Athena Diagnostics, Inc. v Mayo Collaborative Services, et al.

Filing 152

Judge Indira Talwani: ORDER entered. MEMORANDUM AND ORDER GRANTING 131 MOTION to Dismiss the Third Amended Complaint. (DaSilva, Carolina)

UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
ATHENA DIAGONISTICS, INC.,
ISIS INNOVATION LIMITED, and MAXPLANCK-GESELLSCHAFT ZUR
FORDERUNG DER
WISSENSCHAFTEN e.V.,
Plaintiffs,
v.
MAYO COLLABORATIVE
SERVICES, LLC, d/b/a MAYO
MEDICAL LABORATORIES, and
MAYO CLINIC,
Defendants.

*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*

Civil Action No: 15-cv-40075-IT

MEMORANDUM & ORDER
August 4, 2017
TALWANI, D.J.
Plaintiffs Athena Diagnostics, Inc., Isis Innovation Limited, and Max-PlanckGesellschaft zur Forderung der Wissenschaften e.V., allege that two tests developed by
Defendants Mayo Collaborative Services, LLC, and Mayo Clinic, infringe on Plaintiffs’ patent,
U.S. Patent No. 7,267,820 (the “‘820 Patent”). Third Am. Compl. (“Complaint”) [#92].
Defendants moved to dismiss Plaintiffs’ complaint arguing that the ‘820 patent is invalid under
35 U.S.C. § 101 because the claimed method applies routine and conventional techniques to a
law of nature. Defs.’ Rule 12(b)(6) Mot. Dismiss (“Defs.’ Mot. Dismiss”) [#25]. The court was
unable to determine on the papers before it whether the patent used standard techniques in the
art, or whether it was sufficiently inventive to be patentable under § 101, and denied the motion.
Mem. & Order 10 [#103]. At a subsequent hearing, Plaintiffs’ counsel agreed that a statement in

the patent specification (that “[i]odination and immunoprecipitation are standard techniques in
the art”) was undisputed. See ‘820 Patent col. 4 l. 10-11; Tr. Oral Argument, at 17-18, Athena
Diagnostics, Inc. v. Mayo Collaborative Servs., Inc., No. 15-cv-40075 (D. Mass. Oct. 6, 2016).
Based on that statement, the court allowed Defendants the opportunity to renew their motion to
dismiss, and allowed additional briefing by the parties. For the following reasons, the Renewed
Motion to Dismiss [#131] is ALLOWED.
I.

Facts
A. The ‘820 Patent
The ‘820 patent allows for the diagnosis of a form of Myasthenia Gravis, a chronic

autoimmune disorder. ‘820 Patent col. 1 l. 13-14. Patients with Myasthenia Gravis experience
waning muscle strength throughout the day, and symptoms include eye weakness (drooping
eyelids, double vision), leg weakness, dysphagia (difficulty swallowing), and slurred or nasal
speech. Id. col. 1 l. 15-23. In 1960, it was discovered that in 80% of patients with Myasthenia
Gravis, antibodies attack the acetyle choline receptor (AChR) (a neurotransmitter). Id. col. 1 l.
24-26, 34-36. In those patients, diagnosis is achieved through tests which detect the presence of
AChR autoantibodies. See id. col. 1 l. 34-36. Autoantibodies “are naturally occurring antibodies
directed to an antigen which an individual’s immune response recognizes as foreign even though
that antigen actually originated in the individual.” Id. col. 1 l. 42-45. However, 20% of
Myasthenia Gravis patients do not have the AChR autoantibodies despite experiencing the same
symptoms and responding to the same therapies. Id. col. 1 l. 36-40. For the 20% of Myasthenia
Gravis patients who do not have the AChR autoantibodies, the ‘820 patent inventors discovered
that they had IgG antibodies that attack the N-terminal domains of muscle specific tyrosine

2

kinase (“MuSK”), a receptor that is located on the surface of neuromuscular junctions. Id. col. 1
l. 55-61.
The patent describes the method for a more accurate and speedy diagnosis of these
patients. Id. col. 3 l. 4-7. Specifically, the patent describes a method for diagnosing Myasthenia
Gravis in which a radioactive label is attached to MuSK (or a fragment thereof) and is then
introduced to a sample of bodily fluid. Id. col. 3 l. 66-67, col. 4 l. 1-10. The method specifies that
125

