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

Filing 1368

MOTION to Preclude Roche's Experts from Claiming Unproven and Undisclosed FDA Certification by Amgen Inc..(Gottfried, Michael)

Download PDF
Amgen Inc. v. F. Hoffmann-LaRoche LTD et al Doc. 1368 Case 1:05-cv-12237-WGY Document 1368 Filed 10/14/2007 Page 1 of 5 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 TO PRECLUDE ROCHE'S EXPERTS FROM CLAIMING UNPROVEN AND UNDISCLOSED FDA CERTIFICATION Roche's experts should be precluded from providing testimony stating or implying that the FDA "certified" CERA as a "new chemical entity" because Roche never put forward any proof of such FDA or regulatory certification during discovery. It would thus be improper, misleading, and highly prejudicial to Amgen for any Roche expert to suggest that the FDA "certified" "approved" or "recognized" CERA as a "new chemical entity" or "new molecule." Such testimony would only serve to confuse the jury by implying a finding by the FDA that does not exist. 813920 Dockets.Justia.com Case 1:05-cv-12237-WGY Document 1368 Filed 10/14/2007 Page 2 of 5 ARGUMENT Roche's expert Dr. Longmore claims in his report that the "FDA ...certified CERA as a new chemical entity."1 However, Dr. Longmore cites no proof or evidence for this "certification" by the FDA. Other Roche experts make similar claims, again without citing any FDA or regulatory documents in support of their claims.2 Roche should not be allowed to make such baseless and unsupported claims which will confuse the jury by suggesting an official FDA determination has been made which Roche has never proven actually occurred. No FDA materials produced in discovery support the claims of Roche's experts. As detailed previously in Amgen's Motion in Limine No. 13: Exclude Evidence and Argument Regarding Roche's FDA Filings and Communications Withheld Throughout Fact Discovery,3 Roche refused to provide Amgen discovery of Roche's supplemental data and submissions to the FDA. This Court granted Amgen's motion to exclude FDA information that was not produced to Amgen.4 Thus, if there are any documents which support Roche's claim of FDA certification that were not produced to Amgen, Roche should be precluded from relying upon them, and Roche's experts may not so testify. Furthermore, the mere fact that Roche has filed a Biologic License Application ("BLA") for its peg-EPO product is not proof that peg-EPO is a "new chemical entity." Under existing FDA regulations, all biologics must file either a BLA or a New Drug Application ("NDA") in 5/11/2007 Expert Report of Gregory D. Longmore, M.D., at ¶ 86. See 6/13/2007 Supplemental Rebuttal Expert Report of Professor Alexander M. Klibanov at ¶ 58; 4/06/2007 Expert Report of Dr. Robert Langer at ¶ 47. 3 See Docket No. 856 (Motion) and 857 (Memorandum). 4 See 9/24 Docket Order. 2 1 2 Case 1:05-cv-12237-WGY Document 1368 Filed 10/14/2007 Page 3 of 5 order to obtain regulatory approval. The mere fact that Roche filed a BLA does not mean the FDA has certified peg-EPO as a "new chemical entity." CONCLUSION For the foregoing reasons, Roche's experts should be precluded from testifying or implying that the FDA has certified peg-EPO as a "new chemical entity." 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: (857) 488-4200 Facsimile: (857) 488-4201 LLOYD R. DAY, JR DAY CASEBEER MADRID & BATCHELDER LLP 20300 Stevens Creek Boulevard, Suite 400 Cupertino, CA 95014 Telephone: (408) 873-0110 Facsimile: (408) 873-0220 WILLIAM GAEDE III McDERMOTT WILL & EMERY 3150 Porter Drive Palo Alto, CA 94304 Telephone: (650) 813-5000 Facsimile: (650) 813-5100 KEVIN M. FLOWERS 3 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 (805) 447-5000 Case 1:05-cv-12237-WGY Document 1368 Filed 10/14/2007 Page 4 of 5 MARSHALL, GERSTEIN & BORUN LLP 233 South Wacker Drive 6300 Sears Tower Chicago IL 60606 Telephone: (312) 474-6300 Facsimile: (312) 474-0448 4 Case 1:05-cv-12237-WGY Document 1368 Filed 10/14/2007 Page 5 of 5 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 5

Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.


Why Is My Information Online?