Genetic Technologies Limited v. Bristol-Myers Squibb Company

Filing 57

MEMORANDUM OPINION re motions to dismiss. Signed by Judge Leonard P. Stark on 10/30/14. Associated Cases: 1:12-cv-00394-LPS, 1:12-cv-00396-LPS (ntl)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
GENETIC TECHNOLOGIES LTD.,
Plaintiff,
C.A. No. 12-394-LPS

v.
BRISTOL-MYERS SQUIBB
COMPANY,
Defendant.

GENETIC TECHNOLOGIES LTD.,
Plaintiff,
C.A. No. 12-396-LPS

v.

MERIALLLC,
Defendant.

MEMORANDUM OPINION

October 30, 2014
Wilmington, Delaware

t~~.~

STARK, U.S. District Judge:

Presently before the Court are Defendants' motions to dismiss under Federal Rule of
Civil Procedure 12(b)(6). Defendants argue that the patents-in-suit are directed toward
unpatentable subject matter under 35 U.S.C. § 101. The Court agrees that claim 1 of United
States Patent No. 5,612,179 ("the '179 patent") impermissibly claims a natural phenomenon and,
therefore, grants Defendants' motions with regard to this claim. With respect to any remaining
asserted claims, the Court denies the motions without prejudice to renew.

I.

PROCEDURAL BACKGROUND
On May 25, 2011, Genetic Technologies Ltd. ("GTG" or "Plaintiff') filed a patent

infringement action in the District Court for the District of Colorado against several defendants,
including Bristol-Myers Squibb Company ("BMS") and Merial LLC ("Merial") (collectively,
"Defendants"), alleging infringement of the '179 patent. See Genetic Techs. Ltd. v. Agilent
Techs., Inc., C.A. No. 11-1389-WJM-KLM D.I. 1 (D. Colo. May 25, 2011). In March 2012, the
pending claims against BMS and Merial, respectively, were severed and transferred to this
District. See id. at D.I. 314 (D. Colo. March 28, 2012).
On March 29, 2012, GTG filed its First Amended Complaint in this District against BMS,
alleging infringement of the '179 patent as well as United States Patent No. 5,851,762 ("the '762
patent") (collectively, "the patents-in-suit"). (C.A. No. 12-394 D.I. 2) On that same day, GTG
filed its First Amended Complaint in this District against Merial, again alleging infringement of
the '179 patent. 1 (C.A. No. 12-396 D.I. 2)
1

GTG also alleged infringement of the '179 patent against Pfizer, Inc. ("Pfizer") (C.A.
No. 12-395 D.I. 2), Natera Inc. (''Natera") (C.A. No. 12-1737 D.I. 1), and Histogenetics LLC
("Histogenetics") (C.A. No. 12-1738 D.I. 1). Histogenetics filed a motion for judgment on the
1

Generally, the '179 patent relates to a method for detecting alleles of a genetic locus and
haplotypes by amplifying genomic DNA with a primer pair spanning a non-coding sequence in
genetic linkage with the allele to be detected. The '762 patent generally relates to a genomic
mapping method based on the ability to identify haplotypes of individuals through analysis of
non-coding region sequence variation patterns.
On February 3, 2014, BMS and Merial filed motions to dismiss for failure to state a claim
on the basis that the patents-in-suit are directed to patent ineligible subject matter under 35
U.S.C. § 101. (C.A. No. 12-394 D.I. 35; C.A. No. 12-396 D.I. 52) The parties completed
briefing on March 17, 2014. (C.A. No. 12-394 D.I. 36, 43, 48, 49; C.A. No. 12-396 D.I. 58, 63,
642) The Court heard oral argument on the motions on April 4, 2014. (See D.I. 51) ("Tr.")

II.

BACKGROUND 3
The patented technology relates to deoxyribonucleic acid ("DNA"). The building blocks

of DNA, known as "nucleotides," consist of four bases: adenine ("A"), cytosine ("C"), guanine

pleadings on the basis of§ 101 (C.A. No. 12-1738 D.I. 51), but the case was dismissed on
August 15, 2014 (C.A. No. 12-1738 D.I. 74). The action involving Natera has been transferred
to the Northern District of California. (C.A. No. 12-1737 D.I. 42) Natera and Pfizer have not
joined the pending motions. GTG also alleged infringement against Laboratory Corporation of
America Holdings, Laboratory Corporation of America, and 23andMe Inc. of United States
Patent No. 7,615,342 ("the '342 patent"). (C.A. No. 12-1736 D.I. 1) These defendants filed a
motion to dismiss on the basis of§ 101 as well (C.A. No. 12-1736 D.I. 9), which was referred to
Magistrate Judge Christopher J. Burke (C.A. No. 12-1736 D.I. 21). On September 3, 2014,
Judge Burke recommended granting the motion. (C.A. No. 12-1736 D.I. 31) The case was
dismissed on September 9, 2014. (C.A. No. 12-1736 D.I. 32)
2

For simplicity, in the remainder of this Opinion the Court refers to the "D.I." number in
C.A. No. 12-394, unless otherwise indicated.
3

For purposes of evaluating the pending motions, it is appropriate for the Court to derive
this background primarily from the allegations in the operative Complaints, including the
patents-in-suit, which are attached to them.
2

("G"), and thymine ("T"). (Second Amended Complaint ("SAC") at if 7) The nucleotides form
pairs with one another - G pairs with C and T pairs with A - in order to form the double helix
structure of DNA. (Id.) Stretches of this DNA sequence form genes, the units of heredity in an
organism. (Id. at iJ 8) Genes contain regions for coding proteins, known as "exons," as well as
non-coding regions, known as "introns." ('179 patent at 5:40-50, 60:4-5) The DNA of different
individuals varies significantly, and a variation among individuals' genetic sequences at a
particular site in the genome is called a "polymorphism," which can occur in both coding and
non-coding regions. (See SAC at iii! 9, 13) A genetic variation in the coding region of a gene is
called an "allele." (Id. at iJ 9) Certain alleles are correlated with particular traits or diseases.
(See '179 patent at 1:27-2:10; SAC at iJ 9)

Early efforts at determining genetic differences among individuals focused on directly
analyzing the coding region of genes (exons) to detect alleles. (SAC at iJ 9) Although variations
were also known to exist in non-coding DNA, these non-coding regions (introns) were largely
dismissed as irrelevant, garnering the epithet "junk DNA." (Id. at iJ 15)
Through the work of a company called Genetype AG and Dr. Malcolm Simons, it was
discovered that there can be a correlation between variations in non-coding introns and coding
region alleles. (Id. at iJ 16) Through what is referred to as meiosis, duplicate chromosomes
exchange stretches of DNA (in a process called chromosomal crossover), resulting in shuffled
chromosomes. (Id. at iJ 11) Certain regions of each chromosome, however, tend to be inherited
together with only rare shuffling. (Id.) These stretches are said to be linked or in "linkage

3

disequilibrium."4 (Id.) Coding region alleles at adjacent loci that are inherited together are
known as a haplotype. (Id. at if 12) Dr. Simons discovered that single nucleotide polymorphisms
("SNPs") in non-coding DNA regions can also be in linkage disequilibrium with SNPs in coding
regions of DNA. (Id. at if 17)
The Amended Complaint depicts a hypothetical partial genomic DNA sequence (shown
below) illustrating this linkage phenomenon. Arrows 1, 2, 3, and 4 each represent a SNP at four
sites in the sequence:
2

JJ.

