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1 I a DURIE TANGRI LLP DARALYN. DURIE (SBN s) ddurie@durietangri. com MARK A. LEMLEY (SBN s30) mlemley@durietangri. com Leidesdorff Street San Francisco, CA lll Telephone: -3- Facsimile: tì Nicholas Groombridg e Qtro hac vice application to be sribmitted) Rebecca Fett ( tro hac vice application to be submitted) \ osephine Young þro hac vice application to be submitted) PAUL, WEISS, RIFKIND, WHARTON & GARRISON LLP Avenue of the Americas New York, NY 0-0 \ ngroombridge@paulweiss. com ' i\. t t l T 0 l COLINSYL,INIC., V. FO ai MYRIAD GENETICS,INC., IN Plaintiff, Defendant. STATES DISTRICT COURT N.RTTIERN ""'gt ï'3":.ö a g g 3 Nc Case No COMPLAINT FOR DECLATORY UDGMENT URY TRIAL DEMANDED o 3 COMPLAINT FOR DECLATORY UDGMENT / CASE NO

2 3 t t t 0 I 3 Plaintiff Counsyl, Inc. ("Counsyi"), for its Complaint against Defendant Myriad Genetics, Inc. ("Myriad") alleges as follows: NATTIRE OF THE ACTION. 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 andu.s.c. $0: a. U.S. Patent No.,0,, entitled "LINKED BREAST AND OVARIAN CANCER SUSCEPTIBILITY GENE," issued on anuary 0, ("the ' patent"). A true and correct copy of the ' patent is attached as Exhibit L b. U.S. PatentNo.,,, entitled "ITQ-LINKED BREAST AND OVARIAN CANCER SUSCEPTIBILITY GENE," issued on May, ("the' patent"). A true and correct copy of the ' patent is attached as Exhibit. c. U.S. Patent No.,3,, entitled "IQ-LINKED BREAST AND OVARIAN CANCER SUSCEPTIBILITY GENE," issued on May, ("the ' patent"). A true and correct copy of the 'patent is attached as Exhibit 3, d. U.S. Patent No.,,, entitled "METHOD FOR DETERMINING THE HAPLOTYPE OF A HUMAN BRCA GENE," issued on October,0A ("the'patent"). A true and correct copy of the 'I pafent is attached as Exhibit. e. U.S. Patent No.,0,, entitled "LARGE DELETIONS IN HUMAN BRCA GENE AND USE THEREOF," issued on uly 3,00 ("the' patent"). A true and con:ect copy of the' patent is attached as Exhibit. f. U.S. PAtENt NO.,3,, ENtitICd "CHROMOSOME -LINKED BREAST CANCER SUSCEPTIBILITY GENE," issued on November, ("the' patent"). A true and correct copy ofthe'patent is attached as Exhibit. g. U.S. Patent No.,033,, entitled "CHROMOSOME -LINKED BREAST CANCER SUSCEPTIBILITY GENE," issued on March,000 ("the ' patent"). A true and correct copy of the ' patent is attached as Exhibit. I COMPLANT FOR DECLATORY rudgment / CASENO.

3 - h. U.S. Patent No.,0I,3, entitled "CANCER SUSCEPTIBILITY MLIATIONS t0 I l l I l 0 T 3 OF BRCA," issued on April, 000 ("the'3 patent"). A true and correct copy of the '3 patent is attached as Exhibit. THE PÄRTIES. Counsyl is a corporation organized and existing under the laws of the State of Delaware with its principal place of business at Kimball Vy'ay, South San Francisco, California 00. 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. 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 30 Wakara Way, Salt Lake City, Utah. Oninfonnationandbelief,Myriadisanownerorco-ownerofthe',',and'3patents and is an exclusive licensee of the ',',',', and ' patents. BACKGROUND. 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 BRCA genes.. Prior to the priority dates of the ', ', ', ', ', ', ', and '3 patents, it was discovered that alterations in human BRCAI and BRCA genes are associated with an increased risk ofbreast and/or ovarian cancer.. On information and belief, Myriad contends that one or more claims of the',', ',',',', ', and/or'3 patents coverisolated fragments of human BRCAI andbrca genes, as well as methods of using the human -B,R CAI and BRCA genes to screen and/or detect alterations in those genes or to diagnose a predisposition for breast and/or ovarian cancer. On informationandbelief,myriadcontendsthatoneormoreclaimsofthe'ggg,',','i,'g, ',', and/or '3 patents cover methods of using BRCAI and/or BRCA genes in genetic tests and related services, such as the sequencing and analysis af BRCAI and/or BRCA genes. COMPLAINT FOR DECLATORY rudgment / CASE NO.

