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

Filing 320

MEMORANDUM in Support re #319 MOTION to Compel Deposition Testimony under Rule 30(b)(6) filed by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc.. (Attachments: #1 Exhibit A#2 Exhibit B#3 Exhibit C#4 Exhibit D#5 Exhibit E#6 Exhibit F#7 Exhibit G)(Huston, Julia)

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

Doc. 320 Att. 7

Case 1:05-cv-12237-WGY

Document 320-8

Filed 03/15/2007

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EXHIBIT G

Dockets.Justia.com

Case 1:05-cv-12237-WGY

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Will

McDermott Emery
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Boston Brussels Chicago DOeldor london Los Angeles Miam Munich

New York Orange County Rome San Diego Saioon Valey Weshngton. D.C.
Strtegic aliance with MWE China law Ofces (Shanghai)

Wiliam G. Gaee II Attorney allaw wgaede(êmwe.com 650.813.5035

March 13, 2007
VIA FACSIMILE AND E-MAIL

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Vladimir Drozdoff, Esq. Kaye Scholer LLP
425 Park Avenue

New York, NY 10022-3598

Re: Amgen Inc. v. F. Hoffmann-La Roche Ltd., et at Case No. 05 Civ. 12237.WGY
Dear Vladimir:

I wrte to follow up on your letter of Thursday, March 8, 2007, on Amgen's designation of witnesses on Topics 1-10 under Roche's Rule 30(b)(6) deposition notice. You state that

Amgen is not willng to provide witnesses on liabilty topics. That is not the case, as was
previously communicated to Roche in my letter of March 7, 2007. As discussed below, with
respect to Roche Topics 1 - 10 that your letter focuses on, we are providing testimony and/or have provided information on at least nine of the Topics. (Moreover, we are providing testimony
and/or furter interrogatory responses on sixteen of

the remaining nineteen Roche Topics, many

of which fuer touch on liabilty issues.) The ilusion your letter seeks to create that Amgen is not providing discovery on liabilty is simply untre.
The problem lies not in Amgen's willingness to produce witnesses, as the above shows.
. Rather, the problem lies in Roche's insistence of attempting to enforce requests that are
overbroad, unduly burdensome, irrelevant, and lack reasonable paricularty. For example, as
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discussed in fuher detail below, Roche is demanding that Amgen prepare a witness to testify on

the contents of over 120,000 pages of material that have been produced, while refusing to agree to Amgen's common sense solution that Roche identify specifically the documents in that group it is interested in so Amgen can prepare a witness. With this background in mind, we tu to the Topics your letter addresses:
· Topic 1

Roche stated that ths topic requires a witness on all characterizations relied upon (even if

not expressly referred to), discussed, or referred to in the Amgen EPO prosecution histories or opposition proceedings in Europe. As I told Roche in my March 7 letter, Amgen canot prepare

a witness to testify on characterizations that are not stated or referred to anywhere in the
prosecution histories or oppositions. Moreover, given that the volume of materials exceeds over 120,000 pages of material, the issue as framed is lacking reasonable paricularity.

U.S. practice conducted through McDermou Win & Emery lLP.

3150PorterDnve Palo Alto California 94304-1212 Tltleph~nc: 650.813.5000 Facsimile: 650.813.5100 ww.mwe.com

Case 1:05-cv-12237-WGY
Vladimir Drozdoff, Esq.

Document 320-8

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March 13, 2007
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Your letter acknowledges ths burden and breadth, but does litte to address it, demanding that Amgen simply designate someone. Your letter failed to address our good faith efforts to

reach a meaningful compromise on ths point. First, we designated Dr. Strickland and he
appeared as a Rule 30(b)(6) witness on the characterization of any human eryhropoietin relied on, discussed or referred to in his experiments and his declaration that were submitted in the U.S. prosecution or opposition proceedings. Second, we asked Roche to identify any other specific documents from the 120,000 pages at issue addressing specific characterizations, and, assuming reasonable designations and particularty as could be performed with Dr. Strckland, we may be your position in a position to designate a witness(es). Please reconsider the uneasonableness of of refusing to identify the documents that you wish testimony upon, paricularly where you acknowledge the volume of material at issue.
· Topic 2
:~.

