Free Proposed Pretrial Order - District Court of Delaware - Delaware

Case 1:04-cv-00939-GMS

Document 70-4

Filed 06/28/2006

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EXHIBIT 3A

Case 1:04-cv-00939-GMS

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Page 2 of 40

EXHIBIT 3A PLAINTIFF'S EXHIBIT LIST AND DEFENDANT'S OBJECTIONS THERETO Merck v. Teva USA, C.A. No. 04-939 (GMS) Trial Exhibit No.
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. Teva USA's Objections and Basis Hearsay Hearsay Relevance, hearsay Relevance, hearsay Relevance, prejudicial Relevance Relevance Relevance Relevance Relevance None None None None Relevance, hearsay Relevance, hearsay

Description Certified Copy of U.S. Patent 5,994,329 Certified Copy of File History of U. S. Patent 5,994,329 Certified Copy of U.S. Patent 4,621,077 Certified Copy of File History of U.S. Patent 4,621,077 08/17/00 Kenyon & Kenyon's Patent Opinion for U.S. Patent 5,994,329 11/23/99 Merrill Lynch article re "Fosamax - once Weekly looks Good" 03/21/01 Handwritten Note to Krauss and Millonig re Berkman 02/06/02 Mazess facsimile to Krauss re Weissburg 04/24/01 Note re retaining Mazes as a consultant in the area of bisphosphonate technology 04/04/95 Mazess letter to Procter & Gamble re vitamin D compounds 04/1996 Lunar® News, pp. 1-44 07/1996 Lunar® News, pp. 1-36 12/1996 Lunar® News, pp. 1-44 04/1997 Lunar® News, pp. 1-48 Osteoporosis Evaluation: Score Sheet by Bone Measurement Institute 03/06/97 Mazess letter to Mautalen, M.D.

Other Designation

Admitted

Rule 802 802 402, 802 402, 802 402, 403 402 402 402 402 402

T 007339-007473; T 007597-007599 T 003704-003705 MAZ 0001 Mazess 14 Mazess 15 GE 0007

Mazess 7 GE 0024

402, 802 402, 802

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Trial Exhibit No.
17. 18. 19.

Description 06/07/96 Mazess letter to Lindsay, M.D. re PDEXA 08/06/96 Mazess letter to Jeremy C. Allen 02/07/97 Mazess letter to Ray Gilmaritn re densitometry

Other Designation MK 0286436 MK 0272212 -0272213 MK 03344030334436 Mazess 5 MK 0272082 MK 02722140272215 MAZ0004-0005 GE 00350036 T 0071037105 T 007106 T 007107-7108 T 007110-7111 T 001102 T 002470 T 003307 T 002501

Admitted

Teva USA's Objections and Basis Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay None Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay

Rule 402, 802 402, 802 402, 802

20. 21. 22.

04/14/97 Mazess facsimile to Jeremy C. Allen re Meeting at Lunar, 05/21/97 Merck/Lunar Management Meeting, 05/21/97 ­ Agenda 05/23/96 Mazess Letter to Stuart Silverman, M.D. re mass screening using pDEXA 03/13/97 Mazess facsimile to Doris Krunagel re Lunar® News report on biphosphonates 01/27/98 Mazess letter to Nils-Otto Skribeland, M.D. re alendronate 04/06/00 Pre-Product Development Meeting 04/14/00 Hoenscheid memo re Product Development Meeting Minutes ­ 04/11/00 05/18/00 Product Development Meeting Minutes 07/10/00 Salsbury memo re Product Development Meetings ­ 06/29/00 12/07/99 Steve Lonesky E ­ mail to Karen Arnold re Alendronate Tablets 11/19/98 Ziegenfus memo to Kopp from re Alendronate 10/23/98 A. Mattiuz memo to D. McNichol re Avice 200 Teva USA: Sales Forecast Alendronate

402, 802

402, 802

23. 24. 25. 26. 27. 28. 29. 30. 31. 32.

402, 802 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802

2

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Trial Exhibit No.
33. 34. 35. 36. 37.

Description Teva USA: Sales Forecast, Alendronate Tablets ­ 70 mg, Fosamax ­ Merck 12/13/00 Teva USA: Sales Forecast, Alendronate Tablets ­ 70 mg, Foxamax - Merck Does response curve drawing by David Markowitz Page 787 from Mosby's Medical Dictionary, Fourth Edition Uetrecht, "Is it Possible to More Accurately Predict which Drug Candidates will cause Idiosyncratic Drug Reactions?", Current Drug Metabolism, 133-141 (2000) Berkowitz et al., "Gastroparesis After Lung Transplantation", Chest, 108:6, 1602-1607 (1995) Wolfe et al., "Gastrointestinal Toxicity of Nonsteroidal Antiinflammatory Drugs", The New England Journal of Medicine, 340:24, 1888-1899 (1999) 03/13/00 Hoenscheid memo re Project Review Status Report for January & February 2000 08/04/00 Hoenscheid memo re Project Review Status Reports for May, June & July 2000 05/01/00 Lee E-mail to Gailbraith and Rein re 70 mg alendronate formulation 09/18/00 Regulatory Document for Review Patent Issues, with attached alendronate sodium tablets, 70 mg draft patent certification 03/05/01 BfArM Response Report Mutual Recognition

Other Designation T 002482-2485 T 007147

Admitted

Teva USA's Objections and Basis Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay

Rule 402, 802 402, 802 402, 802 402, 802 402, 802

38. 39.

402, 802 402, 802

40. 41. 42. 43.

T 007148007150 T 007154007156 T 007475 T 007612007613 MK 02223530222359 MK 02908860290887

Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay

402, 802 402, 802 402, 802 402, 802

44.

402, 802

45.

02/20/98 Melton E-mail to DiCesare, Santora and Yates re Once a week Fosamax in Prevention of Osteoporosis

402, 802

3

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Trial Exhibit No.
46.

Description 07/19/96 Bissett memo to HHMC Members re Minutes of 7/19/96 HHMC Meeting 05/20/97 Stage 1 Phase V Product Development Plan, Tactical PAC Review Document entitled, "Alendronate 70 mg Once Weekly is Therapeutically Equivalent to Alendronate 10 mg Daily" 03/15/96 Dear Doctor Letter

47.

48. 49.

Other Designation MK 03557910355794 MK 01582420158287 MK 0225375 MK 01564200156421

Admitted

Teva USA's Objections and Basis Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance

Rule 402, 802

402, 802

402, 802 402

50. 51.

52.

53.

54.

FOSAMAX® (Aendronate Sodium Tablets) Package Insert, 2000 Chesnut et al., "Aendronate Treatment of the Postmenopausal Osteoporotic Woman: Effect of Multiple Dosages on Bone Mass and Bone Remodeling", The American Journal of Medicine, 99: 144-152 (1995) Frost, "Treatment of Osteporosis by Manipulation of Coherent Bone Cell Populations", New Treatment of Osteoporosis, 143:227-244 (1979) Reitsma et al., "Kinetic Studies of Bone and Mineral Metabolism During Treatment with (3-Amino-1Hydroxypropylidene)-1, 1-Bisphosphonate (APD) in Rats", Calcif. Tiss. Int. 32:145-157 (1980) Anderson et al., "Preliminary Observations of a Form of Coherence Therapy for Osteoporosis", Calcif. Tissue Int. 36:341-343 (1984)

Relevance, hearsay Relevance, hearsay

402, 802 402, 802

Relevance, hearsay Relevance, hearsay

402 , 802

402, 802

Relevance, hearsay

402 , 802

4

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Trial Exhibit No.
55.

56.

57.

58.

59.

60.

61. 62.

63.

Description Harinck et al., "Efficacious Management with Aminobisphosphonate (APD) in Paget's Disease of Bone", Clinical Orthopaedics and Related Research, 217:79-98 (1987) Harinck et al., "Paget's disease of bone: early and late responses to three different modes of treated with aminohydroxpropylidene bisphosphonate (APD)", British Medical Journal, 295: 1301-1305 (1987) Valkema et al., "Maintained improvement in calcium balance and bone mineral content in patients with osteoporosis treatment with the bisphosphonates APD", Bone and Mineral, 5: 183-192 (1989) Watts et al., "Intermittent Cyclical Etidronate Treatment of Postmenopausal Osteoporosis", The New England Journal of Medicine, 323(2): 73-79 (1990) Storm et al., "Effect of Intermittent Cyclical Etidronate Therapy on Bone Mass and Fracture Rate in Women with Postmenopausal Osteoporosis", The New England Journal of Medicine, 322(18):1265-1271 (1990) Passeri et al., "Intermittent treatment with intravenous 4-amin-1-hydroxybutylidene-1, 1-bisphosphonate (AHBuBP) in the therapy of postmenopausal osteoporosis", Bone and Mineral, 15: 237-247 (1991) Yamada et al., Textbook of Gastroenterology, Vol. 1, 3rd Edition, Chapter 61, pp. 1304-1325 (1999) Harris et al., "Four Year Study of Intermittent Cyclic Etidronate Treatment of Postmenopausal Osteoporosis: Three Years of Blinded Therapy Followed by One Year of Open Therapy", American Journal of Medicine, 95:557-567 (1993) van Holten-Verzantvoort et al., "Palliative Pamidronate Treatment in Patients with Bone Metastases from Breast Cancer", Journal of Clinical Oncology, 11(3):491-498 (1993)

Other Designation

Admitted

Teva USA's Objections and Basis Relevance, hearsay

Rule 402, 802

Relevance, hearsay

402, 802

Relevance, hearsay

402, 802

Relevance, hearsay Relevance, hearsay

402, 802

402, 802

Relevance, hearsay

402, 802

Relevance, hearsay Relevance, hearsay

402, 802 402, 802

Relevance, hearsay

402, 802

5

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Trial Exhibit No.
64.

