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CELG v ACT - Joint Markman Statement

CELG v ACT - Joint Markman Statement

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Published by Daniel Ravicher

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Published by: Daniel Ravicher on May 15, 2014
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05/15/2014

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04841.62499/5478002.4
 - 1 - Charles M. Lizza William C. Baton S
AUL
E
WING
LLP One Riverfront Plaza, Suite 1520  Newark, New Jersey 07102-5426 (973) 286-6700 clizza@saul.com
 Attorneys for Plaintiff Celgene Corporation
James S. Richter W
INSTON
&
 
S
TRAWN
LLP The Legal Center One Riverfront Plaza, 7
th
 Floor  Newark, New Jersey 07102 (973) 848-7676  jrichter@winston.com
 Attorneys for Defendants  Natco Pharma Limited,  Arrow International Limited, and Watson Laboratories, Inc.
 
UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY CELGENE CORPORATION, Plaintiff, v. NATCO PHARMA LIMITED, ARROW INTERNATIONAL LIMITED, and WATSON LABORATORIES, INC., Defendants. Civil Action No. 10-5197 (SDW) (MCA) Hon. Susan D. Wigenton, U.S.D.J. Hon. Madeline C. Arleo, U.S.M.J. (Filed Electronically)
 
CORRECTED JOINT CLAIM CONSTRUCTION AND PREHEARING STATEMENT
Plaintiff Celgene Corporation (“Celgene”) and Defendants Natco Pharma Limited, Arrow International Limited, and Watson Laboratories, Inc. (collectively, “Natco”) hereby submit their Corrected Joint Claim Construction and Prehearing Statement in accordance with Local Patent Rule 4.3.
I.
 
BACKGROUND
This case arises out of Natco’s filing of ANDA No. 201452 with the U.S. Food and Drug Administration (“FDA”), which seeks approval to market a generic version of Celgene’s Revlimid
®
 product. The active ingredient in Revlimid
®
 is lenalidomide. Plaintiffs allege, among
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 1 of 40 PageID: 6728
 
 
04841.62499/5478002.4
 - 2 - other things, that Natco’s submission of ANDA No. 201452 to the FDA constitutes infringement of certain claims of United States Patent Nos. 5,635,517 (the “’517 patent”), 6,045,501 (the “’501 patent”), 6,281,230 (the “’230 patent”), 6,315,720 (the “’720 patent”), 6,555,554 (the “’554 patent”), 6,561,976 (the “’976 patent”), 6,561,977 (the “’977 patent”), 6,755,784 (the “’784 patent”), 7,119,106 (the “’106 patent”), 7,189,740 (the “’740 patent”), 7,465,800 (the “’800 patent”), 7,968,569 (the “’569 patent”), 7,977,357 (the “’357 patent”), 8,193,219 (the “’219 patent”), 8,288,415 (the “’415 patent”), 8,315,886 (the “’886 patent”), 8,404,717 (the “’717 patent”), and 8,431,598 (the “’598 patent) owned by Celgene (collectively, “the patents-in-suit”) under 35 U.S.C. § 271(e)(2). Natco alleges, among other things, that the asserted claims are invalid, unenforceable, and/or not infringed. Pursuant to Local Patent Rules 4.2(a)-(b), on August 5, 2013, the parties exchanged  preliminary claim constructions and identified intrinsic as well as extrinsic evidence in support of their proposed Preliminary Constructions. Pursuant to Local Patent Rule 4.2(c), on August 19, 2013, the parties identified all intrinsic and extrinsic evidence that each party intends to rely upon to oppose any other party’s proposed construction. Pursuant to Local Patent Rule 4.2(d), on August 21, 2013, counsel for the parties met and conferred for the purposes of narrowing the issues and preparation of the Joint Claim Construction and Prehearing Statement.
II.
 
CONSTRUCTION OF PATENT TERMS A.
 
Agreed Upon Claim Constructions
Pursuant to Local Patent Rule 4.3(a), the parties identify the following terms and phrases on which the parties agree. To the extent that claim terms are used repeatedly throughout a  patent or family of patents, any constructions of such terms carry the same meaning throughout a  patent or family of patents unless otherwise specified.
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 2 of 40 PageID: 6729
 
 
04841.62499/5478002.4
 - 3 -
UNITED STATES PATENT NO. 5,635,517
Term Definition Undesirable levels of TNF
α
 in a mammal “non-optimal levels of TNF
α
 in a mammal”
UNITED STATES PATENT NO. 6,281,230
 
Term Definition Inflammation “a local response to cellular injury characterized by pain, redness, swelling and/or loss of function” Inflammatory disease “a disease caused or characterized  by inflammation” Autoimmune disease “a disease caused by an immune reaction against the body’s own cells and/or tissues” An oncogenic or cancerous condition “a condition tending to cause or give rise to tumors”
UNITED STATES PATENT NO. 6,555,554
Term Definition Reducing the level of TNF
α
 “lowering levels of TNF
α
Improving an oncogenic or cancerous condition “making better a condition tending to cause or give rise to tumors” Reducing inflammation “diminishing inflammation” Improving autoimmune disease “making better an autoimmune disease”
Case 2:10-cv-05197-SDW-MCA Document 248 Filed 10/18/13 Page 3 of 40 PageID: 6730

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