I be used as the radioactive label. Id. col. 4 l. 9-10. When 125I-MuSK is introduced into the

sample of bodily fluid, the MuSK autoantibodies, if present, attach to the labeled fragment. Id.
col. 4 l. 2-9. After the bodily fluid is immunoprecipitated, the presence of the radioactive label on
any antibody indicates that the person is suffering from Myasthenia Gravis. Id. col. 4 l. 8-10.
B. Infringement Allegations
Athena’s test, “FMUSK,” uses the patented method to diagnose neurotransmission or
developmental disorders related to MuSK. Compl. ¶ 16 [#92]; ‘820 Patent Claim 1. Plaintiffs
allege that “Defendants, with specific knowledge of the ‘820 patent and the method it covers,
surreptitiously and purposefully designed an alternate test to avoid paying Athena for Athena’s
licensed FMUSK test.” Compl. ¶ 20 [#92]. Plaintiffs allege that Defendants availed themselves
of the technology disclosed in the ‘820 patent, and developed two tests for diagnosing
Myasthenia Gravis patients. Id. ¶ 18. Plaintiffs argue that Defendants’ actions directly or
indirectly, and literally or under the doctrine of equivalents, infringe the ‘820 patent. Id. ¶ 24.
The claims at issue are those listed in Claims 6-9 of the ‘820 patent. Pls.’ Mem. Opp’n Defs.’
Mot. Dismiss. 24 [#37]. Plaintiffs concede that they will not pursue infringement claims against
Defendants based on the other claims in the patent. Id. at 8.

3

II.

Motion to Dismiss
Defendants moved to dismiss the complaint on the ground that the patent seeks to patent

a law of nature, and it uses techniques standard in the art. Defs.’ Mem. Supp. Mot. Dismiss 5-6
[#26]; Defs.’ Renewed Mem. Supp. Mot. Dismiss 4-5 [#132]. Plaintiffs argue that the patent is
not directed at a law of nature because the patent requires the production and use of 125I-MuSK, a
non-naturally occurring protein. Pls.’ Mem. Opp’n Defs.’ Mot. Dismiss 17 [#37]. Plaintiffs also
argue that applying various known types of procedures to a non-naturally occurring protein
transforms the claim and makes it patent eligible. Id. at 13-14.
A. Standard of Review under 35 U.S.C. § 101
In applying § 101 at the pleading stage, the court construes the patent claims in a manner
most favorable to the non-moving party. See Content Extraction & Transmission LLC v. Wells
Fargo Bank, Nat’l Ass’n, 776 F.3d 1343, 1349 (Fed. Cir. 2014). As a threshold requirement for
patent protection, the subject matter of a patent must be patentable under § 101; otherwise, the
patent is invalid. § 101 states that “[w]hoever invents or discovers any new and useful process,
machine, manufacture, or composition of matter, or any new and useful improvement thereof,
may obtain a patent therefor, subject to the conditions and requirements of this title.” 35 U.S.C.
§ 101. The Supreme Court has held that this section contains an implicit exception: “[l]aws of
nature, natural phenomena, and abstract ideas are not patentable.” Alice Corp. Pty. Ltd. v. CLS
Bank Intern., 134 S. Ct. 2347, 2354 (2014) (quoting Ass’n for Molecular Pathology v. Myriad
Genetics, Inc., 133 S. Ct. 2107, 2116 (2013)). Although “all inventions at some level embody,
use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas,” these three
patent-ineligible exceptions prevent “monopolization” of the “basic tools of scientific and

4

technological work” and the impeding of innovation. Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 71 (2012).
To distinguish between patents that claim laws of nature, natural phenomena, and abstract
ideas from patent-eligible inventions, the court must first determine whether the claims at issue
are directed to one of those patent-ineligible concepts. Alice, 134 S. Ct. at 2355. If the concept is
patent ineligible, the court then considers 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. at 2355 (quoting Mayo, 566 U.S. at 78-79). “We
have described step two of this analysis as a search for an ‘inventive concept’ – i.e., an element
or combination of elements that is ‘sufficient to ensure that the patent in practice amounts to
significantly more than a patent upon the [ineligible concept] itself.’” Id. at 2355 (quoting Mayo,
566 U.S. at 72-73). At step two, more is required than well-understood, routine, conventional
activity already engaged in by the scientific community. Rapid Litig. Mgmt., Ltd. v. CellzDirect,
Inc., 827 F.3d 1042, 1047 (Fed. Cir. 2016).
B. Step One: Are Claims Directed to a Patent Ineligible Concept?
Defendants argue that the ‘820 patent is directed at a law of nature: that the bodily fluid
of some people with Myasthenia Gravis have autoantibodies to MuSK. Defs.’ Renewed Mem.
Supp. Mot. Dismiss 4-5 [#132]. Plaintiffs argue that the patent method uses a man-made, patent
eligible molecule, and uses that chemical complex in an innovative and transformative manner.
Pls.’ Surreply Opp’n Mot. Dismiss 4 [#46]. Per Plaintiffs, “the claims are not directed to
MuSK . . . [i]nstead, the claims recite using a man-made chemically-modified version of MuSK
to form a specific complex that does not occur in nature,” and are therefore patent eligible. Id. at
5.

