Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc. et al

Filing 132

Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc. et al

Doc. 132

Case 3:05-cv-04158-MHP

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Filed 12/06/2006

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1 QUINN EMANUEL URQUHART OLIVER & HEDGES, LLP Adrian M. Pruetz (Bar No. 118215) 2 Jeffrey N. Boozell (Bar No. 199507) 865 South Figueroa Street, 10th Floor 3 Los Angeles, California 90017-2543 Telephone: [phone] Facsimile: [phone] E-Mail: [e-mail] 5 [e-mail] m 6 7 8 9 10 11 Robert W. Stone (Bar No. 163513) Brian C. Cannon (Bar No. 193071) Tun-Jen Chiang (Bar No. 235165) 555 Twin Dolphin Drive, Suite 560 Redwood Shores, California 94065 Telephone: [phone] Facsimile: [phone] E-Mail: [e-mail] m [e-mail] m [e-mail] m

Attorneys for Defendants and Counterclaimants Roche 12 Molecular Systems, Inc.; Roche Diagnostics Corporation; and Roche Diagnostics Operations, Inc. 13 UNITED STATES DISTRICT COURT 14 NORTHERN DISTRICT OF CALIFORNIA 15 THE BOARD OF TRUSTEES OF THE LELAND CASE NO. C-05-04158 MHP 16 STANFORD JUNIOR UNIVERSITY, 17 18 vs. Plaint iff, ROCHE'S OBJECTIONS TO EVIDENCE OFFERED IN SUPPORT OF COUNTERCLAIM DEFENDANTS' MOTION FOR SUMMARY JUDGMENT AND IN OPPOSITION TO ROCHE'S MOTION FOR SUMMARY JUDGMENT

19 ROCHE MOLECULAR SYSTEMS, INC.; ROCHE DIAGNOSTICS CORPORATION; ROCHE 20 DIAGNOSTICS OPERATIONS, INC., 21 Defendants.

22 ROCHE MOLECULAR SYSTEMS, INC. ROCHE DIAGNOSTICS CORPORATION; ROCHE 23 DIAGNOSTICS OPERATIONS, INC., 24 25 vs. Counterclaimants, Date: Time: Place: December 4, 2006 2:00 p.m. Hon. Marilyn H. Patel

26 THE BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIVERSITY; THOMAS 27 MERIGAN AND MARK HOLODNIY 28 Counterclaim Defendants.
Case No. C-05-04158 MHP OBJECTIONS TO EVIDENCE Dockets.Justia.com

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1

Defendants and Counterclaimants Roche Molecular Systems, Inc., Roche Diagnostic

2 Corporation, and Roche Diagnostic Operations, Inc. (collectively, "Roche") hereby object to 3 evidence submitted by The Board of Trustees of the Leland Stanford Junior University 4 ("Stanford"), Dr. Thomas Merigan and Dr. Mark Holodniy in support of Stanford, Merigan and 5 Holodniy's motion for summary judgment and opposition to Roche's motion for summary 6 judgment. 7 Evidence 8 1. "These patents generally claim methods for Objection Improper Non-Expert Opinion. (Fed. R. Evid. 701; Dr. Holodniy has not been disclosed as an expert witness under Fed. R. Civ. P. 26.)

9 evaluating the effectiveness of anti-HIV therapy to 10 make therapeutic decisions for treating patients with 11 Acquired Immunodeficiency Syndrome (AIDS)." 12 Declaration of Mark Holodniy, M.D. in Support of 13 Counterclaim Defendants Stanford University, Dr. 14 Merigan and Dr. Holodniy's Motion for Summary 15 Judgment, Dkt. No. 93 ("Holodniy Decl."), ¶ 4. 16 2. "My laboratory notebook from the period when

Hearsay. (Fed. R. Evid. 802.) Lacks Foundation. (Fed. R. Evid. 602.)

17 I first joined the Merigan lab shows that I had been 18 referring to specific publications and had performed 19 PCR assays on HIV and HLA sequences, using primers 20 that I had ordered from a company, Operon 21 Technologies, in the fall of 1988. A copy of excerpts 22 from lab notebook is attached to the Rhyu Declaration 23 as Exhibits 5 and 7." Holodniy Decl., ¶ 8. 24 3. "I understand that Roche claims that I received

Relevance. (Fed. R. Evid. 402.)

25 materials and information from Cetus under a 'Materials 26 Transfer Agreement' that was signed by Drs. Merigan 27 and Schwartz. (Exhibit 29.) I never knew that this 28 -2Case No. C-05-04158 MHP OBJECTIONS TO EVIDENCE

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1 agreement existed prior to this case. No one from Cetus 2 or anywhere else ever told me that this Agreement 3 existed, and no one ever indicated to me that they were 4 giving me materials of information under this 5 agreement. I never signed a Materials Transfer 6 Agreement with Cetus." Holodniy Decl., ¶ 9. 7 4. "I understood that the agreement concerned my Relevance. (Fed. R. Evid. 402; Lenk v. Total-Western, Inc., 89 Cal. App. 4th 959, 970 (2001) (subject ive understanding of contract not relevant).) Inadmissible legal conclusion. Van Winkle v. Crowell, 146 U.S. 42 (1892). "None of these people ever told me that our Relevance. (Fed. R. Evid. 402.)

8 obligations to Cetus' confidential information. I never 9 understood that agreement to cover work that I did 10 when I was not at Cetus and not using confidential 11 information." Holodniy Decl., ¶ 11. 12 13 14 15 5.

