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IN THE UNITED STATES DISTRICT COURTFOR THE DISTRICT OF DELAWARE
SANTARUS, INC., a Delaware corporation, and THE CURATORS OF THE UNIVERSITY OF MISSOURI, a public corporation and body politic of the State of Missouri,
Plaintiffs,
v.
PAR PHARMACEUTICAL, INC., a Delaware corporation,
Defendant.
))))))))))))))
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.
Case 1:07-cv-00551-GMS Document 32 Filed 06/26/2008 Page 1 of 18
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MORRIS, NICHOLS, ARSHT & TUNNELL LLP
/s/ James W. Parrett, Jr.________________________________Jack B. Blumenfeld (#1014)James W. Parrett, Jr. (#4292)1201 North Market StreetP.O. Box 1347Wilmington, DE 19899-1347(302) [email protected]@mnat.com
Counsel for plaintiffs Santarus, Inc. and The Curators of the University of Missouri
RICHARDS, LAYTON & FINGER, P.A.
/s/ Steven J. Fineman_____________________________Frederick L. Cottrell (#2555)Steven J. Fineman (#4025)One Rodney SquareP.O. Box 551Wilmington, DE 19899(302) [email protected]@rlf.com
Of Counsel:For plaintiff Santarus, Inc.:
Morgan ChuGary FrischlingLisa PartainIRELL & MANELLA LLP1800 Avenue of the Stars, Suite 900Los Angeles, CA 90067-4276(310) 277-1010
For plaintiff The Curators of the University of Missouri:
James R. Ferguson Jamison E. LynchMAYER BROWN LLP71 S. Wacker DriveChicago, IL 60606(312) 782-0600
Of Counsel:
Edgar H. HaugJames K. StronskiFROMMER LAWRENCE & HAUG LLP745 Fifth AvenueNew York, NY 10151(212) 588-0800
Attorneys for Defendant
July 26, 20082385078.2
Case 1:07-cv-00551-GMS Document 32 Filed 06/26/2008 Page 2 of 18
EXHIBIT A
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U.S. Patent No. 6,489,346
'346 Claim Terms
Plaintiffs' Proposed
Construction
Par's Proposed
Construction
Plaintiffs' Support Par's Support
Claim 24"solid pharmaceutical composition in a dosage form"
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
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; 15:15-19; 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
Case 1:07-cv-00551-GMS Document 32 Filed 06/26/2008 Page 4 of 18
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'346 Claim Terms
Plaintiffs' Proposed
Construction
Par's Proposed
Construction
Plaintiffs' Support Par's Support
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;
Case 1:07-cv-00551-GMS Document 32 Filed 06/26/2008 Page 5 of 18
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'346 Claim Terms
Plaintiffs' Proposed
Construction
Par's Proposed
Construction
Plaintiffs' Support Par's Support
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. 43-44.
U.S. Application No. 10/797,374File 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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'346 Claim Terms
Plaintiffs' Proposed
Construction
Par's Proposed
Construction
Plaintiffs' Support Par's Support
Claim 57"solid pharmaceutical composition in a dosage form"
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
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; 15:15-19; 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 Specification, p. 22, ll. 26-32;
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'346 Claim Terms
Plaintiffs' Proposed
Construction
Par's Proposed
Construction
Plaintiffs' Support Par's Support
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
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'346 Claim Terms
Plaintiffs' Proposed
Construction
Par's Proposed
Construction
Plaintiffs' Support Par's Support
History July 3, 2001 Response, pp. 81-83, 85-87.
U.S. Patent No. 6,489,346 File History, March 25, 2002 Response, pp. 43-44.
U.S. Application No. 10/797,374File 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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'346 Claim Terms
Plaintiffs' Proposed
Construction
Par's Proposed
Construction
Plaintiffs' Support Par's Support
Claim 90"combining the dosage form of claim 57 with an aqueous medium"
requires combination with a medium that includes water
requires combination with an aqueous medium prior to oral administration to the subject
'346 patent: 15:29-34; 16:20-27; 19:60-67
'346 patent: claim 94
U.S. Patent Application 09/183422 specification: 24:13-25:3
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
Claim 29"solid oral pharmaceutical dosage form"
A solid dosage form that is pharmaceuticallyacceptable for storage, shipping, and oral administration, including a powder that can be combined with an aqueous medium and then orally administered
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
'988 patent: 7:36-55; 8:20-30; 9:40-49; 9:54-10:34; 12:54-62; 13:3-33; 14:9-16; 66-69 [esp. formulations 19-27]
'988 patent: claim 29
'346 patent: claims 50, 81
'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 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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'988 Claim Terms
Plaintiffs' Proposed
Construction
Par's Proposed
Construction
Plaintiffs' Support Par's Support
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;
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'988 Claim Terms
Plaintiffs' Proposed
Construction
Par's Proposed
Construction
Plaintiffs' Support Par's Support
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. 43-44.
