Case: 15-2066 Document: 115-1 Page: 1 Filed: 07/05/2016
`
`Nos. 2015-2066, 2016-1008, -1009, -1010, -1109, -1110, -1283, -1762
`
`UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`
`MILLENNIUM PHARMACEUTICALS, INC.,
`Plaintiff-Appellant,
`
`v.
`SANDOZ INC., ACCORD HEALTHCARE INC., ACTAVIS LLC, MYLAN LABORATORIES
`LIMITED, AGILA SPECIALTIES INC., DR. REDDY’S LABORATORIES, LTD.,
`DR. REDDY’S LABORATORIES, INC., SUN PHARMACEUTICAL INDUSTRIES LIMITED,
`SUN PHARMA GLOBAL FZE, APOTEX CORP., APOTEX INC.,
`TEVA PHARMACEUTICALS USA, INC., GLENMARK PHARMACEUTICALS LTD.,
`GLENMARK GENERICS LTD., GLENMARK GENERICS INC., USA, HOSPIRA, INC.,
`WOCKHARDT BIO AG, WOCKHARDT USA LLC,
`Defendants-Appellees.
`
`
`
`Appeals from the United States District Court for the District of Delaware in Nos.
`1:12-cv-01011-GMS, 1:12-cv-01490-GMS, 1:12-cv-01750-GMS,
`1:13-cv-01874-GMS, 1:14-cv-01156-GMS, 1:15-cv-00040-GMS,
`1:15-cv-00539-GMS, and 1:15-cv-00540-GMS, 1:15-cv-00804-GMS,
`1:16-cv-00034-GMS, Judge Gregory M. Sleet
`
`JOINT APPENDIX VOLUME I OF III
`(A1-A1695)
`
`
`ROBERT M. GALVIN
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`950 Page Mill Road
`Palo Alto, CA 94304
`(650) 858-6000
`
`
`
`
`July 5, 2016
`
`WILLIAM F. LEE
`ANNA E. LUMELSKY
`TASHA J. BAHAL
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`(617) 526-6000
`
`Attorneys for Plaintiff-Appellant
`Millennium Pharmaceuticals, Inc.
`
`
`
`

`

`Case: 15-2066 Document: 115-1 Page: 2 Filed: 07/05/2016
`
`TABLE OF CONTENTS
`
`
`
`
`
`ORDERS AND JUDGMENTS
`
`VOLUME I
`
`Order Construing the Terms of U.S. Patent Nos. 6,958,319 and
`6,713,446, Dkt. No. 56 (Dec. 13, 2013) (12-cv-01011)
`
`Memorandum Opinion, Dkt. No. 148 (Aug. 20, 2015) (12-cv-
`01011)
`
`Order Directing Entry of Final Judgment, Dkt. No. 149 (Aug. 20,
`2015) (12-cv-01011)
`
`Judgment, Dkt. No. 150 (Aug. 24, 2015) (12-cv-01011)
`
`Judgment, Dkt. No. 57 (Oct. 1, 2015) (13-cv-01874)
`
`Judgment, Dkt. No. 18 (Oct. 7, 2015) (14-cv-01156)
`
`Page(s)
`
`
`
`A1-A3
`
`A4-A22
`
`A23
`
`A24
`
`A25-A26
`
`A27
`
`Consent Judgment, Dkt. No. 20 (Sept. 23, 2015) (15-cv-00040)
`
`A28-A30
`
`Judgment, Dkt. No. 15 (Sept. 23, 2015) (15-cv-00539)
`
`Judgment, Dkt. No. 16 (Sept. 16, 2015) (15-cv-00540)
`
`Judgment, Dkt. No. 17 (Dec. 2, 2015) (15-cv-00804)
`
`Judgment, Dkt. No. 11 (Mar. 22, 2016) (16-cv-00034)
`
`PATENT-IN-SUIT
`
`United States Patent No. 6,713,446 (PTX-001)
`
`DISTRICT COURT DOCKET SHEETS
`Civil Docket Sheet for Millennium Pharmaceuticals Inc. v. Sandoz
`Inc., U.S.D.C., D. Del. No. 1:12-cv-01011-GMS
`Civil Docket Sheet for Millennium Pharmaceuticals Inc. v. Apotex
`Corp., U.S.D.C., D. Del. No. 1:13-cv-01874-GMS
`
`A31
`
`A32
`
`A33
`
`A33.1
`
`
`
`A34-A47
`
`
`
`A48-A63
`
`A64-A72
`
`- i -
`
`

