Case 1:18-cv-00924-CFC-SRF Document 49 Filed 11/19/18 Page 1 of 24 PageID #:
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`GENENTECH, INC. and CITY OF HOPE,
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`Plaintiffs,
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`AMGEN INC.,
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`Defendant.
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`C.A. No. 18-00924-CFC
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` [PROPOSED] ORDER FOR DISCOVERY,
`INCLUDING DISCOVERY OF ELECTRONICALLY STORED INFORMATION
`(“ESI”)
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`After conferring on these matters, the Parties hereby stipulate to the following protocol
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`for electronic discovery:
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`1.
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`Definitions
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`The following definitions shall apply for purposes of this agreement.
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`a.
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`“Asserted Patents” means U.S. Patent Nos. 6,407,213, 6,627,196, 7,371,379,
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`8,574,869, 7,993,834, 8,076,066, 6,620,918, 8,512,983, and 9,714,293, and App. No.
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`14/073,659. To the extent that additional patents or patent applications are asserted in this
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`Litigation, “Asserted Patents” as used herein shall include those additional patents or patent
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`applications.
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`b.
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`“Discovery Material” means all documents, testimony, pleadings, exhibits, and all
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`other material or information produced or disclosed in this Litigation, including responses to
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`requests for production of documents and/or things, answers to interrogatories, responses to
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`requests for admissions, documents and things made available for inspection, deposition
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`testimony, expert testimony and reports, and all other discovery taken pursuant to the Federal
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`Rules of Civil Procedure, including Third Party discovery pursuant to Fed. R. Civ. P. 45, matters
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`in evidence and any other information hereafter furnished, directly or indirectly, by or on behalf
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`of any Party, Third Party, or witness in connection with this Litigation. This Document
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`Production Protocol and provisions herein shall apply to all Discovery Material.
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`c.
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`“Document” carries its broadest meaning consistent with Fed. R. Civ. P. 34 and
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`includes ESI, Paper Discovery, and product samples.
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`d.
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`“Electronically Stored Information” or “ESI” carries its broadest possible
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`meaning consistent with Fed. R. Civ. P. 34(a) and Fed. R. Evid. 1001.
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`e.
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`“Email” means a system or network for transmitting messages electronically that
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`will send, store, process and receive information as between computers.
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`f.
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`“Format” means the internal structure of a file, which defines the way it is stored
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`and used.
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`g.
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`“Litigation” refers to the above-captioned case, Genentech Inc., et al. v. Amgen
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`Inc., C.A. No. 1:18-00924-GMS.
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`h.
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`“Native Format” means the format of ESI in the application in which such ESI
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`was originally created.
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`i.
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`“Outside Counsel” means any attorney from a law firm that has at least one
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`attorney who is then a current counsel of record for a Party in this Litigation and which Outside
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`Counsel is not an employee of a Party or of an Affiliate.
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`j.
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`“Paper Discovery” means any document or thing discoverable under Fed. R. Civ.
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`P. 26(b)(1) and Fed. R. Civ. P. 34 that cannot be characterized as ESI.
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`k.
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`“Party” or “Parties” means Plaintiffs Genentech, Inc. and City of Hope and
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`Defendant Amgen Inc.
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`l.
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`m.
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`“Producing Party” means a Party that produces Documents.
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`“Production Volume” means a unique alpha-numeric volume name representing a
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`range of Documents (i.e., batch) sent to the Receiving Party by the Producing Party. The
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`Production Volume is named consecutively beginning with “[Designation Indicating Party]001”
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`and continuing sequentially until all Documents have been produced.
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`n.
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`o.
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`p.
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`“Receiving Party” means a Party to whom Documents are produced.
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`“Requesting Party” means a Party that requests Documents.
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`“Tagged Image File Format” or “TIFF” refers to the CCITT Group IV graphic file
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`format for storing bit-mapped images, with multiple compression formats and resolutions.
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`2.
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`General Provisions
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`a.
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`Non-ESI. The Parties agree that nothing in this Order changes the Parties’
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`obligations under the Federal Rules of Civil Procedure to search for, collect, and produce non-
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`ESI information. Such non-ESI information, including but not limited to paper, will be produced
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`in electronic form, rendered text searchable via OCR or other means by the Producing Party, and
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`include any file folders and/or labels.
