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Nicholas Groombridg e Qtro hac vice application to be sribmitted) \ Rebecca Fett (tro hac vice application to be submitted) Josephine Young ro hac vice application to be submitted) PAUL, WEISS, RIFKIND, WHARTON & GARRISON LLP 1285 Avenue of the Americas \ New York, NY 10019-6064 ngroombridge@paulweiss. com
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N.RTTIERN
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COLINSYL,INIC.,
""'gT '3":. a g g 3 Nc
Case No
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Plaintiff,
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V. T9
MYRIAD GENETICS,INC.,
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Plaintiff Counsyl, Inc. ("Counsyi"), for its Complaint against Defendant Myriad Genetics, Inc.
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("Myriad") alleges
as follows:
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1.
This is an action brought by Counsyl to obtain declaratory judgment that Myriad has no
rights against Counsyl regarding the following patents pursuant to Federal Rules of Civil Procedure 57
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and28U.S.C. $2201:
a.
CANCER SUSCEPTIBILITY GENE," issued on January 20,1998 ("the '999 patent"). A true and
correct copy of the '999 patent is attached as Exhibit L
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b.
CANCER SUSCEPTIBILITY GENE," issued on May 5, 1998 ("the'282 patent"). A true and correct
copy of the '282 patent is attached as Exhibit 2.
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c.
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CANCER SUSCEPTIBILITY GENE," issued on May 1 9, 1998 ("the ' 441 patent"). A true and correct
copy of the '441patent is attached as Exhibit 3,
d.
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'72I
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e.
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GENE AND USE THEREOF," issued on July 31,2007 ("the'497 patent"). A true and con:ect copy
of
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as
Exhibit 5.
f.
CANCER SUSCEPTIBILITY GENE," issued on November 17, 7998 ("the'492 patent"). A true and
correct copy ofthe'492patent is attached as Exhibit 6.
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g.
CANCER SUSCEPTIBILITY GENE," issued on March 7,2000 ("the '857 patent"). A true and correct
copy of the '857 patent is attached as Exhibit 7.
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COMPLANT FOR DECLATORY ruDGMENT / CASENO.
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h.
attached as Exhibit 8.
MLIATIONS
OF BRCA2," issued on
April
18, 2000
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THE PRTIES
2.
Counsyl is a corporation organized and existing under the laws of the State of Delaware
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with its principal place of business at 180 Kimball Vy'ay, South San Francisco, California 94080.
Counsyl is a technology company in the United States focusing on the development of genetic testing
and services for various hereditary diseases and traits, including, but not limited to, the development
of
genetic testing and services in connection with breast and/or ovarian cancer.
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3.
On information and belief, Myriad is a corporation organized and existing under the laws
of the State of Delaware with its principal place of business at 320 Wakara Way, Salt Lake City, Utah 84108. Oninfonnationandbelief,Myriadisanownerorco-ownerofthe'721,'497,and'379patents
and is an exclusive licensee of the
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4. 5. 6.
Counsyl is a technology company with the goal of making the human genome practically
usefrll for individuals making decisions about their life, family, and health.
Counsyl has developed and is prepared to launch genetic tests and related services related
to sequencing and analysis of BRCAI and BRCA2 genes. Prior to the priority dates of the '999, '282, '441, '721, '497 , '492, '857, and '379 patents,
and BRCA2 genes are associated
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with an increased
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On information and belief, Myriad contends that one or more claims of the'999,'282,
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CAI
alterations in those genes or to diagnose a predisposition for breast and/or ovarian cancer. On
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informationandbelief,Myriadcontendsthatoneormoreclaimsofthe'ggg,'282,'441,'72I,'4g7,
'492,'857, and/or '379 patents cover methods of using BRCAI and/or BRCA2 genes in genetic tests and
related services, such as the sequencing and analysis af BRCAI and/or BRCA2 genes.
2 COMPLAINT FOR DECLATORY ruDGMENT / CASE NO.
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Myriad has asserted that it owns and/or has the sole right to enforce tbe'999,'282,'441',
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Myriad itself claims that, by offering its allegedly patented testing services to breast
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and/or ovarian cance patients and their family members, and by excluding any potential competitors
from being able to offer women any altematives to the Myriad test, Myriad has created an extensive
database of genetic variants of
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BRCAl
and
publio health information in this database a secret, and has refused to share it with healthcare workers
and the
public. Thus, Myriad has effectively hindered the medical community from being able to use
patient data to fuither medical research and impeded the ability of clinicians to interpret genomic data.