`

`Case: 15-2066 Document: 115-1 Page: 3 Filed: 07/05/2016
`
`
`
`
`
`Civil Docket Sheet for Millennium Pharmaceuticals Inc. v.
`Glenmark Pharmaceuticals, Ltd., U.S.D.C., D. Del. No. 1:14-cv-
`01156-GMS
`Civil Docket Sheet for Millennium Pharmaceuticals Inc. v. Mylan
`Laboratories Limited, U.S.D.C., D. Del. No. 1:15-cv-00040-GMS
`Civil Docket Sheet for Millennium Pharmaceuticals Inc. v. Dr.
`Reddys Laboratories, Ltd, U.S.D.C., D. Del. No. 1:15-cv-00539-
`GMS
`Civil Docket Sheet for Millennium Pharmaceuticals Inc. v. Sun
`Pharmaceutical Industries Limited, U.S.D.C., D. Del. No. 1:15-cv-
`00540-GMS
`Civil Docket Sheet for Millennium Pharmaceuticals Inc. v.
`Hospira, Inc., U.S.D.C., D. Del. No. 1:15-cv-00804-GMS
`Civil Docket Sheet for Millennium Pharmaceuticals Inc. v.
`Wockhardt Bio AG, U.S.D.C., D. Del. No. (16-cv-00034-GMS)
`TRIAL TRANSCRIPTS
`
`Trial Transcript Day 1 for November 4, 2014, Dkt. No. 139 (Apr.
`15, 2015)
`
`Trial Transcript Day 2 for November 5, 2014, Dkt. No. 140 (Apr.
`15, 2015)
`
`Trial Transcript Day 3 for November 6, 2014, Dkt. No. 141 (Apr.
`15, 2015)
`
`VOLUME II
`
`Page(s)
`
`A73-A76
`
`A77-A82
`
`A83-A85
`
`A86-A89
`
`A90-A92
`
`A93-A95
`
`
`
`A1001-
`A1274
`
`A1275-
`A1537
`
`A1538-
`A1776
`
`Trial Transcript Day 4 for November 7, 2014, Dkt. No. 142 (Apr.
`15, 2015)
`
`A1777-
`A1949
`
`
`
`
`
`
`- ii -
`
`

`

`Case: 15-2066 Document: 115-1 Page: 4 Filed: 07/05/2016
`
`Page(s)
`
`
`
`
`
`DISTRICT COURT FILINGS DESIGNATED BY APPELLANT
`
`
`
`Complaint, Dkt. No. 1 (Aug. 2, 2012) (12-cv-1011)
`
`Statement of Uncontested Facts - Exhibit 1 to Final Pretrial Order,
`Dkt. No. 113-1 (Sept. 12, 2014) (12-cv-1011)
`
`Millennium’s Post Trial Proposed Findings of Fact and
`Conclusions of Law, Dkt. No. 132 (Dec. 19. 2014) (12-cv-1011)
`
`A2001-
`A2039
`
`A2040-
`A2047
`
`A2048-
`A2115
`
`Defendants’ Proposed Findings of Fact & Conclusions of Law, Dkt.
`No. 133 (Dec. 19, 2014) (12-cv-1011)
`
`A2116-
`A2177
`
`DISTRICT COURT FILINGS DESIGNATED BY APPELLEES
`
`
`
`Complaint, Dkt. No. 1 (Nov. 8, 2013) (13-cv-01874)
`
`Complaint, Dkt. No. 1 (Jan. 22, 2014) (14-cv-00093)
`
`Stipulation and Order, Dkt. No. 21 (May 13, 2014) (13-cv-01874)
`
`Stipulation of Infringement and Partial Dismissal, Dkt. No. 44
`(June 5, 2015) (13-cv-01874
`
`Stipulation of Partial Dismissal with Prejudice of Claims and
`Counterclaims Related to Teva Pharmaceuticals USA, Inc., Dkt.
`No. 39 (Mar. 9, 2015) (13-cv-01874)
`
`Stipulation Requesting Entry of Judgment, Dkt. No. 55 (Sept. 24,
`2015) (13-cv-01874)
`
`Stipulation Requesting Entry of Judgment, Dkt. No. 56 (Oct. 1,
`2015) (13-cv-01874)
`
`Stipulation Requesting Entry of Judgment, Dkt. No. 15 (Nov. 30,
`2015) (15-cv-00804)
`
`A4001-
`A4040
`
`A4041-
`A4081
`
`A4082-
`A4083
`
`A4084-
`A4087
`
`A4088-
`A4091
`
`A4092-
`A4097
`
`A4098-
`A4100
`
`A4101-
`A4105
`
`- iii -
`
`

`

`Case: 15-2066 Document: 115-1 Page: 5 Filed: 07/05/2016
`
`
`
`
`
`Stipulation Requesting Entry of Judgment, Dkt. No. 16 (Dec. 2,
`2015) (15-cv-00804)
`
`Stipulation Requesting Entry of Judgment, Dkt. No. 9 (Mar. 17,
`2016) (16-cv-00034)
`
`Stipulation Requesting Entry of Judgment, Dkt. No. 10 (Mar. 22,
`2016) (16-cv-00034)
`
`Stipulation Requesting Entry of Judgment, Dkt. No. 16 (Oct. 5,
`2015) (14-cv-01156)
`
`Stipulation Requesting Entry of Judgment, Dkt. No. 17 (Oct. 7,
`2015) (14-cv-01156)
`
`Stipulation Requesting Entry of Judgment, Dkt. No. 13 (Sept. 22,
`2015) (15-cv-00539)
`
`Stipulation Requesting Entry of Judgment, Dkt. No. 14 (Sept. 23,
`2015) (15-cv-00539)
`
`Stipulation Requesting Entry of Judgment, Dkt. No. 15 (Sept. 14,
`2015) (15-cv-00540)
`
`TRIAL EXHIBITS DESIGNATED BY APPELLANT
`
`PTX-009 - VELCADE® for Injection Now Approved in Over 65
`Countries (Prix Galien Awards) (MILL-VEL-M-00021787-92)
`
`PTX-027 - Monthly Report to NCI (January 28, 1998) (MILL-
`VEL-00010039-46)
`
`PTX-032 - Wanda Waugh Lab Notebook (No. 23) (MILL-VEL-
`00012186-511)
`
`PTX-035 - Monthly Report to NCI (June 27, 1997) (MILL-VEL-
`00042828-47)
`
`PTX-037 - Monthly Report to NCI (December 18, 1997) (MILL-
`VEL-00044643-64)
`
`- iv -
`
`Page(s)
`
`A4106-
`A4108
`
`A4109-
`A4113
`
`A4114-
`A4116
`
`A4117-
`A4121
`
`A4122-
`A4124
`
`A4125-
`A4129
`
`A4130-
`A4132
`
`A4133-
`A4137
`
`
`
`A6001-
`A6006
`
`A6007-
`A6014
`
`A6015-
`A6340
`
`A6341-
`A6360
`
`A6361-
`A6382
`
`

