Case 2:11-cv-06519-MRP-JEM Document 1 Filed 01/25/11 Page 1 of 14 Page ID # :1
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRJCT OF DELAWARE
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`HUMAN GENOME SCIENCES, INC.,
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`Defendants.
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`____________________________ )
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`Plaintiff,
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`V.
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`GENENTECII, INC., and CITY OF HOPE,
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`C.A. No . - - - - - - - -
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`DEMAND FOR JURY TRIAL
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`COMPLAINT FOR DECLARATORY JUDGMENT
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`Plaintiff Human Genome Sciences, Inc. ("HGS"), by and through undersigned
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`counsel, files this Complaint against Genentech, Inc. and City of Hope (collectively,
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`"Defendants") and alleges as follows:
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`NATURE OF THE CASE
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`1.
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`HGS seeks a declaration that U.S. Patent No. 6,331,4] 5 titled "Methods of
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`Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein" (the
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`"Cabilly II Patent," attached as Exhibit A), including the fix Parte Reexamination Certificate
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`issued pmsuant to Reexamination Nos. 90/007,542 and 90/007,859, is invalid, unenforceable and
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`not infringed by the manufacture, use, importation, offer to sell or sale of HGS 's Benlysta®
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`(belimumab) antibody.
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`2.
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`HGS has manufactured and is currently manufacturing Benlysta®, a
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`recombinantly engineered monoclonal antibody which is being developed for the treatment of
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`autoantibody-positive patients with systemic lupus erythematosus ("Lupus"). lf approved,
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`Benlysta® would be the first new approved drug for Lupus in more than fifty years.
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`YCSTOJ ·JOG49228. 1
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`900002.0008
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`Sanofi/Regeneron Ex. 1 053, pg 1198
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`Merck Ex. 1053, pg 1224
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`

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`Case 2:11-cv-06519-MRP-JEM Document 1 Filed 01/25/11 Page 2 of 14 Page ID # :2
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`3.
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`HGS has expended substantial resources researching and developing Benlysta®,
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`including filing a Biologic License Application ("BLA") with the United States Food and Drug
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`Administration ("FDA"). HGS also has expended substantial resources in preparing to launch
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`and commercialize Benlysta®.
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`4.
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`In the near future, HGS ex:pects a decision ft·om the FDA regarding the approval
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`of HGS's BLA for Benlysta®. Upon approval, HGS intends to market Benlysta® in this
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`District.
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`5.
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`Defendants have asserted that the Cabilly II Patent broadly covers the use of
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`certain well-known, conventional recombinant methods to produce virtually any antibody
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`product in any type of host cell. Defendants also have asserted multiple infringement claims
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`under the Cabilly II Patent against companies who have made and sold antibody products that
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`were produced using recombinant methods similar to the methods used by HGS to make
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`Benlysta®. See Medlmmune Inc. v. Genentech, Inc., Case No. 03-cv-02567 (C.D. Cal.);
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`Centocur, inc. v. Genentech, Inc. , Case No. 08-cv-03573 (C.D. Cal.); Glaxo Group Ltd. v.
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`Genentech, Inc., Case No.2: lO~cv-02764 (C.D. Cal.).
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`6.
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`In a pending action pertaining to a different antibody, Arzerra™, Defendants
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`specifically averred that Benlysta® infringes Claims 18 and 20 of the Cab illy II Patent and that
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`they "intend shortly" to assert infringement claims against HGS. See Glaxo Group Ltd. v.
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`Genentech, Inc., Case No. 2:10-cv-02764 (C.D. Cal.) (Genentech, Inc. and City ofHope's
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`Opening Brief on Claim Conslruction dated Jan. 7, 2011), Dkt. No. 83 at FN4. Given
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`Defendants' acts and statements and IIGS ' s intended sale ofBenlysta®, a real, immediate and
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`substantial dispute exists between the parties concerning the Cabi!Jy II Patent for which HGS
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`now seeks declaratory relief.
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`YCSTO I: 10649228.1
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`900002.0008
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`2
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`Sanofi/Regeneron Ex. 1 053, pg 1199
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`Merck Ex. 1053, pg 1225
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`

