Eligible Subject Matter

309
 35 U.S.C. § 101

¡ The patent-eligible subject matter requirement of §101 sets forth the kinds
of inventions that can be patented:

“Whoever 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 . . . .”

¡ Construed to exclude laws of nature, mathematical formulas, physical

phenomena, and abstract ideas.

¡ As technology has matured, the courts have wrestled with boundary issues.

¡ The most interesting cases have involved BIOTECH and PROCESS-

ORIENTED INVENTIONS like SOFTWARE and BUSINESS METHODS.

310
 35 U.S.C. § 101

“Whoever 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 . . . .”

¡ Historically PSM was seldomly an impediment to patent protection; the

heavy lifting being done by §§ 102, 103, and 112.

¡ Now SCOTUS is quite active in the PSM area.

¡ This has led to a lot of confusion and a fair amount of UNCERTAINTY.

311
 DIAMOND V. CHAKRABARTY
477 U.S. 303 (1980)
Chakrabarty sought to patent three
types of claim s:

¡ Process for producing the bacteria

(m ethod of m aking)

¡ An inoculum com prised of a

carrier m aterial floating on water,
and the new bacteria ( m ethod of
use)

¡ Bacteria them selves (com position

of m atter)

Oil-eating bacteria
312
 DIAMOND V. CHAKRABARTY
477 U.S. 303 (1980)
Background:
¡ Examiner allowed method claims but rejected COM claims on 2
grounds:
§ Microorganisms are PRODUCTS OF NATURE
§ Living things aren’t patentable under § 101

¡ PTO Board affirmed rejection on 2d ground

¡ C.C.P.A.: Rev’d → “The fact that microorganisms are alive is w/o legal
significance” (Rich, J.)

¡ ISSUE: Whether the organism constitutes a manufacture or COM

within the meaning of § 101?

313
 DIAMOND V. CHAKRABARTY
477 U.S. 303 (1980)
¡ Does § 101 say anything about living matter?

¡ Arguments for patentability:

§ Broad statutory construction
§ “Anything under the sun that is made by man”
§ “The patentee has produced a new bacterium with markedly different
characteristics from any found in nature and one having the potential for
significant utility. – REMEMBER THESE WORDS

¡ Arguments against patentability:

§ Such a big move should be left to Congress
§ Fear of the unknown and the “gruesome parade of horribles”

314
 DIAMOND V. CHAKRABARTY
477 U.S. 303 (1980)
¡ Allowed patents on a genetically-modified bacterium because it had
“markedly different characteristics from any found in nature.”

¡ In choosing such expansive terms as “manufacture” and “composition

of matter,” modified by the comprehensive “any,” Congress plainly
contemplated that [§ 101] would be given wide scope.

¡ Congress intended patentable subject matter to include “anything under

the sun that is made by man.”

¡ Thus, “markedly different” characteristics and (some degree of) human

intervention seem to be important.

315
 MAYO V. PROMETHEUS
566 U.S. 66 (2012)
PSM AND BASIC PRINICPLES

¡ EXCEPTIONS to § 101 are laws of nature, natural phenomena, and

abstract ideas.
§ EXAMPLE: A new mineral or a new plant found in nature aren’t patentable.
§ What about E = mc 2 or Newton’s law of gravity? They’re “manifestations of
nature, free to all men and reserve exclusively for none.”

¡ POLICY JUSTIFICATION for the judicial exclusions—

§ “[T]hese are the BASIC TOOLS OF SCIENTIFIC AND TECHNOLOGICAL
WORK” that should be free to all; lest they be monopolized.
§ Otherwise, “the grant of a patent would TEND TO IMPEDE INNOVATION
more than it would tend to promote it.”

316
 MAYO V. PROMETHEUS
566 U.S. 66 (2012)
PSM AND BASIC PRINICPLES

¡ LIMITS ON THE EXCLUSIONARY PRINCIPLE.

§ Too broad an interpretation could eviscerate patent law.
§ Why? Because all inventions embody, use, reflect, rest upon, or apply
laws of nature, physical phenomena, and/or abstract ideas.

¡ So what’s the threshold? “[T]o transform an unpatentable law of nature

into a patent-eligible application of such a law, one must do more than
simply state the law of nature while adding the words ‘apply it.’”

317
 MAYO V. PROMETHEUS
566 U.S. 66 (2012)
¡ Claims were directed to optimizing the efficacy of a drug:

1. A method of optimizing therapeutic efficacy for treatment of

an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject

having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having

said immune-mediated gastrointestinal disorder . . . .

318
 MAYO V. PROMETHEUS
566 U.S. 66 (2012)
1. A method of optimizing therapeutic efficacy for treatment of an
i m m u n e - m e d i a t e d g a s t r o i n t e s t i n a l d i s o r d e r, c o m p r i s i n g :

(a) administering a drug providing 6-thioguanine to a subject

having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having

said immune-mediated gastrointestinal disorder . . . .

