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Case5:13-cv-04057-BLF Document86 Filed08/11/14 Page1 of 9
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Juanita R. Brooks (CA Bar No. #75934)
[email protected]
FISH & RICHARDSON P.C.
12390 El Camino Real
San Diego, CA 92130
Telephone: (858) 678-5070
Facsimile: (858) 678-5099
Jonathan E. Singer (CA Bar No. #187908)
[email protected]
FISH & RICHARDSON P.C.
3200 RBC Plaza
60 South Sixth Street
Minneapolis, MN 55402
Telephone: (612) 335-5070
Facsimile: (612) 288-9696
John M. Farrell (CA Bar No. #99649)
[email protected]
FISH & RICHARDSON P.C.
500 Arguello Street, Suite 500
Redwood City, CA 94063
Telephone: (650) 839-5070
Facsimile: (650) 839-5071
Douglas E. McCann (Pro Hac Vice)
[email protected]
FISH & RICHARDSON P.C.
222 Delaware Avenue, 17th Floor
Wilmington, DE 19801
Telephone: (302) 652-5070
Facsimile: (302) 652-0607
Attorneys for Plaintiff
GILEAD SCIENCES, INC.
FRIED, FRANK, HARRIS, SHRIVER
& JACOBSON LLP
STEPHEN S. RABINOWITZ
[email protected]
JAMES W. DABNEY (Pro Hac Vice)
[email protected]
RANDY C. EISENSMITH (Pro Hac Vice)
[email protected]
WANDA FRENCH-BROWN (Pro Hac Vice)
[email protected]
NAZ E. WEHRLI (Pro Hac Vice)
[email protected]
ONE NEW YORK PLAZA
NEW YORK, NEW YORK 10004-1980
Telephone: 212.859.8000
Facsimile: 212.859.4000
DURIE TANGRI LLP
JOSHUA H. LERNER (SBN 220755)
[email protected]
LAURA E. MILLER (SBN 271713)
[email protected]
217 Leidesdorff Street
San Francisco, CA 94111
Telephone: 415-362-6666
Facsimile: 415-236-6300
Attorneys for Defendants
MERCK & CO., INC., MERCK SHARP &
DOHME CORP. and ISIS
PHARMACEUTICALS, INC.
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF CALIFORNIA
(SAN JOSE DIVISION)
GILEAD SCIENCES, INC.,
Plaintiff and
Counterdefendant,
v.
MERCK & CO, INC., MERCK SHARP &
DOHME CORP. and ISIS
PHARMACEUTICALS, INC.,
Case No. 5:13-cv-04057-BLF/PSG
JOINT CLAIM CONSTRUCTION AND
PREHEARING STATEMENT PURSUANT
TO PATENT L.R. 4-3
Defendants and
Counterclaimants.
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JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT PURSUANT TO PATENT L.R. 4-3
Case No. 5:13-cv-04057-BLF/PSG
Case5:13-cv-04057-BLF Document86 Filed08/11/14 Page2 of 9
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Pursuant to Patent L.R. 4-3, plaintiff Gilead Sciences, Inc. (“Plaintiff”) and defendants
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Merck & Co., Inc., Merck Sharp & Dohme Corp. and Isis Pharmaceuticals, Inc. (together,
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“Defendants”) hereby submit their following Joint Claim Construction and Prehearing
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Statement.
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A.
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After meeting and conferring in good faith pursuant to Local Patent Rule 4-2(c), the
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parties have agreed to the following construction of the term “in combination with” in U.S.
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Patent No. 7,105,499 (the “’499 patent”).
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Claim Term
Agreed Construction
in combination with
(claim 2, ’499 patent)
The term “in combination with” means
“together with,” whether given separately at
different times during the course of therapy or
concurrently in divided or single combination
forms.
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Patent L.R. 4-3(a): The Parties’ Agreed Constructions.
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B.
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Patent L.R. 4-3(b): The Parties’ Proposed Constructions for Disputed Claim
Terms and Supporting Evidence.
