Free Proposed Pretrial Order - District Court of Delaware - Delaware

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 1 of 289

EXHIBIT 1

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 2 of 289

EXHIBIT 1 JOINT STATEMENT OF UNCONTESTED FACTS 1. Plaintiff Merck & Co., Inc. ("Merck") is a corporation incorporated under the

laws of the State of New Jersey, with its principal place of business at One Merck Drive, Whitehouse Station, NJ 08889. 2. Defendant Teva Pharmaceuticals USA, Inc. ("Teva USA") is a corporation

incorporated under the laws of the State of Delaware, with its principal place of business at 650 Cathill Road, Sellersville, PA. 3. was issued. 4. 5. issued. 6. 7. Merck is the owner of the `932 patent. Teva USA has filed Abbreviated New Drug Application ("ANDA") No. 77-132, Merck is the owner of the `329 patent. On August 13, 2002, United States Patent No. 6,432,932 ("the `932 patent") was On November 30, 1999, United States Patent No. 5,994,329 ("the `329 patent")

including a certification under Title 21, United States Code § 355(j)(2) with the Food and Drug Administration ("FDA") for tablets containing 35 mg of risedronate sodium. 8. Teva stipulates for the purposes of this trial that the commercial marketing of

Teva USA's proposed 35 mg risedronate sodium tablets, in accordance with ANDA No. 77-132, would infringe claims 20 and 34 of the `329 patent if those claims are valid. 9. 10. The date of invention for claims 20 and 34 of the `329 patent is July 22, 1997. The April and July 1996 Lunar News are prior art publications to the Merck

patents under 35 U.S.C. § 102(a).

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 3 of 289

11.

As set forth by the Federal Circuit in Merck & Co. v. Teva Pharmaceuticals USA,

Inc., 395 F.3d 1364, 1372 (2005), the claim term "about" in the `329 and `932 patents should be given its ordinary meaning of "approximately." 12. 21, 1999. 13. The date on which patients were first administered risedronate on a weekly Procter & Gamble administered weekly doses of risedronate to patients on May

dosage regimen in Procter & Gamble Study No. 1999033 is May 21, 1999. 14. The date on which patients were first administered risedronate on a weekly

dosage regimen in Procter & Gamble Study No. HMR4003E/3001 is September 23, 1999.

STATEMENT OF FACTS THAT TEVA USA CONTENDS SHOULD BE UNCONTESTED Teva USA contends that the following statements of fact cannot in good faith be contested: 1. The history of bisphosphonates as a class is minimally relevant to an analysis of

the obviousness of a once-weekly dose of risedronate with respect to side effects because each bisphosphonate possesses unique characteristics. Merck & Co., Inc. v. Teva Pharmaceuticals USA, Inc., 288 F. Supp. 2d 601, 626 (D. Del. 2003) ("Merck I"). 2. Lunar News was a quarterly newsletter distributed to approximately 15,000 to

20,000 physicians and others working in the field of osteoporosis by Lunar Corporation, a manufacturer of bone densitometry equipment used to diagnose osteoporosis. Merck & Co., Inc. v. Teva Pharmaceuticals USA, Inc., 395 F.3d 1364, 1368 n.5 (Fed. Cir. 2005) ("Merck II"). 3. The Lunar News articles were authored by Dr. Richard Mazess, who was the

director of the Bone Mineral Laboratory at the University of Wisconsin. Dr. Mazess established

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 4 of 289

bone densitometry as a diagnostic tool, founded the first manufacturer of bone densitometry measuring equipment (Lunar), was Lunar's first president, has participated in and designed clinical trials for osteoporosis treatment, and is widely published in the bone disease field. Id. 4. Dr. Mazess was a person working in the field of, or doing research on,

osteoporosis, and so he is skilled in the relevant art. Id. at 1376. 5. 6. Dr. Mazess was an expert in osteoporosis. Id. The April 1996 and July 1996 Lunar News articles suggested the weekly dosing

of bisphosphonates to improve patient compliance with the dosing regimen. Id. at 1368, 1375. 7. The '329 patent and both the April and July 1996 Lunar News articles explain the

motivation for a once-weekly dose as increasing patient compliance, by making it easier to take the drug (and incur the inconvenience of the rigorous dosing regimen less frequently). Id. at 1373. 8. The literature, specifically the October 1996 article by De Groen published in the

New England Journal of Medicine, taught that complications related to alendronate were due to prolonged contact of the drug with the esophagus. Id.; Merck I at 627. 9. In response to reports of adverse GI events with alendronate, Merck revised its

dosing instructions for FOSAMAX® and distributed a "Dear Doctor" letter to physicians. Merck II at 1373. 10. After Merck sent the "Dear Doctor" letter, the reported incidence of

complications with alendronate fell to almost nothing even as the number of patients being prescribed FOSAMAX® doubled by October 1996. Id.

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 5 of 289

11.

The '329 patent, both Lunar News articles, and the prevailing knowledge of those

skilled in the art recognized that taking fewer pills each week could reduce the adverse GI events with alendronate. Id. at 1373-74. 12. The '329 patent provides no motivation to overcome adverse GI events beyond

that provided by the April and July 1996 Lunar News articles. Id. at 1373. 13. The '329 patent provides no data showing the safety and tolerability of the

claimed invention beyond the teachings set forth in the April and July 1996 Lunar News articles. Id. at 1374. 14. Financial success is not significantly probative of the question of nonobviousness

because others were legally barred from commercially testing the Lunar News ideas. Id. at 1377. 15. The July 1996 issue of Lunar News was not cited by the Patent Examiner during

prosecution of the '329 patent, nor was it disclosed to the Patent Examiner by Merck. 16. The July 1996 issue of Lunar News is more relevant than any of the references

cited by the Patent Examiner during the prosecution of the '329 patent.