¡ Questions for the Court:

§ Whether the claims do significantly more than simply describe these natural
relations. To put the matter more precisely: Do the patent claims add enough to
their statements of the correlations to allow the processes they describe to
qualify as patent-eligible processes that apply natural laws?

§ MORE BROADLY: Whether the claimed processes have transformed these

unpatentable natural laws into patent-eligible applications of those laws.

319
 MAYO V. PROMETHEUS
566 U.S. 66 (2012)
1 . A m e t h o d o f o p t i m i z i n g t h e r a p e u t i c e ff i c a c y f o r t r e a t m e n t o f a n
i m m u n e - m e d i a t e d g a s t r o i n t e s t i n a l d i s o r d e r, c o m p r i s i n g :

(a) administering a drug providing 6-thioguanine to a subject

having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having

said immune-mediated gastrointestinal disorder . . . .

¡ H ELD: “To transform an unpatentable law of nature into a patent-eligible

application of such a law, one m ust do m ore than sim ply state the law of
nature while adding the words ‘apply it.’”

¡ CO RO LLARY: “If a law of nature is not patentable, then neither is a

process reciting a law of nature, unless that process has additional features
that provide practical assurance that the process is m ore than a drafting
effort designed to m onopolize the law of nature itself.”
320
 MAYO V. PROMETHEUS
566 U.S. 66 (2012)
1 . A m e t h o d o f o p t i m i z i n g t h e r a p e u t i c e ff i c a c y f o r t r e a t m e n t o f a n
i m m u n e - m e d i a t e d g a s t r o i n t e s t i n a l d i s o r d e r, c o m p r i s i n g :

(a) administering a drug providing 6-thioguanine to a subject

having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having

said immune-mediated gastrointestinal disorder . . . .

¡ W hile the “adm inistering,” “determ ining,” and “wherein” steps aren’t
them selves natural laws, they’re insufficient to transform the nature of the
claim .

¡ “Beyond picking out the relevant audience, nam ely those who adm inister doses
of thiopurine drugs, the claim sim ply tells doctors to: (1) m easure (som ehow)
the current level of the relevant m etabolite, (2) use the particular
(unpatentable) laws of nature (which the claim sets forth) to calculate the
current toxicity/inefficacy lim its, and (3) reconsider the drug dosage in light
of the law.”
321
 MAYO V. PROMETHEUS
566 U.S. 66 (2012)
1 . A m e t h o d o f o p t i m i z i n g t h e r a p e u t i c e ff i c a c y f o r t r e a t m e n t o f a n
i m m u n e - m e d i a t e d g a s t r o i n t e s t i n a l d i s o r d e r, c o m p r i s i n g :

(a) administering a drug providing 6-thioguanine to a subject

having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having

said immune-mediated gastrointestinal disorder . . . .

¡ The claims provide “instructions” that “add nothing specific to the laws
of nature other than what is well-understood, routine, conventional
activity, previously engaged in by those in the field.”

322
 MAYO’S “INVENTIVE CONCEPT”
REQUIREMENT
¡ Mayo demands an “inventive concept sufficient to ensure that the
patent in practice amounts to significantly more than a patent
upon the natural law itself.”

¡ The claims in Mayo don’t “add enough to their statements of the

correlations to allow the processes they describe to qualify as
patent-eligible processes that apply natural laws.”

¡ There’s no “inventive concept” beyond what occurs naturally.

¡ But what’s enough?

323
 MAYO’S “INVENTIVE CONCEPT”
REQUIREMENT
¡ The Court also noted how the additional steps recited in the claimed
invention “consist of well-understood, routine, conventional activity
already engaged in by the scientific community.”

¡ Is this an eligibility or novelty/lack of nonobviousness argument?

¡ If a law of nature is part of a claim, Mayo seems to suggest that

eligibility requires the patentee to set forth the law’s application in a
novel and nonobvious manner; that is, an inventive application.

324
 MAYO’S “INVENTIVE CONCEPT”
REQUIREMENT
¡ An alternative, less restrictive, view of inventive concept supports a
prohibition on a GENERIC APPLICATION of a law of nature.

¡ So Mayo can be read to require the claim to offer more than a law of
nature and instructions to “apply it.”

¡ We’ll see that Alice is sympathetic to this position.

¡ Under either reading, the claims in Mayo are problematic as they show
no more than an underlying correlation between thioguanine levels and
efficacy.

325
 MYRIAD: BACKGROUND

¡ This case involves patents filed by Myriad after it made a medical

breakthrough involving mutations in genetic sequences.