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`Case 2:11-cv-06519-MRP-JEM Document 1 Filed 01/25/11 Page 3 of 14 Page ID #:3
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`PARTIES
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`7.
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`PJaintiffHGS is a corporation duly organized and existing tmdcr the laws of the
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`State of Delaware, with its principal place of business at 14200 Shady Grove Road, Rockville,
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`Maryland 20850.
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`8.
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`Defendant Genentech, Inc. ("Genentech") is a corporation duly organized and
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`existing under the laws ofthe State of Delaware, with its principal place of business in South San
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`Francisco, California.
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`9.
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`Defendant City of Hope is a not-for-profit organization duly organized and
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`existing under the laws of the State of California, vvith its principal place of business in Dumte,
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`Califomia. On information and belief, City ofHope conducts business in the State of Delaware
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`and has developed valuable relationships and generated goodwill through advertising and
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`educational initiatives, including having a Regional Development Office serving Delaware at
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`1 ()08 Walnut Street #1702, Philadelphia, Pennsylvania 19103. On information and belief, as pmt
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`of its business efforts, City ofHope routinely invites businesses in Delaware to donate time and
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`raise funds for its research and treatment programs.
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`10.
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`On information and belief, Genentech and City of Hope are co-assignees of the
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`Cabilly II Patent. On information and belief, City of Hope has an ongoing relationship with
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`Genentech which involves dealings beyond simply receiving royalty income on the Cabilly II
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`Patent, including coordinating patent prosecution and maintenance and the federal litigation of
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`infringement claims (in which City ofHope and Genentech are represented j ointly by counsel) .
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`.TURISDICTION AND VENUE
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`11.
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`This action arises under the Declaratory Judgment Act of 1934 (28 U.S.C. §
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`2201 ), Title 28 of the United States Code, for the purposes of determining an actual and
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`justiciable controversy between the parties, and the patent laws ofthe United States, Title 35 of
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`YCSTO I · J 064922R.l
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`900002. OOOK
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`3
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`Sanofi/Regeneron Ex. 1 053, pg 1200
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`Merck Ex. 1053, pg 1226
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`

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`Case 2:11-cv-06519-MRP-JEM Document 1 Filed 01/25/11 Page 4 of 14 Page ID #:4
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`the United States Code. This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 133 1
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`and 1338(a).
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`12.
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`This Court has personal jurisdiction over Genentech based on its incorporation
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`and business in Delaware. On information and belief, this Court has personal jurisdiction over
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`Cily of Hope based on its business activities in and directed to Delaware and its established and
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`ongoing relationship with its co-assignee Genentech. Because of the multifaceted relaLionship
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`between Cily of Hope and Genentech, including coordinating prosecution and maintenance of
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`the Cab illy II Patent and control over federal litigation, City of Hope has purposefully availed
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`itself of the benefits and protections of Delaware law.
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`13.
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`Venue is proper in this district pursuant to 28 U.S.C. §§ 139l(b) and (c) and
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`l400(b), because Genentech is incorporated, both Defendants do business in the State of
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`Delaware, and HGS intends to market Benlysta® in this District upon approval by the FDA.
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`THE CABILL Y PATENTS
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`14.
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`On April 8, 1983, Shmuel CabiUy, Herbert Heyneker, William Holmes, Arthur
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`Riggs and Ronald Wetzel (the "Cabilly Applicants") filed a patent application in the PTO that
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`issued on March 28, 1989, as U.S. Patent No. 4,816,567 (the "Cabilly I Patent").
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`15.
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`AL the time the Cabilly I Patent issued, the Cabilly Applicants had a continuation
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`application (the "Cabilly IT Application") pending in the United States Patent and Trademark
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`Office ("PTO"). The PTO issued the Cab illy II Patent on December 18, 200 1. On its face, the
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`Cabilly II Patent is assigned to Genentech, and, by certificate of correction, is also assigned Lo
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`City ofHope.
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`Patent Reexamination
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`16.
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`In 2005 , two separate requests to re-examine the Cabilly II Patent were submitted
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`to the PTO. The PTO mailed two separate orders granting a request for reexamination, on Jul y
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`YCSTOl: 1064922K.l
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`900002.0008
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`4
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`Sanofi/Regeneron Ex. 1 053, pg 1201
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`Merck Ex. 1053, pg 1227
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`