65.

66.

67.

68.

69.

70.

71.

72.

Description Thiebaud et al., "Two Years' Effectiveness of Intravenous Pamidronate (APD) Versus Oral Fluoride for Osteoporosis Occuring in the Postmenopause", Osteoporosis Int., 4: 76-83 (1994) Adami et al., "Effects of Two Oral Doses of Alendronate in the Treatment of Paget's Diseaase of Bone", Bone, 15(4): 415-417 (1994) Lufkin et al., "Pamidronate: An Unrecognized Problem in Gastrointestinal Tolerability", Osteoporosis Int'l., 4: 320-322 (1994) Filipponi et al., "Cyclical Clodronate is Effective in Preventing Postmenopausal Bone Loss: A Comparative Study with Transcutaneous Hormone Replacement Therapy", Journal of Bone and Mineral Research, 10(5): 697-703 (1995) Liberman et al., "Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis", The New England Journal of Medicine, 333(22): 1437-1443 (1995) Maconi et al., "Multiple Ulcerative Esophagitis Caused by Alendronate", American Journal of Gastroenterology, 1889-1890 (1995) De Groen et al., "Esophagitis Associated with the Use of Alendronate", The New England Journal of Medicine, 335(14): 1016-1021 (1996) Black et al., "Randomised trial of effect of alendronate at risk of fracture in women with existing vertebral fractures", Lancet, 348:1535-1541 (1996) Spivacow et al., "Tolerability of oral pamidronate in elderly patients with osteoporosis and other metabolic bone diseases", Current Therapeutic Research, 57(2): 123-130 (1996)

Other Designation

Admitted

Teva USA's Objections and Basis Relevance, hearsay

Rule 402, 802

Relevance, hearsay

402, 802

402, 802

Relevance, hearsay

402, 802

None

Relevance, hearsay None

402, 802

None

Relevance, hearsay

402, 802

6

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Trial Exhibit No.
73.

74.

75.

76.

77. 78.

79.

80.

81.

82.

83.

Description Eggelmeijer et al., "Increased bone mass with pamidronate treatment in rheumatoid arthritis", Arthritis & Rheumatism, 39(3): 396-402 (1996) Nightingale SL, "From the FDA: Important Information Regarding Alendronate Adverse Reactions", JAMA 275(20): 1534 (1996) Abdelmalek et al., "Letters to the Editor, "AlendronateInduced Ulcerative Esophagitis", American Journal of Gastroenterology, 91(6):1282-1283 (1996) Anonymous. "Oesophageal reactions with alendronate sodium (Fosamax)", Current Problems in Pharmacovigilance, 22: 5-8 (1996) Sorrentino et al., "Esophageal ulceration due to alendronate", Endoscopy, 28: 529 (1996) Hodsman et al., "Use of bisphosphonates in the treatment of osteoporosis", Canadian Medical Association Journal, 155(7): 945-948 (1996) Castell DO, Letter to Editor, "Pill Esophagitis" - The Case of Alendronate, The New England Journal of Medicine, 335(14): 1058-1059 (1996) Naylor et al., Letter to Editor, "Oesophageal stricture associated with alendronic acid", The Lancet, 348: 1030-1031 (1996) Rimmer et al., Letters to the Editor, "Improper Alendronate Administration and a Case of Pill Esophagitis", American Journal of Gastroenterology, 91(12):2648-2649 (1996) Thiebaud et al., "Three Monthly Intravenous Injections of Ibandronate in the Treatment of Postmenopausal Osteporosis", American Journal of Medicine, 103:298-307(1997) Black et al., "Nonclinical Model for Assessing Gastric Effects of Bisphosphonates", Digestive Diseases and Sciences, 42(2): 281-288 (1997)

Other Designation

Admitted

Teva USA's Objections and Basis Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay None

Rule 402, 802

402, 802

402, 802

402, 802

402, 802 402, 802

Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay

402, 802

402, 802

402, 802

402, 802

7

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Trial Exhibit No.
84.

85.

86.

87.

88.

89. 90.

91. 92.

93.

94.

Description Colina et al., "A new probable increasing cause of esophageal ulceration: Alendronate", American Journal of Gastroenterology, 92(4): 704-706 (1997) Girelli et al., "Esophagitis from alendronate" Report of two cases", Recenti Progressi in Medicina, 88(5) 223-225 (1997) Levine et al., "Esophageal stricture associated with alendronate therapy", The American Journal of Medicine, 102: 489-491 (1997) Lilley et al., "Avoiding Alendronate-Related Esophageal Irritation", American Journal of Nursing, 97(7): 12-14 (1997) Pizzani et al., "Esophagitis associated with alendronate sodium", Virginia Medical Quarterly, 124(3): 181-182 (1997) Fleisch, Herbert; Excerpts from Bisphosponates in bone disease, 1st Edition pp. 126-132, 144 (1993) Fleisch, Herbert; Excerpts from Bisphosphonates in Bone Disease From the Laboratory to the Patient, 2nd Edition pp. 147-154 (1995) Fleisch, Herbert; Excerpts from Bisphosponates in bone disease, 3rd Edition pp. 152-160 (1997) Fleisch, Herbert; Excerpts from Bisphosphonates in Bone Disease From the Laboratory to the Patient, 4th Edition pp. 168-177 (2000) Russell et al., "Clinical Pharmacology of Bisphosphonates", In: Tumor Bone Diseases and Osteoporosis in Cancer Patients, Ed. Body, J-J., Publ. Marcel Dekker, Inc. NY, 377-392 (2000) Kanis et al, "Rational for the Use of Alendronate in Osteoporosis", Osteoporosis Int., 5:1-13 (1995)

Other Designation

Admitted

Teva USA's Objections and Basis Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay

Rule 402, 802

402, 802

402, 802

402, 802

402, 802

402, 802 402, 802

402, 802 402, 802

402, 802

None

8

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Trial Exhibit No.
95.

96.

97.

98.

99.

100.

101.

Description Harris et al., "The Effect of Short Term Treatment with Alendronate on Vertebral Density and Biochemical Markers of Bone Remodeling in Early Postmenopausal Women", J. Clin. Endo. Metab., 76(6):1399-1406 (1993) Graham DY et al., "Primary Amino-Bisphosphonates: A New Class of Gastrotoxic Drugs ­ Comparison of Alendronate and Aspirin", The American Journal of Gastroenterology, 92(8):1322-1325 (1997) Kelly et al., Letter to Editor, "Incidence of gastrointestinal side effects due to alendronate is high in clinical practice", BMJ 315: 1235 (1997) Cameron RB, "Esophagitis dissecans superficialis and alendronate: case report", Gastrointestinal Endoscopy, 46(6) 562-563 (1997) Abraham et al., "Alendronate-Associated Esophagael Injury: Pathologic and Endoscopic Features", Modern Pathology, 12(12): 1152-1157 (1999) Genant et al., "Chronic Intermittent Cyclical Administration of Tiludronate in Postmenopausal Osteoporosis: Report of Two Multicenter Studies in 2316 Patients", JBMR-IBMS Second Joint Meeting, 23(5) Suppl. 1112 (1998) Graham, DY, "What the gastroenterologist should Know About the Gastrointestinal Safety Profile of Bisphosphonates", Digestive Diseases & Sciences, 47(8): 1665-1678 (2002) Lanza et al., "The Upper GI Safety and Tolerability of Oral Alendronate at a Dose of 70 mg Once-Weekly: A PlaceboControlled Endoscopy Study", The American Journal of Gastroenterology, 97(1): 58-64 (2002) Ettinger, et al., Alendronate Use Among 812 Women: Prevalence of Gastrointestinal Compliants, Noncompliance with Patient Instructions, and Discontinuation JMCP, 4(5): 488-492 (1998)

Other Designation

Admitted

Teva USA's Objections and Basis None

Rule

Relevance, hearsay

402, 802

Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay

402, 802

402, 802

402, 802

402, 802

Relevance, hearsay

402, 802

102.

Relevance, hearsay

402, 802

103.

Relevance, hearsay

402, 802

9

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Trial Exhibit No.
104.

105.

106.

107. 108.