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 6 of 289

EXHIBIT 2

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 7 of 289

EXHIBIT 2 PLAINTIFF MERCK'S STATEMENT OF CONTESTED ISSUES OF FACT AND LAW

I. A.

MERCK'S STATEMENT OF CONTESTED ISSUES OF FACT INFRINGEMENT 1. Whether Teva's filing of ANDA No. 77-132 for tablets containing 35 mg of

risedronate sodium infringes claim 6 of the `932 patent. B. INVALIDITY UNDER SECTIONS 102 AND 103 1. 2. 3. 4. 5. 6. Whether the `329 patent is anticipated in light of the prior art cited by Teva. Whether the `932 patent is anticipated in light of the prior art cited by Teva. The scope and content of the prior art. The differences between the prior art and the claims of the `329 and `932 patents. The level of ordinary skill in the art at the time the invention was made. Whether there was any reason, suggestion or motivation found in the prior art

directing a person of ordinary skill in the art to combine the references relied on by Teva at the time of the invention. 7. Whether products covered by the claims of the `329 and '932 patents have been

commercially successful. 8. Whether there is a nexus between the merits of the subject matter claimed in the

`329 and '932 patents and any commercial success of that subject matter. 9. Whether the inventions claimed in the `329 and `932 patents satisfied a long-felt

need in the industry.

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 8 of 289

10. patents. 11. others. 12. results. 13.

Whether others failed to make the inventions claimed in the `329 and `932

Whether the inventions claimed in the `329 and `932 patents were copied by

Whether the inventions claimed in the `329 and `932 patents achieved unexpected

Whether the inventions claimed in the `329 and `932 patents received praise from

the defendant and others in the field. 14. Whether there is any connection between any of the above factors and the

inventions claimed in the `329 and `932 patents. 15. Whether the subject matter claimed in the `329 and `932 patents would have been

obvious to one of ordinary skill in the art at the time the invention was made.

II. A.

MERCK'S STATEMENT OF CONTESTED ISSUES OF LAW INFRINGEMENT 1. The construction of claim 6 of the `932 patent.

Markman v. Westview

Instruments, Inc., 517 U.S. 370 (1996). 2. Whether Teva's submission of an ANDA related to 35 mg risedronate sodium

tablets infringes claim 6 of the `932 patent. 35 U.S.C. § 271(e)(2); Abbott Labs. v. Torpharm, Inc., 300 F.3d 1367 (Fed. Cir. 2002); Bayer AG v. Elan Pharmaceutical Research Corp., 212 F.3d 1241 (Fed. Cir.), cert. denied, 531 U.S. 993 (2000). 3. Whether Teva's filing of an ANDA for 35 mg risedronate sodium tablets

constitutes inducement of infringement of claim 6 of the `932 patent. 35 U.S.C. § 271; Zenith Laboratories, Inc. v. Bristol-Myers Squibb Co., 19 F.3d 1418 (Fed. Cir.), cert. denied, 513 U.S.

2

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 9 of 289

995 (1994); Hewlett-Packard Co. v. Bausch & Lomb, Inc., 909 F.2d 1464, 1468-70 (Fed. Cir. 1990). 4. Whether Teva's filing of an ANDA for 35 mg risedronate sodium tablets

constitutes contributory infringement of claim 6 of the `932 patent. 35 U.S.C. § 271; Aro Manufacturing Co. v. Convertible Top Replacement Co., 377 U.S. 476 (1964). B. VALIDITY 1. Whether Teva has shown by clear and convincing evidence that the `329 patent is

anticipated by the prior art. 35 U.S.C. § 102; Union Carbide Chemicals & Plastics Tech. Corp. v. Shell Oil Co., 308 F.3d 1167 (Fed. Cir. 2002); Purdue Pharma L.P. v. Boehringer Ingelheim GMBH, 237 F.3d 1359 (Fed. Cir. 2001); Bristol-Meyers Squibb Co. v. Ben Venue Labs., 246 F.3d 1368 (Fed. Cir. 2001); Helifix Ltd. v. Blok-Lok, Ltd., 208 F.3d 1339 (Fed. Cir. 2000). B. Whether Teva has shown by clear and convincing evidence that the `932 patent is

anticipated by the prior art. 35 U.S.C. § 102; Union Carbide Chemicals & Plastics Tech. Corp. v. Shell Oil Co., 308 F.3d 1167 (Fed. Cir. 2002); Purdue Pharma L.P. v. Boehringer Ingelheim GMBH, 237 F.3d 1359 (Fed. Cir. 2001); Bristol-Meyers Squibb Co. v. Ben Venue Labs., 246 F.3d 1368 (Fed. Cir. 2001); Helifix Ltd. v. Blok-Lok, Ltd., 208 F.3d 1339 (Fed. Cir. 2000). C. Whether Teva has shown by clear and convincing evidence that the `329 patent

would have been obvious to one of ordinary skill in the art at the time the invention was made. 35 U.S.C. § 103(a). Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120 (Fed. Cir. 2000); Graham v. John Deere Co., 383 U.S. 1 (1966).

3

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 10 of 289

D.

Whether Teva has shown by clear and convincing evidence that the `932 patent

would have been obvious to one of ordinary skill in the art at the time the invention was made. 35 U.S.C. § 103(a). Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120 (Fed. Cir. 2000); Graham v. John Deere Co., 383 U.S. 1 (1966). * * *

If any statement included herein as an issue of law properly should be considered an issue of fact, it should be so considered.

