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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE CUBIST PHARMACEUTICALS, INC., Plaintiff, v. HOSPIRA, INC.

, Defendant. ) ) ) ) ) ) ) ) )

C.A. No. 12-367 (GMS) (CONSOLIDATED)

JOINT CLAIM CONSTRUCTION CHARTS FOR THE PATENTS BEING ASSERTED BY CUBIST PHARMACEUTICALS, INC. The parties have met and conferred, and present the following Joint Claim Construction Charts for the patents being asserted by Cubist Pharmaceuticals, Inc. I. Stipulated Constructions. During the meet and confer process, the parties agreed to the claim construction for twelve claim terms from U.S. Patent Nos. 6,468,967, 6,852,689, RE39,071, 8,129,342, and 8,058,238 as set forth in Exhibit A. The parties jointly and respectfully submit that, if the Court deems it appropriate, the Court include these agreed-upon claim constructions in the ultimate claim construction order. In the alternative, the parties agree that these agreed-upon constructions are binding between the parties. II. Claim Terms Requiring Construction By The Court. The parties Joint Claim Construction Charts for U.S. Patent Nos. 6,468,967, 6,852,689, RE39,071, 8,129,342, and 8,058,238 are attached as Exhibits B through D. Exhibit B summarizes the disputed claim terms and the parties proposed constructions for the five patents. Exhibit C lists the disputed claim term from U.S. Patent Nos. 6,468,967, 6,852,689, 8,129,342, and 8,058,238, and Exhibit D lists the disputed claim term from U.S. Patent No. RE39,071, as well as the parties proposed constructions and the evidence the parties rely upon in support of their proposed constructions for the patents.

MORRIS, NICHOLS, ARSHT & TUNNELL LLP

PHILLIPS, GOLDMAN & SPENCE, P.A.

/s/ Maryellen Noreika


Jack B. Blumenfeld (#1014) Maryellen Noreika (#3208) 1201 North Market Street P.O. Box 1347 Wilmington, DE 19899 (302) 658-9200 jblumenfeld@mnat.com mnoreika@mnat.com OF COUNSEL: William F. Lee Lisa J. Pirozzolo Emily Whelan WILMER CUTLER PICKERING HALE AND DORR LLP 60 State Street Boston, MA 02109 (617) 526-6000

/s/ John C. Phillips, Jr.


John C. Phillips, Jr. (No. 110) Megan C. Haney (No. 5016) 1200 North Broom Street Wilmington, DE 19806 Tel. (302) 655-4200 Fax (302) 655-4210 jcp@pgslaw.com mch@pgslaw.com OF COUNSEL: James F. Hurst WINSTON & STRAWN LLP 35 W. Wacker Drive Chicago, Illinois 60601 (312) 558-5600 E-mail: jhurst@winston.com

Gail J. Standish Peter E. Perkowski WINSTON & STRAWN LLP Attorneys for Plaintiff Cubist Pharmaceuticals, 333 S. Grand Avenue, Suite 3800 Los Angeles, California 90071 Inc. (213) 615-1700 E-mail:gstandish@winston.com E-mail: pperkowski@winston.com

Attorneys for Defendant and Counterclaim Plaintiff HOSPIRA, INC. February 1, 2013
6982415

Exhibit A List of Agreed Upon Claim Term Constructions for U.S. Patent Nos. 6,468,967, 6,852,689, RE39,071, 8,129,342, and 8,058,238 Claim Term Agreed-Upon Construction U.S. Patent Nos. 8,058,238 and 8,129,342 daptomycin that is substantially free of [another compound] (Claims 3-5, 7-9, 50, 55, 56, 58, 61, 62, 64, 87, 88, 90, 165-175 of the 238 patent) (Claims 10, 11, 16 of the 342 patent) daptomycin that is essentially free of [another compound] (Claims 4-5, 9, 50, 56, 59, 62, 65, 88, 91, 165-175, 190 of the 238 patent) (Claims 3, 32, 42 of the 342 patent) anhydro-daptomycin The daptomycin derivative in which the -aspartyl group of daptomycin is transpeptidated to an anhydro-succinimido group, (Claims 3-5, 7, 50, 55, 56, 61, 62, 87, 88, 165-175, 190 of the 238 i.e., patent) (Claims 1, 3-16, 18, 21-23, 32, 33, 41, 42, 53 of the 342 patent) the other compound is present in an amount that is no more than 0.5% of the amount of the daptomycin preparation the other compound is present in an amount that is no more than 1% of the amount of the daptomycin preparation

