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

Filing 922

MEMORANDUM in Support re 921 MOTION in Limine No. 22: Preclude Roche From Introducing, Including in Its Invalildity Opening, Testimony, Evidence or Argument on Pegylation During the Validity Phase of the Trial and to Exclude any Proffered Testimony by Dr. Robert Langer During filed by Amgen Inc.. (Gottfried, Michael)

Download PDF
Amgen Inc. v. F. Hoffmann-LaRoche LTD et al Doc. 922 Case 1:05-cv-12237-WGY Document 922 Filed 08/31/2007 Page 1 of 8 UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS AMGEN INC., 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. ) ) ) ) ) ) ) ) ) ) ) ) ) ) Civil Action No.: 1:05-cv-12237 WGY PLAINTIFF AMGEN INC.'S BRIEF IN SUPPORT OF ITS MOTION IN LIMINE NO. 22 TO PRECLUDE ROCHE FROM INTRODUCING, INCLUDING DURING ITS VALIDITY OPENING TESTIMONY, EVIDENCE OR ARGUMENT ON PEGYLATION DURING THE VALIDITY PHASE OF THE TRIAL AND TO EXCLUDE ANY PROFFERED TESTIMONY BY DR. ROBERT LANGER DURING THE TRIAL MPK 131473-1.041925.0023 Dockets.Justia.com Case 1:05-cv-12237-WGY Document 922 Filed 08/31/2007 Page 2 of 8 TABLE OF CONTENTS Page I. II. INTRODUCTION ...............................................................................................................1 EVIDENCE REGARDING PEGYLATION IS IRRELEVANT TO THE VALIDITY OF THE LIN PATENTS .................................................................................2 A. The Expert Testimony of Dr. Robert Langer Should Be Excluded from the Trial in its Entirety ...................................................................................................2 B. Roche Should Be Precluded From Introducing Deposition Designations Related to Pegylation and/or peg-EPO ....................................................................3 C. Any Other Evidence, Testimony, or Argument Relating to Pegylation Should Be Excluded From the Validity Phase of the Trial and Its Admission Will Likely Lead To Juror Confusion ...................................................4 CONCLUSION....................................................................................................................4 III. MPK 131473-1.041925.0023 Case 1:05-cv-12237-WGY Document 922 Filed 08/31/2007 Page 3 of 8 TABLE OF AUTHORITIES Page CASES Lohnes v. Level 3 Commc'ns, Inc., 272 F.3d 49, 60 (1st Cir. 2001)...................................................................................................3 Cell Genesys, Inc. v. Applied Research Systems ARS Holding, N.V., 2007 U.S. Dist. LEXIS 58658 (D. Mass. Aug. 13, 2007) .........................................................3 FEDERAL STATUTES Fed. R. Civ. P. 26(a)(2)....................................................................................................................3 Fed. R. Civ. P. 37(c)(1)................................................................................................................2, 3 Fed. R. Evid. 401 .............................................................................................................................2 Fed. R. Evid. 402 .............................................................................................................................2 Fed. R. Evid. 403 .............................................................................................................................2 MPK 131473-2.041925.0023 1 PLAINTIFF'S BRIEF RE M/IN LIMINE NO. 22 CIVIL ACTION NO. 1:05-CV-12237 WGY Case 1:05-cv-12237-WGY Document 922 Filed 08/31/2007 Page 4 of 8 I. INTRODUCTION The Court's August 27, 2007, Order granted Amgen's Motion for Summary Judgment That Dr. Lin's Asserted Claims "are described and enabled, because as a matter of law, Dr. Lin must enable one of ordinary skill in the art the full scope of his claimed invention, not how to make pegylated erythropoietin." (emphasis added).1 This rendered moot and irrelevant any lay or expert evidence during the invalidity phase of the trial on the question whether one of ordinary skill in the art could pegylate EPO in 1984, and whether Dr. Lin was in possession of the invention of pegylated EPO. As a consequence, Roche has no legitimate reason to introduce pegylation evidence or argument with respect to the validity of the Lin patents during the validity phase. Nonetheless, Roche has not withdrawn its expert on these issues, Dr. Langer, from the list of witnesses, and its recent designations of deposition testimony of Amgen witnesses all show that Roche still intends