〈日本知財学会誌〉Vol. 16 No. 1― 2019 : 20 30-

Patent-eligible Subject Matter in theLife Sciences in the United States
Joseph J. Koipally（Fish & Richardson P.C., Principal）
Janis K. Fraser（Fish & Richardson P.C., Principal）
Kazuyuki Ojima（Chugai Pharmaceutical Co., Ltd., Department Manager, Intellectual
Property Department, Project & Lifecycle Management Unit）【Abstract】 The concept of “patent eligible subject matter”-whether an invention fits into a category of subject matterrecognized as eligible for patenting-has become an increasingly important factor in recent years when determining
validity of life sciences claims in the United States, both in the courts and in the United States Patent and Trademark
Office (USPTO). The Supreme Court of the United States formulated in 2012 a two-step test for patent eligibility thatthe lower courts and the USPTO have struggled to interpret and apply. Analysis of various court opinions in the years
since 2012 provides some indication of what types of claims are or are not considered to pass this test, and the USPTO
periodically issues guidance documents (most recently in January 2019) to help patent examiners understand how toapply the test when examining claims. Widespread unhappiness with the evolving standards for patent eligibility has
led many in the life sciences industry to call for legislation resetting the standards to something less vague, subjective,
and onerous to patentees. Meanwhile, careful claim drafting is essential to maximize the likelihood of obtaining patenteligible claims.
【Keywords】

1.

101

patent-eligible subject matterlife sciences

methods

compositions

This article begins by summarizing the basic statu-

Introduction

tory framework defining what is patentable in the
United States.

When the Supreme Court of the United States (Su-We then trace how the courts’ views

regarding patent-eligible subject matter in the life sci-preme Court) issued a series of decisions in 2012-2014

ences field have evolved over the years.

We describeinterpreting what categories of inventions are eligible

approaches the USPTO has taken to apply the court-

for patenting in the United States, the results dramati-

made patent-eligibility standards when examining ap-

cally reshaped the patent landscape for a number ofplications.

technologies, particularly life sciences and computer

tive solutions proposed by various organizations insoftware.

Our article then discusses some legisla-

The impact of these decisions has made it

recent years, solutions intended to set new statutory

far more difficult to obtain valid claims covering, forstandards for what constitutes patent-eligible subject

example, diagnostic methods and naturally occurring

matter and thereby address the perceived ambiguity of

biomolecules, and presumably has rendered many suchthe court-made standards as well as the undue impact

previously-granted claims invalid.

the standards have had on an entire industry.

20

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ISSN 1349-421X© 2019IPAJ

The ar-

All rights reserved.

Patent-eligible Subject Matter in the Life Sciences in the United States

ticle concludes with practice tips for minimizing patent-ineligibility problems when drafting claims.

2.

3.1.

Diagnostic Method Claims

The Supreme Court addressed patent-eligibility inthe context of diagnostic claims in Mayo Collaborative

The Statutory FrameworkServs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012).
Prometheus claimed methods of selecting a dose of a

In order to obtain a patent in the United States, a

thiopurine drug that would optimize therapeutic effica-

patent applicant must comply with several statutory

cy for treatment of an immune-mediated gastrointesti-

provisions.

nal disorder.

For example, a patentable claim must be

Doctors had previously been treatingdrawn to a novel and non-obvious invention ; the lan-autoimmune diseases with thiopurine drugs, but had

guage of the claim must be definite ; the patent appli-difficulty determining the ideal dose that balanced effi-

cation must provide a description of the invention suf-

cacy and potential side effects, because patients me-

ficient to show that the applicant was in possession oftabolize the drugs differently.

the claimed invention ; and the application must teachcorrelations between thiopurine metabolite levels inthe skilled person how to make and use the claimed

the blood and the efficacy and side effects of theinvention.

treatment.

In addition to these requirements, aPrometheus identified

Prometheus’ patent claimed methods ofthreshold inquiry is whether the claimed invention isadministering thiopurine drugs and then determining

within a category of subject matter considered to be el-the levels of thiopurine metabolites in the patient’s

igible for patenting in the United States.

blood.

Section 101

The claim concluded with a “wherein” clauseof Title 35 of the United States Code defines four cate-describing how metabolite concentration correlatedgories of inventions that are patent-eligible : process-with efficacy and side effects, but did not specify any

es/methods, machines, manufactures, and composi-

particular action to be taken based on that information.

tions of matter.

Despite this broadly permissive

The Mayo Court introduced a new two-step test for

statutory language, United States courts have, overdetermining patent eligibility of method claims.

the years, interpreted

der the Mayo test, a court must first determine wheth-

101 to exclude laws of nature,physical phenomena, and abstract ideas.

