United States District Court, D. Massachusetts
ATHENA DIAGONISTICS, INC., ISIS INNOVATION LIMITED, and MAX PLANCK-GESELLSCHAFT ZUR FUNG DER WISSENSCHAFTEN e. V., Plaintiffs,
MAYO COLLABORATIVE SERVICES, LLC, d/b/a MAYO MEDICAL LABORATORIES, and MAYO CLINIC, Defendants.
MEMORANDUM & ORDER
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 (“
'820 Patent”). Third Am. Compl.
(“Complaint”) [#92]. Defendants move 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 motion is DENIED.
The '820 Patent
'820 patent allows for the diagnosis of a form of
Myasthenia Gravis, a chronic autoimmune disorder. U.S. Patent
No. 7, 267, 820 col. 1 l. 13. 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. U.S. Patent No. 7, 267, 820 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). In those patients,
diagnosis is achieved through tests which detect the presence
of AChR autoantibodies. U.S. Patent No. 7, 267, 820 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.” U.S.
Patent No. 7, 267, 820 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. U.S. Patent No. 7, 267, 820
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. U.S. Patent No. 7, 267,
820 col. 1 l. 55-61.
patent describes the method for a more accurate and speedy
diagnosis of these patients. U.S. Patent No. 7, 267, 820 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. U.S. Patent No. 7,
267, 820 col. 3-4 l. 65-10. The method specifies that 125I be
used as the radioactive label. U.S. Patent No. 7, 267, 820
col. 4 l. 10. When 125I-MuSK is introduced into the sample of
bodily fluid, the MuSK autoantibodies, if present, attach to
the labeled fragment. After the bodily fluid is
immunoprecipitated, the presence of the radioactive label on
any antibody indicates that the person is suffering from
Myasthenia Gravis. U.S. Patent No. 7, 267, 820 col. 4 l.
test, FMUSK, uses the patented method to diagnose
neurotransmission or developmental disorders related to MuSK.
Compl. [#92 ¶ 16]; U.S. Patent No. 7, 267, 820, 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. [#92 ¶ 20]. Plaintiffs allege that
Defendants availed themselves of the technology disclosed in
the '820 patent, and developed two tests for diagnosing
Myasthenia Gravis patients. Compl. [#92 ¶ 18].
Plaintiffs argue that Defendants' actions directly or
indirectly, and literally or under the doctrine of
equivalents, infringe the '820 patent. Compl. [#92 ¶
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. Pls.' Mem. Opp'n
Defs.' Mot. Dismiss 8 [#37].
Motion to Dismiss
move 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
[#26]. 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.
Plaintiffs also argue that applying various known types of
procedures to a non-naturally occurring protein transforms
the claim and makes it patent eligible. Pls.' Mem.
Opp'n Defs.' Mot. Dismiss 14 [#37].
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),
cert. denied, 136 S.Ct. 119 (2015). As a threshold
requirement for patent protection, the subject matter of a
patent must be patentable under § 101; otherwise, the
patent is invalid. Section 101 states “[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., ___ U.S. ___, 134 S.Ct. 2347, 2354 (2014)
(quoting Association for Molecular Pathology v. Myriad
Genetics, Inc., ___ U.S. ___, 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., ___ U.S. ___, 132 S.Ct. 1289, 1293 (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.” Alice, 134 S.Ct.
at 2355 (quoting Mayo, 132 S.Ct. at 1298, 1297).
“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.'” Alice, 134 S.Ct. at
2355 (quoting Mayo, 132 S.Ct. at 1294). At step two,
more is required than well-understood, routine, conventional
activity already engaged in by the scientific community.
Rapid Litigation Management, Ltd. v. CellzDirect,
Inc., ___ F.3d ___, 2016 WL 3606624, *3 (Fed. Cir. July
Step One: Are Claims Directed to a Patent ...