Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Filing 1254

Opposition re #1217 MOTION to Admit Exhibits into Evidence Roche's Opposition to Amgen's Motion to Admit Exhibits Into Evidence filed by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Fleming, Thomas)

Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Doc. 1254

Case 1:05-cv-12237-WGY

Document 1254

Filed 10/02/2007

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UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS ) ) ) ) ) ) ) ) ) ) ) ) )

AMGEN INC., Plaintiff, v. F. HOFFMANN-LA ROCHE LTD, ROCHE DIAGNOSTICS GmbH and HOFFMANN-LA ROCHE INC. Defendants.

CIVIL ACTION No.: 05-CV-12237WGY

ROCHE'S OPPOSITION TO AMGEN'S MOTION TO ADMIT EXHIBITS INTO EVIDENCE Amgen's motion seeking admission of a raft of journal articles, incomplete portions of irrelevant documents, unauthenticated third party documents, and documents containing multiple layers of hearsay -- all with no sponsoring witness -- should be rejected as a transparent attempt to avoid using its trial time to attempt put evidence in through witnesses. Amgen's gambit should be rejected because there are multiple reasons that each document is not admissible at trial. Roche appends hereto a chart setting forth its specific objections to each document that Amgen proffers. However, there are several broad points that pertain to Amgen's proposed exhibits that warrant discussion. Amgen Cannot Proffer Prior Art or Documents Regarding the State of the Art Amgen claims that numerous of its proposed exhibits are admissible either as prior art or as evidence of the state of the art during the relevant time period. The articles that Amgen offers are not admissible because they cannot be relevant. As the patent holder, Amgen cannot

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invalidate its own patents, and consequently cannot submit evidence of the prior art or state of the prior art. Section 282 by its terms allows for the introduction at trial of prior art and documents "showing the state of the art" only if there is notice in the pleadings or in writing of the publications being relied upon. 35 U.S.C. §282. Because it failed to file a notice pursuant to section 282, Amgen cannot present evidence at trial of either prior art or publications showing the state of the art. Amgen contends that 25 of Amgen's 28 proposed exhibits are relevant as either prior art or reflective of the state of the art . Given the clear mandates of section 282, Amgen may not obtain admission of any of these documents on that basis. In addition, Amgen includes a number of proposed exhibits created after November 1984, and thus cannot constitute evidence of the prior art. (Tabs 12-18). Amgen Fails to Demonstrate How Any Articles Are Evidence of Non-Obviousness Amgen conclusorily contends that certain documents on its list of proposed exhibit list (Tabs 20-23, 28) are admissible because they constitute evidence of non-obviousness as of 198384. Yet, Amgen fails to explain how even one of these proposed exhibits are relevant to any one of the nine factors of non-obviousness delineated by the United States Supreme Court in Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (1966). Amgen offers no explanation in its motion how any of these proposed exhibits are relevant to the Graham factors of non-obviousness. Amgen Cannot Move Articles Relied Upon By its Expert Dr. Lodish Without His Testimony Amgen's list of articles have been relief upon by their experts, particularly Dr. Lodish, who has been identified as Amgen's trial witness. Indeed, many of the articles are authored by him, and Dr. Lodish claims to have relied on most of the articles in support of his opinions in one of his expert reports. Yet rather than presenting these articles during his testimony under the learned treatise exception of FRE 803(18), which notably precludes the article from being

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admitted, Amgen does an end round and seeks actual admission of these articles without basis (see section on ancient documents, infra). The Court should not countenance Amgen's tactic and preclude it from offering evidence that it chose not to introduce with its testifying expert in order to save trial time. Amgen May Not Rely on the Ancient Documents Exception Amgen contends that the first 24 of its 28 proposed exhibits are admissible under the "ancient documents" exception of FRE 803(16). Amgen has failed to show that any of these documents is covered by that exception. Indeed, many of the documents on any of the documents contain hearsay within hearsay. therefore, they should not be admitted because each contains hearsay not subject to any exception. For example, the incomplete excerpts of the Genentech file history (Tab 15) contain hearsay statements regarding the content of scientific articles. In addition, every scientific article contains double hearsay statements regarding the findings of other cited scientific studies and articles. It is well-established that the ancient documents exception "does not justify the admission of double hearsay merely because of its presence in an ancient document." Hicks v. Charles Pfizer & Co., 466 F.Supp.2d 799, 806 (E.D.Tex. 2005). As the Hicks court stated "the danger of faulty perception persists unabated because a narrator, such as a reporter, may not properly record the remarks of the speaker." Id. Numerous other courts, including sister courts within the First Circuit, have similarly held that hearsay within ancient documents cannot be admitted, as Rule 805 plainly requires.. See, e.g., United States v. Hajda, 135 F.3d 439, 444 (7th Cir. 1998) ("if the [ancient] document contains more than one level of hearsay, an appropriate exception must be found for each level"); Elmhart Indus. v. Home Ins. Co., __ F.Supp.2d __, 2007 WL