U.S. Application No. 10/797,374File 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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'988 Claim Terms
Plaintiffs' Proposed
Construction
Par's Proposed
Construction
Plaintiffs' Support Par's Support
"at least one optional Secondary Essential Buffer"
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 25-29'988 file history: original claims at 123-25; February 1, 2002 Office Action; March 25, 2002 Interview Summary; July 11, 2002 Response at 2-18; September 25, 2002 Office Action; December 2, 2002 Response at 7-15; 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
Par's Proposed
Construction
Plaintiffs' Support Par's Support
Claim 1"a solid oral pharmaceutical dosage form"
A solid dosage form that is pharmaceutically acceptable for storage, shipping, and oral administration, including a powder that can be combined
a solid preparation that is administered orally to the subject. Such a preparation would not include powders that are combined
'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;
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'885 Claim Terms
Plaintiffs' Proposed
Construction
Par's Proposed
Construction
Plaintiffs' Support Par's Support
with an aqueous medium and then orally administered
with a liquid prior to administration to the subject
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.
Case 1:07-cv-00551-GMS Document 32 Filed 06/26/2008 Page 15 of 18
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'885 Claim Terms
Plaintiffs' Proposed
Construction
Par's Proposed
Construction
Plaintiffs' Support Par's Support
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. 43-44.
U.S. Application No. 10/797,374
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'885 Claim Terms
Plaintiffs' Proposed
Construction
Par's Proposed
Construction
Plaintiffs' Support Par's Support
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.
Case 1:07-cv-00551-GMS Document 32 Filed 06/26/2008 Page 17 of 18
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'885 Claim Terms
Plaintiffs' Proposed
Construction
Par's Proposed
Construction
Plaintiffs' Support Par's Support
Claim 3"mixing … with an aqueous medium"
requires mixing with a medium that includes water
requires mixing with an aqueous medium prior to oral administration to the subject
'885 patent: 9:66-11:5;21:58-65; 22:53-60; 26-30 (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/US99/25592, p. 27, ll. 3-9.
’346 15:3-13; ’988 12:54-65; ’885 21:29-40; ’882 15:54-65.
PCT/US01/00796, p. 24, ll. 27-30.
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IN THE UNITED STATES DISTRICT COURTFOR THE DISTRICT OF DELAWARE
_________________________________________SANTARUS, INC., a Delaware corporation, )and THE CURATORS OF THE )UNIVERSITY OF MISSOURI, a public )corporation and body politic of the State )of Missouri, )
)Plaintiffs, ) C.A. No. 07-551 (GMS)
)v. ) (CONSOLIDATED)
)PAR PHARMACEUTICAL, INC., a Delaware )corporation, )
)Defendant. )
_________________________________________ )
ORDER CONSTRUING THE TERMS OF U.S. PATENT NOS. 6,489,346; 6,669,885; AND 6,645,988
After considering 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 No. 6,489,346 (the “‘346 patent”), U.S. Patent No. 6,669,885 (the “‘885 patent”), and U.S.
Patent No. 6,645,988 (the “‘988 patent”):
1. The term “solid pharmaceutical composition in a dosage form” in claims 24 and 57 of the
‘346 patent is construed as “a solid dosage form that is pharmaceutically acceptable for
storage, shipping, and administration, including a powder that can be combined with an
aqueous medium then orally administered.”
2. The term “combining the dosage form of claim 57 with an aqueous medium” in claim 90 of
the ‘346 patent is construed as “requires combination with a medium that includes water.”
3. The term a “solid oral pharmaceutical dosage form” in claim 29 of the ‘988 patent and in
claim 1 of the ‘885 patent is construed as “a solid dosage form that is pharmaceutically
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acceptable for storage, shipping, and administration, including a powder that can be
combined with an aqueous medium then orally administered.”
4. The term a “at least one optional Secondary Essential Buffer ” in claim 29 of the ‘988 patent
is construed as “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.”
5. The term “mixing ... with an aqueous medium” in claim 3 of the ‘885 patent is construed as
“requires mixing with a medium that includes water.”
Dated: November 5, 2008 /s/ Gregory M. Sleet CHIEF, UNITED STATES DISTRICT JUDGE
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