*1
Pershing,
employee
receiving
compensa-
was
OWCP
Young,
Michael K.
consistent with this
REVERSED AND REMANDED
The ASSOCIATION FOR MOLECULAR College
PATHOLOGY, The American Genetics,
of Medical The American
Society Pathology, for Clinical
College Pathologists, of American
Haig Kazazian, MD, Arupa Ganguly,
PhD, Wendy Chung, MD, Harry PhD,
Ostrer, MD, Ledbetter, PhD, David Warren, PhD,
Stephen Matloff, Ellen
M.S., Reich, M.S., Elsa Breast Cancer
Action, Boston Women’s Health Book
Collective, Ceriani, Lisbeth Runi Li-
mary, Girard, Fortune, Genae Patrice
Vicky Thomason, and Rak- Kathleen
er, Plaintiffs-Appellees,
v.
UNITED STATES PATENT AND OFFICE,
TRADEMARK
Defendant,
Myriad Genetics, Inc., Defendant-
Appellant, Betz, Boyer, Roger Brittain,
Lorris Jack Combe, Raymond
Arnold B. Geste-
land, Jensen, James John Kendall U.
Morris, Parks, Thomas David W. *4 Hansen,
Christopher A. American Civil Foundation, York, of New Liberties Union NY, argued plaintiffs-appellees. for With Park, him on the brief were S. Sandra Fine, Lapidus. Aden and Lenora M. Of on Daniel B. counsel the brief were Ra- Hassan, and Y. Public vicher Sabrina Pat- Foundation, Cardozo, Benjamin ent N. Law, York, of School of New NY. Castanias, Gregory Day, A. Jones of DC, Washington, argued all defendant- for him on the brief appellants. With were Swize, DC, L. of Washington, Jennifer Is- Mayergoyz rael Sasha and Dennis Mu- rashko, IL, Poissant, Chicago, of Brian M. Falvey, Laura A. and Eileen Coruzzi of York, Benja- New NY. Of were counsel Jackson, Myriad Z. Jay Zhang, min and Genetics, City, of Salt Lake UT. Patterson, Attorney, Melissa N. Civil Di- vision, Staff, Appellate United States De- Justice, DC, Washington, of partment of curiae, argued for amicus United States. her F. With on the brief were Stuart De- General, lery, Attorney Acting Assistant Brinkmann, Deputy Beth S. Assistant At- Mcltosh, torney General and Scott R. At- torney. R. Of counsel was Mark Freeman. Kowalski, PC, Price Thomas J. Vedder York, York, New amicus curiae of New for Corporation. him Protein Sciences With Lu; LLP, DC, Washington, Deborah L. the brief were of for amicus curi- on ae, Rigg, Chicago, IL. Robert S. American Intellectual Property Law Association. With her on brief were Eli Armitage, Lilly A. Com- Robert Litowitz, D. Robert Erika Harmon Arner IN, curiae, Indianapolis, amicus pany, S. David Forman. Of counsel on the Lilly Company. Eli With him on Barber, brief William was G. American Kelley. brief was James J. Association, Property Intellectual Law Holman, University of Christopher M. Arlington, VA. Of counsel were David Law, City School of Missouri-Kansas Hill, Warren American Intellectual Prop- MO, City, Kansas for amicus curiae Law VA, erty, Arlington, and Robert C. M. Christopher Professor Holman. Henderson, Finnegan, Stanley, Farabow, Macedo, Charles R. Amster & Rothstein Dunner, LLP, Atlanta, Garrett & GA. NY, Ebenstein, LLP, York, New Robinson, III, T. William American Bar curiae, amicus New York Intellectual Association, IL, Chicago, for amicus cu- Property Law Association. Of counsel *5 riae, American Bar Association. Of coun- M. Daignault the brief were Ronald and sel on the brief Elwood, were John P. McFarlane, Robins, Kaplan, B. Matthew Elkins, LLP, Vinson & of Washington, Ciresi, York, & of NY. Miller L.L.P. New DC; Valek, and Michael A. Stephen C. Andrews, Lori B. IIT Chieago-Kent Stout, Austin, of TX. Law, IL, College Chicago, of of for amicus curiae, College Embryol- Gatschet, The American of Gatschet, Mark J. Mark John et al. counsel was D. ogy, Of Joshua P.L.L.C., Houston, TX, of for amicus curi- Sarnoff, University College DePaul of ae, Mark J. Gatschet and Richard W. Law, Chicago, of IL. Knight. Of counsel on brief was Rich- Knight, ard W. Knight R.W. P.C. of San Greenfield,
Debra L. UCLA Institute Antonio, TX. Genetics, Society Angeles, and of Los CA, curiae, for amici The National Wom- Laporte, Foley Hoag, LLP, Claire of Network, Health et al. en’s Boston, MA, for amicus curiae Federal Cox, Knowledge
Krista L. In- Ecology Circuit Bar Association. her on the With ternational, DC, Washington, of for amicus Flaherty, brief was James M. Jr. curiae, International, Knowledge Ecology Hendricks, Evert, John L. Hitchcock al.
et LLP, Dallas, TX, curiae, of for amicus Proper- Richard F. Phillips, Intellectual AARP, al. him the et With on brief were Association, DC, ty Owners of Washington, Megan O’Laughlin M. and John T. Tower. curiae, Property for amicus Intellectual Of counsel was Michael R. Schuster. Association. With him Owners on Harness, Timothy Keane, Dickey & J. brief was Kevin H. Rhodes. Of on counsel Pierce, PLC, Louis, MO, of St. for amicus Berghoff, the brief were H. E. Paul Kevin curiae, BioGenerator, et al. Jeffrey Armstrong, Noonan and P. McBee, Baker, Donelson, Susan E. & Hulbert Berghoff, McDonnell Boehnen Bearman, Caldwell, Berkowitz, P.C., and LLP, Chicago, of IL. Of were counsel Washington, DC, curiae, for amicus Im- Herbert Wamsley, Property C. Intellectual Biotechnologie, matics GmbH. With her Owners, DC, Douglas of Washington, and Bryan was the brief W. Jones. Norman, Lilly Eli & Company, Kent Indianapolis, IN. Waxman, Seth P. Wilmer Cutler Picker- Dorr, LLP, ing Rudolph, Finnegan, Washington,
Barbara
R.
Hale
Farabow,
Henderson,
Dunner, DC,
&
curiae,
Garrett
Biotechnology
for amicus
In-
LOURIE,
Judge.
him on
et al.
Circuit
dustry
With
Organization,
Of
Thomas G. Saunders.
the brief was
Genetics,
Myriad
Inc. and the Directors
Fleming,
was Mark C.
on the brief
counsel
Utah
Foun
University
Research
Salter, Bio-
MA,
Hansjorg
Boston,
(collectively, “Myriad”)
from
appeal
dation
Industry
Organization,
technology
the United
District
the decision of
States
was Allen C.
DC. Of counsel
Washington,
for the Southern District of New
Court
Pickering Hale
Nunnally,
Cutler
Wilmer
of medi
holding
York
assortment
Boston,
Dorr, LLP, of
MA.
researchers,
organizations,
genetic
cal
counselors,
(collectively,
patients
Botts,
Gordon, Baker
L.L.P. of
Jennifer
“Plaintiffs”)
standing
De
under the
have
curiae,
NY,
Croplife
York,
for amicus
New
Myri
Act to
claratory Judgment
challenge
her on the brief were
International. With
patents.
ad’s
Ass’n Molecular Pathol
Tempes-
and Jennifer C.
Steven Lendaris
Office,
v.
&
ogy U.S. Patent
Trademark
ta.
(“DJ
(S.D.N.Y.2009)
F.Supp.2d 365
LLP,
Dowd, Wiley Rein
J.
Matthew
Myriad
appeals
the dis
Op.”).
also
curiae,
DC, for amicus
James
Washington,
summary
granting
trict court’s decision
him on the brief was
D. Watson. With
judgment
challenged
that all of
Wallace,
H.
Jr.
James
non-patentable subject mat
are drawn to
§
under
Mo
ter
35 U.S.C.
Ass’n for
Calia, Covington
Burling,
Kurt
&
G.
Trade
Pathology
lecular
v. U.S. Patent &
LLP,
Shores, CA, for amicus
of Redwood
*6
(S.D.N.Y.
Office,
F.Supp.2d
mark
702
181
curiae,
and
Pharmaceutical Research
Man-
2010) (“SJ
part
affirm in
and
Op.”). We
him on
of America. With
ufacturers
in part.
reverse
Long,
A.
and Allison
brief were Robert
Jr.
as,
appeal
This
has returned to us
DC,
Kerndt, Washington,
and Alexa
E.
of
for
filed
petition
having
certiorari
been
Hansen,
Francisco,
R.
of San
CA.
2011,
July 29,
from our
of
decision
Kane,
Eileen
Penn
Dickinson
M.
State
grant
Court of the United States
Park, PA,
Law, University
of
of
for
School
decision,
petition,
ed the
vacated our
and
curiae,
M.
amicus
Professor Eileen
Kane.
to us
further con
remanded the case
Scott,
Law,
of
Genevieve E.
Yale School
Mayo
in
of its
in
light
sideration
decision
curiae,
NY, for amicus
Infor-
Brooklyn,
Prometheus, Inc.,
of
v.
Collaborative Services
at
Society Project Yale Law School
mation
U.S. -,
L.Ed.2d
566
132 S.Ct.
182
on
was
(2012).
her
the brief
Pris-
Scholars. With
Pathology
Ass’n Molecular
—
Genetics, Inc.,
-,
cilla J. Smith.
Myriad
v.
(2012).
