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

Filing 422

Opposition re #377 MOTION to Preclude Further Interference with Third-Party Discovery and Compel Production of Documents And Deposition Testimony, or in the Alternative, Motion to Strike Defendants? Defense Under 35 U.S.C. Section 271(e)(1) filed by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Attachments: #1 Exhibit A#2 Exhibit B)(Toms, Keith)

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Exhibit A
To "Mathie, Belinda I." oebelinda.mathietQkattenlaw.com::; chnstian. kemnitztQkattenlaw.com cc
bcc Roche Email RepositorytQKSFHHNotes
Subject Amgen v. Roche

David

Cousineau /DC/US/KSFHH
03/26/2007 04:25 PM
Phone: [phone]

Belinda,
Following up on our conversations of today, attached is the courts order agreeing to Roche's understanding of what type of information is relevant and discoverable I have also attached the brief we filed with which the court agreed.

In the brief, you wil see that Roche voluntarily agreed to produce documents related to clinical studies
that were completed by April

18, 2006, when Roche submitted the BLA Roche reasoned, however, and

the court agreed, that any information or data related to post-April 18, 2006 clinical trials that have not closed is beyond the relevant issues in this case and beyond the scope of discovery
i learned that the ML20336 and ML20338 protocols we discussed today are ongoing clinical trials and are thus beyond the scope of relevant discovery in this case As such, Roche objects to DaVita's production 18, 2006 of any information that relates in any way to those two protocols or any other post-April uncompleted clinical trials.

Please contact me if you have any questions.
Thank you, David

Order.pdf Brief.pdf

David L. Cousineau Kaye Scholer LLP 901 Fifteenth St, NW Washington, D.C. 20005-2327 Phone: [phone]

Fax: [phone]

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David Cousineau /DC/US/KSFHH
03/28/2007 08:50 PM

To "Mark Hebert" oeHeberttQfr.com::

cc
bee Roche Email RepositorytQKSFHHNotes

Subject Amgen v. Roche~

Mark,

Attached are the courts order and our opposition brief that we discussed earlier today. Please call me if you have any questions about the order or Fridays deposition.

Thanks,
David

Order.pdf Brief.pdf

David L. Cousineau Kaye Scholer LLP 901 Fifteenth St, NW Washington, D.C. 20005-2327 Phone: [phone] Fax: [phone]

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United States District Court
District of

Massachusetts

Notice of

Electronic Filig

The following tranaction was received from Paine, Matthew entered on 3/2/2007 at 12:16 PM
EST and filed on 3/2/2007

Case Name: Amgen Inc. v. F. Hoffan-LaRoche LTD
et al

Case Number: 1:05-cv-12237 Filer: Document Number:
Docket Text:
Judge Wilam G. Young: Electronic ORDER entered re (281) MOTION to Enforce the Cour's Documents. "Motion

December 29,2006 Order and To Compel the Furher Production of

DENIED. Hoffan-La Roche's Position is Correct." (Paine, Matthew)

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UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS

AMGEN INC.,
Plaintiff,
v.

) ) ) )
)

F. HOFFMAN-LA ROCHE LID,
ROCHE DIAGNOSTICS GmbH,

and HOFFMA-LA ROCHE INC.
Defendants.

) ) ) )
)

CIV ACTION

No.: 05-CV-12237WGY

) )
)

DEFENDANTS' OPPOSITION TO AMGEN'S MOTION TO ENFORCE THE COURT'S DECEMBER 29,2006 ORDER AND TO COMPEL THE FURTHER PRODUCTION OF DOCUMENTS
Lee Carl Bromberg (BBO# 058480) Julia Huston (BBO# 562160) Keith E. Toms (BBO# 663369) Nicole A. Rizzo (BBO# 663853) Bromberg & Sun stein LLP 125 Summer Street Boston, MA 02110
TeL. [phone]

Leora Ben-Ami (pro hac vice)

Mark S. Popofsky (pro hac vice) Patricia A. Carson (pro hac vice)
Thomas F. Fleming (pro hac vice)

Howard S. Suh (pro hac vice)
Peter Fratangelo (BBO# 639775) Kaye Scholer LLP 425 Park Avenue