`

`
`
`
`
`Case: 15-2066 Document: 115-1 Page: 6 Filed: 07/05/2016
`
`PTX-038 - Monthly Report to NCI (November 24, 1997) (MILL-
`VEL-00044667-80)
`
`PTX-039 - Monthly Report to NCI (October 24, 1997) (MILL-
`VEL-00044683-94)
`
`PTX-040 - Monthly Report to NCI (September 25, 1997) (MILL-
`VEL-00044698-721)
`
`PTX-044 - Monthly Report to NCI (January 20, 1999) (MILL-
`VEL-00054832-51)
`
`PTX-055 - Monthly Report to NCI (April 24, 1998) (MILL-VEL-
`00117167-207)
`
`PTX-056 - Monthly Report to NCI (June 25, 1998) (MILL-VEL-
`00117760-845)
`
`PTX-058 - Monthly Report to NCI (March 25, 1998) (MILL-VEL-
`00118734-67)
`
`PTX-063 - Public Health Service Exclusive Patent License
`Agreement (MILL-VEL-00253670-96)
`
`VOLUME III
`
`PTX-069 - VELCADE® for Injection FDA Approval and Package
`Insert (May 13, 2003) (MILL-VEL-00385310-33)
`
`PTX-073 - United States Patent No. 5,780,454 to Adams/ProScript
`(MILL-VEL-02256400-36)
`
`PTX-074 - Monthly Report to NCI (October 23, 1998) (MILL-
`VEL-01356453-69)
`
`PTX-076 - Monthly Report to NCI (September 25, 1998) (MILL-
`VEL-01367167-97)
`
`PTX-082 - Bross, P., et al. “Approval Summary for Bortezomib for
`Injection in the Treatment of Multiple Myeloma,” Clin. Cancer
`Res. 10, 3954-3964 (2004) (MILL-VEL-01820583-93)
`
`- v -
`
`Page(s)
`
`A6383-
`A6396
`
`A6397-
`A6408
`
`A6409-
`A6432
`
`A6433-
`A6452
`
`A6453-
`A6493
`
`A6494-
`A6579
`
`A6580-
`A6613
`
`A6614-
`A6640
`
`A6641-
`A6664
`
`A6665-
`A6701
`
`A6702-
`A6718
`
`A6719-
`A6749
`
`A6750-
`A6760
`
`

`

`
`
`
`
`Case: 15-2066 Document: 115-1 Page: 7 Filed: 07/05/2016
`
`PTX-091 - San Miguel, J., et al. “Bortezomib plus Melphalan and
`Prednisone for Initial Treatment of Multiple Myeloma,” N. Engl. J.
`Med. 359:9, 906-917 (2008) (MILL-VEL-02121346-57)
`
`PTX-110 - Herman, B. et al., “The Effect of Bulking Agent on the
`Solid-State Stability of Freeze-Dried Methylprednisolone Sodium
`Succinate,” Pharm. Res. 11(10) 1467-1473 (1994) (MILL-VEL-
`02254004-10)
`
`PTX-125 - Formulation and Stability of MG-341; Author: Larry
`Dick (March 25, 1997) (MILL-VEL-00015070-75)
`
`PTX-126 - Formulation and Stability of MG-341; Author: Larry
`Dick (June 5, 1997) (MILL-VEL-00016824-43)
`
`PTX-128 - Fax from Gupta to Stella, Subject “Structures for
`Assignments 501 through 506,” February 19, 1997 (MILL-VEL-
`00112277-83)
`
`PTX-135 - Final Monthly Report to NCI (July 15, 1997) (MILL-
`VEL-00042814-26)
`
`PTX-137 - Monthly Report to NCI (August 22, 1997) (MILL-VEL-
`00009823-38)
`
`PTX-138 - Monthly Report to NCI (May 23, 1997) (MILL-VEL-
`00113614-39)
`
`Page(s)
`
`A6761-
`A6772
`
`A6773-
`A6779
`
`A6780-
`A6785
`
`A6786-
`A6805
`
`A6806-
`A6812
`
`A6813-
`A6825
`
`A6826-
`A6841
`
`A6842-
`A6867
`
`PDX-1 - Plaintiff’s Demonstrative Exhibits for Opening Statement A6868-
`A6918
`
`PDX-2 - Plaintiff’s Demonstrative Exhibits Used During Direct
`Examination of William Bensinger
`
`PDX-5 - Plaintiff’s Demonstrative Exhibits Used During Direct
`Examination of Roger J. Snow
`
`PDX-6 - Plaintiff’s Demonstrative Exhibits Used During Direct
`Examination of Bradley Anderson
`
`A6919-
`A6920
`
`A6921-
`A6948
`
`A6949-
`A6971
`
`- vi -
`
`

