Life sciences patentees now have another favorable decision from the Federal Circuit to rely on in fending off Section 101 eligibility challenges: Illumina v. Ariosa Diagnostics.[1] The Illumina panel (in a 2-1 decision) found Illumina’s claims eligible because they are not “directed to” a natural phenomenon, but instead “to a patent-eligible method that utilizes it”—namely, “preparing a fraction of cell-free DNA that is enriched in fetal DNA.”[2]

The Illumina decision comes on the heels of the Supreme Court’s denials of certiorari in Athena Diagnostics v. Mayo and Vanda v. Hikma, two notable life sciences eligibility decisions we previously reviewed here. In Athena Diagnostics, claims for diagnosing disease using admittedly well-known assay techniques were held to be invalid.[3] In Vanda, method of treatment claims involving a dosing regimen based on genetic analysis were held to be valid.[4] Despite a recommendation from the Solicitor General to hear Athena Diagnostics, the Supreme Court declined.

Mayo v. Prometheus remains the prevailing law, and understanding the Federal Circuit’s applications of it is a must-do for practitioners.[5] Apart from method of treatment claims, the Federal Circuit has held life sciences claims to be eligible only two other times—first in CellzDirect,[6] and now in Illumina.

The Illumina claims, as in the well-known Ariosa Diagnostics v. Sequenom case,[7] involve the discovery of the natural phenomenon of cell-free fetal DNA in maternal plasma and serum.[8] They also involve the subsequent discovery of the natural phenomenon that fetal and maternal DNA in plasma generally have different sizes, with fetal DNA typically being 500 base pairs or fewer.[9]

The Illumina claims recite (a) extracting DNA from a cell-free fluid sample; (b) preparing a fraction of DNA by size discrimination and removal of DNA that is over a certain size; and (c) analyzing a genetic locus in the fraction. Claim 1 of the asserted ’751 patent includes a lengthy preamble: “a method for preparing a deoxyribonucleic acid (DNA) fragment from a pregnant human female useful for analyzing a genetic locus involved in a fetal chromosomal aberration.” Claim 1 of the asserted ’931 patent does not, simply reciting “a method, comprising.” The main difference between the claims is the cutoff size applied during the size discrimination step.[10]

Below, the district court granted summary judgment of ineligibility. It reasoned, under Step 1 of the Mayo/Alice eligibility test, that the claims result “from a test of naturally occurring fetal DNA and do not transform the naturally occurring product into something new,” and thus “lay claim to test results obtained from the use of fetal DNA.”[11] Under Step 2 of the Mayo/Alice eligibility test, the district court found nothing inventive in the claims, which recite use of “routine and conventional steps to isolate and analyze smaller DNA fragments.”

The panel majority (Judges Lourie and Moore) took a different view in reversing. Calling the Illumina case “a method of preparation case,” the panel concluded the claims are not directed to a natural phenomenon—that “cell-free fetal DNA tends to be shorter than cell-free maternal DNA in a mother’s bloodstream”—but rather to “methods for preparing a fraction of cell-free DNA that is enriched in fetal DNA.”[12] The majority’s reasoning stressed that the claims involved process steps, of a “concrete” nature, that change the makeup of DNA in the sample by removing DNA that is above a certain size. According to the majority, the claims therefore “achieve[] more than simply observing that fetal DNA is shorter than maternal DNA or detecting the presence of that phenomenon.”[13] Under that view, this is different than the claims in Ariosa and Athena Diagnostics, for example, where the method resulted in detecting or observing a natural phenomenon or natural law.

The panel majority found the CellzDirect case instructive. There, the inventors discovered that some cells, called hepatocytes, could survive multiple freeze-thaw cycles and, using that knowledge, developed and claimed a process of preserving hepatocytes that involved the freeze-thaw cycles and concluded with a preparation including a majority viable cells.[14] In Illumina, the panel majority explained the inventors used the knowledge about the different sizes of fetal and maternal DNA in maternal plasma and came up with a method to process a plasma sample so it is enriched with fetal DNA.

In dissent, Judge Reyna faulted the majority for treating Illumina’s claims differently than other process claims and “side-step[ping] well-established precedent” as a result. Judge Reyna recognized the only advance described in the specification was the discovery of the natural phenomenon (the relative sizing of fetal and material DNA in plasma), and that discovery formed the entire basis of the patent.[15] He explained that the claims begin and end with a naturally occurring substance and that the specification identifies the claimed steps for changing the makeup of the sample based on DNA size as “well-known or performed using commercially available tool kits.”[16] Judge Reyna reasoned that under controlling precedent, “[f]or method claims that encompass natural phenomena, the method steps are the additional features that must be new and useful.”[17] “[M]erely chang[ing] the composition of a sample of naturally occurring substances, without altering the naturally occurring substances themselves” does not impart eligibility.[18]

Illumina is a win for life sciences patentees, despite Judge Reyna’s dissent. In future cases, life sciences patentees will no doubt lean on it and CellzDirect to frame their claims as eligible.

[1] Illumina, Inc. v. Ariosa Diagnostics, Inc., 2020 U.S. App. LEXIS 8327 (Fed. Cir. Mar. 17, 2020).

[2] Illumina, at 2020 U.S. App. LEXIS 8327, at *11.

[3] Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 927 F.3d 1333 (Fed. Cir. 2019), reh’g denied 927 F.3d 1333 (Fed. Cir. 2019), cert. denied 140 S. Ct. 855 (Jan. 13, 2020).

[4] Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117, cert. denied sub nom 2020 U.S. LEXIS 98 (Jan. 13, 2020).

[5] Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66.

[6] Rapid Litigation Management Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016).

[7] Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282 (Fed. Cir. 2015).

[8] Illumina, at 2020 U.S. App. LEXIS 8327, at *4.

[9] Id. at *4-5.

[10] Id. at *5-6.

[11] Illumina, Inc. v. Ariosa Diagnostics, Inc., 356 F. Supp. 3d. 925 (N.D. Cal. Dec. 24, 2018), rev’d 2020 U.S. App. LEXIS 8327 (Fed. Cir. Mar. 17, 2020).

[12] Illumina, 2020 U.S. App. LEXIS 8327 at *11.

[13] Id. at *12-13.

[14] CellzDirect, 827 F.3d at 1047.

[15] Id. at *23-24, *26-27.

[16] Id. at *27-30.

[17] Id. at *32.

[18] Id.

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