3

.)}

1

.0,

I

e:xon

promoter

4

J

ll

SNPl C/T lntergeolc r~gum}
5NP~ A/G ~oding reg~on
in linkage disequilibrium,
SNP3 A/T Coding region
two major naplotypes:
SNP4 T/G Deep intronic

exon

SNPl SNP2 SHP3 SNP4
C
A
A
T
T
G
T
G

(Id. at iMf 13, 17) SNPs 1 and 4 are in non-coding regions, while SNPs 2 and 3 are in coding

regions (both in the first exon). (Id.) As the Amended Complaint explains, in this hypothetical
sequence "SNPs 2 and 3 contribute to phenotypic variation, and they are in linkage
disequilibrium with SNPs 1 and 4 because a gene is a unit of inheritance, meaning that
everything within the gene is linked and inherited as a block." (Id.) Therefore, the genotypes of
SNPs 1-4 are correlated, with SNPs 1 and 4 serving as "surrogate markers" for SNPs 2 and 3.

4

The '179 patent specification states: "The term 'linkage disequilibrium,' as used herein,
refers to the co-occurrence of two alleles at linked loci such that the frequency of the
co-occurrence of the alleles is greater than would be expected from the separate frequencies of
occurrence of each allele. Alleles that co-occur with frequencies expected from their separate
frequencies are said to be in 'linkage equilibrium."' ('179 patent at 5:25-30)

4

(Id.

at~

17) The genotypes of SNPs 2 and 3 can be detected by determining the genotype of SNP

1 or SNP 4, as shown in the table above. (Id.)
Throughout a genome, various groups of SNPs are in linkage disequilibrium and, thus,
exhibit the non-coding/coding correlations. (Id.

at~

19) Details of each correlation can vary

and, in some instances, no correlation exists. (Id.)
Prior to the patents-in-suit, it was common for scientists studying DNA to "amplify'' the
portion of interest by making additional copies to allow for analysis. (' 179 patent at 2:45-60,
3:5-12, 3:39-45, 5:55-6:3, 12:53-65) A common method for amplifying DNA was "polymerase
chain reaction," also known as "PCR." ('179 patent at 2:45-60, 3:5-12; SAC

at~

25) In PCR

generally, a pair of short, man-made strands of DNA, called a "primer pair," which each match a
specific short nucleotide sequence along complimentary strands of DNA, can be used in
conjunction with an enzyme known as a "polymerase" to create copies of particular stretches of
the DNA sequence. (See '179 patent at 2:45-60, 3:5-12, 5:66-6:3, 6:10-13; SAC at iMf 23-24)
Also in the prior art was another well-established technique for analyzing amplified DNA:
restriction fragment length polymorphism ("RFLP") pattern. (' 179 patent at 1:50-53)

III.

LEGAL STANDARDS
A.

Motion to Dismiss

In order to survive a motion to dismiss for failure to state a claim pursuant to Federal

Rule of Civil Procedure 12(b)(6), "a complaint must contain sufficient factual matter, accepted as
true, to state a claim to relief that is plausible on its face." Ashcroft v. Iqbal, 556 U.S. 662, 678
(2009). A claim is facially plausible when the factual allegations allow the court to draw the
reasonable inference that the defendant is liable for the misconduct alleged. See id. at 663.

5

The court "must accept as true the factual allegations in the complaint and all reasonable
inferences that can be drawn therefrom." Nami v. Fauver, 82 F.3d 63, 65 (3d Cir. 1996).
However, the court "need not accept as true threadbare recitals of a cause of action's elements,
supported by mere conclusory statements." Iqbal, 556 U.S. at 678.
"In deciding a Rule 12(b)( 6) motion, a court must consider only the complaint, exhibits

attached to the complaint, matters of public record, as well as undisputedly authentic documents
ifthe complainant's claims are based upon these documents." Mayer v. Belichick, 605 F.3d 223,
230 (3d Cir. 2010). A court may also take judicial notice of the prosecution histories, which are
"public records." See Hockerson-Halberstadt, Inc. v. A via Group Int 'l, Inc., 222 F .3d 951, 957
(Fed. Cir. 2000); see also generally Lum v. Bank ofAm., 361 F.3d 217, 222 n.3 (3d Cir. 2004).
The Court of Appeals for the Federal Circuit has stated that to grant dismissal of a patent
infringement suit at the pleading stage for lack of patentable subject matter, "the only plausible
reading of the patent must be that there is clear and convincing evidence of ineligibility."

Ultramercial, Inc. v. Hulu, LLC, 722 F.3d 1335, 1339 (Fed. Cir. 2013), cert. granted, judgment
vacated sub nom. WildTangent, Inc. v. Ultramercial, LLC, -U.S.-, 134 S. Ct. 2870 (2014)
(emphasis in original). Subsequently, the Supreme Court vacated and remanded the Federal
Circuit's decision in Ultramercial for further consideration in light of the Supreme Court's ruling
in Alice Corp. v. CLS Bankint'l, 573 U.S.-, 134 S. Ct. 2347, 189 L. Ed. 2d 296 (2014). See

WildTangent, 134 S. Ct. at 2870. Therefore, Ultramercial no longer has precedential effect. See
Cnty. ofLos Angeles v. Davis, 440 U.S. 625, 634 n.6 (1979) ("[O]ur decision vacating the
judgment of the Court of Appeals deprives that court's opinion of precedential effect.") (internal
quotation marks and citations omitted); In re Joy Global, Inc., 381 B.R. 603, 611 (D. Del. 2007)
6

("[V]acating a lower court's ruling deprives that [lower] court's opinion of precedential effect.")
(internal quotation marks and citations omitted).
Nevertheless, the Court finds the reasoning in Ultramercial at least persuasive here
insofar as it concerns the procedural mechanics of a § 101 challenge at the 12(b)(6) stage particularly the significant burden on a movant given the limited factual record, if any, before the
Court. In addition, Ultramercial is now pending on remand before the Federal Circuit, putting
the substantive § 101 question in light of Alice before that Court, which may well respond by
reinstating the "only plausible reading" standard for § 101 challenges arising at the pleading
stage under Rule 12(b)(6). Finally, while the Federal Circuit made clear in Ultramercial that it
will be "rare" that patent ineligibility is evident at the pleading stage such that a patent suit can be
dismissed on this basis, see 722 F.3d at 1338, the instant matter presents such a rare case. Hence,
application of Ultramercial would not alter the outcome here.