New York, New York 10022
TeL. [phone]
Counsel for Defendants,

Dated: March 1, 2007

F. HOFFMANN-LA ROCHE LTD, ROCHE DIAGNOSTICS GmbH, and HOFFMANN-LA ROCHE INC.

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L Introduction
This motion is Amgen's third bite at the apple, as it essentially seeks reconsideration of

this Court's Orders of December 29, 2006 and January 22, 2007 in which the Court adopted
Roche's compromise position as to ongoing clinical trials and communications with the FDA.
This compromise position requires Roche to provide data relating to the clinical trials that have

closed and for which data has been submitted to the FDA, but not incomplete data or all
communications with the FDA, as the production of such documents would be unduly

burdensome, prejudicial and disruptive to Roche's efforts to gain FDA approvaL. Afer already
seeking the Court's intervention and failing both times to dissuade the Court from a reasonable

compromise position, Amgen now moves to "enforce" an order with which Roche has already
complied. In full good faith compliance with this compromise position, as ordered by the Court,
Roche has produced well over 350,000 pages of documents relating to the completed clinical

trials that underlay the BLA and IN submissions for MICERATM, including over 7,000 pages
related to the only two trials to have been completed after the cutoff date for Roche's April 2006

BLA submission (referenced in Roche's four-month BLA update). In all, to date, Roche has
produced over 6 millon pages of documents in response to all of Amgen' s over 400 document

requests and is continuing to produce documents on a rolling basis as additional discoverable
documents are available.

1 Having been twice rebuffed by the Court on this very issue, Amgen
what it was properly granted.

should not be permitted to expand the scope of

1 Roche has produced a far greater number of documents than Amgen, and Amgen's discovery

responses are woefully deficient in many respects. Roche anticipates fiing a motion to compel
in the near future.

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n. Amgen's Motion Is Moot Because Roche Has Already Complied With The Court's

December 29, 2006 Order.

In Roche's December 28, 2006 Opposition to Amgen's Motion to Compel, Roche
stated its compromise position that documents relating to ongoing discussions with the FDA
were not relevant and extremely burdensome to Roche, but Roche would produce data from the

clinical studies that have been completed and submitted to the FDA. The Court agreed with
Roche and adopted this position in its December 29,2006 Order? Since then, Roche has fully

complied with the Order as described above. Thus, Amgen's Motion is moot because Roche
has complied both with the spirit and letter of

the Court's December 29,2006 Order to produce

data related to completed clinical studies submitted to the FDA. Indeed, Roche has produced
over 350,000 pages (the printouts of

which would fill approximately 140 banker's boxes) of

such documents in response to this Order. To date, Roche has produced over 7,000 pages of

documents related to protocols included in its "Four Month Safety Update" to the FDA,
BA16736 and BA16738, which are the only two studies to have closed afer the cutoff date for
the April 2006 submission.

In addition to Roche's complete BLA and two INs for MICERA TM and many
thousands of pages of data from the completed clinical trial studies that have been submitted to
the FDA, Roche has gone further stil and agreed to provide Amgen with any information

submitted to the FDA that changes the Chemistry Manufacturing and Controls ("CMC") section

of its BLA from the April, 2006 submission. This is the section which describes the relevant

2 Most recently, the Court denied Amgen's so-called motion for "clarification" wherein Amgen
sought to gain access to the ongoing communications between Roche and the FDA regarding the

accused product, and the Court maintained the compromise position which allows suffcient discovery into the completed clinical trials that form the basis of Roche's BLA submission, which describes the structure and properties of the accused product for which Roche seeks
approvaL. See Court Order of 1/22/07. Roche has provided this discovery.
3

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structure, properties, function and method of manufacturing of Roche's proposed product
awaiting approval. Not satisfied with this discovery, Amgen continues to demand access to
incomplete trials and ongoing discussions with the FDA which Amgen knows full well do not

change or affect the attributes of the proposed product described in Roche's BLA. The
production Roche has provided contains this information and fully complies with the Court's
December 29 Order.
ID. Amgen's Stance Regarding Roche's FDA Correspondence and Supplements To Its

BLA Is Not Consistent With the Court-Adopted Compromise Position on This
Issue.

Amgen's thid and present motion seeks to reinvent the Court's December 29 Order,
claiming it now stands for the proposition that Roche must produce each and every supplement
or communication for its.BLA. This is neither the position Roche posited nor the one this Court
endorsed. The Court clearly adopted Roche's compromise position in that only a subset of

the

FDA post-BLA communications be produced, namely, the data from the completed clinical
trials.
In a particularly tortured reading of the Court's Order of

December 29, Amgen seeks to

rely upon Amgen's Request for Production No. 39, a request this Court expressly denied, and

which was referenced in Request No. 41. In its Motion to Enforce The Court's December 29,

2006 Order, Amgen laid out its BLAI related Requests Nos. 37-41. Amgen acknowledged
that the Court

previously denied as overbroad Request Nos. 37-40, reproduced below:

Request for Production No. 37: A copy of each electronic submission of
ROCHE to the FDA relating to or comprising its Biologics License Application

and/or Investigational New Drug Applications (IN) for peg-EPO (in the
electronic form and data format provided to FDA with all embedded links intact and operable), including all communications, updates, supplements and patient data related thereto.