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`b.
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`Cooperation. Parties are expected to reach agreements cooperatively on how to
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`conduct discovery under Fed. R. Civ. P. 26-36. The Parties shall promptly meet and confer as
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`frequently as appropriate to negotiate in good faith to resolve any disputes that arise under this
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`Document Production Protocol.
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`c.
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`Proportionality. Parties are expected to use reasonable, good faith and
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`proportional efforts to preserve, identify and produce relevant information.1 This includes
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`identifying appropriate limits to discovery, including limits on custodians, identification of
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`relevant subject matter, time periods for discovery and other parameters to limit and guide
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`preservation and discovery issues.
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`d.
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`Preservation of Discoverable Information. A party has a common law
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`obligation to take reasonable and proportional steps to preserve discoverable information in the
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`party's possession, custody or control.
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`(i)
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`Absent a showing of good cause by the Requesting Party, the Parties shall
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`not be required to modify, on a going-forward basis, the procedures used by them in the ordinary
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`course of business to back up and archive data; provided, however, that the Parties shall preserve
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`the non-duplicative discoverable information currently in their possession, custody or control.
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`(ii)
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`Absent a showing of good cause by the Requesting Party, the categories of
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`ESI identified in Schedule A attached hereto need not be preserved.
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`e.
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`Privilege.
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`(i)
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`The Parties are to confer on the nature and scope of privilege logs for the
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`case, including whether categories of information may be excluded from any logging
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`requirements and whether alternatives to document-by-document logs can be exchanged.
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`(ii) With respect to information generated after July 31, 2017, the date when
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`Amgen announced the filing of its Biologics License Application for ABP 980, Parties are not
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`required to include any such information in privilege logs.
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`(iii)
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`The Parties will exchange privilege logs no later than 45 days after the
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`1 Information can originate in any form, including ESI and paper, and is not limited to
`information created or stored electronically.
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`substantial completion of document production.
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`(iv) Activities undertaken in compliance with the duty to preserve information
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`are protected from disclosure and discovery under Fed. R. Civ. P. 26(b)(3)(A) and (B).
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`(v)
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`The production of Discovery Material that is protected data or subject to
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`the attorney-client privilege, work-product immunity, or any other privilege or immunity,
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`whether inadvertent or otherwise, will not waive the protection, attorney-client privilege, work-
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`product immunity, or any other privilege or immunity in this Litigation or in any other federal or
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`state proceeding. Further, neither the fact that the information was produced nor the content of
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`such information shall be used in any manner as evidence in support of any such alleged waiver.
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`If a Party has produced information subject to a claim of protection, privilege, or immunity, upon
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`request identifying such information (“Recalled Information”), the information and all copies
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`thereof shall be returned promptly, or a signed verification by Outside Counsel for a Receiving
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`Party certifying that all such information and copies have been destroyed shall be provided to
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`Outside Counsel for the Producing Party no later than fifteen days (as calculated by Fed. R. Civ.
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`P. 6) after a request is made by the Producing Party. Moreover, any notes or summaries
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`describing, referring to or reflecting the content of Recalled Information shall be destroyed.
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`After the return or destruction of Recalled Information, a Receiving Party may challenge the
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`Producing Party’s claim(s) of protection, privilege, or immunity by making an application to the
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`Court. Such an application may rely on the description of the Recalled Information under Rule
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`26(b)(5)(A)(ii), but may not rely in any way on a Receiving Party’s examination of the Recalled
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`Information, including the content of the Recalled Information ascertained during such an
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`examination. The preceding sentence in no way forecloses a Receiving Party from requesting an
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`in camera review by the Court of the Recalled Information. This order shall be interpreted to
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`provide the maximum protection allowed by the Federal Rule of Evidence 502(d). Nothing
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`contained herein is intended to or shall serve to limit a party’s right to conduct a review of
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`Discovery Material for relevance, responsiveness and/or segregation of privileged and/or
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`protected information before production.
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`3.