§ 101 each of the claimed mole- coding because 1. An isolated DNA for a nonnaturally occurring represents cules BRCAl polypeptide, polypeptide said also composition having of matter. We reverse sequence the amino acid set forth Myriad’s SEQ decision that ID the district court’s NO:2. screening potential
method claim to cancer 2. The isolated DNA of claim where- changes growth in cell therapeutics via in said DNA has the sequence nucleotide rates of cells is directed to a transformed SEQ set forth in ID NO:l. scientific patent-ineligible principle. We 5. An isolated DNA at having least 15 however, decision, affirm the court’s nucleotides of the DNA of claim Myriad’s method claims directed “com- '282 col. 1.55—col. 154 1.56.1 sequences
paring” “analyzing” are SEQ ID depicts NO:2 the amino acid se- ineligible; such include no claims quence of protein, SEQ the BRCAl steps only pat- transformative and cover ID NO:l depicts sequence nucleotide abstract, ent-ineligible steps. mental DNA coding region; BRCAl latter sequence colloquially referred to Background as cDNA. Id. col. 11.48-50. brought against Myriad, Plaintiffs suit All but challenged one method challenging patentability certain “analyzing” claims cover methods of composition method relating “comparing” patient’s sequence BRCA genetics. human See Op., DJ normal, or wild-type, sequence F.Supp.2d Specifically, Plain- 369-76. *7 identify the of presence cancer-predispos- tiffs a declaration that sought fifteen ing Representative mutations. method patents assigned claims from seven claims include claims 1 of and the '999 '001 Myriad to patent-ineligible are drawn sub- patents: ject § 101: matter under U.S.C. claims germline 1. A a detecting method 1, 2, 5, 6, 7, 5,747,282 20 of and U.S. Patent alteration in gene, a BRCAl said altera- (“the 6,1, patent”); '282 claims and 7 of tion from group consisting selected (“the 5,837,492 patent”); U.S. Patent '492 of the alterations set forth Tables (“the 5,693,473 claim 1 of Patent '473 12A, 14, or 19 in a human which patent”); 5,709,999 1 of claim U.S. Patent comprises analyzing a of sequence a (“the claim 1 patent”); '999 of U.S. Patent gene BRCAl or from BRCAl RNA a (“the 5,710,001 patent”); '001 claim 1 of sample analyzing sequence human a (“the 5,753,441 patent”); U.S. Patent '441 of BRCAl cDNA made mRNA from 6,033,857 and claims 1 and of U.S. Patent from sample provi- said human (“the patent”). '857 so that said is not a germline alteration composition
The challenged claims cover deletion corresponding of 4 nucleotides genes, SEQ two “isolated” human BRCAl and to base of ID numbers 4184^4187 ” (collectively, BRCA2 NO: 1. “BRCAl/2 1, 2, representative patent; claims include: 6 and 7 '282 addition claims of the 1, 6, patent, patent; and 5 of '282 claims to 7 of the and other and '492 appeal patent. isolated DNA claim 1 of molecules issue in the '473 in the of ryotic host cell absence said (emphases 161 11.17-25 patent col. '999 determining rate of compound, added). presence cell in the growth of said host a screening tumor 1. A method compound growth of of said and rate subject human for a so- a sample from host in the of said cell absence said gene in in a BRCA1 matic alteration comparing growth compound and compar- comprises [ ] said tumor which cells, a rate of said host wherein slower sequence from the ing a selected first growth rate of of said host cell gene consisting of a BRCA1 from group presence compound is said indicative BRCA1 RNA from sample, tumor said therapeutic. of a cancer and BRCA1 cDNA sample tumor said (emphases '282 col. 31.13-24 patent from said tumor sam- made from mRNA added). sequence a selected ple with second challenged The claims thus relate to iso- consisting of BRCA1 group from the sequences gene diagnostic meth- lated sample gene from a nontumor of said in these identifying ods of mutations se- from said subject, BRCA1 RNA nontu- context, quences. place To this suit in we cDNA made sample mor BRCA1 step provide background back to take nontumor from mRNA from said sam- involved, the identifi- including science in the ple, sequence wherein difference genes, the Plain- cation BRCA gene, the BRCA1 BRCA1 RNA or to the and to tiffs’ connections invention sample tumor BRCA1 cDNA said Myriad. sequence gene, of the BRCA1 from the RNA or cDNA from BRCA1 BRCA1 I. sample said nontumor indicates somat- genetics study heredity Human in the ic alteration BRCA1 in said beings.3 genome, in human The human tumor sample. information, entirety of genetic human (emphasis '001 col.155 11.2-17 add- 22,000 approximately genes, contains ed).2 form the of human which basis inheritance. The claim challenged final method majority of act by guiding Plaintiffs is directed to a method screen- production polypeptide chains that form ing potential therapeutics. Specifi- cancer proteins. in turn up having Proteins make cally, claim 20 of the catalyze '282 reads variety matter cellular processes. follows: *8 potential A for screening method Chemically, genome the human is com- therapeutics cancer which comprises: (“DNA”). deoxyribonucleic posed of acid eukaryotic growing a host up repeat- Each DNA molecule is of made transformed containing gene cell altered BRCA1 ing units of four nucleotide bases—adenine causing in presence cancer the a com- (“A”), (“T”), (“C”), thymine cytosine and (“G”> pound suspected being a cancer ther- guanine covalently are —which linked, bonded,4 apeutic, growing together sugar- said euka- or via transformed currently comprehensive 2. The claims us recite discussion of the science before and "analyzing” "comparing” methods of or repeat in case. We the involved '999, sequences BRCA are: 1 of the here. basics '001, patents and '441 1 and 2 of and claims patent. '857 the 4.Covalent bonds are chemical bonds charac- by sharing the terized electrons between opinion, Op., 3. The district court's SJ in a molecule. atoms 192-203, F.Supp.2d at contains a detailed
13H T, or A with phosphate, phosphodiester, pairs Figure backbone. and C with G. two DNA generally depicts DNA exists as strands below the structure of a DNA dou- as a double helix which each ble and the complementary pairing intertwined helix bases, pairs, hybridizes, represented by base on a strand or four nucleotide A, T, C, the other complementary base on strand: G. chemically The order of in a linear nucleotide bases sugar-phosphate different DNA, than DNA is referred to as “se- backbone and it utilizes molecule its (“U”) nucleotide base quence.” place of a uracil sequence gene The is thus (“T”). thymine During As, Gs, transcription, Ts, a linear sequence denoted DNA double helix and each is unwound “DNA or sequencing” “gene Cs. se- non-coding, template, nucleotide refers to quencing” process by which DNA strand is used make a complemen- precise linear order in a of nucleotides tary, single-stranded RNA molecule that DNA A segment gene is determined. ie., strand, the coding mirrors DNA ade- gene’s sequence in turn nucleotide encodes the template nine on DNA strand results sequence for a linear of amino acids that molecule, thymine in uracil the RNA comprise protein gene, encoded adenine, guanine cytosine, results e.g., the BRCAl gene encodes for cytosine in guanine. “pre- The resulting protein. BRCA1 Most have both RNA,” like the DNA from which it was sequences. “exon” and “intron” are Exons generated, contains exon intron both segments necessary Next, sequences. physical- the introns are i.e., protein, creation of a that code for a ly molecule, pre-RNA excised from the protein. segments Introns are of DNA by “splicing” followed produce exons to interspersed that, un- between the exons (“mRNA”). a messenger Figure RNA exons, like a protein. do not code for transcribing below shows the steps of a protein creation from a (exon 1-3) gene that contains three exons *9 comprises steps: two transcription and (intron 2) and introns a pre- two into First, gene sequence translation. is RNA, followed RNA in- excising the “transcribed” into a different nucleic acid splicing produce trons of the exons to (“RNA”). called ribonucleic acid has an containing RNA mRNA exon sequences. transcription splicing, Following into
resulting mRNA is “translated” Genes, protein. their corre-
encoded mRNAs, proteins encode via
sponding called co-
three-nucleotide combinations triplet corresponds to
dons. Each codon twenty amino
one of acids make proteins “stop” signal all or a
up translation. For exam- protein
terminates adenine-thymine-guanine
ple, codon
(ATG, corresponding AUG
mRNA), the amino acid methio- encodes sixty- relationship
nine. between sequences and their possible
four codon amino is known
corresponding acids Figure represents genetic code. below mutations, Changes, sequence in the into that translates mRNA molecule human can alter production, of a (Codon 1, AUG, amino acids protein six structure, resulting function and/or 2, ACG, methionine; threonine; Codon changes point Small-scale include protein. 3, GAG, acid; glutamic Codon Codon single to a change mutations in which CUU, leucine; CGG, arginine; Codon in the single nucleotide amino acid alters serine), AGC, and ends with one Codon For a base protein. example, encoded codons, stop of the three UAG. change changes codon GCU to CCU protein
an alanine in the encoded include proline. Larger scale variations *10 deletion, rearrangement, duplication or from larger segments ranging DNA — núcleo- to over a million hundreds several elimination, Nearly in every body can result cell in the human tides —and misplacement, duplication of an entire genome. contains entire individual’s genes. some mutations While cell, DNA “native” or “ge- called body’s pro- have little or no effect on the DNA, nomic” packaged twenty- is into cesses, an in- others result in disease or pairs three of chromosomes. Chromo- particular developing creased risk of dis- are complex comprising somes structures is sequencing ease. DNA used clinical single extended DNA molecule wrapped diagnostic testing to determine whether a histones, proteins around called as shown gene contains mutations associated with a Figure 4 below. particular disease or disease risk. Each contiguously spans chromosome mil- can gene, amplified then be excised or from the lions of DNA to obtain the isolated encompasses many bases and DNA dis- segment of interest. DNA molecules can crete genes. twenty-two Humans have synthesized be laboratory. also in the One chromosomes, pairs of autosomal num- synthetic type DNA molecule is comple- bered twenty-two according one to to size (“cDNA”). mentary synthe- cDNA is smallest, from largest pair and one using from complementary sized mRNA chromosomes, sex Xtwo chromosomes in pairing analogous base a manner females X Y and one and one chromosome transcription. process RNA results in males. a double-stranded DNA molecule with a Genomic DNA can extracted from its sequence sequence to the corresponding cellular using a environment number of produced body. an mRNA by the Because laboratory well-established techniques. mRNA, A synthesized cDNA con- particular DNA, segment such sequences, as a tains the exon and thus *11 the BRCA ge- within human genes a chro- the sequences, from of the intron
none BRCA genes and gene sequence. nome to isolate and mosomal their exact nucleotide se- determine II. Myriad in turn to quences. This allowed testing the BRCA BRCA diagnostic in services provide mutations Certain risk of breast with an increased to women.5 correlate average The woman ovarian cancer. and has around twelve
in the United States III. risk developing thirteen percent to however, Myriad, was not the enti- her lifetime. with cancer in Women breast BRCA implement testing clinical ser- ty to contrast, mutations, a cumu- BRCA in face 1996, University Starting in vices. fifty eighty per- to risk of between lative Pennsylvania’s Diagnostic Genetic Labora- and a developing breast cancer cent (“GDL”), tory by plaintiffs eo-directed of ovarian cancer be- cumulative risk Kazazian, Jr., Arupa Haig H. M.D. and fifty percent. Diagnostic twenty to tween Ph.D., Ganguly, provided diag- BRCA1/2 of BRCA genetic testing for existence By services to women. nostic how- important an con- mutations is therefore ever, by Myriad that accusations GDL’s of clinical provision sideration in the care BRCA testing infringed pat- services its testing This for breast or ovarian cancer. to such stop providing ents forced the lab with information her provides patient services. hereditary ovarian can- risk breast and dispute The first of a came in ear- sign cers, and in the decision thus aids difficult time, ly 1998. Kazazian At Dr. re- preven- regarding whether undertake Skolnick, with Dr. including sur- calls dinner Mark options, prophylactic tive results can also be an inventor and Chief Science Officer at gery. Diagnostic dinner, important structuring appro- Myriad. factor in an At the Skolnick informed treatment, cancer priate course of since Myriad planning Kazazian that was therapy more certain forms of effective clinical BRCA stop providing GDL from related to BRCA muta- treating cancers testing Myriad’s patents. A light tions. later, in May month or two Kazazi- an received a letter from William A. patents in suit iden- The inventors of Hockett, Corporate Director of Communi- basis of BRCAl- the genetic tified Myriad. cations letter stated that analysis using BRCA2-related cancers Myriad currently knew that Kazazian was cloning. Relying on positional called providing BRCAl diagnostic testing ser- samples large set of DNA from families vices, Myriad, holder cancers, and ovarian inherited breast patents covering of five the isolated the inventors correlated the occurrence of BRCAl diagnostic testing, was family cancer members with individual making to select institutions a certain marker DNA available inheritance of allowed inventors license. Attached to let- sequences. This collaborative Myriad’s identify, or location ter was a collaborative “map,” physical copy covering Myriad application mg patents in suit 5. the first isolated filed leading covering patents diagnostic to the isolated suit BRCA2 DNA and associated meth- diagnostic BRCAl DNA and associated meth- the first ods in December such resulting pat- August ods ent, 1994. The first patent, patent, the '492 issued on November patent, December '473 issued on 17, 1998. Myriad application filed first lead- *12 severely responded by which limit- Terrell agreement, proposed Wight letter on testing 10, 1999, GDL’s services to certain tests ing September stating that “the Uni- of Ashkenazi Jewish descent. patients agrees for that versity accept it will not sam- Ostrer, M.D., Harry Plaintiff researcher ples for BRCA1 testing research from (“NYU”) University New York at School parties.” third J.A. Kazazian thus Medicine, received the same letter and of Dr. informed Ostrer that GDL would no 1998, in al- agreement May collaborative longer accepting patient samples not, time, though laboratory his did at the testing anyone BRCA from him or else as Rather, testing provide such services. patent infringement result asser- patient samples Ostrer sent to GDL by Myriad. result, tions made As a Ostrer genetic testing. BRCA sending patient samples started for BRCA genetic testing to Myriad, which later, became August in Dr. Kaza- Months (and today) remains letter, provider zian received a second time this such Riley of firm services States. George from A. the law United O’Melveny Myers iden- & LLP. The letter period, During Myriad also initiated Myriad patents number “cov- tified five several patent infringement against suits ering, among things, BRCA1 other entities providing clinical BRCA testing. sequence ... and methods for detect- Myriad against filed suit Oncormed Inc. in ing sequence.” alterations the BRCA1 again Myriad Genetics v. J.A. 1145. The letter also indicated that Oncormed, 2:97-cv-922, Nos. 2:98-cv-35 Myriad’s you come to attention that “has (D.Utah), University and the Pennsylva- engaged testing in commercial activi- nia in Myriad v. Genetics Univ. of Myriad’s infringe patents,” that ties Pa., (D.Utah). No. 2:98-cv-829 Both law- “[ujnless ar- licensing that and until a suits were later without preju- dismissed ... rangement completed you is should each agreed dice after defendant to discon- infringing testing activity.” all Id. cease allegedly activity. tinue all infringing noted, however, letter that the cease- the plaintiffs None of besides Drs. Kaza- and-desist notification did not to re- apply zian, Ganguly, Ostrer, allege that Myr- testing purpose search “for the of further- any iad directed or other communi- letters ing programs, non-commercial research regarding cations its patents them. provided results of which are not Rather, the other researchers and medical patient money which and for no is organization simply members state received from the or the patient patient’s knowledge Myriad’s vigorous enforce- insurance.” Id. against ment of its rights others Terrell, June Robert the Gener- stopped them from engaging clinical University Pennsylva- al for the Counsel genetic testing, although they BRCA have nia, received similar cease-and-desist let- personnel, expertise, and facilities as Christopher Wight, Myriad’s ter well provide as the desire to such testing. stated, General Counsel. The letter “It plaintiffs The patient they state that have Haig has come to our attention that Dr. H. been genetic unable obtain BRCA Kazazian, University Pennsyl- Jr. of the testing or their desired BRCA testing, ei- continuing willfully engage vania ther covered their or at a insurance genetic commercial BRCA1 and BRCA2 afford, can price Myr- because of activities, testing in violation of the Uni- protection. iad’s versity Pennsylvania’s previous assur- researchers, that such other testing ances commercial activi- Like the Dr. Kazazi- ties would be discontinued.” J.A. 2890. an if Myriad’s patents states were *13 test- in may engage ing that one would be BRCAl/2 Ganguly Dr. invalid, and he
held infringe- being risk of sued ing the within at testing BRCA to resume able at 390. Myriad.” Id. notes, liability by howev- ment He a few weeks. matter of concluded, actions, had to they “decided the court Myriad’s if er, this is that in the situa- precisely 2852. Gan- Plaintiffs testing.” J.A. “the placed BRCA resume Act patents Declaratory Judgment if the concurs, stating that the tion that guly immediately invalidated, Plaintiffs “I would the to address: designed were was my in testing BRCA resuming engage to ability and desire consider have the Dr. also 2892. Ostrer6 laboratory.” J.A. that well as the belief testing as BRCAl/2 personnel, all the lab has his rights, that but indicates their testing is within such necessary to un- facilities, expertise and infringement risking without cannot do so and em- testing BRCA clinical dertake liability.” Id. imme- that his lab “would
phatically states
Myri-
rejected
holding, the court
In so
perform
to
diately begin
BRCAl/2-related
act
must be some
that there
argument
ad’s
the
upon, invalidation
testing
genetic
Plaintiffs, noting that
the
toward
directed
J.A. 2936-38.
