Free Claim Construction Chart - District Court of Delaware - Delaware

Case 1:07-cv-00551-GMS

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ) ) ) ) ) ) Plaintiffs, ) ) v. ) ) PAR PHARMACEUTICAL, INC., a Delaware ) corporation, ) ) Defendant. ) SANTARUS, INC., a Delaware corporation, and THE CURATORS OF THE UNIVERSITY OF MISSOURI, a public corporation and body politic of the State of Missouri,

C.A. No. 07-551 (GMS) (CONSOLIDATED)

FINAL JOINT CLAIM CONSTRUCTION CHART The parties have met and conferred, and present the following Joint Claim Construction Chart pursuant to paragraph 4 of the Court's Scheduling Order (D.I. 15). The parties' Joint Claim Construction Chart is attached as Exhibit A. This chart identifies the disputed claim terms in each patent, the parties' proposed constructions for the disputed claim terms, and the parties' respective identification of supporting intrinsic evidence for the proposed construction of each claim term.

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MORRIS, NICHOLS, ARSHT & TUNNELL LLP

RICHARDS, LAYTON & FINGER, P.A.

/s/ James W. Parrett, Jr.

________________________________ Jack B. Blumenfeld (#1014) James W. Parrett, Jr. (#4292) 1201 North Market Street P.O. Box 1347 Wilmington, DE 19899-1347 (302) 658-9200 [email protected] [email protected] Counsel for plaintiffs Santarus, Inc. and The Curators of the University of Missouri Of Counsel: For plaintiff Santarus, Inc.: Morgan Chu Gary Frischling Lisa Partain IRELL & MANELLA LLP 1800 Avenue of the Stars, Suite 900 Los Angeles, CA 90067-4276 (310) 277-1010 For plaintiff The Curators of the University of Missouri: James R. Ferguson Jamison E. Lynch MAYER BROWN LLP 71 S. Wacker Drive Chicago, IL 60606 (312) 782-0600 July 26, 2008
2385078.2

/s/ Steven J. Fineman

_____________________________ Frederick L. Cottrell (#2555) Steven J. Fineman (#4025) One Rodney Square P.O. Box 551 Wilmington, DE 19899 (302) 651-7700 [email protected] [email protected]

Of Counsel: Edgar H. Haug James K. Stronski FROMMER LAWRENCE & HAUG LLP 745 Fifth Avenue New York, NY 10151 (212) 588-0800 Attorneys for Defendant

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EXHIBIT A

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U.S. Patent No. 6,489,346
'346 Claim Terms Plaintiffs' Proposed Construction A solid dosage form that is pharmaceutically acceptable for storage, shipping, and administration, including a powder that can be combined with an aqueous medium and then orally administered Par's Proposed Construction
Claim 24

Plaintiffs' Support

Par's Support

"solid pharmaceutical composition in a dosage form"

a solid preparation that is administered orally to the subject. Such a preparation would not include powders that are combined with a liquid prior to administration to the subject

'346 patent: 10:37-55; 11:24-33; 12:39-64; 15:3-46; 16:20-27 '346 patent: claims 50, 81 '885 patent: claim 3 U.S. Patent Application 09/183422 specification: 14:1-5; 14:14-22; 15:1519; 24:10-16 plain meaning

'346 16:20-25; '988 14:9-14; '885 22:53-58; '882 17:9-14; PCT/US01/00796, p. 36, ll. 19-24; PCT/US99/25592, p. 26, l. 26-p. 27, l. 9. '737 10:29-30; '346 15:9-11; '988 12:60-62; '885 21:35-37; '882 15:61-63; U.S. Patent Application No. 09/183,422, Originally-Filed Specification, p. 23, ll. 19-21. '737 2:31-34; '346 7:30-33; '988 4:3-6; '885 4:25-28; '882 7:50-54; U.S Patent Application No. 10/068,437, Originally-Filed Specification, p. 15. '346 10:48-51; '988 7:48-53; '885 8:3-8; '882 11:10-15; U.S. Patent Application No. 10/068,437, Originally-Filed

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Case 1:07-cv-00551-GMS '346 Claim Terms Plaintiffs' Proposed Construction

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Par's Proposed Construction

Specification, p. 22, ll. 26-32; PCT/US01/00796, p. 23, ll. 1-6. '346 15:20-23; '988 13:5-12; '885 21:45-53; '882 16:3-11; U.S. Application No. 09/183,422, Originally-Filed Specification, p. 24, ll. 10-18. U.S. Application No. 09/183,422, Originally-Filed Specification, p. 24, ll. 20-22; PCT/US99/25592, p. 27, ll. 2-4. '737 10:20-33; '346 15:3-13; '988 12:54-65; '885 21:29-40; '882 15:55-65; PCT/US99/25592, p. 25, l. 19-p. 26, l. 4. '885 56:24-30. U.S. Patent No. 6,489,346 File History November 26, 2001 Response, pp. 53, 56-57, 62. U.S. Patent No. 6,489,346 File History, June 25, 2001 Response, pp. 81-83, 85-87; -2-

