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Pre p a re d b y

E co Te ch La w G ro u p , P. C .

Patent-Eligible Subject
Matter Under 35 U.S.C. §
101
1
Patent-Eligible Subject
Matter Under 35 U.S.C. §
101
2
35 U.S.C. § 101 Inventions
patentable

 “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 therefor, subject to the
conditions and requirements of this
title”
• 3
Roadmap of Life Science
Process Claims
 •
Process claims reciting
 

steps of:  Prometheus


(1) inducing a correlation,

(2) data gathering, and

(3) correlating


Process claims reciting



 Metabolite
steps of:
(1)data gathering and

(2)correlating

 Myriad

Process claims reciting only

a step of correlating • 4
Outline of Presentation

• Laboratory Corp. v. Metabolite Labs*
• In re Bilski**
• Prometheus Laboratories, Inc. v. Mayo
Collaborative Services et al.***
• Association for Medical Pathology et al. v.
USPTO, Myriad Genetics & the Directors
of the University of Utah Research
Foundation****

* 548 U.S. 124 (2006).
** 545 F.3d 943 (Fed. Cir. 2008) (en banc), cert. granted, 129 S. Ct. 2735 (June 1, 2009).
*** No. 2008-1403, U.S. App. Lexis 20623 (Fed. Cir. Sept. 16, 2009).
**** Complaint filed on May 12, 2009 in the Southern District of New York.

5
Metabolite Facts

• The Metabolite patent at issue
claimed methods for detecting
deficiencies of cobalamin and/or
folate
• Deficiency in either of these vitamins
leads to serious diseases
• Cobalamin and folate assist in
metabolizing the amino acid
homocysteine 6
Metabolite District Court
Ruling

• Jury found Laboratory Corporation of


America Holdings (“LabCorp”)
induced infringement of the
Metabolite patent

• Metabolite awarded double damages
for willful infringement
7
Metabolite Claim at Issue

13. A method for detecting a deficiency


of cobalamin or folate in warm-blooded
animals comprising the steps of:
 assaying a body fluid for an elevated
level of total homocysteine; and
 correlating an elevated level of total
homocysteine in said body fluid with a
deficiency of cobalamin or folate

• 8
LabCorp’s Unaddressed
Argument

• LabCorp appealed the District Court’s
construction of the claim term
“correlating,” arguing that this
construction rendered claim 13 invalid
under 35 U.S.C. § 101 for attempting
to obtain patent protection for a
natural phenomenon

• Federal Circuit affirmed the District
Court’s claim construction without
addressing the above argument
9

LabCorp’s Supreme Court
Appeal

• A writ of certiorari on LabCorp’s appeal was
initially granted and then later dismissed
as improvidently granted

• Justice Breyer, in a non-binding dissent,


analyzed whether Claim 13 is invalid
because it seeks to claim a monopoly over
a natural phenomenon, i.e., the
correlation between elevated levels of
homocysteine and deficiencies in
cobalamin or folate AND therefore
addressed LabCorp’s argument 10
Metabolite’s Response to the
Unaddressed Argument

• Metabolite conceded that correlation
between homocysteine and vitamin
deficiency is a natural phenomenon

• Metabolite argued that Claim 13 is still


patentable because it recites a process
for detecting vitamin deficiency with
discrete testing and correlating steps
and that a process is not unpatentable
simply because it contains a natural
phenomenon
11

Metabolite’s Response to the
Unaddressed Argument (cont.)

Metabolite also argued that Claim 13 is a


patentable application of a natural


phenomenon because:
• it entails a physical transformation of
matter (e.g., alteration of blood
sample during whatever test is
used); and
• it produces a useful, concrete, and
tangible result (i.e., detection of
vitamin deficiency)
 12
Breyer’s Dissent in
Metabolite

• Breyer states that claim 13 is invalid
because it recites ineligible patent subject
matter as it covers a natural
phenomenon, i.e., the correlation itself

• Breyer believes that Metabolite claimed a


natural law in the abstract natural
language of a process because the
additional assaying step is superfluous

13

Outline of Presentation

• Laboratory Corp. v. Metabolite Labs*
• In re Bilski*
• Prometheus Laboratories, Inc. v. Mayo
Collaborative Services et al.***
• Association for Medical Pathology et al. v.
USPTO, Myriad Genetics & the Directors
of the University of Utah Research
Foundation****

* 548 U.S. at 124 (2006).
** 545 F.3d 943 (Fed. Cir. 2008) (en banc), cert. granted, 129 S. Ct. 2735 (June 1, 2009).
*** No. 2008-1403, U.S. App. Lexis 20623 (Fed. Cir. Sept. 16, 2009).
**** Complaint filed on May 12, 2009 in the Southern District of New York.