TEVA PHARMACEUTICALS USA, INC.'S STATEMENT OF CONTESTED ISSUES OF FACT AND LAW

I.

ISSUES OF FACT REMAINING TO BE LITIGATED The following issues of fact remain to be litigated in this matter: A. INFRINGEMENT

Whether Teva Pharmaceuticals USA, Inc.'s ("Teva USA") filing of ANDA 77-132 for approval to market tablets containing 35 mg of risedronate sodium infringes U.S. Patent No. 6,432,932 ("the `932 patent").

B.

INVALIDITY BASED ON ANTICIPATION

Whether U.S. Patent No. 5,869,471 anticipates claims 20 and 34 of U.S. Patent No. 5,994,329 ("the `329 patent"). Whether clinical trials planned and conducted by The Procter & Gamble Co. anticipate claim 6 of the `932 patent.

4

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 11 of 289

C.

INVALIDITY BASED ON OBVIOUSNESS

In deciding whether the asserted claims of the `329 and `932 patents are obvious in view of the prior art, the Court must make the following factual determinations: 1. 2. The scope and content of the prior art; The differences between the prior art and the inventions claimed in the `329 and

`932 patents; and 3. The level of ordinary skill in the art to which the inventions pertain.

II.

ISSUES OF LAW REMAINING TO BE LITIGATED A. INFRINGEMENT Whether Teva USA's submission of ANDA 77-132 infringes the `932 patent under 35

U.S.C. § 271(e)(2). B. INVALIDITY

1. Invalidity under 35 U.S.C. § 102 Whether claims 20 and 34 of the `329 patent are invalid under 35 U.S.C. § 102 because the claimed invention was described in a printed publication either more than one year before the filing of the application for the `329 patent (35 U.S.C. § 102(b)), or before the invention thereof (35 U.S.C. § 102(a)). In re Cruciferous Sprout Patent Litigation, 301 F.3d 1343, 1349 (Fed.

Cir. 2002); Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1379-80 (Fed. Cir. 2001); Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999); Continental Can Co. USA, Inc. v. Monsanto Co., 948 F.2d 1264, 1267 (Fed. Cir. 1991); In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985); U-Fuel, Inc. (NV) v. Highland Tank & Mfg Co., Inc., 228 F. Supp. 2d 595, 607 (E.D. Pa. 2002); In re `639 Patent Litigation, 154 F. Supp. 2d 157, 172 (D. Mass. 2001).

5

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 12 of 289

Whether claim 6 of the `932 patent is invalid under 35 U.S.C. § 102 because the claimed invention was made by another in the United States before the patentee and not abandoned, suppressed, or concealed. 35 U.S.C. § 102(g); Corona Cord Tire Co. v. Dovan Chem. Corp., 276 U.S. 358 (1928); Monsanto Co. v. Mycogen Plant Science, Inc., 261 F.3d 1356, 1362 (Fed. Cir. 2001); Sandt Technology, Ltd. v. Resco Metal and Plastics Corp., 264 F. 3d 1344, 1350 (Fed. Cir. 2001); Texas Instruments Inc. v. U.S. Int'l Trade Comm'n, 988 F.2d 1165, 1177 (Fed. Cir. 1993); Kimberly-Clark Corp. v. Procter & Gamble Distributing Co., Inc., 973 F.2d 911, 915 (Fed. Cir. 1992); New Idea Farm Equip. Corp. v. Sperry Corp., 916 F.2d 1561, 1566 (Fed. Cir. 1990). 2. Invalidity under 35 U.S.C. § 103 Whether claims 20 and 34 of the `329 patent are invalid under 35 U.S.C. § 103 because the differences between the subject matter of the claims and the prior art are such that the subject matter as a whole would have been obvious to a person of ordinary skill in the art at the time the alleged inventions were made. Graham v. John Deere Co., 383 U.S. 1, 3 (1966); Merck & Co. v. Teva Pharmaceuticals, USA, Inc., 395 F.3d 1364, 1372 (Fed. Cir. 2005); Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1351 (Fed. Cir. 2003); Abbott Laboratories v.

Dey, L.P., 287 F.3d 1097, 1106 (Fed. Cir. 2002); In re Kotzab, 217 F.3d 1365, 1369 (Fed. Cir. 2000); Symbol Tech., Inc., v. Opticon, Inc., 935 F.2d 1569, 1576-77 (Fed. Cir. 1991); In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990) (en banc); In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Whether claim 6 of the `932 patent is invalid under 35 U.S.C. § 103 because the differences between the subject matter of the claim and the prior art are such that the subject matter as a whole would have been obvious to a person of ordinary skill in the art at the time the

6

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 13 of 289

alleged inventions were made. Graham, 383 U.S. at 3; Merck & Co., 395 F.3d at 1372; Amgen, Inc., 314 F.3d at 1351; Abbott Laboratories, 287 F.3d at 1106; In re Kotzab, 217 F.3d at 1369; Symbol Tech., Inc., 935 F.2d at 1576-77; In re Dillon, 919 F.2d at 692; In re Merck & Co., 800 F.2d at 1097.

7

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 14 of 289

EXHIBIT 3A

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 15 of 289

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. 17.

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. 06/07/96 Mazess letter to Lindsay, M.D. re PDEXA

Other Designation

Admitted

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 Relevance,

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 MK 0286436

402, 802 402, 802 402, 802

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 16 of 289

Trial Exhibit No.
18. 19.

