Case 1:18-cv-00924-CFC-SRF Document 219 Filed 05/22/19 Page 1 of 5 PageID #:
`18079
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC. and CITY OF HOPE,
`
`V.
`
`AMGEN INC.,
`
`Plaintiffs,
`
`Defendant.
`
`C.A. No. 18-924-CFC
`
`PUBLIC VERSION
`
`AMGEN INC.'S LETTER IN OPPOSITION
`TO PLAINTIFFS' MOTION TO COMPEL
`
`Of Counsel:
`
`SMITH, KA TZENSTEIN & JENKINS, LLP
`
`Neal C. Belgam (No. 2721)
`Eve H. Ormerod (No. 5369)
`1000 West Street, Suite 1501
`Wilmington, DE 19801
`P (302) 652-8400
`nbelgam@skjlaw.com
`eormerod@skjlaw.com
`
`Attorneys for Defendant Amgen Inc.
`
`Michelle Rhyu
`Daniel Knauss
`Susan Krumplitsch
`Cooley LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
`rhyums@cooley.com
`dknauss@cooley.com
`skrumplitsch@cooley.com
`
`Orion Armon
`Cooley LLP
`380 Interlocken Crescent, Suite 900
`Broomfield, CO 80021-8023
`oarmon@cooley.com
`
`Eamonn Gardner
`Cooley LLP
`4401 Eastgate Mall
`San Diego, CA 92121-1909
`egardner@cooley.com
`
`Nancy Gettel
`Thomas Lavery, IV
`Amgen Inc.
`One Amgen Center Drive
`Thousand Oaks, CA 91320-1799
`P (805) 447-1000
`ngettel@amgen.com
`
`Dated: May 22, 2019
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 219 Filed 05/22/19 Page 2 of 5 PageID #:
`18080
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`Dear Judge Connolly:
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`Defendant Amgen Inc. ("Amgen") hereby opposes the relief requested in Plaintiffs' ("Genentech")
`May 13, 2019 letter brief (D.I. 190). Amgen's document production in this case has been
`comprehensive—including millions of pages of technical documentation (including Amgen's
`original BLA and its supplemental BLA, seeking approval of an additional manufacturing facility
`located in Rhode Island), extensive financial materials (consistent in scope with Genentech's
`production), substantial launch plan information, and relevant marketing documentation. As the
`case has progressed, Amgen has updated its production with documents that were recently created
`and fmalized. Genentech's complaints about Aingen's production are misplaced. For each alleged
`deficiency raised by Genentech, Amgen has negotiated in good faith, and in many instances has
`acceded to Genentech's requests. Despite Amgen's efforts, Genentech's motion continues to
`pursue information that is, at best, marginally relevant (and, in many cases, highly commercially
`sensitive) and not proportional to the needs of the case.
`
`1. Documents related to the pricing and contracting of Kanjintil have already been produced
`Amgen has already produced extensive financial infomiation,
`more than adequate to address remedies and infringement. Genentech now
`seeks more details impinging on Amgen's highly-sensitive business information,
`
`Genentech's overreaching request is not justifiable.
`
`As an initial matter
`
`, such information adds little, if anything, to the remedies analysis in view of the
`detailed information Amgen has already produced. See, e.g., Lakeview Pharm. of Racine, Inc. v.
`Catamaran Corp., No. 3:15-290,2017 WL 4310221, at *7-8 (M.D. Penn. Sept. 28,2017) (denying
`further pricing discovery as disproportionate to needs of the case "[Oven the extensive discovery
`already conducted"). Tellingly, Genentech itself has refused to produce the very same type of
`information it now seeks from Amgen. (See Ex. 1). This is because the burden and risk of
`prejudice associated with providing this information is not proportionate to, and outweighs, any
`probative value that the information may have—especially where the party seeking the information
`is a competitor. Cf Ani. Standard, Inc. v. Pfizer, Inc., 828 F.2d 734, 741 (Fed. Cir. 1987) (citations
`omitted). Genentech's thinly-veiled attempt to obtain highly-sensitive customer information from
`a competitor should be denied.
`
`1 "Kanjinti" is the brand name for Amgen's biosimilar trastuzumab candidate, ABP 980.
`2 Under Federal Food, Drug & Cosmetic Act sections 301 (a), (d) and 505(a) [21 U.S.C. §§ 331(a),
`(d) and 355(a)], a new drug may not be introduced into or delivered for introduction into interstate
`commerce unless an FDA-approved application is in effect for the drug.
`
`