Description Ettinger, et al., "Clinic Visits and Hospital Admissions for Care of Acid-Related Upper Gastrointestinal Disorders in Women Using Alendronate for Osteoporosis", The American Journal of Managed Care, 4(10): 1377-1382 (1998) Delmas et al., "Long Term Effects of Dischloromethylene Diphosphonate in Paget's Disease of Bone", Journal of Clinical Endocrinology and Metabolism, 54(4): 837-844 (1982) Yates et al., "Intravenous Clodronate in the Treatment and Retreatment of Paget's Disease of Bone", The Lancet, 14741477 (1985) 09/21/00 Kenyon & Kenyon's Invoice No. 527081 Heynen et al., "Clinical and biological effects of low doses of (3 amino-1 hydroxypropylidene)-1, 1-bisphosphonate (APD) in Paget's disease of bone", European Journal of Clinical Investigation, 11:29-35 (1982) Harinck et al., "Paget's disease of bone: early and late responses to three different modes of treatment with aminohydroxypropylidene bisphosphonate (APD)", British Medical Journal, 295: 1301-1305 (1987) Khan et al., "Alendronate in the Treatment of Paget's Disease of Bone", Bone, 20(3): 263-271 (1997) Siris et al., "Comparative Study of Alendronate Versus Etidronate for the Treatment of Paget's Disease of Bone", Journal of Clinical Endocrinologyand Metabolism, 81(3): 961-967 (1996) Cassidy et al., "Continuous versus Intermittent Acid Exposure in Production of Esophagitis in Feline Model", Digestive Diseases and Sciences, 37(8): 1206-1211 (1992)

Other Designation

Admitted

Teva USA's Objections and Basis Relevance, hearsay

Rule 402, 802

Relevance, hearsay

402, 802

Relevance, hearsay T 007623-007625 Relevance, hearsay Relevance, hearsay

402, 802

402, 802 402, 802

109.

Relevance, hearsay

402, 802

110. 111.

None None

112.

Relevance, hearsay

402, 802

10

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Trial Exhibit No.
113.

114.

115.

116.

117.

118.

119.

120.

121. 122.

123.

Description Peter et al., "Esophageal Irritation due to Alendronate Sodium Tablets: Possible Mechanisms", Digestive Diseases and Sciences, 43(9), 1998-2002 (1998) Spivacow et al., "Digestive tolerance of oral bisphosphonates in patients with osteoporosis and other medical osteopathies", Medicina, 57 (Suppl. 1):114-118 (1997) Khairi et al., "Sodium Etidronate in the Treatment of Paget's Disease of Bone", Annals of Internal Medicine, 87:656-663 (1977) Kanis et al., "Long-Term Follow-Up Observations on Treatment in Paget's Disease of Bone", Clinical Orthopedics and Related Research, 217:99-125 (1987) Peter et al., "Comparative Study of Potential for Bisphosphonates to Damage Gastric Mucosa of Rats", Digestive Diseases and Sciences, 43(5):10091015 (1998) Ibbertson et al., "Paget's Disease of Bone ­ Clinical Evaluation and Treatment with Diphosphonates", New Zealand Journal of Medicine, 9:31-35 (1979) 12/04/95 Merck letter to FDA re IND 32,033 FosamaxTM (Oral Alendronate Sodium) ­ Information Amendment ­ Clinical 01/24/96 Merck letter to FDA re IND 32,033 FosamaxTM (Alendronate Sodium Tablets) General Correspondence Fracture Intervention Trial Update 01/12/98 Merck letter to FDA re IND 32,033 FosamaxTM Information Amendment Pharmacology/Toxicology 06/08/99 Merck letter to FDA re IND 32,033: Fosamax, Information Amendment ­ Clinical Data Analysis Plan for Protocol 118 06/22/01 Merck letter to FDA re IND 32,033 Fosamax® Tablets Request for Meeting

Other Designation

Admitted

Teva USA's Objections and Basis Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay None

Rule 402, 802

402, 802

402, 802

402, 802

Relevance, hearsay MK 0188346-0188544 MK 0154684-0154694 MK 0382423-0382456 MK 0170895-0170944 MK 0341364-0341395 Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay

402, 802

402, 802

402, 802

402, 802 402, 802

402, 802

11

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Trial Exhibit No.
124. 125.

Description Protocol (MK-217) Phase 1 Single Dose Clinical Study 01/10/00 S. Prahalada Expert Report on the Pharmacotoxicological Documentation of Alendronate Sodium ­ Weekly Dosing Regimen 02/08/94 Alendronate Sodium Expert Report on the Pharmacotoxicological Documentation 02/16/95 Alendronate Sodium Expert Report on the Pharmacotoxicological Documentation Alendronate Sodium Updated Expert Report on the Pharmacotoxicological Documentation 06/28/96 Alendronate Sodium Updated Expert Report on the Pharmacotoxicological Documentation 08/28/96 Updated Expert Report on the Pharmacotoxicological Documentation of Alendronate Sodium 11/05/97 Updated Expert Report on the Pharmacotoxicological Documentation of Alendronate Sodium 06/23/98 Alendronate Sodium Updated Expert Report 12/04/95 Merck letter to FDA re IND 32,033 FosamaxTM (MK-0217) (Oral Alendronate Sodium) IND 31,775: OnclastTM (MK-0217) (I.V. Alendronate Sodium) ­ Information Amendment ­ Clinical 01/17/95 Merck letter to FDA re IND 32,033: Fosamax (Alendronate Sodium) 02/28/95 Merck letter to FDA re IND 32,033: Fosamax (Alendronate Sodium) Postmenopausal Osteoporosis Recent Clinical Advances (1999)

Other Designation MK 0080527-0080585 MK 0384834-0384875 MK 0384876-0384915 MK 0384916-0384946 MK 0384947-0384950 MK 0384951-0384954 MK 0384955-0384959 MK 0384960-0384967 MK 0384968-0384974 MK 0147476-0147556

Admitted

Teva USA's Objections and Basis Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay

Rule 402, 802 402, 802

126. 127. 128. 129. 130. 131. 132. 133.

402, 802 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802

134. 135. 136.

MK 0073319-0073345 MK 0073286-0073318 MK 0357844-0357885

Relevance, hearsay Relevance, hearsay Relevance, hearsay

402, 802 402, 802 402, 802

12

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Trial Exhibit No.
137. 138. 139. 140. 141. 142. 143. 144. 145. 146. 147. 148.

Description Mosaic Study #23 Osteoporosis, (Nov. 2000) Fosamax® Launch Dates for 5 mg, 10 mg, 35 mg, 40 mg and 70 mg Merck's Fosamax® (Alendronate Sodium Tablets) Package Insert, pp. 1-22 from FDA's website Chart ­ Fosamax QD Total Prescriptions, October 1995 ­ September 2002 IMS Health, "Global Insight" from IMS Health's website Chart ­ Fosamax OW Total Prescriptions, November 2000 ­ September 2002 Chart ­ FAME Products Total Prescriptions, January 1995 ­ September 2002 Chart ­ FAME Products New Prescriptions, January 1995 ­ September 2002 Chart ­ Osteoporosis Franchise Business Group Actual Performance Year to Date as of December (1995-2001) IMS Data, Total Prescription for Fosamax QD (Oct. 1995-Sept. 2002) 02/28/01 Ornskov and Barker memo to Miller re The Launch of Fosamax® Once Weekly in the US Market 10/24/00 Document entitled "Once-Weekly Fosamax (Alendronate) Approved in US for Treatment, Prevention of Postmenopausal Osteoporosis" from FDA's website 05/23/00 Business Plan for Fosamax 2001-2005, USHH Osteoporosis TBG Chart ­ Diffusion Model Estimates Predicted and Actual Cumulative New Prescriptions Chart - Fosamax® Gross Sales 1995:Q1 ­ 2001:Q4

Other Designation MK 0277521-0277713 MK 0391736

Admitted

MK 0391628-0391651 MK 0282265-0282269

Teva USA's Objections and Basis Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay

Rule 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802

149. 150. 151.

MK 0378146-0378194

402, 802 402, 802 402, 802

13

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Trial Exhibit No.
152. 153. 154. 155. 156. 157. 158.

Description Fosamax® Catalog Gross Sales 4Q85 ­ 3Q02 Osteoporosis Franchise Business Group YTD Actual Performance December 1995 Actonel® (risedronate sodium tablets) Package Insert from FDA's website Actonel® Brochure, "The race against osteoporosis is a race against fracture" Document entitled, "Actonel CBD Fundamentals" 05/22/02 Document entitled, "Once-weekly Actonel approved in US", from Merck's website Document entitled, "Information for the Patient, Evista® (E-VISS-tah) Tablets, Generic name: raloxifene hydrochloride" from Lilly's website Information for the Patient Miacalcin® (calcitonin-salmon) Nasal Spray from Novartis website Chart ­ Physician Profile, Fosamax Merck document entitled, "Insight into the `At Risk' segment as compared to the Osteoporotic" segment" 1998 IMS Health Services Manual Chapter 30: National Prescription Audit Plus, NPA Plus Terminology, p. 30-58 Miacalcin® brochure, "In the Treatment of patients with postmenopausal osteoporosis ­ One Therapy meets the needs of many" Mahajan and Peterson, "Models for Innovation Diffusion", Number 07-048

Other Designation MK 0391662 MK 0391652-0391658

Admitted

Teva USA's Objections and Basis Relevance, hearsay Relevance, hearsay Relevance, hearsay

Rule 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802

MK 0357233-0357240 MK 0270177 MK 0351676

Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay

159. 160. 161. 162. 163.

