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

Filing 738

MOTION for Leave to File Reply in Support of Defendants' Motion Pursuant to Fed. R. Civ. P. 56(f) for Relief from Amgen's Motion for Summary Judgment of No Inequitable Conduct by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Attachments: #1 Exhibit Defendants' Reply in Support of Its Motion for 56(f) Relief from Plaintiff's Motion for Summary Judgment of No Inequitable Conduct#2 Affidavit Declaration of Thomas Fleming#3 Exhibit Exhibit 1 to Declaration of Thomas Fleming#4 Exhibit Exhibit 2 to Declaration of Thomas Fleming#5 Exhibit Exhibit 3 to Declaration of Thomas Fleming#6 Exhibit Exhibit 4 to Declaration of Thomas Fleming)(Toms, Keith)

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

Doc. 738 Att. 4

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Exhibit 2

UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS

-- --- -- --- --- - - - --------- ----- --- -- ---x
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.: 05-12237 WGY

- -- - -- - - - -- - - - -- --- - -- - - - - - - - - - - - - - - - - x
DEFENDANTS' SUPPLEMENTAL RESPONSES AND OBJECTIONS TO PLAINTIFF AMGEN INC.'S THIRD SET OF INTERROGATORIES TO DEFENDANTS (NO. 26)
Defendants and Counterclaim-plaintiffs F. Hoffmann-La Roche Ltd., Roche Diagnostics

GmbH, and Hoffiann-La Roche Inc. (collectively "Roche") hereby object and respond to
Plaintiff and Counterclaim-defendant Amgen Inc.' s ("Amgen") Third Set of Interrogatories (No.
26).

GENERAL OBJECTIONS
The following general objections apply to all of

Roche's responses and shall be

incorporated in each response as if

fully set forth therein ("General Objections"). To the extent

specific General Objections are cited in response to a specific interrogatory, those specific General Objections are provided because they are believed to be particularly applicable to the specific interrogatory and are not to be construed as waiver of any other General Objections
applicable to the interrogatory.

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acknowledged that its process and resulting in vivo biologically active erythropoietin was

merely an obvious and inherent result of expressing the DNA sequence encoding human

erythropoietin in a host cell: "the particular type of glycosylation linkages was simply a
result of the type of

host cell used to produce the recombinant erythropoietin." (EP 411
.

678 Opposition Proceedings, Statement of Grounds submitted by Amgen 10/8/1992).

Amgen's consistent pattern of failing to apprise the United States examiners of material information from European proceedings is similarly shown through its failure to disclose arguments that were raised during the opposition proceedings to its Kirin-Amgen European Patent Application No. 0 148 605 regarding the high materiality of errors in the

data corresponding to Example 10 of its US patent application. (European Tech. Board of
Appeals 11/21/1994 ("(A)s admitted by the Respondents, the carbohydrate analysis
performed in Example 10 was erroneous."); see also 9/6/2000 BOlUn Trial Tr. 2854:9-25

(incorrect hexose/fucose values in U.S. Patents)).

Amgen also asserted that it was inappropriate for the examiner to consider prior
art (the Yokota 4,695,542 patent) in conjunction with the claims of

the '008 patent to

show that the pending claims were obvious arguing that "as noted in the decisional
authorities, (double patenting) must be determined through consideration of

the claims of

the pending application and issued patent -- and not with reference to the prior art." (AM*

In addition, Amgen also failed to disclose inconsistent arguments made during the following proceedings in Europe: (1) Ortho Pharmaceutical Corp. v. Boehringer Mannheim GmbH (Landgericht Dusseldorf (4 0 150/91)) (Patent infringement action for E 0 148 605), (2) Boehringer Mannheim GmbH v. Janssen-Cilag GmbH (4 0 229/91, Landgericht Dusseldorf) (Cilag I), EP 0 205564 (3) Boehringer Mannheim GmbH v. Janssen-Cilag GmbH (4 0 58/92, Landgericht Dusseldorf) (Cilag II), EP 0 411 678; (4) Boehringer Mannheim GmbH v KirinAmgen, (3 Ni 32/93, Bundespatentgericht (BPG)) and appeals therefrom and (5) Kirin-Amgen and Ortho Pharmaceuticals v. Boehringer Mannheim GmbH and Boehringer Mannheim UK Ltd.,
The High Court Of Justice Chancery Division, Patents Court (CH 1993-K-No. 937).