`

`
`
`
`
`Case: 15-2066 Document: 115-1 Page: 8 Filed: 07/05/2016
`
`PDX-7.1 - Plaintiff’s Demonstrative Exhibit Used During Direct
`Examination of Julian Adams
`
`DTX-020 - US Patent 5,780,454
`
`DTX-051 - Development of Parenteral Formulations of
`Experimental Cytotoxic Agents. I. Rhizoxin (NSC-332598) (MILL-
`VEL-00112432-40)
`
`DTX-074 - Chiral Synthesis via Organoboranes. 9. Crystalline
`“Chelates” from Borinic and Boronic Esters. A Simple Procedure
`for Upgrading Borinates and Boronates of Materials Approaching
`100% Optical Purity
`
`DTX-154 - Kuivila article “Electrophilic Displacement Reactions.
`III. Kinetics of the Reaction between Hydrogen Peroxide and
`Benzeneboronic Acid” (SDZ_BO0065138-42)
`
`DTX-155 - Pizer and Babcock article “Mechanism of the
`Complexation of Boronic Acids with Cathchol and Substituted
`Catechols” (SDZ_BO0065284-88)
`
`DTX-156 - Lorand - Polyol Complexes and Structure of the
`Bezeneboronate Ion” (SDZ_BO0003966-73)
`
`DTX-157 - Pizer and Babcock article “Dynamics of Boron Acid
`Complexation Reactions, Formation of 1:1 Boronic Acid-Ligand
`Complexes” (SDZ_BO0003651-56)
`
`DTX-184 - Snyder et al “Organoboron Compounds, and the Study
`of Reaction Mechanism. Primary Aliphatic Boronic Acids” J.
`Amer. Chem. Soc. Vol 60:105-111 (1938) (SDZ_BO0064973-79)
`
`DTX-194 - Mori et al., “Complex Formation Of p-
`Boronophenylalanine With Some Monosaccharides,” Pigment Cell
`Research, Vol. 2:273-277 (1989) (“Mori 1989”)
`(SDZ_BO0004029-33)
`
`Page(s)
`
`A6971.1
`
`A6972-
`A7008
`
`A7009-
`A7017
`
`A7018-
`A7022
`
`A7023-
`A7027
`
`A7028-
`A7032
`
`A7033-
`A7040
`
`A7041-
`A7046
`
`A7047-
`A7053
`
`A7054-
`A7058
`
`- vii -
`
`

`

`
`
`
`
`Case: 15-2066 Document: 115-1 Page: 9 Filed: 07/05/2016
`
`DTX-204 - Jonkman-de Vries, et al., “Pharmaceutical Development
`of (Investigational) Anticancer Agents for Parenteral Use-A
`Review”, Drug Dev. Ind. Pharmacy, 22(6), 475-494 (1996)
`(SDZ_BO0004599-623)
`
`DTX-205 - Kim et al., “The Physical State Of Mannitol After
`Freeze-Drying: Effects Of Mannitol Concentration, Freezing Rate,
`And A Noncrystallizing Cosolute,” J. Pharmaceutical Sciences,
`Vol. 87:931-935 (“Kim 1998”) (SDZ_BO0065124-28)
`
`DTX-207 - Repta, “Formulation of Investigational Anticancer
`Drugs,” in Topics in Pharmaceutical Sciences, eds. D.D. Breimer &
`P. Speiser (41st Int’l Congress of Pharm. Sci, 1981), 131-51
`(SDZ_BO0064821-41)
`
`DTX-209 - Steinberg et al., “Preparation and Rate of Hydrolysis of
`Boric Acid Esters,” Industrial & Eng’g Chem. 49(2):174-181
`(1957) (SDZ_BO0004402-09)
`
`DTX-529 - Bashir et al., “Evaluation of Excipients in Freeze-Dried
`Products for Injection,” Bulletin of the Parenteral Drug, Vol. 27:68-
`83 (1973) (“Bashir 1973”) (SDZ_BO0003678-94)
`
`DTX-537 - Eisenberg, “Cyclic Butaneboronic Acid Esters: Novel
`Derivatives For The Rapid Separation Of Carbohydrates By Gas-
`Liquid Chromatography,” Carbohydrate Research, Vol. 19: 135-
`138 (1971) (“Eisenberg 1970”) (SDZ_BO0003815-18)
`
`DTX-543 - Kim et al., “The Physical State Of Mannitol After
`Freeze-Drying: Effects Of Mannitol Concentration, Freezing Rate,
`And A Noncrystallizing Cosolute,” J. Pharmaceutical Sciences,
`Vol. 87:931-935 (“Kim 1998”) (SDZ_BO0003954-58)
`
`DTX-556 - “Parenteral Preparations,” Ch. 84 in Remington’s
`Pharmaceutical Sciences, 18th ed., pp. 1565-67 (1990)
`(“Remington’s 1990”) (SDZ_BO0004236-41)
`
`Page(s)
`
`A7059-
`A7083
`
`A7084-
`A7088
`
`A7089-
`A7109
`
`A7110-
`A7117
`
`A7118-
`A7134
`
`A7135-
`A7138
`
`A7139-
`A7143
`
`A7144-
`A7149
`
`DTX-672 - A Report to the National Cancer Institute (MILL-VEL-
`00116974-7003)
`
`A7150-
`A7179
`
`- viii -
`
`