IV.

DISCUSSION
A claim is unpatentable if it merely informs a relevant audience about certain laws of

nature, even newly-discovered ones, and any additional steps collectively consist only of
well-understood, routine, conventional activity already engaged in by the scientific community.

See Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S.-, 132 S. Ct. 1289, 1298,
182 L. Ed. 2d 321 (2012). The claim involved here, claim 1 of the '179 patent, does just that and
no more. 5 Consequently, as explained below, the claimed subject matter is ineligible under§

5

The parties dispute whether there is a case or controversy over all claims of the patentsin-suit, particularly as GTG has yet to identify its asserted claims. The Court addresses the
eligibility of claim 1 of the '179 patent. By separate order, the Court will direct the parties to
apply the analysis set out here to the remaining claims of the '179 and '762 patents and then
advise the Court whether further disputes remain.
7

101.

A.

Patentable Subject Matter

First, the Court discusses the legal standards applicable to the issue of patentable subject
matter. Pursuant to 35 U.S.C. § 101, an applicant may obtain a patent on a new and useful
(1) "process," (2) "machine," (3) "manufacture," or (4) "composition of matter," or "any new and
useful improvement thereof." Although § 101 generally encompasses "anything under the sun
that is made by man," "laws of nature, natural phenomena, and abstract ideas" are not patentable.

Diamond v. Diehr, 450 U.S. 175, 182, 185 (1981 ).
The concern driving these exceptions is pre-emption. See Alice, 134 S. Ct. at 2354;

Mayo, 132 S. Ct. at 1294 (stating case law "wam[s] us against upholding patents that claim
processes that too broadly preempt the use of a natural law"). 6 "[T]oo broad an interpretation of
this exclusionary principle could eviscerate patent law," however, as all inventions "at some level
embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas."

Mayo, 132 S. Ct. at 1293. Therefore, courts must distinguish between patents that claim the
"building blocks" of human ingenuity- and '"would risk disproportionately tying up the use of
the underlying"' natural laws, Alice, 134 S. Ct. at 2354-55 (quoting Mayo, 132 S. Ct. at 1294,
1303) (emphasis added) - and those patents that "integrate the building blocks into something
more, thereby 'transform[ing]' them into a patent-eligible invention," such that they pose no

6

Laws of nature, natural phenomena, and abstract ideas are "the basic tools of scientific
and technological work." Ass 'nfor Molecular Pathology v. Myriad Genetics, Inc., 569 U.S.-,
133 S. Ct. 2107, 2116, 186 L. Ed. 2d 124 (2013). "'[M]onopolization of those tools through the
grant of a patent might tend to impede innovation more than it would tend to promote it,' thereby
thwarting the primary object of the patent laws." Alice, 134 S. Ct. at 2354 (quoting Mayo, 132 S.
Ct. at 1293).
8

comparable risk of pre-emption, id. at 2354-55.
In discussing this distinction, the Supreme Court has recently reiterated that courts are to

apply the two-step framework set out in Mayo Collaborative Servs. v. Prometheus Labs., Inc. A
court first determines "whether the claims at issue are directed to one of those patent-ineligible
concepts." Alice, 134 S. Ct. at 2355 (citing Mayo, 132 S. Ct. at 1296-97). If so, a court then
"consider[s] the elements of each claim both individually and as 'an ordered combination' to
determine whether the additional elements 'transform the nature of the claim' into a
patent-eligible application." Id. (citing Mayo, 132 S. Ct. at 1298). At this second step, courts
examine whether "a process that focuses upon the use of a natural law also contain[ s] other
elements or a combination of elements, sometimes referred to as an 'inventive concept,'
sufficient to ensure that the patent in practice amounts to significantly more than a patent upon
the natural law itself." Mayo, 132 S. Ct. at 1294. Most recently, the Federal Circuit has held that
if '"the additional elements' do not supply an 'inventive concept' in the physical realm of things
and acts - a 'new and useful application' of the ineligible matter in the physical realm - that
ensures that the patent is on something 'significantly more than' the ineligible matter itself," the
claim is outside the scope of§ 101. buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1353 (Fed.
Cir. 2014) (quoting Alice, 134 S. Ct. at 2355, 2357).
In keeping with these principles, '" [p ]henomena of nature, though just discovered,

mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools
of scientific and technological work."' Mayo, 132 S. Ct. at 1293 (quoting Gottschalkv. Benson,
409 U.S. 63, 67 (1972)) (emphasis added). Rather, if"there is to be invention from a discovery
of a law of nature, it must come from the application of the law of nature to a new and useful

9

end." Id. at 1294 (internal alterations and quotation marks omitted).
When the steps of the claim "must be taken in order to apply the [natural] laws in
question," the claim is not necessarily anything more than a dictate to apply the law of nature.
Mayo, 132 S. Ct. at 1299-300; see also id. at 1294 ("[T]o transform an unpatentable law of

nature into a patent-eligible application of such a law, one must do more than simply state the
law of nature while adding the words 'apply it.'") (emphasis in original) (citing Benson, 409 U.S.
at 71-72). If the additional elements or steps in the claimed process, "apart from the natural laws
themselves," involve only "well-understood, routine, conventional activity previously engaged in
by researchers in the field" at the relevant time, they are insufficient. Mayo, 132 S. Ct. at 1294;
see also Ass 'nfor Molecular Pathology v. U.S. Patent & Trademark Office, 689 F.3d 1303,

1354-55 (Fed. Cir. 2012) ("AMP''), a.ff'd in part and rev 'din part on other grounds sub nom.
Ass 'nfor Molecular Pathology v. Myriad Genetics, Inc., 569 U.S.-, 133 S. Ct. 2107, 186 L.