to offer during the validity phase evidence on pegylation. However, as pegylation is irrelevant to the validity of Dr. Lin's claims, as the Court recently adjudicated, evidence on whether pegylation was predictable or whether one of skill in the art could pegylate EPO, as apparently Roche intends to introduce, serves no relevance to the issues in the validity phase and will confuse and mislead the jury. With trial almost at hand Amgen requests the Court to consider this motion before opening oral arguments as it relates to significant issues that are likely to be among the first raised in the initial validity phase of the trial.2 Specifically, Amgen moves to exclude any testimony by Dr. Langer on pegylation, and to exclude the testimony of two Amgen witnesses, Dr. Molineux, and Dr. Elliott, that address this issue.3 The Court's August 27, 2007 Order did not grant part 3 of Amgen's motion relating to the definiteness of the term "human erythropoietin." That portion of Amgen's motion is unrelated to the issues presented in this motion in limine. 2 Amgen files this motion mindful of the fact that the trial of this matter begins in a few days. This motion could not have been filed earlier because the issues it raises first crystallized with the Court's August 27, 2007 Order. 3 Roche incorporated by reference the Expert Report of Dr. Langer into the Supplemental Rebuttal Expert Report of Dr. Klibanov. To the extent that Roche intends to call Dr. Klibanov to testify on these issues during the invalidity phase, such testimony is likewise irrelevant under the Court's summary judgment grant and should be excluded. 1 -1MPK 131473-2.041925.0023 Case 1:05-cv-12237-WGY Document 922 Filed 08/31/2007 Page 5 of 8 II. EVIDENCE REGARDING PEGYLATION VALIDITY OF THE LIN PATENTS IS IRRELEVANT TO THE Relevant evidence is "evidence having any tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence." FED. R. EVID. 401. Given the Court's August 27th Order, evidence relating to pegylation will have no impact on any fact of consequence to the determination of the validity of the Lin patents. Evidence and argument relating to pegylation during the validity phase of the trial is irrelevant and should be excluded under Federal Rule of Evidence 402. Moreover, such evidence and argument should also be excluded under Federal Rule of Evidence 403 due to the substantial likelihood that it would unfairly prejudice Amgen by allowing Roche to urge contentions it never disclosed. See FED. R. EVID. 403. Moreover, any attempt by Roche to offer evidence relating to pegylation for any other purpose during the validity phase of the trial is barred by the Federal Rules of Civil Procedure. In particular, Rule 37(c)(1) would preclude a party who, without substantial justification, fails to supplement its interrogatory responses to disclose additional contentions. FED. R. CIV. PROC. 37(c)(1). A. THE EXPERT TESTIMONY OF DR. ROBERT LANGER SHOULD BE ELUDED FROM THE TRIAL IN ITS ENTIRETY Roche's expert Dr. Robert Langer's expert report is directed solely to the written description and enablement of the Lin patents. Specifically, Dr. Langer's opinion was limited to: "whether these patents would enable a person of skill in the art in 1983-84 to generate analogs of erythropoietin ("EPO") such as a polyethylene glycol ("PEG") modified protein having in vivo erythropoietin-like activity that is therapeutically useful, through routine experimentation" and "whether the specification of the Lin patents provide [sic] adequate written description of a PEG modified protein having in vivo erythropoietin-like activity that is therapeutically useful." [Declaration of William G. Gaede, III ("Gaede Decl."), Ex. 1]. Dr. Langer confirmed during his deposition that he was not providing an opinion on whether the patents-in-suit enable production of recombinant erythropoietin or a process for preparing human erythropoietin. [Gaede Decl., -2MPK 131473-2.041925.0023 Case 1:05-cv-12237-WGY Document 922 Filed 08/31/2007 Page 6 of 8 Ex. 2] Dr. Langer provided no opinions whatsoever relating to infringement or inequitable conduct. [Gaede Decl., 6]. Having opined on nothing more than enablement and written description of PEGmodified proteins, Dr. Langer cannot offer testimony at trial beyond this limited scope. FED. R. CIV. P. 26(a)(2)(B). And because the Court's Summary Judgment Order establishes that Dr. Lin's patents are enabled and adequately described, any testimony that Dr. Langer could give can have no