4 --- a t T T 0 l 3. Myriad has asserted that it owns and/or has the sole right to enforce tbe',','', ',',',', and' 3 patents.. Myriad itself claims that, by offering its allegedly patented testing services to breast and/or ovarian canceï 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 BRCAl and BRCA. Since 00, however, Myriad has kept the vital 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.. Myriad has asserted that any company that makes, uses, sells, or offers to sell genetic tests and related services using the BRCAI and/or BRCA genes, such as the sequencing and analysis of BRCA I and/or BRCA genes, faces the risk of suit for infringement of one or more claims of the ', ',' \,',',',', and' 3 patents.. Certain claims of the ',',',', and ' patents have been the subject of a prior patent litigation, which culminated in the review of the validity of those claims by the Supreme Court. In its decision on une,0,associatiottfor Molecular Pathology v. Myriød Genetics,3 S. Ct.0,0 V/L 3, the Supreme Court held that at least claims and of the' patent and claims i and of the ' patent directed to isolated human BRCA I and BRCA genes are invalid for lack of patentable subject matter under 3 U.S.C. $. Moreovet, in the proceedings leading up to the Supreme Court decision, the Federal Circuit had reviewed claim of the ' patent, claim of the' patent, claims I and of the ' patent directed to methods of using human BRCAI and BRCA genes to detect alterations or to screen for alterations and held that those claims also are invalid for lack of patentable subject matter under 3 U.S.C. $. Ass'n for Molecular Pathology v. U.S. Patent & Tradentark Office, F.3d 303, (Fed. Cir. 0). That decision was not appealed by either parfy. Nofwithstanding these rulings, Myriad has stated that it still intends to aggressively and vigorously enforce the ', ', 'I, ', ', ', ', and'3 patents against any entity that makes, uses, sells, or offers to sell genetic tests and relaed sen ices using the BRCAI and/or BRCA genes, such as the sequencing and analysis of BRCAl and/or BRCA genes. â - COMPLAINT FOR DECLATORY UDGMENT / CASE NO

5 -,- ^ t T t t 0 3. Numerous clinicians and entities performing research on BRCAI andl/or BRCA genes have stated that Myriad has sent them cease and desist letters, effectively prohibiting routine screening of BRCAI and/or BRCA genes for research or clinical practice without a license to the ', ','I, ',',',', and'3 patents.. After the Supreme Courl decision, two other entities, Ambry Genetics Corp. and Gene by Gene Ltd., publicly stated on une, 0, thaf they would begin offering their respective genetic tests and related services that included sequencing and analysis of the BRCAI and/or BRCA genes. In response, Myriad sued Ambry and Gene by Gene on uly, 0, and uly, 0 I 3, respectively, for infringement of certain claims of the ',','I,'I,',', ', and'3 patents. Those suits have been consolidated and are pending in the District of Utah, Central Division. See Univ. of Utah Research Found. v. Ambry Genetics,lrc., No. :-cv-0000 (D. Utah filed uly, 0) and Univ. of (tah Research Found. v. Gene by Gene,No.:-cv-0000 (D. Utah filed uly,0).. 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 BRCA genes.. Counsyl has made a substantial research and development investment in improving genetic tests and providing more access at lower cost to related services connected with sequencing and analysis of BRCAI and BRCA 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 of the'patent, claims and of the'patent, claims,3,33 of the'lpatent, claim of the' patent, claims -0 of the ' patent, claims,,,30 of the 'patenf, claim of the ' patent, and claims -,0- of the '3 patent.. There is a definite, concrete, real and substantial conhoversy befween Counsyl and Myriad of sufficient iminediacy and reality to warrant the issuance of a declaratory judgrnent of at least one of claim of the ' patent, claims and of the 'patent, claims,3,33 of the ' patent, claim of the' patent, claims -0 of the ' patent, claims,,,30 of the 'palent, claim of the ' patent, and claims l-,0- of the '3 patent. A declaration of rights between the parties is both appropriate and necessary to establish that Counsyl does not infünge any valid claim of the ', COMPLAINT FOR DECLATORY UDGMENT / CASE NO.