5

The patent describes a method in which 125I-MuSK is put into a sample of bodily fluid,
and then the bodily fluid is filtered so that autoantibodies attached to the 125I-MuSK are detected.
‘820 Patent col. 3 l. 66-67, col. 4 l. 1-9. The presence of the 125I-MuSK autoantibodies indicates
the person suffers from Myasthenia Gravis. Id. The relevant portion of the patent states:
The invention claimed is:
1. A method for diagnosing neurotransmission or developmental disorders related to
muscle specific tyrosine kinase (MuSK) in a mammal comprising the step of detecting in
a bodily fluid of said mammal autoantibodies to an epitope of muscle specific tyrosine
kinase (MuSK).
2. A method according to claim 1 wherein said method comprises the steps of:
a) contacting said bodily fluid with muscle specific tyrosine kinase (MuSK) or an
antigenic determinant thereof: and
b) detecting any antibody-antigen complexes formed between said receptor
tyrosine kinase or an antigenic fragment thereof and antibodies present in said
bodily fluid, wherein the presence of said complexes is indicative of said mammal
suffering from said neurotransmission or development disorders.
3. A method according to Claim 2 wherein said antibody-antigen complex is detected
using an anti-IgG antibody tagged or labeled with a reporter molecule.
...
6. A method according to claim 3 whereby the intensity of the signal from the
anti-human IgG antibody is indicative of the relative amount of the anti-MuSK
autoantibody in the bodily fluid when compared to a positive and negative control
reading.
7. A method according to claim 1, comprising contacting MuSK or an epitope or
antigenic determinant thereof having a suitable label thereon, with said bodily
fluid, immunoprecipitating any antibody/MuSK complex or antibody/MuSK
epitope or antigenic determinant complex from said bodily fluid and monitoring
for said label on any of said antibody/MuSK complex or antibody/MuSK epitope
or antigen determinant complex, wherein the presence of said label is indicative
of said mammal is suffering from said neurotransmission or developmental
disorder related to muscle specific tyrosine kinase (MuSK).
8. A method according to claim 7 wherein said label is a radioactive label.
9. A method according to claim 8 wherein said label is 125I.

6

‘820 Patent Claims 1-9. Plaintiffs argue that because 125I-MuSK is not naturally occurring, the
claim is patent eligible under § 101. Pls.’ Mem. Opp’n Defs.’ Mot. Dismiss. 11 [#37] (“Those
antibody/MuSK complexes are created in the laboratory and result from the use of a nonnaturally-occurring laboratory-created molecule, 125I-MuSK, and therefore, the antibody/MuSK
complexes formed and detected by claim 9 are not found in nature.”).
While 125I-MuSK and the antibody/MuSK complexes are not found in nature, this does
not transform the patent at issue here to a patent eligible concept. Contrary to Plaintiffs’
argument, the ‘820 patent is not a composition patent directed at the creation of the 125I-MuSK
auto-antibody complex. Rather, the patent is directed at a method for the diagnosis of a disease.
‘820 Patent col. 1 l. 9-11 (“The present invention is concerned with neurotransmission disorders
and, in particular, with a method of diagnosing such disorders in mammals.”). Although the
patented method uses man-made 125I-MuSK, the use of a man-made complex does not transform
the subject matter of the patent. The focus of the claims of the invention is the interaction of the
125

I-MuSK and the bodily fluid, an interaction which is naturally occurring. The purpose of the

patent is to detect whether any antibody-antigen complexes are formed between the 125I-MuSK
receptor and the antibodies “present in said bodily fluid.” Id. Claim 2. Counter to Plaintiffs’
argument, because the patent focuses on this natural occurrence, it is directed to a patentineligible concept. See Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d. 1350, 1353 (Fed. Cir.
2016) (quoting Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36 (Fed. Cir. 2016))
(“[W]e have described the first-stage inquiry as looking at the ‘focus’ of the claims, their
‘character as a whole.’”).
Athena’s patent is similar to the patent invalidated by the Supreme Court in Mayo. In
Mayo, the Supreme Court invalidated the patent of a diagnostic test which measured how well a