16 conversations were confidential or that Cetus 17 considered any of our conversations to be about trade 18 secrets." Holodniy Decl., ¶ 12. 19 6. "During the time that I visited at Cetus, no one Relevance. (Fed. R. Evid. 402.)

20 ever told me that any particular information that I 21 learned or any reagent that I used was confidential. 22 None of the materials given to me were ever labeled 23 confidential. At any given time during this period, I 24 kept a single notebook, which I carried back and forth 25 between Cetus and Stanford. no on requested that I 26 keep a separate notebook for work performed at Cetus, 27 and no one asked me to leave my lab notebook at Cetus, 28 -3Case No. C-05-04158 MHP OBJECTIONS TO EVIDENCE

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1 either when I worked at Stanford, or after I stopped 2 being a visiting scientist." Holodniy Decl., ¶ 14. 3 7. "It was and is my belief that the materials and Relevance. (Fed. R. Evid. 402.)

4 basic protocols shared by Cetus is support of our joint 5 work were not trade secrets or confidential 6 information." Holodniy Decl., ¶ 17. 7 8. "The publication, which is a review article, Improper Non-Expert Opinion. (Fed. R. Evid. 701; Dr. Holodniy has not been disclosed as an expert witness under Fed. R. Civ. P. 26.)

8 establishes that the basic methods for labeling PCR 9 primers with biotin and HRP had been described in 10 scientific literature as early as 1985 and 1988, 11 respectively." Holodniy Decl., ¶ 17(f). 12 9. "This publication disclosed the construction of

Improper Non-Expert Opinion. (Fed. R. Evid. 701; Dr. Holodniy has not been disclosed as an expert witness under Fed. R. Civ. P. 26.)

13 an internal standard similar to the CC1 and CC2 RNA 14 standards." Holodniy Decl., ¶ 17(h). 15 16 10. "This publication also disclosed the construction

Improper Non-Expert Opinion. (Fed. R. Evid. 701; Dr. Holodniy has not been disclosed as an expert witness under Fed. R. Civ. P. 26.)

17 of an internal standard similar to the CC1 and CC2 18 RNA standards." Holodniy Decl., ¶ 17(i). 19 20 11. "Other than the request to fill out this disclosure

Relevance. (Fed. R. Evid. 402.)

21 form, Cetus never communicated to me any interest in 22 patenting the described invention. I concluded that 23 Cetus was not interested in pursuing further 24 development of the assay." Holodniy Decl., ¶ 20. 25 12. "Based on Cetus' consent to publish the JID Relevance. (Fed. R. Evid. 402.) Improper Non-Expert Opinion. (Fed. R. Evid. 701.)

26 article and the two earlier abstracts, I concluded that the 27 work done on the assay was within the public domain." 28 -4-

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1 Holodniy Decl., ¶ 22. 2 3 4 13. "Cetus never asked me to keep the Heparin

Inadmissible legal conclusion. Van Winkle v. Crowell, 146 U.S. 42 (1892). Relevance. (Fed. R. Evid. 402.)

5 work confidential." Holodniy Decl., ¶ 23. 6 14. "While the methods for evaluating the effect of Improper Non-Expert Opinion. (Fed. R. Evid. 701; Dr. Holodniy has not been disclosed as an expert witness under Fed. R. Civ. P. 26.) Inadmissible legal conclusion. Van Winkle v. Crowell, 146 U.S. 42 (1892). "Despite our work on the HIV RNA quantitation Lacks foundation. (Fed. R. Evid. 602.) Hearsay. (Fed. R. Evid. 802.)

7 anti-HIV therapy described in the monitoring patents 8 involve using a quantitative PCR assay, the PCR 9 method itself is not the invention claim in the patents." 10 Holodniy Decl., ¶ 26. 11 12 13 15.

14 assay, it was quite unclear in mid 1990 whether the 15 quantitation technique would work reliably to detect 16 responses to antiviral therapy. For example, there was 17 widespread uncertainty at the time about whether the 18 assay would be sufficiently sensitive and reproducible 19 to measure HIV RNA changes over time in a clinical 20 setting. It was unclear whether the variability of virus 21 levels and changes in virus levels for different 22 individuals would be detectable using this assay. There 23 was much uncertainty in the field about whether nucleic 24 acid levels in plasma could be used to predict the 25 effectiveness of the therapy. There was also an 26 overriding concern about whether the available 27 treatments would be strong enough to produce changes 28 -5-

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1 that could be measured." Holodniy Decl., ¶ 27. 2 16. "Drs. Merigan, Katzenstein, and I worked on Relevance. (Fed. R. Evid. 402; Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1169-71 (Fed. Cir. 2006) (evidence of actual reduction to practice must be corroborated); Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1577 (Fed. Cir. 1996) (conception must be corroborated).) "The work described in the JCI article is the Improper Non-Expert Opinion. (Fed. R. Evid. 701.) Inadmissible legal conclusion. Van Winkle v. Crowell, 146 U.S. 42 (1892). "Based on the fact that the JCI manuscript was Relevance. (Fed. R. Evid. 402.; Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1169-71 (Fed. Cir. 2006) (evidence of actual reduction to practice must be corroborated).)

3 this through the summer and winter of 1990. By early 4 1991, we had demonstrated a correlation between HIV 5 levels and the effectiveness of treatment." Holodniy 6 Decl., ¶ 29. 7 8 9 10 17.

11 central work on which the monitoring patents are 12 based." Holodniy Decl., ¶ 30. 13 14 15 18.

