According to Myriad the majority of academic
researchers operating
laboratories (as opposed to Clinical
Laboratory Improvement Amendments
(“CLIA”)-certified
laboratories) do not believe that they should
share test
results with subjects outside of the standard clinical
setting.
Reilly Decl. ¶¶ 57-59.
As the declarations submitted by the
parties make
clear, there exists a sharp dispute concerning the impact
of
patents directed to isolated DNA on genetic research and
consequently the health
of society. As with the dispute
concerning the effect of the patents-in-suit on
BRCA1/2
genetic testing, the resolution of these disputes of fact
and
policy are not possible within the context of these
motions.
IV. THE
PATENTS
A. Summary of the Patents
The subjects of
this declaratory judgment action
are fifteen claims contained in seven patents
issued by the
79
USPTO:25
claims 1, 2, 5, 6, 7, and 20 of U.S.
patent
5,747,282 (the “'282 patent”);
claims l, 6, and 7 of
U.S.
patent 5,837,492 (the “'492 patent”); c1aim 1 of
U.S.
patent 5,693,473 (the “'473 patent”); claim 1 of
U.S.
patent 5,709,999 (the “'999 patent”); claim 1 of
U.S.
patent 5,710,OOl (the “'001 patent”); claim 1 of
U.S.
patent 5,753,QQl (the “'441 patent”);
and claims l and 2
of U.S. patent 6,033,857 (the
“'857
patent”).26
The claims-in-suit may be
divided into two types
of claims: composition claims and method, or
process,
claims. Independent claim 1 of the '282 patent is
representative
of the group of composition claims and
claims:
An isolated
DNA coding for a BRCA1
polypeptide, said polypeptide having
the amino acid
sequence set forth in
sEQ ID NO:2.
This claim is therefore
directed to an isolated DNA
80
molecule possessing a
nucleotide sequence that translates
into the BRCA1 protein. Because most amino
acids can
result from the translation of more than one DNA codon,
multiple DNA
sequences correspond to the nucleotide
sequence claimed by this claim. Claim 2
of the '282 patent
is dependent on claim 1 but contains an
additional
limitation that identifies the specific BRCA1
nucleotide
sequence of the claimed
DNA.27.
Claims 5 and 6 of the '282
patent
are directed to fragments as short as 15 nucleotides
of the DNA molecules
claimed in claims 1 and 2 of the '282
patent.28
Finally, claim 7 of the '282 patent
and claim 1
of the '473 patent are directed to isolated DNA possessing
one
of the specified mutant BRCA1 gene
sequences.29
Claims 1, 6, and 7 of the
'492 patent are also
81
composition claims covering
isolated DNA molecules
containing certain specified nucleotide sequences
relating
to the BRCA2 gene. Claim 1 is directed to an isolated
DNA
molecule encoding the BRCA2
protein.30
Like claim 1 of the
'282 patent,
claim 1 of the '492 patent is directed to
multiple possible DNA sequences
as a result of the
redundancy of the DNA codons. Claim 6 of the '492
patent,
however, is considerably broader than claim 1 and is
directed to any DNA
nucleotide encoding any mutant BRCA2
protein that is associated with a
predisposition to breast
cancer.31
Claim
7 of the '492 patent depends on claim 6
but is restricted to the mutated
forms of the BRCA2
nucleotide sequence set forth in the
specification.32
As a
result of the breadth of these
composition claims, they
reach isolated BRCA1/2 DNA obtained from any
human being.
Claim 1 of the '999 patent is representative of
the group
of method claims. It claims:
82
A method for
detecting a germline
alteration in a BRCA1 gene, said
alteration selected from a
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.
Thus, claim 1 of the '999 patent covers the process
of
identifying the existence of certain specific mutations in
the BRCAl gene by
“analyzing” the sequence of
the BRCA1
DNA, RNA, or cDNA made
from BRCA1 RNA obtained from a human
sample.
Most of the
remaining method claims-in-suit are
similarly structured and directed to the
comparison of gene
sequences. Claim 1 of the '001 patent claims a method
for
determining whether a human tumor sample contains a
mutation in the BRCA1
gene by “comparing” the sequence of
the BRCA1 gene from the
tumor with the sequence of the
BRCA1 gene from a non-tumor sample from
the same
person.33
83
Claim 1 of the
'441 patent and claim 1 of the '857 are both
directed to the same
process, differing only as to whether
the claimed method is directed to
BRCA1 ('441)
or BRCA2
('857). Both of these
independent claims are directed to
the process of determining whether an
individual has
inherited an altered BRCA1 or BRCA2 gene
by
“comparing” the
individual's BRCA1 or BRCA2 gene
sequence with the wild-type
BRCA1 or BRCA2 gene
sequence.34
Claim 2 of the '857
patent covers a
method for determining whether an
individual has a predisposition for breast
cancer by
“comparing” the individual's BRCA2 gene
sequence
with the
known wild-type BRCA2 gene
sequence.35
84
Finally, claim 20 of
the '282 patent claims a
method for determining the effectiveness of a
potential
cancer therapeutic comprising growing cells carrying an
altered BRCA1
gene known to cause cancer in the presence
and absence Of a potential Cancer
therapeutic, comparing
the growth rates of the cells, and concluding that a
slower
growth rate in the presence of the potential therapeutic
indicates that
it is indeed a cancer
therapeutic.36
B. Construction of
the
Claims37
1. Legal
Standard
Before considering the patent-eligibility of a
patent claim,
the disputed terms in the claims must be
85
construed in order
ensure the scope of the claims is
accurately assessed. See, e.g., Datamize,
LLC v. Plumtree
Software, Inc., 417 F.3d 1342, 1354 (Fed. Cir. 2005)
(“[A]
utility patent protects ‘any new and useful process,
machine,
manufacture, or composition of matter, or any new
or useful improvement
thereof,' 35 U.S.C. § 101 (2000), the
scope of which is defined by the
patent's written
claims.”). Courts are charged with interpreting
disputed
claim terms as a matter of law. Markman v. Westview
Instruments,
Inc., 517 U.S. 370, 384-85 (1996).
In interpreting the meaning of
claim terms,
“words of a claim are generally given their ordinary
and
customary meaning” to a person of ordinary skill in the art
at the
time of invention (i.e., the effective filing date
of the patent application).
Phillips v. AWH Corp.,
415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (internal
citations and
quotation marks omitted). “Importantly, the person
of
ordinary skill in the art is deemed to read the claim term
not only in the
context of the particular claim in which
the disputed term appears, but in the
context of the entire
patent, including the specification.” Id. at
1313. Thus,
the Federal Circuit has emphasized the importance
of
“intrinsic” evidence in claim construction: the words
of
86
the claim themselves, the written description in
the
patent's specification, and, when necessary, the history of
the patent
application's prosecution before the USPTO. Id.
at 1314-17.
The
process of claim construction begins with the
language of the claims themselves.
The language of the
claim is what the patentee chose to use to
“‘particularly
point[] out and distinctly claim[] the subject
matter which
the applicant regards as his invention.‘”
Id.
at 1311-12 (quoting 35 U.S.C. § 112, ¶ 2).
Thus,
“the claims themselves provide substantial guidance as
to the
meaning of particular claim terms.” Id.
at 1314. In addition to
the particular claim being examined,
the context provided by other claims may be
helpful as well.
“For example, the presence of a dependent claim
that
adds a particular limitation gives rise to a presumption that
the
limitation in question is not present in the independent
claim.”
Id. at 1314-15.
Claim language must also be read in the
context
of the specification. Id. at 1315. As the Federal Circuit
has
made clear, “claims, of course, do not stand alone.
Rather, they are part
of ‘a fully integrated written
87
instrument,' consisting
principally of a specification that concludes
with the claims.”
Id. (quoting Markman v. Westview
Instruments, Inc., 52 F.3d 967,
978 (Fed. Cir. 1995)). “For
that reason, claims ‘must be read in
view of the specification, of
which they are a part.’” Id.
(quoting Markman,
52 F.3d at 979). The specification “is always
highly relevant to
the claim construction analysis. Usually it is dispositive;
it is the
single best guide to the meaning of a disputed term.”
Id.
(quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d
1576,
1582 (Fed, Cir. 1996)). Moreover, when the patentee “act[s]
as
his or her own lexicographer” and includes an explicit definition
of a
claim term in the specification, that definition is dispositive
over any
ordinary meaning. Id. at 1319 (internal citation and
quotation marks
omitted); see also Digital Biometrics, Inc. v. Identix,
Inc., 149 F.3d
1335, 1344 (Fed. Cir. 1998).
In relying on the specification to
interpret
claim terms, the Federal Circuit has also “repeatedly
warned
against confining the claims” to the embodiments
described in the
specification. Phillips, 415 F.3d at
1323. The mistake of
“reading a limitation from the
written description into the claims”
is “one of the
88
cardinal sins of patent law.''
Id. at 1320 (quoting
Scimed Life SyS., Inc. v. Advanced
Cardiovascular SyS., Inc.,
242 F.3d 1337, 1340 (Fed. Cir.
2001)).
