Drawing Lines: The Boundary of Patentability in
Personalized-Medicine Diagnostics (*)
Invited Researcher: Kevin Emerson COLLINS (**)
A correlation-based medical diagnostic is a diagnostic technology that is enabled by the discovery of a previously
unknown correlation between an observable attribute of a patient (e.g., a genetic mutation) and a medically useful fact
about, or diagnosis of, a patient (e.g., an inability to metabolize a drug). Correlation-based medical diagnostics are bothcommercially important and socially valuable because they are essential to the development of personalized or precision
medicine.
Patent protection for many correlation-based medical diagnostics is available today in Japan. However, the reasons
why many correlation-based medical diagnostics are patentable have not been clearly articulated, and thus the precise
line between patentable and unpatentable correlation-based medical diagnostics remains uncertain. This report offers anumber of theories about what the limits on the patentability of correlation-based medical diagnostics might be and thus
where the line between patentable and unpatentable correlation-based medical diagnostics might be drawn. Morespecifically, it focuses on the restrictions that the diagnostic-method exclusion of the industrial-applicability requirement
and both the laws of nature and mental activities exclusions of the statutory-invention requirement place on thepatentability of correlation-based medical diagnostics.

I

Introduction

A correlation-based medical diagnostic is adiagnostic technology that is enabled by the discovery ofa previously unknown correlation between an observable
attribute of a patient and a medically useful fact about thepatient. Upon the discovery of previously unknown
correlations between an observable attribute of a patientand a medical fact about that patient, researchers in the
United States were historically able to obtain patent
protection for a two-step diagnostic method with patentclaims that recited (a) the step of determining if a patient
possesses the attribute and (b) the step of mentallyinferring that the medical fact is true if the patient
possesses the attribute. Correlation-based medical
diagnostics are socially and commercially valuable
because they are essential components of thedevelopment of personalized medicine, which is also
sometimes called precision medicine.
Patent protection for correlation-based medical
diagnostics is, today, widely available in Japan, but there
is no convincing explanation of how the line between
patentable and unpatentable diagnostics is being drawn.
Motivated by recent cases issued by the Supreme Court
and Federal Circuit court of Appeals in the United Statesthat radically decreased the amount of patent protectionthat is available for correlation-based medical diagnostics,
this report articulates theories about the current state ofpatent law in Japan that explain why correlation-based
medical diagnostics are patentable and where the line
between patentable and unpatentable diagnostics lies. It
focuses on two provisions in Japanese patent law thatmight, at first glance, be expected to invalidate patents oncorrelation-based medical diagnostics: the exclusion of
method of diagnosis of humans under its
industrial-applicability requirement and both the laws ofnature and mental activities exclusions of thestatutory-invention requirement.

II The Technology: Correlation-Based
Medical Diagnostics and Personalized
Medicine
1

What Is a Correlation-Based Medical Diagnostic?
A correlation-based medical diagnostic is a medical
technology that is enabled by the discovery of a newcorrelation between an observable attribute of a patient(“the attribute”) and a medically relevant fact about apatient (“the medical fact”). Once such a correlation has
been discovered, a new diagnostic technology has beencreated. The new diagnostic test has only two basic steps.
First, a medical professional determines whether a patient
has the attribute. Second, if patient possess the attribute,then the medical professional mentally reasons, or infers,
the medical fact about the patient.

(*) This is a summary of the report published under the 2014FY Industrial Property Research Promotion Project (2014FY-2016FY) Entrusted
by the Japan Patent Office.
(**) Professor of Law, Washington University School of Law, St. Louis, at our institute over a period of approximately 1.5 months from June 3,2015 through July 18, 2015, as an Invited Researcher for the Fiscal Year 2015.
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Examples of Patents on Correlation-Based
Medical Diagnostics[omitted]

III Industrial Applicability in Japan
This section examines the patentability ofcorrelation-based medical diagnostics under the industrial
applicability requirement of Article 29 in Japan, which
the Japanese Patent Office (JPO) has interpreted in its
Examination Guidelines (Guidelines) to make medical
activity, including methods of diagnosis of humans,
industrially inapplicable inventions.
1