16 received by the journal on May 14, 1991, I am 17 confident that the substantive work reported in the 18 article was completed before April 19, 1991. It would 19 have taken at least a month and likely two months from 20 the time I completed the experiments to write up the 21 manuscript, distribute the manuscript to my coauthors 22 for their comments, to incorporate their comments, and 23 to prepare the final manuscript and figures for 24 submission." Holodniy Decl., ¶ 31. 25 19. "I am aware of the work that Drs. Thomas

Lacks foundation. (Fed. R. Evid. 602.) Hearsay. (Fed. R. Evid. 802.)

26 Merigan, Mark Holodniy, David Katzenstein, and Mark 27 Kozal performed that is described in their patents, U.S. 28 -6-

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1 Patent Nos. 5,968,730 (the ''730 patent'), 6,503,705 (the 2 '705 patent'), 5,631,128 (the ''128 patent'); 5,856,086 3 (''086 patent'), 5,650,258 ('268 patent'), and Reissue 4 Patent No. RE38,352 E (''352 patent'). I am also aware 5 that there is a pending application corresponding to the 6 publication US2003/0118986 A1. I note that 7 publication US2001/0018181 A1 corresponds to the 8 '705 patent. Collectively, I will refer to all of these 9 patents and applications and the 'Merigan patents.'" 10 Declaration of Luis R. Mejia in Support of 11 Counterclaim Defendants Stanford University, Dr. 12 Merigan and Dr. Holodniy's Motion for Summary 13 Judgment, Dkt. No. 94 ("Mejia Decl.), ¶ 4. 14 20. The Merigan patents all stem fro m an original

Relevance. (Fed. R. Evid. 402; Docket No. 34, Transcript of May 23, 2006 telephonic hearing at 17:115 (evidence supporting Stanford's motion for summary judgment concerning U.S. Patent Nos. 5,631,128, 5,856,086, 5,650,268, and RE 38,352 is irrelevant to the issues to be resolved in this first phase of the litigation).)

Relevance. (Fed. R. Evid. 402; Docket No. 34, Transcript of May 23, 2006 telephonic hearing at 17:115 (evidence supporting Stanford's motion for summary judgment concerning U.S. Patent Nos. 5,631,128, 5,856,086, 5,650,268, and RE 38,352 is irrelevant to the issues to be resolved in this first phase of the litigation).)

15 patent application, No. 07/883,327 (''327 application'), 16 which was filed on May 14, 1992. Based on the 17 disclosure in this application, the '268 patent issued on 18 July 22, 1997; the '730 patent issued on October 19, 19 1999, and the '705 application issued on January 7, 20 2003. The pending application is also based on the 21 disclosure in the '327 application. A 'continuation-in22 part' of the '327 application was filed on August 15, 23 1994, adding more information to the original 24 disclosure. Based on the continuation-in-part, the '128 25 patent issued on May 20, 1997, the '086 patent issued 26 on January 5, 1999, and the '352 Reissue patent issued 27 on December 16, 2003." Mejia Decl., ¶ 5. 28 -7-

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1 21.

The original '327 application first became

Relevance. (Fed. R. Evid. 402; Docket No. 34, Transcript of May 23, 2006 telephonic hearing at 17:115 (evidence supporting Stanford's motion for summary judgment concerning U.S. Patent Nos. 5,631,128, 5,856,086, 5,650,268, and RE 38,352 is irrelevant to the issues to be resolved in this first phase of the litigation).)

2 publicly available upon issuance of the '268 patent in 3 1997. That application has claims for monitoring the 4 effectiveness of anti-HIV treatment by detect ing HIV 5 nucleic acids using PCR. A copy of the patent 6 application is attached to the Rhyu Declaration as 7 Exhibit 692 at STAN 014837-843." Mejia Decl., ¶ 6. 8 9 10 11 22. "I understand that the research performed and

Lacks foundation. (Fed. R. Evid. 602.) Hearsay. (Fed. R. Evid. 802.)

12 the inventions described in the Merigan patents were all 13 funded by at least two U.S. government grants: (1) the 14 Center for AIDS Research grant AI-27762, and (2) 15 AIDS Clinical Trial Group ('ACTG') Grant AI-27766. 16 Both grants were issued by the National Institutes of 17 Health/National Institute of Allergy and Infectious 18 Diseases (NIH/NIAID)." Mejia Decl., ¶ 8. 19 23. "In the 1990s, I was engaged in seeking

Relevance. (Fed. R. Evid. 402; Docket No. 34, Transcript of May 23, 2006 telephonic hearing at 17:115 (evidence supporting Stanford's motion for summary judgment concerning U.S. Patent Nos. 5,631,128, 5,856,086, 5,650,268, and RE 38,352 is irrelevant to the issues to be resolved in this first phase of

20 licensees tot he inventions in these patents. For 21 example, beginning in the spring of 1998, I sent a series 22 of letters to Tom MacMahon of the Laboratory 23 Corporation of America (LabCrop) to offer a license to 24 the '128 and '268 patents. I sent a letter to Mr. 25 MacMahon dated October 1, 1998 to follow up on my 26 prior inquiries about LabCorp taking a license. A copy 27 of the letter is attached to the Rhyu Declaration as 28 -8-

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1 Exhibit 554A." Mejia Decl., ¶ 9. 2 24. "After the '730 patent issued in 1999, I

the litigation).) Lacks foundation to testify as to relationship between F. HoffmannLa Roche Ltd. in Basel Switzerland and the Defendants. Fed. R. Evid. 602. Improper legal conclusio n as to legal relationship between F. HoffmannLa Roche Ltd. in Basel Switzerland and the Defendants.

