Into the Rabbit Hole:
Invalidation Fallout of Alice Is Not Limited to Computer-Based Inventions
By: Stacey Cohen, Kristen Voorhees
Submitted: February 12, 2015
In December of 2014, the U.S. Court of Appeals for the Federal Circuit extended the
Supreme Court's holding in Alice1 beyond computer-based inventions, finding certain medical
diagnostic composition of matter and method claims to be patent ineligible. Specifically, in
University of Utah Research Foundation v. Ambry Genetics Corp. (In re BRCA1- and BRCA2Based Hereditary Cancer Test Patent Litig.),2 the patents at issue covered compositions of matter
and methods relating to the BRCA1 and BRCA2 genes. After discovering that mutations of
those genes can increase the risk of certain breast and ovarian cancers, Plaintiff-Appellant
Myriad Genetics, Inc., obtained composition of matter claims reciting specific primers used to
target the genetic sequence and method claims reciting techniques by which the particular gene
could be compared against a patient's genetic sequence. While the defendant sought a ruling that
the claims were ineligible under Mayo3 as products of nature and natural phenomenon, the Court
instead applied Alice – a case that has invalidated scores of software-related patent claims since
it issued last summer.
A. The Underlying Lawsuit & District Court Decision
Myriad brought suit alleging patent infringement against Ambry Genetics Corporation,
which sold competing kits for detecting genetic mutations linked to cancer. In March 2014, the
district court denied Myriad's motion for preliminary injunction on the basis that the patent was
likely drawn to ineligible subject matter under 35 U.S.C. § 101 as products of nature. The court
relied primarily on the Mayo decision, which cautioned against allowing claims that risk "tying
up the use of the underlying natural laws, inhibiting their use in the making of further
discoveries."4 Myriad appealed the denial of the motion for preliminary injunction.
1
Alice Corp. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014).
2
774 F.3d 755, 758-59 (Fed. Cir. 2014) [hereinafter In re BRCA1]
3
Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S.Ct. 1289, 1296 (2012).
4
Univ. of Utah Research Found. v. Ambry Genetics Corp. (In re BRCA1- & BRCA2- Based Hereditary Cancer
Test Patent Litig.), 3 F. Supp. 3d 1213, 1270 (D. Utah 2014) (quoting Mayo, 132 S. Ct. at 1294 (internal
quotation marks omitted)), aff’d, In re BRCA1, 774 F.3d 755 (Fed. Cir. 2014).
B. Federal Circuit Breaks Away From Party Arguments to Apply Alice
On appeal, the Federal Circuit found that the composition of matter or "primer" claims
were not distinguishable from isolated DNA because the primers "are structurally identical to the
ends of DNA strands found in nature."5 Rather, "[a] DNA structure with a function similar to
that found in nature can only be patent eligible as a composition of matter if it has a unique
structure, different from anything found in nature."6 Because "[p]rimers do not have such a
different structure," they are not patent eligible.7 With regard to the asserted method claims, the
Federal Circuit also found these claims to be patent ineligible under § 101. Notwithstanding
Ambry's assertions of invalidity under Mayo as ineligible recitations of natural laws or products
of nature, the Federal Circuit found instead that both claims were invalid recitations of abstract
ideas under Alice.8
1. Step One of Alice: Comparison Steps Were Directed to Ineligible Abstract Idea
The claims at issue involve methods for "screening germline of a human subject" for an
altered BRCA1 gene by "comparing" the wild-type sequence with the patient's sequence.9 One
claim further required performing the comparison by "hybridizing a BRCA1 gene probe" and
"detecting the presence of a hybridization product," while the other claim required performing
the comparison by "amplifying all or part of a BRCA1 gene . . . using a set of primers" and
"sequencing the amplified nucleic acids."10
In analyzing the claims, the Court first considered the "comparison step" of the asserted
method claims, and found that this step was unpatentable because "it claimed an abstract mental
process of 'comparing' and 'analyzing' two gene sequences."11 The court listed several reasons
why it considered the claimed method to be an abstract process:12
1. "The number of covered comparisons is unlimited."
2. "The covered comparisons are not restricted by the purpose of the comparison . . . ."
5
In re BRCA1, 774 F.3d at 760.
6
Id. at 761.
7
Id.
8
Id. at 763.
9
Id. at 761.
10
Id. at 764, 761-62; U.S. Patent No. 5,753,441, col. 155, ll. 16-25, 57-63 (filed Jan. 5, 1996) (claim 7); U.S. Pat.
No. 5,753,441, col. 155, ll. 16-25, 64-67 (claim 8).
11
In re BRCA1, 774 F.3d at 763; see also Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 689 F.3d 1303,
1334-35 (Fed. Cir. 2012), aff'd in part, rev'd in part, 133 S. Ct. 2107 (2013) (finding claim 1 invalid).
12
Id.at 763-64.
2
3. "[T]he comparison step covers detection of yet-undiscovered alterations . . . ."
4. "[T]he comparisons are not limited to the detection of risk of breast or ovarian cancer."