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`Case 2:11-cv-06519-MRP-JEM Document 1 Filed 01/25/11 Page 5 of 14 Page ID #:5
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`7, 2005 and January 23, 2006. See Decision Granting Ex Parte Reexamination, Reexamination
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`Control No. 90/007,542 (July 7, 2005); Decision Granting Ex Parte Reexamination,
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`Reexamination Control No. 90/007,859 (January 23, 2006). The reexamination proceedings
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`were merged on June 6, 2006.
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`17.
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`On July 19, 2008, the PTO mailed an Advisory Action, maintaining its final
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`rejection of all claims in the Cabilly II Patent as invalid for reasons including obviousness-type
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`double patenting. Ex Parte Reexaminalion Advisory Action, Reexamination Control Nos.
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`90/007,859 and 90/007,542 (July 19, 2008).
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`18.
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`In response to the final rejection, Defendants filed an Appeal Brief on December
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`9, 2008.
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`19.
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`After an Ex Parte Examiner Jnterview on February 13,2009, Genentech amended
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`claims 21,27 and 32 to overcome the obviousness-type double patenting rejection. See
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`Supplemental Amendment Under 37 C.F.R. § 1.550(b), Reexarninalion Control Nos. 90/007,859
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`and 90/007,542 (February 13, 2009).
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`20.
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`On February 23, 2009, the PTO issued a Notice oflnlent Lo Jssue a
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`Reexamination Certificate to Genentech, confirming claims 1-20 and 33-36 and allowing
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`amended claims 21,27 and 32. Notice oflntent to Issue Ex Parte Reexaminalion Certiticate,
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`Reexamination Conlrol Nos. 90/007,859 and 90/007,542 (Fcbmary 23, 2009). On May 19,
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`2009, the Ex Parte Reexamination Ce1tificate Issued for U.S. Patent No. 6,331 ,415 Cl with
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`amended claims 21, 27 and 32.
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`Defendants' Admissions Regarding State oftlle Art itt Aprill983
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`21.
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`Defendants made a number of admissions in their December 2008 Appeal Brief
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`regarding the state of the art prior to the filing of the Cabilly II Patent application in April 1983.
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`According to Defendants:
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`5
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`YCSTO I: 10649228.1
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`900002.0008
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`Sanofi/Regeneron Ex. 1 053, pg 1202
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`Merck Ex. 1053, pg 1228
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`

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`Case 2:11-cv-06519-MRP-JEM Document 1 Rled 01/25/11 Page 6 of 14 Page ID #:6
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`a. "[I]n April 1983, the biological mechanisms that controlled expression offoreign
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`DNA and assembly of proteins were not well understood. Tllis lack of
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`understanding was especially Lrue for eukaryotic genes, which were known to be
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`far more complex than prokaryotic genes. As Dr. Harris, one of Owners' experls
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`in this case, explained in his 1983 review paper, 'il is clear that not all the rules
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`governing the expression of cloned genes have been elaborated and those rules
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`that do exist are still largely empiricaL"' (Appeal Brief at 20).
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`b. "In early April of 1983, the field of genetic engineeling was still developing ... .
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`A relatively small number of proteins had been made by recombinant DNA
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`technology. Almost all of those were relatively simple monomeric (i.e., one
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`polypeptide chain) proteins." (Appeal Brief Appendix al B551 [Harris Dec!.]).
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`c.
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`''As of April 1983, insulin was the only 'multimcric' protein that had been made
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`using genetic engineering." (Appeal Brief at 21).
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`d.
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`"Several experts with actual expelience in the f1cld of the invention in April1983
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`explained that those references cited by the Examiner that include experimental
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`results show a significant amount ofunprecUctability in achieving success in
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`simpler experiments than what is required by the '4 I 5 patent claims." (Appeal
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`Brief at 28).
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`e.
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`"[S Juccessful production of immunoglobulins was highly dependent on Lhe
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`sequence of expression and levels al which the two immunoglobulin genes were
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`expressed." (Appeal Brief at 63).
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`f.
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`"[L]evels of expression of each immunoglobulin gene could affect production of
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`the other immunoglobulin polypeptide." (Appeal Brief at 63).
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`YCSTO I: l 0649228.1
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`900002.0008
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`6
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`Sanofi/Regeneron Ex. 1 053, pg 1203
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`Merck Ex. 1053, pg 1229
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`

