Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 1 of 36 PageID
`#: 18084
`
`EXHIBIT 1
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 2 of 36 PageID
`#: 18085
`
`Armon, Orion
`Wednesday, May 8, 2019 6:18 PM
`Danford, Andrew J; WH GNE-Amgen Herceptin Service List; DDurie@durietangri.com; abrausa@durietangri.com;
`EWiener@durietangri.com; dsilver@mccarter.com; mkelly@mccarter.com
`Eve H. Ormerod; Neal C. Belgam; z/Amgen-Genentech
`RE: Genentech v. Amgen, No. 18-cv-924 - non-discovery of third-party agreement terms
`
`Lin, Benjamin S
`From:
`Sent:
`To:
`
`Cc:
`Subject:
`
`Counsel: 
`
`As stated during our meet and confer on April 26, and memorialized in Amgen’s Amended Responses and Objections to Genentech’s 30(b)(6) deposition notice, 
`Amgen objects to discovery of commercially sensitive information 
`  Genentech, like Amgen, has objected to and refused to divulge details of its contractual agreements with payers, providers, and 
`distributors.  The burden and unfair prejudice associated with providing the information is not proportionate to, and outweighs, any probative value that the 
`information may have to Genentech’s claims, so it is not subject to discovery in this lawsuit.  Discovery concerning this sensitive business information is also 
`unnecessary because Amgen has produced documents and has designated a witness to testify about its overall marketing strategy 
`  If you intend to 
`.  Amgen will not allow its company witnesses to testify regarding 
`attempt to elicit this commercially sensitive information from any individual witness, please provide your availability to meet and confer on Friday, May 10, so 
`that if necessary we are able to seek a protective order from the Court under Fed. R. Civ. P. 26(c) during the previously‐scheduled discovery hearings upcoming 
`on May 16 and 21. 
`
`-
`
`Sincerely, 
`Orion 
`
`1
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 3 of 36 PageID
`#: 18086
`
`EXHIBIT 2
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 4 of 36 PageID
`#: 18087
`CONTAINS CONFIDENTIAL INFORMATION SUBJECT TO PROTECTIVE ORDER
`
`Cooley
`
`Eamonn Gardner
`+1 858 550 6086
`egardner@cooley.com
`
`March 29, 2019
`
`Nora Q.E. Passamaneck
`Andrew Danford
`Stephanie Lin
`Tim Cook
`Nicole Fontaine Dooley
`
`WilmerHale
`
`Re: Genentech, Inc. et al. v. Amgen, Inc., Case No. 18-924-CFC (D. Del.)-discovery
`
`Counsel,
`
`This is in response to your March 28 letter regarding various discovery issues.
`
`ESI and Search Terms
`
`Thank you for confirming the list of additional proposed ESI terms, which we understand to be the following:
`
`•
`I
`I
`I
`
`I
`
`I
`I
`
`I
`
`Cooley LLP 4401 Eastgate Mall San Diego, CA 92121
`t: (858) 550-6000 f: (858) 550-6420 cooley.com
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 5 of 36 PageID
`#: 18088
`
`Cooley
`
`March 29, 2019
`Page Two
`
`ti I
`
`I
`
`We will begin review immediately and produce responsive documents on a rolling basis.
`
`Supplementation of Interrogatory Responses
`
`Thank you for confirming the date of mutual supplementation of interrogatory responses as April 5.
`Genentech will supplement its responses to Amgen's Interrogatory Nos. 2, 4, and 6. Amgen will supplement
`its responses to Genentech's Interrogatory Nos. 1, 5, 6, 10, 14, and 16.
`
`We understand that you have continued to refuse to supplement your response to Interrogatory No. 3 and
`that your only basis is your assertion that it is a contention interrogatory. We have already explained that
`this is improper. The final contention deadline is the last time to supplement, not the only time. Absent a
`change in Genentech's position, the parties are at an impasse. Amgen reserves all rights to compel or to
`strike any subsequent attempt to introduce new facts after the discovery cutoff.