14
Recent § 101 Cases Before
Bilski


• Federal Circuit held that patent claims relating to a
mandatory arbitration system involving legal
documents, such as wills or contracts were not
patentable subject matter because they “depend
for their operation on human intelligence alone” to
solve practical problems
 In re Comiskey, 499 F.3d 1365, 1378-79 (Fed. Cir.
2007).

• Federal Circuit held that claims to a signal with an


embedded digital watermark encoded according to
a given encoding process were not directed to
statutory subject matter under Section 101 15
 In re Nuijten, 500 F.3d 1346, 1353-54 (Fed. Cir.
Market Landscape Before
Bilski
• Internet fueling new business
method patents
• Business method patents were
being directed to significant
commercial activity
• Increasing number of diagnostic
patents in personalized
medicine space directed to
correlations 16
Bilski’s Claim 1
Original Language Simplified Language
A method for managing the consumption risk costs of a A method of managing a commodity broker’s risk
commodity sold by a commodity provider at a fixed price
comprising the steps of:

initiating a series of transactions between said commodity initiating transactions between a broker and buyers (e.g.,
provider and consumers of said commodity wherein said coal power plants) by which the buyers buy the commodity
consumers purchase said commodity at a fixed rate based upon (e.g., coal) at a fixed price;
historical averages, said fixed rate corresponding to a risk
position of said consumer;

identifying market participants for said commodity having a identifying sellers of the commodity (e.g., coal mines); and
counter-risk position to said consumers; and

initiating a series of transactions between said commodity initiating transactions between the broker and sellers, at a
provider and said market participants at a second fixed rate suchsecond fixed price, such that the buyers’ and sellers’
that said series of market participant transactions balances the respective risk positions balance out
risk position of said series of consumer transactions

17
Federal Circuit’s Analysis

• Analyzed prior Supreme Court rulings
regarding meaning of “process”
• Rejected its test regarding when a
“process” is eligible subject matter
• Adopted the “machine-or-
transformation” test as the only
test to determine eligible subject
matter
18
Prior Supreme Court Ruling

• Meaning of “process” as used in § 101 is narrower
than its ordinary meaning
 Parker v. Flook, 437 U.S. 584, 593 (1978).
• The ordinary meaning of “process” is: “[a]
procedure . . . [a] series of actions, motions, or
operations definitely conducing to an end,
whether voluntary or involuntary”
 WEBSTER'S NEW INTERNATIONAL DICTIONARY
OF THE ENGLISH LANGUAGE 1972 (2d ed. 1952).
• A claim is not a patent-eligible “process” if it
claims “laws of nature, natural phenomena, [or]
abstract ideas”
 Flook, 437 U.S. at 589.
19
Federal Circuit Rejects Its Own
Tests

• Federal Circuit rejects the following tests used in
prior decisions to determine patent-eligible
“process”:
Freeman-Walter-Abele test;
Useful, concrete and tangible result test; and
Technological arts test
• Federal Circuit clarified that the following are also
not the proper test:
Business method exception; and
Mental process that lacks significant “physical
steps”
20
Freeman-Walter-Abele Test

• Based on three Custom Court of Appeals
decisions
 In re Freeman, 573 F.2d 1237 (CCPA 1978);
In re Walter, 618 F.2d 758 (CCPA 1980); and In
re Abele, 684 F.2d 902 (CCPA 1982).

• This test requires:
 (1) determining whether the claim recites an
“algorithm” within the meaning of Benson, then
(2) determining whether that algorithm is
“applied in any manner to physical elements or
process steps”
 Abele, 684 F.2d at 905-07. 21
Useful, Concrete and Tangible
Result


• “[A] process tied to a particular machine, or
transforming or reducing a particular article into a
different state or thing, will generally produce a
‘concrete’ and ‘tangible’ result . . .”
 Bilski, 545 F.3d at 959.