10.
BRCA
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Myriad has asserted that any company that makes, uses, sells, or offers to sell genetic tests
and related services using the BRCAI and/or BRCA2 genes, such as the sequencing and analysis
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and/or BRCA2 genes, faces the risk of suit for infringement of one or more claims of the '999,
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1.
Certain claims of the '999,'282,'441,'492, and '857 patents have been the subject of a
prior patent litigation, which culminated in the review of the validity of those claims by the Supreme
S.
Ct.2707,2013 V/L 2631062, the Supreme Court held that at least claims 1 and 5 of the'282 patent and claims
invalid for
lack of patentable subject matter under 35 U.S.C. $ 101. Moreovet, in the proceedings leading up to the
Supreme Court decision, the Federal Circuit had reviewed claim 1 of the '999 patent, claim 1 of the'441
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patent, claims
and2 of the '857 patent directed to methods of using human BRCAI and BRCA2 genes
to detect alterations or to screen for alterations and held that those claims also are invalid for lack of
patentable subject matter under 35 U.S.C. $ 101. Ass'n
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Tradentark Office,689 F.3d 7303, 1329 (Fed. Cir. 2012). That decision was not appealed by either parfy
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Nofwithstanding these rulings, Myriad has stated that it still intends to aggressively and
vigorously enforce the '999, '282, '44I, '721, '497 , '492, '857 , and'379 patents against any entity that
makes, uses, sells, or offers to sell genetic tests and relaJed senices using the BRCAI and/or BRCA2 genes, such as the sequencing and analysis of BRCAl and/or BRCA2 genes.
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Numerous clinicians and entities performing research on BRCAI andl/or BRCA2 genes
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have stated that Myriad has sent them cease and desist letters, effectively prohibiting routine screening
of
BRCAI and/or BRCA2 genes for research or clinical practice without a license to the '999, '282,'44I,
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After the Supreme Courl decision, two other entities, Ambry Genetics Corp. and Gene by
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, 2013 , thaf they would begin offering their respective genetic tests
and related services that included sequencing and analysis of the BRCAI and/or BRCA2 genes.
In for
response, Myriad sued Ambry and Gene by Gene on July 9 , 2013, and July 10, 20 I 3, respectively,
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Division.
See Univ.
of Utah
Research Found. v. Ambry Genetics,lrc., No. 2:13-cv-000640 (D. Utah filed July 9, 2013) and Univ. (Jtah Research Found. v. Gene by Gene,No.2:13-cv-000640 (D. Utah filed July 10,2013).
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Myriad's conduct, including Myriad's litigation history, puts at risk Counsyl's legal rights
and ability to market its genetic tests and related services related to sequencing and analysis of BRCAI
and BRCA2 genes.
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genetic tests and providing more access at lower cost to related services connected with sequencing and analysis of BRCAI and BRCA2 genes. Accordingly, Counsyl seeks and is lawfully entitled to a declaratory judgment that at least one of the following claims is invalid and/or not infringed: claim 6
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of
patent,
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There is a definite, concrete, real and substantial conhoversy befween Counsyl and
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Myriad of sufficient iminediacy and reality to warrant the issuance of a declaratory judgrnent of at least
one of claim 6 of the '999 patent, claims 5 and 6 of the '282patent, claims
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claim 5 of the'727 patent, claims 1-20 of the '497 patent, claims 5,9,29,30 of the '492palent, claim 4 of the '857 patent, and claims l-25,40-42 of the '379 patent. A declaration of rights between the parties
is both appropriate and necessary to establish that Counsyl does not infnge any valid claim of the '999,
4 COMPLAINT FOR DECLATORY JUDGMENT / CASE NO.
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9 patents.
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This lawsuit is a civil action arising under the patent laws of the United States, 35 U.S.C.
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100, et seq., and the Declaratory Judgment Act, 35 U.S.C. 220I. Accordingly, this Court has subject
matter jurisdiction pursuant to 28 U.S.C. $$ 1331 and 1338(a).
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This Court has personal jurisdiction over Myriad, by virfue of, irer alia, t having
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conducted business in California, having availed itself of the rights and benefits of California law, and having engaged in substantial and continuing contacts with Califomia.
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20.
