Free Claim Construction Chart - District Court of Delaware - Delaware

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE MERCK & CO., INC., Plaintiff and Counterclaim Defendant, v. RANBAXY INC., and RANBAXY LABORATORIES LIMITED, Defendants and Counterclaim Plaintiffs. ) ) ) ) ) ) ) ) ) )

C.A. No. 07-229 (GMS)

THE PARTIES' SECOND REVISED JOINT CLAIM CONSTRUCTION CHART Attached hereto as Exhibit A is the parties' Second Revised Joint Claim Construction Chart for U.S. Patent No. 5,147,868. This further revises the parties' First Revised Joint Claim Construction Chart filed on December 11, 2007. MORRIS, NICHOLS, ARSHT & TUNNELL LLP RICHARDS, LAYTON & FINGER, P.A.

/s/ Mary B. Graham (#2256)
Mary B. Graham (#2256) James W. Parrett, Jr. (#4292) 1201 N. Market Street P.O. Box 1347 Wilmington, DE 19899-1347 302.658.9200 OF COUNSEL: Raymond N. Nimrod JENNER & BLOCK LLP 919 N. Third Avenue 37th Floor New York, NY 10022-3908 Aaron A. Barlow Gregory D. Bonifield JENNER & BLOCK LLP 330 N. Wabash Avenue Chicago, IL 60611-7603 Attorneys for Merck & Co., Inc. Dated: February 25, 2008
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/s/ Kelly E. Farnan (#4395)
Frederick L. Cottrell, III (#2555) Kelly E. Farnan (#4395) One Rodney Square 920 North King Street Wilmington, DE 19801 302.651.7700 OF COUNSEL: Mark Boland Michael Dzwonczyk SUGHRUE MION PLLC 2100 Pennsylvania Avenue, N.W. Washington, D.C. 20037 202.293.7060 Attorneys for Ranbaxy Inc. and Ranbaxy Laboratories Limited

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EXHIBIT A

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MERCK & CO., INC. v. RANBAXY INC. AND RANBAXY LABS. INC. CIVIL ACTION NO. 07-229 (GMS) (D. DEL.) SECOND REVISED JOINT CLAIM CONSTRUCTION CHART Agreed Construction1 Claim Limitation witho pharmaceutically acceptable cation said one to fifteen carbon alkyl Claim at Issue 22 1, 9 1 Construction With Any pharmaceutically acceptable cation useful in the salt form of the claimed pharmaceutical compound. This term need not be construed. It means "said one to fifteen carbon alkyl."

Asserted claims: 1, 2, 9, 19, 20, 22, 23, 24 U.S. Patent No. 5,147,868 Claim Limitation "A compound" 1, 9 Claims at Issue MERCK CONSTRUCTION "A substance composed of atoms or ions of two or more elements in INTRINSIC EVIDENCE `868 patent, Abstract, col. 1, lns. 20-43; col. 5, ln. 20 - col. 10, ln. 46; RANBAXY CONSTRUCTION "A compound" excludes a combination product containing the INTRINSIC EVIDENCE '868 patent, 8:43-51 and applications/patents cited therein and

The parties jointly and respectfully submit that, if the Court deems it appropriate, the Court include the agreed-upon claim construction in its Claim Construction Order, or in the alternative, that this agreed upon construction is a binding stipulation between the parties. 1

1

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION chemical combination." INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE stemming therefrom; '868 patent, 5:20-9:45.

col. 19, lns. 35-67; col. compound and a 20, ln. 35 - col. 21, ln. thienamycin-type 43; col. 38, ln. 9 - col. compound. 40, ln. 40 (Claims 1-24); U.S. Appl. Ser. No. 06/748,300 (6/5/86 Communication to the Examiner under 37 C.F.R. §1.56 enclosing Abstract and accompanying information from the ICAAC, Sept. 22-24, 1980).

1

This formula needs no construction. The formula defines the structure illustrated, which shows the Zstereoconfiguration.

`868 Patent, col. 1, ln. 45 - col. 5, ln. 11; A. Srinavasan et al. Tetrahedron Lett., 891 (1976).

The formula includes racemates, mixtures, isomers, and enantiomers of the free acid form and salt forms of the compound, with the exception of the Estereoisomer form.