`
`Genentech's Manufacture of Polypeptide Products Other than Herceptin
`
`Genentech's expressed "willingness to compromise" is belied by its unreasonable demands to shift the
`burden to Amgen to identify documents in Genentech's possession. We have already narrowed our request
`to four products (Avastin, Rituxan, Lucentis, and Xolair), and specified that we are looking for Genentech's
`use of sparging or glutamine-free media in the manufacturing of these products. We also pointed out, as a
`non-limiting example, that the manufacturing information pertaining to sparging or glutamine-free media
`may be found in sections in the BLA describing manufacturing process and process controls. The '869,
`'293, and '983 patents are Genentech's patents that it has asserted in this case.
`It is not credible for
`Genentech to feign ignorance of its own patents and documents, even if its attorneys may not initially know
`where to search for relevant documents. Genentech's delay tactics and refusal to cooperate are prejudicing
`Amgen's ability to conduct discovery. As a related matter, we note that Genentech has yet to provide a
`substantive response to Amgen's interrogatory no. 3, which seeks information on Genentech's products
`that practice one of more claims of the Patent-in-Suit, even though the interrogatory was served in
`September of last year.
`
`. But
`We appreciate Genentech's confirmation that it is no longer pursuing
`we disagree with your contention that Amgen's discovery into Genentec s ot er pro ucts Is ana ogous to
`Genentech's discovery into Amgen's other products. Whether Genentech has products that practice the
`invention before the critical date of each of the asserted patents goes directly to patent validity and
`damages. On the other hand, whether Amgen has other products in the pipeline would not invalidate
`Genentech's patents and has nothing to do with the ASP 980 product accused in this case. Genentech
`relies on the superficial argument that "what's good for the goose is good for the gander," but fails to
`articulate any basis to account for the different situations between the parties.
`
`Coole y LLP 4401 Eastgate Mall San Diego, CA 92121
`t: (858) 550-6000 f: (858) 550-6420 cooley.com
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 6 of 36 PageID
`#: 18089
`
`Cooley
`
`March 29, 2019
`Page Three
`
`Updated ESI Collection and Review
`
`Sincerely,
`
`Isl Eamonn Gardner
`
`Eamonn Gardner
`
`201202425 v2
`
`Cooley LLP 4401 Eastgate Mall San Diego, CA 92121
`t: (858) 550-6000 f: (858) 550-6420 cooley.com
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 7 of 36 PageID
`#: 18090
`
`EXHIBIT 3
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 8 of 36 PageID
`#: 18091
`CONTAINS CONFIDENTIAL INFORMATION SUBJECT TO PROTECTIVE ORDER
`
`Cooley
`
`Eamonn Gardner
`+1 858 550 6086
`egardner@cooley.com
`
`April 26, 2019
`
`Nora Q.E. Passamaneck
`Andrew Danford
`Stephanie Lin
`Tim Cook
`Nicole Fontaine Dooley
`W ILMERHALE
`
`Re: Genentech, Inc. et al. v. Amgen, Inc., Case No. 18-924-CFC (D. Del.)-ESI
`
`Counsel,
`
`We write in response to your April 10, 2019 letter regarding ESI. Genentech stated it has run all
`of Amgen's requested search terms with the exception of the two following terms:
`
`•
`I
`Please confirm that Genentech will run these final two terms immediately. If documents are not
`produced sufficiently in advance of the depositions of Genentech's witnesses, Amgen reserves
`the right to hold the depositions open.
`
`Regarding ESI updates, and as we noted in a separate letter today, Amgen identifies the following
`custodians and search terms:
`
`Cooley LLP 4401 Eastgate Mall San Diego, CA 92121
`t: (858) 550-6000 f: (858) 550-6420 cooley.com
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 9 of 36 PageID
`#: 18092
`
`Cooley
`
`April 26, 2019
`Page Two
`
`I
`
`I
`I
`
`I
`I
`I
`
`Cooley LLP 4401 Eastgate Mall San Diego, CA 92121
`t: (858) 550-6000 f: (858) 550-6420 cooley.com
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 10 of 36 PageID
`#: 18093
`
`Cooley
`
`April 26, 2019
`Page Three
`
`As requested in our April 4 2019 letter, please advise how Genentech plans to update its own ESI
`production.