This topic relates to the role of any Amgen employee in the prosecution of the EPO
patents in the United States, in Europe, and foreign oppositions in Europe. The request is so
broad that it even asks for Amgen to prepare a individual(s) regarding the characterization of

witness on any "statements" by any such
human EPO.

Your letter did not dispute Ms. Carson's earlier representation that Roche would reserve issue pending Mr. Boru's deposition. Thus, the first time Roche is raising an issue on this Topic is in your letter of March 8. The delay here is on Roche, not on Amgen. Moreover, the volume of material at issue exceeds over 120,000 pages of materials, and this represents a volume and breadth of material that fails to satisfy the reasonable paricularty requirement. . On Friday, Roche requested the deposition of Stuar Watt for March 29,2007. Per my letter of yesterday, we confirmed this date. We will desigIate Mr. Watt to furter testify on this Topic in that he will be prepared to discuss the identity and general role (subject to privilege) of individuals involved in the relevant patent proceedings. Given Roche's failure to identify specific documents at issue (See Topic 1), it is not possible to prepare Mr. Watt, or any other witness, on subsection d, which, as drafted, relates to any representation or "statements" by an
on the

Amgen Employee or Agent on the characterization of EPO absent Roche identifying specific and a limited set of documents.
· Topic 3

Roche stated that it wants testimony on this topic on all successfu and failed attempts, or

alternative strategies, to express human EPO in any cell line with any constrct up to 1995,
excluding production ofEPO, and attempts to identify a source for EPO.

Case 1:05-cv-12237-WGY
Vladimir Drozdoff, Esq. March 13, 2007
Page 3

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As stated in my letter of

March 7, we do not understand the relevance up to 1995 to the

issues in the case. Your letter does nothing to address the issue as to why the timeframe up to 1995 is relevant given that the patent applications at issue relatè back to the 1983-1984 filings.

Amgen proposed as a reasonable compromise that we provide testimony on those examples in the specification as it reflects specific work done prior to the Asserted Patents' priority date. . Nonetheless, Thomas Boone will testify as a Rule 30(b)( 6) witness on post-1984 expression in
cell lines other than Amgen's cell

line developed for production puroses.

As to pre-1985, we are prepared to designate Dr. Lin on the examples in the Specification

of the Asserted Patents as well as efforts to identify cells or tissue expressing or secreting
eryhropoietin. We note that if your intent is to question Dr. Lin on the very specifics performed by Amgen scientists that is set fort in the voluminous quantity of notebooks we have produced,

then you should depose any such individual because preparng a witness on this quatity of

material is uneasonably burdensome and lacks paricularty.
· Topic 4
With this Topic Roche is seeking testimony on efforts by Amgen to express

glycoproteins prior to Janua 1, 1985. Our letter of March 7 stated that we were prepared to provide a deponent on the examples described in the specification of the Asserted Patents that relate to the recombinant expression of EPO as a glycoprotein as Amgen can then prepare a witness to testify on that subject. Your letter proposes that the deposition topic be limited to
"obligate glycoproteins." Mr. Boone will be the Rule 30(b)(6) witness on the recombinant
expression of glycoproteins other th EPO prior to 1985.' Dr. Lin will testify

as a 30(b)(6)

witness on the specific exaples disclosed in the Asserted Patents that relate to the recombinant expression ofEPO as a glycoprotein as discussed in Topics 3 and 6
· Topic 5

Your letter fails to respond in any meaningfl fashion to the points made in my letter of

March 7. Thus, we understand it is confired that Roche agreed that the subject matter of
Amgen's non-ESA pegylated proteins are not at issue under Judge Young's January 3, 2007 Order, and that Roche is not seeking testimony on peg-Aranesp.