Case 1:07-cv-00551-GMS '346 Claim Terms Plaintiffs' Proposed Construction

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Par's Proposed Construction

U.S. Patent No. 6,489,346 File History July 3, 2001 Response, pp. 81-83, 85-87. U.S. Patent No. 6,489,346 File History, March 25, 2002 Response, pp. 4344. U.S. Application No. 10/797,374 File History, October 31, 2007 Response, p. 10. U.S. Application No. 10/797,374, March 21, 2007 Response, pp. 17, 22-23. Ex Parte Reexamination Request No. 90/007,686 File History, September 13, 2006 Interview Summary. Ex Parte Reexamination Request No. 90/007,686 File History, May 24, 2006 Amendment, p. 13.

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Case 1:07-cv-00551-GMS '346 Claim Terms Plaintiffs' Proposed Construction

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Par's Proposed Construction

"solid pharmaceutical composition in a dosage form"

Claim 57 A solid dosage a solid '346 patent: 10:37-55; form that is preparation 11:24-33; 12:39-64; pharmaceutically that is 15:3-46; 16:20-27 acceptable for administered '346 patent: claims 50, storage, orally to the shipping, and subject. Such 81 administration, a preparation '885 patent: claim 3 including a would not powder that can include U.S. Patent Application be combined powders that with an aqueous are combined 09/183422 specification: 14:1-5; 14:14-22; 15:15medium and with a liquid 19; 24:10-16 then orally prior to administered administration plain meaning to the subject

'346 16:20-25; '988 14:9-14; '885 22:53-58; '882 17:9-14; PCT/US01/00796, p. 36, ll. 19-24; PCT/US99/25592, p. 26, l. 26-p. 27, l. 9. '737 10:29-30; '346 15:9-11; '988 12:60-62; '885 21:35-37; '882 15:61-63; U.S. Patent Application No. 09/183,422, Originally-Filed Specification, p. 23, ll. 19-21. '737 2:31-34; '346 7:30-33; '988 4:3-6; '885 4:25-28; '882 7:50-54; U.S Patent Application No. 10/068,437, Originally-Filed Specification, p. 15. '346 10:48-51; '988 7:48-53; '885 8:3-8; '882 11:10-15; U.S. Patent Application No. 10/068,437, Originally-Filed Specification, p. 22, ll. 26-32;

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Case 1:07-cv-00551-GMS '346 Claim Terms Plaintiffs' Proposed Construction

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Par's Proposed Construction

PCT/US01/00796, p. 23, ll. 1-6. '346 15:20-23; '988 13:5-12; '885 21:45-53; '882 16:3-11; U.S. Application No. 09/183,422, Originally-Filed Specification, p. 24, ll. 10-18. U.S. Application No. 09/183,422, Originally-Filed Specification, p. 24, ll. 20-22; PCT/US99/25592, p. 27, ll. 2-4. '737 10:20-33; '346 15:3-13; '988 12:54-65; '885 21:29-40; '882 15:55-65; PCT/US99/25592, p. 25, l. 19-p. 26, l. 4. '885 56:24-30. U.S. Patent No. 6,489,346 File History November 26, 2001 Response, pp. 53, 56-57, 62. U.S. Patent No. 6,489,346 File History, June 25, 2001 Response, pp. 81-83, 85-87; U.S. Patent No. 6,489,346 File -5-

Case 1:07-cv-00551-GMS '346 Claim Terms Plaintiffs' Proposed Construction

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Par's Proposed Construction

History July 3, 2001 Response, pp. 81-83, 85-87. U.S. Patent No. 6,489,346 File History, March 25, 2002 Response, pp. 4344. U.S. Application No. 10/797,374 File History, October 31, 2007 Response, p. 10. U.S. Application No. 10/797,374, March 31, 2007 Response, pp. 17, 22-23. Ex Parte Reexamination Request No. 90/007,686 File History, September 13, 2006 Interview Summary. Ex Parte Reexamination Request No. 90/007,686 File History, May 24, 2006 Amendment, p. 13.

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Case 1:07-cv-00551-GMS '346 Claim Terms Plaintiffs' Proposed Construction requires combination with a medium that includes water

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"combining the dosage form of claim 57 with an aqueous medium"

Claim 90 requires '346 patent: 15:29-34; combination 16:20-27; 19:60-67 with an '346 patent: claim 94 aqueous medium prior U.S. Patent Application to oral administration 09/183422 specification: 24:13-25:3 to the subject plain meaning

'346 (claim 57); '346 (claim 90). '346 15:3-13; '988 12:54-65; '885 21:29-40; '882 15:54-65. U.S. Patent Application Serial No. 09/183,422, Originally-Filed Specification, p. 24, l. 21-p. 25, l. 3; PCT/US99/25592, p. 27, ll. 3-9. PCT/US01/00796, p. 24, ll. 27-30.