• “[C]ertain of mathematical subject matter, standing


alone, represent nothing more than abstract ideas
until reduced to some type of practical application”
 In re Alappat, 33 F.3d 1526, 1543 (Fed. Cir. 1994).

22
Technological Arts Test

• A claimed process is technological to the
extent it applies laws of nature to new
ends
 Benson, 409 U.S. at 67.

• By contrast, a process is non-technological
where its inventive concept is the
application of principles drawn not from
the natural sciences but from disciplines
such as business, law, sociology, or
psychology 23
Machine-or-Transformation
Test
The claim is tied to a particular machine

 OR

The claim transforms an article


 AND

The involvement of a machine or


transformation in the process must not
merely be insignificant extra-solution 24
activity
Application to Bilski’s Claim
1


• No machine tied to the claim
 “The examiner noted that Applicants had admitted
their claims are not limited to operation on a
computer, and he concluded that they were not
limited by any specific apparatus”
 Bilski, 545 F.3d at 950.

• Claim does not transform an article
 “[C]laim 1 does not involve the transformation of
any physical object or substance, or an electronic
signal representative of any physical object or
substance”
 Bilski, 545 F.3d at 964.
25
Dyk’s Concurrence

• English Law: under patent clause of the Statute of
Monopolies, patent subject matter was limited by
the term “manufacture,” and did not include
organization of human activity
• Patent Act of 1790: incorporated and was consistent
with the English Law
• Patent Act of 1793: introduced some of the language
of § 101, had the word “art” instead of “process,”
and was also consistent with English law
• Patent Act of 1952: replaced the word “art” with
“process,” but the Supreme Court has concluded
that this change did not alter the substantive
understanding of the statute
26
Newman’s Dissent


• Majority’s narrow reading of “process” “excludes many
of the kinds of inventions that apply today’s
electronic and photonic technologies, as well as
other processes that handle data and information in
novel ways. Such processes have long been patent
eligible, and contribute to the vigor and variety of
today’s Information Age”
 Bilski, 545 F.3d at 976.

• “Uncertainty is the enemy of innovation. These new


uncertainties not only diminish the incentives
available to new enterprise, but disrupt the settled
expectations of those who relied on the law as it
existed”
 Bilski, 545 F.3d at 977. 27
Newman’s Dissent (cont.)

Newman notes that machine-or-


transformation test has been rejected
as the only test by the Supreme Court
in
• Gottschalk v. Benson
• Parker v. Flook
• Diamond v. Chakrabarty
• Diamond v. Diehr
28
Mayer Dissent

• Agrees with Majority that § 101 should not extend to
protecting process which structure commercial
transactions
• Fervently believes that there should be no protection
for business method patents
• Criticizes machine-or-transformation test for not being
an appropriate test because it can be easily
circumvented by non-technological methods, such
as business methods
• Supports the technological arts test: regardless of a
“physical transformation,” a claimed process should
not be patent eligible unless it is directed to an
advance in science or technology
29
 Bilski, 545 F.3d at 1009.
Rader Dissent

• Machine-or-transformation test applies to
archaic technology and does not apply to
innovation in the modern era
• There is no limit on what is considered
“process” under § 101
• § 101 does not cover laws of nature, natural
phenomenon and abstract ideas
Laws of nature and natural phenomenon cannot
be invented
Abstract ideas must be applied to or
transformed to practical use before they qualify
for protection
• 30
Supports Diagnostic Patents

“Before the invention featured in Lab Corp.,


medical science lacked an affordable, reliable,
and fast means to detect this debilitating
condition. Denial of patent protection for this
innovation—precisely because of its elegance
and simplicity (the chief aims of all good
science)—would undermine and discourage
future research for diagnostic tools. Put another
way, does not Patent Law wish to encourage
researchers to find simple blood tests or urine
tests that predict and diagnose breast cancers
or immunodeficiency diseases?”
31

Outline of Presentation

• Laboratory Corp. v. Metabolite Labs*
• In re Bilski**
• Prometheus Laboratories, Inc. v. Mayo
Collaborative Services et al.***
• Association for Medical Pathology et al. v.
USPTO, Myriad Genetics & the Directors
of the University of Utah Research
Foundation****