Claim Term -isomer of daptomycin (Claims 3-5, 7, 50, 55, 56, 61, 62, 87, 88, 165-175 of the 238 patent) (Claims 1, 3-16, 21-23, 32, 33, 41, 42, 53 of the 342 patent)

Agreed-Upon Construction The daptomycin derivative that contains a -aspartyl group instead of an -aspartyl group, i.e.,

micelle / daptomycin micelle (Claims 21-35, 37-40, 42-45, 99, 104, 106, 107, 108, 131, 138, 143, 145, 146, 147, 165-174, 176-180, 184, 185 of the 238 patent) (Claims 22-23, 30-49 of the 342 patent) aggregate / daptomycin aggregate (Claims 3-5, 7-9, 49-52, 55, 56, 58, 59, 61, 62, 64, 65, 85, 87, 88, 90-109, 113-123, 125-148, 151-161, 164-175, 179, 183-187, 189, 190 of the 238 patent) (Claims 1, 3-23, 25-29, 50-54 of the 342 patent) conditions effective to form daptomycin [micelles/aggregates] (Claims 3-5, 7-9, 37-40, 42-43, 93-107, 125-146, 166-174, conditions that result in the formation of daptomycin micelles/aggregates, including but not limited to one or more of the daptomycin concentration, temperature, salt concentration, and/or pH of a daptomycin solution associated molecules including but not limited to micelles / associated molecules comprising daptomycin including but not limited to daptomycin micelles aggregates of amphipathic molecules / aggregates comprising daptomycin

Claim Term 176-179 of the 238 patent) (Claims 5-6 of the 342 patent) daptomycin purified by a process comprising the steps of: (Claims 3-5, 7, 166-174 of the 238 patent) (Claims 30-39, 50-54 of the 342 patent) daptomycin that is free of [another compound] (Claims 50, 165-175 of the 238 patent) essentially pure daptomycin (Claims 50, 165-175 of the 238 patent) purified daptomycin

Agreed-Upon Construction

daptomycin that has been purified by a process including, but not limited to, the following steps

the other compound is present in an amount that is no more than 0.1% of the amount of the daptomycin preparation at least 98% of a sample is daptomycin daptomycin that is substantially pure, essentially pure, or substantially free, essentially free, or free of another compound

(Claims 8-9, 49-52, 55, 56, 58, 59, 61, 62, 64, 65, 85, 87, 88, 90-109, 113-123, 125-148, 151-161, 164-180, 183187, 189, 190 of the 238 patent) U.S. Patent No. RE 39,071 a combination of a compound of formula 1, a compound of formula 2, and a compound of formula 3 (Claims 18, 19, 26, 28 of the 071 patent) a compound of formula 1, a compound of formula 2, and a compound of formula 3, present together and totaling 100% by weight of the combination

Exhibit B Summary of Proposed Claim Constructions for U.S. Patent Nos. 6,468,967, 6,852,689, 8,129,342, 8,058,238, and RE39,071 Term To Be Construed Cubists Proposed Construction Hospiras Proposed Construction

U.S. Patent Nos. 6,468,967, 6,852,689, 8,129,342, and 8,058,238 daptomycin (Claims 3-5, 16-17, 27-28, 34-35, 42-45 of the 967 patent) (Claims 48-52 of the 689 patent) (Claims 3-5, 7-9, 21-35, 37-40, 42-45, 49-52, 55, 56, 58, 59, 61, 62, 64, 65, 85, 87, 88, 90-109, 113-123, 125-148, 151-161, 164-180, 183-187, 189, 190 of the 238 patent) (Claims 1, 3-23, 25-54 of the 342 patent) The cyclic lipopeptide antibiotic derived from the fermentation of Streptomyces roseosporus, comprised of a decanoyl side chain linked to the N-terminal tryptophan of a cyclic 13-amino acid peptide, i.e., The compound described in the Baltz article at Fig. 1a (Biotechnology of Antibiotics, 2nd Ed., ed. by Strohl, 415-435 (1997)) and in the Tally article at Fig. 1 (Exp. Opin. Invest. Drugs, 8:1223-1238 (1999)), (i.e., having the L-Asn configuration)

(LY146032) or a pharmaceutically acceptable salt thereof.