Description 08/06/96 Mazess letter to Jeremy C. Allen 02/07/97 Mazess letter to Ray Gilmaritn re densitometry 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

Other Designation MK 0272212 -0272213 MK 03344030334436 Mazess 5

Admitted

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

Rule 402, 802 402, 802

20.

402, 802

21.

MK 0272082

22.

23.

MK 02722140272215 MAZ0004-0005

Relevance, hearsay Relevance, hearsay

402, 802

402, 802

24. 25. 26.

GE 00350036 T 0071037105 T 007106

Relevance, hearsay Relevance, hearsay Relevance, hearsay

402, 802 402, 802 402, 802

27. 28. 29.

T 007107-7108 T 007110-7111 T 001102

Relevance, hearsay Relevance, hearsay Relevance, hearsay

402, 802 402, 802 402, 802

- 2 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 17 of 289

Trial Exhibit No.
30.

31.

32. 33. 34. 35.

Description 11/19/98 Ziegenfus memo to Kopp from re Alendronate 10/23/98 A. Mattiuz memo to D. McNichol re Avicel 200 Teva USA: Sales Forecast Alendronate 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

Other Designation T 002470

Admitted

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

Rule 402, 802

T 003307

402, 802

T 002501 T 002482-2485 T 007147

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

36. 37.

402, 802 402, 802

38.

Relevance, hearsay Relevance, hearsay

402, 802

39.

402, 802

40.

T 007148007150 T 007154-

Relevance, hearsay Relevance,

402, 802

41.

402, 802

- 3 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 18 of 289

Trial Exhibit No.
42. 43.

44.

Description 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 02/20/98 Melton E-mail to DiCesare, Santora and Yates re Once a week Fosamax in Prevention of Osteoporosis 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 FOSAMAX® (Aendronate Sodium Tablets) Package Insert, 2000 Chesnut et al.,

Other Designation 007156 T 007475 T 007612007613

Admitted

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

Rule

402, 802 402, 802

45.

46.

47.

48.

MK 02223530222359 MK 02908860290887 MK 03557910355794 MK 01582420158287 MK 0225375

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

402, 802

402, 802

402, 802

402, 802

402, 802

49.

MK 01564200156421

402

50.

Relevance, hearsay

402, 802

51.

Relevance,

402, 802

- 4 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 19 of 289

Trial Exhibit No.

52.

53.

54.

55.

56.

Description "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 (3Amino-1Hydroxypropylidene)-1, 1Bisphosphonate (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. 36:341343 (1984) 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

Other Designation

Admitted

Teva USA's Objections and Basis hearsay

Rule

Relevance, hearsay

402 , 802

Relevance, hearsay

402, 802

Relevance, hearsay

402 , 802

Relevance, hearsay

402, 802

Relevance,

402, 802

- 5 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 20 of 289

Trial Exhibit No.

57.

58.

59.

60.

Description 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: 183192 (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-1hydroxybutylidene-1, 1bisphosphonate (AHBuBP) in the therapy of postmenopausal

Other Designation

Admitted

Teva USA's Objections and Basis hearsay

Rule

Relevance, hearsay

402, 802

Relevance, hearsay

402, 802

Relevance, hearsay

402, 802

Relevance, hearsay

402, 802

- 6 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 21 of 289

Trial Exhibit No.
61.

62.

63.

64.

65.

Description 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) 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)

Other Designation

Admitted

Teva USA's Objections and Basis

Rule

Relevance, hearsay Relevance, hearsay

402, 802

402, 802

Relevance, hearsay

402, 802

Relevance, hearsay

402, 802

Relevance, hearsay

402, 802

- 7 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 22 of 289

Trial Exhibit No.
66. 67.

68.

69.

70.

71.

Description MERCK HAS WITHDRAWN THIS EXHIBIT. PLEASE SEE PTX 313. 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): 14371443 (1995) Maconi et al., "Multiple Ulcerative Esophagitis Caused by Alendronate", American Journal of Gastroenterology, 18891890 (1995) De Groen et al., "Esophagitis Associated with the Use of Alendronate", The New England Journal of Medicine, 335(14): 10161021 (1996) Black et al., "Randomised trial of effect of

Other Designation

Admitted

Teva USA's Objections and Basis

Rule

Relevance, hearsay

402, 802

None

Relevance, hearsay

402, 802

None

None

- 8 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 23 of 289

Trial Exhibit No.

Description 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) 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, "Alendronate-Induced Ulcerative Esophagitis", American Journal of Gastroenterology, 91(6): 1282-1283 (1996) Anonymous. "Oesophageal

Other Designation

Admitted

Teva USA's Objections and Basis

Rule

72.

Relevance, hearsay

402, 802

73.

Relevance, hearsay

402, 802

74.

Relevance, hearsay

402, 802

75.

Relevance, hearsay

402, 802

76.

Relevance,

402, 802

- 9 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 24 of 289

Trial Exhibit No.

77.

78.

79.

80.

81.

Description reactions with alendronate sodium (Fosamax)", Current Problems in Pharmacovigilance, 22: 58 (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

Other Designation

Admitted

Teva USA's Objections and Basis hearsay

Rule

Relevance, hearsay

402, 802

Relevance, hearsay

402, 802

None

Relevance, hearsay

402, 802

Relevance, hearsay

402, 802

- 10 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 25 of 289

Trial Exhibit No.
82.

83. 84.

85.

86.

87.

Description 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) MERCK HAS WITHDRAWN THIS EXHIBIT. PLEASE SEE PTX 304. 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",

Other Designation

Admitted

Teva USA's Objections and Basis

Rule

Relevance, hearsay

402, 802

Relevance, hearsay

402, 802

Relevance, hearsay

402, 802

Relevance, hearsay

402, 802

Relevance, hearsay

402, 802

- 11 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 26 of 289

Trial Exhibit No.