`
`Sincerely,
`
`Isl Eamonn Gardner
`
`Eamonn Gardner
`
`202100099
`
`Cooley LLP 4401 Eastgate Mall San Diego. CA 92121
`t: (858) 550-6000 f: (858) 550-6420 cooley.com
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 11 of 36 PageID
`#: 18094
`
`EXHIBIT 4
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 12 of 36 PageID
`#: 18095
`
`WILMERHALE
`
`Stephanie Lin
`
`+1 617 526 6789 (t}
`+1 617 526 5000 (f}
`stephanie.lin@wilmerhale.com
`
`April 28, 2019
`
`By E-mail
`
`Eamonn Gardner
`Michelle Rhyu
`Susan Krnmplitsch
`Daniel J. Knauss
`Orion Annon
`Benjamin Lin
`Lauren Kricld
`
`COOLEYLLP
`
`RE: Genentech, Inc. et al. v. Amgen, Inc., Case No. 18-924-CFC (D. Del.)- Document
`Production
`
`Counsel,
`
`We address the issues raised in your April 24 and April 26 letters.
`
`First, regarding the issues that Genentech intends to raise with the Comi:
`•
`
`We have cons- · stentl
`
`ABP 980
`
`·mgement, aunch, and remedies.
`which is insufficient.
`In addition, we
`urmg our Apn 19 meet and confer that these documents may be
`spec1 1ca y exp ame
`evidence of offers to sell. Your position was that you would need to speak with your client.
`At the same time, you asked-
`for the first time-whether Genentech planned to update its
`financial and strategy planning documents. The documents Genentech had already
`produced provided more detailed infonnation about pricing and contracting strategy than
`those which Amgen has produced. Nonetheless, Genentech promptly collected and
`reviewed updated financial infonnation as well as additional documents relating to
`biosimilar ent:Iy planning and pricing and contracting sti·ategy post-dating its previous
`collection, which will be produced on Monday, April 29. Amgen has not. As Amgen has
`not agreed to produce the full scope of the requested infonnation, we are moving the Court
`for relief.
`
`Beijing
`
`Berlin
`
`Wilmer C utler Pickering Hale and Dorr LLP, 60 State Street, Boston, Massachusetts 02 109
`Boston
`Brussels
`Denver
`Frankfurt
`London
`Los Angeles
`New York
`Palo Alto
`
`Washington
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 13 of 36 PageID
`#: 18096
`
`WILMERHALE
`
`April 28, 2019
`Page2
`
`explained on several occasions, this info1mation is relevant to infringement and remedies,
`including a prelimina1y injunction. As Amgen has not agreed to produce the full scope of
`the requested info1m ation, we are moving the Comi for relief.
`
`• Documents related to the marketing and/or use of ABP 980 (proposed, planned, or
`actual), including documents provided to physicians, payers, and insurers, as well as
`communications reflecting the same: Your statement that "unapproved drafts would be
`inelevant to any inducement claims because they would not have been disseminated to the
`public," is inconect and reflects the fundamental disagreement between the pa1i ies. ABP
`980 is not approved, and it is contraiyto 35 USC 271(e)(2)(C)-which is explicitly directed
`to how a product will be used upon approval-that only "approved" and "distributed"
`marketing materials are relevant to inducement. For example, purely internal documents
`may be probative of how Amgen intends to mai·ket ABP 980 or how Amgen intends ABP
`980 to be used upon approval. Such documents ai·e clearly relevant.