Term To Be Construed

Cubists Proposed Construction U.S. Patent No. RE39,071

Hospiras Proposed Construction

formula 3 compound / compound of An A21978C cyclic peptide of formula 3 (Claims 18, 26, 28 of the 071 patent)

The FORMULA 3 compound as recited in claims 18 and 26 that re-issued on April 18, 2006 (i.e., having the L-Asn configuration)

wherein RN is n-decanoyl (i.e., LY 146032).

Exhibit C Joint Claim Chart for U.S. Patent Nos. 6,468,967, 6,852,689, 8,129,342, and 8,058,238 Proposed Construction of Disputed Claim Term with Citations to Supporting Evidence Term To Be Construed Daptomycin (Claims 3-5, 16-17, 27-28, 34-35, 42-45 of the 967 patent) (Claims 48-52 of the 689 patent) Cubists Proposed Construction The cyclic lipopeptide antibiotic derived from the fermentation of Streptomyces roseosporus, comprised of a decanoyl side chain linked to the N-terminal tryptophan of a cyclic 13-amino acid peptide, i.e., Intrinsic Evidence Supporting Cubists Construction 967 Patent Specification Col. 1, lns. 10-13 Col. 1, lns. 18-51 Col. 1, ln. 63 Col. 2, ln. 43 Col. 3, lns. 14-28 Col. 3, lns. 36-41 Col. 3, ln. 45 Col. 4, ln. 48 Col. 4, ln. 64 Col. 5, l. 13 Col. 5, lns. 41-56 Col. 5, l. 65 Col. 6, ln. 1 Col. 6, lns. 9-12 Hospiras Proposed Construction Intrinsic Evidence Supporting Hospiras Construction 967 Patent and File History Abstract Col. 1, ln. 2 Col. 3, ln. 12 Col. 14, lns. 38-48 Baltz et al., Biotechnology of Antibiotics, 2nd Ed., ed. by Strohl, 415-435 (1997) (cited at Col. 1, lns. 40-51) Tally et al., Exp. Opin. Invest. Drugs, 8:1223-1238 (1999) (cited at Col. 1, lns. 20-38) 9/11/00 Declaration of

The compound described in the Baltz article at Fig. 1a (Biotechnology of Antibiotics, 2nd Ed., ed. by Strohl, 415-435 (1997)) and in the Tally article at Fig. 1 (Exp. Opin. Invest. Drugs, 8:1223- 1238 (1999)), (i.e., having the L-Asn configuration)

(Claims 3-5, 7-9, 21-35, 37-40, 42-45, 49-52, 55, 56, 58, 59, 61, 62, 64, 65, 85, 87, 88, 90-109, 113-123, 125-148, 151-161, 164-180, 183-187, 189, 190 (LY146032) or a of the 238 patent) pharmaceutically acceptable salt thereof. (Claims 1, 3-23, 25-54 of the 342

Term To Be Construed patent)

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction Col. 6, lns. 17-38 Col. 7, ln. 17 Col. 8, ln. 2 Col. 8, lns. 8-12 Col. 8, lns. 15-17 Col. 8, lns. 21-46 Col. 9, ln. 25 Col. 12, ln. 30 (Examples 1, 2) Col. 12, ln. 62 Col. 14, ln. 27 (Examples 4, 5) Col. 14, ln. 50 Col. 15, ln. 2 (Claims 1-7) Col. 15, ln. 27 Col. 16, ln. 29 (Claims 12-28) Col. 16, lns. 33-62 (Claims 32-45) Figures 1-3 967 Patent Abstract

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction Francis Tally at 5-6 238 Patent and File History Abstract Col. 1, ln. 21 Col. 3, ln. 46 Col. 7, lns. 2-27 Col. 37, lns. 30-40 Claims 49, 50, 66, and 191 Baltz et al., Biotechnology of Antibiotics, 2nd Ed., ed. by Strohl, 415-435 (1997) (cited at Col. 1, lns. 58-66) Tally et al., Exp. Opin. Invest. Drugs, 8:1223-1238 (1999) (cited at Col. 1, lns. 39-57) U.S. Patent No. RE