402, 802 402, 802 402, 802 402, 802 402, 802

MK 0355919-0355934 MK 0369607-0369618

MK 0357276-0357277

164.

402, 802

14

Case 1:04-cv-00939-GMS

Document 70-4

Filed 06/28/2006

Page 16 of 40

Trial Exhibit No.
165.

Description Merk documents re Fosamax/Attribute Tracker

Other Designation MK 0369533-0369606 MK 0276089-0276139 MK 0275664-0275676 MK 0391703-0391710

Admitted

Teva USA's Objections and Basis Relevance, hearsay Incomplete, relevance, hearsay Relevance, hearsay Relevance, hearsay

Rule 402, 802

166.

Merk document entitled, "Fosamax® Plan and Expectations 2001" Merck document entitled, "Osteoporosis Product Attributes" Actonel® brochure, "ActionFact Treat your PMO and GIO patients with efficacy you expect and tolerability you can trust" Document entitled, "Worldwide 20-Year Sales Forescast of Fosamax ­ PMO Only ­ Presentation" Document entitled, "Fosamax® Once Weekly Market Opportunity", Christine Kingsbury, April 27, 1999 Document entitled, "Fosamax® Compliance Study", October, 1999 Fosamax® Promotional Spending 1995 ­ 3Q 2002 MMI Custom Study, Actonel Awareness and Usage Tracking Study Post-Launch Wave 3 (August 2000) prepared for Merck & Co., Inc. Charts ­ Fame Gyn Contacts (Jan. 1998 ­ Sept. 2002)

106, 402, 802

167.

402, 802

168.

402, 802

169.

MK 0310263-0310310 MK 0356790-0356875 MK 0356239-0356281 MK 0391664-0391669 MK 0372271-0373192

Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay

402, 802

170.

402, 802

171.

402, 802

172.

402, 802

173.

402, 802

174.

MK 0391681-0391682

Relevance, hearsay

402, 802

15

Case 1:04-cv-00939-GMS

Document 70-4

Filed 06/28/2006

Page 17 of 40

Trial Exhibit No.
175.

Description Fosamax Data ­ Total Prescriptions

Other Designation MK 0391579-0391624 MK 0391564 MK 0384694-0384707 MK 03847080384726

Admitted

Teva USA's Objections and Basis Relevance, hearsay Relevance, hearsay None

Rule 402, 802

176. 177.

Chart ­ TRX Share Chg 05/17/02 License Agreement Among Merck & Co., Inc. & Procter and Gamble Co. 05/17/02 License Agreement Among Merck & Co., Inc. & Procter and Gamble Co. Merck Annual Report 2001 from Merck's website Merck Annual Report 2001, Financial Section, pp. 13-40 10/30/96, NDA 20-560, FosamaxTM (Alendronate Sodium Tablets) Meeting Background Package 1997 (Supplemental A) Fosamax PDR Entry 1997 (Supplemental B) Fosamax PDR Entry Eaton et al., "Chapter 2: Principles of Toxicology", Casarett and Doull's Toxicology ­ The Basic Science of Poisons, 5th Edition, Klaassen Ed., pp. 13-33 (1996) Kikendall et al., "Pill-Induced Esophageal Injury", Digestive Diseases and Sciences, 28:2, 174-182 (1983) Ovartlarnporn et al., "Medication-Induced Esophageal Injury: Report of 17 cases with Endoscopic Documentation", Am J Gastroenterol, 86(6): 748-50 (1991) Bonavina et al., "Drug-induced Esphageal Strictures", Ann. Surg., pp. 173-183 (1987)

402, 802

178. 179. 180. 181. 182. 183. 184.

MK 0250129-0250220

Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay None Relevance, hearsay Relevance, hearsay

402, 802 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802

185. 186.

402, 802

187.

402, 802

16

Case 1:04-cv-00939-GMS

Document 70-4

Filed 06/28/2006

Page 18 of 40

Trial Exhibit No.
188. 189.

Description 07/16/91 Project Team Minutes 09/14/99 InformationDisclosure Statement Under 37 CFR 1.97 (09/376,315)

Other Designation MK 0135838-0135846 MK 0385375-0385380

Admitted

Teva USA's Objections and Basis Relevance, hearsay Relevance, hearsay, identification, incomplete Relevance, hearsay, identification, incomplete Relevance, hearsay, identification, incomplete Relevance, hearsay, identification, incomplete Relevance, hearsay, identification, incomplete Relevance, hearsay, identification, incomplete Relevance, hearsay, identification, incomplete

Rule 402, 802 402, 802, 106, 901

190.

06/01/00 Interview Summary (09/376,315)

MK 0385206

402, 802, 106, 901

191.

06/07/00 Supplemental Information Disclosure Statement Under 37 CFR 1.97 (09/376,315)

MK 0385371-0385374

402, 802, 106, 901

192.

07/07/00 Office Action with attachments (09/376,315)

MK 0385196-0385205

402, 802, 106, 901

193.

08/30/00 Supplemental Information Disclosure Statement Under 37 CFR 1.97 (09/376,315)

MK 0385356-0385359

402, 802, 106, 901

194.

11/02/00 Final Office Action with attachments (09/376,315)

MK 0385188-0385195

402, 802, 106, 901

195.

05/22/01 Office Action (09/376,315)

MK 0385184-0385187

402, 802, 106, 901

17

Case 1:04-cv-00939-GMS

Document 70-4

Filed 06/28/2006

Page 19 of 40

Trial Exhibit No.
196.

Description 04/16/02 Notice of Improper Request for Continued Examination (RCE) (09/376,315)

Other Designation MK 0385172-0385173

Admitted

197.

06/05/02 Supplemental Information Disclosure Statement Under 37 CFR 1.97 with attachments (09/376,315)

MK 0391738-0391980

198.

06/05/02 Response to Final Rejection (09/376,315)

MK 0385228-0385233

199.

08/21/02 USPTO Notice of Recordation of Assignment Document (09/445,837)

MK 0385162-0385166

200.

08/26/02 USPTO Notice of Recordation of Assignment Document (09/445,837)

MK 0385157-0385161

201.

08/26/02 Information Disclosure Statement by Applicant (09/376,315)

MK 0391210-0391212

202.

08/27/02 Notice of Allowance and Issue Fee Due with attachments (09/376,315)

MK 0385168-0385171

203. 204.

MRL Preclinical Report: MK 0217: Esophageal Irritation Studies in Dogs. TT #96-031-0,-1,-2 (Reference Q-1) MRL Preclinical Report: FOSAMAXTM Esophageal Irritation Studies in Dogs. TT #96-038-0,-1 (Reference Q-2)

MK 0257353-0257374 MK 0257375-0257390

Teva USA's Objections and Basis Relevance, hearsay, identification, incomplete Relevance, hearsay, identification, incomplete Relevance, hearsay, identification, incomplete Relevance, hearsay, identification, incomplete Relevance, hearsay, identification, incomplete Relevance, hearsay, identification, incomplete Relevance, hearsay, identification, incomplete Relevance, hearsay Relevance, hearsay

Rule 402, 802, 106, 901

402, 802, 106, 901

402, 802, 106, 901

402, 802, 106, 901

402, 802, 106, 901

402, 802, 106, 901

402, 802, 106, 901

402, 802 402, 802

18

Case 1:04-cv-00939-GMS

Document 70-4

Filed 06/28/2006

Page 20 of 40

Trial Exhibit No.
205. 206. 207. 208.

Description MRL Preclinical Report: MK-0217: Five-Day Esophageal Irritation Study in Dogs. TT #96-039-0 (Reference Q-3) MRL Preclinical Report: MK-0217: Five-Day Esophageal Irritation Study in Dogs. TT #96-041-0 (Reference Q-4) MRL Preclinical Report: MK-0217: Five-Day Esophageal Irritation Study in Dogs. TT #96-045-0 (Reference Q-5) MRL Preclinical Report: MK-0217: Ten-Day Esophageal Irritation Study in Dogs. TT #96-050-0 (Reference Q-6) MRL Preclinical Report: L-689, 532 (Risendronate Sodium): Five-Day Esophageal Irritation Study in Dogs. TT #96-0470,-1 (Reference Q-7) MRL Preclinical Report: MK-0217: Five-Day Esophageal Irritation Study in Dogs. TT #96-118-0 (Reference Q-8) MRL Preclinical Report: MK-0217: Five-Day Esophageal Irritation Study in Dogs. TT #97-007-0 (Reference Q-9) MRL Preclinical Report: MK-0217, L-689, 532, L-615, 614: Five-Week Oral Gastric Irritation Study in Rats. TT #97-009-0 (Reference Q-10) MRL Preclinical Report: L-767, 693, (Tiludronate Sodium): Five-Day Esophageal Irritation Study in Dogs. TT #97-019-0 (Reference Q-11) MRL Preclinical Report: MK-0217: Single-Dose Esophageal Irritation Study in Dogs With 1- and 7-Day Recovery Periods. TT #97-057-0 (Reference Q-12) MRL Preclinical Report: MK-0217: Five-Week Esophageal Irritation Study in Dogs. TT #97-080-0 (Reference Q-13)

Other Designation MK 0257391-0257405 MK 0257406-0257420 MK 0257421-0257435 MK 0257436-0257450 MK 0257451-0257466 MK 0257467-0257482 MK 0257483-0257498 MK 0257499-0257620 MK 0257621-0257636 MK 0257637-0257657 MK 0257658-0257672

Admitted

Teva USA's Objections and Basis Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay

Rule 402, 802 402, 802 402, 802 402, 802

209.