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U.S. Patent No. 6,645,988
'988 Claim Terms Plaintiffs' Proposed Construction Par's Proposed Construction Plaintiffs' Support Par's Support

"solid oral pharmaceutical dosage form"

Claim 29 A solid dosage a solid '988 patent: 7:36-55; form that is preparation that 8:20-30; 9:40-49; 9:54pharmaceutically is administered 10:34; 12:54-62; 13:3acceptable for orally to the 33; 14:9-16; 66-69 [esp. storage, subject. Such a formulations 19-27] shipping, and preparation '988 patent: claim 29 oral would not administration, include '346 patent: claims 50, including a powders that 81 powder that can are combined be combined with a liquid '885 patent: claim 3 with an aqueous prior to medium and administration U.S. Patent Application then orally to the subject 09/183422 administered specification: 14:1-5; 14:14-22; 15:15-19; 24:10-16 plain meaning

'346 16:20-25; '988 14:9-14; '885 22:53-58; '882 17:9-14; PCT/US01/00796 , p. 36, ll. 19-24; PCT/US99/25592 , p. 26, l. 26-p. 27, l. 9. '737 10:29-30; '346 15:9-11; '988 12:60-62; '885 21:35-37; '882 15:61-63; U.S. Patent Application No. 09/183,422, Originally-Filed Specification, p. 23, ll. 19-21. '737 2:31-34; '346 7:30-33; '988 4:3-6; '885 4:25-28; '882 7:50-54; U.S Patent Application No. 10/068,437, Originally-Filed Specification, p. 15. '346 10:48-51; '988 7:48-53; '885 8:3-8; '882 11:10-15; U.S. Patent Application No. 10/068,437, Originally-Filed

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Case 1:07-cv-00551-GMS '988 Claim Terms Plaintiffs' Proposed Construction

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Specification, p. 22, ll. 26-32; PCT/US01/00796 , p. 23, ll. 1-6. '346 15:20-23; '988 13:5-12; '885 21:45-53; '882 16:3-11; U.S. Application No. 09/183,422, Originally-Filed Specification, p. 24, ll. 10-18. U.S. Application No. 09/183,422, Originally-Filed Specification, p. 24, ll. 20-22; PCT/US99/25592 , p. 27, ll. 2-4. '737 10:20-33; '346 15:3-13; '988 12:54-65; '885 21:29-40; '882 15:55-65; PCT/US99/25592 , p. 25, l. 19-p. 26, l. 4. '885 56:24-30. U.S. Patent No. 6,489,346 File History November 26, 2001 Response, pp. 53, 56-57, 62. U.S. Patent No. 6,489,346 File History, June 25, 2001 Response, pp. 81-83, 85-87; -9-

Case 1:07-cv-00551-GMS '988 Claim Terms Plaintiffs' Proposed Construction

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U.S. Patent No. 6,489,346 File History July 3, 2001 Response, pp. 81-83, 85-87. U.S. Patent No. 6,489,346 File History, March 25, 2002 Response, pp. 4344. U.S. Application No. 10/797,374 File History, October 31, 2007 Response, p. 10. U.S. Application No. 10/797,374, March 31, 2007 Response, pp. 17, 22-23. Ex Parte Reexamination Request No. 90/007,686 File History, September 13, 2006 Interview Summary. Ex Parte Reexamination Request No. 90/007,686 File History, May 24, 2006 Amendment, p. 13.

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Case 1:07-cv-00551-GMS '988 Claim Terms
"at least one optional Secondary Essential Buffer"

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Plaintiffs' Proposed Construction
a buffering agent that is not required in every formulation, but which can be combined with Primary Essential Buffers to produce a higher pH and added neutralization capacity for the formulation

at least one buffer in addition to the recited primary essential buffer, where such additional buffer is unsuitable for use alone because it produces too high a pH value leading to gastrointestinal mucosal irritation

'988 patent: 8:16-18; 45:15-48:22; 55:52-55; 56:8-17; 59:30-60:10; 59-75 [esp. formulations 6, 8, 11-14, 16-18, 20, 22, 23, 28-36, 38, 39] '988 patent: 46:2; 46:7; 50:42; 51:3; 51:28; 51:42; 51:57; 52:22; 52:31; 52:46; 52:61; 58:67; 74:51 '988 patent: Claims 2529 '988 file history: original claims at 123-25; February 1, 2002 Office Action; March 25, 2002 Interview Summary; July 11, 2002 Response at 218; September 25, 2002 Office Action; December 2, 2002 Response at 715; December 18, 2002 Supplemental Amendment at 3-6

U.S. Patent No. 6,645,988 File History, July 11, 2002 Response, p. 18. U.S. Patent No. 6,645,988 File History, December 2, 2002 Response, pp. 10-14. U.S. Patent No. 6,645,988 File History, July 11, 2002 Response, pp. 11-12. '988 46:56-60.