Ed. 2d 124 (2013) ("Myriad"). Similarly, purely "conventional or obvious" "[pre]-solution
activity" is normally "not sufficient to transform an unpatentable law of nature into a
patent-eligible application of such a law." Mayo, 132 S. Ct. at 1298; see also Bilski v. Kappas,
561 U.S. 593, 610-11 (2010) ("[T]he prohibition against patenting abstract ideas 'cannot be
circumvented by attempting to limit the use of the formula to a particular technological
environment"') (quotingDiehr, 450 U.S. at 191); Bilski, 561 U.S. at 612 (limiting abstract idea
to a "field of use" does not confer eligibility) (citing Parker v. Flook, 437 U.S. 584 (1978)).

B.

The Claim Concerns a Process

The present invention claims methods for amplifying and analyzing correlations between
different regions of a DNA sequence. It is undisputed that the claimed invention is a "process"
10

(as opposed to a machine, manufacture, or composition of matter). See Accenture Global Servs.,
GmbH v. Guidewire Software, Inc., 728 F.3d 1336, 1341 (Fed. Cir. 2013) ("First, the court must

identify 'whether the claimed invention fits within one of the four statutory classes set out in
§ 101. "')(quoting CLS Bank Int 'l v. Alice Corp. Pty., 717 F.3d 1269, 1282 (Fed. Cir. 2013), cert.
granted, 134 S. Ct. 734 (2013), afj"d, 134 S. Ct. 2347 (2014)). Thus, the Court will tum to

determining whether one of the exceptions to eligibility applies to this particular process.

C.

The Claim Recites a Natural Phenomenon7

The correlations between variations in non-coding regions of DNA- formerly known as
"junk DNA" - and variations in coding regions of DNA - specifically, alleles - are natural
phenomena. A correlation that preexists in the human body is an unpatentable phenomenon.
See, e.g., Lab. Corp. ofAm. Holdings v. Metabolite Labs., Inc., 548 U.S. 124, 135 (2006)

(finding correlation between homocysteine in human body fluid and vitamin deficiency is
"natural phenomenon"). In Mayo 132 S. Ct. at 1296-97, the Supreme Court evaluated a patent
related to the correlation between concentrations of certain metabolites in the blood and the
likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm. The Court
found that"[ w ]hile it takes a human action (the administration of a thiopurine drug) to trigger a
manifestation of this relation in a particular person, the relation itself exists in principle apart
from any human action." Id. at 1297 ("The relation is a consequence of the ways in which
thiopurine compounds are metabolized by the body- entirely natural processes."). Therefore, in

7

GTG cites to several recent reexaminations conducted by the Patent and Trademark
Office ("PTO") related to certain claims of the patents-in-suit. (See D.I. 43 at 7-8) The reexams,
however, did not consider§ 101. (See Tr. at 51; see also 35 U.S.C. § 302 (limiting reexams to
grounds of invalidity based on "prior art"))
11

Mayo, the patent claiming that natural correlation merely set forth a natural law. See id.
Here, the correlations involved in claim 1 preexist in the human body. More specifically,
the correlations involve a form of "linkage disequilibrium" where (i) variations in the non-coding
region DNA sequence are genetically linked to (ii) the presence of alleles in the coding regions.
The variations, known as polymorphisms, are naturally occurring in the DNA sequence. The
linkage is a result of entirely natural processes in which these sequences are inherited as a block.
Plaintiff contends these correlations are not a natural phenomenon or law because any
given genetic linkage is not universal, is "not present in all species or even amongst other
individuals of a particular species," and "may not have existed in the past and may not exist in
the future" due to evolutionary inherency. (SAC at if 21) Plaintiff insists that a natural
phenomenon must be an immutable, scientific truth. The Court disagrees. Plaintiff cites no
authority for so broad a proposition. Moreover, Plaintiffs position is inconsistent with the
reasoning of Mayo, which acknowledges that a natural phenomenon may vary across organisms.
See 132 S. Ct. at 1295 (explaining "the way in which people metabolize thiopurine compounds
varies, the same dose of a thiopurine drug affects different people differently"). Thus, patent law
does "not distinguish[] among different laws of nature according to whether or not the principles
they embody are sufficiently narrow." Id. at 1289.
Therefore, just as the relationship at issue in Mayo was entirely a consequence of the
body's natural processes for metabolizing thiopurine, so too is the correlation here (between
variations in the non-coding regions and allele presence in the coding regions) a consequence of
the naturally occurring linkages in the DNA sequence. See also Genetic Techs. Ltd. v. Agilent
Techs., Inc., -F.Supp.2d-, 2014 WL 941354, at *3 (N.D. Cal. Mar. 7, 2014) (stating
12

correlations between variation in non-coding and coding regions alone are unpatentable natural
laws despite not being "universal" or "immutable scientific truths"). Regardless of whether the
correlations change over time due to evolution or are not identical across every organism, the
genetic correlations here exist apart from any human action. 8 Accordingly, Plaintiffs arguments
are unavailing.

D.

The Claim's Additional Steps Do Not Give Rise to an "Inventive Concept"

Having determined that claim 1 recites a process focused on a natural law, the Court must
now determine whether the additional steps in the claim are sufficient to satisfy patent eligibility.
Specifically, "do the patent claims add enough to their statements of the correlations to allow the
processes they describe to qualify as patent-eligible processes that apply natural laws?" Mayo,
132 S. Ct. at 1297 (emphasis in original).
When the newly discovered DNA correlations are set aside and the additional steps are
examined, claim 1 of the '179 patent is ineligible. The asserted claim recites a series of steps to
manifest the natural law - that is, to detect the natural correlations between coding and noncoding sequences. The added steps used to discern these correlations consist only of routine and
conventional techniques. The patent specification states this outright, making this one of the
(perhaps rare) occasions in which further factual development and claim construction are not
necessary and invalidity can properly be determined at the 12(b)( 6) stage. 9 Without any

8

See also Agilent, 2014 WL 941354, at *3 ("GTG concedes that the correlations between
genomic variation in non-coding and coding regions are naturally occurring.").
9

There is no factual dispute over what the correlations consist of, allowing the Court to
separate the additional steps from the natural phenomenon without additional fact finding that
might otherwise be required. The parties have only disputed the separate question of whether
those "linkage disequilibrium" correlations constitute a "law of nature," which the Court has
13

inventive steps employed before the correlation is detected, the claims might still meaningfully
limit themselves to an application of this newly-discerned DNA correlation. However, it is
undisputed here that once the correlation is detected, the claim stops. Hence, under the guidance
of Mayo and Myriad, the additional steps do not add enough to transform the claim on a natural
phenomenon into patent eligible subject matter.
1.