The Policy Concerns[omitted]

2 The JPO Examination Guidelines(1) Medical Activities Are Not Industrially
Applicable
The Guidelines articulate a broad exclusion of“medical activity” from industrially applicable inventions,with “medical activity” being defined as “methods ofsurgery, therapy, or diagnosis of humans.”1(2) Defining the Category of Industrially
Inapplicable Methods of Diagnosis of
HumansWith respect to methods of diagnosis, the Guidelines
offer the following definition of the excluded subject
matter: “‘Methods of diagnosis of humans’ include
methods of judging for [] medical purpose[s] the physicalcondition of a human body such as diseases and physicalhealth, the mental condition of a human body, orprescription or treatment/surgery plans based on th[is]condition[].” 2 A 2009 revision to the Guidelines
broadened the reach of patentability in the field of
medical diagnostics. Most importantly, this revision statesthat “methods of analyzing” the data extracted from thehuman body by, for example, “comparing such … datawith standards” are not inherently methods of diagnosis
and thus can be industrially applicable.3

The definition of methods of diagnosis in humans
clearly envisions that some correlation-based medical
diagnostics are inventions that are not capable ofindustrial application. For example, consider again the
one and only case offered to illustrate an industriallyinapplicable method of diagnosis: “Methods of judging
whether the patient has had a stroke by observing theimage obtained by the MRI scan.”4 Assuming that such amethod would, in its detailed form, indicate that certain
features or markings on an MRI scan mean that a patient
has had a stroke, this claim can easily be re-written as acorrelation-based medical diagnostic. That is, it could be
rewritten as “a method of judging whether a patient has
had a stroke comprising (a) determining whether certain
features or markings are present on an MRI scan and (b)inferring that a patient has had a stroke if the features ormarkings are present.” If the exclusion of methods ofdiagnosing humans is to have any impact at all, thissimple reformulation of Case 1 must remain industriallyinapplicable.
(ii) Data-Gathering Methods: Industrial Applicability
The Guidelines also clearly provide an example of acorrelation-based medical diagnostic that is anindustrially applicable method of analyzing samples ordata about the human body: a method of determining
susceptibility to hypertension discussed above as a caseillustrating methods of analyzing extracted samples anddata by, for example, comparing them with standards.5 It
is a classic example of a correlation-based medical
diagnostic. The first step involves determining whether apatient has a particular attribute, namely whether thepatient’s X gene has an A or a G on the nth line of the basesequence. The second step then involves inferring that thepatient’s susceptibility to hypertension is low if there is an
A and high if there is a G.

ApplicationoftheGuidelines
toCorrelation-Based Medical Diagnostics
This Section addresses the patentability ofcorrelation-based medical diagnostics under theprovisions in the Guidelines outlining the exclusion of
medical activity from industrial applicability.

(2) The Reason the Line is Difficult to Draw
The inclusion of methods of analyzing extracted
samples and data by, for example, comparing them withstandards within industrially applicable inventions makes
the line at the boundary of medical activity difficult todraw when patents claim correlation-based medical
diagnostics. After the inclusion of this category, assigninga medical meaning to data extracted from the body is theessence of both industrially inapplicable methods ofdiagnosis of humans, but it can also be the essence ofindustrially inapplicable methods of gathering data about
the human body.

(1) Correlation-Based Medical Diagnostics Can
Be Either Industrially Applicable or
Inapplicable(i) Methods of Diagnosis: No Industrial
Applicability(3) Drawing the Line at the Boundary ofIndustrial Applicability
Based on the examples provided in the Guidelines,
some, but not all, correlation-based medical diagnostics
are industrially applicable in Japan today. This section

3

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therefore articulates, at and times evaluates, a number oftheories as to how Japanese patent law could draw theneeded line.
(i)