We understand that you failed to question Dr. Strickland on ths subject during his
deposition. Accordingly, we withdraw Dr. Strickland. Pursuant to my letter of March 9, 2007, Mr. Boone will be providing testimony on peg-EPO under this Topic.
· Topic 6

Though not addressed in your letter, we are stil confrming that Dr. Lin will be Amgen's deponent on the work disclosed in the specification of the Asserted Patents. We note that if your intent is to question Dr. Un on the very specifics performed by Amgen scientists that is set forth

Case 1:05-cv-12237-WGY
Vladimir Drozdoff, Esq. March 13, 2007
Page 4

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in the voluminous quantity of notebooks we have produced, then you should depose any such individua because preparng a witness on this quantity of material is uneasonably burdensome and lacks particularity.
· Topic 7
.,
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This topic seeks testimony on the earliest effective filing date of each of the asserted claims in Amgen's EPO patents, and surounding facts and circumstances. Roche acknowledged

that this is a contention deposition. Roche earlier stated that it wants testimony on whether
Amgen is going to deviate from the positions taken in the interferences and the bases therefore.

Your letter changes that position, and states that you are seeking a deposition on the underlying subject mater that was included in the Un Application ''tat Amgen may use as
support for varous possible fil;ng dates." Again, if you want to understand fuher the facts underlying the examples disclosed in the Specification in addition to those set fort in Amgen's detailed Supplemental Response to Roche Interrogatory No.3, consistent with the scope of Mr. Un's anticipated deposition on Topic 6, we are prepared to have him testify, assuming we can
confirm on ths point. If you stil seek contentions, as the quoted language from your letter

indicates you may stil be seeking, then we will object at the deposition and instrct not to
answer as such questioning will be beyond our agreed scope. Please confirm.
· Topic 8

This topic addresses the relationship between Eugene Goldwasser and Amgen, including communcations and the transfer, exchange, provision or supply of information, know-how, or
things between them, concerning eryopoietin in severa forms, eryopoietin

radioimmunoassays, purification methods, and antibodies. Roche stated that it will limit the time frame of this topic to prior to 1996.

Dr. Strickland has testified on this Topic for Amgen. Beyond what Dr. Strickland

testifed to, Amgen is unable to identify a curent employee of Amgen who has knowledge
beyond that provided by Dr. Strickland and otherwse recorded in the documents produced and prior testimony of Amgen employees. Accordingly, Amgen's production of witnesses on this Topic is complete.
· Topic 9

Your letter does not dispute our understanding from our Februar 27, 2007, meet and

confer set fort in my March 7 letter that (a) "Roche acknowledged that Amgen has provided the chaacterization information sought by this topic for EPOGEN(g, but still seeks charactenzation information for Aranesp(g" and (b) "Roche indicated that it will reconsider this topic since it is getting Amgen cell lines."

Case 1:05-cv-12237-WGY
Vladimir Drozdoff, Esq.

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March 13,2007
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The first communication from Roche on this Topic that it believed that receipt of

the cell

lines was insuffcient was in your March 8, 2007 letter. Again, any delay is due to Roche, not
Amgen, on this Topic.

Now that you are raising the issue, we stil fail to see the relevance of sub-topics j-o to

the issues in the litigation. These sub-topics request Amgen's knowledge on Aranesp's
interaction with the Epo receptor, pharmacodynamics, pharacokinetics, immunogenicity and/or
antigenicity, internalization and recycling by cells, and maner of clearance.

~. ..

Aranesp is not an accused product. Any attempt to compare products, and justify discovery thereon, rests on an improper infringement analysis. An infringement liability analysis requires the application of the Asserted Claims to the accused Roche product and methods. Your

letter does not explain the relevance of the information sought, and. we do not see how such subject matter on Aranesp generally comports with the Cour's previous Order.
· Topic 10

Topic 10 concerns any comparsons performed by or for Amgen on the active drug
product in AranespCß to any recombinant human eryhropoietin. Your letter failed to ariculate the liabilty issue that such comparisons are relevant to. Furher, as discussed on Topic No.9,

any such comparson rests on an improper infngement analysis. To the extent Roche may
contend that some of such subtopics are potentially relevant to an injunction, Amgen's witnesses will be testifying on facts relevant to an injunction in response to Topic 13. We understand from your letter that Roche intends to seek Court assistance on this Topic, and see no basis to justify such a request.
I look forward to resolving the above remaining issues as soon as possible.

5!
cc: Mike Gottied, Esq.

Very trly yours,

Willam a; II

Krista Carer, Esq. Sandip H. Patel, Esq