The following chart summarizes each party’s proposed construction of each disputed
term found in the ’499 patent and U.S. Patent No. 8,481,712 (the “’712 patent”). Attached as
Exhibit A is a complete chart that contains the identification of all references from the
specification, prosecution history, and extrinsic evidence that supports the parties’ constructions
for these disputed terms. To the extent that any party has identified intrinsic or extrinsic
evidence in support of its construction that was not identified by the other party, the other party
reserves its right to rely upon that evidence in support of its own construction.
Term
administering
Asserted Claims
1 (’499 patent)
Plaintiff’s Proposed
Construction
providing a compound of
the invention or a prodrug
of a compound of the
invention to the individual
in need without reference
to in vivo transformations
of those compounds or
Defendants’ Proposed
Construction
providing a compound of
the invention or a prodrug
of a compound of the
invention to the individual
in need.
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JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT PURSUANT TO PATENT L.R. 4-3
Case No. 5:13-cv-04057-BLF/PSG
Case5:13-cv-04057-BLF Document86 Filed08/11/14 Page3 of 9
prodrugs.
1
2
3
4
compound
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The phrase “prodrug of a
compound” means those
prodrugs that are expressly
claimed.
1, 2 (’499 patent) The term “compound”
refers to synthetically
1-3, 5, 7, 9-11
produced compounds only.
(’712 patent)
a substance that consists of
two or more chemical
elements in union.
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C.
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Pursuant to Patent L.R. 4-3(c), the parties jointly identify the following terms as those for
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Patent L.R. 4-3(c): List of Significant Terms
which construction will be most significant to the resolution of this case:
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1. administering
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2. compound
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D.
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Plaintiff anticipates its claim construction presentation will take one hour.
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Defendants anticipate that their claim construction presentation will take one hour.
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E.
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Patent L.R. 4-3(d): Presentation Time for the Claim Construction Hearing
Patent L.R. 4-3(e): Witnesses To Be Called at the Claim Construction
Hearing
There will be no live witnesses called at the Claim Construction Hearing scheduled for
April 3, 2015.
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Dated: August 11, 2014
FISH & RICHARDSON P.C.
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By: /s/ Elizabeth M. Flanagan
Elizabeth M. Flanagan
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Attorneys for Plaintiff
GILEAD SCIENCES, INC.
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Dated: August 11, 2014
DURIE TANGRI LLP
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JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT PURSUANT TO PATENT L.R. 4-3
Case No. 5:13-cv-04057-BLF/PSG
Case5:13-cv-04057-BLF Document86 Filed08/11/14 Page4 of 9
By: /s/ Laura E. Miller
Laura E. Miller
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Attorneys for Defendants
MERCK & CO., INC.; MERCK SHARP &
DOHME CORP.; ISIS PHARMACEUTICALS,
INC.
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JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT PURSUANT TO PATENT L.R. 4-3
Case No. 5:13-cv-04057-BLF/PSG
Case5:13-cv-04057-BLF Document86 Filed08/11/14 Page5 of 9
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SIGNATURE ATTESTATION
Pursuant to Civil Local Rule 5.1(i)(3), I attest under penalty of perjury that concurrence
in the filing of this document has been obtained from its signatory
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/s/ Elizabeth M. Flanagan
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JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT PURSUANT TO PATENT L.R. 4-3
Case No. 5:13-cv-04057-BLF/PSG
administering
Term
Defendants’ Proposed
Construction
providing a compound
of the invention or a
prodrug of a compound
of the invention to the
individual in need
EXTRINSIC
V. Stella et al, Prodrugs.
Do They Have
Advantages in Clinical
Practice? Drugs 29:
455-473 (1985)
[MERCK0064542-60]
Defendants’
Supporting Evidence
INTRINSIC (’499
Patent)
32:5-8
JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT PURSUANT TO PATENT L.R. 4-3
Case No. 5:13-cv-04057-BLF/PSG
Second Preliminary
Amendment dated
2/1/2005 (received
2/7/2005);
Notice of Allowance,
Allowability, and
Examiner’s
Amendment/Reasons for
Allowance dated
4/26/2005 (mailed
5/5/2005)
Plaintiff’s Supporting
Evidence
INTRINSIC (’499
Patent)
3:48-67;
9:21-41;
30:4-5;
32:5-8;
32:32-39;
32:49-52;
33:7-19;
34:31-34;
The phrase “prodrug of a 34:58-35:4;
compound” means those 35:20-36:13;
37:32-38:19;
prodrugs that are
expressly claimed.