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Request for Production No. 38: All INs fied with the FDA relating to pegEPO, including the original IN fied by ROCHE with FDA in November 2001 and all communications with the FDA related thereto, including any amendment,
supplement or update thereto.

Request for Production No. 39: All documents and things comprising or relating to any supplement or amendment to ROCHE's Biologics License Application for peg-EPO since April 19, 2006, including all communications, updates, analyses and patient data related thereto.

Request for Production No. 40: All documents and things comprising or relating to any

communication, meeting or exchange of information between ROCHE and FDA
regarding peg-EPO orEPO since April

19, 2006.

The Court granted Amgen's request to produce only in response to Request No. 41:
Request for Production No. 41: Documents and things sufficient to confgure correctly and execute properly each electronic copy of submissions made to FDA produced in response to Requests 37-40, above.

The Court's order was therefore simple: to the extent Roche had produced BLAI
related documents responsive to Amgen's Request Nos. 37-40, Roche was now required to
provide electronic copies of those documents in their native format as submitted to the FDA.
Roche has fulfilled that obligation, providing the relevant documents in the electronic format

Amgen preferred. The Court's granting of Request No. 41 was a matter of formatting of
documents produced, not of additional substantive documents, and did not have the effect of

reviving simultaneously denied requests or independently requiring production of all
"submissions made to FDA," including documents contained in Requests the Court denied.
Nevertheless, this is precisely the interpretation Amgen now asserts. Amgen's position is not

consistent with the Court's December 29 Order and its motion to "enforce" the Order is
unfounded and unnecessar.

Moreover, the Court has recognized that the production of ongoing communications with

the FDA would be of no particular relevance to the current issues in this action and would be

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unduly prejudicial and potentially disruptive to the ongoing discussions and negotiations

between Roche and the FDA. There can be no dispute that such pre-approval communications

have no relevance to the issues of infringement or invalidity.3 Amgen's asserted claims in this

case relate solely to the characteristics of the actual accused product, and then arguably to the
processes by which it is made. Nothing in continuing FDA negotiations or incomplete clinical
trial data (which is constantly changing as the trials progress) relate to those issues. In its prior

motions, Amgen has consistently failed to articulate any meaningful basis of relevance for the
production it seeks and offers no new arguments in its current motion that justify it now. At best,

Amgen makes a general allusion to possible relevance in terms of the injunctive phase. As
Roche told Amgen, absent approval, none of these discussions have any relevance at all to such
issues.
Further, Amgen's argument that this discovery is necessary to the factors underlying

injunctive relief is disingenuous in light of Amgen's continued refusal to produce the FDA
fiings and documents, including the BLA, relating to its own AranespiI product which Amgen

contends wil be an adequate market substitute for MICERATM, and wil meet the relevant
public health and economic needs. The Court ruled in its Order of

February 7,2007 (Docket No.

274) that Amgen must produce a reasonable scope of documents related to Amgen's request for
injunctive relief Yet, Amgen has not produced its BLÀ regarding AranespC, and such

documents are not only relevant to issues of infringement and validity in the underlying action,
but particularly relevant under Amgen's reasoning to the injunctive phase, if

required, as Amgen

has positioned Aranesp(ß as an alternative to MICERATM in the marketplace.

3 Roche has briefed the relevance issue at length in its Opposition to Amgen's Motion for
Amgen's Motion to Compel the Production of

Clarification of the Court's December 29, 2006 Order (Docket No. 246) and its Opposition to Documents (Docket No. 199).
6

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Amgen has consistently maintained that AranespQS is covered by at least one of the

claims in the patents in suit (and discovery is ongoing -- although stymied by Amgen's
noncompliance -- to determine if there are other claims) and Amgen has touted its product as an

adequate market substitute for MICERA TM, capable of meeting relevant public health and

economic needs. Amgen implicitly asserts that comparisons between Aranesp(S and
MICERA TM in structre, composition, and mechanism of action are relevant to issues in this

case, as Amgen's memorandum states that it is "currently collecting and wil produce its
regulatory fiings and correspondence with FDA since October 2005 concerning safety and
effcacy of. . . Aranesp(S in the nephrology indication for which Roche's pending BLA seeks
FDA approval." See Amgen Memorandum in Support of

its Motion to Enforce at 6 (Docket No.