On information and belief, Myriad conducts substantial business in this judicial district
and regularly solicits business from, does business with, and derives value from goods and services
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provided to customers in this judicial district. For example, Myriad employs a significant sales and marketing force in this District, markets its tests to thousands of residents within this District, generates
signif,rcant revenues from this District, and has made significant investments in this District, including a $25 million strategic investment in Crescendo Bioscience based in South San Francisco, California, in
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See, e.g.,
Myriad Genetics Makes Strategi.c Debt Investntent Witlt Exclusive Option to Acquire
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60.
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Venue is proper in this District pursuant to 28 U.S.C. $$ 1391(b) and (c) and 1400(b).
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COUNT
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Counsyl incorporates by reference the preceding averments set forth in paragraphs 1-21.
An actual controversy exists between Counsyl and Myriad with respect to Counsyl's
noninfingernent of claim 6 of the'999 patent. Counsyl has not directly or indirectly infringed and is not directly or indirectly infringing
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genetic sequencing and analysis of the BRCAI gene does not directly or indirectly infringe claim 6 of the
COUNT
II
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Counsyl incorporates by reference the preceding averments set forth in paragraphs 1-25.
An actual controversy exists between Counsyl and Myriad with respect to the invalidity of
claim 6 of the '999 patent. Claim 6 of the '999 patent fails to meet one or more of the statutory requirements and,/or
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conditions for patentability under the patent laws of the United States, including but not limited to 35 U.S.C. $$ 101-103, patenting.
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29.
Counsyl hereby seeks a declaration that claim 6 of the '999 patent is invalid.
COUNT
III
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Counsyl incorporates by reference the preceding averments set forth in paragraphs l-29.
An actual controversy exists between Counsyl and Myriad with respect to Counsyl's
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claims 5 and/or 6 of the '282patent as defined by 35 U.S.C. $ 271. Counsyl hereby seeks a declaration that the manufacture, use, offer for sale, or sale of its
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genetic sequencing and analysis of the BRCAI gene does not directly or indirectly infringe claims and/or 6 of the '282 patent.
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COUNT IV
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Counsyl incorporates by reference the preceding averments set forth in paragraphs 1-33.
An actual controversy exists between Counsyl and Myriad with respect to the invalidity of
Claims 5 and/or 6 of the '282 pafent fail to meet one or more of the statutory requirements
and/or conditions for patentability under the patent laws of the United States, including but not limited to
35 U. S.C. $ $ 101- 103, 1I2, et seq., and/or under the judicially created doctrine of obviousness-type
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double patenting.
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Counsyl hereby seeks a declaration that claims 5 and/or 6 of the '282 patent are invalid.
COUNT V
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Counsyl incorporates by reference the preceding averments set forth in paragraphs 1-37.
An actual controversy exists between Counsyl and Myriad with respect to Counsyl's
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41.
and/or 33
Counsyl hereby seeks a declaration that the manufacture, use, offer for sale, or sale of its
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genetic sequencing and analysis of the BRCAI gene does not directly or indirectly infringe claims 8, 23,
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ofthe'441 patent.
COUNT VI
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Counsyl incorporates by reference the preceding averments set forth in paragraphs 1-41.
An actual controversy exists between Counsyl and Myriad with respect to the invalidity of
'44I patent.
Claims 8,23, and/or 33 of the '441 patent fail to rneet one or lnore of the statutory
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requirements and/or conditions for patentability under the patent laws of the United States, including but not limited to 35 U.S.C. $$ 101-103,112, et seq., and/or under the judicially created doctrine obviousness-fype double patenting.
of
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45.
invalid.
Counsyl hereby seeks a declaration that claims 8, 23, andlor 33 of the '441 patent are
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COUNT
VII
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46. 47.
Counsyl incorporates by reference the preceding averments set fofth in paragraphs 1-45.
An actual controversy exists between Counsyl and Myriad with respect to Counsyl's
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'721patent.
Counsyl has not directly or indirectly infringed and is not directly or indirectly infringing
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genetic sequencing and analysis of the BRCAI gene does not directly or indirectly infringe claim 5 of the
COUNT
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Counsyl incorporates by reference the preceding averments set forth in paragraphs 1-49.
An actual controversy exists between Counsyl and Myriad with respect to the invalidity of
claim 5 of the '72I palent. Claim 5 of the '72I patent fails to meet one or more of the statutory requirements and/or
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conditions for patentability under the patent laws of the United States, including but not limited to 35 U.S.C. $$ 101-103, patenting.
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53,
Counsyl hereby seeks a declaration that claim 5 of the '727 pafent is invalid.
COUNT IX
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Counsyl incorporates by reference the preceding averments set forth in paragraphs l-53.