Un-

Recent Su-

er a claim is directed to a patent-ineligible concept, i.e.,

preme Court decisions further elaborating on these ju-

a law of nature, natural phenomenon, or abstract idea.

dicially-created exclusions have significantly affected

If so, the court must then search for an “inventive con-

how lower courts and the USPTO determine what in-

cept” by determining whether additional elements ofthe claim “transform the nature of the claim” into aventions are patent-eligible subject matter.

3.

Recent Jurisprudence Regarding§ 101

patent-eligible application of the law of nature/natural
phenomenon/abstract idea.
The Mayo Court decided that Prometheus’ claims
did not pass this new eligibility test.

In the last few years, United States courts have issued some significant opinions interpreting

Under the firststep of the test, the Court found that the claims were

101 indirected to a law of nature : the correlation between

These are discussed below in theconcentrations of certain metabolites in the blood andcontext of different categories of claims : diagnostic

the likelihood that a given dosage of a thiopurine drug

method claims, method of treatment claims, process

will prove ineffective or cause harm.

claims, and claims drawn to compositions of matter.

Court found that the recited “administering,” “deter-

the life sciences.

In step two, themining,” and “wherein” elements were not “sufficient
to transform the nature of the claim.”

According to21

〈日本知財学会誌〉 Vol.16 No.1― 2019

the Court, the administering step “simply refers to thethat the fetus inherited from its father, and that could

relevant audience, namely doctors who treat patientsbe used to determine a fetus’s gender and identify ge-with certain diseases with thiopurine drugs,” and the

netic defects.

Sequenom’s patent claimed methods of“wherein” clause, at most, added a suggestion thatusing cffDNA that included the steps of amplifying thethose doctors consider the test results when making

cffDNA contained in a sample of plasma from a preg-their treatment decisions.

nant female and detecting the paternally inherited

Following the Mayo decision, the lower courts were

cffDNA.

Despite acknowledging that the invention

left with the unenviable task of interpreting and apply-

was a valuable contribution in that it permitted analyz-

ing the vague test set forth by the Supreme Court.

In

ing the fetus’s genome without the risk of obtaining

all five diagnostic method cases considered by thecells directly from the fetus, the CAFC held that the

Court of Appeals for the Federal Circuit (CAFC) sinceclaims were not patent eligible because they were di-then, the CAFC found the claims to be patent-ineligi-

rected to a naturally occurring phenomenon (existenceble.

of cffDNA in maternal blood), and their remaining

The first of these five cases was In re BRCA1- andsteps (preparing, amplifying, and detecting DNA, in-

BRCA2- Hereditary Cancer Test Patent Litigation, 774

cluding PCR techniques) were merely “conventional.”

F.3d 755 (Fed. Cir. 2014), which involved both claims

In Genetic Technologies Ltd. v. Merial LLC, 818 F.3d

drawn to compositions of matter (discussed below in1369 (Fed. Cir. 2016), the invention stemmed from thesection 3.4) and methods of identifying a mutation in a

discovery that, instead of detecting an allele of a par-patient’s BRCA1 gene by comparing the patient’s

ticular gene by looking at the coding region of theBRCA1 DNA sequences with wild-type BRCA1 se-

gene, one could detect the allele indirectly by amplify-

quences.

ing and analyzing non-coding regions linked to the cod-

The latter claims required that the compari-son be accomplished either by amplifying the subject’s

ing region.

BRCA1 gene using a set of primers and then sequenc-

non-coding region DNA known to be linked to a coding

ing, or by using a probe to detect certain alleles in theregion and analyzing the amplified DNA to determine

patient.

if it correlated to the allele of interest.

The court found the claims ineligible as di-rected to an abstract idea under the Mayo test.

The claims at issue required amplifying

The CAFCAp-

held that the claims were drawn to ineligible subject

plying the first Mayo step, the CAFC found that thematter because they were directed to a “law of na-

method claims were “directed to the patent-ineligibleture” : the linkage between non-coding and coding se-

abstract idea of comparing BRCA sequences and deter-

quences and the tendency of such non-coding sequenc-

mining the existence of alterations.”

In the second

es to be representative of the linked coding sequences.

Mayo step, the court found that the elements describ-

The court also noted that the steps of amplifying DNA

ing the way in which the sequences are compared (viaand analyzing the amplified sequence were well known

probe or via amplification and sequencing) “set forthin the art at the time of filing and did not constitute an

well-understood, routine and conventional activity en-“inventive concept” under step two of the Mayo test.

gaged in by scientists at the time of Myriad’s patent

The claims in The Cleveland Clinic Foundation et al. v.

applications” and did not add enough to make theTrue Health Diagnostics, LLC, 859 F.3d 1352 (Fed. Cir.

claims patent eligible.