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction 967 Patent File History 9/11/2000 Amendment and Response to Office Action at pp. 6-21 (CUBH 000794-809) 9/11/2000 Declaration of Francis P. Tally Under 37 C.F.R. 1.132 at pp. 3-8 (CUBH 000812-17) 06/02/2000 Information Disclosure Statement at p. 2 (CUBH 000845) 01/07/2002 Amendment Under 37 C.F.R. 1.312 at p. 2 (CUBH 000934) References Cited in the Specification or File History of the 967 Patent U.S. Patent No. RE32,310 Col. 2, ln. 51 Col. 11, ln. 62

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction 32,333 to Hamill (cited at Col. 2, lns. 13-19) U.S. Patent No. RE 32,455 to Hamill (cited at Col. 2, lns. 13-19) U.S. Patent No. RE 32,310 to Debono (cited at Col. 2, lns. 20-27) U.S. Patent No. RE 32,311 to Debono (cited at Col. 2, lns. 20-27) U.S. Patent No. 4,537,717 to Abbott (cited at Col. 2, lns. 20-27) U.S. Patent No. 4,482,487 to Abbott (cited at Col. 2, lns. 20-27) U.S. Patent No. 4,524,135 to Abbott (cited at Col. 2, lns.

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction Col. 15, ln.45 Col. 23, ln. 62 U.S. Patent No. RE32,311 Abstract Col. 1, ln. 9 Col. 12, ln. 17 Col. 17, ln. 65 Col. 43, ln. 17 U.S. Patent No. 4,537,717 Abstract Col. 1, ln. 13 Col. 7, ln. 68 Col. 15, ln. 10 Col. 32, ln. 68 U.S. Patent No. 4,482,487 Abstract Col. 1, ln. 11 Col. 6, ln.

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction 20-27) U.S. Patent No. 5,912,226 to Baker (cited at Col. 2, ln. 65 Col. 3, ln. 46) Miao et al., Daptomycin Biosynthesis in Streptomyces roseosporus: Cloning and Analysis of the Gene Cluster and Revision of Peptide Stereochemistry, Microbiology, 151: 1507-23 (2005)

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction 61 Col. 8, ln. 53 Col. 13, ln. 42 Col. 22, ln. 32 Col. 33, ln. 15 U.S. Patent No. 4,524,135 Abstract Col. 1, ln. 13 Col. 6, ln. 56 Col. 8, ln. 47 Col. 13, ln. 40 Col. 21, ln. 60 Col. 32, ln. 30 U.S. Patent No. RE32,333 Col. 1, ln. 40 Col. 2, ln. 16 Col 19, ln. 62 Col. 25, ln. 58

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction U.S. Patent No. RE32,455 Col. 1, ln. 51 Col. 2, ln. 25 Col. 20, ln. 4 Col. 25, ln. 65 U.S. Patent No. 4,800,157 Col. 1, lns. 1-64 Col. 8, ln. 40 Col. 10, ln. 29 U.S. Patent No. 4,874,843 Col. 1, ln. 1 Col. 5, ln. 16 U.S. Patent No. 4,885,243 Col. 1, ln. 1 Col. 8, ln. 7 U.S. Patent N. 4,208,403

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction Abstract Col. 1, ln. 1 Col. 25, ln. 19 Baltz, Lipopeptide Antibiotics Produced by Streptomyces roseosporus and Streptomyces fradiae, BIOTECHNOLOGY OF ANTIBIOTICS, 2d ed. 415-435 (1997) at pp. 415-16, 419-20, 423-26, 430 (HOSP_CUB0004829-30 HOSP_CUB0004833-34, HOSP_CUB0004837-40, HOSP_CUB0004844) Tally et al., Daptomycin: A Novel Agent for Gram-Positive Infections, EXP. OPIN. INVEST. DRUGS 8:1223-1238 (1999) at 1223, -24, 1229-35 (HOSP_CUB0005043-44 HOSP_CUB0005049-55)

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction Oleson et al., Once-Daily Dosing in Dogs Optimizes Daptomycin Safety, ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 44: 2948-2953 (2000) at pp. 2948, 2951-53 (CUB 00487949, CUB 00487952-54) Lee et al., Daptomycin versus Conventional Therapy in the Treatment of Endocarditis and Bacteremia, ABSTRACTS OF THE INTERSCIENCE CONFERENCE ON ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, A885, 1991 Sexton et al., The Use of Daptomycin, a Lipopeptide Antibiotic, in the Treatment of Gram Positive Infections in Man, ABSTRACTS OF THE INTERSCIENCE CONFERENCE ON 8

