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

Filing 971

MEMORANDUM in Support re #970 MOTION in Limine to Preclude Amgen from Introducing Evidence Regarding the Safety of Mircera filed by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Toms, Keith)

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

Doc. 971

Case 1:05-cv-12237-WGY

Document 971

Filed 09/03/2007

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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 MEMORANDUM OF LAW IN SUPPORT OF ITS MOTION IN LIMINE TO PRECLUDE AMGEN FROM INTRODUCING EVIDENCE REGARDING THE SAFETY OF MIRCERAŽ 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) Kaye Scholer LLP 425 Park Avenue New York, New York 10022 Tel. [phone] Lee Carl Bromberg (BBO# 058480) Timothy M. Murphy (BBO# 551926) Julia Huston (BBO# 562160) Keith E. Toms (BBO# 663369) Nicole A. Rizzo (BBO# 663853) Bromberg & Sunstein LLP 125 Summer Street Boston, MA 02110 Tel. [phone] Counsel for Defendants F. Hoffmann-La Roche, Ltd, Roche Diagnostics GmbH, and Hoffmann-La Roche Inc.

Dated: Boston, Massachusetts September 3, 2007

Dockets.Justia.com

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I.

INTRODUCTION In an obvious attempt to prejudice Roche and its product MIRCERAŽ in the minds of

the jury with what this Court has already ruled to be irrelevant and erroneous evidence, Amgen plans to introduce to the jury alleged evidence concerning the safety of MIRCERAŽ. The issue of MIRCERAŽ's safety profile is of no relevance to any issue at this jury trial -- it is not relevant to the question of whether MIRCERAŽ infringes the claims in Amgen's patents, nor can be possibly relevant to the questions of the validity of Amgen's patents or whether Amgen's conduct before the PTO was inequitable. Amgen plainly seeks to introduce this evidence for improper purposes -- to make the baseless suggestion to the jury that Roche's product may raise safety issues, which Amgen well knows is untrue. Moreover, once approved, the FDA will have determined that MIRCERAŽ is safe and efficacious for its approved indication, putting to rest once and for all this spurious attack raised by Amgen.1 Amgen knows that its own products have been the subject of publicized criticism from both the FDA and Congress raising serious health and safety issues, and apparently to deflect whatever publicity that may have been raised as to these products, Amgen seeks to denigrate Roche's product. This entire subject area is unfair and Amgen should not be permitted to raise this issue. This gambit is precisely what FRE 403 protects against. Therefore, the Court should preclude Amgen from introducing evidence, or referring in any way to questions about the safety of MIRCERAŽ.

MIRCERAŽ has already been approved for use outside the United States and thus the allegation of safety issues is wholly inappropriate.
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II. A.

ARGUMENT EVIDENCE ABOUT MIRCERAŽ'S SAFETY PROFILE IS IRRELEVANT Amgen states that it intends to introduce during the patent trial evidence concerning the

safety profile of MIRCERAŽ. This Court has already repeatedly ruled that this evidence is not relevant to the jury phase of the trial. Indeed, one of the ten experts Amgen states that it plans to call at trial, Dr. Glenn Chertow, opines in his report on the clinical safety data of MIRCERAŽ, but Amgen fails to explain how Dr. Chertow's assessment of MIRCERAŽ's safety profile relates to alleged infringement. Another Amgen expert, Dr. John Lubina, whose opinion Dr. Chertow cites in his report, is a biostatistician who opines on the safety data in MIRCERAŽ clinical trials. These opinions are also totally irrelevant to any jury issue.2 B. EVIDENCE REGARDING MIRCERAŽ'S SAFETY PROFILE IS UNDULY PREJUDICIAL UNDER THE FEDERAL RULES OF EVIDENCE RULE 403. While evidence about MIRCERAŽ's safety profile has zero probative value at this trial, the use that Amgen wants to make of it is inaccurate, incomplete, and will create the danger of unfair prejudice. Moreover, the potential for confusing the jurors by the introduction of such irrelevant, erroneous and prejudicial evidence is palpable. If Amgen is allowed to argue safety, the jury will be distracted from core validity and infringement issues by these collateral irrelevant issues. Accordingly, the evidence regarding MIRCERAŽ's safety profile that Amgen seeks to introduce meets every factor of Rule 403's exclusion test -- it encourages the jury to decide the case based on irrelevant, erroneous, and inflammatory allegations of product Amgen has made a motion in limine to preclude Roche from relying on certain clinical safety data that post-dates the filing of its Biologics Licensing Application, Amgen Motion In Limine No. 13, Docket No. 856, dated August 22, 2007. As explained in Roche's opposition to that motion, Roche only relies on that information to rebut the baseless and irrelevant contentions that Amgen raises about safety. Should the Court grant this motion, Roche will not have to rely on post-BLA submission clinical safety data at the jury trial. 2
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disparagement, while wasting the parties' and the Court's of time as competing evidence on safety is presented. As such, the evidence should be excluded. III. CONCLUSION For the foregoing reasons, Defendants request that this Court preclude Amgen from introducing evidence, or referring to evidence, regarding the safety profile of MIRCERAŽ. Dated: September 3, 2007 Boston, Massachusetts Respectfully submitted, F. HOFFMANN-LA ROCHE LTD, ROCHE DIAGNOSTICS GMBH, and HOFFMANN-LA ROCHE INC. By their Attorneys /s/ Keith E. Toms 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] Leora Ben-Ami (pro hac vice) Mark S. Popofsky (pro hac vice) Patricia A. Carson (pro hac vice) Thomas F. Fleming (pro hac vice) Howard S. Suh (pro hac vice) Christopher T. Jagoe (pro hac vice) KAYE SCHOLER LLP 425 Park Avenue New York, New York 10022 Tel. [phone]

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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) and will be delivered to Amgen's trial counsel by electronic mail in the manner requested in the August 29, 2007, letter of Renee DuBord Brown to Thomas F. Fleming. Paper copies will be sent to those indicated as non registered participants on September 4, 2007. /s/ Keith E. Toms Keith E. Toms
03099/00501 732914.1

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