* 548 U.S. at 124 (2006).
** 545 F.3d 943 (Fed. Cir. 2008) (en banc), cert. granted, 129 S. Ct. 2735 (June 1,
2009).
 *** No. 2008-1403, U.S. App. Lexis 20623 (Fed. Cir. Sept. 16, 2009).
****
 Complaint filed on May 12, 2009 in the Southern District of New York. 32
Prometheus v. Mayo


• Involves methods for calculating proper
dosage of thiopurine drugs, i.e., 6-MP and
AZA (which upon administration convert
to 6-MP)

• 6-MP is broken down by the body into
metabolites: 6-MMP, 6-TG and their
nucleotides

• Drugs that deliver 6-TG are widely used for 33
Representative Claim

Claim 1 of U.S. Patent No. 6,355,623 states:


 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
 (c) wherein the levels of 6-thioguanine less than
about 230 pmol per 8x108 red blood cells indicates a need
to increase the amount of said drug subsequently
administered to said subject and
 (d) wherein the levels of 6-thioguanine greater
than about 400 pmol per 8x108 red blood cells indicates a
need to decrease the amount of said drug
subsequently administered to said subject 34
District Court Ruling


• “6-TG and 6-MMP are products of the natural
metabolizing of thiopurinedrugs, and the
inventors merely observed the relationship [or
the correlation] between these naturally
produced metabolites and therapeutic efficacy
and toxicity” Prometheus, slip op. at 9.
• The correlations were natural phenomena
because they resulted from a natural body
process
• The administering and determining steps are
merely necessary data-gathering steps for any
use of the correlations
• The claims wholly preempt the correlations
35
because they cover the correlations
Representative Claim

Claim 1 of U.S. Patent No. 6,355,623 states:


 A method of optimizing therapeutic efficacy for


treatment of an immune mediated gastrointestinal disorder,
comprising:
TRANFORMATIVE → (a) administering a drug providing6-

thioguanine to a STEP subject having said immune-


mediated gastrointestinal disorder; and
TRANFORMATIVE → (b) determining the level of 6-thioguanine in

said subject STEP having said immune-mediated


gastrointestinal disorder
 MENTAL STEP → (c) wherein the levels of 6-thioguanine
less than about 230 pmol per 8x108 red blood cells
indicates a need to increase the amount of said drug
subsequently administered to said subject and
 MENTAL STEP → (d) wherein the levels of 6-thioguanine
greater than about 400 pmol per 8x108 red blood cells
indicates a need to decrease the amount of said drug
subsequently administered to said subject 36
Federal Circuit’s Ruling


 Is a machine or transformation involved?
 Yes, because: (1) following administration of a
man-made drug, the human body undergoes
transformation; (2) the drug transforms into
metabolites; and (3) the tissue sample upon
analysis is transformed

 If so, is the machine or transformation central to


the purpose of the claim?
 Yes, the claim recites a step to provide thiopurine
drugs for the purpose of treating disease, and a step
for measuring the drugs’ metabolite levels for the
purpose of assessing the drugs’ dosage during the
course of treatment 37
Administering Step


• Transformation is the effect on the body
after metabolizing the artificially
administered drugs, which provide 6-TG to
a subject and are thought to be the active
metabolite in the treatment of disease
 Prometheus, slip op. at 25.

• Administration of a drug to a subject to


treat, i.e., transform, the subject is not a
natural process
 Id. 38
Determining Step

• “Determining the levels of 6-TG or 6-MMP in
a subject necessarily involves a
transformation, for those levels cannot be
determined by mere inspection”
 Prometheus, slip op. at 26.

• The court noted that it is necessary to
extract the metabolites from a bodily
sample and determine their concentration
 Id. (quoting Prometheus’s expert (“[A]t
the end of the process, the human blood
sample is no longer human blood; human 39
tissue is no longer human tissue.”))
Transformation is the Central
Purpose

• Mayo did not dispute that the determining
step is transformative, but instead argued
that the transformation was merely a
necessary data-gathering step for using
the correlations

• In response, the court noted:
 “On the contrary, this transformation is
central to the purpose of the claims, since
the determining step is, like the
administering step, a significant part of the
claimed method of treatment”
40
 Prometheus, slip op. at 27.
Important Holding

When a defined group of drugs is


administered to the body to ameliorate
the effects of an undesired condition, it
is always transformative
Prometheus, slip op. at 23.

