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

Filing 970

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

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

Doc. 970

Case 1:05-cv-12237-WGY

Document 970

Filed 09/03/2007

Page 1 of 3

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 MOTION IN LIMINE TO PRECLUDE AMGEN FROM INTRODUCING EVIDENCE REGARDING THE SAFETY OF MIRCERAŽ Defendants F. Hoffmann-La Roche Ltd, Roche Diagnostics GmbH, and Hoffmann-La Roche Inc. (collectively "Roche") respectfully move that the Court preclude Amgen from offering any evidence concerning the safety of Roche's MIRCERAŽ product. 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. Thus, 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.

Dockets.Justia.com

Case 1:05-cv-12237-WGY

Document 970

Filed 09/03/2007

Page 2 of 3

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. For the foregoing reasons, Defendants request that this Court preclude Amgen from introducing evidence, or referring to evidence, regarding the safety profile of MIRCERAŽ.

MIRCERAŽ has already been approved for use outside the United States and thus the allegation of safety issues is wholly inappropriate.
1

2

Case 1:05-cv-12237-WGY

Document 970

Filed 09/03/2007

Page 3 of 3

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] 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

3