`

`Case: 15-2066 Document: 115-1 Page: 10 Filed: 07/05/2016
`
`
`
`
`
`DTX-704 - Korcek, S. et al., “Absolute Rate Constants for the
`Autoxidation of Organometallic Compounds, Part II.
`Benzylboranes and 1- Phenylethylboranes”, J.C.S. Perkin II 242-
`248 (1972) (SDZ_BO0065129-37)
`
`DTX-728 - P.P. DeLuca & J.C. Boylan, “Formulation of Small
`Volume Parenterals” in Pharmaceutical Dosage Forms: Parenteral
`Medications: Volume 1, eds. K.E. Avis et al. (2d ed. 1992), 115-
`248 (SDZ_BO0065406-81)
`
`Page(s)
`
`A7180-
`A7188
`
`A7189-
`A7264
`
`DTX-738 - Handbook of Pharmaceutical Excipients, eds. A. Wade
`& P.J. Weller (2d ed. 1994), 294 (SDZ_BO00004466-72)
`
`A7265-
`A7271
`
`TRIAL EXHIBITS DESIGNATED BY APPELLEES
`
`DTX-17 - Email to V. Stella from S. Gupta, Subject: September
`Monthly Report – Comments (October 6, 1997)
`
`DTX-66 - Plaintiff Millennium Pharmaceuticals, Inc.’s Objections
`to Defendants’ Notice of 30(b)(6) Deposition
`
`DTX-78 - Email to R. Tobin, J. O’Shaughnessy and J. Frank from
`G. Bonifield , Subject: KUCR v. USA and Attachment (Millennium
`Pre-Arbitration Brief)
`
`DTX-138 - NDA 21-602 Velcade (Bortezomib) for Injection -
`Module 3, Quality
`
`DTX-139 - NDA 21-602 Velcade (bortezomib) for Injection -
`Module 3 – Quality
`
`DTX-144 - Email from L. Jin-Wang to Patel, Subject: LDP-341
`Drug Product Related Questions (January 18, 2001)
`
`DTX-255 - University of Kansas and University of Kansas Center
`for Research, Inc. Pre-Arbitration Brief
`
`DTX-261 - Defendants’ Corrected Opening Post Hearing Brief
`(Millennium Post-Arbitration Brief)
`
`
`
`A12001-
`A12001
`
`A12133-
`A12166
`
`A12167-
`A12227
`
`A12228-
`A12813
`
`A12814-
`A12816
`
`A12817-
`A12820
`
`A12970-
`A13050
`
`A13051-
`A13155
`
`- ix -
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`

`

`Case: 15-2066 Document: 115-1 Page: 11 Filed: 07/05/2016
`
`DTX-742 - Letter from Stella to Lerner re: Response to Questions
`and Comments (Apr. 9, 1992)
`
`Page(s)
`
`A13156-
`A13178
`
`PTX-078 - Certificate of Analysis from M-Scan (October 20, 1998) A13201-
`A13202
`
`PTX-127 - Fax from Gupta to Plamondon, Subject: PS 341 aka
`NSC 681238 Lyo Procedure and Stability Data (September 22,
`1998)
`
`A13203-
`A13205
`
`
`
`
`
`
`
`- x -
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`