Courts may also utilize the prosecution history
which
“consists of the complete record of the proceedings
before the PTO and
includes the prior art cited during the
examination of the patent.…
[T]he prosecution
history can often inform the meaning of the claim language
by
demonstrating how the inventor understood the invention
and whether the inventor
limited the invention in the
course of prosecution, making the claim scope
narrower than
it would otherwise be.” Id. at 1317 (internal
citations
omitted). However, the prosecution history “often lacks
the
clarity of the specification and thus is less useful
for claim construction
purposes,” Id.
Lastly, courts may rely on extrinsic
evidence such as dictionaries,
treatises, and expert testimony, which may serve
to provide a source
of “accepted meaning of terms used in various fields
of science
and technology,” or by providing “background on
the
technology at issue.” Id. at 1317-18. However,
such
“extrinsic” evidence is “less significant than
the
intrinsic record in determining the
89
legally operative
meaning of the claim language.”
Id. at
1317 (internal citations
and quotation marks omitted). The
use of extrinsic evidence may not be used to
contradict the
meaning of the claim terms as evidenced by the
intrinsic
evidence. Id. at 1317-19; see also Biagro W. Sales,
Inc.
v. Grow More, Inc., 423 F.3d 1296, 1302 (Fed. Cir.
2005).
2. Resolution of the disputed claim terms
a.
“DNA” and “isolated DNA”
The parties
approach the terms “DNA” and
“isolated DNA” from
opposing
perspectives.38
Plaintiffs
contend that the term
“DNA” means “a sequence of nucleic
acids, also referred to as
nucleotides” and therefore
constitutes a “nucleotide sequence”
or a
“polynucleotide.”
Pl. Br. at 10.39.
Myriad disputes Plaintiffs' definition
of
90
“DNA” insofar as Plaintiffs' definition
suggests
that the
term “DNA” refers merely to information, that
is,
“a
description of the linear order of nucleotide units that
make up
the polynucleotide.” Myriad Br. at 15. Myriad
instead argues that
“DNA” refers to “a real and tangible
molecule, a chemical
composition made up of
deoxyribonucleotides linked by a phosphodiester
backbone.”
Myriad Br. at 14.
As its name implies, DNA, or
deoxyribonucleic
acid, is an acid—a tangible, Chemical Compound.
As
Myriad correctly notes, the specifications make clear that
“DNA,”
as used in the patents, refers to the physical
manifestation of the acid, one
that may be “substantially
separated from other cellular components which
naturally
accompany a gene.“ '473 patent, col. 19:8-9;
'282
patent,
col. 19:10-11; '492 patent, col. 17:64-65. Despite
the
description of the term “DNA” set forth in the briefs,
this
understanding of the meaning of “DNA” is shared by
both
plaintiffs' and Myriad's declarants.
See Kay ¶ 125;
Linck
¶ 45; Schlessinger ¶ 12; Grody ¶ lO; Leonard ¶
30.
91
The term “isolated DNA” is defined by
Plaintiffs
as “a fragment of DNA substantially separated from
other
cellular components and other DNA.” Pl. Br. at 10. Myriad
disputes
Plaintiffs' definition insofar as it implies that
fragments of DNA exist
free-floating in the cell, separate
from other cellular components, such as
proteins and the
other DNA in the chromosome. Myriad Br. at 16. The
patent
specifications expressly define “isolated DNA” as a
DNA
molecule “which is substantially separated from other
cellular
components which naturally accompany a native
human sequence [such as] human
genome sequences and
proteins” and “includes recombinant or cloned
DNA isolates
and chemically synthesized analogs or analogs
biologically
synthesized by heterologous systems.” '473 patent,
col.
19:6-15; '282 patent, col. 19:8-18; '492 patent,
col.
17:62-18:S.
“Isolated DNA” is therefore construed to
refer to
a segment of DNA nucleotides existing separate from other
cellular
components normally associated with native DNA,
including proteins and other DNA
sequences comprising the
remainder of the genome, and includes both DNA
originating
from a cell as well as DNA synthesized through chemical
or
heterologous biological means.
92
b. “BRCA1”
and “BRCA2”
Plaintiffs define the term
“BRCA1” as “a
articular fragment of DNA found on chromosome 17
that
relates to a person's predisposition to develop breast and
ovarian
cancer.” Pl. Br. at 11. Similarly, Plaintiffs
define the te rm
“BRCA2'' as “a particular fragment of DNA
found on chromosome 13
that relate[s] to a person's
predisposition to develop breast and ovarian
cancer.” Pl.
Br. at 14. hs with Plaintiffs' proposed definition
of
“isolated DNA,” Myriad argues that these definitions
are
inconsistent with the patents' definition of “BRCAl”
and
“BRCA2” as “cancer-predisposing gene[s], some alleles
of
which cause susceptibility to breast and ovarian cancers”
because they
suggest that the BRACl and BRCA2 genes are not
integrated into a chromosome, but
are broken, detached, or
otherwise easily removed from their respective
chromosomes.
Myriad Br. at 16.
The specifications of the
patents-in-suit define
the terms “BRCAl” and “BRCA2”
as
“a human breast cancer predisposing gene … some alleles
of which
cause
93
susceptibility to cancer, in particular breast and
ovarian
cancer.” 1282 patent, col. 4:33-36; see also
'282
patent,
col. 1:22-23; '492 patent, col. 1:20-21, 4:28-29.
Further,
neither party disputes that “genes” refer to segments
of
DNA incorporated into chromosomes.
“BRCA1” is therefore
construed to refer to a
human gene, normally integrated into chromosome 17,
some
alleles of which cause susceptibility to breast and ovarian
cancer.
Similarly, “BRCA2” is construed to refer to a
human gene, normally
integrated into chromosome 13, some
alleles of which cause susceptibility to
breast and ovarian
cancer.
V. CONCLUSIONS OF LAW
The
Summary Judgment Standard
Summary judgment is granted only where
there
exists no genuine issue of material fact and the moving
arty is entitled
to judgment as a matter of law. Fed. R.
Civ. P. 56(c); see Celotex Corp. v.
Catrett, 477 U.S. 317,
322-23 (1986); SCS Commc'ns, Inc. v. Herrick
Co., 360 F.3d
329, 338 (2d Cir. 2004). The courts do not try issues
of
94
fact on a motion for Summary Judgment, but,
rather,
determine “whether the evidence presents a sufficient
disagreement
to require submission to a jury or whether it
is so one-sided that one party
must prevail as a matter of
law.” Anderson v. Liberty Lobby,
Inc.,
477 U.S. 242, 251-52 (1986).
“The party seeking
summary judgment bears the
burden of establishing that no genuine issue of
material
fact exists and that the undisputed facts establish [itsJ
right to
judgment as a matter of law.” Rodriguez v. City
of New York, 72 F.3d
1051, 1060-61 (2d Cir. 1995). In
determining whether a genuine issue of
material fact
exists, a court must resolve all ambiguities and draw
all
reasonable inferences against the moving party. See
Matsushita Elec.
Indus. Co. v. 2enith Radio Corp., 475 U.S.
574, 587-88 (1986);
Gibbs-Alfano v. Burton, 281 F.3d 12, 18
(2d Cir. 2002). However,
“the non-moving party may not
rely simply on conclusory allegations or
speculation to
avoid summary judgment, but instead must offer evidence to
show
that its version of the events is not wholly
fanciful.” Morris v.
Lindau, 196 F.3d 102, 109 (2d Cir.
1999) (internal quotation marks
omitted).
95
Summary judgment is appropriate where the
moving
party has shown that “little or no evidence may be found in
support
of the nonmoving party's case. When no rational
jury could find in favor
of the no nm oving party because the
evidence to support its case is so slight,
there is no
genuine issue of material fact and a grant of summary
judgment is
proper.” Gallo v. Prudential Residential
Servs., L.P., 22 F.3d
1219, 1223-24 (2d Cir. 1994)
(internal citations omitted).
B. 35 U.S.C.
§ 101 and Its Scope
Section 101 of Title 35, United States
Code,
provides:
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 therefore,
subject to the
conditions and
requirements of this title.
In interpreting
this language, the Supreme Court
has observed that “Congress plainly
contemplated that the
patent laws would be given wide scope.” Diamond
v.
96
Chakrabarty, 447 U.S. 303, 308 (1980); see
also J.E.M. Ag
Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc., 534 U.S.
124,
131 (2001) (“[W]e are mindful that this Court has already
spoken
clearly concerning the broad scope and applicability
of §
101.”).
However, this broad reading of § 101 and
statutory
patent eligibility is not without limits. “The
Supreme Court has
recognized that scientific principles and
laws of nature, even when for the
first time discovered,
have existed throughout time, define the relationship
of
man to his environment, and, as a consequence, ought not to
be the subject of
exclusive rights to any one person.” In
re Meyer, 688 F.2d 789,
795 (C.C.P.A. 1982) (citing Leroy
v. Tatham, 55 U.S. 155, 175 (1852)).