3 specifically sought to license this technology to Roche. 4 On or about April 6, 2000, I went to Roche in Basel, 5 Switzerland, and made a presentation to Claude 6 Montandon and Andreas Maurer, Roche's then Director 7 of Licensing." Mejia Decl., ¶ 10. 8 9 10 11 25. "I concluded the April 2000 meeting by offering

Lacks foundation to testify as to relationship between F. HoffmannLa Roche Ltd. in Basel Switzerland and the Defendants. Fed. R. Evid. 602. Improper legal conclusio n as to legal relationship between F. HoffmannLa Roche Ltd. in Basel Switzerland and the Defendants.

12 Roche an exclusive license to the '730 patent and 13 related Stanford patents." Mejia Decl, ¶ 11. 14 15 16 17 18 19 20 26. "At no time prior to this suit has Roche

Improper legal conclusio n. Van Winkle v. Crowell, 146 U.S. 42 (1892).

21 indicated to me or the Office of Technology Licensing 22 that it was exercising an option to an exclusive license 23 to the invention in the Merigan patents, or that it was 24 exercising an option to a nonexclusive license. It is my 25 understanding that Roche has never had any license to 26 the inventions in the Merigan patents." Mejia Decl., 27 ¶ 13. 28 -9-

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1 27.

"Stanford has undertaken substantial efforts to

Relevance. (Fed. R. Evid. 402; Docket No. 34, Transcript of May 23, 2006 telephonic hearing at 17:115 (evidence supporting Stanford's motion for summary judgment concerning U.S. Patent Nos. 5,631,128, 5,856,086, 5,650,268, and RE 38,352 is irrelevant to the issues to be resolved in this first phase of the litigation).)

2 license the inventions of the Merigan patents to third 3 parties and has participated in two significant patent 4 litigations relating to the patents." Mejia Decl., ¶ 14. 5 6 7 8 9 10 11 28. "Stanford's Policy on Inventions, Patents, and

Hearsay. (Fed. R. Evid. 802.) Lacks foundation. (Fed. R. Evid. 602.)

12 Licensing that was in effect in the 1980s is reflected in 13 Exhibits 24 and 25, attached to the Rhyu declaration. 14 According to that policy, Stanford allowed rights in 15 inventions to remain with inventors 'if possible.' 16 However, the policy recognized that 'the great majority' 17 of invent ions arose from research that was externally 18 funded and covered by those external funding 19 agreements." Mejia Decl., ¶ 15. 20 29. "In the case of government-funded research,

Improper legal conclusio n. Van Winkle v. Crowell, 146 U.S. 42 (1892).

21 distribution of rights in the invention was governed by 22 the Bayh-Dole Act." Mejia Decl., ¶ 15. 23 30.

"Within the Office of Technology Licensing, the Relevance. (Fed. R. Evid. 402.) Improper legal conclusio n. Van Winkle v. Crowell, 146 U.S. 42 (1892).

24 Bayh-Dole Act is understood to grant the University the 25 first right to retain title to an invention that was made 26 with government grants. If the University does not 27 elect to retain title, and the invention wishes to obtain 28 -10-

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1 rights in the invention, the inventor must petition the 2 granting agency for permission to retain rights in the 3 invention. Only after the government consents can the 4 inventor obtain ownership of the invention." Mejia 5 Decl, ¶ 16. 6 31. "Stanford required employees to assign to Hearsay. (Fed. R. Evid. 802.) Improper legal conclusio n. (Van Winkle v. Crowell, 146 U.S. 42 (1892).) Relevance. (Fed. R. Evid. 402; Raddobenko v. Automated Equip. Corp., 520 F.2d 540, 544 (9th Cir. 1975) (party cannot contradict own testimony at deposition); Rainey v. Am. Forest and Paper Ass'n, Inc., 26 F. Supp. 2d 82, 94 (D.D.C. 1998) (party cannot offer testimony contrary to that of 30(b)(6) witness without explanation); Declaration of Jeffrey N. Boozell, Dkt. No. 110, Ex. 14 (Albertson Dep.) at 199:15-200:1 (no requirement that Stanford emplo yees sign agreement).) "According to the Stanford policy, Stanford had Lacks foundation. (Fed. R. Evid. 602.) Improper legal conclusio n. (Van Winkle v. Crowell, 146 U.S. 42

7 Stanford their interests in inventions that had been 8 supported by U.S. Government grants. The Stanford 9 Copyright and Patent Agreement, Exhibit 23, paragraph 10 2, sets forth this obligation." Mejia Decl, ¶ 17. 11 12 13 14 15 16 17 18 19 20 21 22 23 24 32.

