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CELG v ACT - CELG Response Markman Brief

CELG v ACT - CELG Response Markman Brief

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Published by Daniel Ravicher

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Published by: Daniel Ravicher on May 15, 2014
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 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
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) ______________________________________________________________________________ CELGENE’S RESPONSIVE
 MARKMAN 
 BRIEF ______________________________________________________________________________
Case 2:10-cv-05197-SDW-MCA Document 287 Filed 04/08/14 Page 1 of 47 PageID: 8642
 
 - i -
TABLE OF CONTENTS
I.
 
INTRODUCTION ............................................................................................................. 1
 
II.
 
ARGUMENT ..................................................................................................................... 2
 
A.
 
Crystal Forms of Lenalidomide ............................................................................. 2
 
1.
 
“3-(4-amino-l-oxo-l,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione” ........ 2
 
2.
 
“hemihydrate” ............................................................................................ 5
 
(a)
 
The Claimed “hemihydrate” Does Not Require an Exact Ratio .................................................. 7
 
(b)
 
“Hemihydrate” Is Not Limited to “Form B”................................ 10
 
3.
 
“Form A” ................................................................................................. 13
 
(a)
 
Natco Improperly Seeks to Read Limitations From The Specification into “Form A” ....................................... 15
 
(b)
 
Natco Misconstrues the File Histories of the ’357 and ’598 Patents ......................................... 19
 
(c)
 
Celgene’s Construction Does Not Render the Claims Meaningless or Invalid .................................. 21
 
(d)
 
Natco’s Attempt to Define Lengthy Phrases that Include “Form A” to Mean the Same Thing as “Form A” ....................... 24
 
4.
 
Disputed Polymorph Claim Language That Does
 Not 
 Contain the Term “Form A” ............................................ 24
 
(a)
 
Natco’s Construction Is Not Supported by the Specification of the ’219 and ’598 Patents .................................. 26
 
(b)
 
Natco’s Construction Is Not Supported by the Prosecution Histories of the ’219 and ’598 Patents ..................... 27
 
B.
 
Compounds, Pharmaceutical Compositions, and Related Methods of Use ......... 28
 
1.
 
“said compound has the R-configuration” and “said compound has the S-configuration” ............................................... 28
 
(a)
 
Natco’s “Technical Principles” Argument Is Legally Irrelevant .................................................... 28
 
(b)
 
Natco’s Construction Is Inconsistent with the Intrinsic Evidence .......................................................... 29
 
(c)
 
Natco’s Case Law Is Inapposite ................................................... 31
 
(d)
 
Natco’s Proposed Constructions Ignore the Language of the Claims .............................................. 32
 
2.
 
“Unit Dosage Form” ................................................................................ 33
 
3.
 
“administered cyclically” and “administered in a cycle” ........................ 35
 
Case 2:10-cv-05197-SDW-MCA Document 287 Filed 04/08/14 Page 2 of 47 PageID: 8643
 
TABLE OF CONTENTS (continued) Page
- ii - 4.
 
“cyclically administering” ....................................................................... 38
 
III.
 
CONCLUSION ................................................................................................................ 40
 
Case 2:10-cv-05197-SDW-MCA Document 287 Filed 04/08/14 Page 3 of 47 PageID: 8644

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