Specifically, the
Supreme Court has recognized three categories of
subject-
matter that fall outside the scope of sect; lOl: “The laws
of
nature, physical phenomena, and abstract ideas have been
held not
patentable.” Chakrabarty, 447 U.S. at 309;
see also Diamond v.
Diehr, 450 U.S. 175, 185 (1981).
“The rule
that the discovery of a law
of nature cannot be patented
rests, not on the notion that natural phenomena are
not
processes, but rather on the more fundamental understanding
that they are
not the kind of ‘discovery’ that
the
statute
97
was enacted to protect.” Parker v.
Flook, 431 U.S. 584,
593 (1918).
The exclusion of products
of
nature40 as
patentable subject matter
under § 101 also reflects the
Supreme Court's recognition that
‘[p]henomena of nature,
though just discovered, mental processes, and
abstract
intellectual concepts are not patentable, as they are the
basic tools
of scientific and technological work.”
Gottschalk v. Benson, 409
U.S. 63, 67 (1912). Thus, as
Justice Breyer has observed, “the reason
for this exclusion
is that sometimes too much patent protection can
impede
rather than ‘promote the Progress of Science and
useful
Arts,’ the constitutional objective of patent and
copyright
protection.” Lab. Corp. of Am. Holdings v. Metabolite
Labs.,
Inc., 548 U.S, 124, 126-21 (2006) (Breyer,
J.,
98
dissenting) (quoting U.S. Const., Art. I, § 8,
cl. 8.)
(emphasis in original). For these reasons, “manifestations
of
laws of nature [are] free to all men and reserved
exclusively to none.”
Funk Bros. Seed Co. v. Kalo
Inoculant Co., 333 U.S. 127, 130
(1948).
The inquiry into an invention's patent
eligibility is a
fundamental one, and as such, “[t]he
ob1igation to determine what type of
discovery is sought to
be patented must precede the determination of whether
that
discovery is, in fact, new or obvious.” Flook,
437 U.S. at
593; see also In re Bilski, 545 F.3d 943, 950
(Fed. Cir. 2008) (en
banc), cert. granted, 129 S. Ct. 2735 (2009)
(”Whether a claim is
drawn to patent-eligible subject
matter under § lOl is a threshold inquiry,
and any claim of
an application failing the requirements of § 101 must
be
rejected even if it meets all of the other legal
requirements of
patentability.” (citing In re Comiskey, 499
F.3d 1365, 1372 (Fed.
Cir. 2007)); Prometheus Labs. v. Mayo
Collaborative Servs., 581 F.3d
1336, 1343 (Fed. Cir. 2009)
(noting that in determining patent eligibility,
“it is
improper to consider whether a claimed element or step in a
process
is novel or nonobvious, since such considerations
are separate requirements set
forth in 35 U.S.C. §§ 102 and
99
103,
respectively.” (citing Bilski, 545 F.3d at 958)).
Consistent with
this approach, the courts have rejected
patent claims even when the purported
invention was highly
beneficial or novel, or the research and work that
went
into identifying it was costly or time-consuming. See,
e.g., Funk
Bros., 333 U.S. at 130; Am. Fruit Growers, Inc.
v. Brodgex Co., 283
U.S. 1, 11-13 (1931); Gen. Elec. Co. v_
De Forest Radio Co., 28 F.2d
641, 642-43 (3d Cir. 1928).
The distinction between the § 101
inquiry into
patentable subject matter and the other requirements
for
patentability set forth in Title 35 is of particular
importance in
evaluating the authorities cited by the
parties and the arguments presented.
The discussion of §
101 in In re Bergy, 596 F.2d 952 (C.C.P.A.
1979) by the
late Honorable Giles S. Rich, one of the authors of the
1952 Patent
Act, is particularly informative in clarifying
the proper scope of a § 10l
analysis. There, Judge Rich
stated what considerations were salient—and
importantly,
what considerations were not—in a § 101
analysis:
Section lOl states three requirements:
novelty,
utility, and statutory subject matter. The
understanding that these
three requirements are
separate and distinct is long-standing and has
been
universally accepted.… Thus, the
questions of whether a particular
invention is
100
novel or useful are
questions wholly apart from
whether the invention falls into a category
of
statutory subject matter. Of the three
requirements stated in § 101,
only two, utility
and statutory subject matter, are applied under
§
101. As we shall show, in 1952 Congress voiced
its intent to
consider the novelty of an
invention under § 102 where it is first
made
clear what the statute means by “new,”
notwithstanding the fact
that this requirement is
first named in §
101.
Id. at 960-61 (emphasis added). Judge Rich
further
cautioned that “statements in the older cases must be
handled with
care lest the terms used in their reasoning
clash with the reformed terminology
of the present statute;
lack of meticulous care may lead to distorted
legal
conclusions.” Id. at 959. The Supreme Court
subsequently
affirmed this understanding of the § 101 analysis in
Diehr,
noting that while it had been argued that “novelty is
an
appropriate consideration under § 101,”
“[t]he question
…
of whether a particular invention is novel is ‘wholly
apart from
whether from whether the invention falls into a
category of statutory subject
matter.’” 450 U.S. at 189-90
(quoting Bergy, 596 F.2d at
961); see also _Bilski,
545 F.3d at 958 (“So here, it is
irrelevant to the
§ 101 analysis
whether Applicants' claimed process is
novel or non-
obvious.”).
101
dissenting) (quoting U.S.
Const., Art. I, § 8, cl. 8.)
(emphasis in original). For these reasons,
“manifestations
of laws of nature [are] free to all men and
reserved
exclusively to none.” Funk Bros. Seed Co. v. Kalo
Inoculant
Co., 333 U.S. 127, 130 (1948).
The inquiry into an invention's
patent
eligibility is a fundamental one, and as such, “[t]he
ob1igation to
determine what type of discovery is sought to
be patented must precede the
determination of whether that
discovery is, in fact, new or obvious.”
Flook,
437 U.S. at 593; see also In re Bilski, 545 F.3d 943,
950
(Fed. Cir. 2008) (en banc), cert. granted, 129 S. Ct. 2735
(2009)
(”Whether a claim is drawn to patent-eligible subject
matter under
§ lOl is a threshold inquiry, and any claim of
an application failing the
requirements of § 101 must be
rejected even if it meets all of the other
legal
requirements of patentability.” (citing In re Comiskey,
499
F.3d 1365, 1372 (Fed. Cir. 2007)); Prometheus Labs. v.
Mayo
Collaborative Servs., 581 F.3d 1336, 1343 (Fed. Cir. 2009)
(noting that
in determining patent eligibility, “it is
improper to consider whether a
claimed element or step in a
process is novel or nonobvious, since such
considerations
are separate requirements set forth in 35 U.S.C. §§ 102
and
102
As noted, the issue presented by the instant
motions
with regpect to the composition claims is whether
or not claims directed to
isolated DNA containing
naturally-occurring sequences fall within the products
of
nature exception to § 101. Based upon the reasons set
forth below, it
is concluded that the composition claims-
in-suit are excepted.
1.
Consideration of the merits of Plaintiffs'
challenge is
appropriate.
Myriad offers several arguments for why this
Court
should not engage the substance of Plaintiffs'
claims, but should instead
dismiss them out of hand.
Foremost among them is Myriad's assertion that
Plaintiffs'
claims should be dismissed in light of the
“carefully
considered policy of the USPTO,” which is “entitled
to
great respect from the courts.” Myriad Br. at 26. In so
arguing,
Myriad notes the presumption of validity afforded
to patents, see 35
U.S.C. § 282, and the USPTO's prior
consideration of the eligibility of
gene-related patents,
see Utility Examination Guidelines 66 Fed. Reg.
1092,
1092-99 (Jan. 5, 2001), as well as the Supreme Court's
statements in
J.E.M. Ag Supply, 534 U.S. 124.
103
The Federal Circuit
has previously held that it
owes no deference to USPTO legal determinations.
See,
e.g., Arnold P'Ship v. Dudas, 362 F.3d 1338, 1340 (Fed.
Cir. 2004)
(“This court reviews statutory interpretation,
the central issue in this
case, without deference.”).
While Congress has created a presumption of
validity for
issued patents, approximately 40% of patents challenged in
the
courts have been found invalid, demonstrating that this
presumption is far from
absolute. See Institute for
Intellectual Property & Information Law,
University of
Houston Law Center, Patstats.org, Full Calendar Year
2008
Report,
http://www.patstats.org/2008_Full_Year_Posting.rev3.htm
(indicating
that 40% of all validity determinations in
federal court in 2008 found the
challenged patent invalid);
Paul F. Morgan & Bruce Stoner, Reexamination v.