Semantics: Analyzing or Determining Versus
Diagnosing or Judging
One possibility is that the line between industriallyapplicable and inapplicable correlation-based diagnostics
boils down to semantics, i.e., to the words that a patentdrafter uses when writing the claim. Under this theory, aclaim that employs the terms “judging” or “diagnosing” isindustrially inapplicable, whereas a claim that uses works
like “examining,” “analyzing,” or “determining” isindustrially applicable. Alternatively, the semantic line
could be a one-way rule: using the wrong words will leadto a rejection for a lack of industrial applicability but
simply using the right words will not automatically leadto industrial applicability.
(ii) Deterministic Reasoning Versus Experiential
Judgment
Another way to draw the needed line would be to
distinguish industrially applicable diagnostics that employ
logical, analytically precise reasoning and that are capableof being expressed as a precise algorithm, on the one hand,from industrially inapplicable diagnostics that employ
experiential judgment and that are impossible to codify in a
precise algorithm, on the other hand. Here, the industrial
applicability requirement would roughly sort theunpatentable “art” of diagnosis of humans from thepatentable “science” of methods of analyzing extracted
samples and data.
(iii) Final Diagnoses Versus Objective Data
Supporting Final Diagnoses
Another way to interpret the Guidelines would be to
draw a distinction between industrially inapplicable tests
that generate information that definitively diagnoses thehealth of a patient, on the one hand, and industriallyapplicable tests that merely provide objective, factual
information that only is used as an input into any
definitive diagnosis the health of a patient that a doctor
may eventually make, on the other hand. In other words,
tests that reach a conclusion about a patient’s health may
be industrially inapplicable while tests that merely reveal
information about the physiological state of the patient’s
body may be industrially applicable.
(iv) Laboratory Technicians Versus Medical Doctors
Another way to draw the needed line looks not at theobjective nature of the judgment being made but rather at
the identity person who is most likely to be tasked withperforming the correlation-based medical diagnostic.
What is the profession of the likely infringer? If themethod is the type of method that is likely to be●

IIP Bulletin 2016 Vol.25

performed today by a technician in a clinical laboratory
given the current market structure, then perhaps it is anindustrially applicable method of analyzing samples ordata. However, if the method is today likely to be
performed by a medical doctor, then perhaps it is anindustrially inapplicable method of diagnosing humans.
(v) International Harmonization as the Goal
A final theory about where the line between
industrially applicable and industrially inapplicablecorrelation-based medical diagnostics lies assumes that
the JPO’s 2009 Guideline revisions were intended tobring Japanese patent law on medical diagnostics into linewith patent law in the European Patent Office on medical
diagnostics. Perhaps the expansion in patentability ofdiagnostics methods in the 2009 revisions to the
exclusion of medical activities was meant to mirror the
expansion that had occurred a number of years earlier inthe European Patent Office.

IV Patentable Subject Matter in the US
Recent developments in United States have radicallydecreased the patent protection that is available forcorrelation-based medical diagnostics. More specifically,
courts in the United States have interpreted Section 101
of the Patent Act to exclude correlation-based medical
diagnostics from patentable subject matter for two
independent reasons: they are both laws of nature andmental processes in the abstract.
1

Section 101 and Patentable Subject MatterIn a series of cases in the 1970s and 1980s, theUnited States Supreme Court interpreted Section 101 to
codify several exclusions from statutory subject matter,holding that natural phenomena (i.e., products of nature),laws of nature, abstract ideas, and mental processes are
not patentable subject matter within the four categories
listed in the statute.6 After several decades of inactivity,
the Supreme Court recently returned to the issue ofpatentable subject matter in a series of cases stretchingfrom 2010 to 2014.7 These more recent cases clarified
the methodology for drawing the difficult line between
non-statutory claims to unpatentable subject matter itself
and patentable processes that applied the unpatentablesubject matter. More specifically, the Court held that one
key step in this methodology was determining the part ofthe claimed invention that embodies the “inventive
concept” or advance over the prior art.8
2