¡ Myriad discovered the precise location and sequence of what are now
known as the BRCA1 and BRCA2 genes.

¡ Mutations in these genes can dramatically increase an individual’s risk of

developing breast and ovarian cancer.

¡ The average American woman has a 12-13% risk of developing breast

cancer, but for women with certain genetic mutations, the risk can range
b/w 50-80% for breast cancer and b/w 20-50% for ovarian cancer. (Before
Myriad’s discovery of the BRCA1 and BRCA2 genes, scientists knew that
heredity played a role in establishing a woman’s risk of developing breast
and ovarian cancer, but they did not know which genes were associated
with those cancers).

326
 MYRIAD: BACKGROUND

¡ Thus, many patients seek genetic testing to see if they have mutations
in their genes that are associated with a significantly increased risk of
breast or ovarian cancer.

¡ Myriad obtained patents on BRCA1 and BRCA2. Myriad argues that it

invented something patent-eligible by “isolating” the genes from the
body. The patents gave Myriad the right to decide what research is
carried out on those genes, who could conduct that research, and how
much any resulting therapy or diagnostic test would cost.

¡ Petitioners were primarily medical professionals who regularly use

routine, conventional genetic testing methods to examine genes, but
were prohibited from examining the human genes that Myriad claims.

¡ Certiorari granted to answer the question: Are human genes patentable?

327
 MYRIAD: DEFINITIONS

¡ isolated DNA → separating a specific gene or sequence of nucleotides

from the rest of the chromosome.

¡ cDNA → man-made DNA which contains only coding sequences, w/o

introns.

328
 WHAT DID MYRIAD DO?

¡ M yriad sequenced the two genes and found that each is a version of a norm al
gene that has been corrupted by m utations that alter the DNA sequence.

¡ The isolated DNA sequence can be used in genetic testing to determ ine
whether a person carries a BRCA1 or BRCA2 gene and is thus at a higher risk
for breast or ovarian cancer.

TIM ELINE
¡ 1994: M yriad identified and isolated BRCA1 it from the rest of the DNA and
the tangle of protein that form chrom osom e num ber 17.
¡ 1995: M yriad identified and isolated BRCA2, which resides on chrom osom e
num ber 13.
¡ 1997/1998: M yriad received seven patents on the two isolated genes, various
DNA fragm ents within them , and several m ethod claim s.
¡ Post-issuance: M yriad aggressively enforced its patents . . . .

329
 WHAT DID MYRIAD CLAIM IN ITS
PATENTS?
¡ COMPOSITION OF MATTER CLAIMS directed to isolated DNA
[composition of matter claims]

¡ METHOD CLAIMS directed to “analyzing” and “comparing” the

isolated genes with those of a patient [diagnostic claims]

¡ METHOD CLAIM directed to screening cancer therapeutics involving

“growing” host cells transformed with an altered BRCA1 gene in the
presence or absence of a potential cancer therapeutic, “determining” the
growth rate of the host cells with or without the potential therapeutic,
and “comparing” the growth rate of the host cells [screening claim]

330
 PARKE-DAVIS V. H.K. MULFORD
189 F. 95 (C.C.S.D.N.Y. 1911)

¡ Upheld a patent for a purified

adrenaline salt because removing it
from gland tissue produced a new
composition of matter.

¡ “[The patentee] was the first to make

it available for any use by removing
it from the other gland-tissue in
which it was found, and [thus] it
became for every practical purpose a
new thing commercially and
therapeutically.”

331
 MYRIAD:
DISTRICT COURT (S.D.N.Y. 2010)
¡ “In light of DNA’s unique qualities as a physical embodiment of
information, none of the structural and functional differences cited by
Myriad between native BRCA1/2 DNA and the isolated BRCA1/2 DNA
claimed in the patents-in-suit render the claimed DNA ‘markedly
different.’ ”

¡ “The preservation of this defining characteristic of DNA in its native

and isolated forms mandates the conclusion that the challenged
composition claims are directed to unpatentable products of nature.”

332
 MYRIAD:
FEDERAL CIRCUIT SCOREBOARD
¡ REVERSED District Court (2-1) – composition of matter claims to
“isolated” DNA are patent eligible

¡ REVERSED District Court (3-0) – screening claims directed to

screening cancer therapeutics through changes in cell growth rate are
patent eligible

¡ AFFIRMED District Court (3-0) – diagnostic claims directed to

“comparing” and “analyzing” are patent ineligible (in accord with Mayo
v. Prometheus)

333
 MYRIAD @ CAFC:
“ISOLATED” DNA WAS PATENT ELIGIBLE

¡ “Isolated DNA is not purified DNA. Purification makes pure what was
the same material, but was previously impure.”