41
Federal Circuit Criticizes
District Court


• Federal Circuit criticized the District Court for
following Judge Breyer’s dissent in Metabolite

• Claims at issue in Metabolite are different from
the claims in Prometheus because no drug is
involved

• Federal Circuit also stated that Judge Breyer’s
reasoning in Metabolite was unpersuasive
and appears to disagree with that analysis
because the claim was not analyzed as a 42
Outline of Presentation

• Laboratory Corp. v. Metabolite Labs*
• In re Bilski**
• Prometheus Laboratories, Inc. v. Mayo
Collaborative Services et al.***
• Association for Medical Pathology et al. v.
USPTO, Myriad Genetics & the Directors
of the University of Utah Research
Foundation****

 * 548 U.S. at 124 (2006).
 ** 545 F.3d 943 (Fed. Cir. 2008) (en banc), cert. granted, 129 S. Ct. 2735 (June 1,
2009).
 *** No. 2008-1403, U.S. App. Lexis 20623 (Fed. Cir. Sept. 16, 2009).
 **** Complaint filed on May 12, 2009 in the Southern District of New York. 43
Myriad’s Amicus Brief in
Prometheus
 Claim 1 in Prometheus states: M yria d a rg u e s:

A method of optimizing therapeutic
 A d m in iste rin g a n u n n a tu ra ld ru g is o n e
efficacy for treatment of an immune- va lid b a sis fo r fin d in g th e Pro m e th e u s
mediated gastrointestinal disorder,
comprising:
• cla im s p a te n t- e lig ib le

(a) administering a drug 6-thioguanine


 M yria d a sks th e C o u rt to fin d
to a subject having said immune- Pro m e th e u s’ cla im s a s p a te n t e lig ib le
mediated gastrointestinal disorder; and o n a m o re fu n d a m e n ta lle ve l
(b) in said subject having said immune-

mediated gastrointestinal disorder C la im s a t issu e d o n o t se e k to p re e m p t


th e u se o f a co rre la tio n ; ra th e r, th e y
(c) wherein the levels of 6-thioguanine se e k to fo re clo se o th e rs fro m u sin g
less than about 230 pmol per 8x108 red
blood cells indicates a need to increase th a t co rre la tio n in co n ju n ctio n w ith
the amount of said drug subsequently th e o th e r cla im e d ste p s
administered to said subject
W h e n th e p re a m b le is a lim ita tio n o n
 and
th e cla im s, a s it is in Prometheus ( and
(d) wherein the levels of 6-thioguanine

Metabolite) the claims are drawn to a
greater than about 400 pmol per 8x108 specific and practical application of
red blood cells indicates a need to a correlation
decrease the amount of said drug
subsequently administered to said
subject
44
Background

• Declaratory judgment action brought
by ACLU on behalf of a large group
of sympathetic plaintiffs

• Seeking to invalidate Myriad


Genetics’ patent claims relating to
breast cancer genes BRCA1 and
BRCA2
 45
Plaintiffs

• Four prominent, national organizations
(suing on behalf of members, some of
whom are ready, willing and able to
engage in research and clinical
practice involving BRCA1 and BRCA2
genes if the patents are invalidated)
Association for Molecular Pathology
American College of Medical Genetics
American Society for Clinical Pathology
College of American Pathologists
46
Plaintiffs (cont.)

• Six preeminent geneticists (prohibited
from doing routine screening for
BRCA1 and BRCA2 genes for research
and clinical practice; ready and willing
to perform the tests)
Haig Kazazian, M.D. (received cease and
desist letter)
Arupa Ganguly, Ph.D. (received cease and
desist letter)
Wendy Chung, M.D., Ph.D.
Harry Ostera, M.D.
David Ledbetter, Ph.D. 47
Plaintiffs (cont.)

• Two genetic counselors (having only
one laboratory prevents
independent confirmation of test
results and interpretations of the
meaning of variants of uncertain
significance; ready, willing, and
able to utilize alternative testing
facilities for tests)
Ellen Matloff, M.S.
Elsa W. Reich, M.S. 48
Plaintiffs (cont.)