Myriad patents.”
fact,
had,
affirmative acts
Myriad
taken
and Dr.
Dr.
plaintiffs
Kazazian
toward
IV.
court also
at
The
Id.
387-88.
Ganguly.
suit,
moved
Myriad
filed
After Plaintiffs
that
Myriad’s arguments
rejected
dismissed, alleging that
the case
to have
Ka-
plaintiff
to
letter
cease-and-desist
sent
bring a
standing to
lacked
the Plaintiffs
declaratory
support
too old to
zazian was
challenging the
declaratory judgment suit
legal
that
jurisdiction and
judgment
court
The
patents.
district
validity of its
parties could
brought against third
actions
however,
Plain
holding
that
disagreed,
jurisdictional
in the
considered
standing
Article III
had established
tiffs
con-
The court
analysis.
Id. at 388-89.
ar
test
the circumstances”
the “all
under
to either
rigid
that
adherence
cluded
in MedIm
Supreme Court
ticulated
inconsistent
would be
requirements
these
Genentech, Inc., 549
mune,
Inc. v.
that
mandate
with Medlmmune’s
L.Ed.2d 604
118, 127,
all the
alleged under
assess the facts
court
(2007).
at 385-92.
F.Supp.2d
Op.,
DJ
Id.
circumstances.
Myriad had
found that
court first
The
that
court
found
district
also
acts”
in sufficient “affirmative
engaged
meaningful
alleged
had
sufficient
Plaintiffs
of its
assertion
company’s
based on
to establish
infringement
preparations
engaging
from
others
“right
preclude
to
at
jurisdiction.
Id.
declaratory judgment
through personal
genetic testing
BRCA1/2
researchers,
respect
With
letters,
390-92.
communications, cease-and-desist
they
that
it was sufficient
held
offers,
the result
court
litigation,”
licensing
begin
“ready, willing, and able”
were all
widespread
“the
understand-
was
of which
expertise
conduct such
27, 2011,
the resources
days
we issued
July
two
6. On
before
case,
Myri-
initial,
immediately
so if
testing,
do
decision in
and would
our
now-vacated
Following
was
Ostrer
re-
Myriad
the court
Dr.
patents
notified
were invalidated.
ad’s
Court,
position
at the Al-
leaving
to assume
NYU
also
we have
from
mand
College
and Montef-
of Medicine
bert Einstein
"suggestion Myriad a related
received
Center,
August
effective
iore Medical
or dismiss.
remand
and motion to
mootness”
sup-
response, Plaintiffs submitted
denied the
suggestion and
declined the
We
stating
Ostrer
from Dr.
plemental declaration
the facts
case on
We now review this
motion.
that,
position, he
seeks
his new
still
presented to us.
arguments
briefed
testing, still has
diagnostic
BRCA
undertake
testing within the normal course
pendent
any physical
BRCAl/2
transformations.
research,
of their
rejecting
laboratories’
Id.
233-35.
holding,
In so
the court dis
Myriad’s argument
needed to tinguished Myriad’s claims from those at
allege specific preparatory activities.
Id.
in Mayo
issue
based on the “determining”
rejected
at 390-91. The court
Myri-
also
step
being
latter
construed to in
argument
plaintiffs
ad’s
Kazazian and clude the extraction and measurement of
*14
Ganguly
they
testified
would metabolite
patient
levels from a
sample.
“consider”
engaging
allegedly infringing
Op., 702 F.Supp.2d
SJ
at
(citing
234-35
activities, concluding that
proper
focus
Labs.,
Prometheus
Inc. Mayo
v.
Collaborative
of
inquiry
they
is whether
are mean-
vs.,
1347,
(Fed.
Ser
628 F.3d
1350
ingfully prepared,
not whether
have
—
Cir.2010), rev’d,
-,
U.S.
132 S.Ct.
final,
made a
conclusive
engage
decision to
1289,
(2012)).
The parties then moved summary claims could be read to include the trans judgment on § the merits of Plaintiffs’ 101 formations associated with isolating and challenge Myriad’s patent claims. The sequencing DNA, human these transfor Plaintiffs, district court held concluding mations would constitute no more than challenged the fifteen claims were preparatory data-gathering steps. Id. at drawn to non-patentable subject matter Grams, 236 (citing In re 835, 888 F.2d 840 § and thus invalid under 101. Op., SJ 702 (Fed.Cir.1989)). Finally, the court held F.Supp.2d at 220-37. Regarding the com that the one method claim to “comparing” claims, position the court held that isolated growth rate of cells claimed a basic DNA molecules fall within the judicially principle scientific and that the transfor “products created of nature” exception to mative steps amounted to only preparato § 101 because such isolated DNAs are not ry data gathering. Id. at 237. “markedly different” from native DNAs. Myriad appealed. jurisdiction We have 222, Id. 232 (quoting Diamond v. Chak 1295(a)(1). pursuant § to 28 U.S.C. 303, rabarty, 447 100 U.S. 65 S.Ct. (1980)). L.Ed.2d 144 The court relied on DISCUSSION that,
the fact unlike other biological mole cules, DNAs “physical are the embodiment I. Declaratory Judgment Jurisdiction information,” and that this information A. only preserved is not in the claimed isolat molecules, ed DNA but also essential to The question first we must address is utility their as molecular tools. Id. at 228- whether the district court correctly exer- declaratory cised judgment jurisdiction over this suit. The Declaratory Judgment Turning claims, to the method the court provides that, Act “In a case actual held them patent ineligible under controversy jurisdiction within its ... any court’s then-definitive machine-or-transfor court may United States ... mation test. declare (citing Id. at 233 In re Bil ski, rights (en and (Fed.Cir.2008) legal 545 F.3d other banc), 943 relations of interested grounds, party seeking declaration, on other such v. Kappos, Bilski aff'd - -, or 3218, 3225, U.S. 130 whether not 177 further relief or could be (2010)). 2201(a). L.Ed.2d 792 sought.” § The court held that 28 U.S.C. the claims “analyzing” covered or “a phrase “com case of actual controversy” in paring” DNA sequences by any method, the Act types refers of “cases” and and thus processes mental covered inde- justiciable “controversies” that are under Wildlife, Lujan v. Aet- ments.” Constitution. III the U.S.
Article
Defenders
Haworth,
555, 560,
Ins. v.
112 S.Ct.
na Life
(1937).
L.Ed. 617
239-40,
(1992).
“First,
plaintiff
L.Ed.2d
injury in fact—an
must have suffered an
rule exists for
bright-line
no
Although
legally protected
of a
interest
invasion
judg
declaratory
determining whether
(a)
particularized,
concrete and
Ill’s
which is
Article
case-or-
action satisfies
ment
(b)
imminent,
conjectural
controversy
requirement,
actual
dispute
must be
(internal
has held that
Court
Id.
citations
hypothetical.”
concrete, touching
legal
“definite
omitted). “Second,
there
quotations
having
legal
parties
adverse
relations
must
a causal connection between the
substantial,” and
interests,”
“real
complained
the conduct
of—the
injury and
through
specific relief
a decree
“admi[t]
*15
...
trace
to
injury
‘fairly
[able]
has to be
character, as distinguished
of a conclusive
challenged
action of
defen-
advising what
the law
opinion
from
v. E.
(quoting
Ky.
dant. ...’” Id.
Simon
hypothetical
upon a
state
would be
26, 41-42,
Org.,
96
Rights
426 U.S.
Welfare
127,
MedImmune,
127
549 U.S. at
facts.”
(1976)).
1917,
450
S.Ct.
48 L.Ed.2d
at
Life,
Aetna
300
(quoting
764
U.S.
S.Ct.
“Third,
‘likely,’
opposed
must be
as
to
461).
240-41,
“Basically, the
57 S.Ct.
injury
that the
will
merely ‘speculative,’
facts
in each case is whether the
question
”
aby
decision.’ Id. at
‘redressed
favorable
circumstances,
under all the
show
alleged,
Simon,
561,
2130 (quoting
112 S.Ct.
426
a
controversy,
there is
be
substantial
1917).
38, 43, 96 S.Ct.
U.S. at
parties having
legal
adverse
inter
tween
ests,
immediacy
reality
to
of sufficient
an actual case or con
“Whether
judg
declaratory
the issuance of a
warrant
may
so that a
court
troversy exists
district
Pac.
(quoting
ment.” Id.
Md. Cas. Co. v.
declaratory judg
an action for a
entertain
Co.,
270, 273,
Oil
Coal &
312 U.S.
non-infringement
invalidity
ment of
(1941)).
and/or
510, L.Ed.
85
826
by
governed
Federal Circuit
law.”
applying
In
Medlmmune’s all-the-cir
Centocor, Inc.,
MedImmune,
Inc. v.
409
declaratory judgment
test
cumstances
to
(Fed.Cir.2005),
1376,
F.3d
1378
overruled
action,
by
guided
we
MedImmune, 549
grounds,
on
other
three-part
framework for deter
Court’s
130-31,
Following
at
“[T]he constitutional standing contains three ele- 1377. minimum claratory Judgment
B.
Act was intended to
they
address:
must either
proceed
challenges
Myriad
district
liability
BRCA-related activities and risk
jurisdictional
decision on the
court’s
infringement,
or refrain from
and the Plaintiffs do
grounds
Myriad
despite believing
such
Myriad’s
activities
legal
and that
have adverse
interests
patents are invalid.
allege
Plaintiffs have failed
controver
sy
immediacy
reality to
of sufficient
alleged
Under
facts
this
judg
a declaratory
warrant the issuance of
case,
Plaintiff,
conclude
we
that one
Dr.
Specifically, Myriad argues
ment.
that Ostrer,
standing
has established
to main
allege any
failed to
“affir
Plaintiffs have
declaratory
tain
judgment
suit. All
Myriad
mative
within
ten
past
acts”
standing
Plaintiffs claim
under the Declar
years
relating
patents
suit
atory Judgment Act based on the same
According
Plaintiff.
directed at
alleged injury: that they cannot undertake
Myriad,
by relying
court
the district
erred
the BRCA-related activities that
de
communications”
Drs.