'179 Patent - Claim 1

The Court concludes the only plausible reading of claim 1 of the '179 patent is that its
additional steps, which consist only of routine and conventional techniques, fail to give rise to an
"inventive concept," such that when, taken as a whole, the claim does not provide meaningful
limitations that restrict the natural correlation to an application.
In Mayo, the inventor claimed a method of optimizing therapeutic efficacy for treatment

of an immune-mediated gastrointestinal disorder, comprising: "(a) administering a drug
providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder" and
"(b) determining the level of 6-thioguanine in said subject having said immune-mediated

gastrointestinal disorder." Mayo, 132 S. Ct. at 1295 (quoting '623 patent-in-suit at 20:10-20)
(emphasis added). In addition to these steps, the claim contained two other limitations:
"(c) wherein the level of 6-thioguanine less than about 230 pmol per 8x10 8 red blood cells
indicates a need to increase the amount of said drug subsequently administered to said subject"
and (d) "wherein the level of 6-thioguanine greater than about 400 pmol per 8x 10 8 red blood
cells indicates a need to decrease the amount of said drug subsequently administered to said
subject." Id. (emphasis added).

concluded they do (as explained above).
14

The Court held that the "administering" step simply referred to the relevant audience
(e.g., doctors using those drugs to treat patients), the "determining" step ''tells doctors to engage
in well-understood, routine, conventional activity previously engaged in by scientists who work
in the field," and the "wherein" steps simply tell a doctor in greater detail about the natural law
itself. Id. at 1297-98. The Court concluded the claims "inform a relevant audience about certain
laws of nature; any additional steps consist of well-understood, routine, conventional activity
already engaged in by the scientific community; and those steps, when viewed as a whole, add
nothing significant beyond the sum of their parts taken separately." Id. Thus, the steps were "not
sufficient to transform unpatentable natural correlations into patentable applications." Id.
Here, likewise, the steps of claim 1 of the ' 179 patent add nothing more to the natural
linkage correlation than routine activity already well known in the field. Claim 1 recites:
A method for detection of at least one coding region allele of a
multi-allelic genetic locus comprising:
a) amplifying genomic DNA with a primer pair that spans a
non-coding region sequence, said primer pair defining a DNA
sequence which is in genetic linkage with said genetic locus and
contains a sufficient number of non-coding region sequence
nucleotides to produce an amplified DNA sequence characteristic
of said allele; and
b) analyzing the amplified DNA sequence to detect the allele.

('179 Patent at 59:57-67) (emphasis added) The additional steps consist of the (i) "amplifying"
and (ii) "analyzing" limitations, along with (iii) a descriptive limitation about what kind of DNA
sequence the primer pair in the amplifying step delineates.
As with the "administering" and "determining" steps in Mayo, the "amplifying" step here
tells scientists to engage in "well-understood, routine, conventional activity previously engaged
15

in" by those in the field. Mayo, 132 S. Ct. at 1298. According to the patent itself, all of the
techniques it discloses for DNA amplification, including PCR analysis, were previously well
known methods. (See generally '179 patent 2:45-60, 3:5-8, 3:39-45, 12:53-64; SAC at iM! 14,
23-25) The use of "primers" for amplification was also well known. 10 (See, e.g., '179 patent at
2:45-60; D.I. 37 at A109 ('179 Patent Prosecution History) (Am. in Resp. to Office Action of
Jan. 13, 1994) ("[M]ethods of selecting primers to amplify a selected region of DNA are well
known."); id. at A126-27 (Resp. to Office Action of May 17, 1994) (stating examiner was
"clearly aware" amplification was a technique readily practiced by those in the field at the
relevant time))
In GTG's view, the claims are ''unconventional methods" because they teach 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. (D.I. 43 at 4) (emphasis added) In its Second
Amended Complaint, GTG concedes "PCR amplification was known" but contends "no one had
used a primer pair to amplify non-coding DNA to define a DNA sequence in genetic linkage with
a coding region allele in order to detect that allele." (SAC at if 25; see also Tr. at 46 (conceding
primers, which Plaintiff likens to "scissors," are in prior art, but arguing "the use of scissors to
cut a particular region of DNA ... is new")) Therefore, GTG's argument is that directing
conventional amplification techniques to discern a newfound natural correlation - linkage

10

"Primer pair" is expressly defined in the patent as "a set of primers including a 5'
upstream primer that hybridizes with the 5' end of the DNA sequence to be amplified and a 3'
downstream primer that hybridizes with the complement of the 3' end of the sequence to be
amplified." ('179 patent at 5:66-67, 6:1-3) The patent further states: "It is well understood that
for each primer pair, the 5' upstream primer hybridizes with the 5' end of the sequence to be
amplified and the 3' downstream primer hybridizes with the complement of the 3' end of the
sequence." (Id. at 38:39-42)
16

l

disequilibrium between non-coding sequences and alleles - constitutes an "unconventional"
amplification technique for detecting those alleles.
GTG fails to separate the unpatentable natural law from the purportedly unconventional
"amplifying" technique. Mayo sets out that when "the steps in the claimed processes (apart from
the natural laws themselves) involve well-understood, routine, conventional activity previously
engaged in by researchers in the field," the subject matter is ineligible without more. 132 S. Ct.
at 1294 (emphasis added). Claim 1 here directs a geneticist to a particular set of DNA
sequences: those containing the natural "linkage disequilibrium" correlation. However, apart
from the natural phenomenon - of a DNA sequence that spans a non-coding region in linkage
disequilibrium with a coding-region allele - claim 1 only recites amplifying a DNA sequence
using routine and conventional amplification techniques. Therefore, GTG's argument fails. 11
GTG urges the Court to follow Genetic Techs. Ltd. v. Agilent Techs., Inc., -F.Supp.2d
- , 2014 WL 941354 (N.D. Cal. Mar. 7, 2014), which denied a motion to dismiss after the
defendant there failed to persuade the Agilent court the '1 79 patent is patent ineligible. The
Court here declines to do so. 12 As an initial matter, the Agilent court largely did not reach the

11

Recently, in multi-district litigation captioned In re BRCAJ-, BRCA2-Based Hereditary
Cancer Test Patent Litig., the District of Utah applied Mayo and rejected a similar attempt to
argue that the claimed steps were not "routine and conventional" because the primers were
designed using the discovery of a new sequence, i.e., the BRCAl and BRCA2 gene sequences.
See No. 2:13-CV-00640-RJS, 2014 WL 931057, at *51 (D. Utah Mar. 10, 2014) (analyzing
§ 101 ineligibility under "likelihood of success"). The Court concluded that "[a]side from the
patent ineligible, naturally occurring nucleotide sequence of the BRCAl and BRCA 2 genes, the
other steps set forth in the Method Claims are conventional activities that were well-understood
and uniformly employed by those working with DNA at the time." Id.
12