• Six individual women (Myriad will not accept
some health care coverage; “genetic
variant of uncertain significance;” seeking
second opinions; seeking additional BRCA
testing that looks for other large genetic
rearrangements)
Lisbeth Ceriani
Runi Limary
Genae Girard
Patrice Fortune
Vicky Thomason
Kathleen Raker
49
Defendants


• United States Patent and Trademark Office: granted the
patents-in-suit and authored policies that authorized
patent grants on the composition of matter claims


• Myriad Genetics: co-owner of one patent and formerly co-
owner of several other patents; has an exclusive license
for all of the patents-in-suit


• 10 Directors of the University of Utah Research Foundation:
owner or part-owner of all the patents-in-suit

• Other part-owners of patent-in-suit: not named because 50


Myriad, as exclusive licensee of all patents, is capable of
Procedural History

• Case filed May 12, 2009 in the Federal
District Court for the Southern District of
New York
• USPTO and Myriad/Directors of the
University of Utah Research Foundation
have filed separate motions to dismiss on
procedural grounds – the motions have
been fully briefed
• At least 10 amicus briefs have been filed on
behalf of Plaintiffs, none to date on behalf
of Defendants
• Plaintiffs brought a summary judgment
motion on August 26, 2009 51
The Patents-in-Suit



• 5,747,282 (“the ’282 patent”): claims 1, 2, 5, 6, 7
(composition) and 20 (process)
• 5,693,473 (“the ’473 patent”): claim 1 (composition)
• 5,709,999 (“the ’999 patent”): claim 1 (process)
• 5,710,001 (“the ’001 patent”): claim 1 (process)
• 5,753,441 (“the ’441 patent”): claim 1 (process)
• 5,837,492 (“the ’492 patent”): claims 1, 6, 7 (composition)
• 6,033,857 (“the ’857 patent”): claims 1 & 2 (process)

These patent claims cover breast cancer genes BRCA1



52
(chromosome 17) and BRCA2 (chromosome 13)
BRACAnalysis®


• BRACAnalysis® is Myriad’s genetic screening
test that assesses a woman’s risk of
developing breast or ovarian cancer based on
detection of mutations in the BRCA1 and
BRCA2 genes

• Due to patent protection, BRACAnalysis® is the
only means for women to diagnose
susceptibility to breast cancer or ovarian
cancer related to BRCA1 and BRCA2
mutations
53

Causes of Action


• Because human genes are products of nature,
laws of nature and/or natural phenomena,
and abstract ideas or basic human knowledge
or thought, the challenged claims are invalid
under Article 1, section 8, clause 8 of the
United States Constitution and 35 U.S.C.
section 101

• All of the challenged claims represent patents


on abstract ideas or basic human knowledge
and/or though and as such are
unconstitutional under the First and 54
Fourteenth Amendments to the United States
Prayer for Relief

• Declaratory Judgment of invalidity
and/or unenforceability

• Enjoin defendants from taking any
action to enforce the claims at
issue

• Attorneys’ fees and costs
55
Types of Process Claims at
Issue


• Analyzing genes to determine if they contain certain
mutations

• Analyzing whether genes in a particular patient differ
from the wild-type gene

• Analyzing whether two genes are different and
whether that difference indicates a predisposition to
breast cancer

56
• Comparing growth rates of a cell with a mutated BRCA
Analyzing Genes for Certain
Mutations

A method for detecting a germline alteration


in a BRCA1 gene, said alteration selected from
the group consisting of the alterations set
forth in Tables 12A, 14, 18 or 19 in a human
which comprises analyzing a sequence of a
BRCA1 gene or BRCA1 RNA from a human
sample or analyzing a sequence of BRCA1
cDNA made from mRNA from said human
sample with the proviso that said germline
alteration is not a deletion of 4 nucleotides
corresponding to base numbers 4184-4187 of
SEQ ID NO: 1 57

Comparing Two Genes and Correlating
Differences to Alterations

A method for screening germline of a human


subject for an alteration of a BRCA1 gene which
comprises comparing germline sequence of a
BRCA1 gene or BRCA1 RNA from a tissue sample
from said subject or a sequence of BRCA1 cDNA
made from mRNA from said sample with germline
sequences of wild-type BRCA1 gene, wild-type
BRCA1 RNA or wild-type BRCA1 cDNA, wherein a
difference in the sequence of the BRCA1 gene,
BRCA1 RNA or BRCA1 cDNA of the subject from
wild-type indicates an alteration in the BRCA1
gene in said subject
e.g., claim 1 of the ‘441 patent.
58
Comparing Two Genes and Correlating
Differences to Susceptibility to Breast
Cancer