25 the first right to have title in the Merigan patents. 26 Stanford exercised that right and the inventors have 27 assigned the patents to Stanford." Mejia Decl, ¶ 18. 28 -11-

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1 2 33. Declaration of Michelle S. Rhyu in Support of

(1892).) Lacks foundation. (Fed. R. Evid. 602.) Hearsay. (Fed. R. Evid. 802.) Lacks corroboration. (Villiarimo v. Aloha Island Air, Inc., 281 F.3d 1054, 1061 (9th Cir. 2002) (selfserving, uncorroborated testimony by a party may be disregarded).) Rhyu Decl., ¶ 2, Ex. A, 161:16-163:19 Improper Non-Expert Opinion. (Fed. R. Evid. 701; Dr. Merigan has not been disclosed as an expert witness under Fed. R. Civ. P. 26.) Improper legal conclusio n. Van Winkle v. Crowell, 146 U.S. 42 (1892). Rhyu Decl., ¶ 10, Ex. I, 144:5-18, 144:22Relevance. (Fed. R. Evid. 402.) Improper legal conclusio n. (Van Winkle v. Crowell, 146 U.S. 42 (1892).) Rhyu Decl., ¶ 10, Ex. I, 83:7-20, 86:10-18. Relevance. (Fed. R. Evid. 402.) Improper legal conclusio n. (Van Winkle v. Crowell, 146 U.S. 42 (1892).) Rhyu Decl., ¶ 16, Ex. 5. Rhyu Decl., ¶ 17, Ex. 7. Rhyu Decl, ¶ 22, Ex. 23. Hearsay. (Fed. R. Evid. 802.) Hearsay. (Fed. R. Evid. 802.) Hearsay. (Fed. R. Evid. 802.)

3 Counterclaim Defendants Stanford University, Dr. 4 Merigan and Dr. Holodniy's Motion for Summary 5 Judgment, Dkt. No. 95 ("Rhyu Decl."), ¶ 2, Ex. A, 6 117:2-24. 7 8 9 10 34. 11 12 13 14 15 16 17 35.

18 145:10, 147:13-25. 19 20 21 36. 22 23 24 25 37. 26 38. 27 39. 28 -12-

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1 2 3 4 5 40. 6 7 8 9 41. 10 11 12 13 42. 14 43. 15 44. 16 45. 17 18 19 20 46. 21 22 47. 23 24 48. 25 26 27 28 -13Rhyu Decl., ¶¶ 45-46, Exs. 554 & 554A. Rhyu Decl., ¶ 41, Ex. 525 Rhyu Decl., ¶ 40, Ex. 518 Rhyu Decl., ¶ 25, Ex. 28. Rhyu Decl, ¶ 33, Ex. 46. Rhyu Decl, ¶ 34, Ex. 87. Rhyu Decl., ¶ 35, Ex. 123. Rhyu Decl., ¶ 24, Ex. 25. Rhyu Decl., ¶ 23, Ex. 24.

Simmons Creek Coal Co. v. Doran, 142 U. S. 417, 437 (1892) (recitals not competent evidence against thirdparties). Lacks foundation. (Fed. R. Evid. 602.) Authent icat ion. (Fed. R. Evid. 901.) Hearsay. (Fed. R. Evid. 802.) Lacks foundation. (Fed. R. Evid. 602.) Authent icat ion. (Fed. R. Evid. 901.) Hearsay. (Fed. R. Evid. 802.) Hearsay. (Fed. R. Evid. 802.) Hearsay. (Fed. R. Evid. 802.) Hearsay. (Fed. R. Evid. 802.) Lacks foundation. (Fed. R. Evid. 602.) Authent icat ion. (Fed. R. Evid. 901.) Hearsay. (Fed. R. Evid. 802.) Lacks foundation to authenticate. Fed. R. Evid. 602, 901. Lacks foundation to authenticate. Fed. R. Evid. 602, 901. Relevance. (Fed. R. Evid. 402; Docket No. 34, Transcript of May 23, 2006 telephonic hearing at 17:115 (evidence supporting Stanford's

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1 2 3 4 5 6 7 8 49. 9 10 11 12 13 14 15 16 17 18 50. 19 20 21 22 23 24 25 26 27 28 -14Rhyu Decl., ¶ 53, Ex. 684. Rhyu Decl., ¶¶ 47-48, Exs. 555-556.

mot ion for summary judgment concerning U.S. Patent Nos. 5,631,128, 5,856,086, 5,650,268, and RE 38,352 is irrelevant to the issues to be resolved in this first phase of the litigation).) Hearsay. (Fed. R. Evid. 802.) Relevance. (Fed. R. Evid. 402; Docket No. 34, Transcript of May 23, 2006 telephonic hearing at 17:115 (evidence supporting Stanford's motion for summary judgment concerning U.S. Patent Nos. 5,631,128, 5,856,086, 5,650,268, and RE 38,352 is irrelevant to the issues to be resolved in this first phase of the litigation).) Relevance. (Fed. R. Evid. 402; Docket No. 34, Transcript of May 23, 2006 telephonic hearing at 17:115 (evidence supporting Stanford's motion for summary judgment concerning U.S. Patent Nos. 5,631,128, 5,856,086, 5,650,268, and RE 38,352 is irrelevant to the issues to be resolved in this first phase of the litigation).)

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1 51. 2 3 4 5 6 7 8 9 10 11 52. 12 53. 13 14 15 16 17 18 19 20 21 22 54.

Rhyu Decl., ¶ 55, Ex. 692.

Relevance. (Fed. R. Evid. 402; Docket No. 34, Transcript of May 23, 2006 telephonic hearing at 17:115 (evidence supporting Stanford's motion for summary judgment concerning U.S. Patent Nos. 5,631,128, 5,856,086, 5,650,268, and RE 38,352 is irrelevant to the issues to be resolved in this first phase of the litigation).)

Rhyu Decl., ¶ 56, Ex. 693. Rhyu Decl., ¶ 64, Ex. 701.