Judicial Interpretations of Section 101
Invalidating Correlation-Based Medical
Diagnostics
Within the last several years, both the Supreme
Court and the Federal Circuit have invalidated claims to3 ●correlation-based medical diagnostics for failure to recite
patentable subject matter under Section 101.
(1) The Laws of Nature Exclusion
The Supreme Court’s decision in Mayo
Collaborative Services v. Prometheus Laboratories is theleading case that explains why a patent on acorrelation-based medical diagnostic is an unpatentable
law of nature under section 101.9(2) The Mental Processes Exclusion
The Federal Circuit opinion in In re BRCA1- andBRCA2-Based Hereditary Cancer Test Patent Litigation
demonstrates how the Supreme Court’s recent opinions
on patentable subject matter suggest that patents oncorrelation-based medical diagnostics are unpatentablemental processes under section 101.10

V Statutory Inventions in Japan
Japanese patent law has a statutory-invention
requirement codified in Article 2(1) stating that aninvention is a “creation of technical ideas utilizing a lawof nature.”11 Section 101 in the United States and Article
2(1) in Japan are similar on paper, but they produce
radically different outcomes in practice when they arebrought to bear on patents on correlation-based medical
diagnostics. Although such patents are regularly
invalidated for lack of patentable subject matter in the
United States, they are unquestioningly assumed to be
statutory inventions in Japan today. In the absence of
judicial opinions, Guidelines, or scholarly commentary
explaining why patents on correlation-based diagnostics
describe neither unpatentable laws of nature as such nor
unpatentable mental activities, this section offers sometheories about how Japanese patent law might draw theline between statutory and non-statutory inventions in thistechnological area.
1

Article 2(1) and Statutory Inventions
The Guidelines attempt to create some clarity in thisrequirement by reciting a list of non-statutory
inventions.12 Most importantly for the present argument,
the list includes two types of subject matters that do not
utilize a law of nature. First, a law of nature as such is nota statutory invention.13 Second, mental activities are notstatutory inventions.14
2

Why AreCorrelation-Based
MedicalDiagnostics Statutory Inventions?
This section offers provisional theories to explain
why correlation-based medical diagnostics areunquestioningly presumed to be statutory inventions
under Article 2(1) in Japan.

●(1) The Laws of Nature Exclusion
In theory, there are two possible reasons why patents
on correlation-based medical diagnostics might not bepatents on laws of nature as such in Japan: either the
newly discovered correlations that enable the methods are
not laws of nature, or, if they are, the patents do not claim
the correlations “as such.” It is likely the latter reason that
explains the difference between United States andJapanese treatment of correlation-based medical
diagnostics. The Japanese definition of a claim to a law ofnature “as such” is likely very narrow.
(2) The Mental Activities Exclusion
Again, in theory, there are two distinct reasons why apatent on a correlation-based medical diagnostic might
not be labeled as a patent on a mental activity in Japan:
either steps like comparing and inferring are not mental
activities as that term is used in the Guidelines, or, if they
are, the claimed invention nonetheless utilizes laws ofnature when it is considered as a whole because the initialdetermining step is a technical, statutory step. Here, either
one of these reasons may be sufficient to explain the
difference between the application of the doctrine ofpatentable subject matter in the United States and thestatutory-invention requirement in Japan.
(i)What Is a Mental Activity?
This report addresses two different theories about
why mental processes are not statutory invention and thus
two different definitions of inventions that implicate
mental processes under Japanese patent law.
A first, plain-meaning theory more or less tracks thedefinition of a mental process in the United States andthus encompasses any activity that can be performed in ahuman mind. Under this theory, the inferring step in acorrelation-based medical diagnostic is clearly a mental
activity.
However, a second theory posits a much narrower
definition of a mental activity and suggests that theinferring step of a correlation-based medical diagnostic is
not a mental activity and is thus a statutory invention evenin isolation. In gross, this theory proposes that thenormative justification of the mental-activity exclusion of
Article 2(1) is that non-repeatable processes should not
be patentable. The Guidelines state that mental activities
are excluded from patentability because they areexamples of subject matter that fail to utilize a law ofnature.15 One of the classic hallmarks of an invention thatutilizes a law of nature is that the invention must be
repeatable in the sense that it is always able to attain thesame effect. So, perhaps the Guidelines are only narrowlyreferring to non-repeatable mental activities when they
identify the category “mental activities” that is excluded
from statutory inventions. Under the non-repeatability
theory, thought processes that occur within the human
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mind are not mental activities as that phrase is used as aterm of art in patent law if they are repeatable,
algorithmic processes that model the laws of the naturalsciences. The non-repeatability theory transforms
repeatability from a necessary condition for a statutory
invention—a non-repeatable creation is not a statutory
invention—into a sufficient condition—any creation thatis repeatable is a statutory invention, even if the creation
exists only as a logical process within a human mind.
The Intellectual Property High Court embraced avariant of this non-repeatability theory of mental activities
in the course of allowing a patent as a statutory invention
in its well-known Bilingual Dictionary Case.16(ii) When Does an Invention that Includes a Mental
Activity Utilize a Law of Nature?
Assuming that the inferring step of a claim to acorrelation-based medical diagnostic does recite a mental
activity, the claim may still recite a statutory invention in
Japan if it is a “mixed” claim—a claim that recites both astep that is a mental activity and other steps that recite
technical, extra-mental activities. Because the existenceof a statutory invention is judged by looking at the claim
as a whole, the presence of the technical steps in theclaimed method mean that the claim as a whole does notrecite a mental activity. However, the Guidelines do notgive a clear explanation of the conditions under which aclaimed invention as a whole does or does not utilize alaw of nature. Three different theories for making theneeded distinction are raised as possibilities: the “anytechnical element” theory, the “inventive concept” theory,and the “centrality” theory. The recent Interactive Dental
Network opinion authored by the Intellectual Property
High Court suggests that Japan has adopted the centrality
theory,17 but further clarification is still needed for adefinitive answer.