402, 802

210. 211. 212.

402, 802 402, 802 402, 802

213.

402, 802

214.

402, 802

215.

402, 802

19

Case 1:04-cv-00939-GMS

Document 70-4

Filed 06/28/2006

Page 21 of 40

Trial Exhibit No.
216. 217.

Description MRL Preclinical Report: MK-0217: Five-Week Esophageal Irritation Study in Dogs. TT #98-004-0 (Reference Q-14) MRL Preclinical Report: MK-0217/Geranylgeraniol: Five-Day Esophageal Irritation Study in Dogs. TT #98-124-0 (Reference Q-15) 04/19/02 Teva's Response to Merck's First Set of Interrogatories Nos. 1-11 10/04/02 Teva's Response to Merck's Second Set of Interrogatories Nos. 12-50 01/09/03 Teva's Responses to Merck's Supplemental Response to Merck's Interrogatories Nos. 34, 35, 38 and 39 10/04/02 Teva's Response to Merck's First Set of Requests for Admissions Nos. 1-26 10/04/02 Teva's Response to Merck's Second Set of Requests for Admissions Nos. 27-50 11/04/02 Memorandum Opinion, Merck v. Teva and Zenithi, CA Nos. 00-035-JJF and 00-052-JJF, Consolidated Action 12/02/02 Final Judgment Order, Merck v. Teva and Zenith, C.A. Nos. 00-035-JJF and 00-052-JJF, Consolidated Action Merck/Lunar Management Meeting, 05/21/97 ­ Agenda Chart ­ Promotion + CDP, 1995-2002 Actual Profit Plan 2000 Fosamax®, September 9, 1999 Charts ­ Contacts

Other Designation MK 2576763-0257688 MK 0257689-0257704

Admitted

Teva USA's Objections and Basis Relevance, hearsay Relevance, hearsay Relevance Relevance Relevance Relevance Relevance Relevance, hearsay Relevance, hearsay None Relevance, hearsay Relevance, hearsay Relevance, hearsay

Rule 402, 802 402, 802

218. 219. 220. 221. 222. 223. 224. 225. 226. 227. 228.

402 402 402 402 402 402, 802 402, 802

MK 0272085-0272086

402, 802 402, 802 402, 802

MK 02572410275281

20

Case 1:04-cv-00939-GMS

Document 70-4

Filed 06/28/2006

Page 22 of 40

Trial Exhibit No.
229.

Description 01/27/03 Wolfe E-mail to Counihan re once weekly expenses/marketing plan Excerpt from Electronic Orange Book ­ Approved Drugs, from FDA website re Alendronate Sodium Administration on Aging, "Aging Internet Information Notes: Osteoporosis" Administration on Aging, "A Profile of Older Americans: 2001, The Older Population" Excerpt Merck Annual Report 2000 Fosamax Sales Approach $1.3 Billion in 2000 and Keep Climbing National Osteoporosis Foundation, "Osteoporosis: Bone Mass Measurement 07/11/01 Davies and Lewis memo to Jordan re USHH Perspectives on Fosamax and the Osteoporosis Market Environment: 2Q01 Current Situation ­ Competitor Activities Liebman, "Awakening the Silent Osteoporosis Market", Media Marketing & Media, 04/2002 "Yahoo! Health Encyclopedia: Osteoporosis" National Osteoporosis Foundation, "NOF Applauds USPSTF Recommendations on BMD Tests", 09/16/02 Environment, Market Review "NPD Reports Treatment of Osteoporosis Is On the Rise", NPD Press Release, 11/27/00

Other Designation MK 0392082-0392124

Admitted

230. 231. 232. 233. 234. 235.

MK 0270407-0270413 MK 0290024

236. 237. 238. 239. 240. 241.

MK 0226830-0266836

Teva USA's Objections and Basis Incomplete, relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Incomplete, relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay

Rule 106, 402, 802

402, 802 402, 802 402, 802 402, 802 402, 802 106, 402, 802

402, 802 402, 802 402, 802 402, 802 402, 802 402, 802

21

Case 1:04-cv-00939-GMS

Document 70-4

Filed 06/28/2006

Page 23 of 40

Trial Exhibit No.
242.

243. 244. 245. 246.

Description National Osteoporosis Foundation, "New Scientific Advances in Osteoporosis Research Presented at International Meeting", 06/15/00 Merck Annual Report 2000, Financial Section, pp. 21-48 National Osteoporosis Foundation, "Osteoporosis: Men and Osteoporosis" Schorr, "Men at Risk? Osteoporosis Can Also Affect Men; Women's Drug Treatment Can Help" 08/30/02 Fosamax Product Workshop, April 12, 2000, Background Packet, Business Plan for Fosamax®, 2001-2005 Jaret, "What to Tell Patients About HRT", Hippocrates, 14(12) (2000) 09/14/90 FDA letter to Eli Lilly and Co. re advertisement for Evista tablets Damodar Gujarati, Basic Econometrics, 2nd Edition, (New York: McGraw-Hill), 1988, pp. 442-448 James Hilton, Time Series Analysis, (Princeton: Princeton University Press), 1994, pp. 109-112 May, "2001PERQ/HCI Mid-Year Advertising Spending Review: Ad Spending Plummets" Mahajan et al., "New Product Diffusion Models in Marketing: A Review and Directions for Research", Journal of Marketing, pp. 1-26 National Osteoporosis Foundation, "New Study Finds Costs of Treating Osteoporosis Significantly Underestimated" National Osteoporosis Foundation, "America's Bone Health: The State of Osteoporosis and Low Bone Mass" Simon, "Marketing Science's Pilgrimage to the Ivory Tower", Chapter 2 in Gilles Laurent, pp. 27-43 (1994)

Other Designation

Admitted

Teva USA's Objections and Basis Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay None Relevance, hearsay

Rule 402, 802

402, 802 402, 802 402, 802 402, 802

MK 03775090377533

247. 248. 249. 250. 251. 252.

402, 802 402, 802 402, 802 402, 802 402, 802 402, 802

MK 0377035-0377042

253. 254. 255.

402, 802

402, 802

22

Case 1:04-cv-00939-GMS

Document 70-4

Filed 06/28/2006

Page 24 of 40

Trial Exhibit No.
256.

257. 258.

Description Sheth and Sisodia, "Revisiting Marketing's Lawlike Generalizations", Journal of the Academy of Marketing Science, 27(1): p. 76 (1999) Profit Plan 2001 Fosamax®, August 30, 2001 Khoury et al., "Selection and Application of Intellectual Property Valuation Methods in Portfolio Management and Value Extraction", les Nouvelles, 36(3): pp. 77-86 (2001) McGavock et al., "FactorsAffecting Royalty Rates", les Nouvelles, 27(2): pp. 107-116 (1992) Gross, "Actual Royalty Rates in Patient-, Know-Howand Computerprogram-License Agreements", CASRIP Newsletter, Vol. 413 Degnan et al., "A Survey of Licensed Royalties", les Nouvelles, 22(2): pp. 91-96 (1997) Russell, R.G.G. et al., "Clodronate; Etidronate; Pamidronate", Therapeutic Drugs, Vol. 1, Ed. C. Dollery, Publ. Churchill Livingstone (1991) Douglas et al., "Drug Treatment of Primary Hyperparathyroidism: use of clodronate disodium", Clinical Research, British Medical Journal, Vol. 286, pp. 587-590 (1983) Russell et al., "Diphosphonates in Paget's Disease", The Lancet, pp. 894-898 (1974) Papapoulos et al., Bisphosphonates on Bone, Ch. 15, pp. 231245; Ch. 28, pp. 403-418, Bijvoet, Fleisch, Canfield and Russell (eds.), (1995)

Other Designation

Admitted

Teva USA's Objections and Basis Relevance, hearsay Relevance, hearsay Relevance, hearsay None

Rule 402, 802

MK 0377329-0377344

402, 802 402, 802

259.

260.

Relevance, hearsay None Relevance, hearsay Relevance, hearsay

402, 802

261. 262.

402, 802

263.