“stale
directed at
Myriad’s
sire
because
enforcement of its
Kazazian,
and Ostrer
a dec
Ganguly,
over
rights covering
Only
BRCAl/2.7
ten-year-old licensing
ade
ago, as well
however,
plaintiffs,
allege
three
an injury
third
litigation
activities directed at
*16
Myriad;
Kazazian,
traceable to
only Drs.
parties,
jurisdiction
and thus exercised
Ganguly,
Ostrer allege
pat
affirmative
solely
subjective
Plaintiffs’
fear
based
on
ent enforcement actions directed at them
suit,
innuendo
of
from rumor
arising
by Myriad.
three,
Of these
Dr. Ostrer
community.
in the research
alleges a
clearly
sufficiently
and immi
real
respond
they
Plaintiffs
have stand-
injury
nent
because
an
alleges
he
intention
ing under Medlmmune’s all-the-eircum-
to
actually
immediately engage in al
because,
stances test
not
legedly infringing BRCA-related activities.
undisputedly
immediately
to
un-
prepared
We
each in
address
turn.
activities,
potentially infringing
dertake
Although Medlmmune
relaxed this
Myriad
but also
took sufficient affirmative
court’s
appre-
more restrictive “reasonable
patents
acts with
to the
in suit.
respect
suit”
declaratory judg-
hension of
test for
latter,
Regarding the
Plaintiffs assert
SanDisk,
jurisdiction,
ment
480 F.3d at
Myriad sued,
sue,
threatened to
or de-
not
alter “the
rule that
did
bedrock
agreements
every
manded license
from
controversy
a case or
based on a
must be
offering
known institution
clinical
BRCA
injury
real and immediate
threat
of
testing, including university labs directed
injury
future
is caused
Kazazian,
by plaintiffs
Ganguly, and Ostr-
defen-
dants,” Prasco, LLC v. Medicis Pharm.
er, forcing
testing.
to
each
cease such
(Fed.Cir.2008).
F.3d
Corp., 537
And,
Plaintiffs,
according to
the awareness
Medlmmune,
Accordingly, following
this
Myriad’s vigorous
of
patent
assertion of its
court has continued to
declarato-
rights
suppress
still continues to
abil-
hold that
their
jurisdiction
ity
perform
plac-
ry judgment
to
testing,
clinical BRCA
will
arise
ing
very
merely
De-
party
Plaintiffs
dilemma the
on
basis that a
learns of
patients
allege
injury
pressed
indepen-
7. Certain
also
based
an
Plaintiffs have not
as an
gain
inability
Moreover,
on
their
access to
ground
affordable
standing.
dent
for
we fail
genetic testing
Myriad’s pat-
BRCA
because of
inability
patented
a
see how
to afford
ent dominance
such
denial
services. While
invention could establish an invasion of a
can,
of health
services
certain circum-
legally protected
purposes
interest
stances,
judicially cognizable injury,
state a
standing.
Simon,
40-41,
see
at
Myriad’s letter,
Kaza-
adversely
Ostrer received
Dr.
patent,
held
existence of
that,
patent poses
Myri-
him
that such
zian informed
because of
perceives
or even
in the absence of
infringement,
patent
against
of its
rights
risk
ad’s assertion
by the patentee.
act
him,
affirmative
accepting
some
no longer
would
GDL
Thus,
SanDisk,
at 1380-81.
480 F.3d
patient samples
genetic testing.
for BRCA
the outer boundaries
defining
without
Myriad’s
patent
rights
assertion
its
declaratory
jurisdiction, we have
judgment
against
patent
Kazazian escalated into a
rights
asserts
patentee
held that “where a
infringement
by Myriad against
suit
on certain
under a
based
identified
Pennsylvania,
la-
University of
which was
planned activity
par-
ongoing or
another
prejudice
ter
without
after the
dismissed
party
that it
ty, and where that
contends
University agreed to
all accused
cease
right
engage
accused
has the
testing
Myriad
BRCA
also sued
services.
license,
activity without
an Article III case
based
infringement
Oncormed for
1381;
controversy
will arise....”
Id. at
genetic
on its
As
testing
BRCA
services.
(“A
Prasco,
also
537 F.3d
see
Myriad’s patent
a result of
enforcement
injury
can
... an
patentee
cause
[suffi-
actions,
all
Dr. Ostrer was forced to send
controversy]
actual
in a
cient to create an
patient
Myriad,
the sole
samples to
now
variety ways,
example, by creating
diagnostic
provider
testing
of BRCA
ser-
infringe-
of an
apprehension
reasonable
vices.
suit,
demanding the
right
ment
[or]
Ostrer,
hand,
Dr.
maintains
other
(internal
royalty payments.”
omit-
citations
proceeded
that he could have
with his
ted)).
UISCA-related clinical activities without
case,
In this
Myriad
royalty
demanded a
taking
Myriad.
This asser-
license
patents
its
from Dr.
under
Ostrer based on
*17
patents
tion is
on his belief
based
that
clinical
In
his
BRCA-related activities.
Myriad claims cover such activities are
1998,
May
Director of
Myriad’s
Corporate
genes
invalid
are patent-ineligible
because
pro-
Communications sent Ostrer
letter
belief,
products of nature.
Acting
his
posing
collaborative license. The letter
Ostrer seeks
this lawsuit a declaration
aware
Myriad
stated
was
that Ostrer
of his
to
right
undertake BRCA-related
currently providing,
either
in-
was
or was
clinical activities without a license. Ac-
in initiating,
diagnostic
terested
BRCAl
Myriad and
have
cordingly,
Dr. Ostrer
testing
Myriad,
services and that
as holder
legal positions regarding
taken adverse
patents covering
of U.S.
the BRCAl
engage
whether or not Ostrer can
BRCAl,
diagnostic
testing
was
testing
infringing
genetic
BRCA
without
institution,
making available to his
NYU
any
to
DNAs
valid claim “isolated” BRCA
Center,
Medical
li-
a limited collaborative
“analyzing”
“comparing”
methods of
required
cense.
collaborative license
Myriad’s
as
sequences,
BRCA
recited
to
payment Myriad
NYU make a
to
patents.
Life,
at
See Aetna
300 U.S.
performed.
each non-research BRCA test
(holding declaratory judgment
Myriad seeks to avoid this result
boring
Myriad’s
under
threat of infringe
timing
based on the
of its enforcement
liability,
attempted
ment
has not
pro
to
Specifically, Myriad argues
actions.
that
BRCA
yet,
researcher,
vide
testing;
as a
extinguished
time has
immediacy
he
position
remains
the same
with
reality
any controversy,
of
re
relying on lan
spect to
pre-Med
guage
ability
that
his
and his desire to
pro
hearkens back to our
Immwne reasonable
vide BRCA
apprehension
testing
as in the late
of suit
1990s.
See,
e.g., Appellants’
Br.,
Furthermore,
test.
nothing
2010
sug
WL
the record
(“[A]
4600106, at
patentee’s ten-year
26
gests
researcher or institution has
Co.,
Myriad’s analogy
(Fed.
8.
to laches is also uncon-
Chaides Const.
960 F.2d
1041
vincing.
recovery
pre-
Cir.1992) (en banc) ("[Ljaches
Laches bars the
bars relief on
filing damages;
preclude
patent
it does not
patentee's
respect
claim
with
to dam-
relief,
prospective
type
action for
of relief
suit.”).
ages
prior
accrued
to
sought here. See A.C. Aukerman Co. v. R.L.
money
and for
compete
patient
to
with ed to the
which no
successfully attempted
added).
in any way
has
Myriad
(emphasis
or that
received.”
J.A.
Myriad,
regard
contrast,
with
to its
changed
agreement requires pay-
its
position
as active enforcement
rights.
Just
patent
Myriad
“Testing
ment
for each
Service”
against
can
patent rights
others
of one’s
performed,
“Testing
Services” de-
controversy
immediate
maintain real and
testing ...
laboratory
fined as “medical
Micron,
time, see
passage
despite
or absence of BRCAl
presence
too can the
F.3d at
so
successful
purpose
determining
mutations for
when the relevant
rights
assertion of such
to,
predicting predisposition
or assess-
Thus,
unchanged.
circumstances remain
ing the
cancer in
risk of breast
ovarian
purpose of the Declara
consistent with the
Thus, Myriad’s
humans.” J.A. 2966-67.
Act,
Judgment
Ostrer need not risk
tory
targeted
never
enforcement actions
damages for
in
liability
and treble
the non-clinical BRCA
now cited
research
seeking a
fringement before
declaration
by Myriad,
ability
perform
and Ostrer’s
See
legal rights.
contested
MedIm
his
injury
not
such research does
address the
mune,
134, 127
at
S.Ct.
here.
asserted
that the
Myriad
argues
also
record re-
Finally, Myriad argued
reply
in its
that he has
futes Ostrer’s claim
been re-
argument
brief and at oral
that Plaintiffs’
from
RifCA-related
engaging
strained
declaratory action will not
afford them
ar-
gene sequencing. Specifically, Myriad
want,
they
requirement
relief
for stand
gues
Myriad published
its dis-
since
ing.
560-61,
at
Lujan, 504 U.S.
genes
and BRCA2
coveries
the BRCAl
2130;
MedImmune,
see also
1996, respec-
in October 1994 and March
(“[A]
127 n.
litigant may
1323
ordinance,
exclusionary zoning
as the ordi-
Although we affirm the district
“an
nance stood as
absolute barrier” to the
court’s decision to exercise declaratory
housing development Metropolitan Hous-
judgment jurisdiction
case,
over this
we do
(“MHDC”)
ing Development Corp.
had so on
grounds.
narrower
The district
provide
village.
contracted to
in the
429 court
jurisdictional
failed to limit its
hold
252, 261,
U.S.
In this
on isolated
challenged compo-
DNA se
undisputedly pro-
sition and method claims
quences
suffering
or even
attenuated,
vide “an absolute barrier” to Dr. Ostrer’s non-proximate, effect from the existence of
ability
diagnostic
to undertake BRCA
test-
a patent does not meet
the Supreme
activities,
ing
and a declaration of those
requirement
Court’s
for an
legal
adverse
invalidity
claims’
would remove that barri-
controversy of sufficient immediacy and
er. See
at
II.
to
claims directed
Myriad’s composition
Act,
Patent
“Whoever
the
Under
molecules,
method
DNA
its
“isolated”
any new and useful
or
invents
discovers
“compar
or
“analyzing”
to
claims directed
manufacture,
machine,
compo
or
process,
a
claim to
sequences, and its
ing” DNA
and useful
matter,
any new
of
sition
potential cancer
screening
method
thereof,
patent
may obtain
improvement
each
turn.
We address
therapeutics.
re
conditions and
therefor,
to the
subject
of the
reviewing
applicability
the
Before
§ 101.
35 U.S.C.
this title.”
of
quirements
holding to the
Mayo
Supreme Court’s
consistently con
has
Supreme Court
The
however, it is
Myriad patents,
claims of the
explaining
“[i]n
that
broadly,
§ 101
strued
not
appeal is
to state what this
important
... modi
terms
expansive
choosing such
individuals
It
not about
about.
is
whether
‘any,’ Congress
comprehensive
by
fied
risk of
having an increased
suspected of
laws
that the
contemplated
plainly
cancer
entitled to
developing breast
are
v.
scope.” Bilski
given wide
would be
about whether
opinion. Nor is it
second
—
3218,
-,
130 S.Ct.
U.S.
Kappos,
Utah,
owner of the
University of
(2010) (quoting
3225,
792
177 L.Ed.2d
exclusive
Myriad,
patents,
instant
308,
at
100 S.Ct.
447 U.S.
Chakrabarty,
licensee,
improperly
its licens
has acted
2204).
respect to
policies with
ing or enforcement
Court, however, has
The
is also not
question
patents.
101, although
§
consistently held
also
company
for one
is it desirable
whether
broad,
Id. The Court’s
not unlimited.
is
covering a test
hold a
or license
judicially created
provide
lives,
three
precedents
or for other
people’s
save
may
§
patent-eligibili
101’sbroad
market
exceptions
be excluded
companies to
from
nature, natural
“‘Laws of
is
ty principles:
patent—that
such
encompassed
ie.,
are not
provided by
patent,
and abstract
ideas’
right
basic
phenomena,
practicing
patent
at
132 S.Ct.
1293
others
Mayo,
exclude
patentable.”
Diehr,
175,
It is
not whether
ed
matter.
also
subject
v.