Litigation
— Making Intelligent Decisions in Challenging Patent
Validity,
86 J. Pat. & Trademark Off. Soc'y 441-461 (2004)
(citing USPTO statistics
showing that 74% of patents
previously issued by the Patent Office and later
challenged
through the reexamination process were either canceled or
changed by
the USPTO). Moreover, the lack of Congressional
action to specifically prohibit
gene patents in response to
the USPTO's prior grant of such patents does
not preclude
104
their review by the courts. For example, in
Bilski, 545
F.3d 943, the Federal Circuit set out a test for
the
patentability of method claims that potentially will
invalidate thousands of
patents on business method patents,
degpite Congress' silence concerning the
patentability of
such methods. Finally, while the Supreme Court in J.E.M.
Ag
Supply noted the USPTO's practice of issuing patents on
sexually reproducing
plants in concluding that such plants
represented patentable subject matter
under § 101, that
passing observation was neither dispositive nor central
to
the Court's holding and does not establish a rule of
judicial deference to
the USPTO's practices. See J.E.M. Ag
_Supply, 534 U.S. at 144-45.
Indeed, the judicial deference
urged by Myriad is difficult to reconcile with
the courts'
consideration of the substantive issues presented in cases
such
as Chakrabarty and indeed, J.E.M. Ag
Supply
itself.
Moreover, in the absence of a § 101 challenge
to
patent validity, the fact that courts have previously
upheld the validity of
patents directed to biological
products in response to § 102 and/or §
103 challenges has
no bearing on the present inquiry. See e.g., In
re Kubin,
561 F.3d 1351 (Fed. Cir. 2009) (considering obviousness
of
claims); In re O'Farrell, 853 F.2d 894 (Fed. Cir.
1988)
105
(same). The Patent Act sets out patent invalidity
as an
issue to be raised by the parties, see 35 U.S.C. § 282, and
it
would be erroneous to treat a case involving DNA-related
patents as holding that
isolated human genes constitute
patentable subject matter under § 101.
Were that the case,
the Supreme Court could have proceeded with
its
consideration of Metabolite Labs., after it granted
certiorari and
the parties and amici had fully briefed the
issue of patentable subject matter
eligibility, rather than
dismissing certiorari as improvidently granted based on
the
parties' failure to raise the § lOl issue below. 548
U.S.
124.
Finally, Myriad's suggestion that invalidating
the
patents-in-suit would constitute an unconstitutional
taking in violation of the
Fifth Amendment of the
Constitution or a violation of the United
States'
obligations under the Agreement on Trade-Related Aspects
of
Intellectual Property Rights (“TRIPS”) is unpersuasive.
Myriad's
novel takings argument runs counter to a long
history of invalidation of patent
claims by the courts and
is unsupported by legal precedent. Similarly, Articles
8.1
and 27.3 of TRIPS permit governments to incorporate public
health concerns
into their intellectual property laws and
106
to exclude from
patentability diagnostic, therapeutic, or
surgical methods as well as particular
inventions on the
grounds of public interest. As a result, invalidation of
the
patents-in-suit would constitute neither a
constitutional violation nor a
conflict with the United
States' treaty obligations.
2.
Patentable subject matter must be “markedly
different” from a
product of nature
Supreme Court precedent has established
that
products of nature do not constitute patentable subject
matter absent a
change that results in the creation of a
fundamentally new product. In
American Fruit Growers, the
Supreme Court rejected patent claims covering
fruit whose
skin had been treated with mold-resistant borax
acknowledging that
the “complete article is not found in
nature,” and “treatment,
labor and manipulation”
went into
producing the fruit, the Court
nonetheless held that the
fruit did not become an “article of
manufacture” unless it
“possesses a new or distinctive form,
quality, or property”
compared to the naturally-occurring
article.41
283 U.S. at 11. The Court went on to
observe:
107
Manufacture implies a change, but every
change is
not manufacture, and yet every change in an
article is the result of
treatment, labor, and
manipulation. But something more is
necessary.…
There must be transformation; a new and
different article
must emerge having a
distinctive name, character, or
use.
Id. at 12-13 (quoting Annheuser-Busch Brewing
Ass'n v.
United States, 207 U.S. 556, 562 (1908)) (internal citation
and
quotation marks omitted).
Similarly, in Funk Brothers, the
Supreme Court
considered whether a mixture of several
naturally-occurring
species of bacteria was
patentable.42
333 U.S. at 128-31.
Each species of
bacteria in the mixture could extract
nitrogen from the air for plant usage.
While the patent
holder had created a mixture by selecting and testing
for
strains of bacteria that did not mutually inhibit
one
108
another, the Court concluded that the patent holder
“did
not create a state of inhibition or of non-inhibition in
the
bacteria. Their qualities are the work of nature.
Those qualities are of course
not patentable.” Id. at 130.
Most recently, the Supreme
Court addressed the
application of § 101 to product claims in Diamond
v.
Chakrabarty, 447 U.S. 303. In Chakrabarty, the Court
considered
whether a “live, human-made micro-organism is
patentable subject matter
under 35 U.S.C. § 101.”
Id. at 305. The microorganism in
question was a bacterium that
had been genetically engineered to break down
multiple
components of crude oil and possessed considerable utility
in the
treatment of oil spills. Id. In concluding that
the man-made bacterial
strain was patentable, the Court
observed that the claim “is not to a
hitherto unknown
natural phenomenon, but to a nonnaturally occurring
manufacture
or composition of matter—a product of human
ingenuity ‘having a
distinctive name, character [and]
use.’” Id. at 309-10
(quoting
Hartranft v. Wiegmann, 121
U.S. 609, 615 (1887)). The Court
went on to contrast the
Chakrabarty bacterium with the bacterial mixture at
issue
in Funk Brothers, stating that in Chakrabarty's case,
“the
patentee has produced a new bacterium with
markedly
109
different characteristics from any found in
nature and one
having the potential for significant utility. His
discovery is
not nature's handiwork, but his own.…”
Id. at
310.43
This requirement that an invention
possess
“markedly different characteristics” for purposes of §
101
reflects the oft-repeated requirement that an invention
have “a new or
distinctive form, quality, or property” from
a product of nature. Am.
Fruit Growers, 283 U.S. at 11; In
re Merz, 97 F.2d 599, 601
(C.C.P.A. 1935) (“[M]ere
purification of known materials does not result
in a
patentable product,” unless “the product obtained in such
a
case had properties and characteristics which were
different in kind from
those of the known product rather
than in degree.”).
Courts have
also specifically held that
“purification” of a natural compound,
without more, is
insufficient to render a product of nature patentable.
In
The American Wood-Paper Co. v. The Fibre Disintearating
Co., 90 U.S.
(23 Wall.) 566 (1874), the Supreme Court held
110
that
refined cellulose, consisting of purified pulp derived
from wood and vegetable,
was unpatentable because it was
“an extract obtained by the decomposition
or disintegration
of material substance.” Id. at 593. As the
Court
observed:
There are many things well known and valuable
in
medicine or in the arts which may be extracted
from divers[e] substances.
But the extract is
the same, no matter from what it has been taken
A process to
obtain it from a subject from which
it has never been taken may be the creature
of
invention, but the thing itself when obtained
cannot be called a new
manufacture.
Id. at 593-94.44
Similarly, in Cochrane v. Badische
Anilin
& Soda Fabrik, 111 U.S. 293 (1884), the Court rejected a
patent
on an artificial version of a natural red dye called
alizarine that was produced
by manipulating another
compound through acid, heat, water or distillation.
See
generally, _id. Although the artificial version of the dye
was of a
brighter hue than the naturally occurring dye, the
Court concluded that
“[c]alling it artificial alizarine did
not make it a new composition of
matter, and patentable as
such.…” Id. at 311
(citing
Am. Wood-Paper, 90 U.S.
(23 Wall.) at
593).
111
In General Electric, 28 F.2d at 642, the
Third
Circuit Court of hppeals considered the patentability of
purified
tungsten, which possessed superior characteristics
and utility over its brittle,
naturally-occurring form.
The court first noted that “[i]f it is a natural
thing then
clearly, even if [the patentee] was the first to uncover it
and bring
it into view, he cannot have a patent for it
because a patent cannot be aHarded
for a discovery or for a
product of nature, or for a chemical element.”
Id. The
court went on to state:
Naturally He inquire
who created pure tungsten.
Coolidge? No. It existed in nature and
doubtless
has existed there for centuries. The
fact that no one before Coolidge found it
there
does not negative its origin or existence.
The second part of the
claim reads: “Having
ductility and high tensile strength.”
Did
Coolidge give those qualities to “substantially
pure tungsten”?
We think not for it is now
conceded that tungsten pure is ductile cold. If
it
possess that quality now it is certain that it
possessed it
always.
Id. at 643. The Court of Customs and Patent
Appeals
(“C.C.P.A.“), the precursor to the Federal Circuit Court
of
112
Appeals,45
subsequently relied on General
Electric in
rejecting patents claiming purified uraniwn and vanadium.
See
In re Marden, 47 F.2d 957, 957-58 (C.C.P.A. 1931)
(“Marden
I”); In re Marden, 47 F.2d 958,
1059 (C.C.P.A.