2017), recited methods for characterizing a subject’s

The patent at issue in Ariosa Diagnostics, Inc. v. Se-

risk for cardiovascular disease by determining the level

quenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015), involvedof myeloperoxidase (MPO) in a sample from the pa-

Sequenom’s discovery that maternal blood plasma har-tient and comparing that with the MPO levels in con-bored a small amount of cell-free fetal DNA (cffDNA)

trol subjects not having cardiovascular disease.

22

De-

Patent-eligible Subject Matter in the Life Sciences in the United States

pendent claims limited the way MPO is detected (suchas by flow cytometry) and how the MPO values in thecontrol subjects are evaluated.

3.2.

Method of Treatment Claims

The Supreme Court has not spoken on the patent

The court found theeligibility of method of treatment claims, other than toclaims to be directed to a naturally occurring phenom-

provide a remark in Mayo indirectly implying that, un-enon (correlation of the level of MPO in a biologicallike the diagnostic methods claimed by Prometheus,

sample to the presence of cardiovascular disease), andmethods of treatment with drugs will generally qualify

opined that the process steps merely described theas patent eligible : “[u]nlike, say, a typical patent on acorrelations and did not recite any new detection or

new drug or a new way of using an existing drug, theanalytical techniques.

[Prometheus] patent claims do not confine their reachMore recently, the CAFC in Roche Molecular Sys-

to particular applications of those laws.”

tems, Inc. v. Cepheid, 905 F. 3d 1363 (Fed. Cir. 2018),

The CAFC recently had occasion to consider that

addressed claims that were directed to a method for

dictum from Mayo when evaluating the method of

detecting Mycobacterium tuberculosis (MTB) in a bio-

treatment claimed in Vanda Pharmaceuticals Inc. v.

logical sample, as well as composition of matter claims

West-Ward Laboratories, Inc., 887 F.3d 1117 (Fed. Cir.

we discuss in section 3.4 below.

2018).

Roche’s scientists

Vanda’s claim was drawn to a method of treat-

had discovered eleven position-specific “signature nu-

ing schizophrenia that involved determining the pa-

cleotides” diagnostic for MTB.

The method claims

tient’s CYP2D6 metabolizer genotype and administer-required amplifying DNA segments using PCR primers

ing iloperidone in a dose range that varied in acustomized for the signature nucleotides and detecting

particular way depending on the patient’s CYP2D6

the presence or absence of the amplification product togenotype.

determine if MTB is present.

The CAFC held thatpatent-eligible under the first step of the Mayo test,

the claims were directed to a natural phenomenon

holding that the claims were directed to a method of(correlating the presence of these signature nucleo-using iloperidone to treat schizophrenia, and not to atides with the presence of MTB), and found that, sincecorrelation or other natural law.

The CAFC concluded that the claim was

However, despite

the PCR step was well-known and the determining

this hopeful clue that claims drawn to methods of treat-

step was merely a mental process, there was no inven-ment may be spared the wholesale invalidation wetive concept, and thus the claims were patent-ineligi-

have seen applied to diagnostic method claims, it is im-ble.

portant to note that only two of the three judges on the

The above cases lead to a view that, after Mayo, theVanda panel agreed with the decision.

It remains to

CAFC is categorically unwilling to uphold any method

be seen what other CAFC panels will say about patentof diagnosis claims that simply recite a natural correla-eligibility of other treatment claims, or whether thetion (regardless of how novel it is) and employ routine

Supreme Court will eventually weigh in with a defini-methods to detect it.

tive ruling on this subject.

The courts seem to be demand-ing that the claims specify a novel way of measuringsomething, or some other detail that they can latch
onto as providing an “inventive concept” in Step 2 of
the Mayo test.

3.3.

Process Claims

The CAFC applied the Mayo test to process claims

Since many innovations in the diag-in Rapid Litigation Mgmt, Ltd. v. CellzDirect, Inc., 827

nostic industry involve discovery of a new correlation,

F.3d 1042 (Fed. Cir. 2016), ultimately finding the claims

and not a new detection tool, it has become very diffi-

to be patent-eligible.

cult to find a path forward to patent-eligibility for diag-

involved a process for cryopreserving hepatocytes in a

nostic method claims.

manner that produced cells able to survive multiple

The patent at issue in that case23

〈日本知財学会誌〉 Vol.16 No.1― 2019

free-thaw cycles.

The conventional wisdom was that

preted to be a product of nature.