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`case 2:11-cv-06519-MRP-JEM Document 1 Filed 01/25/11 Page 7 of 14 Page ID # :7
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`g. "Such a person would have been familiar with the many complications of
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`producing eukaryotic polypeptides in bacterial host cells !mown hy April 1983."
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`(Appeal Brief at 73).
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`h.
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`"I believe a person of ordinary skill in the art, in early April of 1983, would have
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`thought that succe~sful expression of two immunoglobulin proteins in one
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`transformed host cell would have been unpredictable and that assembly of the two
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`proteins into an immunoglobulin tetramer would have been even more
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`unpredictable." (Appeal Brief Apendix at B224 [McKnight Decl.]).
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`1.
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`"Experimental results would have been important to a person of ordinary skill in
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`the art in April 1983 because many of the biological mechanisms that controlled
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`expression of foreign DNA and assembly of proteins were not well understood at
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`that time." (Appeal Brief Appendix at B376 [Second McKnight Decl.J).
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`J·
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`"Each of these papers show~ that successful transformation and expression of
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`even one foreign immunoglobulin gene in a lymphoid host cell could not be
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`reasonably expected in April 1983. T do not believe these references can be read
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`as ~uggesting that something even more challenging -
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`expressing two different
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`foreign immunoglobulin genes in one transformed cell - would have been
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`something that could be predictably achieved at that time." (Appeal Brief
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`Appendix at B382 [Second McKnight Dec!.).
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`k. " ... I disagree vvith the suggestion, that by early April1983, my PNAS paper had
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`made routine or predictable the task of expressing exogenous immunoglobulin
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`light and heavy l:hain genes in the same cell. In later experiments, I attempted to
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`use the techniques described in the PNAS paper to introduce and express single Ig
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`genes into other lymphoid cell lines. Most of these experiments failed to produce
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`YCSTOl : 10649228.1
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`900002.0008
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`7
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`Sanofi/Regeneron Ex. 1 053, pg 1204
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`Merck Ex. 1053, pg 1230
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`

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`Case 2:11-cv-06519-MRP-JEM Document 1 Filed 01/25/11 Page 8 of 14 Page ID # :8
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`stable transfectants. Thus, my experience was that using the same transfection and
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`selection conditions described in the PNAS paper with other cell lines or other Tg
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`genes did not routinely yield stable transformants containing even a single
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`exogenous Ig gene." (Appeal Brief Appendix at B391 [Rice Decl.]).
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`HGS'S BENLYSTA® (BELIMUMAB)
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`22.
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`Benlysta® (belimumab) is a new, human monoclonal antibody that targets the B-
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`lymphocyte stimulator ("BLyS"), a naturally occurring protein, which is involved in the
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`mediation of immunological responses and autoimmune diseases, including Lupus. HGS first
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`discovered BLyS in 1996 and published a scientific article describing its activity in the journal
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`Science in July 1999. Following Lhat discovery, HGS initiated a program to develop human
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`monoclonal antibodies that would specifically recognize and inhibit the biological activity of
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`BLyS.
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`23.
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`After years of research and development, on June 2, 2010, HG S subrnitted a BLA
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`to the FDA seeking to market Benlysta® with an indication for the treatment of autoantibody(cid:173)
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`positive patients with Lupus. If approved, Benlysta® would be the first new approved drug for
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`Lupus in more than fifty years.
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`24.
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`HGS has expended substantial revenues researching and developing Benlysta®.
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`HGS also has expended substantial revenues preparing to launch and commercialize Benlysta@.
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`25.
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`HGS currently manufactures belimumab in Rockville, Maryland in anticipation of
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`commercial sales in the United States as the Benlysta® product. In addition, copies of the
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`working cell bank used to produce Benlysta® are maintained by HGS in RockviUe, Maryland.
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`26.
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`The FDA Atthritis Advisory Committee met to consider the Benlysta® BLA on
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`November 16, 2010, voting 13 to 2 to recommend that the FDA approve Bcnlysta®.
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`YCS!O l : 1Uh4~228 . 1
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`900002.0008
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`8
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`Sanofi/Regeneron Ex. 1 053, pg 1205
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`Merck Ex. 1053, pg 1231
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`