402, 802

264. 265.

Relevance, hearsay Relevance, hearsay

402, 802 402, 802

23

Case 1:04-cv-00939-GMS

Document 70-4

Filed 06/28/2006

Page 25 of 40

Trial Exhibit No.
266.

Description Russell et al., "Bisphosphonates: Pharmacology, Mechanisms of Action and Clinical Uses", Osteoporosis Int., Suppl. 2:S66S80, pp. 66-80 (1999) Dr. Russell's edits to draft of Dr. Fleisch's book, Section 3.1 Paget's disease Dr. Russell's edits to draft of Dr. Fleisch's book, Section 2.5 Animal toxicology Dr. Russell's edits to draft of Dr. Fleisch's book, Section 3.8 Adverse events Affidavit of Dr. Graham Russell from Canadian case Proctor & Gamble v The Minister of Health and Genpharm. O'Doherty et al., "Paget's Disease of Bone," Current Orthopaedics, pp. 262-269 (1989) Merck's demonstratives from trial in matter of Merck & Co., Inc. v. Teva Pharmaceuticals, USA, Inc., C. A. No. 01-048 (JJF) U. S. Patent No. 6,476,006 Teva PCT Patent Application No. WO 03-057136 Certified copy of U.S. Patent No. 6,432,932 Certified copy of File History of U.S. Patent No. 6,432,932 Certified copy of U.S. Patent No. 6,465,443 Certified copy of File History of U.S. Patent No. 6,465,443 The package insert for Risedronate Sodium Tablets 5, 30 and 35 mg from Teva's Abbreviated New Drug Application No. 77-132

Other Designation

Admitted

Teva USA's Objections and Basis Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Hearsay Hearsay Relevance, hearsay Relevance, hearsay None

Rule 402, 802

267. 268. 269. 270.

402, 802 402, 802 402, 802 402, 802

271. 272.

402, 802 402, 802

273. 274. 275. 276. 277. 278. 279.

402, 802 402, 802 802 802 402, 802 402, 802

TEVA R 0631406345

24

Case 1:04-cv-00939-GMS

Document 70-4

Filed 06/28/2006

Page 26 of 40

Trial Exhibit No.
280.

281.

282. 283. 284. 285. 286.

287.

288.

Description The Opinion of the United States Court of Appeals for the Federal Circuit published as Merck & Co., Inc. v. Teva Pharmaceuticals, USA, 395 F.3d 1364 (Fed. Cir. 2005) The PCT patent application entitled "Use of Certain Methanebisphosphonic Acid Derivatives to Prevent Prosthesis Loosening and Prosthesis Migration." WO 95/30421, with Allen E. Goodship et al as listed inventors U.S. Patent No. 5,869,471 April 1996 Lunar News, "Update: Bisphosphonate" section, p. 31 July 1996 Lunar News, "Update: Bisphosphonate" section, p. 23-24 April 1997 Lunar News, "Update: Bisphosphonate" section, p. 31-33 Delmas PD, Chapuy MC, Vignon E, Charhon S, Briancon D, Alexandre C, Edouard C, and Meunier PJ. Long term effects of dichloromethylene diphosphonate in Paget's disease. Journal of Clinical Endocrinology and Metabolism 1982; 54(4):837-844 Yates AJP, Gray RES, Urwin GH, Preston CJ, Russell RGG, Percival RC, Atkins RM, Harndy NAT, Beneton MNC, and Kanis JA. Intravenous clodronate in the treatment and retreatment of Paget's disease of bone. The Lancet 1985; 1474-1477 Heynen G, Delwaide P, Bijvoet O, and Franchimont P. Clinical and biological effects of low doses of (3-amino-1 hydroxypropylidene)-1, 1-bisphosphonate (APD) in Paget's disease of bone. European Journal of Clinical Investigation 1982; 11:29-35

Other Designation

Admitted

Teva USA's Objections and Basis None

Rule

None

None Incomplete Incomplete Incomplete Relevance, hearsay

106 106 106 402, 802

Relevance, hearsay

402, 802

Relevance, hearsay

402, 802

25

Case 1:04-cv-00939-GMS

Document 70-4

Filed 06/28/2006

Page 27 of 40

Trial Exhibit No.
289.

290.

291.

292.

293. 294.

295.

296.

Description Harinck HIJ, Papapoulos SE, Blanksma HJ, Moolenaar AJ, Vermeij P, and Bijvoet OLM. Paget's disease of bone: early and late responses to three different modes of treatment with aminchydroxypropylidene bisphosphonate (APD). British Medical Journal 1985; 295: 1301-1305 Van Holten-Verzantvoort ATM, Kroon HM, Bijvoet OLM, Cleton FJ, Beex LVAM, Blijham G, Hermans J, Neijt JP, Papapoulos SE, Sleeboom HP, Vermey P, and Zwinderman AH.. Palliative pamidronate treatment in patients with bone metastases from breast cancer. Journal of Clinical Oncology 1993; 11(3): 491-498 Maconi G, and Porro GB. Multiple ulcerative esophagitis caused by alendronate. American Journal of Gastroenterology 1995; 90:1889-1890 Abdelmalek MF, and Douglas DD. Letter to Editor, "Alendronate-Induced Ulcerative Esophagitis." American Journal of Gastroenterology 1996; 91(6): 1282-1283 Sorrentino D. Esophageal ulceration due to alendronate. Endoscopy 1996; 28:529 De Groen PC, Lubbe DF, Hirsch LJ, Daifotis A, Stephenson W, Freedholm D, Pryor-Tillotson S, Seleznick MJ, Pinkas H, and Wang KK. Esophagitis associated with the use of alendronate. The New England Journal of Medicine 1996; 335(14):1016-1021 Castell DO. Letter to Editor, "'Pill Esophagitis' - The Case of Alendronate." The New England Journal of Medicine 1996; 335(14):1058-1059 Naylor G and Davies MH. Letter to Editor, "Oesophageal stricture associated with alendronic acid." The Lancet 1996; 348: 1030-1031

Other Designation

Admitted

Teva USA's Objections and Basis Relevance, hearsay

Rule 402, 802

Relevance, hearsay

402, 802

Relevance, hearsay Relevance, hearsay Relevance, hearsay None

402, 802

402, 802

402, 802

None

Relevance, hearsay

402, 802

26

Case 1:04-cv-00939-GMS

Document 70-4

Filed 06/28/2006

Page 28 of 40

Trial Exhibit No.
297.

298.

299.

300.

301.

302.

303.

304.

Description Rimmer DE and Rawls DE. Letter to the Editor, "Improper Alendronate Administration and a Case of Pill Esophagitis." American Journal of Gastroenterology 1996; 91(12):26482649 Colina RE, et al. A new probable increasing cause of esophageal ulceration: Alendronate. American Journal of Gastroenterology April 1997; 92(4): 704-706 Levine J and Nelson D. Esophageal stricture associated with alendronate therapy. The American Journal of Medicine May 1997; 102:489-491 Girelli CM, Reguzzoni G, and Rocca Francesco. Esophagitis associated with the use of alendronate: report of two cases. Recenti Progressi in Medicina May 1997; 88(5): 223-225 Pizzani E and Valenzuela G. Esophagitis associated with alendronate sodium. Virginia Medical Quarterly Summer 1997; 124(3): 181-182 Lilley LL and Guanci R. Avoiding alendronate-related esophageal irritation. American Journal of Nursing July 1997; 97(7): 12-14 Chesnut CH, McClung MR, Ensrud KE, Bell NH, Genant HK, Harris ST, Singer FR, Stock JL, Yood RA, Delmas PD, Kher U, Pryor-Tillotson S, and Santora AC. Alendronate Treatment of the Postmenopausal Osteoporotic Woman: Effect of Multiple Dosages on Bone Mass and Bone Remodeling. The American Journal of medicine 1995; 99:144-152 Blank MA, Ems BL, Gibson GW, Myers WR, Berman SK, Phipps RJ, and Smith PN. Nonclinical model for assessing gastric effects of bisphosphonates. Digestive Diseases and Sciences February 1997; 42(2): 281-288

Other Designation

Admitted

Teva USA's Objections and Basis Relevance, hearsay

Rule 402, 802

Relevance, hearsay Relevance, hearsay Relevance, hearsay

402, 802

402, 802

402, 802

Relevance, hearsay Relevance, hearsay Relevance, hearsay

402, 802

402, 802

402, 802

Relevance, hearsay

402, 802

27

Case 1:04-cv-00939-GMS

Document 70-4

Filed 06/28/2006

Page 29 of 40

Trial Exhibit No.
305.

306.

307.

308.

309.

310.

311.