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`Initial Discovery Conference. On July 31, 2018, counsel for the Parties participated in a
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`telephone conference pursuant to the Court’s Order Re: Case Management in Civil Cases and as
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`required by the Fed. R. Civ. P. 26(f). (D.I. 29.) The Parties participated in further telephone
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`conferences on August 23, 2018 and September 27, 2018. (See id.)
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`4.
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`Notice. The Parties shall make a good faith effort to identify in a timely fashion any
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`issues regarding responsive information that the Parties become aware of relating to: (i) any ESI
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`(by type, date, custodian, electronic system or other criteria) that a party asserts is not reasonably
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`accessible under Fed. R. Civ. P. 26(b)(2)(C)(i); (ii) third-party discovery under Fed. R. Civ. P. 45
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`and otherwise, including the timing and sequencing of such discovery; or (iii) production of
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`information subject to privacy protections, including information that may need to be produced
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`from outside of the United States and subject to foreign laws.
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`5.
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`Initial Discovery in Patent Litigation.
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`a.
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`As expressed in the Parties’ Joint Status Report (D.I. 29), given the Parties’
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`exchanges under the BPCIA, the Parties shall forgo the initial discovery in patent litigation
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`provided under Delaware Default Discovery Standard Rule 4. Any final supplementation of
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`contentions shall occur by the close of fact discovery.
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`6.
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`Specific E-Discovery Issues.
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`a.
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`On-site inspection of electronic media. Such an inspection shall not be
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`permitted absent a demonstration by the Requesting Party of specific need and good cause.
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`b.
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`ESI Search methodology.
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`(i)
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`Search terms. If the Producing Party elects to use search terms to locate
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`potentially responsive ESI, it shall disclose the search terms to the
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`Requesting Party. Absent a showing of good cause, a Requesting Party
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`may request no more than twelve (12) additional terms in total to be used
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`in connection with the electronic search(es) of the Producing Party’s
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`custodial data, with eight (8) such additional terms to be provided within
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`fourteen (14) days of receipt of the Producing Party’s disclosure of search
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`terms, and with the remaining four (4) additional search terms to be
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`provided at least thirty (30) days before the substantial completion of
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`document production. The Parties will undertake their best efforts to meet
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`the substantial completion of document production deadline, but
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`acknowledge that providing search terms after fourteen (14) days of
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`receipt of the Producing Party’s disclosure of search terms may affect a
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`Party’s ability to meet this deadline. The search terms proposed by the
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`Requesting Party shall be narrowly tailored to the particular issues in the
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`case. Focused terms, rather than over-broad terms (e.g., product and
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`company names), shall be employed. The Parties acknowledge that there
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`may be certain instances where the volume of ESI is particularly high.
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`The Parties agree that in the event of a claim that a particular search term
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`or combination of terms is too burdensome, the Parties will exchange
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`information showing the number of “hits” for each such term or
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`combination of terms, and agree to work in good faith to resolve such
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`issues on a case-by-case basis. The Parties shall meet and confer on any
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`modifications to the Requesting Parties’ proposed terms (including with
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`respect to translation issues) needed to improve their efficacy in locating
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`discoverable information and in excluding information that is not
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`proportional to the needs of the case under Fed. R. Civ. P. 26(b), including
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`modifying terms where the burden or expense of the proposed terms
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`outweighs the likely benefit. The Parties shall promptly cooperate to test
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`proposed search terms prior to committing to their use. Indiscriminate
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`terms, such as the producing company’s name, are inappropriate unless
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`combined with narrowing search criteria that sufficiently reduce the risk of
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`overinclusion. A conjunctive combination of multiple words or phrases
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`(e.g., “computer” and “system”) narrows the search and shall count as a
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`single search term. A disjunctive combination of multiple words or
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`phrases (e.g., “computer” or “system”) broadens the search, and thus each
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`word or phrase shall count as a separate search term unless they are
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`variants of the same word. Unless otherwise agreed-to by the Parties, the
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`Producing Party need only search (i) the non-custodial data sources
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`identified in accordance with Section 6(b)(ii); and (ii) emails and other
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`ESI maintained by the custodian in accordance with Section 6(b)(ii).