TheAgilent court provided a thorough, well-reasoned, and helpful consideration of the
specific arguments presented by the defendant there (Agilent) in support of its motion, and
emphasized the high burden facing defendants seeking dismissal based on a section § 101
17

question of whether the additional steps involved "routine and conventional" techniques because
it found Agilent improperly conflated§ 101 with§§ 102 and 103. See id. at *4. However, on a
separate but related point, the court did find, "The application of primer pair amplification to
intron sequences ... may well have been 'novel and unconventional.' As discussed herein,
whether those in the field would consider applying genomic amplification to non-coding regions
conventional or routine is a factual question better addressed at a later stage." Id. at *4 n.9
(refusing to find GTG's "novel and unconventional" position necessarily inconsistent with
patentee's concession during prosecution that it did not invent genomic amplification using
primer pair).
To use theAgilent's court's statements in the way GTG suggests here would risk
collapsing the natural law into the additional steps in the same manner discussed (and rejected)
above. Mayo requires that the additional steps be viewed apart from the natural law. Otherwise,
whenever a natural law is newly discovered, any "additional step" - no matter how routine or
conventional in that field - could be tacked onto it and become patent eligible by virtue of the
fact it takes advantage of the naturally occurring phenomenon. See Mayo, 132 S. Ct. at 1300
("[S]imply appending conventional steps, specified at a high level of generality, to laws of
nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas
patentable."). Here, GTG's application of the otherwise conventional technique of amplifying a
DNA sequence to the newly-discovered natural law does not make its claim patent eligible.

challenge on a 12(b)(6) motion. This Court reaches a different conclusion on the instant motion
based on its conclusion that the moving defendants here, BMS and Merial, have carried their
burden, a conclusion that is not necessarily inconsistent with the conclusion reached by the
Agilent court based on the record and arguments before it.
18

l
Consequently, the "amplifying" step is insufficient to meaningfully limit the claims. See

I

l

Mayo, 132 S. Ct. at 1298 ("Purely 'conventional or obvious' 'pre-solution activity' is normally
not sufficient to transform an unpatentable law of nature into a patent-eligible application of such
a law.") (internal punctuation omitted). 13
The "said primer pair" limitation merely recites the natural phenomenon itself - the
linkage correlation - just as the "wherein" steps in Mayo recited the characteristics of the
metabolite correlations. See id. at 1297 ("[T]hese clauses tell the relevant audience about the
laws while trusting them to use those laws appropriately where they are relevant to their
decision[-]making (rather like Einstein telling linear accelerator operators about his basic law and
then trusting them to use it where relevant)."). The primer pair must define a DNA sequence that
has enough non-coding region sequence nucleotides in "genetic linkage" with the allele such that
when amplified, the sequence is characteristic of the allele. In short, the DNA sequence must
contain the correlation. The limitation sets forth a condition that is inherently required in order
to implement the natural law and, therefore, does nothing to impart an "inventive concept."
Finally, the "analyzing" step is akin to the "determining" step in Mayo, which told the
physician to determine the level of the relevant metabolites in the blood ''through whatever

13

GTG also contends that Defendants' arguments regarding "conventional and obvious"
steps conflate the § 101 analysis with the other requirements of patentability, namely§§ 102 and
103. The Court disagrees. Bilski, Diehr, Flook, and Benson all "rest their holdings upon section
101, not later sections." Mayo, 132 S. Ct. at 1303. In announcing that "conventional and
obvious" post-solution steps are insufficient to transform an ineligible law of nature, these cases
instruct courts to examine well-known techniques and routine practices, which may at times
overlap with or implicate the prior art. See also id. at 1304 ("§ 101 patent-eligibility inquiry and
... the § 102 novelty inquiry might sometimes overlap."). The Court finds Defendants properly
limit their arguments to a§ 101 eligibility framework and do not conflate it with the distinct
analysis of the prior art that would be involved in a novelty or obviousness challenge under
§§ 102 and 103.
19

process the doctor or the laboratory wishes to use." Id. at 1297-98. Here, the relevant audience
is simply instructed to analyze the amplified DNA sequence to detect the allele through whatever
method the scientist chooses, a step which does not meaningfully limit the claim. See also

Agilent, 2014 WL 941354, at *6 (stating "analyzing" step of claim 1 of '179 patent "does not
require any particular method of analysis or explain how the allele is to be detected; such general
instructions provide no direction to the relevant audience and do not meaningfully limit the
claim"). Furthermore, analyzing the "DNA sequence to detect an allele" is inherently required in
order to use the natural law. 14
When viewed as "an ordered combination," the "amplifying," "primer pair defining," and
"analyzing" steps together do not alter the outcome here. Indeed, as with the steps in Mayo, the
"steps as an ordered combination add[] nothing to the laws of nature that is not already present
when the steps are considered separately." Mayo, 132 S. Ct. at 1298.

2.

'762 Patent

In light of the limited analysis the parties provided in their briefing and during oral
argument on the patent eligibility of the '762 patent- which includes ten steps in claim 1 alonethe Court will require additional assistance from the parties to apply the foregoing analysis to the
'762 patent (and to the remaining claims of the '179 patent as well).

E.

Machine or Transformation Test

Plaintiff contends that claim 1 of the '1 79 patent is patent eligible because it satisfies the

14

ln addition, the specification states that all of the techniques to accomplish the
"analyzing" step (RFLP pattern analysis) disclosed in the specific embodiments of the invention
are well known. (' 179 patent at 16:28-29)
20

l
machine or transformation test in three ways. First, in GTG's view, the claims require
amplification, which "must be performed with a machine." Second, primers are tools, and
therefore the method claims use "machines." Finally, the output of amplification is man-made
DNA, which also makes the claims transformative. Plaintiff's arguments are unpersuasive.
The "machine or transformation test" is "not a definitive test of patent eligibility, but only