`
`Your chai·acterization of our statements during the meet and confer improperly collapses
`two issues into one. As you know, Genentech has several discove1y requests seeking
`launch-related infonnation and has been pushing for Amgen's production of such launch(cid:173)
`related documents for several months. The existence of approved marketing materials and
`outward facing communications with third pa1iies regarding ABP 980 is probative of
`launch-hence our request that Amgen include them along with the rest of its launch(cid:173)
`related production. See infra at 3-4 (identifying the paities' agreement as Amgen's
`production of launch-related documents
`in response
`to Genentech's discove1y
`requests). But Genentech has separate discove1y requests seeking documents related to
`Amgen's intended marketing and/or use of ABP 980. In response to those requests, we
`have never taken the position that Amgen can limit production to "approved" and
`"distributed" mai·keting materials. Our position has consistently been that Genentech is
`entitled to production of all documents relating to the intended use of ABP 980, regai·dless
`of whether the document is a "draft" or intended only for internal distribution. See, e.g. ,
`April 22 Letter from S. Lin. Amgen's April 24 letter confmned that Amgen refuses to
`produce such internal documents. In that letter, Amgen stated that it would only produce
`"representative" mai·keting materials approved and actually distributed externally. Hence,
`the pa1ties' impasse. As Amgen has not agreed to produce the full scope of the requested
`info1mation, we ai·e moving the Comi for relief.
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 14 of 36 PageID
`#: 18097
`
`WILMERHALE
`
`April 28, 2019
`Page 3
`
`asking for this infonnation for several weeks. Amgen's disclosure of this info1mation,
`however, does not moot the paii ies' impasse.
`
`As an initial matter, Amgen again refuses to identify a date ce1iain by which these
`documents- which should have been produced long ago-will be produced. Indeed, the
`fact that Amgen is just now disclosing the identity of its custodians and search te1ms
`strongly suggests that Amgen has not yet even begun the process of reviewing and
`producing these documents. That is concerning.
`
`To the extent that Amgen can
`o so, muc o t e 1spute on t 1s topic will be resolved. It would not
`con nm t at 1t w1
`completely remove the issue, however, because Amgen still refuses to provide a date
`certain by which it will produce the documents. That is unacceptable given the upcoming
`close of fact discove1y and the long-since passed document production deadline.
`Accordingly, as Amgen has not agreed to produce these documents by a date ce1iain, we
`ai·e moving the Comi for an order compelling Amgen to do so.
`
`Genentech notes that Amgen is proposing to nm only a subset of the paiiies' previously
`agreed-to seai·ch te1ms on these custodians. While Genentech objects to Amgen's delayed
`disclosure of these seai·ch te1ms, in order to avoid burdening the Comi with an additional
`dispute, Genentech will not press that issue.
`
`Outstanding Production from Amgen: Finally, there are additional categories of
`documents for which Amgen has promised production but has so fai· failed to produce:
`(1) Amgen 's April 4 collllllitment to produce responsive documents hitting on the seai·ches
`identified in our March 28 and April 1 letters; and (2) Amgen's April 18 agreement to
`provide Genentech with non-privileged launch-related documents, including (i) documents
`showing Amgen 's projected la1mch date and documents located in response to Genentech's
`related request for additional ESI material, and (ii) updated materials which show projected
`market shai·e, projected sales, and planning infonnation, and (iii) any sufficiently final
`and/or approved U.S. marketing materials for ABP 980. As to catego1y number 2, as
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 15 of 36 PageID
`#: 18098
`
`WILMERHALE
`
`April 28, 2019
`Page4
`
`discussed on the April 18-19 meet and confers, Genentech can only agree to a mutual
`exchange of these documents with Genentech's settlement agreements with third pa1ties if
`there is an extension of the fact discove1y deadline. If the patties cannot reach agreement
`on an extension of fact discove1y, we will ask the Court to compel production by a date
`certain.
`
`Second, Genentech addresses Amgen 's letters regai·ding Genentech's document productions:
`
`• Search terms: Genentech ran the search strings identified in your April 26 letter and has
`aheady reviewed and produced these documents.