450 U.S.
(quoting Diamond
(1981)).
novel or nonobvious
the claims at issue are
185, 101
issues not before us. As will be on § within meaning of 101. According to us, questions the limited before we con- Myriad, the district court came to a con- composition clude that the claims and the (1) trary conclusion misreading Su- screening involving claim growing a trans- preme precedent Court as excluding from formed host cell meet the standards for patent eligibility all “products of nature” patent eligibility, while the claimed meth- “markedly unless different” naturally from “analyzing” “comparing” ods for or do not. (2) ones; occurring incorrectly focus- ing not on the differences between isolated Composition A. Claims: Isolated DNAs, and native but on one similarity: DNA Molecules Rather, their informational content. Myri- argues, ad an isolated DNA molecule is i. is, patent eligible claimed, because it as “a principal patents claims of the nonnaturally be- occurring manufacture or fore us on remand relate to isolated composition of matter” with “a distinctive Mayo name, molecules. character, does not control the and use.” Appellants’ question patent-eligibility Br., such 2010 WL at 41-42 (quoting They claims. compositions are claims to Chakrabarby, 309-10, 447 U.S. at matter, 2204). expressly authorized as Myriad suitable contends that isolated patent-eligible subject § matter 101. DNA not does exist in nature and that claims, As to those DNAs, issue of patent- DNAs, isolated unlike native can be remains, eligibility as it was on the first used primers probes as for diagnosing court, appeal to they Moreover, whether claim Myriad cancer. asserts that an patent-ineligible products of nature. ultimately-derived-from We “products of na- they hold that do not. The isolated DNA ture” exception would be unwork- able, molecules before us are not is, found na- every composition as of matter They level, ture. are obtained in laboratory composed materials, some of natural man-made, and are product of human contrary but also would be to this court’s ingenuity. prepared While are precedents, from Utility PTO’s 2001 Exami- nature, products Guidelines, every so is other com- nation Congress’s role in position of All matter. new chemical enacting Regarding laws. molecules, biological by syn- Mayo, Myriad whether made argues that the Supreme thesis or decomposition, are made from Court’s decision did not address or alter natural example, materials. For virtually patent-eligibility established test for every by today’s claims, medicine utilized composition medical such that the stan- practitioners, every manufactured dards announced Chakrabarby gov- still plastic product, synthesized is either appeal. ern this To the extent that the (most natural petroleum general materials often principles discussed in Mayo bear fractions) claims, plant derived from natural Myriad the DNA maintains that But, such, they materials. represents nonnatural, different isolated DNA materials, from natural if they even are man-made invention distinct from the lack ultimately ingenuity derived from them. The same of human underlying the method is true of isolated DNA molecules. claims there at issue. *22 nature, products of since patent-ineligible to isolated that claims respond
Plaintiffs sequences exist because their nucleotide § 101 satisfy be- fail molecules evolution, man. not phenome- cover natural claims cause such According to of nature. govern- products argument, na and the At the first oral by way estab- a so- Plaintiffs, precedent position Court ment illustrated its Supreme (an inven- microscope” test “magic called pat- nature is not product that a lishes itself, not although probably tion in and claimed, if, it has un- even eligible ent Arg. at 46:50^47:50. Oral patent-eligible). change from useful highly dergone some then, if According government’s to the test assert, Rather, Plaintiffs natural form. its could focus in on imaginary microscope an mat- composition of eligible a patent to be it DNA molecule as exists the claimed name, have distinctive also ter must ineligible body, the claim covers the human use, “markedly character, making and ar- government The thus subject matter. In product. natural from the different” microscope could gued that because such case, conclude because Plaintiffs the claimed isolated BRCAl focus part of the same DNAs retain isolated they exist in the sequences as BRCA2 DNAs, they native sequence as nucleotide covering those body, human the claims char- “markedly different” any have do not In con- patent eligible. are not sequences Furthermore, according to acteristics. contended, trast, because government Plaintiffs, DNA claims isolated microscope could not focus imaginary nature, and laws of ex- products preempt which is sequence, vivo on a cDNA with the working cluding anyone together non- by splice man to engineered genetic information genes and the BRCA (ie., exons), contiguous coding sequences Plaintiffs as- convey. Mayo, they Under patent eligible. covering claims cDNAs are rela- differences structural sert sum, although parties In and genes do chromosomal BRCA tive to the that isolated appear agree government underlying natural “enough” to the not add matter, they compositions DNAs are Myriad’s render iso- genetic sequences to degree to what disagree on whether and under patentable DNA molecules lated exception such molecules fall within below, we of nature. As set forth products § 101. to iso- challenged that the conclude as amicus curiae does government DNAs, whether limited to cDNAs lated position longstanding not defend the not, subject patent-eligible are directed to PTO, agency, that isolated government § 101. matter under eligible, argu- patent DNA molecules are ground. Specifi- ing instead for a middle iii. argues that DNA cally, government con- Mayo and earlier decisions While man, including engineered
molecules provide cerning patentability method claim cDNAs,9 compositions patent-eligible broad, illuminate insights valuable because, exceptions, rare of matter Supreme principles, foundational nature, occur in either iso- do not Chakrabarty decisions in Court’s within a contiguous sequences lation or as primary frame- Funk Brothers set out contrast, government chromosome. deciding patent eligibility work for asserts, genomic matter, including isolated and unmodified isolated compositions molecules.10 eligible, but rather DNA DNAs are not cited Court decisions According government, several of the 10. Other to the suit, relating patented parties amici composition claims at issue in this in- compositions of matter patent, manufactures cluding claim 2 of the '282 are limited novelty, on lack of eligible. agree. We were decided based thus to cDNA and
1327
67,
Brothers,
In
Chakrabarty,
In
the Court addressed
Isolated
purified
oft-cited case held the
“Adrenalin”
larger,
of a
natural DNA
standing portion
subject
patent-eligible
to be
matter.
Id.
DNA has been cleaved
molecule. Isolated
similarly inap
are
The In re Marden cases
(i.e., had covalent bonds in its backbone
they
patent
are to the
severed)
posite, directed
chemically
synthesized
to con-
ineligibility
purified
natural elements—
just
naturally
sist of
a fraction of a
occur-
1046,
uranium,
47 F.2d
ductile
18 CCPA
ring
example,
DNA molecule. For
(1931),
vanadium,
18 CCPA
BRCAl
in its native state resides on
(1931)
inherently
intervention. See
447 U.S.
bond,”
of a “chemical
presumably meaning
(“the
313,
at
The above
consider
holding
aggregate]
independent
[the
as an
isolated DNA molecules to
patent-eligi-
species”
molecular
point.
underlines the
Bergy, relating
purified
synthetically produced,
11. In re
substantially pure
microor-
2-
952,
(CCPA 1979),
ganism,
acid,
F.2d
596
967-68
methyl-2-pentenoic
a chemical
companion
Chakrabarty
was once a
case to
gives strawberries their
flavor. 592 F.2d
but
vacated
was
Court and
1169,
(CCPA 1979);
King,
1170
see also In re
remanded for dismissal as moot when the
754,
618,
(1939) (hold-
27 CCPA
107 F.2d
619
inventors withdrew their claim from the
ing claims to vitamin C invalid
lack
pending application. Diamond v. Chakrabar-
novelty,
"[a]ppellants
as
were not the first to
1028,
696,
ty, 444 U.S.
100 S.Ct.
62 L.Ed.2d
produce
pure
discover or
[vitamin C]
its
(1980).
664
Other CCPA
cited
cases
Merz,
1314,
form”); In re
25 CCPA
97 F.2d
parties and amici were not decided based on
(1938) (holding
601
claims to artificial
patent eligibility.
Bergstrom,
re
In In
impu-
ultramarine that contains non-floatable
pure prostaglandin
court held that
com-
“inventive,”
rities invalid as not
and thus
PGE(2)
PGE(3),
pounds,
improperly
were
obvious).
rejected
lacking novelty.
as
57 CCPA
(1970);
Bergy,
427 F.2d
see
2 and 7
Claims
of the '282
(recognizing Bergstrom
F.2d at 961
a case
as
claim 7 of the '492
recite isolated
102).
§
Similarly
decided under
In re
cDNA molecules.
Kratz, the court held nonobvious claims to
limitations and conditions which
connect
laws
in this case
bonds
The covalent
” Bilski,
expressed,’
legislature
one another.
has
moieties to
chemical
different
Diehr,
at
450 U.S.
(quoting
at 3226
argue that because
Plaintiffs
1048),
repeatedly
and has
101 S.Ct.
the same
DNAs retain
isolated
the claimed
rejected
categorical exclusions
new
DNAs, they
native
sequence as
nucleotide
(rejecting
§
id. at 3227-28
scope,
101’s
see
char
“markedly different”
have
do not
pat
method
argument
that business
however, looks
approach,
This
acteristics.
categorically excluded from
ents should be
are marked
isolated DNAs
not at whether
314-17,
101);
Chakrabarty,
§
characteris
a distinctive
ly different —have
(same
living organisms).
DNAs,
occurring
naturally
tic—from
of the district
Contrary to the conclusions
directed, but at
has
Supreme Court
suggestions
of Plaintiffs and
court and
infor
key
one: the
similarity, albeit
one
amici,
applies equally
§ 101
to all
some
contained
isolated
mation content
inventions,
isolated DNA is
putative
sequences.
nucleotide
native DNAs’
special
not and should not be considered
court
approach, the district
Adopting this
un
purposes
patent eligibility
case for
*26
patent eligibility of isolated
disparaged the
See, e.g.,
Op., 702
existing
der
law.
SJ
func
genetic
because their
DNA molecules
(“DNA represents
at
the
F.Supp.2d
information. We dis
tion is to transmit
biological
informa
physical embodiment
nature of
it is the distinctive
agree, as
tion,
characteristics
distinct
its essential
compositions
molecules as isolated
DNA
in na
from
other chemical found
eligi
patent
that determines their
matter
ture.”);
Suppl. Br.
4-5
Appellees’
than
use or
bility
physiological
rather
their
(“Unlike
chemicals, the information
other
may
of chemical
benefit. Uses
substances
primary
reflects its
bio
by
encoded
of these
to the nonobviousness
be relevant
function....”).
logical
embodying
or to method
substances
uses,
eligibility
§
of an
patent
statutory
those
but the
rubric of
iso
Under the
negated
not
because it has
tangible,
compo
isolated DNA is
a
man-made
lated DNA is
a differ
properties
informational
distinguished
similar
sition of matter defined
ent,
complex natural material. The
more
objectively discernible chemical
its
DNA molecules are dis
claimed isolated
structure. Whether its unusual status as
por
tinct from their natural existence as
conveys
in
entity
genetic
a chemical
that
entities,
informa
larger
tions of
and their
un
singular
formation warrants
treatment
fact.
content
is irrelevant
to that
tional
court
patent
the
laws as the district
der
biologists may
think of
recognize
We
are not
policy question
did is a
we
uses,
genes
their
molecules
terms of
but
to address.
Nat’l Fed’n
entitled
Cf.
—
having
in fact
a chemical
are
materials
Sebelius,
U.S. -,
Indep. Bus. v.