Description 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.,

Other Designation

Admitted

Teva USA's Objections and Basis

Rule

88.

Relevance, hearsay

402, 802

89.

Relevance, hearsay

402, 802

90.

Relevance, hearsay

402, 802

91.

Relevance, hearsay

402, 802

92.

Relevance, hearsay

402, 802

93.

Relevance, hearsay

402, 802

- 12 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 27 of 289

Trial Exhibit No.

Description 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) 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 AminoBisphosphonates: 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

Other Designation

Admitted

Teva USA's Objections and Basis

Rule

94.

None

95.

None

96.

Relevance, hearsay

402, 802

97.

Relevance, hearsay

402, 802

98.

Relevance, hearsay

402, 802

- 13 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 28 of 289

Trial Exhibit No.

Description 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): 11521157 (1999) Genant et al., "Chronic Intermittent Cyclical Administration of Tiludronate in Postmenopausal Osteoporosis: Report of Two Multicenter Studies in 2316 Patients", JBMRIBMS 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

Other Designation

Admitted

Teva USA's Objections and Basis

Rule

99.

Relevance, hearsay

402, 802

100.

Relevance, hearsay

402, 802

101.

Relevance, hearsay

402, 802

- 14 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 29 of 289

Trial Exhibit No.
(2002) 102.

Description

Other Designation

Admitted

Teva USA's Objections and Basis

Rule

Lanza et al., "The Upper GI Safety and Tolerability of Oral Alendronate at a Dose of 70 mg Once-Weekly: A Placebo-Controlled 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) 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):

Relevance, hearsay

402, 802

103.

Relevance, hearsay

402, 802

104.

Relevance, hearsay

402, 802

- 15 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 30 of 289

Trial Exhibit No.
1377-1382 (1998) 105.

Description

Other Designation

Admitted

Teva USA's Objections and Basis

Rule

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, 1bisphosphonate (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

Relevance, hearsay

402, 802

106.

Relevance, hearsay

402, 802

107.

T 007623-007625

Relevance, hearsay Relevance, hearsay

402, 802

108.

402, 802

109.

Relevance, hearsay

402, 802

- 16 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 31 of 289

Trial Exhibit No.

Description 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 Endocrinology and 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): 12061211 (1992) Peter et al., "Esophageal Irritation due to Alendronate Sodium Tablets: Possible Mechanisms", Digestive Diseases and Sciences,

Other Designation

Admitted

Teva USA's Objections and Basis

Rule

110.

None

111.

None

112.

Relevance, hearsay

402, 802

113.

Relevance, hearsay

402, 802

- 17 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 32 of 289

Trial Exhibit No.
43(9), 1998-2002 (1998) 114.

Description

Other Designation

Admitted

Teva USA's Objections and Basis

Rule

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)

Relevance, hearsay

402, 802

115.

Relevance, hearsay

402, 802

116.

Relevance, hearsay

402, 802

117.

None

- 18 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 33 of 289

Trial Exhibit No.
118.

Description 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

Other Designation

Admitted

Teva USA's Objections and Basis Relevance, hearsay

Rule 402, 802

119.

MK 0188346-0188544

Relevance, hearsay

402, 802

120.

MK 0154684-0154694

Relevance, hearsay

402, 802

121.

MK 0382423-0382456

Relevance, hearsay

402, 802

122.

MK 0170895-0170944

Relevance, hearsay

402, 802

- 19 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 34 of 289

Trial Exhibit No.
Protocol 118 123.

Description

Other Designation

Admitted

Teva USA's Objections and Basis

Rule

06/22/01 Merck letter to FDA re IND 32,033 Fosamax® Tablets Request for Meeting 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

MK 0341364-0341395

Relevance, hearsay

402, 802

124. 125.

MK 0080527-0080585 MK 0384834-0384875

Relevance, hearsay Relevance, hearsay

402, 802 402, 802

126.

MK 0384876-0384915

Relevance, hearsay

402, 802

127.

MK 0384916-0384946

Relevance, hearsay

402, 802

128.

MK 0384947-0384950

Relevance, hearsay

402, 802

129.

MK 0384951-0384954

Relevance, hearsay

402, 802

- 20 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 35 of 289

Trial Exhibit No.
Documentation 130. 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

Description

Other Designation MK 0384955-0384959

Admitted

Teva USA's Objections and Basis Relevance, hearsay

Rule 402, 802

131.

MK 0384960-0384967

Relevance, hearsay

402, 802

132.

MK 0384968-0384974

Relevance, hearsay

402, 802

133.

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

MK 0147476-0147556

Relevance, hearsay

402, 802

134.

MK 0073319-0073345

Relevance, hearsay

402, 802

135.

MK

Relevance,

402, 802

- 21 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 36 of 289

Trial Exhibit No.
FDA re IND 32,033: Fosamax (Alendronate Sodium) 136.

Description

Other Designation 0073286-0073318

Admitted

Teva USA's Objections and Basis hearsay

Rule

Postmenopausal Osteoporosis Recent Clinical Advances (1999) 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

MK 0357844-0357885

Relevance, hearsay

402, 802

137.

MK 0277521-0277713 MK 0391736

Relevance, hearsay Relevance, hearsay

402, 802

138.

402, 802

139.

Relevance, hearsay

402, 802

140.

Relevance, hearsay

402, 802

141.

Relevance, hearsay

402, 802

142.

Relevance, hearsay

402, 802

- 22 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 37 of 289

Trial Exhibit No.
143.