Though the claimed

hepatocytes could be frozen only once, making it diffi-

mixture did not occur in nature, each individual strain

cult to pool hepatocytes collected from multiple donors

of bacteria did.

over time.

And though discovering the particular

The patentee obtained claims directed to astrains that were “mutually non-inhibitive” when com-method of producing a preparation of cryopreserved

bined required effort and was not predictable, thehepatocytes that included steps of subjecting hepato-

Court dismissed these facts, saying “The combination

cytes that had been previously frozen and thawed toof species produces no new bacteria, no change in thedensity gradient fractionation to separate viable cells

six species of bacteria, and no enlargement of thefrom non-viable cells, and refreezing the collected via-

range of their utility.

ble cells.

fect it always had. The bacteria perform in their natu-

In analyzing the claims under step one ofEach species has the same ef-

the Mayo test, the court considered the defendant’s

ral way.

position that the claims were directed to a natural phe-in any way their natural functioning.

nomenon, but determined they were not.

ends nature originally provided, and act quite indepen-

The court

reasoned that the claims were directed to a better way

Their use in combination does not improve
They serve thedently of any effort of the patentee.”of preserving hepatocytes, not to the inherent ability of

In 1980, the Supreme Court decided another signifi-

some hepatocytes to survive multiple free-thaw cy-

cant case pertaining to biological compositions : Dia-cles.

mond v. Chakrabarty, 447 U.S. 303 (1980).

The court noted that the end result of the

The pat-claimed method was not simply an observation or de-entee had identified four plasmids encoding enzymes

tection of the ability of hepatocytes to survive multiple

capable of degrading four different oil components.

freeze-thaw cycles, but rather was a new and useful

These plasmids could be transferred to a Pseudomonas

method of preserving hepatocyte cells̶a useful appli-

bacterium, which itself has no ability to degrade oil,cation of the discovery.

The court went on to say thatconverting that bacterium into a genetically engineered

step two of the Mayo test did not need to be reached inorganism potentially useful for the treatment of oil

this case, but added that, even if the second step were

spills.

considered, it would also result in a finding of patent-tion claim drawn to the genetically engineered bacteri-eligibility. According to the court, while the individual

um was patent-eligible.

steps of freezing and thawing were well known anding that “the patentee had produced a new bacterium

routine if viewed in isolation, the claimed combination

with markedly different characteristics from any foundof steps, taken as a whole, was far from routine or con-in nature and one having the potential for significant

ventional.

utility.

The issue in this case was whether a composiThe Court said it was, stat-His discovery is not nature’s handiwork, but

his own ; accordingly it is patentable subject matter.”
3.4.

Composition Claims

Thirty-three years later, the Supreme Court revisit-

Important Supreme Court cases assessing patent el-

ed the patent eligibility of compositions of matter inigibility of composition claims in the life sciences date

Ass’n for Molecular Pathology v. Myriad Genetics, Inc.,

back at least to 1948.

In Funk Brothers Seed Co. v.

569 U.S. 576 (2013).

Myriad had discovered the loca-

Kalo Inoculant Co., 333 U.S. 127 (1948), the Court con-tion and nucleic acid sequences of the BRCA1 andsidered a claim drawn to an inoculant for leguminous

BRCA2 genes that, when mutated, are associated withplants comprising a plurality of selected “mutually

predisposition to breast and ovarian cancers.

non-inhibitive strains” of different bacterial species ofpreme Court was asked to decide whether claims di-

the genus Rhizobium, and found the claim was not pat-rected to “isolated” DNA encoding BRCA1 or BRCA2,

ent-eligible as it encompassed what the Court inter-or alternatively to isolated complementary DNA (cDNA)

24

The Su-Patent-eligible Subject Matter in the Life Sciences in the United States

encoding BRCA1 or BRCA2, were patent eligible sub-in the context of diagnostic assay claims also dealt with

ject matter.

composition claims challenged on patent eligibility

The Court held that a segment of a naturally occur-

grounds.

The composition claims were directed toring DNA is a product of nature and does not becomepairs of single stranded DNA primers used to detect

patent eligible undermutant BRCA1 and BRCA2 genes in a sample.

101 merely because it has been“isolated” from the surrounding genetic material.

In

The

court stated that a DNA molecule with a function simi-

contrast, the Court found Myriad’s cDNA claims to be

lar to that found in nature can be patent-eligible as apatent eligible, reasoning that BRCA1 and BRCA2

composition of matter only if it has a unique structure,

cDNAs lack the introns present in their genomic coun-

different from anything found in nature.

terparts, and so do not exist in nature.