relevance to the validity of the patents. In addition, Dr. Langer cannot offer testimony during the infringement or inequitable conduct phases of the trial, having expressed no opinions in his report on these issues. See Cell Genesys, Inc. v. Applied Research Systems ARS Holding, N.V., No. 05-12448-MLW and 0411810-MLW, 2007 U.S. Dist. LEXIS 58658, at *58-59 (D. Mass. Aug. 13, 2007) (an expert may not provide evidence or opinions that were not disclosed as required by Rule 26(a)(2)(B), except in certain, specified circumstances). "A party proposing to rely on evidence or testimony which it did not properly disclose to its adversary in discovery bears the burden of demonstrating a `substantial justification' for the failure to disclose or that such failure was `harmless.'" Id. (citing FED. R. CIV. P. 37(c)(1)). Neither branch of the exception applies to this case. Any attempt by Roche to have Dr. Langer testify during the infringement or inequitable conduct phases of the trial would be exactly the type of unfair tactical advantage that the disclosure rules were designed to eradicate. See Lohnes v. Level 3 Commc'ns, Inc., 272 F.3d 49, 60 (1st Cir. 2001). B. ROCHE SHOULD BE PRECLUDED FROM INTRODUCING DESIGNATIONS RELATED TO PEGYLATION AND/OR PEG-EPO DEPOSITION The deposition testimony designated by Roche of two Amgen witnesses, Graham Molineux and Stephen Elliott, relate to pegylation and its predictability or unpredictability. The Court's grant of summary judgment renders irrelevant such testimony as it does not relate to an issue present during the validity phase of the trial. Because the Court has ruled that Dr. Lin's patent claims are adequately described and enabled, and the Lin patents need not describe or enable how to make pegylated erythropoietin, the designated testimony of witnesses Molineux -3MPK 131473-2.041925.0023 Case 1:05-cv-12237-WGY Document 922 Filed 08/31/2007 Page 7 of 8 and Elliott has no relevance to any issue related to validity in this case. Roche should be precluded from offering these deposition designations as testimony during the validity phase of the trial, as more particularly set out in the deposition excerpts attached hereto. [Gaede Decl., Exs. 3 and 4]. C. ANY OTHER EVIDENCE, TESTIMONY, OR ARGUMENT RELATING PEGYLATION SHOULD BE EXCLUDED FROM THE VALIDITY PHASE OF TRIAL AND ITS ADMISSION WILL LIKELY LEAD TO JUROR CONFUSION TO THE Other evidence, testimony, or argument relating to pegylation or Roche's product should be excluded from the validity phase of the trial because it is irrelevant to any issue of patent validity. Moreover, admission of any such evidence will lead to juror confusion. The validity phase of the case should be limited to an evaluation of Lin's inventions and not an explanation of Roche's peg-EPO. Introducing evidence of pegylation, its predictability, and whether it could have been done in 1984 will confuse the jurors, waste judicial resources, and may lead to an erroneous result. Such evidence has no probative value, but even if it did, its prejudicial effect far outweighs that value and should be excluded. III. CONCLUSION For the reasons stated above, Roche should be excluded at trial from introducing evidence or argument on pegylation during the validity phase of the trial. DATED: August 31, 2007 Respectfully Submitted, AMGEN INC., /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 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 (805) 447-5000 -4MPK 131473-2.041925.0023 Case 1:05-cv-12237-WGY Document 922 Filed 08/31/2007 Page 8 of 8 Lloyd R. Day, Jr. (pro hac vice) DAY CASEBEER MADRID & BATCHELDER LLP 20300 Stevens Creek Boulevard, Suite 400 Cupertino, CA 95014 Telephone: (408) 873-0110 Facsimile: (408) 873-0220 William G. Gaede III (pro hac vice) McDERMOTT WILL & EMERY 3150 Porter Drive Palo Alto, CA 94304 Telephone: (650) 813-5000 Facsimile: (650) 813-5100 Kevin M. Flowers (pro hac vice) MARSHALL, GERSTEIN & BORUN LLP 233 South Wacker Drive 6300 Sears Tower Chicago, IL 60606 Telephone: (312) 474-6300 Facsimile: (312) 474-0448 CERTIFICATE OF SERVICE I hereby certify that this document filed through the Electronic Case Filing (ECF) system will be sent electronically to the registered participants as identified on the Notice of Electronic Filing (NEF) and paper copies will be sent to those indicated as non registered participants on the above date. /s/ Michael R. Gottfried Michael R. Gottfried -5MPK 131473-2.041925.0023

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?