6 l t t t r 0 l 3 ',' I,',',',', and' 3 patents. URISDICTION AND VENUE. This lawsuit is a civil action arising under the patent laws of the United States, 3 U.S.C. ç 0, et seq., and the Declaratory udgment Act, 3 U.S.C. ç 0I. Accordingly, this Court has subject matter jurisdiction pursuant to U.S.C. $$ 3 and 3(a).. This Court has personal jurisdiction over Myriad, by virfue of, irúer alia, ít having conducted business in California, having availed itself of the rights and benefits of California law, and having engaged in substantial and continuing contacts with Califomia. 0. On information and belief, Myriad conducts substantial business in this judicial district and regularly solicits business from, does business with, and derives value from goods and services provided to customers in this judicial district. For example, Myriad employs a significant sales and marketing force in this District, markets its tests to thousands of residents within this District, generates signif,rcant revenues from this District, and has made significant investments in this District, including a $ million strategic investment in Crescendo Bioscience based in South San Francisco, California, in 0ll. See, e.g., Myriad Genetics Makes Strategi.c Debt Investntent Witlt Exclusive Option to Acquire Crescendo Bioscience, Myriad Investor Relations Press Releases (Sept., 0), http ://investor.myriad. com/releasedetail. cfm?releaseid:0 0.. Venue is proper in this District pursuant to U.S.C. $$ (b) and (c) and 0(b). COUNT I DECLARATORY UDGMENT OF NONINFRINGEMENT OF THE ' PATENT. Counsyl incorporates by reference the preceding averments set forth in paragraphs An actual controversy exists between Counsyl and Myriad with respect to Counsyl's noninfiìngernent of claim of the' patent.. Counsyl has not directly or indirectly infringed and is not directly or indirectly infringing claim of the ' patent as defined by 3 U.S,C. ç L. Counsyl hereby seeks a declaration that the manufacture, use, offer for sale, or sale of its genetic sequencing and analysis of the BRCAI gene does not directly or indirectly infringe claim of the ' patent. COMPLAINT FOR DECLATORY UDGMENT / CASE NO.

7 T l t T 0 l 3 COUNT II DECLARATORY UDGMENT OF ITWALIDITY OF THE ' PATENT. Counsyl incorporates by reference the preceding averments set forth in paragraphs -.. An actual controversy exists between Counsyl and Myriad with respect to the invalidity of claim of the ' patent.. Claim of the ' patent fails 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 3 U.S.C. $$ -3, li, et seq., andlor under the judicially created doctrine of obviousness-type double patenting.. Counsyl hereby seeks a declaration that claim of the ' patent is invalid. COUNT III DECLARATORY UDGMENT OF NONINFRINGEMENT OF TIIE ' PATENT 30. Counsyl incorporates by reference the preceding averments set forth in paragraphs l-. 3. An actual controversy exists between Counsyl and Myriad with respect to Counsyl's noninfüngement of at least one of claims and/or of the 'patent. 3. Counsyl has not directly or indirectly infringed and is not directly or indirectly infringing claims and/or of the 'patent as defined by 3 U.S.C. $. 33. Counsyl hereby seeks a declaration that the manufacture, use, offer for sale, or sale of its genetic sequencing and analysis of the BRCAI gene does not directly or indirectly infringe claims and/or of the ' patent. COUNT IV DECLARATORY UDGMENT OF INVALIDITY OF TIE' PATENT 3. Counsyl incorporates by reference the preceding averments set forth in paragraphs An actual controversy exists between Counsyl and Myriad with respect to the invalidity of at least one of claims and/or of the ' patent. 3. Claims and/or of the ' 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 3 U. S.C. $ $ - 3, I, et seq., and/or under the judicially created doctrine of obviousness-type COMPLANT FOR DECLATORY UDGMENT / CASE NO.