'868 patent, 2:18-5:10, Table I, cols. 11-20 and Examples 1-23, Claims 1, 9, 19 and 20; Application Ser. No. 06/465,577: Office Action dated February 24, 1984; Response under 37 C.F.R. §1.111 dated July 7, 1984; Office Action dated December 4, 1984;

2

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE Application Ser. No. 06/748,300, Office Action of February 24, 1985, Amendment dated May 15, 1986, Communication to the Examiner under 37 C.F.R. §1.56, dated June 5, 1986; Ashton, et al. Abstract no. 271 and "poster session," (ICAAC) Sept. 22-24, 1980; Application Ser. No. 06/878,391: Office Action dated Nov. 6, 1986; Amendment under 37 C.F.R. §1.116 received April 6, 1987; J. E. Blackwood et al., J. Am. Chem. Soc., 90, p. 509 (1968); A. Srinavasan et al. Tetrahedron Lett., 891 (1976).

3

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION This phrase as a whole needs no construction. The phrase "R1 is hydrogen" needs no claim construction. The term "pharmaceutically acceptable cation" is defined by the parties above. INTRINSIC EVIDENCE `868 patent, col. 1, ln. 45 - col. 2, ln. 45; col. 5, lns. 12-18; col. 38, lns. 10-66 (Claim 1).

RANBAXY CONSTRUCTION R1 defines two mutually exclusive subgenera: (1) a free acid form in which R1 is hydrogen, and (2) salt forms in which R1 is a pharmaceutically acceptable cation. INTRINSIC EVIDENCE '868 patent 1:60-5:6, 5:11-19; 2:18-5:10, Table I, cols. 11-20 and Examples 1-23, Claims 1, 9, 19 and 20.

R1 is hydrogen or a 1 pharmaceutically acceptable cation;

X

1

"X" needs no `868 patent, col. 1, ln. construction. The claim 45 - col. 5, ln. 10; col. defines "X" to mean: 10, ln. 45 - col. 38, ln. 8; col. 38, lns. 9-66 (Claim "unsubstituted or 1). substituted branched or linear alkyl of three to ten carbon atoms wherein a non-terminal methylene can be replaced by oxygen, sulfur or SO2, where 4

X includes at least:

a branched or linear alkyl group of four carbons substituted with a cycloalkyl group of six Application Ser. No. 06/878,391: Office carbons (i.e., a Action dated Nov. 6, cyclohexyl group), 1986; Amendment under 37 C.F.R. §1. 116 a branched or linear received April 6, 1987; alkyl group of five carbons substituted with Office Action dated July 24, 1987; Amendment

not defined (cf.. '868 patent, 1:60-5:19, cols. 11-20 (Table 1) and Examples 1-23).

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION said substituents are selected from the group consisting of halogen or cycloalkyl of three to six carbon atoms, with the proviso that, when said alkyl is substituted by said cycloalkyl, X is not more than ten total carbon atoms, with the further proviso that not more than six hydrogens of said alkyl can be substituted by said halogen, and with the further proviso that the carbon adjacent to the carbonyl cannot be tertiary;" INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION a cycloalkyl group of five carbons (i.e., a cyclopentyl group), a branched or linear alkyl group of six carbons substituted with a cycloalkyl group of four carbons (i.e., a cyclobutyl group), and a branched or linear alkyl group of seven carbons substituted with a cycloalkyl group of three carbons (i.e., a cyclopropyl group). INTRINSIC EVIDENCE under 37 C.F.R. §1.116 dated Oct. 30, 1987; Office Action dated February 7, 1988; Amendment under 37 C.F.R. §1.116 dated May 24, 1988; Application Ser. No. 07/244,527: Preliminary Amendment dated January 23, 1989; Office Action dated March 14, 1990; Amendment dated August 6, 1980; Office Action dated October 12, 1990; Application Ser. No. 07/641,317: Preliminary Amendment dated Jan. 14, 1991; Office Action dated March 20, 1991; Amendment and Response dated September 23, 1981; Office Action dated December 9, 1991; 5

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE Application Ser. No. 07/839,725: Preliminary Amendment and Response dated Feb. 19, 1992; Examiner Interview Summary dated March 30, 1992; Notice of Allowability dated March 30, 1992.

Y

1

"Y" needs no construction. The claim defines "Y" to mean: "cycloalkyl of three to six carbon atoms, unsubstituted or substituted with one or two substituents where said substituents are selected from the group consisting of halogen or alkyl of one to four carbon atoms, with the proviso that, when said cycloalkyl is substituted

`868 patent, col. 1, ln. 45 - col. 5, ln. 10; col. 10, ln. 45 - col. 38, ln. 8; col. 38, lns. 9-66 (Claim 1).