`
`• Damages/biosimilar planning documents after November 2018: As noted above,
`Genentech will produce updated financial infonnation as well as additional documents
`relating to biosimilar planning as well as pricing and contracting strategy post-dating its
`previous collection on Monday, April 29.
`
`• Celltrion and Pfizer's 3(b) and 3(c) statements: These documents ai·e mai·ked
`confidential, and Pfizer and Celltrion have not agreed for Genentech to produce them.
`Amgen may wish to reach out to counsel for Pfizer (Michael Johnson at Wilkie FaiT &
`Gallagher) and Celltrion (Linnea Cipriano at Goodwin Procter) . We note that for the first
`time in its April 24 letter Amgen also seeks 3(c) statements. Plaintiffs assume that Amgen
`is requesting only those statements addressing validity, but in any event, they ai·e likewise
`marked confidential and therefore Amgen should raise the issue with Celltrion and Pfizer.
`
`• Documents with slip-sheet "file could not be printed." We are investigating the
`availability of the requested info1m ation for the range identified in your letter and will let
`you know whether we ai·e able to produce it.
`
`• LSCC meeting minutes: Genentech reviewed and produced all the LSCC meeting minutes
`found in its collection.
`
`• Documents concerning the use of sparging and glutamine-free media during the
`manufacturing process for Genentech's polypeptide products Avastin, Rituxan,
`Lucentis, and Xolair. As stated in our April 12 letter, Genentech is willing to produce
`these documents, but explicitly noted that (1) collection and review will take some time,
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 16 of 36 PageID
`#: 18099
`
`WILMERHALE
`
`
`April 28, 2019
`Page 5
`
`
`
`and (2) production could be expedited if Amgen identified with particularity the BLA
`sections it seeks. For reasons that are not clear to us, Amgen has refused to identify the
`documents it is looking for. Nonetheless, Genentech expects to make a production of
`documents related to this topic by May 10. To be clear, this is a problem of Amgen’s
`making—the parties had initially discussed this issue several months ago and Amgen
`waited until a few weeks ago to narrow the scope of its request to the identified products.
`Having waited so long to follow up on its request, and having refused to identify specific
`documents, Amgen is not in position to complain about the timing of Genentech’s
`production.
`
` ARTC: Genentech has reviewed and produced all of the ARTC documents found in its
`collection.
`
` Shak production: Dr. Shak collected and produced responsive documents that he located
`after a reasonably diligent search. Dr. Shak is not withholding any responsive non-
`privileged documents.
`
` December 2007 Provisional Application: Amgen raised this for the first time on April
`22. Genentech is working to locate the filed application in its internal files and will produce
`it.
`
`In response to Amgen’s unbounded request that Genentech update its ESI, Genentech has been
`and will continue to supplement its production as required under the applicable rules. If Amgen
`has specific requests for supplemental production of discrete categories of documents, we are
`happy to consider them. For example, Genentech agreed to run additional search terms on the ESI
`of custodian Bob Mass, and produced those documents. See Dec. 17, 2018 Passamaneck letter to
`Amgen. But Genentech has no plans to conduct a full ESI refresh. The parties are not similarly
`situated. As of April 26, Genentech has produced 324,295 documents, the substantial bulk of
`which was produced by January 14, 2019, in accordance with the Court’s scheduling order. By
`comparison, Amgen had produced 14,954 documents. Moreover, the accused Amgen product
`ABP 980 has undergone several changes since Amgen’s custodial collection in this case—
`Genentech’s product has not. As Amgen’s ESI custodial production regarding the accused product
`is not current, it is entirely appropriate (and indeed required) for Amgen to conduct the ESI refresh
`we have asked for in order for Amgen to comply with its discovery obligations under the local and
`Federal Rules.