I
j

j

an important and useful clue." Mayo, 132 S. Ct. at 1296 (discussing Bilski, 561 U.S. 593).
Therefore, contrary to GTG's suggestion, the Supreme Court has "neither said nor implied that
the test trumps the 'law of nature' exclusion." Id. at 1289 (finding test did not confer eligibility
even though claims involved transforming human body by administering drug, and transforming
blood by analyzing metabolite levels). As the Federal Circuit has noted, "to impart
patent-eligibility to an otherwise unpatentable process under the theory that the process is linked
to a machine, the use of the machine 'must impose meaningful limits on the claim's scope."'
Fort Properties, Inc. v. Am. Master Lease LLC, 671 F.3d 1317, 1323 (Fed. Cir. 2012). Given
these principles, the three grounds GTG proposes to satisfy the machine or transformation test all
fail.
With regard to GTG's argument that the claims require use of a machine to amplify the
DNA, the asserted claims do not tie amplification to a "particular machine" and, therefore, do not
meet the machine or transformation test on these grounds. See Bilski, 130 S. Ct. at 3225-26; 15
CyberFone Sys., LLC v. Cellco P'ship, 885 F. Supp. 2d 710, 716 & n.5 (D. Del. 2012), aff'd sub
nom. Cyberfone Sys., LLCv. CNN Interactive Grp., Inc., 558 F. App'x 988 (Fed. Cir. 2014)
15

Under the test, a process may be patentable if"(l) it is tied to a particular machine or
apparatus, or (2) it transforms a particular article into a different state or thing." Bilski, 561 U.S.
at 602.
21

l

I
i

l
I

(rejecting argument that "sending of exploded data transactions over a channel ... also requires a
machine" because "plaintiff only summarily makes this argument and does not indicate what
type of machine is required") (emphasis in original). Here, the use of machines generally does
not impose a meaningful limit on claim scope.
GTG devotes a single line of its brief to its second argument that the claims are also tied
to a machine, and thus patentable, because the well-known primers are a man-made tool that is
used to selectively amplify DNA. Even if primers could be characterized as machines, GTG's
argument cannot prevail. Carried to its logical conclusion, accepting GTG's position would
mean that any time a claim covering a natural law also employs a well-known, routine, or
conventional man-made implement- such as a basic thermometer to take a patient's temperature,
a conventional syringe to introduce a known drug, or a primer for beginning DNA amplification
- this machine would confer patentability. Such a result would eviscerate the holding in Mayo
regarding the ineligibility of "conventional or routine" steps. Relatedly, such a conventional
machine would always trump the "law of nature" exception. See Mayo, 132 S. Ct. at 1303.
Plaintiff's third argument, by which it contends that amplified DNA is "man-made,"
relies chiefly on Plaintiff's interpretation of the Supreme Court's decision in Myriad regarding
cDNA. According to GTG, Myriad stands for the proposition that "man-made DNA that is
molecularly different from naturally occurring DNA is patent eligible in of itself;" based on this
reading, GTG contends that because "amplified DNA is molecularly distinct and distinguishable
from naturally occurring DNA from which it was derived," it, too, is "man-made." (D.1. 43 at
22) This, in GTG's view, makes its methods using amplified DNA patent eligible: "once one has
determined that a claimed composition of matter is patent-eligible subject matter, applying
22

I

l
i

various known types of procedures to it is not merely applying conventional steps." See AMP,
689 F.3d at 1336. 16
Plaintiff misreads Myriad. First, Myriad did not address the broad category of"manmade DNA" GTG describes here; nor did it establish such a sweeping principle of eligibility.
Instead, in Myriad, the Supreme Court specifically addressed the patent eligibility of (i) "isolated
native DNA," which it found ineligible, and (ii) "cDNA," which it held was eligible on the basis
that it was a synthesized DNA sequence from which the non-coding regions had been removed
and, thus, did not occur in nature. See 133 S. Ct. at 2116-19; see also In re BRCAJ-,
BRCA2-Based Hereditary Cancer Test Patent Litig., 2014 WL 931057, at *45 ("Plaintiffs are
incorrect in contending that the [Myriad] Court found all synthetic DNA to be patent eligible.").
GTG's attempt to liken amplified DNA to cDNA contradicts the reasoning of Myriad and
related Federal Circuit precedent, which focus on what the claims recite rather than unclaimed
chemical differences identified post-hoc during litigation. GTG concedes that "like cDNA, the
nucleotide sequence of amplified DNA is dictated by the naturally occurring DNA," but contends
"the process of amplification does not copy the methylation status of the DNA and incorporates
cytosines into the final product instead of the naturally occurring 5-methylcytosines." (D.I. 43 at
22; see also SAC at if 27) However the Supreme Court and Federal Circuit analyses lead to the
conclusion that changing a DNA molecule's "methylation" and removing it from its context in
the genome do not confer patent eligibility if the claim is directed to the genetic sequence - i.e.,
the genetic information - rather than the chemical composition of the physical DNA molecule.

16

The Court is mindful that cases such as Myriad concerned composition claims only, not
method claims. However, GTG's arguments rest on the supposition that the claims here are
patent eligible because they incorporate a man-made composition.
23

In Myriad, before ruling on the cDNA claims, the Court held Myriad's composition

claims over the isolated native DNA sequence containing the BRCAl and BRCA2 genes were
not patent eligible, despite the fact that "isolating DNA from the human genome severs chemical

I

I

I

bonds and thereby creates a nonnaturally occurring molecule." Myriad, 133 S. Ct. at 2118. The
Court reasoned that Myriad's "claims are simply not expressed in terms of chemical
composition, nor do they rely in any way on the chemical changes that result from the isolation of
a particular section of DNA," but rather "focus on the genetic information encoded in the
BRCAl and BRCA2 genes." Id. (emphasis added). By contrast, the Court found the claims on
cDNA presented no such problem because removal of the non-coding region sequence
''unquestionably creates something new," even though the coding regions are retained. Id. at
2119 ("[ C]reation of a cDNA sequence from mRNA results in an exons-only molecule that is not
naturally occurring.") (emphasis added). 17 However, the Court emphasized that a "very short
series of DNA may have no intervening introns to remove when creating cDNA. In that
situation, a short strand of cDNA may be indistinguishable from natural DNA." Id.
Similarly, in AMP, in which the Federal Circuit analyzed the eligibility of the method
claims that were not subject to review in Myriad, the Federal Circuit based its determination on
what the claims recited rather than on unclaimed differences in chemical composition. See AMP,
689 F.3d at 1334, cert. granted in part, 133 S. Ct. 694 (U.S. 2012), aff'd in part, rev 'din part,
133 S. Ct. 2107 (reversing eligibility ruling for isolated DNA composition claims). In an attempt