Y includes at least: cyclopropyl, cyclobutyl, cyclopentyl, and cyclohexyl, unsubstituted or substituted with one or two substituents including alkyl of one to four carbon atoms, provided that the total number of carbon atoms in substituted Y is not more than ten carbon atoms.

not defined (cf. '868 patent, 1:60-5:19, cols. 11-20 (Table 1) and Examples 1-23). Application Ser. No. 06/878,391: Office Action dated Nov. 6, 1986; Amendment under 37 C.F.R. §1. 116 received April 6, 1987; Office Action dated July 24, 1987; Amendment under 37 C.F.R. §1.116 dated Oct. 30, 1987; Office Action dated February 7, 1988;

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION by said alkyl, Y is not more than ten total carbon atoms;" INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE Amendment under 37 C.F.R. §1.116 dated May 24, 1988; Application Ser. No. 07/244,527: Preliminary Amendment dated January 23, 1989; Office Action dated March 14, 1990; Amendment dated August 6, 1980; Office Action dated October 12, 1990; Application Ser. No. 07/641,317: Preliminary Amendment dated Jan. 14, 1991; Office Action dated March 20, 1991; Amendment and Response dated September 23, 1981; Office Action dated December 9, 1991; Application Ser. No. 07/839,725: Preliminary Amendment and 7

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE Response dated Feb. 19, 1992; Examiner Interview Summary dated March 30, 1992; Notice of Allowability dated March 30, 1992.

trialkylammonium, quaternary hydroxyalkyldialkylammonium, phosphonylalkylamino, hydroxyalkylamino, alkylamidino, N,Ndialkyguanidino, alkylcarbonyloxy, alkoxycarbonyl,

1

The term "alkyl" means "a paraffinic hydrocarbon group which may be derived from an alkane by dropping one hydrogen from the formula." The term "alkyl" used as part of a larger chemical group or moiety has the meaning understood by persons of ordinary skill in the art in the context of that larger chemical group or moiety.

`868 patent, col. 1, ln. 45 - col. 5, ln. 10; col. 21, ln. 44 - col. 23, ln. 23; col. 31, ln. 37 - col. 38, ln. 8; col. 38, lns. 966 (Claim 1).

Each alkyl group in each substituent includes a linear, branched, or cyclic alkyl group without limitation as to number of carbon atoms.

not defined (cf. '868 patent, 1:60-5:6, cols. 11-20 (Table 1), and Examples 1-23); Claims 1, 9, 22). Application Ser. No. 06/878,391: Office Action dated Nov. 6, 1986; Amendment under 37 C.F.R. §1. 116 received April 6, 1987; Office Action dated July 24, 1987; Amendment under 37 C.F.R. §1.116 dated Oct. 30, 1987; Office Action dated February 7, 1988; Amendment under 37 C.F.R. §1.116 dated May 24, 1988;

8

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U.S. Patent No. 5,147,868 Claim Limitation N,Ndialkylcarbamoyl

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE Application Ser. No. 07/244,527: Preliminary Amendment dated January 23, 1989; Office Action dated March 14, 1990; Amendment dated August 6, 1980; Office Action dated October 12, 1990; Application Ser. No. 07/641,317: Preliminary Amendment dated Jan. 14, 1991; Office Action dated March 20, 1991; Amendment and Response dated September 23, 1981; Office Action dated December 9, 1991; Application Ser. No. 07/839,725: Preliminary Amendment and Response dated Feb. 19, 1992; Examiner Interview Summary 9

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE dated March 30, 1992; Notice of Allowability dated March 30, 1992.

2,2-dimethylcyclopropyl

2, 9

This term needs no construction. The term means "2,2dimethylcyclopropyl."

`868 patent, col. 38, lns. 67-68 (Claim 2); col. 39, lns. 18-35 (Claim 9); col. 40, lns. 21-23 (Claim 19).

(S)-2,2dimethylcyclopropyl, (R)-2,2dimethylcyclopropyl, and mixtures thereof.

'868 patent, 2:18-5:10, Table I, cols. 11-20, Examples 1-23; Application Ser. No. 06/748,300, Office Action of February 24, 1985, Amendment dated May 15, 1986, Communication to the Examiner under 37 C.F.R. §1.56, dated June 5, 1986; Ashton, et al. Abstract no. 271 and "poster session, " (ICAAC) Sept. 22-24, 1980; J. E. Blackwood et al., J. Am. Chem. Soc., 90, p. 509 (1968); A. Srinavasan et al. Tetrahedron Lett., 891 (1976).