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, A932, 1988 689 Patent Specification Col. 1, lns. 13-16 Col. 1, lns. 21-53 Col.1, ln. 65 Col. 2, ln. 45 Col. 3, lns. 17-30 Col. 3, lns. 38-43 Col. 3, ln. 48 Col. 4, ln. 50 Col. 4, ln. 66 Col. 5, ln. 16 Col. 5, lns. 43-58 Col. 5, ln. 67 Col. 6, ln. 3 Col. 6, lns. 11-14

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction Col. 6, lns. 19-40 Col. 7, ln. 38 Col. 8, ln. 4 Col. 8, lns. 10-14 Col. 8, lns. 17-19 Col. 8, lns. 23-48 Col. 9, ln. 29 Col. 12, ln. 30 (Examples 1, 2) Col. 12, ln. 63 Col. 14, ln. 25 (Examples 4, 5) Col. 14, lns. 48-62 (Claims 1-5) Col. 15, ln. 21 Col. 16, ln. 65 (Claims 10-57) Figures 1-3 689 Patent Abstract 689 Patent File History 02/20/2002 Information Disclosure Statement at p.

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Intrinsic Evidence Supporting Hospiras Construction

10

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Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction 2 (CUBH 001680) 11/20/2002 Amendment at pp. 6-17 (CUBH 001530-41) References Cited in the Specification or File History of the 689 Patent U.S. Patent No. RE32,310 Col. 2, ln. 51 Col. 11, ln. 62 Col. 15, ln.45 Col. 23, ln. 62 U.S. Patent No. RE32,311 Abstract Col. 1, ln. 9 Col. 12, ln. 17 Col. 17, ln. 65 Col. 43, ln. 17 U.S. Patent No. 11

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction 4,537,717 Abstract Col. 1, ln. 13 Col. 7, ln. 68 Col. 15, ln. 10 Col. 32, ln. 68 U.S. Patent No. 4,482,487 Abstract Col. 1, ln. 11 Col. 6, ln. 61 Col. 8, ln. 53 Col. 13, ln. 42 Col. 22, ln. 32 Col. 33, ln. 15 U.S. Patent No. 4,524,135 Abstract Col. 1, ln. 13 Col. 6, ln.

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

12

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction 56 Col. 8, ln. 47 Col. 13, ln. 40 Col. 21, ln. 60 Col. 32, ln. 30 U.S. Patent No. RE32,333 Col. 1, ln. 40 Col. 2, ln. 16 Col 19, ln. 62 Col. 25, ln. 58 U.S. Patent No. RE32,455 Col. 1, ln. 51 Col. 2, ln. 25 Col. 20, ln. 4 Col. 25, ln. 65 U.S. Patent No. 4,800,157 Col. 1, lns. 1-64

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

13

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Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction Col. 8, ln. 40 Col. 10, ln. 29 U.S. Patent No. 4,874,843 Col. 1, ln. 1 Col. 5, ln. 16 U.S. Patent No. 4,885,243 Col. 1, ln. 1 Col. 8, ln. 7 U.S. Patent N. 4,208,403 Abstract Col. 1, ln. 1 Col. 25, ln. 19 Baltz, Lipopeptide Antibiotics Produced by Streptomyces roseosporus and Streptomyces fradiae, BIOTECHNOLOGY OF ANTIBIOTICS, 2d ed. 415-435 (1997) at pp. 415-16, 419-20, 423-26,

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

14

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction 430 (HOSP_CUB0004829-30 , HOSP_CUB0004833-34, HOSP_CUB0004837-40, HOSP_CUB0004844) Tally et al., Daptomycin: A Novel Agent for Gram-Positive Infections, EXP. OPIN. INVEST. DRUGS 8:1223-1238 (1999) at 1223, -24, 1229-35 (HOSP_CUB0005043-44 HOSP_CUB0005049-55) Oleson et al., Once-Daily Dosing in Dogs Optimizes Daptomycin Safety, ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 44: 2948-2953 (2000) at pp. 2948, 2951-53 (CUB 00487949, CUB 00487952-54) Lee et al., Daptomycin versus Conventional

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

15

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction Therapy in the Treatment of Endocarditis and Bacteremia, ABSTRACTS OF THE INTERSCIENCE CONFERENCE ON ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, A885, 1991 Sexton et al., The Use of Daptomycin, a Lipopeptide Antibiotic, in the Treatment of Gram Positive Infections in Man, ABSTRACTS OF THE INTERSCIENCE CONFERENCE ON ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, A932, 1988 238 Patent Specification: Fig. 1. Col. 1, lns. 21-25 Col. 1, lns. 39-57 Col. 1, ln. 57 Col. 2, ln.