282). Notably, Amgen does not actually say it wil produce its AranespQS BLA and the actual
AranespQS BLA predates October 2005. Amgen should have produced this BLA long ago, as it

has had Roche's BLA for almost nine months now. For all its qualifications and cut-outs,
despite the fact that no regulatory fiings have been produced for a product already approved and
on the market, Amgen stil impugns the completeness of

Roche's production. It is disingenuous

for Amgen to assert a need for supplements to Roche's BLA pursuant to its prayer for injunctive
relief

while continuing to deflect requests for its AranespQS BLA. Amgen's refusal to produce

these documents totally undermines its argument that the discovery it demands from Roche is

needed in conjunction with the question of injunctive relief, especially in light of the Court's
rulings that discovery be reciprocaL. See Order of January 23, 2007 (Docket No. 298). For these

reasons and those discussed below, Amgen's motion to reconsider, styled as a motion to enforce,
should be denied in fulL.

7

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N. Amgen's Requests for Roche's Communications with FDA Regarding its
MIRCERATM BLA Are Unduly Burdensome and Have Already Been Denied.
Amgen further continues to ignore this Court's prior rulings by refusing to narow the
scope of its discovery requests. See Court's Order of December 29, 2006, denying Amgen's

Motion to Compel Request for Production No. 40. Below is Amgen's denied Request No. 40

regarding communications with FDA, compared with its revised, purportedly "narowed"
Request No. 301:

Request for Production No. 40: All documents and things comprising or

relating to any communication, meeting or exchange of information
between ROCHE and FDA regarding peg-EPO or EPO since April

19,

2006.

Request for Production No. 301: Documents suffcient to show each
communication, meeting or exchange of information between ROCHE 19, 2006. and FDA regarding peg-EPO or EPO since April

In addition to being completely inconsistent on the compromise position ordered by the

Court this purportedly "narrowed" request fails to follow the Court's prior rulings and
instructions. Amgen has made it clear that it wants Roche to do more than merely identify its

FDA communications, such as by providing a list, but instead seeks to discover the
communications themselves. Amgen's renewed request is on its face substantively unchanged
from its previous request and therefore cannot revive the previously denied request. Documents

"suffcient to show" communications with the FDA encompass the same universe as "documents

relating to" communications with the FDA. For example, if Roche were in possession of a
presentation which included information which reflects a FDA communication, this document
would be responsive to the "narowed" request as a document "showing" a communication with

the FDA, just as it would be responsive to the original request as a document "relating to" a
communication with the FDA. Amgen has simply substituted synonymous words in its requests,

8

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and has not effectively limited the universe of documents which the requests cover. This Court has denied this request once before due to the undue burden it would cause Roche, and Amgen
has done nothing to overcome the Court's prior ruling or its adoption ofthe compromise position
advanced by Roche. Such tactics are yet another example of Amgen attempting to circumvent

and rewrite the Court's December 29, 2006 Order. In addition, it is not proper for Amgen to
seek to "enforce" the Order with respect to requests such as this one that were never before the
Court.
IV. Conclusion

For all of the foregoing reasons, the relief sought in Amgen's Motion to Enforce the
Court's December 29, 2006 Order and to Compel the Further Production of

Documents should

be denied in full.

Dated: March 1, 2007 Boston, Massachusetts

Respectfully submitted,

F. HOFFMAN-LA ROCHE LTD, ROCHE DIAGNOSTICS GMBH, and

HOFFMA-LA ROCHE INC.
By their Attorneys,

Is/ Nicole A. Rizzo Lee Carl Bromberg (BBO# 058480) Julia Huston (BBO# 562160) Keith E. Toms (BBO# 663369) Nicole A. Rizzo (BBO# 663853) stein LLP Bromberg & Sun
125 Summer Street

Boston, MA 02110
TeL. [phone]

nrizzo~bromsun.com

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Leora Ben-Ami (pro hac vice)

Mark S. Popofsky (pro hac vice)
Patricia A. Carson (pro hac vice)

Thomas F. Fleming (pro hac vice) Howard S. Suh (pro hac vice) Peter Fratangelo (BBO# 639775) Kaye Scholer LLP
425 Park Avenue

New York, New York 10022
TeL. [phone]

CERTIFICATE OF SERVICE

I hereby certify that this document fied through the ECF system wil be sent
Electronic Filing (NF) and paper copies wil be sent to those indicated as non registered paricipants on the above date.
electronically to the registered participants as identified on the Notice of

/s/ Nicole A. Rizzo Nicole A. Rizzo
03099/00501 626296.1

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