1

JPO Examination Guidelines, Chapter 2.1.1 [hereinafter JPO
Guidelines],
https://www.jpo.go.jp/tetuzuki_e/t_tokkyo_e/1312-002_e.htm.
2 Id. at 2.1.1.1(3).
3 Id. at 2.1.1.2(3)(a).
4 Id. at 2.1.1.1(3).
5 Id. at 2.1.1.2(3)(a), Case 5.
6 Diamond v. Diehr, 450 U.S. 175 (1981); Diamond v.
Chakrabarty, 447 U.S. 303 (1980); Parker v. Flook, 437 U.S. 584(1978); Gottschalk v. Benson, 409 U.S. 64 (1972).
7 Bilski v. Kappos, 561 U.S. 593 (2010); Mayo Collaborative
Servs. v. Prometheus Labs., 132 S.Ct. 1289 (2012); Ass’n for
Molecular Pathology v. Myriad Genetics, 133 S.Ct. 2107 (2013);
Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S.Ct. 2347 (2014).
8 Mayo, 132 S.Ct. at 1297–98; Alice, 134 S.Ct. at 2357–59.
9 Mayo Collaborative Servs. v. Prometheus Labs., 132 S.Ct. 1289
(2012).
10 In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent
Litig., 774 F.3d 755 (Fed. Cir. 2014).
11 Tokkyohô [Japanese Patent Law], Law No. 121 of 1959, Article
2(1).
12 JPO Guidelines, supra note 1, at 1.1.
13 Id. at 1.1(1).
14
Id. at 1.1(4).
15 Id. at 1.1(4).
16 Intellectual Property High Court, Decision of August 26, 2008,
Hanrei Jiho, No. 2031 – Bilingual Dictionary Case.
17 Intellectual Property High Court, Decision of June 24, 2008,2007 (Gyo-Ke) 10369 – Interactive Dental Network Case.

VI Conclusion
Motivated by recent cases issued by the Supreme
Court and Federal Circuit Court of Appeals in the UnitedStates that radically decreased the amount of patent
protection that is available for correlation-based medical
diagnostics, this report examines the patentability of suchdiagnostics in Japan under both the industrial-applicability
requirement and the statutory-invention requirement.
Patent protection for correlation-based medical
diagnostics is today widely available in Japan, but thereasons why this patent protection is available have notbeen clearly articulated. The line between patentable andunpatentable correlation-based medical diagnostics
therefore remains uncertain. This report offers a numberof possible theories to explain why this patent protection
is available and suggests a number of lines that may
function as the boundary of patent protection.
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