A method for diagnosing a predisposition for


breast cancer in a human subject which
comprises comparing the germline sequence
of the BRCA2 gene or the sequence of its
mRNA in a tissue sample from said subject
with the germline sequence of the wild-type
BRCA2 gene or the sequence of its mRNA,
wherein an alteration in the germline
sequence of the BRCA2 gene or the sequence
of its mRNA of the subject indicates a
predisposition to said cancer
e.g., claim 2 of the ‘857 patent.
59
Comparing a Cell’s Growth Rates
in the Presence and Absence of a
Drug

A method for screening potential cancer therapeutics


which comprises: growing a transformed eukaryotic host
cell containing an altered BRCA1 gene causing cancer in
the presence of a compound suspected of being a cancer
therapeutic, growing said transformed eukaryotic host
cell in the absence of said compound, determining the
rate of growth of said host cell in the presence of said
compound and the rate of growth of said host cell in the
absence of said compound and comparing the growth
rate of said host cells, wherein a slower rate of growth of
said host cell in the presence of said compound is
indicative of a cancer therapeutic
e.g., claim 20 of the ‘282 patent


60
Plaintiffs’ Arguments on the
Process Claims


• The process claims require comparing
characteristics, e.g., sequences or cellular
growth rates

• Plaintiffs argue that such a comparison is
merely a mental step

• Similarities or differences resulting from
comparison are not the creation of an
inventor 61
Plaintiffs’ Arguments on the
Process Claims (cont.)


• The claims do not disclose a particular method
of sequencing or a particular method of
looking for mutations. They simply claim the
“idea” of looking for a mutation. A person
infringes by noting natural facts about
whether two genes are the same or different

• “Phenomena of nature, though just discovered,
mental process, and abstract intellectual
concepts are not patentable, as they are the
basic tools of scientific and technological
work” 62
Plaintiffs’ Policy Arguments


• The patent system is intended to promote technological growth


• There is evidence that patents were not necessary to sequence
and analyze the BRCA1 and BRCA2 genes


• The gene sequence claims in effect patent any use of the BRCA
genes. The patents cover the genes themselves. Because the
function of the genes both in the body and in the defendant’s
lab is to convey information, they cover all of the information
for all of its uses, and consequently, chill further research


• Defendants have gained critical scientific evidence of previously 63
unknown alteration, including deleterious mutations, and have
Plaintiffs’ First Amendment
Arguments


Plaintiffs’ Argue That the Process Claims Violate

the First Amendment

Free speech protection prevents the


government from limiting thought
64
Defendants’ Legal Arguments
on the Process Claims

• Claims at issue do not seek to
preempt the use of a correlation;
rather, they seek to foreclose
others from using that correlation
in conjunction with the other
claimed steps

• When the preamble is a limitation on
the claims, the claims are drawn to
a specific and practical application
65
Defendants’ Policy Arguments
on the Process Claims


• Because there are numerous possible correlations for
a particular disease character, a patent monopoly
on a particular diagnostic use of a particular
correlation would actually incentivize scientists to
discover new correlations and develop better
personalized medicine products

• Patent claims to diagnostic use of correlations are
necessary to incentivize and reward the massive
investment required to research and develop
personalized medicine products
• 66
Types of Composition Claims at
Issue


• Purified and isolated natural human
genes

• Purified and isolated natural human
genes with natural mutations

67
Purified and Isolated Natural
Human Genes

“An isolated DNA coding for a BRCA1


polypeptide, said polypeptide having
the amino acid sequence set forth in
SEQ ID NO:2”
e.g., Claim 1 of the ’282 patent


 68
Purified and Isolated Natural
Human Genes With Natural
Mutations

“An isolated DNA comprising an


altered BRCA1 DNA having at least one
of the alterations set forth in Tables
12A, 14, 18 or 19 with the proviso that
the alteration is not a deletion of four
nucleotides corresponding to base
numbers 4184-4187 in SEQ. ID. NO:1”
e.g., claim 1 of the ’473 patent.