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2782989 (D.R.I. Sept. 26, 2007) (excluding documents under the ancient documents exceptions that were "littered with admissibility issues" some of which contained "more than one level of hearsay"). Finally, it does not make sense to allow Amgen to get around the bar in the learned treatise exception to the admission of scientific articles relied upon by its experts, simply by denominating article over 20 years old as ancient documents. There is no basis to consider scientific articles written over 20 years ago to be more "truthful" than those written more recently. The rationale for the ancient documents exception -- that "age affords the assurance that the writing antedates the present controversy." FRE 803(16) (Advisory Comm. Notes) -should not apply to scientific literature, which is presumably written without an eye towards any legal disputes. Amgen Is Unable to Authenticate the Proposed Exhibits Amgen fails to provide any evidence to authenticate many of the proposed exhibits that it seeks to admit. It has not authenticated third party documents, including those as to which it seeks admission as ancient documents. Federal Rule of Evidence 901(b)(8) provides a multipronged test to establish the authenticity of an ancient document. Under that test, it is Amgen's burden to "prove[] that the item is 20 years old, is in a condition that does not raise suspicions as to authenticity, and was found in a place of natural custody for such an item." 31 Wright & Miller § 7113 at 131 (2000). Amgen fails to explain how it meets this test as to documents that are not periodicals that it claims are ancient. *** In addition, as set forth on the accompanying chart, many of the proposed exhibits are incomplete and should not be admitted and concern patently irrelevant matters.

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CONCLUSION For the foregoing reasons, the Court should deny Amgen's Motion to Admit Exhibits Into Evidence in its entirety. Dated: October 2, 2007 Boston, Massachusetts Respectfully submitted, F. HOFFMANN-LA ROCHE LTD, ROCHE DIAGNOSTICS GMBH, and HOFFMANN-LA ROCHE INC. By their Attorneys, /s/ Thomas F. Fleming Leora Ben-Ami (pro hac vice) Patricia A. Carson (pro hac vice) Thomas F. Fleming (pro hac vice) Howard S. Suh (pro hac vice) Peter Fratangelo (BBO# 639775) Vladimir Drozdoff (pro hac vice) KAYE SCHOLER LLP 425 Park Avenue New York, New York 10022 Tel. [phone] Lee Carl Bromberg (BBO# 058480) Robert L. Kann (BBO# 258025) Julia Huston (BBO# 562160) Keith E. Toms (BBO# 663369) Nicole A. Rizzo (BBO# 663853) Kregg T. Brooks (BBO# 667348) BROMBERG & SUNSTEIN LLP 125 Summer Street Boston, MA 02110 Tel. [phone] [e-mail]

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CERTIFICATE OF SERVICE I hereby certify that this document filed through the ECF system will be sent electronically to the registered participants as identified on the Notice of Electronic Filing (NEF). Pursuant to agreement of counsel dated September 9, 2007, paper copies will not be sent to those indicated as non registered participants. /s/ Thomas F. Fleming Thomas F. Fleming

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EXHIBIT CHART WITH DEFENDANTS' OBJECTIONS

Amgen, Inc. v. F. Hoffman-LaRoche Ltd. et al. Case No. 1:05CV12237 WGY
Tab 1. Ex.# DOK Date 00/00/1974 (CATEGORY A) Description Goldwasser, et al, "On the mechanism of erythropoietin-induced differentiation: XIII. The role of sialic acid in erythropoietin action," J. Biol. Chem. 249(13):4202-6 (1974) Korninger, C., et al., "Turnover of Human Extrinsic Plasminogen Activator in Rabbits," Thormb. Haemostasis 46, 658661 (1981) Lodish, "Post-Translational Modification of Proteins," Enzyme Microb Technol. 1981 Jul: 3(3):177-280, at 186 Gutterman, et al., "Recombinant Leukocyte A Interferon: Pharmacokinetics, Single Dose Tolerance, and Biological Effects in Cancer Patients," Annals of Internal Medicine 96:549-566 (1982) Kelker et al., "Effects of Glycosidase Treatment on the Physiochemical Properties and Biological Activity of Human Interferon-" J. Biol. Chem. 258:8010-13 (1983) Konrad, M. et al., "Applications of genetic engineering to the pharmaceutical Basis for Objection Amgen cannot introduce prior art; improper ancient document; improper to admit without sponsoring witness; double hearsay. Amgen cannot introduce prior art; improper ancient document; improper to admit without sponsoring witness; relied upon by Dr. Lodish in his expert report; double hearsay Amgen cannot introduce prior art; improper ancient document; improper to admit without sponsoring witness; relied upon by Dr. Lodish in his expert report, double hearsay.. Amgen cannot introduce prior art; improper ancient document; improper to admit without sponsoring witness; relied upon by Dr. Lodish in his expert report; double hearsay Amgen cannot introduce prior art; improper ancient document; improper to admit without sponsoring witness; relied upon by Dr. Lodish in his expert report; double hearsay Amgen cannot introduce prior art; improper ancient document; improper

