by arguing, “American Axle invented a new process for making a new, useful and tangible thing—a quieter automobile driveshaft.” It then recites the “bitterly divided” six-to-six split at the Federal Circuit and quotes Judge Moore saying, “Our nation’s lone patent court is ‘at a loss as to how to uniformly apply § 101’” in two different portions of the petition.
Like Ariosa, American Axle asks the Court to help explain what it means for a claim to be “directed to” a patent-ineligible concept. American Axle further asks the Court to weigh in on whether eligibility ought to be a question of law for the court based on the scope of the claims, or a question of fact for the jury based on the state of the art at the time of the patent.
American Axle takes a similar approach to Ariosa by outlining the various calls for Section 101 help:
Judges, industry leaders, scholars, Directors of the USPTO, and the Solicitor General of the United States have warned for years that the recurring confusion and uncertainty surrounding patent eligibility under 35 U.S.C. § 101, and the steady expansion of the three non-textual exceptions to the statutory text (natural laws, natural phenomena, and abstract ideas) would lead to the invalidation of patent claims ”which have historically been eligible to receive patent-law protection.” Diamond v. Diehr, 450 U.S. 175, 184 (1981). The warnings are now a reality.
American Axle again quotes Judge Moore, noting her statement that the type of invention the company patented is “the type of process which has been eligible since the invention of the car itself.” American Axle runs through the details of how its multi-step process addresses two types of driveshaft vibration—”the type of invention that has been eligible for patenting since the dawn of patent law in the United States.” It faults the Federal Circuit for saying that the claims, though they do not recite any natural law and require manufacturing steps beyond application of a natural law, invoke an equation known as “Hooke’s law” and “nothing more.” American Axle includes photographs of a driveshaft and two pickup trucks (though unclear exactly why those are needed) and several diagrams to illustrate how thin-walled driveshafts in vehicles are prone to two types of vibration—when under stress the shafts bend from end to end, and they also bend so that they don’t remain circular in cross-section. The diagrams also show how American Axle’s process of positioning and inserting “tuned liners” within the shafts addresses both of these vibration modes.
Embracing the “discover” term that Ariosa used in a manner suggesting ineligibility, American Axle asserts it was the first to discover that liners could be tuned to a certain frequency of vibration and that liners could be used to reduce both types of vibration. American Axle then argues that the corresponding industrial benefit addressed a long-felt need: “Just ask Neapco, which itself had an ‘issue’ with attenuating both types of driveshaft vibration—until, of course, it discovered the ‘911 patent.”
American Axle’s complaint with the analyses put forth by Neapco and the Federal Circuit focuses on a purported lack of clarity as to what exactly the “ineligible concept” is to which the claims are directed. American Axle counts at least five different theories that have been asserted and says this is evidence of “just how malleable Section 101 has become.” American Axle also urges that the “directed to” inquiry has conflated Section 112 requirements (applicable to the specification) with Section 101 to result in a new requirement that claims themselves “must sufficiently teach how to make and use the claimed invention.”
After walking through the previously mentioned Diehr case in greater detail (in which a process for curing rubber based on the Arrhenius equation was determined to be patent eligible), American Axle provides a different, but similar, collection of concerns as Ariosa did in its petition. American Axle cites two law review articles, which separately suggest that misapplication of § 101 could readily lead to a determination of ineligibility for landmark inventions such as an automobile’s internal combustion engine, the cotton gin, the electric motor and Edison’s light bulb. American Axle starkly notes that “The warnings are now a reality. The Federal Circuit invalidated claims to manufacturing processes for producing improved driveshafts for cars…. Section 101 has reached Detroit.”
American Axle underscores that “Diehr is law, not nostaligia” and repeats the Court’s warning from Alice “that the non-textual exceptions to Section 101 must be construed narrowly, lest they ‘swallow all of patent law.’”
American Axle concludes its petition with three separate sections urging why the Court should address this issue again by taking up this case. The first is a section entitled, “The entire patent system is calling for guidance from the Court,” in which it walks through the Federal Circuit judges’ requests for guidance, similar calls from former USPTO Director Iancu and his predecessors David Kappos and Q. Todd Dickenson, and sentiments expressed by industry leaders, practitioners and scholars, as well as those of the Solicitor General. The second section, quoted in part above, explains why it is the Court’s role—not that of Congress—to address the judicially created exceptions, and cites our Bilski Blog for reporting on how Congress has to date failed to act. The third section details why American Axle believes its case “presents the ideal vehicle [pun apparently not intended] for the Court to provide much-needed guidance on Section 101.”
American Axle explains that, “This is not your run-of-the-mill Section 101 case.” Unlike others involving business methods, internet or financial methods, and diagnostic inventions (the only passing mention of Ariosa being here in still another quote from Judge Moore), American Axle urges that this case involves the manufacture of car parts and so provides a “unique opportunity to clarify the law on Section 101 as to all technologies and industries and, at the same time, reign in the non-textual exceptions that have steadily crept into our nation’s manufacturing sector.”
Observations and Next Steps
While these two petitions both ask the Supreme Court to address the same niche issue regarding the same statutory provision, substantively they bear little resemblance to one another. Ariosa leans heavily on Myriad but does not cite Diehr at all, while American Axle relies strongly on Diehr but doesn’t even mention Myriad. While some of this can be explained by the very different subject matters involved in the current cases, it seems that at least modest reference might be made to these other Supreme Court cases that are considered controlling. Another difference is that Ariosa celebrates the Supreme Court for its cabining of Section 101, while American Axle asserts that the Court “is the most appropriate branch to clarify or correct such judicially-created doctrines.” And Ariosa appears to hint that “discovery” suggests ineligibility, whereas American Axle embraces this term with about half a dozen uses of it (or variants).
Even more remarkable is that neither the petition in the Ariosa case, nor the one in the American Axle case, makes any substantive reference to the other. Ultimately, the two cases will be considered together; responses to both petitions are due on February 4, 2021, and we will be summarizing those responses together as we have with these petitions.
From those responses, we anxiously await learning the reasons that will surely be presented as to why the Court need not take up either of these cases. In the meantime, however, it is worthwhile to give thought to the varied and independent arguments that both Ariosa and American Axle have provided for why the Court should take up yet another Section 101 case (or two).