Description Khan SA, Vasikaran S, McCloskey EV, Benton MNC, Rogers S, Coulton L, Orgee J, Coombes G, and Kanis JA. Alendronate in the treatment of Paget's disease of bone. Bone 1997; 20(3):263-271 Siris E, Weinstein RS, Altman R, Conte JM, Favus M, Lombardi A, Lyles K, McIlwain H, Murphy WA, Reda C, Rude R, Seton M, Tiegs R, Thompson D, Tucci JR, Yates AJ, and Zimering M. Comparative study of alendronate versus etidronate for the treatment of Paget's disease of bone. Journal of Clinical Endocrinology and Metabolism 1996; 81(3): 961-967 Cassidy KT, Geisinger KR, Kraus BB, and Castell DO. Continuous versus intermittent acid exposure in production of esophagitis in feline model. Digestive Diseases and Sciences 1992; 37(8): 1206-1211 Lanza F, Sahba B, Schwartz H, Winograd S, Torosis J, Quan H, Reyes R, Musliner T, Daifotis A, and Leung A. The upper GI safety and tolerability of oral alendronate at a dose of 70 milligrams once-weekly: a placebo-controlled endoscopy study. The American Journal of Gastroenterology 2002; 97(1): 58-64 Peter CP, Handt LK, and Smith SM. Esophageal irritation due to alendronate sodium tablets: possible mechanisms. Digestive Diseases and Sciences 1998; 43(9):1998-2002 Graham DY. What the gastroenterologist should know about the gastrointestinal safety profiles of bisphosphonates. Digestive Diseases and Sciences 2002; 47(8): 1665-1678 Harinck HIJ, Bijvoet OLM, Blanksma HJ, and DahlinghausNienhuys PJ. Efficacious management with aminobisphosphonate (APD) in Paget's disease of bone. Clinical Orthopedics and Related Research 1987; 217:79-98

Other Designation

Admitted

Teva USA's Objections and Basis None

Rule

None

Relevance, hearsay

402, 802

Relevance, hearsay

402, 802

Relevance, hearsay Relevance, hearsay Relevance, hearsay

402, 802

402, 802

402, 802

28

Case 1:04-cv-00939-GMS

Document 70-4

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Page 30 of 40

Trial Exhibit No.
312.

313.

314.

315.

316.

317.

318.

319.

Description Adami S, Mian M, Gatti P, Rossini M, Zamberlan N, Bertoldo F, and Lo Cascio V. Effects of two oral doses of alendronate in the treatment of Paget's disease of bone. Bone 1994; 15(4): 415-417 Lufkin EG, Argueta R, Whitaker MD, Cameron AL, Wong VH, Egan KS, O'Fallon WM, Riggs BL. Pamidronate: an unrecognized problem in gastrointestinal tolerability. Osteoporosis International 1994; 4:320-322 Spivacow R, Roldan EJA, Zanetti D, Piccinni E, and Zanchetta JR. Digestive tolerance of oral bisphosphonates in patients with osteoporosis and other medical osteopathies. Medicina 1997; 57 (Supplement 1):114-118 Eggelmeijer F, Papapoulos SE, van Paassen HC, Dijkmans BAC, Valkema R, Westedt ML, Landman JO, Pauwels EKJ, and Breedveld FC. Increased bone mass with pamidronate in rheumatoid arthritis. Arthritis & Rheumatism 1996; 39(3):396402 Nightingale SL. From the FDA: "Important Information Regarding Alendronate Adverse Reactions." Journal of the American Medical Association 1996; 275(20): 1534 Graham DY, Malaty HM, and Goodgame R. Primary aminobisphosphonates: a new class of gastrotoxic drugs-comparison of alendronate and aspirin. The American Journal of Gastroenterology 1997; 92(8): 1322-1325 Kelly R and Taggart H. Letter to the editor, "Incidence of gastrointestinal side effects due to alendronate in clinical practice is high." British Medical Journal 1997; 315:1235 Cameron RB. Esophagitis dissecans superficialis and alendronate: case report. Gastrointestinal Endoscopy 1997; 46(6):562-563

Other Designation

Admitted

Teva USA's Objections and Basis Relevance, hearsay

Rule 402, 802

Relevance, hearsay

402, 802

Relevance, hearsay

402, 802

Relevance, hearsay

402, 802

Relevance, hearsay Relevance, hearsay

402, 802

402, 802

Relevance, hearsay Relevance, hearsay

402, 802

402, 802

29

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Trial Exhibit No.
320.

321.

322.

323.

324.

325.

326.

327.

328.

Description Abraham SC, Cruz-Correa M, Lee LA, Yardley JH, and Wu TT. Alendronateassociated esophageal injury: pathologic and endoscopic features. Modern Pathology 1999; 12(12):1152-1157 Anonymous. Oesophageal reactions with alendronate sodium (Fosamax). Current Problems in Pharmacovigilance 1996; 22:5 Hodsman A, Adachi J, and Olszynski W. Use of bisphosphonates in the treatment of osteoporosis. Can Med Assoc J 1996; 155(7):945-948 Valentin-Opran A. Risedronate: Preliminary Results of a Pharmacologic Study in Pagetic Patients. J. Bone Mineral Research 1990; 5:s119 (suppl. 2; abstr. 182) Khairi MRA, Altman RD, DeRosa GP, Zimmermann J, Schenk RK, and Johnston CC. Sodium etidronate in the treatment of Paget's disease of bone. Annals of Internal Medicine 1977; 87: 656-663 Kanis JA and Gray RES. Long-term follow-up observations on treatment in Paget's disease of bone. Clinical Orthopedics and Related Research 1987; 217: 99-125 Peter CP, Kindt MV, and Majka JA. Comparative study of potential for bisphosphonates to damage gastric mucosa of rats. Digestive Diseases and Sciences 1998; 43(5): 10091015 Ibbertson HK, Henley JW, Fraser TR, Tait B, Stephens EJ, and Scott DJ. Paget's disease of bone--clinical evaluation and treatment with diphosphonate. New Zealand Journal of Medicine 1979; 9:31-35 Brown JP, Kylstra JW, Bekker PJ, Axelrod DW, Siris ES, Altman RD, and Singer FR. Risedronate in Paget's disease: Preliminary Results of a Multicenter Study. Seminars in Arthritis and Rheumatism 1994; 23(4): 272

Other Designation

Admitted

Teva USA's Objections and Basis Relevance, hearsay

Rule 402, 802

Relevance, hearsay Relevance, hearsay None

402, 802

402, 802

Relevance, hearsay

402, 802

Relevance, hearsay None

402, 802

Relevance, hearsay

402, 802

None

30

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Trial Exhibit No.
329. 330. 331.

332.

333.

334.

335. 336. 337. 338. 339. 340. 341.

Description ACTONEL® product insert downloaded from www.actonel.com Frost & Sullivan, "U.S. Emerging Osteoporosis Therapeutics Markets", 2002 Actonel (risendronate sodium tablets) Product Information http.//ww.fda.gov/cder/foi/label/2004/20835slr014_actonel _lbl.pdf, pp. 25-26, last accessed March 1, 2006 Actonel Press Release: U.S. FDA Approves Actonel Plus Calcium (http://www.actonel.com/pressrelease/fda/jsp, last accessed March 1, 2006 Actonel (risendronate sodium tablets) Product Information http.//ww.fda.gov/cder/foi/label/2004/20835slr014_actonel _lbl.pdf http://ww.imshealth.com/ims/portal/front/indexC/0,2478.65 99_1825,00.htm, last accessed March 1, 2006--IMS Health Company Information Proprietary Data IMS Health Presentation re: Customer Marketing Plans Actonel Presentation "The race against osteoporosis is a race against fracture" Chart: Fosamax Total Prescriptions Oct. 1995 to Nov. 2005, Monthly http.//ww.fda.gov/cder/foi/label/2005/020560s038_021575s 007lbl.pdf, pp. 1, 21, last accessed February 12, 2006 Proprietary Data of IMS Health http://www.prnewsire.com/cgibin/micro_stories.pl?ACCT=103068&TICK=PDII&STOR Y=/www/story/10-022001/0001583646&EDATE=Oct+2._2001, last accessed March 1, 2006---Investor Relations-Press Releases

Other Designation

Admitted

Teva USA's Objections and Basis None Relevance, hearsay None

Rule

PGK00014545 ­ PGK00014712

402, 802

Relevance, hearsay Relevance, hearsay Relevance, hearsay MK 09349960935004 PGK00024172 ­ PGK00024221 PGK00015641 ­ PGK00015645 Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay

402, 802

402, 802

402, 802

402, 802 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802

MK 09349870935004

31

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Trial Exhibit No.
342. 343.

Description U.S. Osteoporosis Market History 08/30/00 http://www.evista.com/understand_evista/how_to_take.jsp? reqNavId=1.2.1, last accessed March 1, 2006--"Understanding Evista" http://www.pharma.us.novartis.com/product/pi/pdf/miacalc in_nasal.pdf, last accessed March 1, 2006 "FFABME" Osteoporosis Pharmaceutical Prescriptions Total Prescriptions, January 1995-November 2005, Monthly http://www.fda.gov/cder/foi/label/2002/21318_forteo_lbl.p df -- Actonel Production Information http://www.rxlist.com/cgi/generic3/forteo_pui.htm, last accessed March 1, 2006---Patient Information-Medication Guide http.//ww.fda.gov/cder/foi/label/2003/21455_boniva_lbl.pd f,, last accessed February 16, 2006 http://www.fda.gov.cder.rdmt.ESCY05AP.htm, last accessed February 16, 2006 Actonel Consultancy Panel Feedback Summary Report Actonel 2001-2014 Forecasts 03/09/2001 04/25/1995 Memo re: Risedronate Business Opportunity Actonel US Launch Plan 2000 Memo re: Risedronate Business Strategy 07/10/95 Health care Initiative Tracking 04/16/2002 P&G Pharmaceuticals Memo re: Actonel U.S. Business Review-Launch Results 05/00-11/00

Other Designation PGK00015235 ­ PGK00015240

Admitted

Teva USA's Objections and Basis Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay

Rule 402, 802 402, 802

344. 345.