U.S. Patent No. 6,699,885
'885 Claim Terms Plaintiffs' Proposed Construction A solid dosage form that is pharmaceutically acceptable for storage, shipping, and oral administration, including a powder that can be combined Par's Proposed Construction Claim 1 "a solid oral pharmaceutical dosage form" a solid preparation that is administered orally to the subject. Such a preparation would not include powders that are combined -11'885 patent: 7:59-65; 7:66-8:11; 8:45-55; 9:46-51; 11:66-12:11; 14:45-55; 21:29-22:10; 22:53-60; 82-85 [esp. formulations 19-27] Reexamination 90/0067,686 Statement of Reasons for Patentability and/or '346 16:20-25; '988 14:9-14; '885 22:53-58; '882 17:9-14; PCT/US01/00796 , p. 36, ll. 19-24; PCT/US99/25592 , p. 26, l. 26-p. 27, l. 9. '737 10:29-30; Plaintiffs' Support Par's Support

Case 1:07-cv-00551-GMS '885 Claim Terms Plaintiffs' Proposed Construction with an aqueous medium and then orally administered

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Confirmation '885 patent: claim 3 U.S. Patent Application 09/183422 specification, 14:1-5; 14:14-22; 15:15-19; 24:10-16 plain meaning

'346 15:9-11; '988 12:60-62; '885 21:35-37; '882 15:61-63; U.S. Patent Application No. 09/183,422, Originally-Filed Specification, p. 23, ll. 19-21. '737 2:31-34; '346 7:30-33; '988 4:3-6; '885 4:25-28; '882 7:50-54; U.S Patent Application No. 10/068,437, Originally-Filed Specification, p. 15. '346 10:48-51; '988 7:48-53; '885 8:3-8; '882 11:10-15; U.S. Patent Application No. 10/068,437, Originally-Filed Specification, p. 22, ll. 26-32; PCT/US01/00796 , p. 23, ll. 1-6. '346 15:20-23; '988 13:5-12; '885 21:45-53; '882 16:3-11; U.S. Application No. 09/183,422, Originally-Filed Specification, p. 24, ll. 10-18.

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Case 1:07-cv-00551-GMS '885 Claim Terms Plaintiffs' Proposed Construction

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U.S. Application No. 09/183,422, Originally-Filed Specification, p. 24, ll. 20-22; PCT/US99/25592 , p. 27, ll. 2-4. '737 10:20-33; '346 15:3-13; '988 12:54-65; '885 21:29-40; '882 15:55-65; PCT/US99/25592 , p. 25, l. 19-p. 26, l. 4. '885 56:24-30. U.S. Patent No. 6,489,346 File History November 26, 2001 Response, pp. 53, 56-57, 62. U.S. Patent No. 6,489,346 File History, June 25, 2001 Response, pp. 81-83, 85-87; U.S. Patent No. 6,489,346 File History July 3, 2001 Response, pp. 81-83, 85-87. U.S. Patent No. 6,489,346 File History, March 25, 2002 Response, pp. 4344. U.S. Application No. 10/797,374 -13-

Case 1:07-cv-00551-GMS '885 Claim Terms Plaintiffs' Proposed Construction

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File History, October 31, 2007 Response, p. 10. U.S. Application No. 10/797,374, March 31, 2007 Response, pp. 17, 22-23. Ex Parte Reexamination Request No. 90/007,686 File History, September 13, 2006 Interview Summary. Ex Parte Reexamination Request No. 90/007,686 File History, May 24, 2006 Amendment, p. 13.

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Case 1:07-cv-00551-GMS '885 Claim Terms Plaintiffs' Proposed Construction requires mixing with a medium that includes water

Document 32 Par's Proposed Construction Claim 3 requires mixing with an aqueous medium prior to oral administration to the subject

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"mixing ... with an aqueous medium"

'885 patent: 9:66-11:5; 21:58-65; 22:53-60; 2630 (esp. 30:40-41); 31:1-11; 59:44-52 U.S. Patent Application 09/183422 specification 24:13-25:3 plain meaning

'885 (claim 1); '885 (claim 3). U.S. Patent Application No. 09/183,422, Originally-Filed Specification, p. 24, l. 21-p. 25, l. 3; PCT/US99/2559 2, p. 27, ll. 3-9. '346 15:3-13; '988 12:54-65; '885 21:29-40; '882 15:54-65. PCT/US01/007 96, p. 24, ll. 2730.

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