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`(ii)
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`Custodians and non-custodial data sources. In addition to the inventors
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`of the Asserted Patents, within seven (7) days of the date this ESI Order is
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`entered by the Court, or by November 27, 2018, whichever is later,
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`Plaintiff Genentech shall identify the seven (7) non-inventor custodians
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`most likely to have potentially responsive information in their possession,
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`custody or control. Within seven (7) days of the date this ESI Order is
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`entered by the Court, or by November 27, 2018, whichever is later,
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`Defendant shall identify the ten (10) custodians most likely to have
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`potentially responsive information in their possession, custody or control.
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`Because discovery is ongoing, the Parties reserve the right to request
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`additional non-inventor custodians upon a showing of good cause and as
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`the need arises. The Parties will undertake their best efforts to meet the
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`substantial completion of document production deadline, but acknowledge
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`that an agreement to include additional non-inventor custodians may affect
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`a party’s ability to meet this deadline. The custodians shall be identified
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`by name, title, role in the instant dispute, and a brief description of the
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`nature of information expected to be located in the custodian’s ESI. The
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`Parties shall search the emails and other ESI of their respective custodians.
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`Email and ESI of the inventors of the Asserted Patents need only be
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`searched through the issue dates of the respective Asserted Patents. To the
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`extent that any inventor of the Asserted Patents continued or continues to
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`be meaningfully involved in a relevant aspect of the research,
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`development, manufacturing, or prescribing of Herceptin past the issue
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`date of his or her patent, that inventor’s email and ESI shall be searched
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`beyond the issue date of his or her patent, through a time to be agreed
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`upon by the Parties. The Parties further agree to cooperate in good faith to
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`identify which inventors were or are meaningfully involved in a relevant
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`aspect of the research, development, manufacturing, or prescribing of
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`Herceptin past the issue date of his or her patent. The Parties shall also
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`make a good faith effort to identify and search non-custodial data sources2
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`likely to contain non-duplicative responsive information. Each Producing
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`Party shall provide a list of the non-custodial data sources that such
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`Producing Party represents are most likely to contain non-duplicative
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`discoverable information for preservation and production consideration,
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`along with a brief description of the nature of information expected to be
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`located within such sources, within seven (7) days of the date this ESI
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`Order is entered by the Court, or November 27, 2018, whichever is later.
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`c.
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`Format. ESI and non-ESI shall be produced to the Requesting Party as text
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`searchable image files in black-and-white format, except as provided in Sections 6.d-g. When a
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`text-searchable image file is produced, the Producing Party must preserve the integrity of the
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`underlying ESI, i.e., the original formatting and metadata, to the extent such metadata exists (see
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`infra Section 6.j). The Parties shall produce their information in the following format: single
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`page TIFF images and associated multipage text files containing extracted text or OCR with
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`Concordance and Opticon load files containing all requisite information including relevant
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`metadata. The production data will be exchanged between counsel in encrypted form (e.g.,
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`PGP). Each production shall be provided in the following folder structure: Top-level folder:
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`This folder will indicate the production volume (i.e., ABC-001); Sub-folders:
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`(i)
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`IMAGES: This folder will contain multiple sub-folders with ONLY TIFF
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`2 That is, a system or container that stores ESI, but over which an individual custodian does not
`organize, manage or maintain the ESI in the system or container (e.g., enterprise system or
`database).
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`files in them. No other type of file should reside in the “IMAGES” folder.
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`Except as provided in Sections 6.c and 6.d, ESI shall be produced
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`electronically, as single page, uniquely and sequentially numbered Black-
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`and-White Group IV TIFF files not less than 300 dpi resolution. Color
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`images should be provided in .JPG format when color is necessary in
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`accordance with 5.h. Each file will be assigned a control number which
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`will be the starting Bates number of the document. Sub-folders shall not
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`contain more than 1000 images per folder. Original document orientation
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`should be maintained (i.e., portrait to portrait and landscape to landscape).