1931)
(“Marden II”) (“The quality of
purity of vanadium
or
its ductility is a quality of a natural product and as such
is not
patentable.”). Similarly, in Ex Parte Latimer, the
Patent
Commissioner refused to allow a patent on pine
needle fibers that were better
suited for textile
production, even though it was necessary to remove the
needle
from its sheath and other resinous material. 1889
Dec. Comm'r Pat. 123, 125
(1889) (“Nature made them so and
not the process by which they are taken
from the leaf or
needle.”).
Myriad argues that purification of
“‘naturally
occurring’ compounds that ‘do not exist in
nature in pure
form’ renders such compounds patent-eligible.”
Myriad Br.
at 21 (quoting In re Bergstrom, 427 F.2d 1394,
1401
(C.C.P.A. 1970)). However, Myriad cites no Supreme
Court
113
authority that would rebut the authorities presented
by
Plaintiffs, nor do the cited cases support
Myriad's
position.
Myriad has relied heavily on the holding of
the
Honorable Learned Hand in Parke-Davis & Co. v. H.K. Mulford
Co.
189 F.2d 95
(S.D.N.Y. 1911).46
In
Parke-Davis, Judge
Land considered a challenge to the validity of a
patent
114
claiming an adrenaline compound that had been
isolated and
purified from animal suprarenal glands. Id. at 97. It
had
been known that suprarenal glands in powdered form had
hemostatic,
blood-pressure-raising and astringent
properties, but could not be used for
those purposes in
gross form. The isolated adrenaline, however, possessed
the
desired therapeutic properties and could be
administered to
humans.
Although Myriad argues that the holding in
Parke-Davis
establishes that the purification of a natural
product necessarily renders it
patentable, the opinion,
read closely, fails to support such a conclusion.
The
question before the court in Parke-Davis was one of novelty
(a
modern-day § 102 question), not of patentable subject
matter (the §
lOl question before this Court). In framing
the issue, Judge Hand observed
that, “[the validity of the
claims] is attacked, first, because they are
anticipated in
the art; and second, for a number of technical
grounds
which I shall take up in turn.” Id. at 101
(emphasis
added). He went on to conclude that the patented purified
extract was
not, in fact, different from the prior art
“only for a degree of
purity,” but rather was a different
chemical substance from that found in
the prior art. Id.
115
at 103 (observing that
“no one had ever isolated a
substance [adrenaline] which was not in salt
form” and that
“the [claimed] base [form of adrenaline] was an
original
production of [the patentee's]”). Thus, Judge Hand held
that the
purified adrenaline was not anticipated by the
prior art, namely, the ground
paradrenal gland that was
known to possess certain beneficial properties.
See Merck
& Co. v. Olin Mathieson Chem. Corp., 253 F.2d 156, 162
(4th
Cir. 1958) (“It was further held [in Parke-Davis] that
the
invention was not anticipated, though the principle was
known to exist in
the suprarenal glands.”).
Only after concluding that the claimed
purified
adrenaline was novel over the prior art did Judge Hand
Offer, as dicta,
the statement to Which Myriad cites: “But,
even if it were merely an
extracted product without change,
there is no rule that such products are not
patentable.”
Id. at 103. While the accuracy of this statement at
the
time was written is dubious in light of American Wood-Paper
(to which
Judge Hand did not cite) it is certainly no
longer good law in light of
subsequent Supreme Court cases,
which, as noted above, require that a claimed
invention
possess “markedly different characteristics” over
products
existing in nature in order for it to constitute
patentable
116
subject matter.47
Chakrabarty, 447 U.S. at 310;
see also
Funk Bros., 333 U.S. at 130-32. By the same token, Judge
Hand's
suggestion that a claimed invention was patentable
since it was a “new
thing commercially and
therapeutically,” Parke-Davis, 189 F.2d at
103, is firmly
contradicted by subsequent case law establishing that
“it
is improper to consider whether a claimed element or step
in a process
is novel or nonobvious, since such
congiderations are separate
requirements” when evaluating
whether a claim is patent-eligible subject
matter.
Prometheus, 581 F.3d at 1343; see also Bergy, 596 F.2d
at
960-61. Such an approach would also be inconsistent with
the Supreme Court's
rejection of the patentability of the
commercially useful mixture of bacteria in
Funk Brothers,
the refined cellulose in American Wood-Paper, and
the
electromagnetic communication devices in O'Reilly v. Morse,
56 U.S.
(15 How.) 62 (1853).
The distinction between considerations of
novelty
and patentable subject matter similarly undermines Myriad's
reliance on
Bergstrom and In re Kratz, 592 F.2d 1169
(C.C.P.A. 1979), both of
which presented issues of novelty
117
and anticipation rather
than the question of patentable
subject matter. In Bergstrom, the
C.C.P.A. considered an
appeal from a rejection by the Board of Patent
and
Interferences (“BPAI”) of a patent claiming the
purified
rostaglandins PGE2 and PGE3 that had
been
extracted from
human or animal prostate glands. 427 F.2d at 1398.
Although
the BPAI cited § 101 in its rejection, the
C.C.P.A. recognized the issue as
a § 102 question of
novelty. Id. at 1400 (“Tested by the
conventional
evidentiary criteria or ‘conditions for
patentability’
relevant to the present factual situation which
Congress
has expressed in the various provisions of 35 U.S.C. §
102,
appellants are undoubtedly correct, for the Patent Office
has not been able
to … establish that the claimed
subject matter lacks
'novelty.’”);
see also id. at 1401
(“[T]he fundamental
error in the board's position, as we
see it, is the analysis and answer it gave
to the sole
issue it accurately posed - whether the claimed pure
materials are
novel as compared with the less pure
materials of the reference.”
(internal citation and
uotation marks omitted)). Indeed, the C.C.P.A. itself
has
subsequently recognized that Bergstrom is properly viewed
as a case
concerning novelty. Bergy, 596 F.2d at 961
(“Our research has
disclosed only two instances in which
118
rejections for lack
of novelty were made by the PTO under §
101.… In In re
Berastrom we in effect treated the
rejection as if it had been made under
§ 102, obServing in
the process that ‘The word “new” in
§ 101
is defined and to
be construed in accordance with the provisions
of
§ 102.’”
(internal citation
omitted)).
Kratz examined the rejection of a patent claiming
a
substantially purified chemical compound naturally
occurring in strawberries,
called 2-methyl-2-pentenoic acid
(“2M2PA”). 592 F.2d at 1170. The
patentee had appealed
from the BPAI's determination that the purified
compound
was obvious over the prior art under § 103. See
_id.
Although there was some discussion about whether the
composition
claimed was a naturally-occurring compound, the
C.C.P.A. did not view the
question before it as a § 101
inquiry. Instead, the court treated the
appeal as a
question of novelty and anticipation pursuant to §
102.48
See, e.g., id. at 1174
(“It should be clear that an
119
anticipation rejection
in such a case is necessarily based
on a dual
footing.”).49
Finally, Merck & Co.,
Inc. v. Olin Mathieson
Chem. Corp., 253 F.2d 156, cited by Myriad, is
entirely
consistent with the principle set forth in Funk Brothers
and
American Fruit Growers that something derived from a
product of nature
must “possess a new or distinctive form,
quality, or property” in
order to become patentable subject
matter. Am. Fruit Growers, 283 U.S.
at 11.
In Merck, the
Fourth Circuit considered the validity of a patent
claiming
a Vitamin B12 composition useful for treating
pernicious
anemia. Id. at 157. Although naturally occurring
Vitamin
B12 produced in cows had known therapeutic properties and
was
commercially available, the court found the purified B12
Compositipn,
which was obtained from a microorganism,
patentable. In upholding the validity
of the patent, the
court held:
Every slight step in
purification does not
produce a new product. What is gained may be
the
120
old product, but with a greater
degree of purity.
Alpha alumina purified is still alpha alumina, In
re
Ridgway, 76 F.2d 602,[] and ultramarine from
which floatable impurities have
been removed is
still ultramarine, In re Merz, 97 F.2d 599
…
Id. at 163. Because the court concluded that
the purified
B12 was more than a “mere advance in the degree
of
purity of
a known product,” it determined that the claimed invention
was
entitled to patent protection. Id. at 164.
In sum, the clear
line of Supreme Court precedent
and accompanying lower court authorities,
stretching from
American Wood-Paper through to Chakrabarty,
establishes
that purification of a product of nature, without more,
cannot
transform it into patentable subject matter.
Rather, the purified product must
pogsess “markedly
different characteristics” in order to satisfy
the
requirements of § 101.
3. The claimed isolated DNA is not
“markedly different”
from native DNA
The question thus
presented by Plaintiffs'
challenge to the composition claims is whether the
isolated
DNA claimed by Myriad possesses “markedly
different
121
NOTES
25
The USPTO granted these patents pursuant
to a formal written policy
that permits the patenting of “isolated and
purified” DNA encoding
human genes and pursuant to a practice that permits
such DNA patents
and the patenting of correlations created by nature between
natural
elements of the body and a predisposition to disease. See
Utility
Examination Guidelines, 66 Fed. Reg. 1,093 (Jan. 5, 2001).
