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

Filing 1263

Opposition re #1255 MOTION Defendants' Request for Permission to File Opposition to Amgen's In Limine Motion Regarding MIRCERA European Approval and Label re #1251 MOTION in Limine TO PRECLUDE ROCHE FROM CLAIMING DURING THE INFRINGEMENT CASE THAT (1) MIRCER MOTION Defendants' Request for Permission to File Opposition to Amgen's In Limine Motion Regarding MIRCERA European Approval and Label re #1251 MOTION in Limine TO PRECLUDE ROCHE FROM CLAIMING DURING THE INFRINGEMENT CASE THAT (1) MIRCER MOTION Defendants' Request for Permission to File Opposition to Amgen's In Limine Motion Regarding MIRCERA European Approval and Label re #1251 MOTION in Limine TO PRECLUDE ROCHE FROM CLAIMING DURING THE INFRINGEMENT CASE THAT (1) MIRCER MOTION Defendants' Request for Permission to File Opposition to Amgen's In Limine Motion Regarding MIRCERA European Approval and Label re #1251 MOTION in Limine TO PRECLUDE ROCHE FROM CLAIMING DURING THE INFRINGEMENT CASE THAT (1) MIRCER filed by Amgen Inc.. (Rich, Patricia)

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

Doc. 1263

Case 1:05-cv-12237-WGY

Document 1263

Filed 10/03/2007

Page 1 of 4

UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS ____________________________________ ) AMGEN INC., ) ) Plaintiff, ) ) v. ) ) CIVIL ACTION No: 05-CV-12237WGY F. HOFFMAN-LAROCHE LTD ) ROCHE DIAGNOSTICS GmbH ) and HOFFMAN-LA ROCHE INC. ) ) Defendants. ) ____________________________________) AMGEN INC.'S OPPOSITION TO DEFENDANTS' REQUEST FOR PERMISSION TO FILE OPPOSITION TO AMGEN'S IN LIMINE MOTION REGARDING MIRCERA EUROPEAN APPROVAL AND LABEL Roche's "request" to file an opposition to Amgen's Motion in Limine that European approval of MIRCERAŽ is irrelevant fails to address how Roche can now possibly claim that European approval is "highly relevant" when throughout discovery Roche refused to produce documents related to submissions to foreign governmental agencies because "documents and things concerning foreign governmental agencies and bodies ... have no relevance to any claim or defense in this action. 1" As set forth in Amgen's original motion, the European Commission's approval of MIRCERAŽ has no relevance to whether MIRCERAŽ infringes Amgen's U.S. patents. Statements made by the European Commission about the label for MIRCERAŽ in Europe or its uses in Europe, have no relevance to this patent case. Indeed, the European Commission has never made, as Roche appears ready to claim, a determination that

1

See Responses 43 and 44 of Roche's Responses and Objections to Amgen's First Set of Requests for Production of Documents and Things (Nos. 1 to 224), attached as Exhibit A to Declaration of Daniel A. Curto in Support of Amgen's Motion in Limine.

Error! Unknown document property name.

Dockets.Justia.com

Case 1:05-cv-12237-WGY

Document 1263

Filed 10/03/2007

Page 2 of 4

MIRCERAŽ is not EPO within Amgen's patents. Moreover, even if it had, the European Commission has no basis under U.S. patent laws or this Court's claim construction to make that judgment. Roche will have every opportunity through opinion and fact testimony to explain its contentions as to whether MIRCERAŽ is materially changed. Moreover, it is Roche that fails to set forth the facts regarding discovery in this matter. Throughout discovery, Roche refused to produce any documents related to Roche's submissions to foreign governmental agencies.2 Roche claimed then that these documents were not relevant. That Roche -- after the close of fact discovery -- gave Amgen a handful of self-serving documents related to the European Commission's approval of MIRCERAŽ, makes Roche's failure to produce documents more, not less, prejudicial to Amgen. Roche, through its discovery tactics, denied Amgen the ability to obtain documents and conduct discovery related to Roche's submissions to foreign agencies. This prejudice alone demands that Roche not be able to use this information at trial. Finally, the foundation of Amgen's motion in limine No. 13 regarding Roche's use of FDA documents was that Roche could not use those documents to show the potential FDA approved label and uses for MIRCERAŽ because Roche refused to produce them during discovery. The situation is practically identical regarding Roche's submissions to foreign agencies. Roche has refused to produce documents related to its submissions to foreign agencies. The fact that Roche received an approval letter in Europe after the close of fact discovery does not change Roche's failure during discovery to produce any of its regulatory documents. Like the FDA documents subject to motion in limine No. 13, Roche should not be allowed to use foreign regulatory documents to make statements about the characteristics of
2

Id.

2
Error! Unknown document property name.

Case 1:05-cv-12237-WGY

Document 1263

Filed 10/03/2007

Page 3 of 4

MIRCERAŽ.

Dated: October 3, 2007

Respectfully Submitted, AMGEN INC., By its attorneys, /s/ Patricia R. Rich D. DENNIS ALLEGRETTI (BBO#545511) MICHAEL R. GOTTFRIED (BBO#542156) PATRICIA R. RICH (BBO#640578) DUANE MORRIS LLP 470 Atlantic Avenue, Suite Boston, MA 02210 Telephone: [phone] Facsimile: [phone] LLOYD R. DAY, JR DAY CASEBEER MADRID & BATCHELDER LLP 20300 Stevens Creek Boulevard, Suite 400 Cupertino, CA 95014 Telephone: [phone] Facsimile: [phone] WILLIAM GAEDE III McDERMOTT WILL & EMERY 3150 Porter Drive Palo Alto, CA 94304 Telephone: [phone] Facsimile: [phone] KEVIN M. FLOWERS MARSHALL, GERSTEIN & BORUN LLP 233 South Wacker Drive 6300 Sears Tower Chicago IL 60606 Telephone: [phone] Facsimile: [phone]

Of Counsel: STUART L. WATT WENDY A. WHITEFORD MONIQUE L. CORDRAY DARRELL G. DOTSON KIMBERLIN L. MORLEY ERICA S. OLSON AMGEN INC. One Amgen Center Drive Thousand Oaks, CA 91320-1889 [phone]

500

3
Error! Unknown document property name.

Case 1:05-cv-12237-WGY

Document 1263

Filed 10/03/2007

Page 4 of 4

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 and paper copies will be sent to those indicated as non-registered participants on October 3, 2007. /s/ Patricia R. Rich Patricia R. Rich

Error! Unknown document property name.