Free Letter - District Court of Delaware - Delaware

Case 1:04-cv-00833-KAJ

Document 284-4

Filed 09/14/2006

Page 1 of 9

EXHIBIT C

Case 1:04-cv-00833-KAJ
DEFENDANTS' DEFENDANTS' DEPOSITION TRIAL EXHIBIT EXHIBIT NUMBER NUMBER

Document 284-4

Filed 09/14/2006

Page 2 of 9
PHARMACIA'S OBJECTIONS

PRELIMINARY DRAFT AS OF SEPTEMBER 12, 2006
DESCRIPTION BATES RANGE PHASE OF LITIGATION1

1.

1.

Work Order - NY Patent 1, issued under the Master Research & Development Agreement between Pfizer, Inc. and Nerviano Medical Services on May 14, 2004 Work Order - NY Patent 2, issued under the Master Research & Development Agreement between Pfizer, Inc. and Nerviano Medical Services on May 14, 2004 Printout from Nerviano Medical Sciences webpage dated 12/7/05 on Nerviano's "Management, News and History" United States Patent 6,107,285

PI 17791-17795

Liability

2.

2.

PI 17796-17800

Liability

3.

3.

N/A

Liability

4.

4.

N/A

Liability

The "Phase of Litigation" column refers to whether the exhibit is intended to be introduced in the liability phase, willfulness/damages phase, and/or the inequitable conduct/unclean hands bench trial. Sicor reserves the right to introduce exhibits identified for use in the "liability" phase in the willfulness/damages phase and/or the inequitable conduct/unclean hands bench trial. However, Sicor will not introduce in the "liability" phase documents identified exclusively for use in the "willfulness/damages" phase and/or the "inequitable conduct/unclean hands" bench trial. Moreover, Sicor states that additional exhibits would have been included herein to prove non-infringement had the Court accepted Sicor's proposed construction of the disputed claims in this case. Such exhibits would have included, but not been limited to, those exhibits to Sicor's Memorandum of Law in Support of Summary Judgment on Non-Infringement, or in the Alternative for Invalidity for Lack of Written Description (D.I. 246, 247), and Reply Memorandum of Law in Support of Summary Judgment on Non-Infringement, or in the Alternative for Invalidity for Lack of Written Description (D.I. 269), which exhibits are not identified herein. Potential rebuttal and/or impeachment exhibits are not included herein.

1

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Case 1:04-cv-00833-KAJ
DEFENDANTS' DEFENDANTS' DEPOSITION TRIAL EXHIBIT EXHIBIT NUMBER NUMBER

Document 284-4

Filed 09/14/2006

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PHARMACIA'S OBJECTIONS

PRELIMINARY DRAFT AS OF SEPTEMBER 12, 2006
DESCRIPTION BATES RANGE PHASE OF LITIGATION1

5.

5.

Email from D. Boehnen to [email protected] dated May 19, 2005, regarding arranging a consulting agreement to assist in case involving the `285 patent. Letter from Dr. Francavilla to Dr. Robinson dated June 7, 1985, regarding the status of development and decisions taken about some projects of galenical development. Letter from G. Tosolini to Dr. Irminger cc: B. Beck, F. Grab, M. Meyers, D. Robison, P. Francivilla dated July 23, 1985 regarding Adriamycin RTU solution. Farmitalia Carlo Erba - Research and Development: Step-by-Step Procedure to Calculate A Product Shelf-Life in Terms of t90% From Real Stability Data prepared on July, 1990 by R&D/Galenics Galenical Controls Department Declaration, Power of Attorney, and Petition 6/23/86 regarding Great Britain Application No. 8519452

PI 17757-17758

Liability

6.

6.

PU 00111620011165

Liability

7.

7.

PU 00111600011161

Liability

8.

8.

PU 00282800028287

Liability

9.

9.

N/A

Liability

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Case 1:04-cv-00833-KAJ
DEFENDANTS' DEFENDANTS' DEPOSITION TRIAL EXHIBIT EXHIBIT NUMBER NUMBER

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PHARMACIA'S OBJECTIONS

PRELIMINARY DRAFT AS OF SEPTEMBER 12, 2006
DESCRIPTION BATES RANGE PHASE OF LITIGATION1

10.

10.