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`Case 1:18-cv-00924-CFC-SRF Document 219 Filed 05/22/19 Page 3 of 5 PageID #:
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`2. Future manufacturing plans are speculative and not proportional
`The parties' dispute boils down to Genentech's demand for documents related to future
`manufacturing activities, i.e., events that have not yet occurred and are subject to change. First,
`Genentech argues that this information is relevant to infringement. But it is well established that
`35 U.S.C. § 271(e)(2) does not encompass future acts of infringement. See AstraZeneca Pharm.
`LP v. Apotex Corp., 669 F.3d 1370, 1380-81 (Fed. Cir. 2012. Second, Genentech relies on
`remedies as the basis for relevance, but fails to ex lain
`
`This is because Genentech does not
`
`need manufacturina lans for its remedies anal sis.
`
`. It views
`Amgen's future manufacturing plans as a proxy for this information, but fails to recognize that not
`only is a future act not an infringement, but that courts traditionally protect information relating to
`the ability to launch because it is so highly commercially sensitive that any alleged need for it is
`outweighed by the potential harm in producing it. See Teva Pharms. USA, Inc. v. Sandoz, Inc.,
`No. 08-cv-7611, 2010 WL 8760315, at *1 (S.D.N.Y. Oct. 12, 2010) ("Defendants are under no
`legal obligation to provide Plaintiffs with notice of its intent and ability to launch"); see also
`Novartis Pharms. Corp. v. Accord Healthcare hic., et. al, No. 18-1043-LPS, Transcript D.I. 308)
`at *38-39 (D. Del. Dec. 21, 2018) (denying discovery of "specific launch plans, specific dates, or
`other information about the launch plans"); Otsuka Pharm. Co., Ltd. v. Torrent Phanns. Ltd., Inc.,
`99 F. Supp. 3d 461, 471 (D.N.J. 2015) (declining to order launch date disclosure, citin
`"confidential and sensitive nature of these defendants' launch intentions").
`Genentech's further fishing
`expedition is not reasonable, especially in view of what has already been produced.
`
`3. Internal, unapproved, draft marketing documents are not relevant
`Am en has ahead a eed to roduce relevant marketm documents, mcludin. :
`
`Genentech, however, wants a third category of documents: draft, unapproved marketing
`documents that will never be shared with third-parties. Contrary to Genentech's position, these
`types of internal drafts are not relevant to an inducement claims because the will not be
`disseminated to the ublic without a roval.3
`
`o not re ia y represent ow Kanjinti wi actua Y
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`Unapproved marketing documents
`eted.
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`3 Genentech's reliance on 35 U.S.C. § 271(e)(2)(C) to support its request is misplaced. That
`section "treats the mere submission of a biosimilar application as an 'artificial' act of infringement,
`enabling parties to bring patent infringement actions at certain points in the application process
`even if the applicant has not committed a traditional act of patent infringement." Sandoz Inc. v.
`Amgen Inc., 137 S. Ct. 1664, 1666 (2017). It does not make the applicant's internal, unapproved,
`draft marketing materials relevant to any claims or defenses in this action.
`
`

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`Case 1:18-cv-00924-CFC-SRF Document 219 Filed 05/22/19 Page 4 of 5 PageID #:
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`4. Amgen is already producing updated ESI documents on an expedited basis
`The parties were actively negotiatin the roduction of additional EST documents until recent'
`Dunn • a meet-and-confer in March,
`
`Ex. 2 at 3. On Anil 4,
`
`, and asked Genentech how it planned to update its own EST production.
`(Ex. 5 at 2.) Genentech did not respond to that question until April 28, when it agreed to consider
`specific requests. When Amgen requested that Genentech provide an EST refresh from a single
`Genentech custodian Genentech refused to do so and has yet to provide any EST
`updates to Amgen. (See Ex. 6 at 4.) Despite Genentech's unresponsiveness, Amgen agreed to
`produce and is in the midst of reviewing and producing documents from three Amgen custodians.
`
`5. Amgen has complied with its discovery obligations and is expediting its production of
`remaining documents
`While Genentech complains that the deadline to substantially complete document production was
`in January, the current dispute largely comprises EST documents dated after January, which Amgen
`has been diligently collecting and producing on a rolling basis. To no one's surprise, both sides
`have been supplementing their productions after January, even though Genentech has expressly
`refused to update its own EST. Contrary to Genentech's assertions, the need to extend the discovery
`period was mutual—both parties continued to make supplemental productions, and determined
`that a short one-month extension would be appropriate. In fact, depositions for multiple Genentech
`witnesses had to be rescheduled (e.g., Abreu, Glasgow) due to Genentech's failure to complete its
`production of relevant documents. (Ex. 7 at 2.) And Amgen was forced to keep open an inventor
`deposition due to the late production of documents. (Ex. 8 at 3.) Amgen has produced millions
`of nages in discovery. including over 10.000 custodial documents.
`
`In comparison, Genentech's Herceptin product lias been
`on the market for nearly two decades and it has no credible excuse for its delayed production of
`documents. Amgen has continued to supplement its production as relevant and responsive
`documents are created and finalized. Because the depositions of Amgen's marketing witnesses
`have not yet occurred, Genentech has not identified any reasonable grounds for prejudice, and its
`request should be denied.
`
`For the reasons set forth above, Amgen respectfully requests that the Court deny Genentech's
`motion to compel.
`
`4 As promised, Amgen offered two custodians, but Genentech was not satisfied and demanded a
`third. (Ex. 3 at 1-2; Ex. 4 at 3.) Despite the questionable relevance of these documents, in addition
`to resource and time constraints, Amgen has been diligently working to collect documents for all
`three custodians and to produce responsive documents on a rolling, expedited basis.
`
`

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`Case 1:18-cv-00924-CFC-SRF Document 219 Filed 05/22/19 Page 5 of 5 PageID #:
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`Respectfully submitted,
`
`/s/ Neal C. Belgam
`
`Neal C. Belgam (#2721)
`
`cc: All Counsel of Record (via email)
`Enclosures
`
`