136:57-61;
Claims 1 and 2
Plaintiff’s Proposed
Construction
providing a compound
of the invention or a
prodrug of a compound
of the invention to the
individual in need
without reference to in
vivo transformations of
those compounds or
prodrugs.
Exhibit A to Joint Claim Construction and Prehearing Statement
Case5:13-cv-04057-BLF Document86 Filed08/11/14 Page6 of 9
The term “compound”
refers to synthetically
produced compounds
only.
compound
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EXTRINSIC
American Heritage
Dictionary (administer;
provide)
[GILEAD00000986989];
Webster’s Medical Desk
Dictionary (administer)
[GILEAD00000990992];
Webster’s Ninth New
Collegiate Dictionary
(provide)
[GILEAD00000993995];
Merck Manual (1999)
excerpts from Section
22, Clinical
Pharmacology
[GILEAD000009961007]
INTRINSIC (’499
Patent)
Abstract;
1:18-26;
2:31-3:10;
3:24-45;
3:48-9:11;
9:15-20
9:22-14:49;
15:29-20:35;
Plaintiff’s Supporting
Evidence
a substance that consists
of two or more chemical
elements in union
Defendants’ Proposed
Construction
INTRINSIC (’712
Patent)
9:39-11:52
INTRINSIC (’499
Patent)
9:23-11:33
32:5-8
40:34-37
Defendants’
Supporting Evidence
JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT PURSUANT TO PATENT L.R. 4-3
Case No. 5:13-cv-04057-BLF/PSG
Plaintiff’s Proposed
Construction
Term
Case5:13-cv-04057-BLF Document86 Filed08/11/14 Page7 of 9
Term
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INTRINSIC (’712
Patent)
Abstract;
1:25-33;
2:42-3:21;
Notice of Allowance,
Allowability, and
Examiner’s
Amendment/Reasons for
Allowance dated
4/26/2005 (mailed
5/5/2005)
Plaintiff’s Supporting
Evidence
20:36-25:10;
25:11-37;
25:38-27:28;
27:28-29:54;
30:66-31:34;
31:60-32:4;
32:9-48;
33:31-62;
34:13-35:4;
35:20-25;
35:39-36:13
37:1-10;
37:32-40:42;
Examples 1-154;
Claim 1-2
6,348,587
6,784,161
Defendants’ Proposed
Construction
V. Stella et al, Prodrugs.
Do They Have
Advantages in Clinical
Practice? Drugs 29:
455-473 (1985)
[MERCK0064542-60]
Mosby’s Medical,
Nursing & Allied Health
Dictionary (6th ed.,
2002), p. 406
[MERCK0064533-35]
Stedman’s Medical
Dictionary (27th ed.,
2000), p. 392
[MERCK0064539-41]
EXTRINSIC
Dorland’s Illustrated
Medical Dictionary
(29th ed., 2000), p. 388
[MERCK0064536-38]
Defendants’
Supporting Evidence
32:51-54
40:59-62
JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT PURSUANT TO PATENT L.R. 4-3
Case No. 5:13-cv-04057-BLF/PSG
Plaintiff’s Proposed
Construction
Case5:13-cv-04057-BLF Document86 Filed08/11/14 Page8 of 9
Term
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EXTRINSIC
Merck Manual (1999)
excerpts from Section
22, Clinical
Pharmacology
[GILEAD000009961007]
Plaintiff’s Supporting
Evidence
3:33-54;
3:58-9:25;
9:26-34;
9:37-14:67;
15:48-20:51;
20:52-25:28;
25:29-61;
25:62-27:62;
27:63-30:21;
31:33-32:10;
32:39-50;
32:55-33:26;
34:7-39;
34:55-35:46;
35:62-36:2;
36:16-24;
37:28-38;
37:59-40:67;
Examples 1-154
Claims 1-3, 9-11
Defendants’ Proposed
Construction
Defendants’
Supporting Evidence
JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT PURSUANT TO PATENT L.R. 4-3
Case No. 5:13-cv-04057-BLF/PSG
Plaintiff’s Proposed
Construction
Case5:13-cv-04057-BLF Document86 Filed08/11/14 Page9 of 9