`
`Sincerely,
`
`/s/ Stephanie Lin
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 17 of 36 PageID
`#: 18100
`
`EXHIBIT 5
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 18 of 36 PageID
`#: 18101
`CONTAINS CONFIDENTIAL INFORMATION SUBJECT TO PROTECTIVE ORDER
`
`Cooley
`
`Eamonn Gardner
`+1 858 550 6086
`egardner@cooley.com
`
`April 4, 2019
`
`Nora Q.E. Passamaneck
`Andrew Danford
`Stephanie Lin
`Tim Cook
`Nicole Fontaine Dooley
`WILMERHALE
`
`Re: Genentech, Inc. et al. v. Amgen, Inc., Case No. 18-924-CFC (D. Del.)-ESI
`
`Counsel,
`
`We write in response to your April 1, 2019 letter regarding ESI, where you acknowledge for the
`first time since January that outstanding disputes remain as to the proposed search terms. We
`appreciate your attempt to narrow the terms, and we agree to review documents that hit on the
`following three terms per your request:
`
`•
`
`I
`
`I
`
`We note that Genentech still has not responded to Amgen's inquiries, including the hit results for
`Amgen's requested terms and whether Genentech is running all of the terms and producing
`responsive documents for each term. See 4/ 1 Gardner letter; 1/22 email from Lin to Neely.
`Although Genentech claims that it has generally complied with its discovery obligations, it has yet
`to specify what the alleged compliance is based upon. Please provide the information requested
`above as soon as practicable.
`
`Regarding timing, you purported to set a deadline on April 1 for "all responsive documents [to be]
`produced by April 5." Given that Genentech is the reason for delay, the arbitrary deadlines set
`forth in your letter are unreasonable and unduly burdensome. Nevertheless, as we stated in our
`March 29, 2019 letter, Amgen will produce responsive documents for additional terms on a rolling
`basis.
`
`Cooley LLP 4401 Eastgate Mall San Diego, CA 92121
`t: (858) 550-6000 f: (858) 550-6420 cooley.com
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 19 of 36 PageID
`#: 18102
`
`Cooley
`
`April 4, 2019
`Page Two
`
`To the extent that your request
`ocumen s, requiring a never-ending series of document
`see s an in 1scnmma e up a e o a
`collection of all custodians over an indefinite period of time, we object to such a request as unduly
`burdensome and not proportional to the needs of this case. In response to your request, Amgen
`proposes the following:
`
`In line with Genentech's request, please advise how Genentech plans to update its own ESI
`production.
`
`Sincerely,
`
`Isl Eamonn Gardner
`
`Eamonn Gardner
`
`201397386
`
`Cooley LLP 4401 Eastgate Mall San Diego. CA 92121
`t: (858) 550-6000 f: (858) 550-6420 cooley.com
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 20 of 36 PageID
`#: 18103
`
`EXHIBIT 6
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 21 of 36 PageID
`#: 18104
`
`WILMERI-IALE
`
`Stephanie Lin
`
`+1 617 526 6789 (I}
`+1 617 526 5000 (f}
`stephanie.lin@wilmerhale.com
`
`May 6, 2019
`
`Eamonn Gardner
`Michelle Rhyu
`Susan Krnmplitsch
`Daniel J. Knauss
`Orion Almon
`Benjamin Lin
`Lamen Kridel
`
`COOLEYLLP
`
`Re: Genentech, Inc. et al. v. Amgen, Inc., Case No. 18-924-CFC (D. Del.)-Document
`Production
`
`Counsel,
`
`We write in response to yom letters of April 27, 2019 and May 2, 2019.
`
`Genentech's Issues for the Court:
`
`• Documents related to the pricing and contracting of ABP 980, including
`communications with insurers and payers related to same: The dispute is not
`obviated. We are still without production of the requested documents. Given where we
`are in the schedule, it is not sufficient for Amgen to "consider producing" them at some
`unspecified later date. We have been waiting long enough. The documents must be
`produced now. If they are not by the time of when Genentech 's letter is due to the Comi
`in advance of the May 16 hearing, then we will seek to compel them.