402, 802 402, 802

346. 347.

402, 802 402, 802

348. 349. 350. 351. 352. 353. 354. 355. 356.

402, 802 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802

PGK00024547 ­ PGK00024560 PGK00004188 ­ PGK00004218 PGK00009389 ­ PGK00009395 PGK00013806 ­ PGK00013812 PGK00009396 ­ PGK00009403 PGK00009552 ­ PGK00009556 PGK00023999 ­ PGK00024003

32

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Trial Exhibit No.
357. 358.

Description P&G Pharmaceuticals-Quarterly Letter-OND'00 Actonel n the Osteoporosis Market Key Results from Ongoing Launch Tracking Research Wave 5 Physpulse TM 08/07/2001 Italy Meeting Fosamax 70mg effect (05/23/01) Market Overview w/notes Actonel 2002-2014 Forecasts 05/20/02 Actonel Marketing Plan Agenda P&G Aventis Slide NABU CI Monthly Letter October 2001 10/31/2001 License Agreement Among Merck & Co., Inc., and The P&G Company "Pharmaceuticals ­ Monthly Letter", August '03, 09/04/2003 "Pharmaceuticals ­ Monthly Letter", February '03, 03/05/2003 "Pharmaceuticals ­ Monthly Letter", April '04, 05/05/2004, p. 1 "Actonel 2003-2014 Forecasts", 06/17/2003 "Actonel Business Update: Global Product Supply Committee", 07/13/2004 "Actonel Business Update: Global Product Supply Committee", 07/13/2004, p. 30 "U.S. Launch Tracking," 05/28/2001 p.11

Other Designation PGK00004115 ­ PGK00004119 PGK00015090 ­ PGK00015152 PGK00014149 ­ PGK00014229 PGK00013225 ­ PGK00013232 PGK00017605 ­ PGK00017638 PGK00013626 ­ PGK00013714 PGK00013453 ­ PGK00013526 PGK00009814 ­ PGK00009816 MK 0384741-759 PGK00025691 PGK00025694 PGK00025437

Admitted

Teva USA's Objections and Basis Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay None Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay

Rule 402, 802 402, 802

359. 360. 361. 362. 363. 364. 365. 366. 367. 368. 369. 370. 371. 372.

402, 802 402, 802 402, 802 402, 802 402, 802 402, 802

402, 802 402, 802 402, 802 402, 802 402, 802 402, 802 402, 802

PGK0025069 PGK00025603

33

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Trial Exhibit No.
373.

374. 375. 376. 377. 378. 379. 380. 381. 382. 383. 384. 385.

Description Vijay Mahajan, Eitan Muller, and Yoram Wind, eds., New-Product Diffusion Models, Kluwer Academic Publishers, 2000 DRAFT US Professional Marketing Plan Recommendation 2001 ­ 2002 http://www.pg.com/annualreports/2005/pdf/pg2005annualr eport.pdf, last accessed February 14, 2006 Expert Report and exhibits of Dr. Socrates E. Papapoulos 01/31/06 Expert Report and exhibits of Dr. Socrates E. Papapoulos on Validity ­ 03/01/06 Expert Report and exhibits of M. Brian Fennerty, M.D. ­ 03/01/06 Expert Report and exhibits of Jesse David, PhD - 04/06/06 Expert Report and exhibits of Christopher A. Vellturo, PhD ­ 03/01/06 Curriculum Vitae of M. Brian Fennerty, MD Curriculum Vitae of Dr. Socrates E. Papapoulos Curriculum Vitae of Christopher A. Vellturo, PhD Article: Bisphosphonates in Bone Disease From the Laboratory to the Patient Article: Restoring and Maintaining Bone in Osteopenic Female Rat Skeleton: I. Changes in Bone Mass and Structure 1992 Article: Extra Cancellous Bone Induced by Combined Prostaglandin E2 and Risedronate Administration is Maintained after Their Withdrawal in Older Female Rats 1995

Other Designation

Admitted

Teva USA's Objections and Basis None

Rule

PGK00015307 ­ PGK00015318

PDX 2 PDX 3

Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay None Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay Relevance, hearsay None

402, 802 402, 802 402, 802 402, 802 402, 802

402, 802 402, 802 402, 802 402, 802 402, 802

386.

PDX 4

None

34

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Trial Exhibit No.
387.

388. 389. 390. 391.

392. 393. 394. 395. 396.

397.

398. 399. 400. 401. 402.

Description Article: Partial Maintenance of Extra Cancellous Bone Mass by Antiresorptive Agents After Discontinuation of Human Parathyroid Hormone (1-38) in Right Hindlimb Immobilized Rats 1995 Article: The Bisphosphonate Alendronate (MK-217) Inhibits Bone Loss Due to Ovariectomy in Rats 1991 US Patent No. 5,730,715 US Patent No. 5,869,471 Article: Alendronate Treatment of the Postmenopausal Osteoporotic Woman: Effect of Multiple Dosages on Bone Mass and Bone Remodeling 08/1995 Article: Multiple Ulcerative Esophagitis Caused by Alendronate 10/1995 De Groen Article: Esophagitis Associated With The Use of Alendronate 10/03/1996 Article in Lunar News: 04/1996 Article in Lunar News: 07/1996 2001 Program and Abstract for the 23rd Annual Meeting of the American Society for Bone and Mineral Research 10/1216/2001 2001 Program and Abstract for the 23rd Annual Meeting of the American Society for Bone and Mineral Research 10/1216/2001 Letter to the Editor in New England Journal of Medicine Article in New England Journal of Medicine: "Pill Esophagitis" ­ The Case of Alendronate 10/03/1996 Fosamax Package Insert Physician's Desk Reference 2002 Provisional Application of Patent for Method of Increasing Bioavailability of Alendronate or Other Biphosphonates by Predose Administration of Alfacalcidol, 12/16/2002

Other Designation PDX 5

Admitted

Teva USA's Objections and Basis None

Rule

PDX 6 PDX 7 PDX 8 PDX 9

None None None Relevance, hearsay Relevance, hearsay None None None Relevance

402, 802

PDX 10 PDX 11 PDX 12 PDX 13 PDX 15

402, 802

402

PDX 16

Relevance

402

PDX 21 PDX 22 PDX 23 PDX 24 PDX 25

None None Relevance, hearsay None Relevance 402, 802

402

35

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Trial Exhibit No.
403. 404.

405. 406. 407. 408. 409. 410.

411.

412.

413.

Description Teva's ANDA 77-132 Risedronate Sodium Tablets, 5 mg, 30 mg, and 35 mg Teva's ANDA 77-132 Risedronate Sodium Tablets, 5 mg, 30 mg, and 35 mg AMENDMENT ­ Response to August 26, 2004 Review Letter and Addition of 35 mg Blister Package 07/20/05 Teva's Responses to Merck's First Requests for Admissions (1-27) 07/20/05 Teva's Responses to Merck's First Set of Interrogatories (1-36) 5/25/05 Teva's Response and Objections to Merck's First Set of Requests for the Production of Documents and Things (1-85) June 2, 2006 Transcript of Telephonic Hearing before Judge Sleet Merck & Co., Inc. v. Teva Pharmaceuticals USA, Inc., 288 F Supp 2d 601 (D.Del 2003) Teva Pharmaceuticals USA, Inc.'s Post-Trial Brief, Merck & Co., Inc. v. Teva Pharmaceuticals USA, Inc., C.A. No. 01-048 (JJF), March 28, 2003 Teva Pharmaceuticals USA, Inc.'s Post-Trial Reply Brief, Merck & Co., Inc. v. Teva Pharmaceuticals USA, Inc., C.A. No. 01-048 (JJF), April 11, 2003 Brief for Defendant-Appellant Teva Pharmaceuticals USA, Inc., Merck & Co., Inc. v. Teva Pharmaceuticals USA, Inc., Appeal No. 04-1005 in the United States Court of Appeals for the Federal Circuit, December 17, 2003 Reply Brief for Defendant-Appellant Teva Pharmaceuticals USA, Inc., Merck & Co., Inc. v. Teva Pharmaceuticals USA, Inc., Appeal No. 04-1005 in the United States Court of Appeals for the Federal Circuit, April 15, 2004

Other Designation

Admitted

Teva USA's Objections and Basis None None

Rule

Relevance Relevance Relevance R