An actual controversy exists between Counsyl and Myriad with respect to Counsyl's
noninfringement of at least one of claims 1-20 of the '497 patent. Counsyl has not directly or indirectly infringed and is not directly or indirectly infringing
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Counsyl hereby seeks a declaration that the manufacture, use, offer for sale, ot sale of its
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genetic sequencing and analysis of the BRCAl gene does not directly or indirectly infringe claims 1-20 of
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58.
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59. 60.
An actual controversy exists between Counsyl and Myriad with respect to the invalidity of
Claims 1-20 of the '497 patent fail to meet one or more of the statutory requirements
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and/or conditions for patentability under the patent laws of the United States, including but not limited to 35 U.S.C. $$ 101-103, double patenting.
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61.
Counsyl hereby seeks a declaration that claims 1-20 of the '497 patent are invalid.
COUNT XI
Counsyl incorporates by reference the preceding averments set forth in paragraphs 1-6i.
An actual controversy exists between Counsyl and Myriad with respect to Counsyl's
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claims 5 and./or 9 of the '492 palent as defined by 35 U.S.C. 271. Counsyl hereby seeks a declaration that the manufacture, use, offer for sale, or sale of its
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genetic sequencing and analysis of the BRCA2 gene does not directly or indirectly infringe claims and/or 9 of the' 492 patent.
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COUNT
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Counsyl incorporates by reference the preceding averments set forth in paragraphs 1-65.
An actual controversy exists between Counsyl and Myriad with respect to the invalidify of
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Claims 5 and/or 9 of the '492 patent fail to meet one or more of the statutory requirements
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and/or conditions for patentability under the patent laws of the United States, including but not limited to
35 U.S.C. $$ 101-103,
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double patenting.
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Counsyl hereby seeks a declaration that claims 5 and/or 9 of the '492 patent are invalid.
COUNT
XIII
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Counsyl incorporates by reference the preceding averments set forth in paragraphs 1-69.
An actual controversy exists between Counsyl and Myriad with respect to Counsyl's
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genetic sequencing and analysis of the BRCA2 gene does not directly or indirectly infringe clatm 4 of the
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COUNT XIV
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Counsyl incorporates by reference the preceding averments set forth in paragraphs 1-73.
An actual controversy exists between Counsyl and Myriad with respect to the invalidify of
claim 4 of the '857 patent. Claim 4 of the '857 patent fails to meet one or more of the statutory requirements and/or
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conditions for patentability under the patent laws of the United States, including but not limited to 35 U.S.C. $$ 101-103, patenting.
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Counsyl hereby seeks a declaration that claim 4 of the '857 patent is invalid.
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COUNT XV
Counsyl incorporates by reference the preceding averments set forth in paragraphs l-77.
An actual controversy exists between Counsyl and Myriad with respect to Counsyl's
Counsyl hereby seeks a declaration that the manufacture, use) offer for sale, or sale of its
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genetic sequencing and analysis of the BRCA2 gene does not directly or indirectly infringe claims 1-20,
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COUNT XVI
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Counsyl incorporates by reference the preceding aveunents set forth in paragraphs 1-81.
An actual controversy exists between Counsyl and Myriad with respect to the invalidity of
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statutory requirements and/or conditions for patentability under the patent laws of the United States,
including but not limited to 35 U.S.C. $$ 101-103,112, et seq., and/or under the judicially created
do
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85.
Counsyl hereby seeks a declaration that claims 7-20, 24, 25, 40 and/or
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A.
Judgment be entered declaring that Counsyl has not infringed, induced infringement of, or
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contributed to the infringement of and is not infringing, inducing the infringement of, or contributing to
the infringement of any one of the following clairns: claim 6 of the '999 patent, claims 5, 6, of the '282 patent, clairns
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of the'497
patent,
claims 5, 9 of the '492patent claim 4 of the '857 patent, and/or claims l-20,24,25,40 and/or 41 of the '379 patent;
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B.
patent, claims
of lhe '282
8,23,33 of the'441
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claims 5,9 of the'492patent, claim4 of the'857patent,and/or claims l-20,24,25,40 and/or41 of the '379 palent are invalid;
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C.
Judgment be entered finding that this is an exceptional case entitling Counsyl to an award
of attorneys' fees for bringing and prosecuting this action, together with interest, and costs of the action
under 35 U.S.C. $ 285; and
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Such other and further relief as this Court may deem just and proper.
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Dated: September
20,2013
By
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COMPLAINT FOR DECLATORY ruDGMENT / CASE NO