United States District Court, D. Massachusetts
ATHENA DIAGONISTICS, INC., ISIS INNOVATION LIMITED, and MAX-PLANCK-GESELLSCHAFT ZUR FORDERUNG DER WISSENSCHAFTEN e.V., Plaintiffs,
MAYO COLLABORATIVE SERVICES, LLC, d/b/a MAYO MEDICAL LABORATORIES, and MAYO CLINIC, Defendants.
MEMORANDUM & ORDER
TALWANI UNITED STATES DISTRICT COURT JUDGE
Athena Diagnostics, Inc., Isis Innovation Limited, and
Max-Planck-Gesellschaft 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
The ‘820 Patent
‘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 kinase (“MuSK”), a receptor
that is located on the surface of neuromuscular junctions.
Id. col. 1 l. 55-61.
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 125I 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.
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.
Motion to Dismiss
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.
Standard of Review under 35 U.S.C. § 101
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 technological work” and the impeding of
innovation. Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 71 (2012).
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).
Step One: Are Claims Directed to a Patent ...