`
`manufacturing plans and/or forecasts through the end of
`2019: We are not gomg to continue litigating this in discove1y correspondence. We have
`identified th e relevance in prior correspondence and dming th e meet and confer. The
`asse1iion in your letter that Amgen has "already produced numerous documents having
`launch-related infonnation" does not satisfy Amgen 's discove1y obligations. As you
`know, Amgen has failed to produce anything more recent than August 2018- which, of
`comse, is several months before Amgen 's resubmission, and, thus is woefully out-of(cid:173)
`date. Y om letter confoms th at th ere is a dispute requiring resolution by the Comi.
`
`• Documents related to the marketing and/or use of ABP 980 (proposed, planned, or
`actual) including documents provided to physicians, payers, and insurers, as well as
`communications reflecting the same: The pa1iies dispute on this topic is ah-eady well(cid:173)
`c1ystallized. We write to address the statement in yom letter that we "raised the issue
`
`Beijing
`
`Berlin
`
`W ilmer Cutler Pickering Hale and Dorr lLP, 60 Scare Street, Boston, Massachusetts 02 109
`Boston
`Brussels
`Denver
`Frankfurt
`London
`Los Angeles
`New York
`Palo Alto
`
`Washington
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 22 of 36 PageID
`#: 18105
`
`WILMERI-IALE
`
`May 6, 2019
`Page2
`
`about internal marketing materials for the first time during the April 18, 2019 meet and
`confer. " That is demonstrably inconect. See, e.g.,:
`
`o April 2 Letter from Ms. Lin
`"materials concernin
`
`education material.");
`
`o April 12 Letter f01m Ms. Passamaneck (stating that Amgen has no basis to
`withhold "internal documents regarding Amgen's label changes, as well as
`marketing materials and communications regarding ABP 980");
`
`o REQUEST FOR PRODUCTION NO. 47 (All documents concerning Amgen 's
`marketing or anticipated, projected, or intended marketing of any HER2
`Product.);
`
`o REQUEST FOR PRODUCTION NO. 99 ("All documents to date relating to the
`impact of any label change on Amgen's pre-marketing or planned pre-marketing
`of ABP 980, including documents sufficient to show any changes to At-en's
`k f
`1
`f
`h
`t the proposed
`! I
`I
`•
`");
`
`o REQUEST FOR PRODUCTION NO. 103 ("Documents to date, including drafts,
`sufficient to show Amgen's adve1iising material for ABP 980, including (i) any
`materials that will be or have been presented to, given to, or made available to
`marketing and sales representatives and/or medical science liaisons who will
`paiiicipate in the marketing, discussion with medical providers, and/or sale ABP
`980; (ii) any adve1i ising for ABP 980, including print, television, internet, or other
`media; and (iii) product websites.");
`
`o REQUEST FOR PRODUCTION NO. 97 ("All documents to date relating to the
`impact of any label change on Amgen's adve1i ising, promotional materials, or
`healthcai·e provider educational materials (draft or othe1w ise), including
`documents sufficient to show any chan es to such materials as a conse uence of
`h
`t th
`osed label
`!