26
For purposes of understanding what the
claim terms would have meant
to a person of ordinary skill in the art at the
time of the application
for the patents, an application date of August 1994 is
presumed for the
'282, '473, '999, '001, and '441
patents and
December 1995 for the '492
and '857 patents.
27
Claim 2 of the '282 patent reads:
“The isolated DNA of claim 1,
wherein said DNA has the nucleotide sequence
get forth in SEQ ID NO:1.”
28
Claim 5 of the '282 patent claims:
“An isolated DNA having at least
15 nucleotides of the DNA of claim
1.”
Claim 6 of the '282 patent reads: “An isolated DNA
having
at least 15
nucleotides of the DNA of claim 2.”
29
Claim 7 of the '282 patent reads:
“An isolated DNA selected
from the
group consisting of: (a) a DNA having
the nucleotide sequence get forth
in SEQ ID NO:1 having T at nucleotide position
4056; (b) a DNA having
the nucleotide sequence set forth in SEQ ID NO:1 having
an extra C at
nucleotide position 5385; (c) a DNA having the nucleotide
sequence set
forth in SEQ ID NO:1 having G at nucleotide position 5443; and (d)
a
DNA having the nucleotide sequence set forth in SEQ ID NO:1 having 11
base
pairs at nucleotide positions 189-199 deleted.”
Claim 1 of the '473
patent reads: “An isolated DNA comprising an
altered BRCA1 DNA having at
least one of the alterations set forth in
Tableg 12A, 14, 18 or 19 with the
proviso that the alteration is not a
deletion of four nucleotides corre9ponding
to base numbers 4184-4187 in
SEQ. ID. NO:1.”
30
Claim 1 of the '492 patent reads:
“An isolated DNA molecule
coding for a BRCA2 polypeptide, said DNA
molecule comprising a nucleic acid
sequence encoding the amino acid sequence set
forth in SEQ ID NO:2.”
31
Claim 6 of the '492 patent reads:
“An isolated DNA
molecule coding
for a mutated form of the BRCA2
polypeptide set forth in SEQ ID NO:2,
wherein said mutated form of the BRCA2
polypeptide is associated with
susceptibility to cancer.”
32
32 claim 7 of the '492 patent reads:
“The isolated DNA
molecule of claim
6, wherein the DNA molecule comprises
a mutated nucleotide gequence set
forth in SEQ ID cNO:1.”
33
Claim 1 of the '001 patent reads:
“A method for screening a tumor
semple from a human subject for a somatic
alteration in a BRCA1 gene in
said tumor which comprises gene comparing a first
sequence selected
form [sic] the group consisting of a BRCA1 gene from said
tumor sample,
BRCA1 RNA from said tumor sample and BRCA1 cDNA made from mRNA
from
said tumor sample with a second sequence selected from the group
consisting
of BRCA1 gene from a nontumor sample of said subject, BRCA1
DNA from said
nontumor sample and BRCA1 cDNA made from mRNA from said
nontumor sample, wherein
a difference in the sequence of the BRCA1
gene, BRCA1 RNA or BRCA1 cDNA from
said tumor sample from the sequence
of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA
from said nontumor sample
indicates a somatic alteration in the BRCA1 gene in
said tumor sample.”
34
Claim 1 of the '441 patent reads:
“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
samp1e 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.”
Claim 1 of the '857 patent claims: “A method for
identifying
a mutant
BRCA2 nucleotide sequence in a suspected mutant BRCA2
allele which
comprises comparing the nucleotide sequence of the suspected
mutant
BRCA2 allele with the wild-type BRCA2 nucleotide sequence, wherein
a
difference between the suspected mutant and the wild-type sequences
identifies
a mutant BRCA2 nucleotide sequence.”
35
Claim 2 of the '857 patent reads:
“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.”
36
Claim 20
of the '282 patent reads: “A method for screening
potential cancer
therapeutics which comprises: growing a transformed
eukaryotic host cell
containing an altered BRCA1 gene causing cancer n 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.”
37
In addition to the claim terms discussed
below, the parties also
dispute the proper interpretation of the method
claims—i.e.,
whether they may be construed to encompass certain
transformative steps.
Because this issue is broader in scope than simple claim
term
definition, it is addressed infra in Section VII.D.
38
The degree to which the parties actually
disagree on the meaning of
the discussed claim terms is unclear; however, to the
extent some
digagreement has been noted by the parties, this section seeks
to
resolve them.
39
For purposes
of this opinion, “Pl. Br.” refers to
Plaintiffs' Memorandum of
Law in Support of Motion for Summary Judgment;
“Myriad Br.” refers
to Myriad Defendants' Memorandum
of Law (l) in Support of Their Motion for
Summary Judgment and (2) in
Opposition to Plaintiffs' Motion for Summary
Judgment;
“Pl. Reply” refers to the Memorandum of
Law (l) in Further
Support of Plaintiffs' Motion for Summary Judgment
ngainst All Defendants
and (2) in Opposition to the Myriad Defendants'
Motion for Summary Judgment
and (3) in Opposition to Defendant United
States Patent and Trademark
Office's Motion for Judgment on the
Pleadings; “Myriad Reply”
refers to Myriad Defendants'
Memorandum in Reply to Plaintiffs'
Opposition to Myriad Defendants'
Motion for
Summary Judgment; and
“USPTO Reply” refers to the
Reply Memorandwn of Law in Further
Support of Defendant United States
Patent and Trademark Office's Motion for
Judgment on the Pleadings
and in Opposition to Plaintiffs' Motion for
Summary Judgment.
40
Myriad
distinguishes between “laws of nature,”
”natural
phenomena,”
and “abstract ideas,” which it concedes are not
patentable, and
“products of nature,” for which it appears to argue
no
prohibition to
patentability exists. Although the digtinction between these
two
categories is unclear, it is well established that
“products of
nature”
are not patentable. See e.g., Chakrabarty, 447 U.S. at 13
(stating
that relevant distinction for § 101 patentability
is
“between products
of nature, whether living or not, and human-made
inventions”);
Gen. Elec. Co. v. De Forest Radio Co., 28 F.2d 641,
642 (3d Cir. 1928)
(noting that “a patent cannot be awarded for a
discovery or for a
product of nature, or for a chemical element”);
In
re Marden, 47 F.2d 957, 957 (C.C.P.A. 1931) (concluding
that
“[u]ranium is a product of
nature, and the appellant is not entitled
to a patent on the same, or
upon any of the inherent natural qualities of that
metal”); In re
Marden, 47 F.2d 958, 959 (C.C.P.A. 1931) (stating
that
“pure vanadium
is not new in the inventive sense, and, it being a
product of nature,
no one is entitled to a monopoly of the
same.”).
41
Myriad argues
that American Fruit Growers was decided on novelty
grounds, rather than
subject matter patentability. See Myriad Br. at
26. However, the Court's
novelty discussion was restricted to its
analysis of the process claims. Am.
Fruit Growers, 283 U.S. at 13-14
(“If it be assumed that the process
claims under consideration cover an
invention, we think this lacked novelty when
application was made for
the patent August 13, 1923”). In contrast, its
rejection of the
composition claims was based on an analysis of subject
matter
patentability. See id. at 11 (“Is an orange,
the rind of
which has
become impregnated with borax, through immersion in a solution,
and
thereby resistant to blue mold decay, a ‘manufacture,’
or
manufactured
article, within the meaning of section 31, title 35, U.S.
Code?”).
42
Myriad suggests
that the Supreme Court's holding in
Funk Brothers was
premised on an
obviousness determination, rather than patentable
subject matter. Subsequent
Supreme Court opinions, however, have
treated the holding in Funk
Brothers as a statement of patentable
subject matter. See
Chakrabarty, 447 U.S. at 309-lO;
F1ook, 437 U.S.
at 591-92;
Benson, 409 U.S. at 67-68.
43
Although Chakrabarty is often cited
for the proposition that
“anything under the sun that is made by
man” is patentable,
id. at 309,
that phrase is a misleading
quotation from the legislative history of
the Patent Act of 1952. The full
quote clearly acknowledges the
statutory limitations to patentable subject
matter: “A person may have
‘invented’ a machine or a
manufacture, which may include
anything under
the sun made by man, but it ig not
necessarily patentable under section
101 unless the conditions of the title are
fulfilled.” H.R. Rep. No.
1923, 82d Cong., 2d Sess. 6 (1952).
44
Given the posture of the challenge to the
patent's validity, the
Court rested its holding on the fact that the patent in
question was
invalid as non-novel. Id.
45
The decisions of the C.C.P.A. remain
binding precedent in patent
cases. See South CorD. v. Untted States, 690
F.2d J368, 1370-71 (Fed.
Cir. 19B2) (en banc) (adopting “[t]hat body of
law represented by the
holdings of … the Court of Customs and Patent
Appeals&rellip; as
“precedent” for the then-new Federal Circuit so
as to
“continu[el the
stability in those areas of the law previously
within the jurisdiction
of our predecessor courts”).