and,
such,
are
described
nature
best
(2012)
2566, 2579,
innovation. One cannot visualize a composition claims are mere reflections of molecule, complex of a including a DNA a Respectfully, they law of nature. containing particular gene, a and will it not, any any product more than of man unique entity. into isolation as a Visual- ization par- does cleave and isolate the reflects and is consistent awith law of DNA; ticular act is the of human Everything everyone nature. comes invention. nature, following from its laws. But the compositions here are not natural prod- Mayo Court focused on They man, ucts. are the products of albeit permitting patents its concern that on par- do, following, all as materials laws of na- subject prevent ticular matter would use of, in Mayo, others the correlation re- ture. 5, 2015; Specifically, patent expire patent expire May 13. the '441 will on '282 will on 12, 2014; August expire the '473 will patents expire the '492 and '857 will on De- 2, 2014; on December the '999 and '001 cember 20, 2015; patents expire January will adequacy patents’ li- not the disclosure that “elemental indicates The dissent elements) (like not be Nor is it lack support particular would to claims. thium other matter, obviousness, if it subject even could patentability for as the dis- patentable through nature an intimates, only be extracted sent that is before us. the isolation here But process.” isolation finally attempts analogize The dissent to from extraneous simple separation is not a DNAs in this the creation of the isolated materials, to a different conversion but kidney a from the to the removal of case facts entity. again, And these molecular body, indicating that the latter does human us, attempt we do not to so are not before matter, subject patent-eligible not create patentability of one form evaluate the do claimed isolated DNAs also hence the cases; decide another. Courts lithium over Ex- analogy misplaced. not. an is Such comprehensive legal not draft do kidney body a from a does not tracting however, say, that if it to treatises. Suffice composition, in a as patent-eligible result than in the earth other lithium is found gene an has been and should be. isolated it reacts with air elemental lithium because kidney organ, A not a well defined form, lithium example, to and water composition matter or an article of man- hydroxide, it is a different oxide or lithium § specified by ufacture 101. No one could compound A lithium is not ele- material. to confuse extensive research needed lo- mental lithium. cate, identify, with the and isolate dispute to important It is also body. organ extraction of an from a One analogy snapping leaf from dissent’s patents is what are intended stimulate no one could contem respect, tree. With properly patent and hence are research on from a tree plate snapping leaf other, obviously eligible, and the while es- worthy patent, of a whereas iso would be wellbeing, sential to human is not what lating genes provide diagnostic useful patents are understood to cover under the surely what tools and medicines is prop- statute. An isolated DNA is encourage patent laws are intended erly composition characterized as a of mat- a leaf from a tree is a protect. Snapping *28 101; § ter no one would so charac- under by anyone. physical separation, easily done body organ. terize an isolated entity is the work Creating a new chemical Finally, our decision that isolated DNA transformation, skill, requiring of human eligible comports patent molecules are Mayo, and effort. See 132 knowledge, longstanding practice with of the (“While a truth ... S.Ct. at 1294 scientific Supreme PTO and the courts. The invention, patentable a novel and is not changes that repeatedly Court has stated with the aid of useful structure created be.”) may longstanding practice should come knowledge of scientific truth Tel. Co. v. Ra In (quoting Mackay Congress, Radio & not courts. 94, Am., 86, Corp. dio 306 U.S. Ag Supply, Inc. v. Pioneer Hi- J.E.M. (1939)). 427, 506 Inc., 83 L.Ed. International, the Court re- Bred jected plants that did not argument times The dissent also mentions several 101, relying § fall in scope within the opinion “breathtaking! breadth ]” its fact that has as- part on the “the PTO grounds objecting of certain for claims as for at signed utility patents plants However, patentability. to their we do not been no in- years least 16 and there has any rejection have here or invalidation on Congress agencies from either breadth, dication relating to grounds the various in- expertise coverage that such is § 112. The such as 35 U.S.C. issue 101, § patent law].” under consistent with 534 U.S. eligibility [federal before us is
1333 144-45, 593, 124, rope far-reaching 122 151 L.Ed.2d careful not to off S.Ct. areas (2001); Corp. Festo v. Shok see also patent eligibility. 508 Co., 535 Kogyo Kinzoku Kabushiki etsu Accordingly, again we once conclude 739, 1831, 722, 152 1, 2, 5, 6, that claims and 7 of the '282 (2002) (“[C]ourts must be L.Ed.2d 944 1, 6, patent; and 7 of the '492 changes that adopting cautious before patent; and claim 1 of the patent '473 of the in disrupt expectations the settled directed to isolated DNA molecules recite venting community.” (citing Warner-Jen subject patent-eligible § matter under Co., v. Hilton Davis Chem. kinson Co. Mayo change does not that In result. so 1040, 17, 28, 117 S.Ct. doing, we reiterate the issue before us Pharms., (1997))); Ariad L.Ed.2d 146 eligibility, patentability, Co., Lilly 598 F.3d Inc. v. Eli & express opinion. about which we no (Fed.Cir.2010) (en banc) (upholding description requirement sepa a written III. Method Claims part based in rate from enablement turn Myriad’s We next to chal decisis). stare lenged method claims. This court in its case, In patents the PTO has issued 29, 2011, July now-vacated decision of had thir- relating to DNA molecules for almost '999, '001, held method claims of the and 1980s, ty years. early In the the Office patents, '441 as well as method claims 1 gene patents. the first human See granted 2 of the '857 of which Rogers, Eric Patent J. Can You Genes? —all analyzing comparing consist of certain No, Pat. & Trademark Off. Yes and 93 J. sequences (2010). patent-eligible to be Soc’y 19 It is estimated that the —not 2,645 subject claiming ground matter on the patents PTO has issued past twenty-nine DNA” over the processes. “isolated claim abstract mental In years, and that had J.A. light Court’s decision in 40,000 granted patents DNA-related relat- Mayo, we reaffirm that prior holding. to, form, ing non-native diagnostic The Court made clear that such genome, Rogers, supra human at 40. in that essentially methods case claim nat Utility the PTO issued Examination ural eligible patent. laws are not Guidelines, agency’s which reaffirmed expressly analyzing Without the instant position that isolated DNA molecules are method claims in the context the Court’s (Jan. patent eligible, Fed.Reg. 1092-94 reasoning, light but in of the Court’s hold 5, 2001), Congress has not indicated ing, prior view of our own reason *29 position that the is inconsistent with PTO’s below, ing, set forth herein those method changed, § If to the law is be and cannot stand. from DNA inventions excluded the broad decision, however, prior In our re-we § scope contrary of to the settled holding versed the district court’s that expectation inventing investing and patent eligible claim 20 of the '282 was not communities, come, not the decision must patent. ground, We did so on the inter courts, Congress. from but alia, that, step in addition to the of com- effects” possible dissent mentions “adverse rates, claim paring growth the cells’ may that occur if DNAs are held isolated steps growing also recites the of trans- But, patent eligible. respectfully, to be determining growth cells those formed and that a is the adverse effects on innovation on the fact that those rates. We relied holding ineligibility might of cause. Pat- Although the steps were transformative. en- encourage ents innovation and even around; now held that transfor- courage inventing we must be Court has certain 1334 they § claim abstract necessarily sufficient 101 because are not steps
mative Benson, steps only rely at processes. § if the recited mental See under laws, (“Phenomena nature, again, once even on natural we at the same conclu- light Mayo, arrive processes, ... mental and abstract intel- patent-eligibility because sion patentable, are not as concepts lectual cell, of claim 20 is transformed heart are the basic tools of scientific and techno- man, in contrast to a by is made which work.”). recite, logical The claims for ex- natural material. ample, screening a “method for a tumor sample,” by “comparing” a first BRCAl “Comparing” A. or Methods sequence sample from a tumor and a sec- “Analyzing” Sequences sequence ond BRCAl from a non-tumor claims to meth- Myriad argued its sample, sequence wherein a difference “analyzing” BRCA “comparing” ods of an alteration in the tumor sam- indicates satisfy the machine-or-transfor- sequences '001 claim 1. This claim thus ple. requires mation test each trans- because nothing more than the abstract recites extracting sequencing formation — necessary to steps compare mental two human sample- DNA molecules from a sequences: different nucleotide one looks can sequences compared before the position sequence; at the first in a first Myriad, the analyzed. According to dis- sequence the nucleotide at that determines recognize the transfor- trict court failed to position first looks at the first position; (1) mative nature of the claims miscon- sequence; a second determines the nucleo- “sequence” as struing the claim term sequence position; tide at that first deter- information, merely physical rather than a position if at the first mines the nucleotide (2) molecule; erroneously concluding, sequence position in the first and the first alternative, Myriad’s proposed in the sequence in the second are the same or data-gathering were mere transformations different, latter wherein the indicates purpose than to the steps, rather central alteration; repeats process for the the claims. position. next responded Plaintiffs that these method just Limiting comparison claims are drawn to the abstract idea or, the BRCA the case of claim comparing one to a reference sequence just sequence preempt phenomenon patent, of the '999 the identifica alterations, genetic nature —the correlation of muta- particular tion of fails to ren And, predisposition tions with a to cancer. patent-eligible. process der the claimed Plaintiffs, according limiting held, to the pro As the Court has “the technologi- application specific claims’ against patenting hibition abstract ideas field, ie., sequences, cal BRCA attempting ‘cannot be circumvented insufficient to render the claims particular limit the the formula to a use of ” eligible. Plaintiffs also assert Bilski, technological environment.’ the machine-or-trans- claims do not meet Diehr, (quoting S.Ct. at 3230 450 U.S. at *30 plain formation test because the claims’ 191-92, 1048); see id. at also language just step includes the one of (“Flook limiting established “comparing” “analyzing” or two se- one of use ... did not abstract idea to field quences. concept patentable.”). Although make the application the of a formula or abstract Myriad’s
We renew our conclusion that
may
process
patent-
idea
describe
“comparing”
“analyzing”
claims to
or
two
matter,
subject
Myri-
id. at
gene sequences
scope
eligible
fall outside the
of
apply
step
the
of com-
subject,
ad’s claims do
bolite levels
the
wherein the
in a
paring
sequences
pro-
two nucleotide
measured metabolite
compared
levels are
Rather,
step
comparing
of
two
cess.
predetermined
with
optimize
levels to
drug
sequences
process
DNA
is the entire
In
dosage.
holding
Id.
the claims
claimed.
§
that,
satisfied
court
concluded
in addition to the “administering” step be-
result, Myriad attempts
To avoid this
transformative,
additional,
ing
“determining”
step
read into its method claims
al-
legedly transformative
de-
steps. As
was both transformative and central to the
above, Myriad
Prometheus,
scribed
reads into its claims purpose of the claims.
(1) extracting
DNA
steps
from a
However,
F.3d at 1357.
the Supreme
(2)
sample,
sequencing
human
steps
Court held that the
of administering
molecule,
DNA
arguing
BRCA
that both
determining,
combined with a correla-
necessarily precede
step
steps
com-
clause,
tive “wherein”
sufficiently
were not
paring
sequences.
nucleotide
The claims
transformative of what was otherwise a
themselves, however, do not include either
claim to a natural
holding
law. That
gov-
steps.
specify
of these
The claims do not
Myriad’s
erns
claims to methods of “com-
any
step
action
prior
“comparing”
paring” and “analyzing”
sequences.
DNA
“analyzing”
sequences;
or
two
the claims
Myriad’s other claims do not even in-
just
step
“comparing”
recite
the one
or
Mayo-like
clude a
step
“determining”
Moreover,
“analyzing.”
plain
those terms’
sequence
genes
by, e.g.,
BRCA
isolat-
meaning
Myriad’s pro-
does not include
ing
sample
from a blood
posed sample-processing steps; neither
them,
sequencing
other putatively
comparing
analyzing
implies
nor
means or
Rather,
step.
transformative
compari-
“extracting”
“sequencing”
DNA or oth-
sequences
son between the two
can be
“processing”
sample.
a human
erwise
accomplished by mere inspection alone.
Myriad
“comparing”
claims that
Accordingly, Myriad’s claimed methods of
“analyzing” take on
meaning
such
when
comparing or analyzing nucleotide se-
light
patent specifications.
read in
quences
only
are
directed to the abstract
Specifically, Myriad argues that the speci-
process
mental
of comparing two nucleo-
fications show that
the claim term “se-
such,
sequences.
tide
As
we hold claims 1
information,
quence” refers not
but
patent,
of the '999
'001 patent, and '441
molecule,
physical
rather to a
whose
patent and claims 1 and 2 of the '857
sequence must be determined
it can
before
§
invalid
claiming
under
101 for
true,
compared.
may
That
be
but the
patent-ineligible processes.
steps,
recite mental
not the
physical
structure of
DNA molecules.
B.
Screening
Method of
Potential
Myriad’s
Accordingly,
challenged meth-
Therapeutics
Cancer
od claims
indistinguishable
from the
Lastly,
turn
we
to claim 20 of the
claims the
Court found invalid
patent,
'282
directed
method for
§
Mayo. Mayo,
pat-
under
101 in
screening potential
therapeutics
cancer
via
ents claimed
optimizing
methods for
changes
growth
cell
rates of trans
dosage
thiopurine
drugs administered to
parties agree
formed cells.- The
that those
patients
gastrointestinal
disorders.
effort;
transformed cells arose from human
written,
1337
machine, manufacture,
process,
or absence of
and useful
presence
in the
grown
matter,
any
or
new and
According-
composition
or
therapeutic.
type of
specific
thereof’ to obtain a
improvement
useful
pat-
claim 20 of the '282
hold that
ly, we
language of this statute
patent.
plain
The
subject matter
patent-eligible
ent recites
that an invention be “new
only requires
processes,
§
such
101. Whether
under
useful,”
into
four cate
20,
and fall
one of
other tests for
including claim
meet
machine, manufacture,
gories:
“process,
novelty or
such as
nonobvi-
patentability,
in
composition
“Congress
of matter.”
ousness, is not before us.
statutory subject matter to ‘include
tended
anything
under the sun that is made
Conclusion
”man.’
v.
Chakrabarty,
Diamond
U.S.
reasons, we affirm the
foregoing
For the
2204,
303, 309,
100 S.Ct.
65 L.Ed.2d
exercise declara-
court’s decision to
district
(1980) (quoting
statutory history).
case,
jurisdiction over this
tory judgment
grant
court’s
plain language
we reverse the district
Wdiile the
used
Con
regard Myri-
to
summary judgment
gress
scope
patentable
with
did not limit the
DNAs,
statute,
subject
composition claims to isolated
matter in the
the “Court’s
ad’s
cDNAs,
affirm the district
including
precedents provide
specific excep
we
three
summary judgment
§
with
grant
patent-eligibility
court’s
tions to
101’s broad
nature,
Myriad’s
phe
method claims directed
regard
principles:
physical
to
‘laws
”
nomena,
analyzing gene sequences,
comparing
to
and abstract
ideas.’ Bilski v.
—
-,
3218,
grant
court’s
of Kappos,
and we reverse the district
130 S.Ct.
(2010)
Myri- 3226,
summary judgment
regard
(quoting
with
to
pure products,
reconsider whether
the claims at
We
utility.” Chakrabar
significant
tential for
patenta-
in this case are directed to
issue
310, 100
ty, 447 U.S.
following
matter
the remand
subject
ble
contrast,
light
of its
purification
mere
of a natu-
Court
v.
rally
typically
opinion Mayo
is
insuffi-
Collaborative Services
occurring element
—
Laboratories,
Inc.,
patentable subject matter.