`•
`•
`");
`
`o REQUEST FOR PRODUCTION NO. 49 ("All documents related to the strategy
`for selling or marketing of ABP 980 both before and after any launch, including
`but not limited to anticipated or actual mai·ket shai·e, forecasted or actual impact
`on competitors, forecasted or actual price, forecasted or actual sales, forecasted or
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 23 of 36 PageID
`#: 18106
`
`WILMERHALE
`
`
`May 6, 2019
`Page 3
`
`
`
`actual revenue, forecasted or actual costs, forecasted or actual profits; documents
`identifying target markets and planned points of market entry; sales action plans
`including regional or district action plans; notes, memoranda, communications, or
`emails summarizing communications or meetings with physicians or payors;
`marketing or sales materials developed for physicians, patients, payors, or other
`customers; presentations, telewebs, memoranda, emails, training materials,
`objection handlers, and any other documents used to communicate with and/or
`train sales representatives; documents relating to launch strategies or simulations;
`documents relating to speaker bureaus and sales and marketing strategies relating
`thereto; long range plans or projections; and brand plans.”);
`
`o REQUEST FOR PRODUCTION NO. 12 (“All documents evidencing, referring
`to, or reflecting the factors Amgen considered in deciding to seek FDA approval
`to market a HER2 Product in the United States, including but not limited to all
`documents concerning Amgen’s decision to file Amgen’s IND and Amgen’s
`aBLA, such as pharmaceutical, chemical, and/or medical research concerning any
`HER2 Product, all economic and marketing research, analyses, forecasts, or
`reports concerning the sales, potential sales, or potential market share of any
`HER2 Product, and all communications, records, notes, and memoranda
`concerning the desirability of obtaining FDA approval for a HER2 Product.”);
`
`o REQUEST FOR PRODUCTION NO. 13 (“All documents concerning the
`decision to develop, manufacture, and sell ABP 980, including, without
`limitation, documents concerning drug and compound reviews, business plans,
`regulatory plans, product or project proposals and approvals, meeting minutes,
`patent clearance or infringement reviews or investigations, strategic plans or
`forecasts, market studies, market or sales projects or forecasts, marketing plans,
`and competitive analyses.”);
`
`o REQUEST FOR PRODUCTION NO. 14 (“All documents concerning Amgen’s
`forecasted or actual experience with market effects of biosimilar competition, in
`both the United States and abroad, including but not limited to evidence showing
`or refuting actual or forecasted price erosion or actual or forecasted loss of market
`share due to biosimilar competition on HERCEPTIN®; adjustments in marketing
`or sales strategy adopted after biosimilar entry; and industry analysis, competitive
`analysis, or market reports developed by Amgen or by a Third Party.”);
`
`o REQUEST FOR PRODUCTION NO. 51 (“All documents concerning any
`proposed labeling, advertising, promotional materials, or healthcare provider
`educational materials concerning ABP 980, including but not limited to any
`proposed communications relating to the use of ABP 980 in combination with any
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219-1 Filed 05/22/19 Page 24 of 36 PageID
`#: 18107
`
`WILMERI-IALE
`
`May 6, 2019
`Page 4
`
`oth er chug (whether promoting or discouraging such use), including taxoids,
`anthracycline derivatives, or any other chemotherapeutic agents, or relating to any
`diagnostic tests that may be perfo1med in deciding whether or how to achninister
`ABP 980.");
`
`o REQUEST FOR PRODUCTION NO. 96 ("All documents to date relating to the
`impact of any label change on Amgen's marketing plans or forecasts for ABP
`980, including documents sufficient to show any changes to m a 1~
`forecasts as a conse uence of an chan es to the proposed l a b e l (cid:173)
`");
`
`o REQUEST FOR PRODUCTION NO. 100 ("Documents to date sufficient to
`show Amgen's assessments or analyses of the impact o~
`to
`market ABP 980 with the chan es to the roposed l a b e -
`");
`
`o REQUEST FOR PRODUCTION NO. 113 ("All documents, including ch·afts, of
`actual marketing materials referencing the July 2018 aii icle published in Lancet
`Oncology by Gunter von Minckwitz et. al. , titled "Efficacy and safety of ABP 980
`compai·ed with reference trastuzumab in women with HER2-positive eai·ly breast
`cancer (LILAC study): a randomized, double-blind, phase 3 trial").
`
`dated custodial ESI re arding the changes
`regarding ABP 980, including changes to the
`manufacturing and proposed label of ABP 980, and documents and communications
`about these chan es: We decline our ro osal.
`
`Your appeal to limited "resource
`and time constraints" is not well-taken. This is a problem of Am g e n~
`Am en has roduced fewer than 8 000 custodial documents overall, -
`. Genentech identified these issues with
`as tried to work Amgen for several months in
`Amgen ' s ESI pro ucb on m J anuai·y an
`an effo1i to have Amgen rectify them on its own. Having stalled and rebuffed those
`efforts, Amgen cannot now point to the short time remaining in fact discove1y to excuse
`work that it should have done months ago. We will ask for the comi to compel
`product