17

The Court found that synthesis of cDNA using mRNA results in "the inverse of the
mRNA's inverse image of the original DNA, with one important distinction: Because the natural
creation of mRNA involves splicing that removes introns, the synthetic DNA created from
mRNA also contains only the exon sequences." Myriad, 133 S. Ct. at 2112.
24

t

l
'

to read a transformative step into the "abstract mental processes" of "comparing" or "analyzing"
two gene sequences, the patentee argued that the specifications showed that the claim term
"sequence" refers "not to information, but rather to a physical DNA molecule, whose sequence
must be determined before it can be compared." Id. at 1335. The Federal Circuit rejected this
argument, finding "the claims only recite mental steps, not the structure of physical DNA
molecules." Id. (holding claimed methods indistinguishable from ineligible claims in Mayo that
recite only "administering" and "determining" steps).
Most recently, in In re Ros/in Inst. (Edinburgh), 750 F.3d 1333 (Fed. Cir. 2014), the
Federal Circuit again rejected several unclaimed chemical and phenotypical differences as a basis
for eligibility of composition claims on the first cloned animal. See id. at 1338 (affirming finding
of ineligibility because "Dolly's" genetic identity to her donor parent rendered her unpatentable
and "any difference in mitochondrial DNA between the donor and cloned mammals is ...
unclaimed").
Here, claim 1 is undisputedly directed to genetic information. More precisely, the claim
recites a method for detecting a coding region allele using genomic DNA, specifically a naturally
occurring non-coding region sequence, which is amplified and analyzed. The claim is focused
on the information in that genetic sequence, and the "linkage disequilibrium" between variations
in the non-coding region sequence and variations in the coding region sequence, not the chemical
structure of the molecule. It is undisputed that the genetic information in the amplified sequence
is the same - nucleotide after nucleotide, in the same order - as the native DNA sequence. (See
D.I. 43 at 22) ("[T]he nucleotide sequence of amplified DNA is dictated by the naturally
occurring DNA.") Therefore, although amplification is carried out in a laboratory by a human, it
25

I
I

is a replication of the native DNA sequence, resulting in a mirror image of the naturallyoccurring genetic information. The claims do not depend on the altered methylation. The
chemical changes that may indeed occur during amplification are unrelated to the claimed
method and, therefore, do not impose a meaningful limitation. 18
For these reasons, the Court declines to follow Agilent on this point. Agilent observed
that "GTG does not provide any explanation why the absence of this methylation is important to
their claimed method," but nonetheless concluded that "considering the averment that the
amplification step creates a chemically distinguishable molecule, no clear and convincing
evidence indicates an absence of transformation." Agilent, 2014 WL 941354, at *7. The Agilent
court took the averment in the complaint as governing (at the Rule 12(b)(6) stage) on the
machine or transformation question. Here, however, even while taking the factual averments in
the amended complaints as true and in the light most favorable to GTG, and accepting that
amplified DNA "does not copy the methylation status of the DNA and incorporates cytosines
into the final product instead of the naturally occurring 5-methylcytosines to GTG," it is clear
that the claim does not in any way depend on that difference in chemical composition. Hence,
the Court is compelled (even at this early stage of the litigation) to conclude that claim 1 is not
patentable.
The Court concludes, therefore, that the machine or transformation test is not satisfied,
nor does it provide a basis for finding claim 1 here is meaningfully limited.

18

At the hearing, Plaintiff described amplification as a "copy machine." (Tr. 43-44)
26

F.

Defendants' Motions Are Not Premature 19
1.

Factual Disputes

GTG suggests there are "numerous factual issues" underlying Defendants' motions but
fails to explain how any factual dispute prevents Defendants from satisfying their (albeit heavy)
burden. An alleged infringer raising an invalidity defense bears the burden of proving invalidity
by clear and convincing evidence. See Microsoft Corp. v. i4i Ltd. P'ship, -U.S.-, 131 S.
Ct. 2238, 2242, 180 L. Ed. 2d 131 (2011) (analyzing burden on validity challenges brought under
§§ 102, 103); see also id. at 2253 (Breyer, J., concurring) ("[T]he evidentiary standard of proof
applies to questions of fact and not to questions oflaw."). In Ultramercial, the Federal Circuit
explained that dismissal on eligibility grounds is typically inappropriate at this preliminary
12(b)(6) stage in large part due to the "presence of factual issues coupled with the requirement
for clear and convincing evidence." Ultramercial, 722 F.3d at 1339. However, after viewing all
factual allegations in the complaint as true, and drawing all reasonable inferences therefrom in
Plaintiffs favor, the only plausible reading of claim 1 here is that it claims only patent ineligible
1

9The Court has reviewed Plaintiffs Notice of Subsequent Authority (D.I. 56), advising
of the recent decision in Genetic Techs. Ltd. v. GlaxoSmithKline, LLC, No. 1: 12-CV-299-CCEJL, slip op. at 3 (M.D.N.C. Aug. 22, 2014), in which defendant GlaxoSmithKline's ("GSK")
motion to dismiss the '179 patent on the basis of§ 101 was denied. The Court's disposition here
is unaltered by the GlaxoSmithKline decision, which was largely based on a rejection of GSK's
argument that the Supreme Court's recent decision in Alice required dismissal of the action. See
id. at 1-3 (distinguishing Alice's "computer implementation of an abstract idea" as arising in "a
completely different factual context" and "different procedural context," i.e., summary
judgment). Moreover, in finding that GSK had not provided "clear and convincing evidence of
ineligibility," the GlaxoSmithKline court relied on GTG's same allegations "that the methods of
the patents were neither routine nor conventional" - despite the fact that, once more, these
allegations in GTG's complaint do not separate the natural law from the additional steps, as is
required under Mayo. These allegations fold the newly-discovered natural law into the additional
steps and use it as the basis for a factual dispute that the step cannot be ''routine or obvious." In
this Court's view, GTG's approach renders its arguments unavailing.
27

subject matter. Accordingly (and perhaps unusually), no factual disputes render premature
Defendants' request for a determination of invalidity at this early stage.
2.

l
1

Claim Construction

GTG also contends that claim construction is necessary before the Court can determine
patent eligibility. The Court disagrees. GTG has identified no claim term in dispute that could
alter the Court's conclusions. Also, the Court finds no factual disputes underlying the scope of
the claims that prevent it from finding Defendants have met their high burden on the issue of
ineligibility. As discussed above, the only plausible reading of the claims is that there is clear
and convincing evidence that they cover only ineligible natural correlations between non-coding
sequences and alleles. Defendants' motion, therefore, is not premature.
V.

CONCLUSION
For the reasons stated above, the Court finds claim 1 of the '179 patent recites only

ineligible subject matter under§ 101. Defendants' motions to dismiss will be granted with
respect to this claim. The Court will require further input from the parties before it can
determine whether all of the other asserted claims of the patents-in-suit are invalid, if this
question even remains in dispute.
An appropriate Order follows.

28