2.

DRF

00/00/1981

3.

DSB

07/00/1981

4.

DPI

00/00/1982

5.

DQQ

00/00/1983

6.

DRC

00/00/1983

industry," Ann n Y Acad Sci. 413:12-22 (1983) 7. DIU 00/00/1984 Colby, C.B., et al., "Immunologic differentiation between E. coli and CHO cell-derived recombinant and natural human beta-interferons," J. Immunol. 133(6):3091-5 (1984) Gaylis, F.D., et al., "In vitro models of human testicular germ-cell tumors." World J. of Urol. 2:2-5, 5 (1984) Hagiwara, et al., "Erythorpoietin production in a primary culture of human renal carcinoma cells maintained in nude mice." Blood 63(4):828-835 (1984) Little, S.P., et al., "Functional Properties of Carbohydrate Depleted Tissue Plasminogen Activator," Biochemistry 23, 6191-6195 (1984) Nilsson, T., et al., "In vivo metabolism of human tissue-type plasm" Scand J. Haematol. 33, 49-53 (1984) Kopito et al., "Primary structure and transmembrane orientation of the murine anion exchange protein", Nature (1985) 316: pp. 234-238

8.

DNY

00/00/1984

9.

CXJ

04/00/1984

10.

DAH

00/00/1984

11.

DCI

00/00/1984

12.

GWV

07/18/1985

to admit without sponsoring witness; relied upon by Dr. Lodish in his expert report; double hearsay Amgen cannot introduce prior art; improper ancient document; improper to admit without sponsoring witness; relied upon by Dr. Lodish in his expert report; double hearsay Amgen cannot introduce prior art; improper ancient document; improper to admit without sponsoring witness; relied upon by Dr. Lodish in his expert report; double hearsay Amgen cannot introduce prior art; improper ancient document; improper to admit without sponsoring witness; relied upon by Dr. Lodish in his expert report; double hearsay Amgen cannot introduce prior art; improper ancient document; improper to admit without sponsoring witness; relied upon by Dr. Lodish in his expert report; double hearsay Amgen cannot introduce prior art; improper ancient document; improper to admit without sponsoring witness; relied upon by Dr. Lodish in his expert report double hearsay Postdates November 1984; Irrelevant because the paper is not on EPO, but a murine band 3 protein, which is not a hormone; Amgen cannot introduce documents regarding the state of the

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13.

DCD

00/00/1985

Mueckler et al., "Sequence and structure of a human glucose transporter," Science, Vol. 229, pp. 941-5

14.

GWW

02/25/1985

Spiess et al., "Sequence of Human Asialoglycoprotein Receptor cDNA", Jounal of Bio Chem., 260:pp. 1979-1982

15.

ABZ

10/21/1985

Paper 16, "Amendment," from certified file history of U.S. Patent No. 4,766,075

16.

CUE

00/00/1986

Erslev, A.J., and Caro, J., "Physiologic and molecular biology of erythropoietin," Med. Oncol. Tumor. Pharmacother. 3(34):159-64 (1986)

art; improper ancient document; improper to admit without sponsoring witness double hearsay. Postdates November 1984; Irrelevant because not an article on EPO, but a human glucose transporter, which is not a hormone; Amgen cannot introduce documents regarding state of the art; improper ancient document; improper to admit without sponsoring witness; relied upon by Dr. Lodish in his expert report double hearsay Postdates November 1984; Irrelevant because not an article on EPO, but a human asialoglycoprotein receptor; Amgen cannot introduce documents regarding state of the art; improper ancient document; improper to admit without sponsoring witness; double hearsay Postdates November 1984; Incomplete document; Not authenticated as an ancient document; hearsay within hearsay; irrelevant as it is a file history of Genentech; improper ancient document; improper to admit without sponsoring witness; Amgen cannot introduce documents regarding the state of the art double hearsay Postdates November 1984; Irrelevant as state of the art because it does not discuss the cloning and expression of DNA, only EPO's mechanism within

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17.

