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

Filing 1422

MOTION in Limine Regarding Flavell No. 8: To Preclude Richard A. Flavell from Offering Opinions that were Rejected by this Court's Holding that PEG-EPO Infringes Claim 1 of Dr. Lin's '422 Patent by Amgen Inc..(Gottfried, Michael)

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

Doc. 1422

Case 1:05-cv-12237-WGY

Document 1422

Filed 10/15/2007

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UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS AMGEN INC., ) ) ) ) Civil Action No.: 1:05-cv-12237 WGY ) ) ) ) ) ) ) ) )

F. HOFFMANN-LA ROCHE LTD, a Swiss Company, ROCHE DIAGNOSTICS GMBH, a German Company, and HOFFMANN LA ROCHE INC., a New Jersey Corporation,

AMGEN'S MOTION IN LIMINE REGARDING FLAVELL NO. 8: TO PRECLUDE RICHARD A. FLAVELL FROM OFFERING OPINIONS THAT WERE REJECTED BY THIS COURT'S HOLDING THAT PEG-EPO INFRINGES CLAIM 1 OF DR. LIN'S `422 PATENT The law of the case doctrine and Fed. R. Civ. P. 56(d) bar Roche from arguing or presenting evidence that contradicts this Court's order that peg-EPO infringes claim 1 of Amgen's `422 patent. Roche's expert, Richard A. Flavell, however, offers opinions in his expert reports that directly contradict the foundation of this Court's order. Rule 56(d) prohibits Dr. Flavell from providing such testimony at trial. As set forth in Rule 56(d), where there has been a partial adjudication of facts, "the fact so specified shall be deemed established, and the trial shall be conducted accordingly." Dr. Flavell should be precluded from offering any opinions that contradict facts adjudicated by this Court's order of summary judgment. The first opinion that Dr. Flavell offers that contradicts this Court's order of summary judgment is that Roche's peg-EPO is not a pharmaceutical composition comprising "human erythropoietin." Dr. Flavell's bases for this opinion are twofold. First, he claims that Amgen's patents cover only "human erythropoietin" with a 166 amino acid sequence, and peg-EPO contains a 165 amino acid EPO. Second, he claims that the "human erythropoietin" covered by 1
MOTION IN LIMINE RE FLAVELL CONTRADICTING THIS COURT'S ORDER OF SUMMARY JUDGMENT.

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Case 1:05-cv-12237-WGY

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Amgen's patents pertains only to "obligate glycoproteins" and CERA is not comprised of EPO with an obligate glycoprotein. In light of the Court's order of summary judgment on claim 1 of the `422 patent, Dr. Flavell should be precluded from any testimony that (1) "human erythropoietin" is limited to a 166 amino acid sequence; or (2) that "human erythropoietin" includes only EPO with an obligate glycoprotein. In addition, Dr. Flavell also contradicts this Court's order of summary judgment by claiming that peg-EPO is not comprised of human erythropoietin purified from mammalian cells grown in culture. Dr. Flavell asserts this opinion by referencing only the end product of Roche's pegylation of EPO. He ignores, entirely, the epoetin beta component that Roche incorporates into its peg-EPO. It is the law of this case, however, that this epoetin beta component is purified from mammalian cells grown in culture. Dr. Flavell should be precluded from offering any contrary opinion. Pursuant to Rule 56(d) and the law of the case doctrine,1 as well as this Court grant of Amgen's motion to preclude testimony that: "(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"2 Roche should be precluded from contradicting the Court's factual determination as a matter of law. Specifically, Dr. Flavell should not be allowed to present testimony or evidence that See United States v. Medina, 219 Fed. Appx. 20, 21-22 (1st Cir. 2007) (Under the relevant branch of the law of the case doctrine, "a legal decision made at one stage of a civil or criminal proceeding ... remain[s] the law of that case throughout the litigation, unless and until the decision is modified or overruled by a higher court" citing United States v. Moran, 393 F1, 7 (1st Cir. 2004). 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 10/2/07, Note 3. 2
MOTION IN LIMINE RE FLAVELL CONTRADICTING THIS COURT'S ORDER OF SUMMARY JUDGMENT. 2 1

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contradicts this Court's holding that peg-EPO contains human erythropoietin that is purified from mammalian cells grown in culture. DATED: 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 G. 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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MOTION IN LIMINE RE FLAVELL CONTRADICTING THIS COURT'S ORDER OF SUMMARY JUDGMENT.

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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 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

BST99 1554290-1.041925.0056