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

16

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction 60 Col. 3, lns. 33-38 Col. 4, ln. 21 Col. 5, lns. 22-36 Col. 7, lns. 24-27 Col. 9, lns 9-15 Col. 9, lns. 16-22 Col. 14, lns 13-30 Col. 21, lns. 8-17 Col. 26, lns. 46-49 Col. 26, lns. 56-60 Col. 28, lns. 1-18 Cols. 30-37 238 File History 08/11/2009 Office Action at CUBH 001937

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

17

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction 3/16/2010 Information Disclosure Statement at CUBH 001893 References Cited in the Specification or File History of the 238 Patent U.S. Patent No. RE32,310 Col. 2, ln. 51 Col. 11, ln. 62 Col. 15, ln. 45 Col. 23, ln. 62 U.S. Patent No. RE32,311 Abstract Col. 1, ln. 9 Col. 12, ln. 17 Col. 17, ln. 65 Col. 43, ln. 17 U.S. Patent No. 4,537,717

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

18

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction Abstract Col. 1, ln. 13 Col. 7, ln. 68 Col. 15, ln. 10 Col. 32, ln. 68 U.S. Patent No. 4,482,487 Abstract Col. 1, ln. 11 Col. 6, ln. 61 Col. 8, ln. 53 Col. 13, ln. 42 Col. 22, ln. 32 Col. 33, ln. 15 U.S. Patent No. 4,524,135 Abstract Col. 1, ln. 13 Col. 6, ln. 56 Col. 8, ln. 47 Col. 13,

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

19

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction ln. 40 Col. 21, ln. 60 Col. 32, ln. 30 U.S. Patent No. RE32,333 Col. 1, ln. 40 Col. 2, ln.16 Col 19, ln. 62 Col. 25, ln. 58 U.S. Patent No. RE32,455 Col. 1, ln. 51 Col. 2, ln. 25 Col. 20, ln. 4 Col. 25, ln. 65 U.S. Patent No. 4,800,157 Col. 1, lns. 1-64 Col. 8, ln. 40 Col. 10, ln. 29

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

20

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction U.S. Patent No. 4,874,843 Col. 1, ln. 1 Col. 5, ln. 16 U.S. Patent No. 4,885,243 Col. 1, ln. 1 Col. 8, ln. 7 U.S. Patent N. 4,208,403 Abstract Col. 1, ln. 1 Col. 25, ln. 19 Baltz, Lipopeptide Antibiotics Produced by Streptomyces roseosporus and Streptomyces fradiae, BIOTECHNOLOGY OF ANTIBIOTICS, 2d ed. 415-435 (1997) at pp. 415-16, 419-20, 423-26, 430 (HOSP_CUB0004829-30 HOSP_CUB0004833-34,

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

21

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction HOSP_CUB0004837-40, HOSP_CUB0004844) Tally et al., Daptomycin: A Novel Agent for Gram-Positive Infections, Exp. Opin. Invest. Drugs 8:1223-1238 (1999) at pp. 1223, -24, 1229-35 (HOSP_CUB0005043-44 HOSP_CUB0005049-55) Miao et al., Daptomycin Biosynthesis in Streptomyces roseosporus: Cloning and Analysis of the Gene Cluster and Revision of Peptide Stereochemistry, MICROBIOLOGY 151: 1507-23 (2005) at pp. 1507-08, 1512, 1520-21 (CUBH 000441-42, CUBH 000446, CUBH 000454-55) 342 Patent Specification: Fig. 1.