In the Court’s

claimed primer pairs ineligible under this standard be-

It held theview, a patentee “unquestionably creates somethingcause they necessarily have sequences identical to a

new when cDNA is made” (at least when the corre-

portion (sense or antisense) of the naturally occurring

sponding genomic sequence contains introns).

BRCA1 or BRCA2 genomic sequence and are structur-

The Court’s decision finding claims to “isolated
DNA” ineligible under

101 disrupted decades of un-ally identical to the ends of DNA strands found innature.

The court rejected the argument that the fact

questioned acceptance of such claims by both thethat the primer pairs were synthetically created meant

USPTO and the courts.

they were patent eligible.

It instantly rendered an un-

It also rejected argumentsthat the primer pairs were not naturally occurring be-

told number of issued claims invalid.
The first post-Myriad case in which the CAFC con-cause single-stranded DNA cannot be found in the hu-

sidered patent eligibility of composition claims was

man body, explaining that (as held in Myriad) separat-

In re Roslin Institute (Edinburgh), 750 F.3d 1333 (Fed.

ing DNA from its surrounding genetic material is not

Cir. 2014), which related to the famous “Dolly thean act of invention.

Sheep” : the first mammal ever cloned from an adulttion that the primers have a fundamentally different

somatic cell.

The claims sought by Roslin, but reject-

function than the same sequences incorporated into a

It further rejected Myriad’s posi-

ed by the USPTO, were directed to a live-born clone ofnaturally occurring genomic DNA strand, noting thata pre-existing, non-embryonic, donor mammal, where

the natural DNA would similarly function to bind tothe mammal was selected from cattle, sheep, pigs, andcomplementary nucleotide sequences.

The court’s central inquiry was whether the

A subsequent CAFC case that similarly involved

claimed subject matter possessed “markedly different

consideration of DNA primer claims along with diag-characteristics” from any animal found in nature.

nostic assay claims is the Roche Molecular Systems, Inc.

goats.

The

court found that Roslin’s chief innovation was the pres-v. Cepheid case described above.

ervation of the donor DNA such that the clone is an

the claimed primers, which hybridize to a particular

exact copy of the mammal from which the somatic cell

MTB gene at a particular site, were chemically andwas taken.

As Dolly herself was said to be an exact

structurally distinct from any nucleic acid that occurs

genetic replica of another sheep, that led to the court’s

in nature because the primers have a 3’ end and a 3’

conclusion that the claimed clones were ineligible un-hydroxyl group, which are absent in the circular chro-dermosome that constitutes the naturally-occurring MTB

101 because they did not possess characteristics

Roche argued that“markedly different” from those of farm animals foundgenome.

in nature.

sufficient distinction from the naturally occurring DNA,The CAFC’s In re BRCA1- and BRCA2- Hereditary
Cancer Test Patent Litigation opinion discussed above

The court dismissed this argument as not aand declared the primer claims to be invalid as drawn
to patent-ineligible subject matter.
25

〈日本知財学会誌〉 Vol.16 No.1― 20194.

Section 101 Guidance from theUnited States Patent and Trademark Officecase law as it comes out and attempting to integrate it
into a coherent approach.

Most recently, the USPTO

issued its “2019 Revised Patent Subject Matter Eligibility Guidance” in January 20191.

In its 2019 guid-ance, the USPTO has refined the analysis under Step
Applying the Mayo test in a consistent manner

2A in two ways.

across technologies has proven to be difficult and cre-The first change in the 2019 guidance pertains toated significant uncertainty for all interested parties.

how examiners are to ascertain whether a claim recites

The USPTO’s approach employs three steps, labeled

an “abstract idea” type of judicial exception.

Step 1, Step 2A, and Step 2B.

Step 1 requires the ex-vious approach directed examiners to rely on analogy

aminer to confirm whether the claim is directed to a

to the wording of claims held by a court to recite an ab-category of invention recognized under the statute asstract idea ; under the new guidance, examiners arepatent-eligible, i.e., is the claim drawn to a process,instead to determine whether the limitation in ques-machine, manufacture or composition of matter?

tion falls within any of the following subject matterIf

the claim clears that low bar, then the examiner must

The pre-groupings of abstract ideas :proceed to Step 2A (corresponding to the first step ofmathematical concepts̶mathematical relationships,

the Mayo test), determining whether the claim is “di-mathematical formulas or equations, mathematical cal-rected to” a “judicially recognized exception,” i.e., aculations ;law of nature, a natural phenomenon (e.g., product ofnature), or an abstract idea.

