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. 3

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¡Exhibit 11

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.
- - -- -- - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - x

Civil Action No.: 05-12237 WGY

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

GmbH, and Hoffinann-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 iffully 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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Amgen's consistent pattern offailing 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 Borun Trial Tr. 2854:9-25
(incorrect hexoes/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
authoritites, (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." (AMITC 00953700). Amgen presented no authority in support of

this proposition, and
prior art may be

consequently misstated the law, which provides that consideration of

necessary to determine whether one of skil in the art would deem the later claim to be
merely an obvious variation on the earlier one. See e.g. MPEP §804 ("Claim P) rejected

Boehringer Mannheim Gmbl-'I 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 0411 678; (4) Boehringer Mannheim GmbH v Kirin-

Amgen, (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 i 993-K-No. 937).

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Examiner of

the '933 patent. (AM-ITC 00092853 ("Where it is possible to compare r-HuEPO
the methods.";

and u-HuEPO, the two materials were shown to be identical within the error of

"The most relevant findings are the overall similarity of

the oligosaccharide structures and the

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 the 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 of CHO 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.

Amgen's Affrmative Misrepresentations and Omissions Regarding Molecular Weight
In addition to the information out lined 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-P AGE."

(AM-ITC 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: ex, ß and asialo. The ex and ß forms differ slightly

in carbohydrate components, but have the same potency, biological activity and molecular

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. The June 20, 1989 rejection by Examiner Kushan rejecting, among others, claims 67-73

under 1) the doctrine of obviousness-type double patenting as being unpatentable over the prior invention as set forth in claim 1 to 11 ofV.S. Patent No. 4,667,016, 2) 35 V.S.C. 102(b)
as anticipated by or, in the alternative, under 35 V.S.C. 103 as obvious over Sugimoto et aL. and 3) 35 V.S.C. 103 as unpatentable over Sugimoto et aL. in view ofPapayannopoulo et aL.

Amgen argued for the patentability of claims substantially similar to the rejected claims in the'179, '741, '073 and' 197 applications and again failed to disclose the prior rejection by Examiner Kushan. (AM-ITC 00899084; AM-ITC00899123-27; AM-ITC 00899151-54; AM-ITC 0095320709, AM-ITC 00953638-39; AM-ITC 00953205-25; AM-ITC 0095363748);
. The September 18, 1989 rejection by Examiner Kushan rejecting, among others, claims 67-

73 under the doctrine of obviousness-type double patenting as being unpatentable over the
U.S. Patent No. 4,667,016. Amgen argued for the patentability of claims substantially similar to the rejected claims in the' 179, '741, '073 prior invention as set forth in claim 1 to 11 of

and' 197 applications and again failed to disclose the prior rejection by Examiner Kushan. (AM-ITC 00899084; AM-ITC00899123-27; AM-ITC 00899151-54; AM-ITC 0095320709, AM-ITC 00953638-39; AM-ITC 00953205-25; AM-ITC 00953637-48).

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.

DATED:

March 14, 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

New York, NY 10022 Tel: [phone]

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and

Lee Carl Bromberg (BBO# 058480) Julia Huston (BBO# 562160) Keith E. Toms (BBO# 663369) BROMBERG & SUN STEIN LLP 125 Summer Street Boston, MA 021 10
TeL. [phone]

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CERTIFICATE OF SERVICE

, RESPONSES AN OBJECTIONS TO PLAINTIFF AMGEN INC.'S THIR SET OF INTERROGATORIES TO DEFENDANTS record for the plaintiff (as listed below) by overnight (NO. 26) was served upon the attorneys of mail and facsimile on the above date.
I hereby certfy that a copy of DEFENDANTS

Lloyd R. Day, Jr. (pro hac vice) David A. Madrd (pro hac vice) Linda A. Sasaki-Baxley (pro hac vice)

D. Dennis Allegretti (BBO#545511) Michael R. Gottfred (BBO#542156)
Patrcia R. Rich (BBO# 640578)

DAY CASEBEER MADRI &
BATCHELDER LLP 20300 Stevens Creek Boulevard, Suite 400 Cupertino, CA 95014 Telephone: [phone] Facsimile: [phone]

DVAN MORRIS LLP
470 Atlantic Avenue, Suite 500 Boston, MA 02210
Telephone: [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) MASHALL, GERSTEIN & BORUN LLP 233 South Wacker Drive 6300 Sears Tower \ Chicago IL60606 Telephone: [phone] Facsimile: (3J~ 474-0448

17 '- / //, 1. Ç/ ¡
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I\ i Deni . Lopez

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