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`Case 2:11-cv-06519-MRP-JEM Document 1 Rled 01/25/11 Page 9 of 14 Page ID #:9
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`27.
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`In the near future, HGS expects a decision from the FDA on the approval of
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`HGS's BLA for Benlysta®. Upon approval, HGS will begin marketing Benlysta® in the United
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`States, including in this District.
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`HGS'S DISPUTE WITH DEFENDANTS REGARDING THE CABILLY II PATENT
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`28.
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`Through its statements and actions, Genentech has made clear to the
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`biophmmaccutical industry generally and to HGS particularly that it contends that the claims of
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`the Cabilly II Patenl preclude others from commercially manufacturing recombinantly produced
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`monoclonal antibodies without Genentech's permission. In 2002, after the Cabilly II Patent
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`issued, Sean Johnston, then Genentech's Vice President oflntcllcctual Property and now
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`Genentech's Senior Vice President and General Counsel said:
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`"The recently issued patent broadly covers the co-expression of immunoglobulin heavy
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`and light chain genes in a single host cell ... We do not believe that the daims are
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`limited by type of antibody (murine, humanized, or hmnan) or by host cell type."
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`Genentech Awarded Critical Antibody Patent, Nature Biotechnology, vol. 20, p. 108 (Feb. 2002)
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`(emphasis added).
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`29.
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`According to Defendants, the manufacturing methods claimed in the Cabilly 11
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`Patent are "the backbone of recombinant antibody production in the biotech industry."
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`Centncnr, Inc. v. Genentech, Inc., Case No. 2:08-cv-03573 (C.D. Cal.) (Opening Brief of Claim
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`Construction, March 24, 2009), Dkt. No. 78.
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`30.
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`Genentech has asserted the Cabilly II Patent in litigation against other
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`manufacturers of recombinant monoclonal antibodies, including Medlmmune, Inc., Centocor
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`Otibo Biotech Inc. and GlaxoSmithK.linc LLC. See Medimmune Inc. v. Genentech, Inc., Case
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`No. 03-cv-02567 (C.D. Cal.); Centocor, Inc. v. Genentech, Inc:., Case No. 08-cv-03573 (C.D.
`
`Cal.); Glaxo Group Ltd. v. Genentech, Inc., Case No. 2:10-cv-02764 (C.D. Cal.).
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`YCSTO I: I 0649228.1
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`900002.0008
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`9
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`Sanofi/Regeneron Ex. 1 053, pg 1206
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`Merck Ex. 1053, pg 1232
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`

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`case 2:11-cv-06519-MRP-JEM Document 1 Filed 01/25/11 Page 10 of 14 Page ID #:10
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`31.
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`On information and belief, Genentech contends that the process and cetiain
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`starting materials used to prodtlce Benlysta® infringe one or more claims of the Cabilly II
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`Patent.
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`32.
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`Because Defendants have consistently alleged that the use of well-known,
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`conventional recombinant methods to produce monoclonal antibodies in mammalian cell culture
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`is within the scope of claims of the Cab illy II Patent and have assetied the patent against others
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`who are similarly situated to HUS, Defendants' prior statements and conduct necessarily
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`establish an actual and substantial dispute between HGS and Defendants regarding the invalidity,
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`unenforceability and noninfringement of the claims of the Cabilly II Patent. Therefore, HGS has
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`a reasonable apprehension of suit by Genentech and City of Hope regarding the Cab illy II Patent.
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`33.
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`In addition to the statements and conduct directed at others, Defendants have
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`made statements and engaged in conduct directed at HGS that create a real and immediate
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`dispute between the parties regarding the Cabilly II Patent.
`
`34.
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`Genentech has made public statements about pursuing an aggressive litigation
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`policy to protect its products against competition and to protect against alleged infringement of
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`the Cabilly II Patent claims in its 2009 Fotm 1 0-K filing with the Securities and Exchange
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`Commission. Genentech states:
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`"lntellectual property protection of our products is crucial to our business. Loss of
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`effective intellectual property protection could result in lost sales to competing products
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`and loss of royalty payments (for example, royalty income associated with the Cabilly
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`patent) from licensees. We are often involved in disputes over contracts and intellectual
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`property, and we work to resolve these disputes in confidential negotiations or litigation.
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`We expect legal challenges in this area to continue. We plan to continue to build upon
`
`and defend our intellectual property position."
`
`10
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`YCSTO 1: 1064922X. I
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`900002.0008
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`Sanofi/Regeneron Ex. 1 053, pg 1207
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`Merck Ex. 1053, pg 1233
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`