Prometheus
cient to make it
-,
court held
the chemical
diagnostic genetic
cules as the basis for
(breaking
DNA
the covalent
and isolated
clearly
“enlargement
of the
testing is
bonds),
is suffi-
agree
I cannot
that
utility”
compared
...
to na-
range of
claims to human
cient to hold that
Bros.,
ture. Funk
subject
patentable
are directed to
Prometheus,
genes are a
agree
matter.
I
that isolated
at issue were
held that the claims
Court
molecule and are therefore
different
subject
patentable
matter
not directed to
miner-
analogous
unpatentable
squarely
they merely “set forth laws of
because
als,
by nature without
assis-
created
namely,
relationships
between
nature —
DNA
of man. The claimed isolated
tance
in the
of certain metabolites
concentrations
(with
molecules,
dif-
which are truncations
dosage
of a
and the likelihood that
blood
ends)
naturally occurring
of the
ferent
drug
prove
will
ineffective or
thiopurine
chromosome
part
DNA found as
of the
at 1296-97. The
cause harm.” 132 S.Ct.
nature,
naturally produced without
are not
consequence of
relationship was “a
claimed
of man.
the intervention
my reasoning
patent,
portions
pie claim 6 of the '282
to shorter
2. To the extent the claims
sequences
the isolated
naturally occurring
is the same as for
se-
of cDNA include
chromosome,
discussed below.
for exam-
claim
quences found in the
thiopurine compounds
support my
in which
ways
conclusion that small isolated
body entirely
nat-
molecules are directed to patent-
metabolized
—
eligible subject
processes.”
ural
Id. at 1297.
matter. The dissent ex
plains why the baseball bat is directed to
suggestion
There is no
that the human patent eligible subject matter: “man has
body naturally
primers
uses 15-mers as
parts
defined the
that are to be retained
DNA,
synthesize
or
the attendant
discarded,
parts
and the
that are to be
process
“probing”
patient’s
DNA to
he has
portion
molded the retained
into a
detect a mutation is somehow a natural
product
that bears little resemblance to
ability
law. The
to use
short strand of
that which
naturally.”
occurs
Dissent at
primer
probe
DNA as a
to determine
1353. The exact
thing
same
is true with
patient
whether a
has a mutation is a new regard
primer
probe
claims. Man
important utility substantially
differ
has whittled the chromosomal DNA mole
ent
from the role of
DNA as it occurs
cule
sequence—
down to
15 nucleotide
Indeed, many
plaintiffs
nature.
defining
parts
to be retained and disc
in this case submitted declarations indicat
arded.3
product
And the result is a
ing
wanted to either offer such a
(primer
probe)
function
that is entire
testing
testing.
or receive such
Unlike
ly
different
the full
from which
Prometheus,
the claims to short isolated it was obtained.4 I conclude that
strands of DNA are not directed to the
*37
small, isolated DNA molecules are an al
relationship between the mutation and teration of the
product
natural
“with mark
cancer, but rather to a new tool that can edly different characteristics
any
from
be
if
relationship
used to determine
found in
having
nature and one
poten
the
exists. The short
sequences
isolated DNA
tial for significant utility.” 447 U.S. at
markedly
have
properties
different
which 310,
bined with the different and beneficial util
issue,
example
for
'282
claim are
ity that leads me to conclude that small
claims,
genus
broadly enough
drafted
to
isolated DNA fragments
patentable
are
include both
fragments
short
as
aswell
subject
matter.
Id. at
from organic germs of
issued to
of patentable subject
argued
matter
in this
1873);
Louis Pasteur
Berg
In re
cf.
case
destroying
“risk[s]
legitimate
ex-
strom,
57 CCPA
1345 (3d Nature the Chemical Bond 6 sought the PTO to strike The various balances ed.1960)). numerous which issuing patents the when and which would be yet expired not have The dissent claims that the Patent Of- ” Festo, decision.’ 535 U.S. affected our views past “substantially fice’s under- (quoting Warner at S.Ct. position government mined the the has Co., v. Hilton Davis Chem.
-Jenkinson Co. in this Dissent at taken case.” 1357-58. 6, 117 n. prior practice, Patent The Office’s howev- (1997)). L.Ed.2d 146 er, particularly important is since it result- large property rights ed in a number of Although Patent has consis- Office past government If the over the decades. for a dec- tently policy the same followed change to course in decided the Patent (and more), century a arguably ade Office, patents and decline to issue new States, amicus, argues as an now United genes, impact it isolated would these published guide- that Patent Office’s This, however, existing property rights. and a lines are incorrect misstatement government argues not what the in this these place guidelines, the law. In government case. Instead the argues “magic mi- suggested government entirely interpretation different of the croscope” provide metaphor useful would destroy existing law that would property analysis. section guiding our Although points rights. the dissent out however, not see magic microscope, would Chakrabarty overturned the Patent in this the claimed DNA molecules at issue practice denying patents to mi- Office’s dif- An DNA molecule has case. isolated croorganisms, there is clear difference compared ferent chemical bonds allowing patent protec- additional between in the chromosome sequence “unisolated” existed, previously where none tion different). (the short, ends are (or protection denying patent decades cen- in nature claimed cannot seen molecules turies) fact, thereby eliminating after the microscope. you through magic While rights. large property number Chakra- of DNA may be able to see order barty, language consistent with the broad chromosome, the isolat- nucleotides in the statute, patents of the allowed additional fragment is a different mole- ed of DNA previously none existed. In con- where Creating cule. the claimed isolated trast, government proposes destroy distinctly sequences results in a therefore existing property rights judge based on a dissent unnatural molecule.7 Even the exception made to that same broad lan- at agrees the isolated DNA molecules step This is a that I guage. dramatic bonds, require cleaving chemical issue Congress. best left believe is importance though disputes the ” “ Nevertheless, government claims resulting species.’ distinct ‘molecular pure is a Pauling, question that “this law” (quoting Dissent Linus *40 1350-51 contrast, occurring why an iso- government’s lithium salts. 7. This also illustrates the elements, sequence necessarily DNA did not exist analogies dealing with lated to situations lithium, reacting produce example Even further to the corre- inapposite. are before naturally occurring assuming sponding that chromosomal government’s contention the salt, currently Unlike a lithium the chromosome exist in isolated DNA. lithium does not nature, imply an isolated DNA molecule clear that does not that form in it is nevertheless lithium, building pro- even a block of 15 nucleotides—or elemental basic —necessari- nature, ly by point previously have existed as isolated molecule at some must vided with, naturally e.g., in nature. water to form the reacted ignore feel to there many that we can therefore free “that institutions ... years practice patents Patent Office and the have human genes,” extensive on H7248, H7274, expectations practice Cong. Rec. it accompanying explicitly industry. govern- legislation The to implement created within declined to “af argues ment that we should not defer to fect of those current existing pat (all language unchanged 149 Cong. broad but ents.” Rec. E2417-01. To the 1793) Congress contrary, since it provided language made clear that the statute, or allow patent Congress to decide to “human organisms” related was not in necessary change whether to correct the Pat- to poli it is tended the Patent Office’s legislation. through cy respect ent Office’s practice genes, to claims to stem judicial power cells, It is to use our tempting other similar inventions.8 Far fashion, especially when the to patents patenting genes, from oblivious question substantial and ethi- Congress raise moral pass introduced and declined to cal to awarding property put issues related bills which several would moratori of human DNA— n right portions to gene patents,9 isolated um on funding authorize humans, very thing study makes us genes ought for the of whether not chimpanzees. patentable,10 exempt patent infringement anyone patented uses who I tempting, The invitation is but decline genes for non-commercial research pur opportunity Congress to act where poses medical practitioners who use has to. Congress chosen not at least im- genetic diagnostic Congress tests.11 plicitly approved of the Patent Office’s obviously presented aware of the issues policy awarding patents on I “[a]ny this case and believe recalibration For sequences. Congress example, of the standard of [patentability] remains included, part of the Patent Office’s Ltd., Corp. v. 141 its hands.” Microsoft appropriations, language affirming the — -, 2238, 2252, U.S. interpretation Patent Office’s of section (2011). L.Ed.2d 101 to prohibit patents on organ- human Act, isms. Appropriations Consolidated judiciary in an ad engage The cannot 108-199, 634, § Pub.L. No. hoc innovation-based analysis, 118 Stat. which is Although 101. Congress was aware why exceptions patentability apply point 8. (S.387 "What I want to out is that Gene mal and Patent Bill Moratorium already Patent has patents issued 1993). on Office cells, genes, genes, stem animals with human non-biologic products a host of used Genomic Technology Science and In- humans, patents but has not issued (H.R.3966). Act novation of 2002 organisms, claims directed to human includ- ing embryos My human and fetuses. amend- Diagnostic 11. The Genomic Research and Ac- former, ment would but not would affect (H.R.3967). cessibility Act of 2002 As the simply Cong. the latter.” affirm Rec. sponsor explained: important bill’s "It is added); (emphasis E2417-01 see also 157 note that this section would overturn the Cong. (resubmitting Rec. 177-04 El this testi- rights commercial holders. If a mony in the context of the current [organization] utilizing exemp- research legislation). reform commercially finding, tion makes a viable he negotiate any rights or she would still have Congress 9. At least bill one was introduced in *41 put discovery patents patent to to the new moratorium on to human market with the See, sequences. or e.g., Cong. The Ani- 148 holder.” Rec. E353-03.
1347 nobody far I can as tell ever a new mineral but to clearest cases: only the organs thought isolating from someone’s earth, plant or a in the new discovered discovery “that body was the kind of the E=mc2, wild, or law of or the in the found to protect.” was con- statute enacted Congress, with “the consti It is gravity. trast, prod- purifying isolating natural the authority and institutional tutional historically exactly has been the kind ucts fully the varied ability accommodate to discovery protected stat- that interests permutations competing century-long history There is a utes. by such new tech inevitably implicated are affirming patent protection isolated Corp. America v. Univer nology,” Sony biological products ranging purified 431, Studios, Inc., 417, 464 U.S. City sal proteins to vitamins to to from hormones (1984), who 78 574 104 L.Ed.2d S.Ct. must antibiotics. These inventions have to necessary it is whether must decide time, at providing seemed miraculous change scope of section to exclude unknown options previously therapeutic to at issue isolated DNA claims the kind of The fact these treat sickness. that mole- not clear to me that Chakra here. It is might have existed in nature did cules not Brothers, or Prometheus barty, Funk in view of protection foreclose conclusion that iso inexorably leads extraordinary benefits accessible man patentable are not lated DNA molecules after isolation. subject I the invitation matter. decline exception. the law of nature broaden has, The Patent Office for more than a decade, affirmatively stated its belief that complicated technology Given DNA is for the patentable isolated same here, any at issue conflicting incentives reasons as isolated vitamins or hormones. Congress. change come from See must Congress There is no indication from that 72-73, Benson, 409 U.S. v. Gottschalk wrong; contrary, this view is to the (A (1972) 34 L.Ed.2d appears Congress also believes DNA is analysis raises “considerable section long-term policy This patentable. pro- ... which committees problems DNA has tecting isolated molecules result- powers for broad Congress manage, can explosion ed in an of innovation in the needed, including hear- investigation are which, industry, industry biotechnology an variety of ings which the wide canvass industry unlike the financial services in this field operating views which those depends industry, even software technological problems entertain. patents Holding to survive. isolated DNA ... [by parties] indicate to us tendered destroy long patentable would settled by the Congress that action considered industry expectations for no reason other needed.”). gut feeling is too close to than DNA arbitrary patentable,
nature to be an deci- judge-made exception. I sion based on TV. fragments, isolated DNA believe that discovery law of rule that of a “The changes have both chemical which patented rests ... on the nature cannot be occurring DNA as naturally genomic understanding ... fundamental utility, kind of well as new “the ‘discov- kind are not the of ‘discoveries’ to pro- that the statute was enacted eries’ Flook, protect.” was enacted to I decline to extend the statute tect.” therefore exception iso- S.Ct. 2522. Is “laws of nature” include not, sequences. kidney patentable? Probably lated isolated *42 1348 typifies by BRYSON, an Judge,
This case
observation
Circuit
concurring
part
dissenting in
Judge Markey,
part:
our first
and
late Chief
Chief
Judge,
“[o]nly
from noth-
God works
I concur
portions
with the
of this court’s
old
ing. Men must work with
elements.”
judgment
that are directed to standing,
Plate, Inc.,
Fromson v. Advance
Offset
patentability
claims,
of the cDNA
and
(Fed.Cir.1985)
1549,
n.