46
The invocation of Judge Hand is frequently
practiced in this Circuit.
See, e.g.,United States v. Rigas, 583 F.3d
108, 121 n.3 (2d Cir. 2009)
(quoting Learned Hand for the proposition that
appellate cour [ Reply to This | Parent | # ]
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old product, but with a greater degree of purity.
Alpha alumina
purified is still alpha alumina, In
re Ridgway, 76 F.2d 602,[] and
ultramarine from
which floatable impurities have been removed is
still
ultramarine, In re Merz, 97 F.2d 599
…
Id. at 163. Because the court concluded that
the purified
B12 was more than a “mere advance in the degree
of
purity of
a known product,” it determined that the claimed invention
was
entitled to patent protection. Id. at 164.
In sum, the clear
line of Supreme Court precedent
and accompanying lower court authorities,
stretching from
American Wood-Paper through to Chakrabarty,
establishes
that purification of a product of nature, without more,
cannot
transform it into patentable subject matter.
Rather, the purified product must
pogsess “markedly
different characteristics” in order to satisfy
the
requirements of § 101.
3. The claimed isolated DNA is not
“markedly different”
from native DNA
The question thus
presented by Plaintiffs'
challenge to the composition claims is whether the
isolated
DNA claimed by Myriad possesses “markedly
different
121
characteristics” from a product
of
nature.50
Chakrabarty,
447 U.S.
at 310. In support of its position, Myriad cites
several differences between
the isolated DNA claimed in the
patents and the native DNA found within human
cells. None,
however, establish the subject matter patentability of
isolated
BRCA1/2 DNA.
The central premise of Myriad's argument that
the
claimed DNA is “markedly different” from DNA found in
nature is
the assertion that “[i]solated DNA molecules
should be treated no
differently than other chemical
compounds for patent eligibility,” Myriad
Br. at 26, and
that the alleged “difference in the structural
and
functional properties of isolated DNA” render the claimed
DNA
patentable subject matter, Myriad Br. at 31.
Myriad's focus on the
chemical nature of DNA,
however, fails to acknowledge the unique characteristics
of
DNA that differentiate it from other chemical compounds.
As Myriad's expert
Dr. Joseph Straus observed: “Genes are
of double nature: On the one hand,
they are chemical
substances or molecules. On the other hand, they
are
122
physical carriers of information, i.e., where the
actual
biological function of this information is coding for
proteins. Thus,
inherently genes are multifunctional.”
Straus Decl ¶ 20; see
also The Cell at 98, 104
(“Today the
idea that DNA carries
genetic information in its long chain
of nucleotides is so fundamental to
biological thought that
it is sometimes difficult to realize the
enormous
intellectual gap that it filled.…
DNA is relatively
inert
chemically.”); Kevin Davies & Michael White,
Breakthrough: The Race
to Find the Breast Cancer Gene 166
(1996) (noting that Myriad Genetics'
April 1994 press
release described itself as a “genetic
information
business”) . This informational quality is unique among
the
chemical compounds found in our bodies, and it would be
erroneous to view
DNA as “no different[]” than other
chemicals previously the subject
of
patents.51
123
Myriad's argument
that all chemical compounds,
such as the adrenaline at issue in
Parke-Davis, necessarily
conveys some information ignores the biological
realities
of DNA in comparison to other chemical compounds in the
body. The
information encoded in DNA is not information
about its own molecular structure
incidental to its
biological function, as is the case with adrenaline or
other
chemicals found in the body. Rather, the information
encoded by DNA reflects
its primary biological function:
directing the synthesis of other
molecules in the body -
namely, proteins, “biological molecules of
enormous
importance” which “catalyze biochemical reactions”
and
constitute the “major structural materials of the animal
body.”
O'Farrell, 854 F.2d at 895-96. DNA, and in
particular the ordering of its
nucleotides, therefore
serves as the physical embodiment of laws of
nature—those
that define the construction of the human body.
Any
“information” that may be embodied by adrenaline and
similar
molecules serves no comparable function, and none
of the declarations submitted
by Myriad support such a
conclusion. Consequently, the use of simple
analogies
comparing DNA with chemical compounds previously the
subject of
patents cannot replace consideration of the
distinctive characteristics of
DNA.
124
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
BRCAI/2 DNA and the isolated
BRCAI/2 DNA claimed in the
patents-in-suit render the claimed DNA
“markedly
different.” This conclusion is driven by the
overriding
importance of DNA's nucleotide sequence to both its
natural
biological function as well as the utility associated with
DNA in its
isolated form. 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.
Myriad argues that the § 101 inquiry into the
subject
matter patentability of isolated DNA should focus
exclusively on the differences
alleged to exist between
native and isolated DNA, rather than considering
the
similarities that exist between the two forms of DNA.
See, e.g.,
Myriad Reply at 8-9 (“[T]he observation
that isolated
DNA and native DNA
share this single property [i.e. the
same protein coding sequences] is
irrelevant to the
critical issue of whether there are differences in
their
125
properties. It is the differences that are
legally
relevant to the novelty inquiry under Section 101, not the
properties
held in common.” (emphasis in original)); Myriad
Br. at 8. Setting aside
the fact that considerations such
as novelty are irrelevant for § 101
purposes, see Bergy,
596 F.2d at 960-61, Myriad offers no authorities
supporting
such an approach. To the contrary, the Supreme Court has
held that
“[i]n determining the eligibility of [a] claimed
process for patent
protection under § 101, [the] claims
must be considered as a whole.”
Diehr, 450 U.S. at 188.
Similarly, the Federal Circuit has expressly held
that
“[i]n the final analysis under § 101, the claimed
invention, as
a whole, must be evaluated for what it is.”
In re Grams, 888 F.2d
835, 839 (Fed. Cir. 1989) (quoting In
re Abele, 684 F.2d 902, 907
(C.C.P.A. 1982)).
Were Myriad's approach the law, it is difficult
to
discern how any invention could fail the test. For
example, the bacterial
mixture in Funk Brothers was
unquestionably different from any
preexisting bacterial
mixture; yet the Supreme Court recognized that a
patent
directed to the mixture, considered as a whole, did no more
than patent
“the handiwork of nature.” 333 U.S. at 131.
There will almost
inevitably be some identifiable
126
differences between a
claimed invention and a product of
nature; the appropriate § 101 inquiry is
whether,
considering the claimed invention as a whole, it is
sufficiently
distinct in its fundamental characteristics
from natural phenomena to possess
the required “distinctive
name, character, [and] use.”
Chakrabarty, 447
U.S. at 309-10.
None of Myriad's arguments
establish the
distinctive nature of the claimed DNA. Myriad's argument
that
association of chromosomal proteins with native DNA
establishes the existence of
“structural differences”
between native and isolated DNA relies on
an incorrect
comparison between isolated DNA and chromatin, which
are
indeed different insofar as chromatin includes chromosomal
proteins normally
associated with DNA. The proper
comparison is between the claimed isolated DNA
and the
corresponding native DNA, and the presence or absence of
chromosomal
proteins merely constitutes a difference in
purity that cannot serve to
establish subject matter
patentability.
See Gen. Elec., 28 F.2d at
642-43; Marden
I, 47 F.2d at 957-58; Marden II, 47 F.2d at
1059.
127
Myriad also attempts to rely on its assertion
that
native DNA contains intron sequences that are absent
in the claimed
BRCAI/2 DNA. However, some of the claims,
such as claim 1 of the
'282 patent, are directed broadly to
DNA “coding for a BRCA1
polypeptide.” Native BRCA1 DNA, by
definition, encodes the BRCA1
protein; thus claim 1 of the
'282 patent would cover purified BRCA1
DNA possessing the
exact same structure found in the human cell, introns
and
all.52
See also '492
patent, claim 1 (similarly claiming
isolated DNA “coding for a BRCA2
polypeptide”). In
addition, several of the composition claims are
directed to
isolated DNA containing as few as 15 nucleotides of the
BRCA1
coding sequence, see, e. g.,
'282 patent, claims 5 &
6, and at
least some of these short DNA sequences will be
found within a single exon of
the native BRCA1 gene
sequence. See Adam Pavlicek, et al.,
Evolution of the
Tumor Suppressor BRCA1 Locus in Primates:
Implications for
Cancer Predisposition, 13 Human Molecular Genetics
2737,
2737 (2004) (noting BRCA1 exons range from 37 to 3427
nucleotides in
length). Therefore, for these small DNA
fragments, the existence of introns in
native BRCA1 DNA is
completely irrelevant to the question of
structural
128
differences when comparing these short DNA
molecules with
native BRCAI DNA.
More generally, the fact that the
BRCAI/2 cDNA
molecules covered by the composition claims-in-suit
contain
only the protein coding exons and not the introns found in
native DNA
does not render these cDNAs and their native
counterparts “markedly
different.” The splice variants
represented by these cDNAs are the result
of the naturally-occurring
splicing of pre-mRNA into mature mRNA.