7

person metabolized thiopurine drugs. 566 U.S. at 74. The patent claimed a method in which the
drug 6-thioguanine was given to a person, after which the level of 6-thioguanine in the person’s
blood stream was measured. Id. The Court held that the patent method was directed to observing
a law of nature. “‘Prometheus’ patents set forth laws of nature—namely, relationships between
concentrations of certain metabolites in the blood and the likelihood that a dosage of thiopurine
drug will prove ineffective or cause harm.” Id. at 77. While the Court acknowledged that it took
human action (the administration of a thiopurine drug) to trigger the desired reaction, the
reaction itself happened apart from any human action. Id. at 78. The Court found the claim
invalid because the method sought to measure how well a person metabolizes the drug, which the
Court described as “entirely natural processes.” Id. at 77. Likewise, Plaintiffs’ method seeks to
measure autoantibodies that have attached to a receptor protein, an interaction which is a
similarly natural process. In Mayo, a man-made substance was administered to a person, and the
by-product of the metabolization of that man-made substance was observed. Id.; see also Genetic
Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376 (Fed. Cir. 2016) (finding that when the patent
claim focuses on a newly discovered fact about human biology, the claim is directed to
unpatentable subject matter). Here, a man-made substance (125I-MuSK) is administered to a
sample of bodily fluid, and the by-product (125I-MuSK autoantibodies) is observed.
Further support can be found in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d
1372 (Fed. Cir. 2015). That case involved the patent for a method using fetal DNA for the
diagnosis of certain conditions. The inventors discovered that cell-free fetal DNA (“cffDNA”)
was present in maternal plasma and serum. By implementing a method for detecting the small
fraction of paternal cffDNA in the maternal plasma or serum, the inventors were able to
determine certain inherited characteristics. Id. at 1373. The patent method isolated and amplified

8

cffDNA, allowing for greater efficiency in diagnosis of genetic defects. As the court noted,
“[t]he only subject matter new and useful as of the date of the application was the discovery of
the presence of cffDNA in maternal plasma or serum . . .” Id. at 1377. Likewise, what is new and
useful here is the discovery that some patients with Myasthenia Gravis have MuSK
autoantibodies in their bodily fluid.
Relying on CellzDirect, 827 F.3d at 1042, Plaintiffs seek to distinguish the ‘820 patent
from Ariosa and Mayo by arguing that the ‘820 patent is focused on the steps required by the
claimed method, rather than on the outcome of the diagnostic test. In CellzDirect, patent
inventors discovered that hepatocytes, special liver cells that are used for testing, diagnostic, and
treatment purposes, could be refrozen. Id. at 1045. Refreezing of hepatocytes was a breakthrough
because the cells naturally have a short life span, and can only be harvested from a limited
number of people. Id. Prior to the discovery, hepatocytes could only be frozen one time, which
limited their utility. Id. The patented method importantly allowed for multi-donor hepatocyte
pools, a useful research tool that allows the study of a drug’s impact on a representative
population. Id. The Federal Circuit found the “end result of the ‘929 patent claims is not simply
an observation or detection of the ability of hepatocytes to survive multiple freeze thaw cycles.
Rather, the claims are directed to a new and useful method of preserving hepatocyte cells.” Id. at
1048. The court found that the process’ “desired outcome” was a method to produce something
useful, and therefore was not directed at a patent ineligible concept. Id. at 1048-49. The method
allowed for refrozen hepatocyte cells to be used in a myriad of ways. Conversely, the desired
outcome of the Plaintiffs’ method is the detection of MuSK autoantibodies. It does not produce
something useful beyond that diagnosis.
Plaintiffs’ argument that the patent is transformed by the use of a man-made molecule is

9

unavailing. The stated purpose of the patent is to diagnose Myasthenia Gravis, and the method is
directed to a patent ineligible law of nature under § 101.
C. Step Two: Does the Inventiveness of the Claim make it Patent Eligible?
While the patent is directed to a patent ineligible concept under § 101, the patent can still
be upheld if the method contains an “inventive concept.” See Alice, 134 S. Ct. at 2355; Genetic
Techs. Ltd., 818 F.3d at 1376 (“[T]he application must provide something inventive beyond
mere ‘well-understood, routine, conventional activity.’”). The Supreme Court has “described
step two of this analysis as a search for an ‘inventive concept’ – i.e., an element or combination
of elements that is ‘sufficient to ensure that the patent in practice amounts to significantly more
than a patent upon the [ineligible concept] itself.’” Alice, 134 S. Ct. at 2355 (quoting Mayo, 566
U.S. at 72-73). At step two the claims are examined “in light of the written description,” Amdocs
(Israel) Ltd. V. Openet Telecom, Inc., 841 F.3d 1288, 1299 (Fed. Cir. 2016), and “more is
required than well-understood, routine, conventional activity already engaged in by the scientific
community.” CellzDirect, 827 F.3d at 1047 (internal quotations omitted).
Defendants argue that Plaintiffs’ patent fails step two of § 101 analysis because it uses
well-known techniques for identifying the presence of autoantibodies to MuSK and therefore
does not contain an “inventive concept.” Defs.’ Mem. Supp. Mot. Dismiss 14 [#26] (“[P]rocess
steps that recite techniques scientists would have already known to use in conjunction with the
newfound natural law cannot supply the inventive concept.”). Defendants cite to the patent
specification which states that “[i]ondination and immunoprecipitation are standard techniques in
the art, the details of which can be found in references (4 and 6).” Id. at 10; ‘820 Patent col. 4 l.
9-12. Defendants note that the two publications referenced in the specification date from 1976
and 1985, and according to Defendants the publications “describe (1) the introduction of a 125I-