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`case 2:11-cv-06519-MRP-JEM Document 1 Filed 01/25/11 Page 11 of 14 Page ID #:11
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`(emphasis added). Genentech also states: "We have in the past been, are cmrently, and may in
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`the future be involved in material litigation and other legal proceedings related to our
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`proprietary rights, such as the Cabilly patent litigation and reexamination .... "(emphasis
`
`added).
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`35.
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`On January 7, 2011, Defendants averred in a comt filing that HGS 's process to
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`make Benlysta® infringes the Cabilly II Patent. Specifically, in Defendants' Opening Brief on
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`Claim Construction, a patent infringement action involving GlaxoSrnithKline's antibody
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`ArzenaTM and the Cabilly JJ Patent, Defendants stated:
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`"Genentech and City of Hope intend shortly to ask the Court for leave to add
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`infringement allegations against a new GSK product, Benlysta® (belimumab), a
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`recombinantly engineered monoclonal antibody for the treatment of lupus . . . . The
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`process used to make Benlysta® is similar to that for Arzerra, except that it uses two
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`vectors instead of one (and thus will implicate claims 1 X and 20)."
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`Glaxo Group Ltd. v. Genenlech, Inc., Case No. 2:10-cv-02764 (C.D. Cal.), Dkt. No . 83 at FN4
`
`(emphasis added)
`
`36.
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`Taken together, Genentech's statements that it will enforce the Cabilly II Patent to
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`defend its products against competing products, and Defendants' sworn contention that HGS' s
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`Bcnlysta® infringes at least two claims of the Cabilly II Patent, establish that a real and
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`immediate dispute exists between the parties with adverse legal interests l.:oncerning the Cabilly
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`II Patent. HGS therefore has a reasonable apprehension of suit by Gcnentech and City of Hope
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`regarding the Cabilly IJ Patent
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`FIRST CAUSE OF ACTION
`NON-INFRINGEMENT
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`37.
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`IIGS incorporates the all egations ofpmagraphs 1 through 36 as if fully set forth
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`herein.
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`YCSTO I:I064922&. 1
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`11
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`Y00002.000&
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`Sanofi/Regeneron Ex. 1 053, pg 1208
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`Merck Ex. 1053, pg 1234
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`

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`case 2:11-cv-06519-MRP-JEM Document 1 Filed 01/25/11 Page 12 of 14 Page ID #:12
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`38.
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`An actual controversy has arisen and now exists between the patiies concerning
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`whether HGS's manuta.cture ofBenlysta® (belimumab) infringes any valid and enforceable
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`claim of the Cabilly II Patent, either directly or indirectly, literally, under the doctrine of
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`equivalents, or otherwise.
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`39.
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`HGS seeks a declaratory judgment that making, using, impmiing, offering to sell,
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`and selling Benlysta® (belirnumab) does not and will not infringe any valid and enforceable
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`claim of the Cabilly II Patent.
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`SECOND CAUSE OF ACTION
`INVALIDITY
`
`40.
`
`HGS incorporates the allegations of paragraphs 1 tlu·ough 39 as iffully set forth
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`herein.
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`41.
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`The Cabilly II Patent is invalid because it is anticipated and/or obvious tmder 35
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`tJ.S.C. §§ 102 and 103.
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`42.
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`The Cabilly II Patent is invalid based on the judicially created doctrine of
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`obviousness-type double patenting and/or under 35 U.S.C. §§ 101 and/or 103.
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`43.
`
`The Cabilly f1 Patent is invalid under 35 U .S.C. § 112.
`
`44.
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`Claims 21 -32 of the Cabilly II Patent are invalid as being broadened in scope
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`during reexamination in violation of35 U.S.C. § 305.
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`45.
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`HGS seeks a declaratory judgment that the Cabilly II Patent is invalid under 35
`
`U .S.C. §§ 101,102,103, 112 and 305 and/or under the judicially created doctrine of
`
`obviousness-type double patenting.
`
`THIRD CAUSE OF ACTION
`PROSECUTION LACHES
`
`46.
`
`HGS incorporates the allegations of paragraphs 1 through 45 as if fully set forth
`
`herein.
`
`12
`
`YCSTO J: 10649228. 1
`
`900002.0008
`
`Sanofi/Regeneron Ex. 1 053, pg 1209
`
`Merck Ex. 1053, pg 1235
`
`