`

`
`
`Case 1:12-cv-01011-GMS Document 56 Filed 12/13/13 Page 1 of 3 PageID #: 725Case: 15-2066 Document: 115-1 Page: 12 Filed: 07/05/2016
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELA WARE
`
`MILLENNIUM PHARMACEUTICALS, INC.,
`
`v.
`
`SANDOZ, INC., et al.
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`Plaintiff,
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`Defendants.
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`MILLENNIUM PHARMACEUTICALS, INC.,
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`Plaintiff,
`
`v.
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`FRESENIUS KABI USA, LLC, et al.,
`
`Defendants
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`Civil Action No. 12-1011 (GMS)
`CONSOLIDATED
`
`Civil Action No. 13-467 (GMS)
`
`ORDER CONSTRUING THE TERMS OF U.S. PATENT NOS. 6,958,319 AND 6,713,446
`
`After having considered the submissions of the parties and hearing oral argument on the
`
`matter, IT IS HEREBY ORDERED, ADJUDGED, and DECREED that, as used in the asserted
`
`claims of U.S. Patent Nos. 6,958,319 (the '"319 patent") ~d 6,713,446 (the '"446 patent"):
`
`1.
`
`The term "sugar" is construed to mean "saccharides, including monosaccharides,
`
`disaccharides, and reduced sugars, that are suitable for administration to a
`
`mammalian subject." 1
`
`The plaintiff, Millennium Pharmaceuticals, Inc. ("Millennium"), contends that "sugar" means "glucose,
`sucrose, fructose, trehalose, xylitol, mannitol, sorbitol, or similar saccharide". (DJ. 41at5; DJ. 43 at 1.) In turn, the
`defendants, Sandoz Inc., Actavis, Inc., Accord Healthcare Inc., Fresenius Kabi USA LLC, Fresenius Kabi
`
`A1
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`Case 1:12-cv-01011-GMS Document 56 Filed 12/13/13 Page 2 of 3 PageID #: 726Case: 15-2066 Document: 115-1 Page: 13 Filed: 07/05/2016
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`Pharmaceuticals Holding Inc., Fresenius Kabi USA Inc. (collectively "Sandoz"), argue in their briefs that "sugar"
`means "saccharides, including monosaccharides, disaccharides, and reduced sugars". (D.I. 51at5; D.I. 45 at l.) At
`the Markman Hearing, however, Sandoz advanced a new proposal: "monosaccharides, disaccharides,
`oligosaccharides, and reduced sugars."
`(D.I. 39: 15-40: 14.) For the reasons that follow, the court rejects both
`Millennium and Sandoz's proposed constructions and, instead, construes "sugar" to mean "saccharides, including
`monosaccharides, disaccharides, and reduced sugars, that are suitable for administration to a mammalian subject."
`As the Federal Circuit has instructed, "claim terms must be construed in light of the entirety of the patent,
`including its specification''. Sun Pharm Indus., Ltd. v. Eli Lilly & Co., 611F.3d1381, 1388 (Fed. Cir. 2010). Indeed,
`"the specification 'is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the
`single best guide to the meaning of a disputed term."' Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005)
`(quoting Vitronics Corp. v. Conceptronic Corp., 90 F.3d 1576, 1582 (1996)). Here, the specifications of the patents(cid:173)
`in-suit establish that "sugar" must encompass at least monosaccharides, disaccharides, and reduced sugars. As the
`specifications state, "[t]he sugar is preferably a monosaccharide or disaccharide. Non-limiting examples of suitable
`sugars include, glucose, sucrose, fructose, trehalose, xylitol, mannitol, and sorbitol. In certain preferred embodiments,
`the sugar is a reduced sugar, more preferably mannitol or sorbitol." ('319 patent 6:47-51; '446 patent 6:38-42.)
`That "sugar" must include at least monosaccharides, disaccharides, and reduced sugars is further confirmed
`by an examination of the claims. Claims 14-16 and 18 of the '319 patent are instructive. Claim 14 states:
`
`14. A lyophilized compound of the formula (1)
`
`wherein ... Zl and Z2 together form a moiety derived from a sugar,
`wherein the atom attached to boron in each case is an
`oxygen atom.
`
`Claims 15, 16, and 18 depend from claim 14 and state:
`
`15. The compound of claim 14, Wherein the sugar is a
`monosaccharide or disaccharide.
`
`16. The compound of claim 14, Wherein the sugar is a
`reduced sugar.
`
`18. The compound of claim 16, Wherein the reduced sugar
`is sorbito I.
`
`Because claims 15, 16, and 18 encompass monosaccharides, disaccharides, and reduced sugars, the term
`"sugar," as used in claim 14, must include and be broader than these three categories under the doctrine of claim
`differentiation. See, e.g., Intamin Ltd. v. Magnetar Techs., Corp., 483 F.3d 1328, 1335 (Fed. Cir. 2007) ("An
`independent claim impliedly embraces more subject matter than its narrower dependent claim."); Phillips, 415 F.3d
`at 1324-25 ("An independent claim should be given broader scope than a dependent claim to avoid rendering the
`dependent claim redundant.") (citing Dow Chem. Co. v. United States, 226 F.3d 1334, 1341-42 (Fed. Cir. 2000)); AK
`Steel Corp. v. So/lac & Ugine, 344 F.3d 1234, 1242 (Fed. Cir. 2003) ("Under the doctrine of claim differentiation,
`dependent claims are presumed to be of narrower scope than the independent claims from which they depend.").
`In light of the fact that "sugar" must include at least monosaccharides, disaccharides, and reduced sugars,
`Millennium's proposed construction is inadequate. Millennium's proposed construction seeks to narrow "sugar" to
`saccharides similar to glucose, sucrose, fructose, trehalose, xylitol, mannitol, and sorbitol - the examples recited in
`2
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`A2
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`Case 1:12-cv-01011-GMS Document 56 Filed 12/13/13 Page 3 of 3 PageID #: 727Case: 15-2066 Document: 115-1 Page: 14 Filed: 07/05/2016
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`Dated: December Jl_, 2013
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`the specifications. While the presence of examples in the specification can guide the court's construction of a term,