Therefore, not
only are the coding sequences contained in
the claimed DNA identical to those
found in native DNA, the
particular arrangement of those coding sequences is
the
result of the natural phenomena of RNA splicing. Finally,
at least in the
case of BRCA1, the claimed cDNA sequences
are actually found in the human
genome in the form of a
naturally occurring pseudogene. See Mason Supp.
Decl.
¶ 18.53
129
Myriad's argument
that the functional differences
between native and isolated DNA demonstrates
that they are
“markedly different” relies on the fact that isolated
DNA
may be used in applications for which native DNA is
unsuitable, namely, in
“molecular diagnostic tests (e.g.,
as probes, primers, templates for
sequencing reactions), in
biotechnological processes (e.g. production of pure
BRCA1
and BRCA2 protein), and even in medical treatments
(e.g.
gene therapy).” Myriad Reply at 9; see also Myriad Br.
at
30-32.
Isolated DNA's utility as a primer or a molecular
probe (for
example, for Southern blots) arises from its
ability to “target and
interact with other DNA molecules,”
that is, the ability of a given DNA
molecule to bind
exclusively to a specific DNA target sequence. Myriad Br.
at
33; see Kay Decl. ¶ 138. Thus, for example, a 24
nucleotide segment
of isolated BRCA1 DNA can be used as a
primer because it will bind only
to its corresponding
location in the BRCAl gene. However, the basis for
this
utility is the fact that the isolated DNA possesses the
identical
nucleotide sequence as the target DNA
sequence,54
130
thus allowing
target specific hybridization between the DNA
primer and the portion of the
target DNA molecule
possessing the corresponding sequence. Kay Decl.
¶¶
135-36, 138. In contrast, another 24 nucleotide segment of
DNA
possessing the same nucleotide composition but a different
nucleotide
sequence would not have the same utility because
it would be unable to hybridize
to the proper location in
the BRCA1
gene.55
Indeed, Myriad implicitly
acknowledges
this fact when it states that the usefulness of isolated
DNA
molecules “is based on their ability to target and
interact with other DNA
molecules, which is a function of
their own individual structure and
chemistry.”
Myriad Br.
at 33 (emphasis added). Therefore, the cited
utility of
the isolated DNA as a primer or probe is primarily a
function of the
nucleotide sequence identity between native
and isolated BRCA1/2
DNA.
Similarly, the utility of isolated DNA as a
sequencing target
relies on the preservation of native
DNA's nucleotide sequence. Indeed, one
need look no
further than Myriad's BRACAnalysis testing, which relies on
the
sequencing of isolated DNA (i.e. the PCR amplified
131
exons
of BRCA1/2) , to determine the sequence of the
corresponding DNA coding
sequences found in the cell. The
entire premise behind Myriad's genetic testing
is that the
claimed isolated DNA retains, in all relevant respects,
the
identical nucleotide sequence found in native DNA. The use
of isolated
BRCA1/2 DNA in the production of BRCA1/2
proteins or in gene therapy also
relies on the identity
between the native DNA sequences and the
sequences
contained in the isolated DNA molecule. Were the
isolated
BRCA1/2 sequences different in any significant way, the
entire
point of their use—the production of BRCA1/2
proteins—would be
undermined.
While the absence of proteins and other
nucleotide
sequences is currently required for DNA to be
useful for the cited purposes, the
purification of native
DNA does not alter its essential
characteristic—its
nucleotide sequence—that is defined by nature and
central
to both its biological function within the cell and its
utility as a
research tool in the lab. The requirement
that the DNA used be
“isolated” is ultimately a
technological limitation to the use of
DNA in this fashion,
and a time may come when the use of DNA for molecular
and
diagnostic purposes may not require such purification.
The
132
nucleotide sequence, however, is the
defining
characteristic of the isolated DNA that will always be
required to
provide the sequence-specific targeting and
protein coding ability that allows
isolated DNA to be used
for the various applications cited by Myriad. For
these
reasons, the use of isolated DNA for the various purposes
cited by Myriad
does not establish the existence of
differences “in kind” between
native and isolated DNA that
would establish the subject matter patentability of
what is
otherwise a product of nature.
See Am. Fruit Growers, 283 U.S. at
11.
Finally, the isolated BRCA1/2 DNA claimed in
Myriad's patents
bears comparison to the bacterial mixture
in Funk Brothers. In
explaining why the claimed mixture of
bacteria did not constitute an invention,
the Court
observed that the first part of the claimed invention was
the
“[d]iscovery of the fact that certain strains of each
species of these
bacteria can be mixed without harmful
effect to the properties of either”
which was “a discovery
of their qualities of non-inhibition. It is no
more than
the discovery of some of the handiwork of nature and hence
is not
patentable.” 33 U.S. at 131. The Court went on to
observe that the second
part of the claimed invention was
133
“[t]he aggregation
of select strains of the several species
into one product[, ] an application of
that newly-discovered
natural principle. But however ingenious the
discovery of
that natural principle may have been, the
application of it is hardly more than
an advance in the
packaging of the inoculants.”
Id.
According to Myriad, the invention claimed in its
patents
required the identification of the specific
segments of chromosomes 17 and 13
that correlated with
breast and ovarian cancer (BRCA1 and
BRCA2)
followed by the
isolation of these sequences away from other
genomic DNA
and cellular components. Myriad Reply at 6 (“By
identifying
these particular BRCA DNAs and isolating them
away from other genomic DNA
and other cellular components,
the inventors created the claimed isolated
BRCA DNA
molecules.”). Like the discovery of the
mutual
non-inhibition of the bacteria in Funk Brothers, discovery of
this
important correlation was a discovery of the handiwork
of nature—the
natural effect of certain mutations in a
particular segment of the human genome.
And like the
aggregation of bacteria in Funk Brothers, the isolation
of
the BRCA1 and BRCA2 DNA, while requiring technical skill
and
considerable labor, was simply the application
of
134
techniques well-known to those skilled in the
art.
See Parthasarathy Decl. ¶ 19.
The identification of the
BRCA1
and BRCA2 gene sequences is unquestionably a
valuable
scientific achievement for which Myriad deserves
recognition, but that
is not the same as concluding that it
is something for which they are entitled
to a patent. See
Funk Bros., 33 U.S. at 132 (“[O]nce nature's
secret of the
non-inhibitive quality of certain strains of the [nitrogen-
fixing
bacteria] was discovered, the state of the art made
the production of a mixed
inoculant a simple step. Even
though it may have been the product of skill, it
certainly
was not the product of invention.”).
Because the
claimed isolated DNA is not markedly
different from native DNA as it exists in
nature, it
constitutes unpatentable subject matter under 35 U.S.C.
§
101.
D. The Method Claims are Invalid Under
35 U.S.C. §
101
“Phenomena of nature, though just discovered,
mental
processes, and abstract intellectual concepts are
not patentable, as they are
the basic tools of scientific
and technological work.”
Benson, 409 U.S. at
67. However,
135
NOTES
50
50 The parties do not appear to dispute
that isolated DNA claimed in the
patents-in-suit are “useful” for
purposes of § 101.
51
Myriad
and many of the amici suggest that the invalidation of the
patents-in-suit will
result in the decimation of the biotechnology
industry. See, e.g.,
Myriad Br. at 28-29 (suggesting that a finding
that DNA is unpatentable subject
matter will invalidate patents to
important chemical compounds such as the
anticancer drug Taxol
(paclitaxel) and leave “little to nothing” of
the United States
biotechnology industry). The conclusions reached in this
opinion
concerning the subject matter patentability of isolated DNA,
however,
are based on the unique properties of DNA that distinguish it from
all
other chemicals and biological molecules found in nature. As a
result,
Myriad's predictions for the future of the U.S. biotechnology
industry
are unfounded.
52
To the
extent a claim reads on unpatentable subject matter, the
entire claim must be
deemed invalid.
See Titanium Metals Corp. of Am.
v. Banner, 778 F.2d 775,
782 (Fed. Cir. 1985).
53
Native
DNA is sometimes methylated, but that methylation is preserved
when the DNA is
extracted and purified. Nussbaum Decl. ¶ 20.
Since
the claimed
“isolated DNA” includes DNA extracted and
purified from the
body,
methylation of DNA in the body does not distinguish native DNA
from the claimed
DNA. In addition, DNA in the body also exists in a
non-methylated state, just
as the synthesized DNA claimed in the
patents would not be methylated. More
importantly, while methylation
affects the transcription of a gene in the body,
it does not have any
impact on the genetic information contained within the DNA.
Indeed, DNA
is demethylated and remethylated as it passes from the germline of
one
generation to the next. Nussbaum Decl. ¶ 28.
54
To be precise, the isolated
single-stranded DNA molecule utilized as
a primer or probe has the identical
sequence as the complementary DNA
strand to the DNA strand containing the target
DNA sequence. The
description in the text is meant to serve as a short-hand
description
of this relationship.
55
55 The same reasoning applies with respect
to the use of isolated DNA as
a probe. See Kay Decl. ¶¶
135-36.
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