¡ Not the case here because “claimed isolated DNA molecules do not
exist as in nature within a physical mixture to be purified” – they need
to be “chemically cleaved [i.e. covalent bond broken] from their
chemical combination with other genetic materials. [Accordingly, this
is not Parke-Davis.]”

¡ “Thus, when cleaved, an isolated DNA molecule is not a purified form

of a natural material, but a distinct chemical entity.”

¡ The “distinctive nature” of DNA molecules determines patent

eligibility rather than similarity of information content.

334
 MYRIAD @ CAFC:
JUDGE MOORE’S CONCURRENCE

“If the law is to be changed, and DNA

inventions excluded from the broad
scope of [35 U.S.C. § 101] contrary to
the settled expectation of the
inventing com m unity, the decision
m ust com e not from the courts, but
from Congress.”

335
 MYRIAD @ CAFC:
JUDGE LOURIE ON HUMAN INGENUITY
¡ “The isolated DNA molecules
before us are not found in nature.
They are obtained in the laboratory
and are man-made, the product of
human ingenuity. While they are
prepared from products of nature,
so is every other composition of
matter.”

¡ “All new chemical or biological

molecules, whether made by
synthesis or decomposition, are
made from natural materials.”

¡ “But, as such, they are different

from natural materials, even if they
are ultimately derived from them.
The same is true of isolated DNA
molecules.”

336
 MYRIAD @ CAFC:
JUDGE BRYSON’S DISSENT
¡ Disagreed with bond-breaking/part of larger
structure reasoning

¡ Although the claim ed DNA m olecules m ay

be isolated, the sequences correspond to
m olecules in nature in every m eaningful
sense

¡ The differences between isolated and natural

DNA are not m aterial to the claim ed uses.
The isolated m olecules are useful only to
the degree that they faithfully copy the
inform ation stored and transm itted in
naturally occurring DNA and, therefore, are
not “m arkedly different” in a way that
should m atter to the law

¡ Thus, M yriad’s claim s go too far and claim

natural phenom ena 337
 WHAT DID THE SUPREME COURT
CONSIDER?
¡ The Patent Office had issued patents directed to isolated DNA molecules
for almost 30 years

¡ Nearly 20% of the genome—more than 4,000 genes—are already covered

by at least one U.S. patent (including genes for Alzheimer ’s disease, colon
cancer, asthma, and insulin production)

¡ The Court wants the subject-matter categories of § 101 to do real work

that other patentability criteria cannot do (Mayo)

¡ By granting/upholding the patent:

§ “How much future innovation is foreclosed relative to the contribution of the
inventor?” (Mayo)
§ Would this “inhibit future discovery” or “impede innovation more than it
would tend to promote it” by granting monopolies [overuse of laws of nature,
natural phenomena, manifestations of nature, and abstract ideas]? (Mayo)
338
 MYRIAD
569 U.S. 576 (2013)
(The Court only addressed the COM claims.)

¡ “Myriad did not create anything.”

¡ Did Myriad create or alter any of the genetic information encoded

in the BRCA1 and BRCA2 genes? No.
§ The location and order of the nucleotides existed in nature before
Myriad found them.
§ Nor did Myriad create or alter the genetic structure of DNA.
§ Instead, Myriad’s principal contribution was uncovering the
precise location and genetic sequence of the BRCA1 and BRCA2
genes within chromosomes 17 and 13.

339
 MYRIAD
569 U.S. 576 (2013)
¡ The PTO’s past practices are NOT entitled to deference.

¡ cDNA is patentable.
§ Why? cDNA “does not present the same obstacles to patentability as
naturally occurring, isolated DNA segments” because “creation of a
cDNA sequence from mRNA results in an exons-only molecule that is
not naturally occurring” and as such was patent eligible.

§ A technician CREATES SOMETHING NEW when cDNA is made

¡ What is NOT IMPLICATED by the opinion:

§ method claims
§ altered DNA

340
 MYRIAD: IMPLICATIONS

¡ EXISTING PATENT PORTFOLIOS.

§ Will biotech companies reevaluate their portfolios and perhaps shift toward
TRADE SECRET PROTECTION for DNA-based inventions?
§ REISSUE. Depending on business models, patentees might consider requesting
reissue of issued patents claiming “isolated DNA,” particularly if those claims
encompass genomic DNA and there are no backup claims limited to cDNA.

¡ CLAIM DRAFTING. It’s clear that any claim ed DNA with an altered sequence
or with other chem ical structures not found in nature likely will pass the
patent eligibility hurdle.

¡ OTHER NATURALLY-OCCURRING SUBSTANCES.

§ What about other “naturally occurring” chemicals, such as antibodies, hormones,
therapeutic RNA, and other biological molecules?
§ But to the extent that such molecules can be claimed with modifications not
found in nature, the claims likely will be found patent eligible.

341