`"[u]njustifiably importing limitations from the specification is the 'cardinal skin of claim construction."' Teleflex,
`Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1324 (Fed. Cir. 2002); see also Dealertrack, Inc. v. Huber, 674 F.3d 1315,
`1322 (Fed. Cir. 2012) ("The disclosure of multiple examples does not necessarily mean that such list is exhaustive or
`that non-enumerated examples should be excluded."); Kara Tech. Inc. v. Stamps.com, Inc., 582 F.3d 1341 (Fed. Cir.
`2009) ("The patentee is entitled to the full scope of his claims, and we will not limit him to his preferred embodiment
`or import a limitation from the specification into the claims."). Indeed, the specifications here expressly state that the
`examples given are "non-limiting". ('319 patent, 6:49-50 ("Non-limiting examples of suitable sugars include, glucose,
`sucrose, fructose, trehalose, xylitol, mannitol, and sorbitol."; '446 patent, 6:39-40 (same).)
`In contrast to Millennium's proposed construction, Sandoz's proposed construction correctly recognizes that
`"sugar" must include all monosaccharides, disaccharides, and reduced sugars. The court rejects Sandoz's construction
`as overbroad, however, because of its mention of"saccharides including .... " In construing a term, it is important not
`to "allow the claim language to become divorced from what the specification conveys is the invention." Retractable
`Techs, Inc. v. Becton, Dickinson & Co., 653 F.3d 1296, 1305 (Fed. Cir. 2011). The specifications of both patents state
`that the inventions are for "pharmaceutically acceptable compositions", ('319 patent, 3:25-26; '446 patent, 3:21-22),
`and must be "suitable for administration to a mammalian subject, preferably a human", ('319 patent, 3:33-34; '446
`patent, 30-31). Thus, one of skill in the art would understand that "sugar" cannot mean all saccharides, as Sandoz's
`proposed construction suggests, since not all saccharides are pharmaceutically acceptable and suitable for parenteral
`use in mammals. See Phillips, 415 F.3d at 1313 ("[T]he person of ordinary skill in the art is deemed to read the claim
`term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire
`patent, including the specification.") Instead, the construction of"sugar" must be constrained to saccharides suitable
`for the pharmaceutical uses to which the invention is to be put.
`For the foregoing reasons, the court concludes that the parties' proposed constructions are inconsistent with
`the claim language and the specification. Thus, the court adopts neither party's proposed construction and instead
`construes "sugar" to mean "saccharides, including monosaccharides, disaccharides, and reduced sugars, suitable for
`administration to a mammalian subject."
`
`3
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`Case 1:12-cv-01011-GMS Document 148 Filed 08/20/15 Page 1 of 19 PageID #: 2865Case: 15-2066 Document: 115-1 Page: 15 Filed: 07/05/2016
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELA WARE
`
`MILLENNIUM PHARMACEUTICALS, INC.,
`
`)
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`Defendants.
`~~~~~~~~~~~~~~~~~-)
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`Plaintiff,
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`C.A. No. 12-1011-GMS
`CONSOLIDATED
`
`v.
`
`SANDOZ INC., et al.,
`
`MEMORANDUM OPINION
`
`I.
`
`INTRODUCTION
`
`In this patent infringement action, the plaintiff Millennium Pharmaceuticals, Inc.
`
`("Millennium") alleges that Abbreviated New Drug Applications ("ANDAs") filed by the
`
`defendants Sandoz Inc. ("Sandoz"), Accord Healthcare, Inc. ("Accord"), and Actavis LLC
`
`("Actavis") (collectively, "the defendants") infringe claims 20, 31, 49, and 53 of U.S. Patent No.
`
`6,713,446 ("the '446 patent"). 1 (D.I. 1.2) The court held a four-day bench trial in this matter on
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`November 4 through November 7, 2014.
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`(D.I. 139-42.) Presently before the court are the
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`parties' post-trial proposed findings of fact and conclusions of law concerning the validity of the
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`'446 patent, specifically whether the asserted claims of the '446 are invalid as obvious under 35
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`U.S.C. § 103. (D.I. 132, 133.)
`
`1 The parties filed stipulations dismissing allegations that the defendants infringed U.S. Patent No. 6,958,319
`on November 3, 2014. (See D.I. 122; 123; 124.)
`2 All citations to the court's docket refer to Civil Action Number 12-1011-GMS.
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`A4
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`Case 1:12-cv-01011-GMS Document 148 Filed 08/20/15 Page 2 of 19 PageID #: 2866Case: 15-2066 Document: 115-1 Page: 16 Filed: 07/05/2016
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`II.
`
`BACKGROUND3
`
`A.
`
`The Parties
`
`1.
`Millennium is a corporation organized and ex1stmg under the laws of the State of
`Delaware, with its principal place of business at 40 Landsdowne Street, Cambridge,
`Massachusetts.
`
`Sandoz is a corporation organized and existing under the laws of the State of Colorado,
`2.
`with its principal place of business at 56 Carnegie Center, Suite 400, Princeton, New Jersey.
`
`Accord is a corporation organized and existing under the laws of the State of North
`3.
`Carolina, with its principal place of business at 1009 Slater Road, Suite 210B, Durham, North
`Carolina, 27703.
`·
`
`Actavis is a limited liability company organized and existing under the laws of the State of
`4.
`Delaware, with its principal place of business at Morris Corporate Center III, 400 Interpace
`Parkway, Parsippany, New Jersey.
`
`B.
`
`The Invention
`
`VELCADE® (bortezomib) for Injection is a proteasome inhibitor used in the treatment of
`5.
`patients with multiple myeloma and patients with mantle cell lymphoma who have received at
`least one prior therapy.
`
`In 2003, the Food and Drng Administration ("FDA") granted "accelerated approval" to