Hearsay. (Fed. R. Evid. 802.) Relevance. (Fed. R. Evid. 402; Docket No. 34, Transcript of May 23, 2006 telephonic hearing at 17:115 (evidence supporting Stanford's motion for summary judgment concerning U.S. Patent Nos. 5,631,128, 5,856,086, 5,650,268, and RE 38,352 is irrelevant to the issues to be resolved in this first phase of the litigation).)

Supplemental Declarat ion of Michelle S. Rhyu

Best Evidence. (Fed. R. Evid. 1002.)

23 in Support of Counterclaim Defendants Stanford 24 University, Dr. Merigan and Dr. Holodniy's Opposition 25 to Counterclaimant RMS's Motion for Summary 26 Judgment, Dkt. No. 113 ("Rhyu Supp. Decl."), ¶ 2 and 27 Exhibit O, 254:3-257:15. 28 -15Case No. C-05-04158 MHP OBJECTIONS TO EVIDENCE

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1 55. 2 3 4 5 6 56. 7 8 57. 9 10 11 12 58. 13 14 15 16 59. 17 18 19 20 21 22 23 24 25 26 60. 27 28

Rhyu Supp. Decl., ¶ 3, Ex. P, 293:20-295:10

Relevance. (Fed. R. Evid. 402; Lenk v. Total-Western, Inc., 89 Cal. App. 4th 959, 970 (2001) (subjective understanding of contract not relevant).)

Rhyu Supp. Decl., ¶ 4, Ex. Q, 134:22-138:19

Lacks foundation. (Fed. R. Evid. 602)

Rhyu Supp. Decl., ¶ 13, Ex. 8.

Lacks foundation. (Fed. R. Evid. 602.) Authent icat ion. (Fed. R. Evid. 901.) Hearsay. (Fed. R. Evid. 802.)

Rhyu Supp. Decl., ¶ 18, Ex. 703.

Lacks foundation. (Fed. R. Evid. 602.) Authent icat ion. (Fed. R. Evid. 901.) Hearsay. (Fed. R. Evid. 802.)

Rhyu Supp. Decl., ¶ 19, Ex. 704.

Relevance. (Fed. R. Evid. 402; Docket No. 34, Transcript of May 23, 2006 telephonic hearing at 17:115 (evidence supporting Stanford's motion for summary judgment concerning U.S. Patent Nos. 5,631,128, 5,856,086, 5,650,268, and RE 38,352 is irrelevant to the issues to be resolved in this first phase of the litigation).)

Rhyu Supp. Decl., ¶ 20, Ex. 705.

Lacks foundation. (Fed. R. Evid. 602.)

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1 2 3 61. 4 5 6 7 62. 8 9 10 11 63. 12 13 14 15 16 64. 17 18 19 20 21 65. 22 66. Rhyu Supp. Decl., ¶ 27, Ex. 713. " It was my understanding at that time that the Rhyu Supp. Decl., ¶ 26, Ex. 712.. Rhyu Supp. Decl., ¶ 25, Ex. 711. Rhyu Supp. Decl., ¶ 24, Ex. 710. Rhyu Supp. Decl., ¶ 23, Ex. 708.

Authent icat ion. (Fed. R. Evid. 901.) Hearsay. (Fed. R. Evid. 802.) Lacks foundation. (Fed. R. Evid. 602.) Authent icat ion. (Fed. R. Evid. 901.) Hearsay. (Fed. R. Evid. 802.) Lacks foundation. (Fed. R. Evid. 602.) Authent icat ion. (Fed. R. Evid. 901.) Hearsay. (Fed. R. Evid. 802.) Hearsay. (Fed. R. Evid. 802; Simmons Creek Coal Co. v. Doran, 142 U. S. 417, 437 (1892) (recitals not competent evidence against thirdparties).) Hearsay. (Fed. R. Evid. 802; Simmons Creek Coal Co. v. Doran, 142 U. S. 417, 437 (1892) (recitals not competent evidence against thirdparties).) Hearsay. Fed. R. Evid. 802. Relevance. (Fed. R. Evid. 402; Raddobenko v. Automated Equip. Corp., 520 F.2d 540, 544 (9th Cir. 1975) (party cannot contradict own testimony at deposition); Rainey v. Am. Forest and Paper Ass'n, Inc., 26

23 MTA applied to the Cetus proprietary protocol that Dr. 24 Schwartz and I intended to repeat using the interleukin25 2 study samples corresponding to the samples we had 26 previously sent to Cetus )the "interleukin-2 PCR 27 experiments"). The proprietary protocol is specifically 28 -17-

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1 referred to in paragraph 2 of the MTA. It was my 2 understanding that the MTA applied only to materials 3 given to either myself of Dr. Schwartz in relation to the 4 use of the proprietary protocol that Cetus had in 5 December of 1988." Declaration of Thomas C. 6 Merigan, M.D., in Support of Counterclaim Defendants 7 Stanford University, Dr. Merigan and Dr. Holodniy's 8 Opposition to Counterclaimant RMS's Motion for 9 Summary Judgment, Dkt. No. 112 ("Merigan Decl."), ¶ 10 7. 11 12 13 14 15 16 67. "It was also my understanding at the time that if