If it is not directed to oneof those exceptions, the claim satisfies
is no need to go on to Step 2B.

certain methods of organizing human activity̶fundamental economic principles or practices (including

101, and there

hedging, insurance, mitigating risk) ; commercial or

But if the claim is di-legal interactions (including agreements in the form ofrected to one of those exceptions, the examiner must

contracts ; legal obligations ; advertising, marketingnext determine under Step 2B (i.e., the second Mayoor sales activities or behaviors ; business relations) ;step) whether the claim provides an inventive concept

managing personal behavior or relationships or inter-by reciting “additional elements that amount to signifi-

actions between people (including social activities,

cantly more than the judicial exception.”teaching, and following rules or instructions) ; andFor theabove analysis, the examiner is asked to construe themental processes̶concepts performed in the hu-

claim under its broadest reasonable interpretation andman mind (including an observation, evaluation, judg-

to analyze the claim as a whole, rather than limitation-

ment, opinion).
The above change to how examiners are to define

by-limitation.
As the standards to be applied at each of Steps 2A“abstract idea” does not affect the other broad catego-and 2B are determinative of whether a given claim

ries of judicial exceptions that are more often at issue

passes muster under those steps, the USPTO has been

for life sciences inventions : “law of nature and “natu-

trying to digest the Supreme Court and CAFC case law

ral phenomenon.”to guide patent examiners and administrative patent

Step 2A introduced by the 2019 guidance is likely tojudges of the Patent Trial and Appeal Board (PTAB) in

have a major effect in applicants’ favor on how the

how to apply the Mayo test in a way that produces rea-

USPTO weighs patent eligibility of all types of claims

sonably consistent and predictable results across allunder all of the categories of judicial exceptions, re-technologies.

sulting in many fewer rejections under

To that end, the USPTO periodically is-sues updated “guidance” documents discussing new
26

However, the second change to101.

This important second change to the eligibility anal-

Patent-eligible Subject Matter in the Life Sciences in the United Statesysis draws a distinction between a claim that merely
recites a judicial exception and one that is “directed to”
a judicial exception, with the latter being the criticalfactor under the USPTO’s revised Step 2A.

the USPTO’s new analysis remains to be seen.

5.

Legislative Solutions

Under

the new framework, merely reciting a judicial excep-

The recent jurisprudence redefining entire catego-tion does not equate to being “directed to” thatries of inventions as “patent-ineligible” is based on

exception.

Instead, if a claim recites a judicial excep-

ambiguous standards that appear nowhere in the stat-tion, it must then be analyzed to determine whetherute, have retroactively invalidated whole categories of

the claim integrates that recited judicial exception intolife sciences patents, and are difficult to apply consis-

a practical application of that exception.

tently.

If it does so,

These problems have led many in the life sci-the claim is not “directed to” a judicial exception, andences industry to call for a legislative fix.

the eligibility analysis ends there, at Step 2A, with athree major intellectual property organizations haveconclusion that the claim is patent-eligible.

responded by proposing amendments to the statutory

If theAt least

claim does not integrate that recited judicial exception

language of

into a practical application, then it is deemed to be “di-101 : Intellectual Property Owners As-

sociation (IPO)2, American Intellectual Property Law

rected to” that judicial exception under Step 2A, andAssociation (AIPLA)3, and American Bar Association/

the examiner must move on to Step 2B in order toIntellectual Property Law Section (ABA/IPL)4.

make the final determination of patent eligibility by de-three proposed amendments attempt to clarify thetermining if there is some “inventive concept” in thestandards for patent eligibility by including in the stat-claim, other than the judicial exception.

ute a new subsection (b) that specifies what wouldAll

The 2019 guidance directs examiners to assess “in-constitute exceptions to eligibility, essentially overrul-

tegration into a practical application” by : (a) identify-

ing the Supreme Court’s vaguely stated judicial excep-

ing whether there are any additional elements recitedtions and, in the process, permitting more inventionsin the claim beyond the judicial exception ; and (b)to qualify as patent-eligible.

The IPO and AIPLA

evaluating those additional elements individually andproposals both say that a claimed invention is patent-

in combination to determine whether they integrateineligible only if the claimed invention, as a whole, ex-the exception into a practical application.

Importantly,

ists in nature independently of and prior to any humanthe examiner is explicitly told not to take into consid-

activity, or exists solely (or can be performed solely) ineration whether the additional elements are “routine”

the human mind, and both of these proposals charac-

or “conventional” or “well-known,” instead reserving

terize these two specified exceptions as the “sole ex-that consideration for Step 2B, if reaching Step 2B is

ceptions” to make it clear to the courts that they arenecessary.

not free to make up additional ones.