DCQ

00/00/1986

Opdenakker et al., "Influence of Carbohydrate Side Chains on Activity of Tissue-Type Plasminogen Activator," Proc. Soc. Experimental Biology and Medicine 182:248-257 (1986)

18.

DHA

00/00/1986

Vehar et al., "Characterization studies of human tissue-type plasminogen activator produced by recombinant DNA technology." Cold Spring Harbor Symp. On Quant. Biol. 51:551-562 (1986)

19.

CVS

07/00/1983

Fisher. Control of erythropoietin production. Proc Soc Exp. Biol. Med. 1983 Jul;173(3):289-305 Fisher. Mechanism of the anemia of chronic renal failure. Nephron. 1980; 25(3):106-11 Van Dyke et al., Erythropoietin Therapy in the Renoprival Pateint, U.S. Atomic

20.

DNJ

00/00/1980

21.

GWL

00/00/1967

the body; improper ancient document; improper to admit without sponsoring witness; relied upon by Dr. Lodish in his expert report; Amgen cannot introduce documents regarding the state of the art double hearsay Postdates November 1984; Irrelevant because it concerns tPA not EPO; improper ancient document; improper to admit without sponsoring witness; relied upon by Dr. Lodish in his expert report; Amgen cannot introduce documents regarding the state of the art; double hearsay Postdates November 1984; Irrelevant because it concerns tPA not EPO; improper ancient document; improper to admit without sponsoring witness; relied upon by Dr. Lodish in his expert report; Amgen cannot introduce documents regarding the state of the art; double hearsay Amgen cannot introduce prior art; improper ancient document; improper to admit without sponsoring witness.;double hearsay Amgen cannot introduce prior art; improper ancient document; improper to admit without sponsoring witness;; irrelevant to objective evidence of nonobviousness; double hearsay Amgen cannot introduce prior art; improper ancient document; improper

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Energy Commission, UCRL (1967) 17481:127-132 22. DTL 08/00/1971 Nakao et al. Erythorpoiesis in anephric or kidney transplanted pateints. Isr. J. Med. Sci. 1971 Jul-Aug; 7(7): 98690 Erslev. The search for erythropoietin. N. Engl. J. Med. 1971 Jul-Aug;7(7):986-90

23.

DMJ

04/15/1971

24.

FJT

08/2/1984

Letter from Schmergel to Albert Einstein College of Medicine re Failure of GI to express EPO from cell line (authenticated via WYETH declaration)

to admit without sponsoring witness;; irrelevant to objective evidence of nonobviousness; double hearsay Amgen cannot introduce prior art; improper ancient document; improper to admit without sponsoring witness;; irrelevant to objective evidence of nonobviousness; double hearsay Amgen cannot introduce prior art; improper ancient document; improper to admit without sponsoring witness;; irrelevant to objective evidence of nonobviousness; double hearsay Failure to authenticate as an ancient document; hearsay; irrelevant.

Tab 25.

Ex.# AJK

Date 11/02/2001

(CATEGORY B) Description Roche patent, U.S. Patent No. 6,544,748 B2, "Preparation of Erythropoietin by Endogenous Gene Activation," (Assignee Roche Diagnostics GmbH) (CATEGORY C) Description Paper 6, "Amendment," from certified file history of U.S. Patent No. 5,869,314

Basis for Objection Irrelevant; cannot constitute state of the art evidence since the document is dated in 2001

Tab 26.

Ex.# AHF

Date 07/02/1996

Basis for Objection Hearsay; lack of authentication; incomplete document; Amgen cannot introduce documents regarding the

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27.

AHQ

11/21/1996

Paper 6, "Amendment," from certified file history of U.S. Patent No. 5,753,486

stateof the art; Irrelevant as a Genentech file history Hearsay; lack of authentication; incomplete document; Amgen cannot introduce documents regarding the stateof the art; Irrelevant as a Genentech file history

Tab 28.

Ex.# FUP

Date 2006

(CATEGORY D) Description US Renal Data Service Annual Report on incidence of ESRD (2006)

Basis for Objection Irrelevant to objective evidence of nonobviousness; no foundation for admission under FRE 803(17); lack of authentication; hearsay

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