Description 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

Other Designation

Admitted

Teva USA's Objections and Basis Relevance, hearsay

Rule 402, 802

144.

Relevance, hearsay

402, 802

145.

Relevance, hearsay

402, 802

146.

MK 0391628-0391651

Relevance, hearsay

402, 802

147.

MK 0282265-0282269

Relevance, hearsay

402, 802

148.

Relevance, hearsay

402, 802

- 23 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 38 of 289

Trial Exhibit No.
149.

Description 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 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

Other Designation MK 0378146-0378194

Admitted

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

Rule 402, 802

150.

402, 802

151. 152. 153.

Relevance, hearsay MK 0391662 MK 0391652-0391658 Relevance, hearsay Relevance, hearsay

402, 802 402, 802 402, 802

154.

Relevance, hearsay MK 0357233-0357240 MK 0270177 Relevance, hearsay Relevance, hearsay Relevance, hearsay

402, 802

155.

402, 802

156.

402, 802

157.

MK 0351676

402, 802

- 24 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 39 of 289

Trial Exhibit No.
158.

Description Document entitled, "Information for the Patient, Evista® (E-VISStah) Tablets, Generic name: raloxifene hydrochloride" from Lilly's website Information for the Patient Miacalcin® (calcitoninsalmon) 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"

Other Designation

Admitted

Teva USA's Objections and Basis Relevance, hearsay

Rule 402, 802

159.

Relevance, hearsay

402, 802

160.

MK 0355919-0355934 MK 0369607-0369618

Relevance, hearsay Relevance, hearsay

402, 802

161.

402, 802

162.

Relevance, hearsay

402, 802

163.

MK 0357276-0357277

Relevance, hearsay

402, 802

- 25 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 40 of 289

Trial Exhibit No.
164.

Description Mahajan and Peterson, "Models for Innovation Diffusion", Number 07-048 Merk documents re Fosamax/Attribute Tracker 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,

Other Designation

Admitted

Teva USA's Objections and Basis Relevance, hearsay

Rule 402, 802

165.

MK 0369533-0369606 MK 0276089-0276139

Relevance, hearsay Incomplete, relevance, hearsay Relevance, hearsay

402, 802

166.

106, 402, 802

167.

MK 0275664-0275676

402, 802

168.

MK 0391703-0391710

Relevance, hearsay

402, 802

169.

MK 0310263-0310310

Relevance, hearsay

402, 802

170.

MK 0356790-0356875

Relevance, hearsay

402, 802

171.

MK

Relevance,

402, 802

- 26 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 41 of 289

Trial Exhibit No.
"Fosamax® Compliance Study", October, 1999 172.

Description

Other Designation 0356239-0356281

Admitted

Teva USA's Objections and Basis hearsay

Rule

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) Fosamax Data ­ Total Prescriptions 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.

MK 0391664-0391669 MK 0372271-0373192

Relevance, hearsay Relevance, hearsay

402, 802

173.

402, 802

174.

MK 0391681-0391682

Relevance, hearsay

402, 802

175.

MK 0391579-0391624 MK 0391564 MK 0384694-0384707

Relevance, hearsay Relevance, hearsay None

402, 802

176. 177.

402, 802

178.

MK 03847080384726

Relevance, hearsay

402, 802

- 27 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 42 of 289

Trial Exhibit No.
179.

Description 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., "PillInduced Esophageal Injury", Digestive Diseases and Sciences, 28:2, 174182 (1983) Ovartlarnporn et al., "Medication-Induced

Other Designation

Admitted

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

Rule 402, 802

180.

402, 802

181.

MK 0250129-0250220

Relevance, hearsay

402, 802

182.

Relevance, hearsay Relevance, hearsay Relevance, hearsay

402, 802

183.

402, 802

184.

402, 802

185.

None

186.

Relevance, hearsay

402, 802

- 28 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 43 of 289

Trial Exhibit No.

Description Esophageal Injury: Report of 17 cases with Endoscopic Documentation", Am J Gastroenterol, 86(6): 74850 (1991) Bonavina et al., "Druginduced Esphageal Strictures", Ann. Surg., pp. 173-183 (1987) 07/16/91 Project Team Minutes 09/14/99 Information Disclosure Statement Under 37 CFR 1.97 (09/376,315) 06/01/00 Interview Summary (09/376,315)

Other Designation

Admitted

Teva USA's Objections and Basis

Rule

187.

Relevance, hearsay

402, 802

188. 189.

MK 0135838-0135846 MK 0385375-0385380

Relevance, hearsay Relevance, hearsay, identification, incomplete Relevance, hearsay, identification, incomplete Relevance, hearsay, identification, incomplete Relevance, hearsay, identification, incomplete Relevance, hearsay,

402, 802 402, 802, 106, 901

190.

MK 0385206

402, 802, 106, 901

191.

06/07/00 Supplemental Information Disclosure Statement Under 37 CFR 1.97 (09/376,315) 07/07/00 Office Action with attachments (09/376,315) 08/30/00 Supplemental Information Disclosure

MK 0385371-0385374

402, 802, 106, 901

192.

MK 0385196-0385205

402, 802, 106, 901

193.

MK 0385356-0385359

402, 802, 106, 901

- 29 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 44 of 289

Trial Exhibit No.
194. Statement Under 37 CFR 1.97 (09/376,315) 11/02/00 Final Office Action with attachments (09/376,315) 05/22/01 Office Action (09/376,315)

Description

Other Designation

Admitted

MK 0385188-0385195

195.

MK 0385184-0385187

196.

197.

198.