And reaching Step 2B is necessary only if

By insisting thatthe claim fails Step 2A, i.e., fails to integrate the judi-

the claimed invention be assessed “as a whole,” thesecial exception into any practical application.

proposals reject the current propensity of the courts toThis change to how Step 2A is applied has had a no-

focus the eligibility analysis on what the court deems

ticeable effect already on patent prosecution, with ex-

to be the “gist” of the claim, which can be embodied inaminers increasingly willing to withdraw prior rejec-a single limitation or even not recited in the claim attions under

all.

101.

However, the USPTO’s guidance

are merely guidance for examiners, and do not have
They may be withdrawn or modified

defining what constitutes an exception to eligibility, fo-

And whether the courts will agree withcusing on whether the claim “preempts” all practicalthe force of law.
at any time.

The ABA/IPL proposal takes a different approach to27

〈日本知財学会誌〉 Vol.16 No.1― 2019

applications of a law of nature, natural phenomenon, or

created by the Supreme Court, many in the fields ofabstract idea.

According to this proposed amend-

software and computers would resist any changes toment, when a claim does preempt all practical applica-

the status quo, as they appreciate having a quick routetions of a law of nature, natural phenomenon, or ab-

to invalidating the patents of the non-practicing enti-

stract idea, the claim “may be denied eligibility”

ties (often disparaged as so-called “patent trolls”) that(though the proposed language apparently does not re-bring a significant percentage of infringement suits inquire that it be denied eligibility).

the software and computer industries.

Furthermore, theTo begin the

proposed amendment takes care to say that, if the sub-conversation, the United States Senate called a closed-

ject matter of the claim, taking into account all limita-

door hearing in December 2018 to take testimony fromtions of the claim as a whole, is a practical application

invited parties from various industries on the subjectof a law of nature, natural phenomenon, or abstractof whether

idea, the claim’s patent eligibility “shall not be negat-

We therefore may see some movement on this topic ined.” The ABA/IPL proposal does not seem otherwise

2019.

to address the existing jurisprudence regarding patenteligibility, and it is not clear from the awkward wording

6.

of the proposed amendment what effect if any it would

101 should be revamped, and if so, how.

Tips for Dealing with § 101 Problems in Prosecution

have on reining in the courts’ freedom to create new
exceptions in the future.

Unless and until there is a legislative fix, one must

All three proposals address another significant issue

deal with

101 issues on a claim-by-claim basis.

A

pertaining to much of the jurisprudence regarding pat-few general strategies one might employ in differentent eligibility : the courts’ tendency to bring into thesituations are described below.

It is generally a good

101 analysis questions regarding topics that should

idea to prosecute a number of different independent

not have any bearing on patent eligibility : novelty, ob-claims that employ different strategies, as just because

viousness, and scope of enablement.

This issue typi-

the USPTO decides that a given claim is patent-eligi-

cally comes into play when a court is attempting to as-

ble does not mean a court evaluating that claim in liti-

sess whether a claim that includes a limitation deemed

gation will agree.

to be a “natural phenomenon” or “abstract idea” is anattempt to patent that exception, or instead has other

6.1.

Claiming Natural Products

limitations constituting “something more” or an “in-If the invention is a biological molecule, think care-ventive concept” that could make the claim patent-eli-

fully about whether it could be construed to covergible subject matter.

A limitation deemed to besomething known to occur in nature, and if so, add“well-known” or “routine” is typically simply dis-some structural limitation to exclude that possibility.

missed by the court as not qualifying as the essential

The limitation “isolated” or “purified” can no longer be“something more” or “inventive concept.”

This un-relied upon to do that job. So, if the invention is thefortunate confusion of prior art issues with patent eli-discovery of a naturally occurring polypeptide, one

gibility issues has been heavily criticized by manymight claim the polypeptide attached to something,United States patent attorneys, and would be forbiddensuch as an IgG Fc moiety or other heterologous poly-by all three proposed amendments to

peptide, a detectable label, or PEG, or perhaps instead

101.

Although there is much support in the life sciences

claim a mixture of the polypeptide with something thatindustry and among United States patent attorneys tois either non-naturally occurring or that alters theoverhaulfunction of the polypeptide compared to how it func-

28

101 in order to fix the perceived problems

Patent-eligible Subject Matter in the Life Sciences in the United States

tions in nature.

Claiming a method of manufacturingceptable, as it raises an issue of divided infringement,

the polypeptide synthetically or recombinantly andi.e., whether a single party would ever infringe allthen enforcing that method claim under 35 U.S.C.

steps of such a claim.

271(g) of the infringement statute is another strategy
to get around the problem.

However, thoughtful claim

drafting can sometimes mitigate the divided infringement issue.

If the invention is a naturally occurring polynucleotide, or a portion thereof, one could claim it incorporat-

6.3.