United States Patent and Trademark Office - Request for Priority Under 35 U.S.C. 119 and the International Convention in US Application No. 878784 Example 2: Excerpt from Scientific Notebook - Scientific Notes for Doxorubicin Example 3: Excerpt from Scientific Notebook - Scientific Notes for Doxorubicin Excerpt from Scientific Notebook Scientific Notes for Doxorubicin Declaration Under Rule 1.132: Carlo Confalonieri, 3/10/1987, Certificate of Facsimile Transmission, and Supplemental Amendment Under 37 C.F.R.& 1.116 dated 7/23/96 Letter from K. Weston to G. Tabusso 8/22/86 with attached Adriamycin Document (Scientific notes and graphs)

N/A

Liability

11.

11.

PU 00228020022819

Liability

12.

12.

PU 00227850022801

Liability

13. 14.

13. 14.

PU 00233500023368 N/A

Liability

Liability

15.

15.

PU 00191840019266

Liability

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Case 1:04-cv-00833-KAJ
DEFENDANTS' DEFENDANTS' DEPOSITION TRIAL EXHIBIT EXHIBIT NUMBER NUMBER

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PHARMACIA'S OBJECTIONS

PRELIMINARY DRAFT AS OF SEPTEMBER 12, 2006
DESCRIPTION BATES RANGE PHASE OF LITIGATION1

16.

16.

Vigevani and Williamson, "Doxorubicin" from Analytical Profiles of Drug Substances: Volume 9 - Edited by Klaus Florey Doxorubicin: Description, Physical Properties, Synthesis, Stability, Metabolism, Methods of Analysis, Determination of Doxorubicin in Biological Fluids, Analysis of Pharmaceutical Formulations, Miscellaneous, Acknowledgements, and References Janssen (1985) International Journal of Pharmaceuticals - Research Papers: Doxorubicin decomposition on storage. Effect of pH, type of buffer and liposome encapsulation Wassermann et al: "Kinetics of the acid-catalyzed hydrolysis of doxorubicin," Esevier Biomedical Press (1983) Declaration Pursuant to 37 C.F.R. 1.132, Carlo Confalonieri 5/27/1991 Facsimile Message to Dr. G. Tosolini, November 11, 1985 Facsimile Message to Dr. G. Tosolini, November 11, 1985 with handwritten notes

N/A

Liability

18.

18.

N/A

Liability

19.

19.

N/A

Liability

20. 21. 22.

20. 21. 22.

N/A

Inequitable Conduct/Unclean Hands Liability

PU 0010361

PU 0018369

Liability

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Case 1:04-cv-00833-KAJ
DEFENDANTS' DEFENDANTS' DEPOSITION TRIAL EXHIBIT EXHIBIT NUMBER NUMBER

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PHARMACIA'S OBJECTIONS

PRELIMINARY DRAFT AS OF SEPTEMBER 12, 2006
DESCRIPTION BATES RANGE PHASE OF LITIGATION1

23. 24.

23. 24.

Handwritten Notes (Wassermann and Bundgaard) Furuya, "Pharmaceutical of Doxorubicin Salt" Patent Abstracts of Japan Rule 1.132 Declaration, Carlo Confalonieri August 11, 1989 Declaration of Carlo Confalonieri January 12, 199_ Letter from C. Confalonieri to Dr. W. Wright, July 12, 1991 - Re: U.S. Pharmacopoeia Monograph for Doxorubicin Hydrochloride Injection Adria: Inter-Office Communication from R. L. Wolgemuth and S. Penco, May 31, 1985 FICE/Adria Review of the Ohio State Anthracycline Projects Rule 1.132 Declaration of Carlo Confalonieri November 21, 1988 Declaration of Carlo Confalonieri Pursuant to 37 C.F.R. 1.132 December 9, 1992 Declaration Pursuant to 37 C.F.R. 1.132, Carlo Confalonieri December 20, 1990

PU 0021810

Liability

N/A

Liability

25. 26. 27.

25. 26. 27.

N/A

Liability

N/A

Liability

PU 00216820021684

Liability

28.

28.

PU 00181170018119

Liability

29. 30.

29. 30.

PU 00092150009226 N/A

Liability

Inequitable Conduct/Unclean Hands

31.

31.

N/A

Liability

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Case 1:04-cv-00833-KAJ
DEFENDANTS' DEFENDANTS' DEPOSITION TRIAL EXHIBIT EXHIBIT NUMBER NUMBER

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PHARMACIA'S OBJECTIONS

PRELIMINARY DRAFT AS OF SEPTEMBER 12, 2006
DESCRIPTION BATES RANGE PHASE OF LITIGATION1

32. 33.

32. 33.

