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

Filing 1378

BRIEF by Amgen Inc. = Bench Memorandum to Preclude Roche From Introducing Testimony of Dr. Longmore That Is Contrary To The Court's Prior Orders Regarding Safety, Dosing, Undisclosed FDA Commuincations, And Whether MIRCERA Contains Human EPO. (Gottfried, Michael)

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

Doc. 1378

Case 1:05-cv-12237-WGY

Document 1378

Filed 10/15/2007

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

Civil Action No.: 05-12237 WGY

AMGEN'S BENCH MEMORANDUM TO PRECLUDE ROCHE FROM INTRODUCING TESTIMONY OF DR. LONGMORE THAT IS CONTRARY TO THE COURT'S PRIOR ORDERS REGARDING SAFETY, DOSING, UNDISCLOSED FDA COMMUNICATIONS, AND WHETHER MIRCERA CONTAINS HUMAN EPO In accordance with this Court's prior Orders regarding the admissibility and relevance of certain categories of information, Roche's expert witness, Dr. Longmore, should be precluded from introducing the following evidence or testimony regarding: 1) Safety, efficacy or dosing of peg-EPO, and clinical comparisons with other ESAs,1 2) FDA communications or post-filing submissions to the FDA not produced to Amgen, 2 3) Claims that MIRCERA does not comprise human EPO. 3

See Amgen Inc.'s Motion Preclude Roche from Introducing Evidence or Testimony Regarding the Safety or Efficacy of PEG-EPO Because Roche has Asserted that these Topics are Irrelevant and on that Basis Denied Amgen Fulsome Discovery, Docket No. 1265, Granted 10/4/07. 2 See Amgen's Motion in Limine No. 13: Exclude Evidence and Argument Regarding Roche's FDA Filings and Communications Withheld Throughout Fact Discovery, Docket No. 856, Granted 9/24/07. 3 See Amgen's Motion in Limine To Preclude Roche From Claiming During The Infringement Case That (1) MIRCERA Does Not Comprise Human EPO, In Contradiction Of This Courts Finding Of Infringement On Claim 1 Of The 422 Patent And (2) That European Regulatory Approval Has Any Relevance To The Claims In This Lawsuit, Docket No. 1251, Granted
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ARGUMENT Dr. Longmore should be precluded from testifying about the clinical benefits of pegEPO, including its dosing regimen. This Court previously granted Amgen's motion to preclude testimony regarding: "[A]rgument or evidence related to the safety and efficacy of its accused product--including dosing regimens, perceived clinical benefits, and clinical improvements over established ESAs."4 Dr. Longmore discusses these issues in the following paragraphs of his May 11, 2007 expert report: ¶¶168-186 (clinical benefits); ¶¶80-81 (injection frequency); ¶126 (CERA immunogenicity); ¶142 (dosing and quality of life); ¶143 (medical benefits); ¶147 (dosing); ¶¶213-214 (dosing). Roche also disclosed to Amgen in its evidentiary disclosures for Dr. Longmore's direct examination numerous demonstratives describing injection frequency (GL-4, GL-5, GL-6, GL-7, GL-31, GL32, GL-34) ­ further proof that Roche intends to elicit this prohibited testimony. Dr. Longmore should also be precluded from testifying about FDA communications not produced to Amgen. This Court previously granted Amgen's motion to preclude testimony regarding: "The potential FDA approved label and uses of peg-EPO," including "supplemental BLA submissions," post-filing evidence relating to the safety of peg-EPO, and expert testimony relying on such post-filing submissions.5 Dr. Longmore discusses FDA "certification" in ¶86 of his May 11, 2007 expert report, but never explains or provides a basis for this testimony. This testimony should be excluded as unsupported by any FDA-related document produced by Roche in this litigation. 6 10/2/07. 4 Supra note 1. 5 Supra note 2. 6 See also Plaintiff Amgen Inc.'s Motion to Preclude Roche's Experts from Claiming Unproven
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Finally, Dr. Longmore should be precluded from testifying that MIRCERA does not contain "human EPO." This Court previously granted Amgen's motion to preclude testimony regarding: "(1) [MIRCERA Does Not Comprise Human EPO, In Contradiction of This Courts Finding of Infringement on Claim 1 of the 422 Patent] only insofar as the claim may relate to claim 1 of the `422 patent."7 Dr. Longmore opines on this topic in the following paragraphs of his May 11, 2007 expert report: ¶¶ 25-26 and 206-211, and any such testimony should be excluded. CONCLUSION For the foregoing reasons, Dr. Longmore should be precluded from testifying contrary to this Court's prior Orders on the topics noted above.

and Undisclosed FDA Certification, filed 10/14/07. 7 Supra note 3.
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October 15, 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. (pro hac vice) DAY CASEBEER MADRID & BATCHELDER LLP 20300 Stevens Creek Boulevard, Suite 400 Cupertino, CA 95014 Telephone: [phone] Facsimile: [phone] WILLIAM GAEDE III (pro hac vice) McDERMOTT WILL & EMERY 3150 Porter Drive Palo Alto, CA 94304 Telephone: [phone] Facsimile: [phone] KEVIN M. FLOWERS (pro hac vice) 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 91320-1789 [phone]

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Case 1:05-cv-12237-WGY

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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. By agreement of the parties, paper copies will not be sent to those indicated as non-registered participants.

/s/ Michael R. Gottfried Michael R. Gottfried

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