04/16/02 Notice of Improper Request for Continued Examination (RCE) (09/376,315) 06/05/02 Supplemental Information Disclosure Statement Under 37 CFR 1.97 with attachments (09/376,315) 06/05/02 Response to Final Rejection (09/376,315)

MK 0385172-0385173

MK 0391738-0391980

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

Rule

402, 802, 106, 901

402, 802, 106, 901

402, 802, 106, 901

402, 802, 106, 901

MK 0385228-0385233

402, 802, 106, 901

199.

08/21/02 USPTO Notice of Recordation of Assignment Document (09/445,837) 08/26/02 USPTO Notice of Recordation of Assignment Document (09/445,837) 08/26/02 Information Disclosure Statement by

MK 0385162-0385166

402, 802, 106, 901

200.

MK 0385157-0385161

402, 802, 106, 901

201.

MK 0391210-0391212

402, 802, 106, 901

- 30 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 45 of 289

Trial Exhibit No.
Applicant (09/376,315) 202.

Description

Other Designation

Admitted

203.

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

MK 0385168-0385171

MK 0257353-0257374

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

Rule

402, 802, 106, 901

402, 802

204.

MK 0257375-0257390

Relevance, hearsay

402, 802

205.

MK 0257391-0257405

Relevance, hearsay

402, 802

206.

MK 0257406-0257420

Relevance, hearsay

402, 802

207.

MK 0257421-0257435

Relevance, hearsay

402, 802

- 31 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 46 of 289

Trial Exhibit No.
(Reference Q-5) 208.

Description 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 #96047-0,-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, L615, 614: Five-Week Oral Gastric Irritation Study in Rats. TT #97-009-0 (Reference Q-10) MRL Preclinical Report: L-767, 693, (Tiludronate

Other Designation MK 0257436-0257450

Admitted

Teva USA's Objections and Basis Relevance, hearsay

Rule 402, 802

209.

MK 0257451-0257466

Relevance, hearsay

402, 802

210.

MK 0257467-0257482

Relevance, hearsay

402, 802

211.

MK 0257483-0257498

Relevance, hearsay

402, 802

212.

MK 0257499-0257620

Relevance, hearsay

402, 802

213.

MK 0257621-0257636

Relevance, hearsay

402, 802

- 32 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 47 of 289

Trial Exhibit No.

Description Sodium): Five-Day Esophageal Irritation Study in Dogs. TT #97-019-0 (Reference Q-11)

Other Designation

Admitted

Teva USA's Objections and Basis

Rule

214.

MRL Preclinical Report: MK-0217: Single-Dose Esophageal Irritation Study in Dogs With 1- and 7-Day Recovery Periods. TT #97057-0 (Reference Q-12) MRL Preclinical Report: MK-0217: Five-Week Esophageal Irritation Study in Dogs. TT #97-080-0 (Reference Q-13) 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

MK 0257637-0257657

Relevance, hearsay

402, 802

215.

MK 0257658-0257672

Relevance, hearsay

402, 802

216.

MK 2576763-0257688

Relevance, hearsay

402, 802

217.

MK 0257689-0257704

Relevance, hearsay

402, 802

218.

Relevance

402

219.

Relevance

402

- 33 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 48 of 289

Trial Exhibit No.

220.

221.

222.

223.

224.

225.

226. 227.

Description 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. 00-035JJF and 00-052-JJF, Consolidated Action Merck/Lunar Management Meeting, 05/21/97 ­ Agenda Chart ­ Promotion + CDP, 1995-2002 Actual Profit Plan 2000

Other Designation

Admitted

Teva USA's Objections and Basis

Rule

Relevance

402

Relevance

402

Relevance

402

Relevance, hearsay

402, 802

Relevance, hearsay

402, 802

MK 0272085-0272086

None

MK 0257241-

Relevance, hearsay Relevance,

402, 802 402, 802

- 34 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 49 of 289

Trial Exhibit No.

228. 229.

Description Fosamax®, September 9, 1999 Charts ­ Contacts 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

Other Designation 0275281

Admitted

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

Rule

402, 802 106, 402, 802

MK 0392082-0392124

230.

402, 802

231.

Relevance, hearsay

402, 802

232.

Relevance, hearsay

402, 802

233.

Relevance, hearsay

402, 802

234.

Relevance, hearsay MK 0270407-0270413 Incomplete, relevance, hearsay

402, 802

235.

106, 402, 802

- 35 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 50 of 289

Trial Exhibit No.
236. 237.

238.

239.

240. 241.

242.

243.

Description 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 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

Other Designation MK 0290024

Admitted

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

Rule 402, 802 402, 802

Relevance, hearsay Relevance, hearsay

402, 802

402, 802

MK 0226830-0266836

Relevance, hearsay Relevance, hearsay

402, 802 402, 802

Relevance, hearsay

402, 802

Relevance, hearsay

402, 802

- 36 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 51 of 289

Trial Exhibit No.
244.

Description 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"

Other Designation

Admitted

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

Rule 402, 802

245.

402, 802

246.

MK 03775090377533

Relevance, hearsay

402, 802

247.

Relevance, hearsay MK 0377035-0377042 Relevance, hearsay

402, 802

248.

402, 802

249.

Relevance, hearsay

402, 802

250.

Relevance, hearsay

402, 802

251.

Relevance, hearsay

402, 802

- 37 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 52 of 289

Trial Exhibit No.
252.

Description 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) 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

Other Designation

Admitted

Teva USA's Objections and Basis Relevance, hearsay

Rule 402, 802

253.

Relevance, hearsay

402, 802

254.

None

255.

Relevance, hearsay

402, 802

256.