`
`Case 2:11-cv-06519-MRP-JEM Document 1 Filed 01/25/11 Page 13 of 14 Page ID #:13
`
`47.
`
`An actual controversy has arisen and now exists between the pa1ties concerning
`
`the enforceability of the Cabilly J1 Patent.
`
`48.
`
`The Cabilly II Patent is unenforceable under the doctrine of prosecution laches.
`
`The Cabilly II Patent issued after an unreasonable and unexplained delay in the interference
`
`proceedings between the Cabilly II Application and U.S. Patent No. 4,816,397. Genentech also
`
`unreasonably delayed the prosecution of claims 21, 22,27-30 and 32, which were filed as part of
`
`the Cabilly II Application in 1983 but did not issue until 2001.
`
`49.
`
`HGS seeks a declaralory judgment that the Cahilly II Patent is unenforceable due
`
`to prosecution laches.
`
`DEMAND FOR JURY TRIAL
`
`50.
`
`Pursuant to Rule 3 8(b) of the Federal Rules of Civil Procedure, HGS demands a
`
`Lrial by jury of all issues so triable.
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`PRAYER FOR RELIEF
`
`WHEREFORE, HGS requests that judgment be entered in favor ofHGS and
`
`against Defendants Genentech and City of Hope:
`
`a)
`
`Declaring that the manufacture, use, imp01tation, offer to sell, or sale ofHGS's
`
`Ben.lysta® (belimumab) product does not infi-inge any valid and enforceable
`
`b)
`
`c)
`
`d)
`
`e)
`
`claim of the Cabilly II Patent;
`
`Declaring that the Cabilly 11 Patent is invalid;
`
`Enjoining Genentcch and City of Hope from enforcing the Cabilly II Patent;
`
`Awarding costs to HGS in accordance ·with 35 U .S.C. § 2S4;
`
`Declaring HGS's case to be exceptional and awarding IIGS its attorneys' fees and
`
`expenses under 35 U.S.C. § 285; and
`
`YCSTOI : 10649228.1
`
`900002.0008
`
`13
`
`Sanofi/Regeneron Ex. 1 053, pg 121 0
`
`Merck Ex. 1053, pg 1236
`
`

`
`Case 2:11-cv-06519-MRP-JEM Document 1 Filed 01/25/11 Page 14 of 14 Page ID #:14
`
`f)
`
`Awarding HGS such other relief as the Court may deem just, equitable, and
`
`proper.
`
`Of Counsel:
`
`Henry B. Gutman
`Noah M. Leibowitz
`SIMPSON THACHER & BARTLETT LLP
`425 Lexington A venue
`New York, New York 10017
`Telephone: (212) 455-2000
`
`Harrison J. Frahn
`S TMPSON THACHER & BARTLETT LLP
`2550 Hanover Sb:eet
`Palo Alto, CA 94304
`Telephone: (650) 462-9406
`
`Dated: January 25 , 2011
`
`o. 3990)
`. o
`Adam
`Monte T . Squire (No. 4764)
`The Brandywine Building
`1 00 West S treel, 1 7lh Floor
`Wilmington, DE 19899-0391
`(302) 571-6600
`apoff@ycst.com
`msquire@ycst.com
`
`Attorneys for Plaintiff Human Genome
`Sciences, Inc.
`
`Y CSTO I : J 0649228. I
`
`900002.0008
`
`14
`
`Sanofi/Regeneron Ex. 1 053, pg 1211
`
`Merck Ex. 1053, pg 1237