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

22

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Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction Col. 1, lns. 18-22 Col. 1, ln. 36 Col. 2, ln. 57 Col. 3, lns. 30-36 Col. 4, ln. 18 Col. 5, lns. 17-31 Col. 7, lns. 17-20 Col. 9, lns. 4-1. Col. 9, lns 11-17 Col. 14, lns. 8-12 Col. 14, lns. 17-26 Col. 21, lns. 1-11 Col. 26, lns. 39-42 Col. 26, lns. 49-53 Col. 27, ln. 60 Col. 28, ln. 10

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Intrinsic Evidence Supporting Hospiras Construction

23

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Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction Cols. 30-37 342 File History 07/29/2011 Office Action at CUBH 000283 08/12/2011 Information Disclosure Statement at CUBH 000199 12/08/2011 Information Disclosure Statement at CUBH 000192 References Cited in the Specification or File History of the 342 Patent Cubicin (daptomycin for injection) Label 1004 September 2003 Cubicin (daptomycin for injection) Label 1004-1 Revised August 200 Cubicin (daptomycin for injection) Label

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Intrinsic Evidence Supporting Hospiras Construction

24

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Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction 1004-2 Revised June 2005 Cubicin (daptomycin for injection) Label 1004-10-1 August 2010 U.S. Patent No. RE32,310 Col. 2, ln. 51 Col. 11, ln. 62 Col. 15, ln.45 Col. 23, ln. 62 U.S. Patent No. RE32,311 Abstract Col. 1, ln. 9 Col. 12, ln. 17 Col. 17, ln. 65 Col. 43, ln. 17 U.S. Patent No. 4,537,717

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

25

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction Abstract Col. 1, ln. 13 Col. 7, ln. 68 Col. 15, ln. 10 Col. 32, ln. 68 U.S. Patent No. 4,482,487 Abstract Col. 1, ln. 11 Col. 6, ln. 61 Col. 8, ln. 53 Col. 13, ln. 42 Col. 22, ln. 32 Col. 33, ln. 15 U.S. Patent No. 4,524,135 Abstract Col. 1, ln. 13 Col. 6, ln. 56 Col. 8, ln. 47 Col. 13,

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

26

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction ln. 40 Col. 21, ln. 60 Col. 32, ln. 30 U.S. Patent No. RE32,333 Col. 1, ln. 40 Col. 2, ln. 16 Col 19, ln. 62 Col. 25, ln. 58 U.S. Patent No. RE32,455 Col. 1, ln. 51 Col. 2, ln. 25 Col. 20, ln. 4 Col. 25, ln. 65 U.S. Patent No. 4,800,157 Col. 1, lns. 1-64 Col. 8, ln. 40 Col. 10, ln. 29

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

27

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction U.S. Patent No. 4,874,843 Col. 1, ln. 1 Col. 5, ln. 16 U.S. Patent No. 4,885,243 Col. 1, ln. 1 Col. 8, ln. 7 U.S. Patent N. 4,208,403 Abstract Col. 1, ln. 1 Col. 25, ln. 19 Baltz, Lipopeptide Antibiotics Produced by Streptomyces roseosporus and Streptomyces fradiae, BIOTECHNOLOGY OF ANTIBIOTICS, 2d ed. 415-435 (1997) at pp. 415-16, 419-20, 423-26, 430 (HOSP_CUB0004829-30 HOSP_CUB0004833-34,

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

28

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction HOSP_CUB0004837-40, HOSP_CUB0004844) Tally et al., Daptomycin: A Novel Agent for Gram-Positive Infections, Exp. Opin. Invest. Drugs 8:1223-1238 (1999) at pp. 1223, -24, 1229-35 (HOSP_CUB0005043-44 HOSP_CUB0005049-55) Miao et al., Daptomycin Biosynthesis in Streptomyces roseosporus: Cloning and Analysis of the Gene Cluster and Revision of Peptide Stereochemistry, MICROBIOLOGY 151: 1507-23 (2005) at pp. 1507-08, 1512, 1520-21 (CUBH 000441-42, CUBH 000446, CUBH 000454-55)