F. Supp. 2d 82, 94 (D.D.C. 1998) (party cannot offer testimony contrary to that of 30(b)(6) witness without explanation); see Roche's Motion to Strike, Section I.) Lacks foundation. (Fed. R. Evid. 602.) Relevance. (Fed. R. Evid. 402; Lenk v. Total-Western, Inc., 89 Cal. App. 4th 959, 970 (2001) (subjective understanding of contract not relevant).) Inadmissible legal conclusion. Van Winkle v. Crowell, 146 U.S. 42 (1892). Relevance. (Fed. R. Evid. 402; Raddobenko v. Automated Equip. Corp., 520 F.2d 540, 544 (9th Cir. 1975) (party cannot contradict own testimony at deposition); Rainey v. Am. Forest and Paper Ass'n, Inc., 26 F. Supp. 2d 82, 94 (D.D.C. 1998)

17 the interleukin-2 PCR experiments resulted in an 18 invention, Cetus would have the first option to an 19 exclusive license at a reasonable royalty rate to be 20 negotiated at a later time. If Cetus did not want an 21 exclusive license, it also had the option to take a 22 nonexclusive license to that invention, also at a

23 reasonable royalty rate to be negotiated at a later time. I (party cannot offer testimony 24 never understood and never would have understood the 25 MTA to grant Cetus a blanket nonexclusive license 26 with no royalty." Merigan Decl., ¶ 8. 27 28 -18Case No. C-05-04158 MHP OBJECTIONS TO EVIDENCE

contrary to that of 30(b)(6) witness without explanation); see Roche's Motion to Strike, Section I.) Lacks foundation. (Fed. R. Evid.

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1 2 3 4 5 6 7 8 9 10 68. "I discussed these understandings with Cetus

602.) Relevance. (Fed. R. Evid. 402; Lenk v. Total-Western, Inc., 89 Cal. App. 4th 959, 970 (2001) (subjective understanding of contract not relevant).) Inadmissible legal conclusion. Van Winkle v. Crowell, 146 U.S. 42 (1892). Relevance. (Fed. R. Evid. 402; Raddobenko v. Automated Equip. Corp., 520 F.2d 540, 544 (9th Cir. 1975) (party cannot contradict own testimony at deposition); Rainey v. Am. Forest and Paper Ass'n, Inc., 26 F. Supp. 2d 82, 94 (D.D.C. 1998) (party cannot offer testimony contrary to that of 30(b)(6) witness without explanation); see Roche's Motion to Strike, Section I.) Lacks foundation. (Fed. R. Evid. 602.) "Dr. Holodniy's research in my laboratory was Lacks foundation. (Fed. R. Evid. 602.) Hearsay. (Fed. R. Evid. 802.)

11 employees, including Jeff Price, at this time." 12 Merigan Decl., ¶ 9. 13 14 15 16 17 18 19 20 21 22 23 69.

24 performed under two grants from the National Institutes 25 of Health: AI27762 (the 'Center for AIDS Reseach 26 grant') and AI27666 (the 'AIDS Clinical Trial Group 27 grant"). I note that, in some documents, there is a 28 -19-

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1 typographical error that refers to this as the AI27766 2 grant. Both numbers refer to the same grant." Merigan 3 Decl., ¶ 14. 4 70. "I did not understand or expect that any Relevance. (Fed. R. Evid. 402; Lenk v. Total-Western, Inc., 89 Cal. App. 4th 959, 970 (2001) (subjective understanding of contract not relevant).) Inadmissible legal conclusion. Van Winkle v. Crowell, 146 U.S. 42 (1892).

5 materials or information that Dr. Holodniy may have 6 access to at Cetus would be covered by the MTA that 7 was signed by me and Dr. Schwartz. I never told Dr. 8 Holodniy about the existence of the MTA, because it 9 never occurred to me that the MTA would apply to Dr. 10 Holodniy. No one from Cetus ever communicated to 11 me that the MTA covered materials that Dr. Holodniy 12 obtained and used at Cetus." Merigan Decl., ¶ 15. 13 71. "Several mo nths after Dr. Holodniy stopped

Relevance. (Fed. R. Evid. 402.; Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1169-71 (Fed. Cir. 2006) (evidence of actual reduction to practice must be corroborated); Mahurkar v. C.R. Bard, Inc., 79 F.3d

14 visiting Cetus to work on developing a quantitative 15 assay, he worked with me and Dr. David Katzenstein at 16 Stanford on a different clinical study that followed 17 AIDS patients who had been treated with ddi and AZT. 18 Working with those patients, we developed a method of

19 monitoring the efficacy of HIV treatments using a PCR- 1572, 1577 (Fed. Cir. 1996) 20 based assay, and demonstrated that the assay could be 21 used for determining the efficacy of treatment." 22 Merigan Decl., ¶ 16. 23 72. "The JCI article demonstrates the usefulness of a Improper Non-Expert Opinion. (Fed. (conception must be corroborated).)

24 PCR based approach for monitoring anti HIV treatment, R. Evid. 701; Dr. Merigan has not 25 which was not appreciated and highly doubted prior to 26 this work." Merigan Decl., ¶ 19. 27 28 -20Case No. C-05-04158 MHP OBJECTIONS TO EVIDENCE

been disclosed as an expert witness under Fed. R. Civ. P. 26.) Lacks foundation. (Fed. R. Evid.