• 69
On Patenting DNA
Sequences

• Courts have not yet addressed
patentability of DNA sequences
under 35 U.S.C. § 101

• Courts have been very lenient with
affirming claims to DNA sequences
on non-obviousness grounds

70
Plaintiffs’ Arguments on the
Composition Claims

• A genetic sequence is biological information
itself

• All the claims embody products and laws of
nature

• Merely extracting, purifying, or changing a
natural product does not render that
product patent-eligible, unless a
fundamentally new product is created
• 71
Is Purifying and Isolating
Enough to Warrant
Patentability?


• The following Supreme Court cases hold that patentability
requires more than removing a natural product from its
environment and purifying it. There must be a change in
function:
American Wood Paper, 90 U.S. 566, 570 (1874)
Cochrane v. Badische Anilin & Soda Fabrik, 111 U.S. 293 (1884)
American Fruit Growers, Inc. v. Brodgex Co., 283 U.S. 1, 11
(1931)
Funk Brothers, Seed Co., 333 U.S. 127, 128-31 (1948)


• But, genes are products of nature, and sequencing genes
does not produce something with a new function.
Sequencing is designed solely to reveal the functions of
the gene dictated by nature 72
USPTO’s Position(s) on
Patentability of Genes


• Discoveries can be patentable (“by securing for
… Inventors the exclusive Right to their
respective … Discoveries”)

• An excised gene is eligible for a patent as a
composition of matter or as an article of
manufacture because that DNA molecule
does not occur in that isolated form in nature

• Synthetic DNA preparations are eligible for
patents because their purified state is 73
USPTO’s Position(s) on
Patentability of Genes



• Comments to Utility Examination Guidelines, 66 Fed. Reg. No. 4 at 1093
(January 5, 2001)


• Relies on:
Louis Pasteur claimed “[y]east, free from organic germs of disease, as an
article of manufacture”
 U.S. Patent No. 141,072.
In an early patent covering adrenaline, the court noted that purified
adrenaline “became for every practical purpose a new thing
commercially and therapeutically”
 Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95, 103 (S.D.N.Y.
1911).
74
Regarding a patent on purified prostaglandins, “What appellants claim . .
How Will Myriad Be
Resolved?

• Procedural Hurdles:
Declaratory Judgment requires: (1) the patent owner
must have taken some affirmative action relevant
to the plaintiff; and (2) the plaintiff must have a
concrete plan to take potentially infringing action

• Summary Judgment?:
Plaintiff bears burden of proof at trial
No discovery
Plaintiffs must get helpful claim construction
Plaintiffs must assert a novel reading of patent law
(no instances of “isolated” genes being found an
unpatentable product of nature)
75
How Will Myriad Be Resolved?
(cont.)

• Trial court unlikely to find the


composition claims invalid under
current law

• Opportunity to narrow process claims

• Appeal is an almost certainty

• Federal Circuit?
• 76
How Will Myriad Be Resolved?
(cont.) Significance?

• Patents-in-suit will expire in 2015-16


• The Human Genome Project has made the entirety of


the genome, along with all of its encoded proteins,
prior art

• Composition claims on DNA are likely to be more


difficult as obviousness rejections become more
likely
 In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009) (holding
claim to DNA sequence obvious where protein was
known and DNA sequence was determined by
conventional methodologies known to those skilled in77
Summary of Life Science
Process Claims
 •
Process claims reciting steps of 

(1)inducing a correlation,  Prometheus


(2)data gathering, and
(3)correlating •
are patent eligible



Process claims reciting steps of 
(1)data gathering and
(2)correlating
 Metabolite

may or may not be patent

eligible 



Process claims reciting only a 
step of correlating are least
likely to be patent eligible  Myriad
  78
Practice Recommendations

• Presenting many claims of varying scope

• If applicable, explicitly recite a transformation
or at least a transformative step

• If possible, tie claims to machine or composition

• For diagnostic claims, body of claims should
include purpose (typically found in preamble)
• 79
• Tie diagnostic correlation to a method of
Questions for Consideration
Questions


• Should the Supreme Court’s test under § 101 should
address whether progress in science and technology is
advanced or impeded by these types of patents?


• What is the Supreme Court going to do with Bilski?


• What place does Breyer’s rationale in Metabolite have in
future decisions?


• How should the Metabolite decision be considered in light of
Prometheus? 80

Related Interests