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction

29

Exhibit D Joint Claim Chart for U.S. Patent Nos. RE39,071 Proposed Construction of Disputed Claim Term with Citations to Supporting Evidence Term To Be Construed formula 3 compound/ compound of formula 3 (Claims 18, 26, 28 of the 071 patent) Cubists Proposed Construction An A21978C cyclic peptide of Intrinsic Evidence Supporting Cubists Construction 071 Patent Specification Abstract Col. 1, lns. 26-35 Col. 2, lns. 29-31 Col. 7, ln. 1 Col. 8, ln. 25 Col. 8, lns. 46-67 Col. 15, ln. 50 Col. 17, ln. 4 (Claim 18) Col. 17, ln. 8 Col. 19, ln. 30 (Claim 20) Col. 20, ln. 26 Col. 22, ln. 45 (Claim 26) Col. 23, ln. 1 Col. 26, ln. 6 (Claim 30) wherein RN is n-decanoyl 01/29/2008 Certificate of Hospiras Proposed Construction Intrinsic Evidence Supporting Hospiras Construction 071 Patent and File History Abstract Col. 1, lns. 14-35 Col. 1, ln. 60 Col. 2, ln. 31 Col. 6, ln. 56 Col. 7, ln. 60 Col. 8, lns. 50-60 Col. 9, ln. 47 Col. 10, ln. 67 Claims 1, 2, 18, 20, 26, 30 as re-issued on April 18, 2006 6/10/87 Patent Application at 11

The FORMULA 3 compound as recited in claims 18 and 26 that re-issued on April 18, 2006 (i.e., having the L-Asn configuration)

Term To Be Construed

Cubists Proposed Construction (i.e., LY 146032).

Intrinsic Evidence Supporting Cubists Construction Correction 071 Patent File History 01/29/2008 Certificate of Correction (CUBH 000436) 10/18/2007 Request for Certificate of Correction at pp. 1-4 (CUBH 000437-40) and Attachment at pp. 1507-08, 1512, 1520-21 (CUBH 000442-42, CUBH 000446, CUBH 000454-55) References Cited in Specification or Prosecution History of the 071 Patent U.S. Patent No. 4,885,243 Col. 2, lns. 9-15 Col. 2, lns. 20-25 Col. 2, lns. 33-42

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction 5/5/88 Office Action at 4 11/16/88 Amendment at 5-6 9/5/89 Amendment at 6 12/12/89 Office Action at 4 6/28/90 Amendment at 5-6 9/14/90 Office Action at 2 8/14/91 Office Action at 2-4 11/13/91 Amendment 3, 5, 7 9/1/92 Declaration of Manuel Debono at 2-3 11/5/92 Office Action at 3 3/9/93 Response at 3, 6, 8 5/27/93 Appeal Brief at 5,

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction Col. 3, ln. 57 Col. 8, ln. 7 (Examples 1-10) U.S. Patent No. 4,537,717 Col. 2, lns. 54-57 Col. 17, lns. 20-22 U.S. Patent No. 4,208,403 Col. 1, lns. 64-67 Miao et al., Daptomycin Biosynthesis in Streptomyces roseosporus: Cloning and Analysis of the Gene Cluster and Revision of Peptide Stereochemistry, MICROBIOLOGY 151: 1507-23 (2005) at pp. 1507-08, 1512, 1520-21 (CUBH 000441-42, CUBH 000446, CUBH 000454-55)

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction 11 12/5/93 Reply Brief at 2 3/5/98 BPAI Decision at 6-7, 10 4/11/00 Reissue Application at 4-5, claims 18, 26 8/22/00 Office Action at 6-8 10/18/07 Certificate of Correction Request at 1-2 1/29/08 Certificate of Correction U.S. Patent No. 4,208,403 to Hamill (cited at Col. 6, lns. 58-64) U.S. Patent No. 4,537,717 to Abbott (cited at Col. 7, lns. 42-60) U.S. Patent No.

Term To Be Construed

Cubists Proposed Construction

Intrinsic Evidence Supporting Cubists Construction

Hospiras Proposed Construction

Intrinsic Evidence Supporting Hospiras Construction 4,399,067 to Debono (cited in 5/5/88 Office Action) U.S. Patent No. RE 32,311 to Debono (cited in 5/5/88 Office Action) U.S. Patent No. 5,912,226 to Baker (cited in 4/11/00 Reissue Application) U.S.A.N and the USP Dictionary of Drug Names (1989) (cited as Exhibit 1 in 6/28/90 Amendment) Miao et al., Daptomycin Biosynthesis in Streptomyces roseosporus: Cloning and Analysis of the Gene Cluster and Revision of Peptide Stereochemistry, Microbiology, 151: 1507-23 (2005)

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