Relevance, hearsay

402, 802

257.

MK 0377329-0377344

Relevance, hearsay Relevance, hearsay

402, 802

258.

402, 802

- 38 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 53 of 289

Trial Exhibit No.

Description Intellectual Property Valuation Methods in Portfolio Management and Value Extraction", les Nouvelles, 36(3): pp. 77-86 (2001) McGavock et al., "Factors Affecting Royalty Rates", les Nouvelles, 27(2): pp. 107-116 (1992) Gross, "Actual Royalty Rates in Patient-, KnowHow-and 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

Other Designation

Admitted

Teva USA's Objections and Basis

Rule

259.

None

260.

Relevance, hearsay

402, 802

261.

None

262.

Relevance, hearsay

402, 802

263.

Relevance, hearsay

402, 802

- 39 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 54 of 289

Trial Exhibit No.

Description 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. 231-245; Ch. 28, pp. 403-418, Bijvoet, Fleisch, Canfield and Russell (eds.), (1995) Russell et al., "Bisphosphonates: Pharmacology, Mechanisms of Action and Clinical Uses", Osteoporosis Int., Suppl. 2:S66-S80, 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

Other Designation

Admitted

Teva USA's Objections and Basis

Rule

264.

Relevance, hearsay

402, 802

265.

Relevance, hearsay

402, 802

266.

Relevance, hearsay

402, 802

267.

Relevance, hearsay Relevance, hearsay

402, 802

268.

402, 802

269.

Relevance, hearsay

402, 802

- 40 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 55 of 289

Trial Exhibit No.
270.

Description 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 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

Other Designation

Admitted

Teva USA's Objections and Basis Relevance, hearsay

Rule 402, 802

271.

Relevance, hearsay

402, 802

272.

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

402, 802

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

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

TEVA R 0631406345

280.

None

281.

None

- 41 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 56 of 289

Trial Exhibit No.
282. 283. 284. 285. 286. 287. 288. 289. 290. 291. 292. 293. 294. 295. 296. 297.

Description U.S. Patent No. 5,869,471 MERCK HAS WITHDRAWN THIS EXHIBIT. SEE PTX 11. MERCK HAS WITHDRAWN THIS EXHIBIT. SEE PTX 12. MERCK HAS WITHDRAWN THIS EXHIBIT. SEE PTX 13. MERCK HAS WITHDRAWN THIS EXHIBIT. SEE PTX 105. MERCK HAS WITHDRAWN THIS EXHIBIT. SEE PTX 106. MERCK HAS WITHDRAWN THIS EXHIBIT. SEE PTX 108. MERCK HAS WITHDRAWN THIS EXHIBIT. SEE PTX 56. MERCK HAS WITHDRAWN THIS EXHIBIT. SEE PTX 63. MERCK HAS WITHDRAWN THIS EXHIBIT. SEE PTX 69. MERCK HAS WITHDRAWN THIS EXHIBIT. SEE PTX 75. MERCK HAS WITHDRAWN THIS EXHIBIT. SEE PTX 77. MERCK HAS WITHDRAWN THIS EXHIBIT. SEE PTX 70. MERCK HAS WITHDRAWN THIS EXHIBIT. SEE PTX 79. MERCK HAS WITHDRAWN THIS EXHIBIT. SEE PTX 80. MERCK HAS WITHDRAWN THIS EXHIBIT. SEE PTX 81.

Other Designation PLEASE PLEASE PLEASE PLEASE PLEASE PLEASE PLEASE PLEASE PLEASE PLEASE PLEASE PLEASE PLEASE PLEASE PLEASE

Admitted

Teva USA's Objections and Basis None

Rule

- 42 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 57 of 289

Trial Exhibit No.
298. 299. 300. 301. 302. 303. 304.

305. 306. 307. 308. 309. 310. 311. 312.

Description MERCK HAS WITHDRAWN THIS EXHIBIT. PLEASE SEE PTX 84. MERCK HAS WITHDRAWN THIS EXHIBIT. PLEASE SEE PTX 86. MERCK HAS WITHDRAWN THIS EXHIBIT. PLEASE SEE PTX 85. MERCK HAS WITHDRAWN THIS EXHIBIT. PLEASE SEE PTX 88. MERCK HAS WITHDRAWN THIS EXHIBIT. PLEASE SEE PTX 87. MERCK HAS WITHDRAWN THIS EXHIBIT. PLEASE SEE PTX 51. 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 MERCK HAS WITHDRAWN THIS EXHIBIT. PLEASE SEE PTX 110. MERCK HAS WITHDRAWN THIS EXHIBIT. PLEASE SEE PTX 111. MERCK HAS WITHDRAWN THIS EXHIBIT. PLEASE SEE PTX 112. MERCK HAS WITHDRAWN THIS EXHIBIT. PLEASE SEE PTX 102. MERCK HAS WITHDRAWN THIS EXHIBIT. PLEASE SEE PTX 113. MERCK HAS WITHDRAWN THIS EXHIBIT. PLEASE SEE PTX 101. MERCK HAS WITHDRAWN THIS EXHIBIT. PLEASE SEE PTX 55. MERCK HAS WITHDRAWN THIS EXHIBIT. PLEASE SEE PTX 65.

Other Designation

Admitted

Teva USA's Objections and Basis

Rule

Relevance, hearsay

402, 802

- 43 -AT

Case 1:04-cv-00939-GMS

Document 71-2

Filed 07/24/2006

Page 58 of 289

Trial Exhibit No.
313.

314.

315. 316. 317. 318. 319. 320. 321. 322. 323.

324. 325. 326