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

Filing 1377

MOTION for Leave to File A Reply to Roche's Opposition to Amgen's Bench Memorandum Regarding Evidence of Infringement of '349 Claim 7 by Amgen Inc.. (Attachments: #1 Exhibit A)(Gottfried, Michael)

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

Doc. 1377

Case 1:05-cv-12237-WGY

Document 1377

Filed 10/14/2007

Page 1 of 4

UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS ) ) ) Plaintiff, ) v. ) ) ) F. HOFFMANN-LAROCHE LTD., a Swiss Company, ROCHE DIAGNOSTICS ) ) GMBH, a German Company, and ) HOFFMANN LAROCHE INC., a New ) Jersey Corporation, ) ) Defendants. AMGEN, INC.,

Civil Action No. 05 CV 12237 WGY

PLAINTIFF AMGEN INC.'S MOTION FOR LEAVE TO FILE A REPLY TO ROCHE'S OPPOSITION TO AMGEN'S BENCH MEMORANDUM REGARDING EVIDENCE OF INFRINGEMENT OF `349 CLAIM 7 Amgen respectfully requests leave to file a Reply to Roche's Opposition to Amgen's Bench Memorandum Regarding Evidence of Infringement of `349 Claim 7.1 As grounds for this request, Amgen states that a reply is necessary to address certain arguments raised by Roche in its Opposition. Specifically, a reply is necessary to demonstrate that, contrary to the attorney argument that forms the sole basis for Roche's Opposition, Dr. Lodish's testimony and Roche's own documents provide three separate and sufficient bases for a finding of infringement of `349 claim 7: 1. Dr. Lodish's opinion that Roche's cells are capable upon growth in culture of producing EPO in excess of 100 U per 106 cells in 48 hours based upon his review of and reliance upon radioimmunoassay tests performed by Dr. McLawhon on Roche's cells grown in culture by Dr. Kolodner.2

1 2

A copy of Amgen's Proposed Reply is attached hereto as Exhibit A. Trial Tr. 2452:19 ­ 2455:11.

DM1\1206849.1

Dockets.Justia.com

Case 1:05-cv-12237-WGY

Document 1377

Filed 10/14/2007

Page 2 of 4

2. Dr. Lodish's calculation based on data reported in Roche's BLA (Ex. 52) that Roche's commercial cells produce "in round numbers 1,500 units of EPO per million cells in 48 hours." This calculation was based upon an ELISA assay reported in the BLA which Dr. Lodish described as "a similar assay" to a radioimmunoassay ­ "both assays use an antibody to EPO which binds specifically to EPO to measure how much EPO is in the culture fluid" ­ and the results "would be very similar, if not identical."3 3. Roche's BLA shows that Roche follows the teachings of Example 10 in Dr. Lin's patents to make the EPO component of peg-EPO. Using these steps, the same cells described in Dr. Lin's Example 10 produced EPO well in excess of the production levels recited in the `349 claims.4 Since Roche follows these same steps, it would be more than reasonable for the jury to conclude that Roche's cells are capable of achieving the same "high level of expression of EPO" as Dr. Lin's cells. Based on the foregoing, Amgen submits that a brief reply is necessary to more fully address the foregoing and will aid the Court in deciding this matter.

3 4

Trial Tr. 2449:23 -2451:15. Trial Ex. 1, Col. 26, lines 43 ­ 65; Col. 28, lines 6-10.

2
DM1\1206849.1

Case 1:05-cv-12237-WGY

Document 1377

Filed 10/14/2007

Page 3 of 4

Dated: October 14, 2007

Respectfully Submitted, AMGEN INC., By its attorneys, /s/ Michael R. Gottfried D. DENNIS ALLEGRETTI (BBO#545511) MICHAEL R. GOTTFRIED (BBO#542156) PATRICIA R. RICH (BBO#640578) DUANE MORRIS LLP 470 Atlantic Avenue, Suite 500 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]

3
DM1\1206849.1

Case 1:05-cv-12237-WGY

Document 1377

Filed 10/14/2007

Page 4 of 4

CERTIFICATE PURSUANT TO LOCAL RULE 7.1 I certify that counsel for the parties have conferred in an attempt to resolve or narrow the issues presented by this motion and no agreement was reached. /s/ Michael R. Gottfried Michael R. Gottfried

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 14, 2007. /s/ Michael R. Gottfried Michael R. Gottfried

4
DM1\1206849.1