10

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE `868 Patent, col. 1, ln. 45 - col. 5, ln. 11; col. 38, lns. 10-66 (Claim 1); col. 39, lns. 18-36 (Claim 9); A. Srinavasan et al. Tetrahedron Lett., 891 (1976).

RANBAXY CONSTRUCTION The formula includes racemates, mixtures, isomers, and enantiomers of the free acid form, salt forms, and ester forms of the compound, with the exception of the Estereoisomer form. INTRINSIC EVIDENCE '868 patent, 2:18-5:10, Table I, cols. 11-20 and Examples 1-23, Claims 1, 9, 19 and 20; Application Ser. No. 06/465,577: Office Action dated February 24, 1984; Response under 37 C.F.R. §1.111 dated July 7, 1984; Office Action dated December 4, 1984; Application Ser. No. 06/748,300, Office Action of February 24, 1985, Amendment dated May 15, 1986, Communication to the Examiner under 37 C.F.R. §1.56, dated June 5, 1986; Ashton, et al. Abstract no. 271 and "poster session," (ICAAC) Sept. 22-24, 1980; Application Ser. No. 11

9

This formula needs no construction. The formula defines the structure illustrated, which shows the Zstereoconfiguration.

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE 06/878,391: Office Action dated Nov. 6, 1986; Amendment under 37 C.F.R. §1. 116 received April 6, 1987; J. E. Blackwood et al., J. Am. Chem. Soc., 90, p. 509 (1968); A. Srinavasan et al. Tetrahedron Lett., 891 (1976).

R1 is hydrogen, loweralkyl of 1-6 carbon atoms, dialkylaminoalkyl, or a pharmaceutically acceptable cation

9

This phrase as a whole needs no construction. The phrase "R1 is hydrogen" needs no claim construction. The term "loweralkyl of 1-6 carbon atoms" needs no construction. The term "dialkylaminoalkyl" needs no construction. The term

`868 patent, col. 1, ln. 45 - col. 2, ln. 45; col. 5, lns. 12-18; col. 39, lns. 18-36 (Claim 9).

R1 defines three mutually exclusive subgenera: (1) a free acid form in which R1 is hydrogen, (2) ester forms in which R1 is loweralkyl of 1-6 carbon atoms, or dialkylaminoalkyl, and (3) salt forms in which R1 is a pharmaceutically acceptable cation.

'868 patent 1:60-5:6, 5:11-19; 2:18-5:10, Table I, cols. 11-20 and Examples 1-23, Claims 1, 19 and 20. Application Ser. No. 06/878,391: Office Action dated Nov. 6, 1986; Amendment under 37 C.F.R. §1. 116 received April 6, 1987; Office Action dated July 24, 1987; Amendment under 37 C.F.R. §1.116 dated Oct. 30, 1987; Office Action dated

12

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION "pharmaceutically acceptable cation" is defined by the parties above. INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE February 7, 1988; Amendment under 37 C.F.R. §1.116 dated May 24, 1988; Application Ser. No. 07/244,527: Preliminary Amendment dated January 23, 1989; Office Action dated March 14, 1990; Amendment dated August 6, 1980; Office Action dated October 12, 1990; Application Ser. No. 07/641,317: Preliminary Amendment dated Jan. 14, 1991; Office Action dated March 20, 1991; Amendment and Response dated September 23, 1981; Office Action dated December 9, 1991; Application Ser. No. 07/839,725: Preliminary 13

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE Amendment and Response dated Feb. 19, 1992; Examiner Interview Summary dated March 30, 1992; Notice of Allowability dated March 30, 1992.

7-(L-2-amino-219 carboxyethylthio)2-(2,2dimethylcyclopropanecarboxamido)-2-heptenoic acid

This term means "the free acid, ester and salt forms of 7-(L-2-amino2-carboxyethylthio)-2(2,2-dimethylcyclopropanecarboxamido)-2heptenoic acid."