8 l double patenting. 3, Counsyl hereby seeks a declaration that claims and/or of the ' patent are invalid. COUNT V DECLARATORY UDGMENT OF NONINFRINGEMENT OF THE ' PATENT 3. Counsyl incorporates by reference the preceding averments set forth in paragraphs An actual controversy exists between Counsyl and Myriad with respect to Counsyl's noninfringement of at least one of claims,3, and/or 33 of the ' patent. A. Counsyl has not directly or indirectly infringed and is not directly or indirectly infringing claims, 3, and/ or 33 of the' patent as defined by 3 U. S.C. ç. Counsyl hereby seeks a declaration that the manufacture, use, offer for sale, or sale of its genetic sequencing and analysis of the BRCAI gene does not directly or indirectly infringe claims, 3, l. l and/or 33 ofthe' patent. COUNT VI T l t 0 DECLARATORY UDGMENT OF INVAIIDITY OF THE ' PATENT. Counsyl incorporates by reference the preceding averments set forth in paragraphs An actual controversy exists between Counsyl and Myriad with respect to the invalidity of at least one of clairns,3, and/or 33 of the 'I patent.. Claims,3, and/or 33 of the ' patent fail to rneet one or lnore of the statutory requirements and/or conditions for patentability under the patent laws of the United States, including but not limited to 3 U.S.C. $$ -3,, et seq., and/or under the judicially created doctrine of obviousness-fype double patenting.. Counsyl hereby seeks a declaration that claims, 3, andlor 33 of the ' patent are 3 invalid. COUNT VII DECLARATORY UDGMENT OF NONINFRINGEMENT OF THE ' PATENT. Counsyl incorporates by reference the preceding averments set fofth in paragraphs -.. An actual controversy exists between Counsyl and Myriad with respect to Counsyl's noninfringement of claim of the 'palent. COMPLAINT FOR DECLATORY UDGMENT / CASE NO

9 I T T I l 0 3. Counsyl has not directly or indirectly infringed and is not directly or indirectly infringing claim of the ' patent as defined by 3 U.S.C. ç.. Counsyl hereby seeks a declaration that the manufacture, use, offer for sale, or sale of its genetic sequencing and analysis of the BRCAI gene does not directly or indirectly infringe claim of the 'patent. COUNT VIII DECLARATORY UDGMENT OF INVAI-IDITY OF THE.'I PATENT 0. Counsyl incorporates by reference the preceding averments set forth in paragraphs -.. An actual controversy exists between Counsyl and Myriad with respect to the invalidity of claim of the 'I palent.. Claim of the 'I patent fails 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 3 U.S.C. $$ -3, ll, et seq., and/or under the judicially created doctrine of obviousness-type double patenting. 3, Counsyl hereby seeks a declaration that claim of the ' pafent is invalid. COUNT IX DECLARATORY UDGMENT OF NONINFRINGEMENT OF THE ' PATENT. Counsyl incorporates by reference the preceding averments set forth in paragraphs l-3.. An actual controversy exists between Counsyl and Myriad with respect to Counsyl's noninfringement of at least one of claims -0 of the ' patent.. Counsyl has not directly or indirectly infringed and is not directly or indirectly infringing claims -0 of the ' patent as defined by 3 U.S.C. ç.. Counsyl hereby seeks a declaration that the manufacture, use, offer for sale, ot sale of its genetic sequencing and analysis of the BRCAl gene does not directly or indirectly infringe claims -0 of the' patent. COUNT X DECLARATORY UDGMENT OF INVALIDITY OF THE' PATENT. Counsyl incorporates by reference the preceding averrnents set foth in paragraphs -. COMPLAINT FOR DECLATORY UDGME "T / CASE NO

10 - t l t l 0 3. An actual controversy exists between Counsyl and Myriad with respect to the invalidity of at least one of claims -0 of the' patenf. 0. Claims -0 of the ' patent 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 3 U.S.C. $$ -3, li, et seq., and/or under the judicially created doctrine of obviousness-type double patenting.. Counsyl hereby seeks a declaration that claims -0 of the ' patent are invalid. COUNT XI DECLARATORY UDGMENT OF NONINFRINGEMENT OF THE ' PATENT. Counsyl incorporates by reference the preceding averments set forth in paragraphs -i. 3. An actual controversy exists between Counsyl and Myriad with respect to Counsyl's noninfringement of at least one of claims and/or of the ' patenf'. Counsyl has not directly or indirectly infringed and is not directly or indirectly infringing claims and./or of the ' palent as defined by 3 U.S.C. ç.. Counsyl hereby seeks a declaration that the manufacture, use, offer for sale, or sale of its genetic sequencing and analysis of the BRCA gene does not directly or indirectly infringe claims and/or of the' patent. COUNT XII DECLARATORY UDGMENT OF INVALIDITY OF THE' PATENT. Counsyl incorporates by reference the preceding averments set forth in paragraphs -.. An actual controversy exists between Counsyl and Myriad with respect to the invalidify of at least one of claims and/or of the ' patent.. Claims and/or of the ' patent fail to meet one or more of the statutory requirements and/or conditions for patentability under the patent laws of the United States, including but not limited to 3 U.S.C. $$ -3, li, et seq., and/or under the judicially created doctrine of obviousness-type double patenting.. Counsyl hereby seeks a declaration that claims and/or of the ' patent are invalid. COMPLAINT FOR DECLATORY UDGMENT / CASE NO