Claiming Methods of Treatment

ed into an expression vector, or, if it is intended to

If the invention is a method of treatment, we gener-

function as a probe, claim a radiolabeled version.

ally avoid including in the claim an explicit description

Claims to vectors, recombinant cells, and methods ofof a natural phenomenon, such as the drug’s mecha-

expressing the polynucleotide can be other ways tonism of action.

capture the invention without claiming a naturally oc-

suggests that, if the method is claimed with some de-curring molecule per se.

gree of specificity (e.g., the particular disease, patient

The Vanda decision discussed above

population, drug, and/or dosage), that would be benefi6.2.

Claiming Diagnostic Assays

cial for patent-eligibility.

However, there are situa-

For diagnostic assay inventions, we look for ways totions where the invention has broad applicability thatword the claim that minimize the abstract idea/law of

can be expressed in the claim only by reciting a natural

nature/natural phenomenon aspects and emphasize

phenomenon (e.g., an IL-2 inhibitor useful for treating

physical steps.

Ideally the claim would lack any limi-

any disease characterized by over-expression of IL-2),

tation that appears to recite an abstract idea, law of na-

and does not lend itself to the specificity that charac-

ture or natural phenomenon, such as a mental step or aterized the Vanda claim.

correlation between a measurement and a disease, andrelying on the fact that the claim includes a treatment

instead recite only the physical steps of the assay.

step that integrates the natural phenomenon into aThis may be impossible for many diagnostic assay

practical application, per the USPTO’s 2019 guidance,

claims, where the invention is the correlation and not aand point to both the Vanda holding and to other indi-

new assay technique.

cations (albeit only dicta) in the case law that methods

In such a case, another idea is

to follow the USPTO’s new 2019 guidance and ensurethat the claim recites not only the judicial exception,
but also other limitations that either integrate that ju-

In such a case, one can tryof treatment are generally patent-eligible.

7.

Conclusion

dicial exception into a practical application (e.g., a specific treatment step that follows from the diagnosis), or

Recent jurisprudence in the United States has ex-

are not routine or conventional (e.g., a rarely used as-

panded the types of subject matter that are deemed in-say technique).

The patent-eligible claim at issue ineligible for patenting, thereby invalidating many issued

the Vanda case discussed above was styled as a meth-patents and making it increasingly difficult to obtain al-

od of treatment, but in fact included both an assay step

lowance of claims to certain kinds of life sciences(determining the patient’s CYP2D6 metabolizer geno-

inventions.

type) and a treatment step with a dosage that was de-both to provide more clarity to how the USPTO willtermined based on what was found in the assay̶i.e., aexamine claims for patent-eligibility, and to relax topractical application of the correlation recited at thesome degree the very strict standards previously ap-

end of the claim.

plied by the USPTO during prosecution.

In some situations, adding a treat-ment step to a diagnostic assay claim may not be ac-

The USPTO’s 2019 guidance attempts

However,that guidance is not law and will not dictate how the29

〈日本知財学会誌〉 Vol.16 No.1― 2019

courts view the subject.

Until there is a legislativechange to the statute, we must rely on careful claim

2

drafting with a view to both the case law and the
USPTO guidance in order to maximize the likelihoodof obtaining patent-eligible claims.
References
1 2019 Revised Patent Subject Matter Eligibility Guidance,
84 Fed. Reg. 4, 50 (January 7, 2019)(https://www.govinfo.
gov/content/pkg/FR-2019-01-07/pdf/2018-28282.
pdf) ; and United States Patent and Trademark Office, Frequently Asked Questions (FAQs) on the 2019 Revised
Patent Subject Matter Eligibility Guidance (2019)(https://www.uspto.gov/sites/default/files/documents/faqs_

30

3

4

on_2019peg_20190107.pdf).
Intellectual Property Owners Association, Section 101
Legislation Task Force, Proposed Amendments to Patent
Eligible Subject Matter Under 35 U.S.C. § 101 (2017).
Available at : http://www.patents4life.com/wp-content/
uploads/2017/05/20170207_IPO-101-TF-ProposedAmendments-and-Report.pdf
American Intellectual Property Law Association, AIPLA
Legislative Proposal and Report on Patent Eligible Subject
Matter (2017). Available at : http://www.patents4life.
com/wp-content/uploads/2017/05/AIPLA-Report-on101-Reform-5-12-17.pdf
Donna P Suchy, American Bar Association Section of Intellectual Property Law, Supplemental Comments Related to Patent Subject Matter Eligibility (2017). Available at : http://
www.patents4life.com/wp-content/uploads/2017/05/ABA101-proposal.pdf