`6.
`New Drng Application No. 21-602 for VELCADE® for Injection, for the treatment by intravenous
`administration of patients with multiple myeloma who have received at least two prior therapies
`and have demonstrated disease progression on the last therapy.
`
`VELCADE® for Injection was subsequently approved in 2005 for treatment by
`7.
`intravenous administration of patients with multiple myeloma who had received at least one prior
`therapy; in 2006 for treatment by intravenous administration of patients with mantle cell
`lymphoma who had failed at least one prior therapy; in 2008 for frontline treatment by
`intravenous administration of patients with multiple myeloma; in 2012 for subcutaneous
`administration; and in 2014 for treatment of adult patients with multiple myeloma who had
`previously responded to VELCADE® for Injection therapy and relapsed at least six months
`following completion of prior VELCADE® for Injection treatment.
`
`The '446 patent has been listed in connection with VELCADE®for Injection in the FDA's
`8.
`publication, Approved Drug Products with Therapeutic Equivalence Evaluations, referred to as
`the "Orange Book."
`
`3 These facts are drawn primarily from the parties' jointly submitted statement of uncontested facts. (See
`D.I. 112-1.)
`
`2
`
`A5
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`Case 1:12-cv-01011-GMS Document 148 Filed 08/20/15 Page 3 of 19 PageID #: 2867Case: 15-2066 Document: 115-1 Page: 17 Filed: 07/05/2016
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`U.S. Patent No. 5,780,454 ("the '454 patent"), among others, is also listed in the Orange
`9.
`Book in connection with VELCADE® for Injection. The '454 patent, entitled "Boronic Ester and
`Acid Compounds," issued on July 14, 1998, is assigned to Millennium, and will expire on May 3,
`2017. The '454 patent is prior art to the '446 patent and is of record in the prosecution of the '446
`patent.4
`
`10. Millennium sells VELCADE® for Injection in the United States.
`
`C.
`
`The Patent-in-Suit
`
`The '446 patent, entitled "Formulation ofBoronic Acid Compounds," issued on March 30,
`11.
`2004, naming Shanker Lal Gupta as the inventor. The '446 patent claims priority to Provisional
`Application No. 60/264, 160, filed on January 25, 2001 ("the '160 provisional").
`
`12.
`
`A Certificate of Correction issued for the '446 patent on September 6, 2005.
`
`The '446 patent is assigned to the United States of America as Represented by the
`13.
`Secretary of Health and Human Services.
`
`14. Millennium holds an exclusive worldwide license to the '446 patent for the research,
`development, and manufacture of Bortezomib for distribution, sale and use in oncology disease
`states. Pursuant to its license, Millennium has the right to bring suit for infringement and defend
`invalidity counterclaims in its own name and own behalf.
`
`1. The Asserted Claims
`
`15. Millennium asserts claims 20, 31, 49, and 53 ("Asserted Claims") of the '446 patent.
`
`i.
`
`'446 Patent, Claim 20
`
`Claim 20 of the '446 patent is directed to directed to lyophilized mannitol boronate ester
`16.
`compounds, including the lyophilized mannitol ester ofbortezomib.
`
`ii.
`
`'446 Patent, Claim 31
`
`Claim 31 of the '446 patent is directed to preparing the lyophilized mannitol ester of
`17.
`bortezomib by lyophilizing a mixture of water, bortezomib and mannitol.
`
`iii.
`
`'446 Patent, Claim 49
`
`Claim 49 of the '446 patent is directed to a lyophilized cake comprising the lyophilized
`18.
`mannitol ester of bortezomib.
`
`4 The parties agreed to refer to the '454 patent as the "Adams patent" because the number is similar to the
`patent-in-suit. Tr. 47.
`
`3
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`A6
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`iv.
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`'446 Patent, Claim 53
`
`Claim 53 of the '446 patent adds to the method of claim 31 the further step of
`19.
`reconstituting the lyophilized mixture comprising the mannitol ester of bortezomib with a
`pharmaceutically-acceptable carrier.
`
`2. The Accused Products
`
`i. ANDAs Filed by the Defendants
`
`20. Millennium's VELCADE® for Injection is FDA-approved to treat multiple myeloma and
`mantle cell lymphoma. (D.I. 112-1, ifif 11-13.)
`
`Sandoz, Accord, and Actavis filed ANDA Nos. 203654, 204405, and 204332,
`21.
`respectively, seeking approval for the commercial manufacture, use, and sale of generic versions
`ofVELCADE®for Injection. (Id, ifif 16, 20, 25.)
`
`22.
`
`The defendants dispute that any of the asserted claims are valid. (Id., ifi! 18, 23, 28.)
`
`The defendants previously entered into stipulations regarding infringement of certain
`23.
`claims of the '446 patent including the Asserted Claims with the exception of Claim 53, which
`(See D.I. 86, 92, 94.) The defendants challenge the alleged
`relies on induced infringement.
`induced infringement of Claim 53. The primary issue presented at trial was obviousness.
`
`D.
`
`Procedural History
`
`In separately-captioned actions, Millennium filed complaints for patent infringement
`24.
`against Sandoz (C.A. 12-1011-GMS), Accord (12-490-GMS), and Actavis (12-1750-GMS) on
`August 2, 2012, November 19, 2012, and December 21, 2012, respectively.
`
`25. Millennium's actions against Accord and Actavis were consolidated with the Sandoz
`action on April 23, 2013. (D.I. 21.)
`
`III.
`
`FINDINGS OF FACT AND CONCLUSIONS OF LAW
`
`The court has subject matter jurisdiction over this matter pursuant to 28 U.S.C. §§ 1331,
`
`1338, and 2201. Venue is proper in this court under 28 U.S.C. §§ 1391 and 1400(b). The court
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`has considered whether the asserted claims are invalid due to obviousness and, if so, whether the
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`defendants induced infringement of Claim 5 3 of the '446 patent. After having reviewed the entire
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`record in this case, the p