GENETIC TECHNOLOGIES LIMITED loses appeal at CAFC; 101 issues resolved in 12(b)(6) motion
Genetic Technologies Limited (“GTG”) brought suit
against Merial L.L.C. (“Merial”) and Bristol-Myers Squibb
(“BMS”) (together, “appellees”). GTG alleged that appellees
had infringed U.S. Patent No. 5,612,179 (“the ’179
patent”), which relates to methods of detecting genetic
variations. The district court granted appellees’ motions
to dismiss for failure to state a claim and entered final
judgment that claims 1–25 and 33–36 of the ’179 patent
are ineligible for patenting under 35 U.S.C. § 101. For
purposes of this appeal, the parties have stipulated that
claim 1 is representative of all of the invalidated claims.
Because we agree that claim 1 is directed to unpatentable
subject matter, we affirm.
This is a 12(b)(6) case
We review de novo the dismissal for failure to state a
claim under Rule 12(b)(6). Content Extraction & Transmission
LLC v. Wells Fargo Bank, Nat’l Ass’n, 776 F.3d
1343, 1346 (Fed. Cir. 2014); Sands v. McCormick, 502
F.3d 263, 267 (3d Cir. 2007). Patent eligibility under
35 U.S.C. § 101 is a question of law that we review de
novo. OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d
1359, 1362 (Fed. Cir. 2015); Content Extraction, 776 F.3d
We have repeatedly recognized that in many cases it
is possible and proper to determine patent eligibility
under 35 U.S.C. § 101 on a Rule 12(b)(6) motion. See, e.g.,
OIP Techs., 788 F.3d at 1362; Content Extraction, 776
F.3d at 1351; buySAFE, Inc. v. Google, Inc., 765 F.3d
1350, 1355 (Fed. Cir. 2014). In many cases, too, evaluation
of a patent claim’s subject matter eligibility under
§ 101 can proceed even before a formal claim construction.
“[C]laim construction is not an inviolable prerequisite to a
validity determination under § 101.” Bancorp Servs.,
L.L.C. v. Sun Life Assurance Co. of Canada (U.S.), 687
F.3d 1266, 1273 (Fed. Cir. 2012); see also Content Extraction,
776 F.3d at 1349. Here, there is no claim construction
dispute relevant to the eligibility issue.
Claim 1 recites a method of detecting an allele of interest
at a multi-allelic locus (i.e., a location on the chromosome
where multiple variations of a particular gene
are known) by amplifying a sequence of non-coding region
DNA known to be linked with the allele and then analyzing
the non-coding region to detect the allele. In somewhat
plainer terms, claim 1 covers a method of detecting
a coding region of a person’s genome by amplifying and
analyzing a linked non-coding region of that person’s
Claim 1 covers any comparison, for any purpose, of
any non-coding region sequence known to be linked with a
coding region allele at a multi-allelic locus. The ’179
patent states that “[t]he method can be used to detect
alleles of genetic loci for any eukaryotic organism,” ’179
patent col. 4 ll. 12–13, and “is generally applicable to
detection of any type of genetic trait,” id. at col. 46 ll. 8–9.
The ’179 patent does not limit its scope to methods of
detecting any particular alleles linked to any particular
non-coding sequences, although the specification does
provide some examples of linked alleles known to be
diagnostic of inherited diseases such as cystic fibrosis and
muscular dystrophy. See generally, ’179 patent col. 43
l. 43–col. 46 l. 6. Claim 1 broadly covers essentially all
applications, via standard experimental techniques, of the
law of linkage disequilibrium to the problem of detecting
coding sequences of DNA.
The product of the method of claim 1 is information
about a patient’s natural genetic makeup—at least one
coding region allele.
The similarity of claim 1 to the claims evaluated in
Mayo and Ariosa requires the conclusion that claim 1 is
directed to a law of nature. The sole function of the
“primer pair defining a DNA sequence which is in genetic
linkage with [a multi-allelic] genetic locus” is to amplify a
sequence of non-coding DNA in linkage disequilibrium
with a sequence of coding DNA of interest. ’179 patent
col. 59 ll. 60–62. “The method comprises amplifying
genomic DNA with a primer pair that spans an intron
sequence and defines a DNA sequence in genetic linkage
with an allele to be detected.” Id. at col. 4 ll. 37–39. The
claim is directed to a natural law—the principle that
certain non-coding and coding sequences are in linkage
disequilibrium with one another.2 We hold that claim 1 is
directed to unpatentable subject matter at the first step of
the Mayo/Alice test.
We thus proceed to step two of the Mayo/Alice analysis.
At step two, after identifying a claim directed to
unpatentable subject matter, “we must examine the
elements of the claim to determine whether it contains an
inventive concept sufficient to transform the claimed
abstract idea [or law of nature] into a patent-eligible
application.” Alice, 134 S. Ct. at 2357 (internal quotation
marks omitted) (citing Mayo, 132 S. Ct. at 1294, 1298).
“The question . . . is whether the claims do significantly
more than simply describe [a] natural relation.” Mayo,
132 S. Ct. at 1297. (...)
Claims directed to laws of
nature are ineligible for patent protection when, “(apart
from the natural laws themselves) [they] involve wellunderstood,
routine, conventional activity previously
engaged in by researchers in the field.” Mayo, 132 S. Ct.
We conclude that the additional elements of claim 1
are insufficient to provide the inventive concept necessary
to render the claim patent-eligible.
An allusion to Mayo:
Mayo itself considered and rejected diagnostic and
therapeutic method claims that combined routine and
conventional physical implementation of a law of nature
with a simple mental process step.
Mayo held that the “‘wherein’ clauses
simply tell a doctor about the relevant natural laws, at
most adding a suggestion that he should take those laws
into account when treating his patient.” Id. at 1297.
That is, “these clauses tell the relevant audience about
the laws while trusting them to use those laws appropriately
where they are relevant to their decisionmaking
(rather like Einstein telling linear accelerator operators
about his basic law and then trusting them to use it
where relevant).” Id.
Here, the phrase “to detect the allele” in claim 1 of the
’179 patent also merely informs the relevant audience—
e.g., doctors or others seeking to make a genetic diagnosis—
to apply a law of nature for a purpose—detecting a
polymorphism within a coding region of an allele of interest.
An allusion to BRCA:
Our decision in In re BRCA1- & BRCA2-Based Hereditary
Cancer Test, 774 F.3d 755 (Fed. Cir. 2014), is also
instructive. Claim 8 of U.S. Patent No. 5,753,441 evaluated
in that case recited a method of screening for alterations
of the BRCA1 gene that included the steps of
“amplifying all or part of a BRCA1 gene from [a] sample
using a set of primers to produce amplified nucleic acids
and sequencing the amplified nucleic acids” and “comparing”
the sequence with wild-type BRCA1. Id. at 761–62.
We held that claim to be invalid because it was directed to
an abstract idea and did not add enough to distinguish it
from a claim to the abstract idea. Id. at 762–65. An
aspect of our analysis there supports our analysis of the
law-of-nature issue here.
UPDATE: see also