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demonstration that all of

the carbohydrate structures in r-HuEPO are also found in u-EPO.");

AM-ITC 00092884; AM-ITC 00092981-83). Nor did Amgen explain to the examiner(s) that
purported differences in glycosylation and carbohydrate composition were not due to differences
between CHO rEPO and urinary EPO, but because of different purification techniques in certain

instances and variability and error in testing techniques. These documents and information were
not submitted to the examiners.
Furthermore, after Amgen learned of the error in its reporting of

the carbohydrate

analysis ofCHO rEPO and urinary EPO in example 10 ('933 patent 28:51-67), it did not make
that error known to the various examiners or the public by disclosing the mistake in any response

or amendment in the file history. But for Amgen's misconduct conduct at least claims 1,2 and 6
of the '933 patent and claim 1 of

the '080 patent would not have issued. Accordingly, the '933

patent and the related '080 patents are unenforceable for inequitable conduct.

Amgen's Affrmative Misrepresentations and Omissions Regarding Molecular Weight
In addition to the information outlined above regarding COS rEPO and CHO rEPO (hereby incorporated), in 1995 Mr. Borun presented for the first time a claim requiring that "said

product has a higher molecular weight than human urinary EPO as measured by SDS-PAGE."
(AM-1TC 00941545), and the claim was allowed without a rejection or any amendment. ('933
patent). Relevant literature, as well as Lin's specification, acknowledged that human urinary

erythropoietin is a glycoprotein with a molecular weight of approximately 34,000 daltons (e.g. '933, co!. 5:48-52 ("Erythropoietin, an acidic glycoprotein of approximately 34,000 dalton

molecular weight, may occur in three forms: a, ß and asialo. The a and ß forms differ slightly
in carbohydrate components, but have the same potency, biological activity and molecular

weight."); AM-ITC 00987639-49 ("The human asialo hormone has an apparent molecular

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et al., "Inducible Production of

Eryhropoietin by a Human Yolk Sac Tumor Cell Line", Am.

Fed. Clin. Res. 31 :307 A (1983) ("We have identified a human yolk sac tumor-derived cell line

(1411 H) which can be induced to produce significant amounts of Ep."); Ascensao et al.,
"Erythropoietin Production by a Human Testicular Germ Cell Line", Blood 62(5): 1132-34

(1983) ("We have identified a human testis germ cell line 141 I-H, that produces significant
amounts ofEp. The erythopoietic activity was demonstrated by the ability of cell-free

supernatants to stimulate eryhropoiesis in exhypoxic polycythemic mice.")).
Amgen's inequitable conduct in securing the '008 claims infects all the patents-in-suit,
rendering each unenforceable.

No individual affliated with Roche, other than counsel, furnished information or is "most
knowledgeable regarding the subject matter of

this Interrogatory."

Roche expressly reserves the right to amend and/or supplement its interrogatory response
as fact discovery and expert discovery progresses (including the availability of

finalized

deposition transcripts with errata).
DATED:

April 2, 2007 F. HOFFMANN-LA ROCHE LTD, ROCHE DIAGNOSTICS GMBH, and HOFFMANN-LA ROCHE INC.

By its attorneys,

/s/ Thomas F. Fleming

Leora Ben-Ami (pro hac vice)
Patricia A. Carson (pro hac vice) Thomas F. Fleming (pro hac vice)

Howard S. Suh (pro hac vice)
KA YE SCHOLER LLP 425 Park Avenue
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New York, NY 10022 Tel: [phone]
and

Lee Carl Bromberg (BBO# 058480) Julia Huston (BBO# 562160) Keith E. Toms (BBO# 663369) BROMBERG & SUNSTEIN LLP 125 Summer Street Boston, MA 02110
TeL. [phone]

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CERTIFICA TE OF SERVICE

DEFENDANTS' RESPONSES AND OBJECTIONS TO 1 hereby certify that a copy of PLAINTIFF AMGEN INC.'S THIRD SET OF INTERROGATORIES TO DEFENDANTS record for the plaintiff(as listed below) by email on (NO. 26) was served upon the attorneys of the above date.

Lloyd R. Day, Jr. (pro hac vice) David A. Madrid (pro hac vice) Linda A. Sasaki-Baxley (pro hac vice) DAY CASEBEER MADRID & BATCHELDER LLP
20300 Stevens Creek Boulevard, Suite 400

D. Dennis Allegretti (BBO#545511) Michael R. Gottfried (BBO#542156) Patricia R. Rich (BBO# 640578) DUANE MORRS LLP 470 Atlantic Avenue, Suite 500 Boston, MA 02210
Telephone: [phone]

Cupertino, CA 95014 Telephone: [phone] Facsimile: [phone]

Facsimile: [phone]

Willam G. Gaede II (pro hac vice) McDERMOTT WILL & EMERY 3150 Porter Drive Palo Alto, CA 94304 Telephone: [phone] Facsimile: [phone]

Kevin M. Flowers (pro hac vice) Thomas 1. Ross (pro hac vice) MARSHALL, GERSTEIN & BORUN LLP 233 South Wacker Drive 6300 Sears Tower Chicago IL 60606 Telephone: [phone] Facsimile: [phone]

Isl Denise F. Lopez
Denise F. Lopez

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