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1 2 3 73. "The claims of the '705 and '730 patents capture

602.) Hearsay. (Fed. R. Evid. 802.) Improper Non-Expert Opinion. (Fed. R. Evid. 701; Dr. Merigan has not been disclosed as an expert witness under Fed. R. Civ. P. 26.) Improper legal conclusio n. Van Winkle v. Crowell, 146 U.S. 42 (1892). "In addition to the work for Drs. Holodniy, Relevance. (Fed. R. Evid. 402; Docket No. 34, Transcript of May 23, 2006 telephonic hearing at 17:115 (evidence supporting Stanford's motion for summary judgment concerning U.S. Patent Nos. 5,631,128, 5,856,086, 5,650,268, and RE 38,352 is irrelevant to the issues to be resolved in this first phase of the litigation).) "The work that Dr. Kozal and I did on detection Relevance. (Fed. R. Evid. 402; Docket No. 34, Transcript of May 23, 2006 telephonic hearing at 17:115 (evidence supporting Stanford's motion for summary judgment concerning U.S. Patent Nos. 5,631,128, 5,856,086, 5,650,268, and RE 38,352 is irrelevant to the issues

4 the discovery demonstrated in the JCI article." Merigan 5 Decl., ¶ 20. 6 7 8 9 10 74.

11 Katzenstein, and myself, another fellow in my 12 laboratory, Mike Kozal, identified mutations in the HIV 13 reverse transcription gene that could be tracked to 14 follow the efficacy of therapy." Merigan Decl., ¶ 21. 15 16 17 18 19 20 75.

21 of HIV gene mutations that could be used to predict the 22 utility of therapy was published under the title HIV-1 23 Synctium-Inducing Phenotype, Virus Burden, Codon 24 215 Reverse Transcritpas Mutation and Cd4 Cell 25 Decline in Zidovudine-Treated Patents, J. AIDS, 7:83226 38 (1994). This article and the JCI publication formed 27 the basis of the parent application that developed into 28 -21-

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1 the '705 and '730 patents. A copy of this article is 2 attached to the Supplemental Declaration of Michelle 3 Rhyu at Exhibit 704." Merigan Decl., ¶ 22. 4 76. "Dr. Kozal's work was done entirely at Stanford.

to be resolved in this first phase of the litigation).)

Relevance. (Fed. R. Evid. 402; Docket No. 34, Transcript of May 23, 2006 telephonic hearing at 17:115 (evidence supporting Stanford's motion for summary judgment concerning U.S. Patent Nos. 5,631,128, 5,856,086, 5,650,268, and RE 38,352 is irrelevant to the issues to be resolved in this first phase of the litigation).)

5 None of it took place at Cetus." Merigan Decl., ¶ 23. 6 7 8 9 10 11 12 13 14 77. Supplemental Declarat ion of Luis R. Mejia in

Unt imely. (Civil Local Rule 7-2(d), 7-3(a) (affidavits or declarations should be filed with motion papers).)

15 Support of Stanford University, Dr. Merigan and Dr. 16 Holodniy's Opposition to Defendants' Motion to Strike, 17 Dkt. No. 130 ("Mejia Supp. Decl."). 18 78. "Dr. Merigan identified in the invention

Hearsay. (Fed. R. Evid. 802.)

19 disclosure that the work was sponsored by 'NIH,' which 20 I understood to be the National Institutes of Health. 21 (Id.) Dr. Merigan further identified in that disclosure 22 that the work was funded by U.S. government grants 23 Nos. AI27762-04 and AI277666-07. (Id.)" Mejia 24 Supp. Decl., ¶ 3. 25 79. "According to this pattern and practice, at or Lacks foundation. (Fed. R. Evid. 602.)

26 near the time the disclosure was submitted, I, or 27 someone working under my direction, would have 28 -22-

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1 verified that the grant numbers listed in the April 9, 2 1992 invention disclosure corresponded to existing 3 grants applicable to Dr. Merigan." Mejia Supp. Decl., 4 ¶ 3. 5 80. 6 81. 7 82. Mejia Supp. Decl., ¶ 6. Mejia Supp. Decl., ¶ 7 Declaration of Benjamin G. Damstedt in Hearsay. (Fed. R. Evid. 802.) Hearsay. (Fed. R. Evid. 802.) Lacks foundation. (Fed. R. Evid. 602.) Hearsay. (Fed. R. Evid. 802.) Inadmissible legal conclusion. Van Winkle v. Crowell, 146 U.S. 42 (1892). Damstedt Decl., ¶ 3, Ex. B, 279:15-281:9. Relevance. (Fed. R. Evid. 402; Lenk v. Total-Western, Inc., 89 Cal. App. 4th 959, 970 (2001) (subjective understanding of contract not relevant).) Lacks foundation. (Fed. R. Evid. 602.) Hearsay. (Fed. R. Evid. 802.) Inadmissible legal conclusion. Van Winkle v. Crowell, 146 U.S. 42 (1892). Damstedt Decl., ¶ 3, Ex. B, 120:8-18, 122:9Inadmissible legal conclusion. Van Winkle v. Crowell, 146 U.S. 42 (1892).

8 Support of Stanford University, Dr. Merigan and Dr. 9 Holodniy's Opposition to Defendants' Motion to Strike, 10 Dkt. No. 131 ("Damstedt Decl."), ¶ 2, Ex. A, 61:4-18, 11 289:10-291:8. 12 13 83. 14 15 16 17 18 19 20 21 22 23 24 84.

25 123:19. 26 27 28 -23-

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

Dated: December 6, 2006

QUINN EMANUEL URQUHART OLIVER & HEDGES, LLP ADRIAN M. PRUETZ JEFFREY N. BOOZELL ROBERT W. STONE TUN-JEN CHIANG /s/ Tun-Jen Chiang Tun-Jen Chiang Attorneys for Defendants and Counterclaim Plaintiff Roche Molecular Systems, Inc.; Roche Diagnostics Corporation; and Roche Diagnostics Operations, Inc.

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