(quota-
F.2d
1556 3
patentability
of the method claims.
I
omitted).
tion,
is,
Human DNA
citations
respectfully dissent from the court’s hold-
worse,
for better
one
old ele-
ing that Myriad’s
gene
BRCA
claims and
to
bequeathed
ments
to men
use in their
gene
its
fragments
patent-
claims to
are
patents
work.
in this case
The
revealed a
view,
eligible.
my
In
those
are not
understanding
new molecular
about our-
matter,
patentable subject
directed to
and
selves; “the
most benefiting
inventions
decision,
sustained,
if
likely
court’s
will
‘push
those
mankind are
back the
have
consequences,
broad
such
chemistry, physics,
frontiers of
and the
preempting
whole-genome
methods for
se-
316,
Chakrabarty,
like.’”
at
U.S.
100 quencing,
though Myriad’s
even
contribu-
(quoting
S.Ct. 2204
A. & P. Tea
Great
Co.
tion to
remotely
the field is not
consonant
147,
v. Supermarket Corp.,
with such effects.
(1950)).
71 S.Ct.
1349
(claims
2
7 of the
and
'282
and
Familial Breast Can-
age
Early-Onset
of
patent);
250
7 of
'492
and claims that
17q21,
Science
claim
the
to Chromosome
cer
(1990).
Myriad
genes
not invent a
the
portions
And
did
cover
of
BRCA
and
1684
sequencing.
In-
long
of nucleotide
as
as 15
new method
cDNA
small
nucleotides
stead,
(claims
tech-
sequencing
known
applied
patent).
5
of the
I first
and 6
'282
the nucleotide
of
identify
to
order
niques
genes.
the claims to the BRCA
address
discovery of
genes.1 Myriad’s
BRCA
work,
difficult
sequences entailed
those
A
sequences have
im-
had
and
identified
fight against
portant applications in
In the
case of
v.
seminal
Diamond
discovery
But
of the
cancer.
breast
303,
2204,
Chakrabarty, 447 U.S.
100 S.Ct.
fact,
unprotectable
just
sequences is
(1980),
L.Ed.2d 144
Court
65
discovery
Dr.
of the chromo-
King’s
like
held that an artificial life form could be
gene.
of the
somal location
BRCA1
opinion,
In the course
its
patented.
of
and
critically
reasoning,
of its
purposes
course, Myriad
patent appli-
is free to
Of
living
not
things
stated that
all
Court
discovery.
party
As the first
cations
its
subject
were
other items found
nature
Myriad
knowledge
sequences,
of the
explained
The Court
that
patenting.
to
to claim
position
appli-
in an
was
excellent
although
language
section 101 of the
Many of its
knowledge.
cations of that
broad, it
Patent Act is
is not
case that
limited
such
unchallenged claims are
every
no
or that
it “has
limits
it embraces
See, e.g.,
patent,
'441
claim
applications.
309,
discovery.” Id. at
and making those that alterations are at- B tendant to their extraction does not give right extractor the prod- Myriad’s claims to the isolated BRCA ucts themselves. genes clearly seem to me to fall on the “unpatentable” side of line the Court majority The characterizes the isolated Chakrabarby. drew in Myriad is claiming genes new as molecules considers themselves, the genes appear which in na- them different substances from the corre- ture on living the chromosomes sponding human native DNA.2 Because native beings. only change material genes made to BRCA are chemically bonded to oth- Although recognize conclusions, Judge I analytical Lourie and mate paths have taken Moore, Judge reaching while respects, same ulti- some differ in I convenience does natu- majority pie, isolated lithium not occur proteins, and histone er genes rally water bonds iso because reacts air and cleaving those concludes part and thus is found nature genes turns isolated the BRCA late compound, ionically bound to materials.” Yet a chemical into “different Krebs, The bond that other elements. Robert E. magic no a chemical there is *45 product History Our Chemical a new and Use Earth’s recognize us to requires of ed.2006). (2d isolated, Elements 48 Once chemical bond is created bro when a many applications, lithium industrial ken, when atomic or molecu has not other but lithium, in A chemical bond is order to isolate it is neces- lar are altered.3 forces in lithium sary two atoms or break ionic bonds the merely a force between compounds “to that are found in nature. But strong enough atoms make it groups of (like plain the consider it seems that elemental lithium for chemist to [the convenient elements) an other would not independent patentable as molecular be aggregate] matter, if subject The even species.” Pauling, Linus Nature it could of ed.1960). (3d nature through the Bond 6 Weak extracted from an isolation Chemical when, process. be broken er interatomic forces will example, dirty for a diamond is cleaned analysis The principles underlying that solvent, but or another
with water
apply
genetic material as
In order
well.
make the
diamond a human-
does not
clean
necessary
gene,
to isolate the BRCA
it is
Growers,
Fruit
made invention. See Am.
gene
to break chemical bonds that hold the
Co.,
1, 12, 51
Brogdex
Inc. v.
place
body,
genetic
in its
in the
but the
(1931)
(cleaning a
patentable unless it results in a functioning marked genes, and to their utili- Merz, change functionality. ty In in their re 25 isolated form. The use to which (hold (1938) 1314, 599, genetic i.e., 97 F.2d 601 material can put, CCPA be deter- mining sequence its in a clinical ing right setting, that there was no to a use; not a ultramarine, only new it is purer consequence recog version of but possession. sequence order to an iso- nizing that if a claimed article is “of such gene, gene lated each must function purity degree that it differs not but same laboratory manner as it does may in kind it patentable”); see also In Indeed, in the human body. identity 754, 618, King, re 27 CCPA 107 F.2d of function in the isolated key is the (1939)(same, C); purified vitamin In re to its naturally value. The occurring ge- Marden, 18 CCPA F.2d netic material thus has not been altered (1931) (same, vanadium); purified Gen. way that would matter under the stan- Co., Elec. Co. v. DeForest Radio 28 F.2d dard set forth in Chakrabarty. For that (3d Cir.1928) (same, for purified reason, the isolation of the naturally occur- hand, tungsten). purified On the other ring genetic material does not make the natural patentable substance is if “pu claims to the isolated BRCA patent- rification” results in a product with such eligible. distinct characteristics that it becomes “for every practical purpose a new thing com The Supreme Court’s recent decision in
mercially and therapeutically.”
Parke- Mayo Collaborative Services v. Prome-
Co.,
Davis & Co. v. H.K.
189 F.
Mulford
—
Laboratories,
Inc.,
theus
-,
(C.C.S.D.N.Y.1911);
see also
1289, 1293,
is a
perform
how to
such
it is known
“[i]f
II
likely
doing
product
so ‘is
an isolation
ordinary skill
noted,
not of innovation but of
to the BRCA
As
addition
”
above,
Aventis
Pharma
sense.’
the claims at issue
common
discussed
claims
Ltd.,
Lupin,
four claims to BRCA
appeal
v.
include
Deutschland GmbH
(Fed.Cir.2007),
of the
quoting
portions
claims to
cDNA and two
F.3d
Inc.,
as small as 15
genes and cDNA
Teleflex,
550 U.S. BRCA
Int’l
v.
KSR
Co.
long.
705 nucleotides
398, 421,
167 L.Ed.2d
Myriad
I
with the court that the
agree
easily
could
have claimed more
eligible
narrowly
for patenting.
BRCA cDNA
to achieve the utility it attaches
nature,
The cDNA cannot
from
segments
be isolated
of cDNA. It contends that
but instead must be created in the labora-
those segments can be
probes
used as
tory.5 The
product
primers.
end
is a human-made
probes
chemically
must be
invention with distinct structure because
altered or “tagged”
before
can be so
used,
the introns that are found in the
Myriad
native
could have claimed the
gene are removed from the cDNA seg-
tagged segments to
probe
achieve
func-
Additionally, the
tionality.
ment.
cDNA has a utili-
A claim
tagged segments
ty
in the
present
naturally occurring
would not encompass the BRCA1 exons.
BRCA DNA and mRNA
primer
because cDNA As to
functionality, many of the
promoter
can be attached to a
and inserted
cDNA segments will not work. Some will
into a non-human cell to
protein
drive
ex- be
long.
too
Some will be too short.
pression.
palindromic
Some will be
and fold in on
Myriad
themselves.
could have identified
However, disagree
I
with the court as to
a subset of the segments that work as
segments
two claims to short
of DNA
primers, and such a claim
patent-
could be
having at least 15 nucleotides. Claim 6 of
able if it
species
were limited to
any sequence
the '282
covers
of the
“markedly different characteristics
BRCA1 cDNA
is at least 15 nucleo-
any found in nature
having
and ...
long.
tides
That claim encompasses each
potential
significant utility.”
Chakra-
exon,
though
BRCA1
even
each exon is
barty,
innovation medicine— authority as rulemaking lacks substantive New sequencing. whole-genome and tests patentability. Animal to issues such as to se- being developed technologies are Quigg, v. 932 F.2d Legal Fund Def. hu- an entire many genes or even quence (Fed.Cir.1991). In areas of developing but firms rapidly, genome man only commensu scope, we owe deference encountering a technologies are those of its consid thoroughness rate with “the Secretary’s Advisory patents. thicket of validity reasoning.” and the its eration Comm, Genetics, Health, Society, on Kessler, 1543, 1550 v. 80 F.3d Merck & Co. Servs., & Human Gene Dep’t of Health (Fed.Cir.1996). The comments Licensing Practices Patents guide time of its 2001 PTO issued at the Patient Access to Genetic Impact Their suggestions that isolat response lines in (2010). sequence order Tests 49-62 are, patentable not human were ed have to a firm would genome, entire Conley John M. frankly, perfunctory. See many patents thousands license Makowski, Back to the Future: & Roberte id. at 50-51. licensors. See different Doc Product Nature Rethinking the patents include many if of those Even Biotechnology Pat as a Barrier trine anticipation that are invalid ents, Soc’y Pat. & Trademark Off. 85 J. obviousness, involved in deter- the costs comments, (2003). Because those patents of all of those mining scope face, thorough do not reflect least on their 51-52; id. at prohibitive. See could be issue, study I do consideration Eisenberg, Noncompliance, S. Rebecca weight worthy of much regard them as Rethink- Nonproblem? Nonenforcement, *51 complex question. analysis in the Re- in Biomedical ing the Anticommons Second, views force the PTO’s 1059, whatever search, L.Rev. 1076-1080 45 Hou. may have eligibility issue of (2008) on the existing studies (concluding least, has, very been at the past had in the relatively little attention on “have focused by position the substantially undermined and development” product downstream has taken in government Although my this case. to us. colleagues believe our analysis Department legal question of Justice has of the in twice filed this case should be influenced purported expecta- a brief on behalf of the United States tions of inventing community based on position Myriad’s taking this court past practice the PTO’s of issuing patents (other claims) gene claims than the cDNA human genes, give is effect to patent-eligible. Although are not the PTO lawmaking authority the PTO that Con- “sign” did not the brief on either occasion gress has not accorded it.6 no There is guess and we are left to about the status of right collective possession adverse any possible continuing inter-agency dis- property, intellectual and we should not issue, agreements about the Depart- create one. Our interpret role is to speaks ment of Justice for the Executive that Congress law has written accor- Branch, part and the PTO is of the Execu- dance with the governing precedents. I Branch, tive it is fair so to conclude that would do so and would affirm the district the Executive Branch has po- modified its rulings court’s as to the BRCA sition from the one taken PTO its gene segment BRCA claims. and, guidelines informally, before that.
Finally, prior Supreme to the Court’s
decision in Chakrabarty, the PTO had de- microorganisms
termined that were not
subject to patenting, but gave
Court no regarded indication that it
that view as entitled to deference. More-
over, gave the Court short shrift to the (which
Commissioner’s contention was argument made the lead govern- AFTG-TG, Phillip LLC and M. case) ment’s brief in that that the patenta- Associates, LLC, Adams & bility of life-forms was an issue that should Plaintiffs-Appellants, Congress. be left to Citing Marbury v. Madison, (1 Cranch) 137, 5 U.S. 2 L.Ed. v. (1803), explained Court that “Con- NUVOTON TECHNOLOGY CORPO gress performed has its constitutional role Technology RATION and Nuvoton
in defining patentable subject matter in
Corporation America, Defendants,
101;
§
perform
we
in construing
ours
language Congress has employed.” Chak-
rabarty,
315,
We have the same responsibility and
Pegatron Corporation, Pegatron Tech
shy away
should not
deciding
nology Service,
Inc.,
Unihan,
issues of law
parties
that the
brought
Defendants-Appellees.
have
Co.,
Because the asserted
Kogyo
reliance interest
Kabushiki
535 U.S.
Kinzoku
practice
prior judi
based on PTO
not on
(2002),
122 S.Ct.