'868 Patent, col. 5, lns. 11-19; col. 8, ln. 42-col. 9, ln. 45; col. 10, lns. 25-44; col. 19, lns. 3567; col. 20, ln. 35-col. 23 ln. 23; col. 34, lns. 968; col. 38, lns. 9-66 (Claim 1); col. 39, lns. 19-35 (Claim 9); col. 40, lns. 21-25 (Claims 1920).

the free acid form of 7(L-2-amino-2carboxyethylthio)-2(2,2-dimethylcyclopropanecarboxamido)-2heptenoic acid, excluding a pharmaceutically acceptable cation, the free acid form including the (S)-(2,2dimethylcyclopropanecarboxamido) form, the (R)-(2,2dimethylcyclopropanecarboxamido) form, and mixtures

'868 patent 1:60-5:6, 5:11-19; 2:18-5:10, Table I, cols. 11-20 , Claims 1, 9, 19 and 20.

'868 patent, 2:18-5:10; Table I, cols. 11-20; Claims 1, 9, 19 and 20; Application Ser. No. 06/465,577: Office Action dated February 24, 1984; Response under 37 C.F.R. §1.111

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION thereof. INTRINSIC EVIDENCE dated July 7, 1984; Office Action dated December 4, 1984; Application Ser. No. 06/748,300, Office Action of February 24, 1985, Amendment dated May 15, 1986, Communication to the Examiner under 37 C.F.R. §1.56, dated June 5, 1986; Ashton, et al. Abstract no. 271 and "poster session," (ICAAC) Sept. 22-24, 1980; Application Ser. No. 06/878,391: Office Action dated Nov. 6, 1986; Amendment under 37 C.F.R. §1. 116 received April 6, 1987; J. E. Blackwood et al., J. Am. Chem. Soc., 90, p. 509 (1968); A. Srinavasan et al. Tetrahedron Lett., 891 (1976). 15

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U.S. Patent No. 5,147,868 Claim Limitation the sodium, potassium calcium or magnesium salt form

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE '868 Patent, col. 5, lns. 11-19; col. 8, ln. 42-col. 9, ln. 45; col. 10, lns. 25-44; col. 19, lns. 3567; col. 20, ln. 35-col. 23 ln. 23; col. 34, lns. 968; col. 38, lns. 9-66 (Claim 1); col. 39, lns. 19-35 (Claim 9); col. 40, lns. 3-8 (Claims 13-14); col. 40, lns. 21-25 (Claims 19-20). `868 patent, col. 40, lns. 28-33 (Claim 22).

RANBAXY CONSTRUCTION the sodium, potassium calcium or magnesium salt form, excluding the free acid form. INTRINSIC EVIDENCE '868 patent 1:60-5:6, 5:11-19; 2:18-5:10, Table I, cols. 11-20, Claims 1, 9, 19 and 20.

20

This term needs no construction. This term means "the sodium, potassium, calcium, or magnesium salt form."

R2

22

"R2" needs no construction. The claim defines "R2" to mean: "cycloalkyl of three to six carbon atoms substituted by two alkyl substituents of one to three carbon atoms each, with the proviso that R2 cannot contain more than ten carbon atoms."

R2 includes at least: cyclopropyl substituted by two substituents of one, two, or three carbon atoms each; cyclobutyl substituted by two substituents of one, two, or three carbon atoms each; cyclopentyl substituted by one substituent of one, two, or three carbon atoms and by

not defined (cf. '868 patent, 1:60-5:6, cols. 11-20 (Table I), Examples 1-23; Claims 1-22). Application Ser. No. 06/878,391: Office Action dated Nov. 6, 1986; Amendment under 37 C.F.R. §1. 116 received April 6, 1987; Office Action dated July 24, 1987; Amendment under 37 C.F.R. §1.116 dated Oct. 30, 1987;

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE

one substituent of one or Office Action dated two carbon atoms; and February 7, 1988; Amendment under 37 cyclohexyl substituted C.F.R. §1.116 dated by one substituent of May 24, 1988; one, two, or three carbon atoms and by Application Ser. No. one substituent of one 07/244,527: carbon atom, or Preliminary Amendment cyclohexyl substituted dated January 23, 1989; by one substituent of Office Action dated one or two carbon atoms March 14, 1990; and by one substituent Amendment dated of one or two carbon August 6, 1980; Office atoms. Action dated October 12, 1990; Application Ser. No. 07/641,317: Preliminary Amendment dated Jan. 14, 1991; Office Action dated March 20, 1991; Amendment and Response dated September 23, 1981; Office Action dated December 9, 1991; Application Ser. No. 17

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE 07/839,725: Preliminary Amendment and Response dated Feb. 19, 1992; Examiner Interview Summary dated March 30, 1992; Notice of Allowability dated March 30, 1992.

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