10

labeled antigen (AChR) into a bodily fluid sample, (2) immunoprecipitation, and (3) detecting
the radioactive label.” Defs.’ Mem. Supp. Mot. Dismiss 10 [#26]. Defendants argue that the
publications show that the methods described in the patent are commonly used by researchers in
the field, and thus the claims do not pass step two of the analysis under § 101.
Plaintiffs argue that at the time the invention was made, the step of “detecting”
autoantibodies was neither well understood nor routine, and that the step of contacting MuSK or
a MuSK epitope with a suitable label was novel. Pls.’ Memo. Opp’n Defs.’ Renew Mot. Dismiss
8 [#136]. Plaintiffs admit that the specification states “[i]odination and immunoprecipitation are
standard techniques in the art,” but Plaintiffs argue that none of those steps are routine when
applied to proteins. According to Plaintiffs, proteins are complex, and getting known iodination
methods to work with proteins is not routine. Id. at 11.
Plaintiffs’ argument is unavailing. Patent applications are required to provide the precise
description of the manner and process of making the invention. 35 U.S.C. § 112(a) (“The
specification shall contain a written description of the invention, and of the manner and process
of making and using it, in such full, clear, concise, and exact terms as to enable any person
skilled in the art to which it pertains, or with which it is most nearly connected, to make and use
the same, and shall set forth the best mode contemplated by the inventor or joint inventor of
carrying out the invention.”); see also In re TLI Commc’ns LLC Patent Litig., 823 F.3d 607,
613-614 (Fed. Cir. 2016) (“[W]e must be mindful of extraneous fact finding outside the record,
particularly at the motion to dismiss stage, here we need to only look to the specification . . . .”).
None of the complexity to which Plaintiffs cite is described or claimed in the patent. While
Plaintiffs argue that “Production of ‘MuSK or an epitope or antigenic determinant thereof having
a suitable label thereon’ required several steps that were neither well-known, not standard, nor

11

conventional for MuSK,” Pls.’ Mem. Opp’n Defs.’ Renewed Mot. Dismiss 15 [#136], this
statement directly contradicts the language in the specification. In the specification, the inventors
simply state that the “suitable label” is 125I or the like, and that iodination of the label is a
standard technique in the art. ‘820 Patent col. 4 l. 9-12. Furthermore, complexity alone does not
make their method patentable. See Myriad, 133 S. Ct. at 2117 (“Groundbreaking, innovative, or
even brilliant discovery does not by itself satisfy the § 101 inquiry.”).
Plaintiff also argues that the use of a man-made molecule necessarily makes the claims
patent eligible. Plaintiffs’ claim that “[a] process that requires the use of a novel non-naturallyoccurring patent-eligible element is necessarily a patent-eligible process.” Pls.’ Mem. Law.
Opp’n Defs.’s Renewed Mot. Dismiss 8 [#136]. However, the patent specification itself states
that the “present invention is concerned with neurotransmission disorders and, in particular with
a method of diagnosing such disorders in mammals.” ‘820 Patent col.1 l.9-11. The patent claims
it is “for diagnosing neurotransimission or developmental disorders related to muscle specific
tyrosine kinase (MuSK) in a mammal compromising the step of detecting in a bodily fluid of
said mammal autoantibodies to an epitope of muscle specific tyrosine kinase (MuSK).” Id. Claim
1. On its face, the patent claims a process for detecting autoantibodies, not a process for creating
the 125I-MuSK. See Myriad, 133 S. Ct. at 2119 (“Had Myriad created an innovative method of
manipulating genes while searching for the BRCA1 and BRCA2 genes, it could have possibly
sought a method patent.”).
III.

Conclusion
For the foregoing reasons, Defendants’ Renewed Motion to Dismiss [#131] is

GRANTED.
Date: August 4, 2017

/s/ Indira Talwani
United States District Court

12