11 l0 l T t t 0 t z3 COUNT XIII DECLARATORY UDGMENT OF'NONINFRINGEMENT OF TTIE ' PATENT 0. Counsyl incorporates by reference the preceding averments set forth in paragraphs -.. An actual controversy exists between Counsyl and Myriad with respect to Counsyl's noninfüngement of claim of the ' patent.. Counsyl has not directly or indirectly infringed and is not directly or indirectly in-&inging claim of the ' patent as defined by 3 U.S.C. ç. 3. Counsyl hereby seeks a declaration that the manufacture, use, offer for sale, ot sale of its genetic sequencing and analysis of the BRCA gene does not directly or indirectly infringe clatm of the ' patent. COUNT XIV DECLARATORY UDGMENT OF INVA.LIDITY OF THB ' PATENT. Counsyl incorporates by reference the preceding averments set forth in paragraphs -3.. An actual controversy exists between Counsyl and Myriad with respect to the invalidify of claim of the ' patent.. Claim of the ' patent fails 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 3 U.S.C. $$ -3, li, et seq., andlor under the judicially created doctrine of obviousness-type double patenting.. Counsyl hereby seeks a declaration that claim of the ' patent is invalid. COUNT XV DECLARATORY UDGMENT OF NONINFRINGEMBNT OF TI{E '3 PATENT. Counsyl incorporates by reference the preceding averments set forth in paragraphs l-.. An actual controversy exists between Counsyl and Myriad with respect to Counsyl's noninfringementof atleastoneof claims l-0,,,0 and/or of the'3palent. 0. Counsyl has not directly or indirectly infringed and is not directly or indirectly infringing claims l-0,,, 0 and/or of the '3 patenl as defined by 3 U,S.C. $.. Counsyl hereby seeks a declaration that the manufacture, use) offer for sale, or sale of its COMPLAINT FOR DECLATORY UDGMENT / CASE NO.

12 genetic sequencing and analysis of the BRCA gene does not directly or indirectly infringe claims -0, I t t I 0 t 3,, 0 andlor of the '3 patent. COUNT XVI DECLARATORY UDGMENT OF IIWALIDITY OF THE '3 PATENT. Counsyl incorporates by reference the preceding aveunents set forth in paragraphs An actual controversy exists between Counsyl and Myriad with respect to the invalidity of at least one of claims -0,,,0 and/or of the '3 patent.. Claims -0,,,0 and/or ofthe'3tpatentfailtomeetoneormoreofthe statutory requirements and/or conditions for patentability under the patent laws of the United States, including but not limited to 3 U.S.C. $$ -3,, et seq., and/or under the judicially created do ctrine of obviousness-type double patenting.. Counsyl hereby seeks a declaration that claims -0,,, 0 and/or l of the '3 patent are invalid. PRAYBR FOR RELIEF V/HEREFORE, Counsyl respectfully requests that: A. udgment be entered declaring that Counsyl has not infringed, induced infringement of, or 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 of the ' patent, claims,, of the ' patent, clairns,3,33 of the'patent, claim of the' patent, claims l-0 of the' patent, claims, of the 'patent claim of the ' patent, and/or claims l-0,,,0 and/or of the '3 patent; B. udgment be entered declaring that claim of the ' patent, claims,, of lhe ' patent, claims,3,33 of the' patent, claim of the ' patent claims -0 of the ' patent, claims, of the'patent, claim of the'patent,and/or claims l-0,,,0 and/or of the '3 palent are invalid; C. udgment 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 3 U.S.C. $ ; and COMPLAINT FOR DECLATORY UDGMENT / CASE NO

13 : D. Such other and further relief as this Court may deem just and proper. a URY DEMAND Plaintiff hereby requests a trial by jury, pursuant to Federal Rule of Civil Procedure 3(b), on all issues so triable. Dated: September 0,0 DURIE TANGRI LLP By DARALYN. DURIE MARK A. LEMLEY Attomeys for Plaintiff COUNSYL.INC. l l T t 0 t 3 I COMPLAINT FOR DECLATORY rudgment / CASE NO