5. "[A]llowing a patent on the comparison step could impede a great swath of research
relating to the BRCA genes . . . ."
6. "[I]t is antithetical to the patent laws to allow these basic building blocks of scientific
research to be monopolized."
The court also briefly addressed the "pre-emption" issue13 of Alice, noting that "[t]he
preemptive nature of the claims is not ameliorated even if we accept Myriad's argument that
other methods of comparison exist. If the combination of certain routine steps were patent
eligible, so too would different combinations of other routine steps."14 Although the court's
reasoning begs the question of what it means to "preempt an idea" if the patent does, in fact,
leave untouched other methods for performing the abstract idea, it may nonetheless foreclose
future attempts to argue that the existence of non-infringing alternatives minimizes the risk of
preemption and renders the claim patent eligible.
2. Step Two of Alice: Comparison Techniques Did Not Add Enough to Save Claims
Moving on to step two of the analysis under Alice, the court found that the "particular
mechanism for the comparisons" at issue did not "add 'enough' to make the claims as a whole
patent-eligible."15 Specifically, the court held that "[n]othing is added by identifying the
techniques to be used in making the comparison because those comparison techniques were the
well-understood, routine, and conventional techniques that a scientist would have thought of
when instructed to compare two gene sequences."16 Because the "second paragraphs recite only
routine and conventional steps," the court held, "the claims, therefore, are directed to patentineligible subject matter."
C. Practice Points For Patent Practitioners
That the court in In re BRCA1 went out of its way to apply Alice rather than Mayo to
invalidate the claims at issue is an indication that Section 101 analyses under Alice may play an
13
Before articulating the two-part test, Alice emphasized that "pre-emption" is the concern that "drives" the
judicially-created exceptions to Section 101 patent-eligibility. Because "[l]aws of nature, natural phenomena,
and abstract ideas are 'the basic tools of scientific and technological work', [m]onopolization of those tools
through the grant of a patent might tend to impede innovation more than it would tend to promote it . . . ."
Alice, 134 S. Ct. at 2354 (internal quotation marks omitted and citation omitted). The Court indicated that
certain applications of the "building blocks of human ingenuity" may remain eligible for patent protection if
they do not pose a disproportionate risk of "pre-emption." See id. at 2355.
14
In re BRCA1, 774 F.3d at 764 n.4.
15
Id. at 764.
16
Id.
3
increased role in litigations involving the pharma and biotech industries in the future. The
ramifications of Alice have been significant: early reports indicate that motions seeking a
determination of invalidity under Alice have experienced at least a 69% success rate in 2015.17
While the majority of those decisions concerned software, online business methods, and other
computer-related patents, at least one series of cases involved patents for correlating the presence
of certain genes with athletic performance.18 This, along with the court's decision in In re BRCA,
suggests that the invalidating fallout of Alice will not necessarily be confined to business
methods and software.
However, the Federal Circuit's decision in In re BRCA also appears to give guidance as to
how to avoid the rabbit hole of patent ineligibility under Alice. Specifically, the Federal Circuit
noted differences between the method claims at issue and another claim in the patent, claim 21,
which future litigants may be able to use to distinguish the case. The district court had suggested
that claim 21 might be a patent-eligible application of Myriad's knowledge of the BRCA genes.
The Federal Circuit, however, expressed no view on the patentability of claim 21, but noted that
the claims at issue in In re BRCA were "significantly broader and more abstract, as they claim all
comparisons between the patient's BRCA genes and the wild-type BRCA genes" while claim 21
was limited to methods of detecting only certain "expressly identified" alterations.19 This could
be viewed as a guidepost for avoiding future determinations of patent ineligibility.
17
18
19
See, e.g., Patent Docket Report for February 5, 2015, DOCKET NAVIGATOR, Feb. 5, 2015, at 1 (on file with
authors) ("The success rate of motions seeking a determination of invalidity for unpatentable subject matter has
increased to 69% in 2015, up from 58% in 2014 and 25% in 2010.").
See Genetic Techs. Ltd. v. Lab. Corp. of Am. Holdings, No. 12-1736-LPS-CJB, 2014 U.S. Dist. LEXIS 122780,
at *3-4, *47 (D. Del. Sept. 3, 2014) (finding the only asserted claim ineligible under Section 101, which claimed
"a method to predict potential sprinting, strength, or power performance in a human"); Genetic Techs. Ltd. v.
Bristol-Myers Squibb Co., Nos. 12-394-LPS, 12-396-LPS, 2014 U.S. Dist. LEXIS 154443, at *43 (D. Del. Oct.
30, 2014) (holding one claim ineligible under Section 101, and requesting additional input from parties before
determining validity of remaining claims); see also Genetic Techs. Ltd. v. Glaxosmithkline, LLC, No. 1:12-CV299, 2014 U.S. Dist. LEXIS 156473 (M.D.N.C. Aug. 22, 2014) (denying motion to dismiss under Section 101,
but currently stayed pending appeal of final judgments in the related cases).
In re BRCA1, 774 F.3d at 765.
4