Rule 1.132 Declaration, Carlo Confalonieri August 11, 1989 Master Research and Development Agreement - May 14 2004 - Pfizer Inc. as Contractor and Nerviano Medical Science S.r.l. as Provider Allen & Overy Milan Memo on New Pharmaceutical Forms Requested by International Division by Marketing Estero-May 28, 1985 Table I: Stability Studies Data Comparison of solutions adjusted to pH 3.0 with different acids Doxorubicin Scientific Notebook Table II: Stability Studies Data Comparison of pH's 2 mg/ml Doxorubicin.HCI Solutions in Water adjusted to various pH's with HCl Accelerated test at 55 degrees C Doxorubicin Scientific Notebook European Patent No. 0 143 478

N/A

Liability

PI 17770-17790

Liability

34.

34.

PU 00112470011251

Liability

35.

35.

PU 00230650023078

Liability

36.

36.

PU 00229910023021

Liability

37. 38.

37. 38.

PU 00363200036329 PI 18030-18034

Liability

Chart: Department Div-Mkt-Ent Version - Currency - Exchange Rate Set - Accumulation Method

Liability

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Case 1:04-cv-00833-KAJ
DEFENDANTS' DEFENDANTS' DEPOSITION TRIAL EXHIBIT EXHIBIT NUMBER NUMBER

Document 284-4

Filed 09/14/2006

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PHARMACIA'S OBJECTIONS

PRELIMINARY DRAFT AS OF SEPTEMBER 12, 2006
DESCRIPTION BATES RANGE PHASE OF LITIGATION1

39.

39.

Idarubicin/Idamycin - Pharmaceutical Market Company United States (excluding Greenstone) - 11USA - P & L Sort Order P & L Account Code Idamycin Chart - Net Sales, Medical Affairs, Sales & Marketing Expenses, etc Product: Idamycin 10mg/10ml - Code: 300132586916 - CCS #: 5429 - Lot Size: 11,060.000 Idamycin Net Sales & Quantity by SKU - Idamycin Gross to Net Sales Sku Product - Product Description Year - Month - Account GQTY - Gross Qty RQTY - Return Qty For Pfizer Inc and Pharmacia

PI 18035

Damages/Willfulness

40.

40.

PI 18036-18038

Damages/Willfulness y

41.

41.

PI 18387-18396

Damages/Willfulness

42.

42.

PI 18039-18058

Damages/Willfulness

43.

43.

PI 17919-17945

Damages/Willfulness

44.

44.

Pharmacia - Oncology Sales - Mike Brown - Oncology Sales Organization Structure Global Oncology Franchise - Start Plan 2003-2005 - Pharmacia Oncology

PU 00475040047532

Damages/Willfulness

45.

45.

PU 0045030

Damages/Willfulness

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Case 1:04-cv-00833-KAJ
DEFENDANTS' DEFENDANTS' DEPOSITION TRIAL EXHIBIT EXHIBIT NUMBER NUMBER

Document 284-4

Filed 09/14/2006

Page 9 of 9
PHARMACIA'S OBJECTIONS

PRELIMINARY DRAFT AS OF SEPTEMBER 12, 2006
DESCRIPTION BATES RANGE PHASE OF LITIGATION1

46.

46.

Oncology Franchise Products - Global Prescription Business - 2003-2005 Start Plan (Pass 4) - Net Sales - EBIT - Pharmacia Idarubicin/Idamycin - Global Prescription Business 2003-2005 Start Plan (Pass 4) - Net Sales - EBIT Pharmacia - with blank cover page Global Oncology Franchise 20032005 Start Plan - Financials (Pass 4) Pharmacia Oncology - Oncology Franchise: Graphs and Tables Oncology Salesforce - USMC (Pass 3) - Charts Global Oncology Franchise - Direct & Allocated NPP 2002 Budget and 2003-2005 Start Plan: PASS 4 with blank cover page Pharmacia Oncology Idamycin PFS Zavedos - Lifecycle Management Plan - March 2002 - Tables and Graphs Reformatted Demonstratives Idamycin Contracting - Grace Squillaci - October 15, 2002 Reformatted Demonstratives Pharmaceutical Pricing Management Memorandum

PU 00450550045063

Damages/Willfulness

47.

47.

PU 00450760045086

Damages/Willfulness

48.

48.

PI 18553-18584

Damages/Willfulness

49. 50.

49. 50.

PU 00451260045133 PU 00451560045160

Damages/Willfulness

Damages/Willfulness

51.

51.

PU 00467860046803

Damages/Willfulness

52.

52.

PU 00468240046826

Damages/Willfulness

53.

53.

PU 00436370043704

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