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`(ii)
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`TEXT: Except with regard to ESI that is redacted, the images shall be
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`accompanied by text files, in UTF8 format, in a separate folder labeled
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`TEXT matching the folder structure of the IMAGES folder. These text
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`files will contain the extracted text on a Document basis, if available. All
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`native files for which EXTRACTED TEXT may reasonably be obtained
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`and reviewed will be produced as images with EXTRACTED TEXT files
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`and field data. Native files with hidden attributes may be subject to print
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`scan OCR. For native files for which EXTRACTED TEXT is not
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`reasonably obtained (e.g. redacted documents, paper documents (as
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`provided in Section 6.e, or graphics files), an electronically generated
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`OCR file will be exchanged along with the TIFF images and extracted
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`metadata. The text files shall be named to match the endorsed Document
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`Number (a/k/a Bates number) assigned to the image of the first page of the
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`Document per Section 6.i.
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`(iii) DATA: Documents produced to each party shall include load files and
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`file structures compatible with Concordance version 10 or above and
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`Opticon.
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`Specifically, the images shall be accompanied by an image cross-
`reference load file, including an Opticon .OPT file compatible
`with Concordance version 10 or above providing the beginning
`and ending endorsed number of each document and the number of
`pages it comprises.
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`Opticon Image Load File (.opt) Configuration:
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`Page level comma-delimited file containing seven fields per line.
`PageID, VolumeLabel,
`ImageFilePath, DocumentBreak,
`PageCount
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`ABC-
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`Example
`JD00030005„\ABC002\Images\001\ABC-JD-00030005.tif,Y
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`The Producing Party shall also provide a data load file (“Data
`Load File” or “.DAT”) corresponding to the TIFF files,
`compatible with Concordance version 10 or above, that shall
`contain the metadata, as reasonably available, associated with
`each field specified in Section 6.j. For the avoidance of any
`doubt, there is no obligation on the Producing Party to create
`metadata where none exists or is not reasonably available, or to
`produce metadata where such metadata may comprise attorney
`work product. However, if metadata is withheld on attorney work
`product grounds, it shall be logged on a privilege log in
`accordance with Section 2.e.
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`(iv) NATIVES: This folder will contain only native files subject to Section
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`6.d. A Producing Party shall not modify the content of any native file.
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`d.
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`Native files. The only files that should be produced in Native Format are files not
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`easily converted to image format, such as Excel and Access files, or files that lack utility when
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`converted to image format, such as structural data (e.g., .pdb files) or DNA sequence
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`chromatograms (e.g., .abi files). A Receiving Party may request that a file be produced in Native
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`Format, and if that request an unreasonable or undue burden on the Producing Party, the
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`Producing Party shall notify the Receiving Party of the objection and the Parties shall meet and
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`confer about the issue.
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`e.
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`Production of Paper Discovery: Paper Discovery will be produced in electronic
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`form. The production will be provided in the same folder structure stated in Section 6.c. The
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`data load file stated in Section 6.c.iii shall contain the metadata associated with each Production
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`Field specified in Schedule B. Paper Discovery produced in electronic form will be rendered
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`text searchable via OCR or other means to the extent possible by the Producing Party. If a
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`document that was originally generated by a software application (e.g., Microsoft Word or
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`Microsoft Outlook) is collected from a custodian in hard copy form, the Producing Party has no
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`obligation to locate and produce the electronic file from which the hard copy was created. For
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`Paper Discovery found in file folders and other similar containers that have labels or other
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`identifying information, such file folder and label shall be scanned.
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`f.
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`Appearance and Content. Subject to any necessary redaction, each Document’s
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`TIFF image file shall contain the same information and same physical representation as the
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`Document did in its original format, whether paper or electronic, consistent with the processing
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`specifications set forth in Section 6.r. If a produced Document presents imaging or formatting
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`problems that the Producing Party was not able to resolve at the time of production, the
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`Receiving Party, upon discovery, may request a replacement copy from the Producing Party of
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`the problematic Document and such requests shall not be unreasonably denied and shall be
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`promptly satisfied.
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`g.
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`Color. The Parties agree to produce TIFFs in black-and-white format, except
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`that (a) documents that are illegible in black-and-white shall be reproduced in color upon request
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`and (b) a Producing Party that intends to rely upon a color version of the document in any filing,
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`discovery response, deposition, or trial must produce the document in color as a single page
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`TIFF image, PDF, JPEG, or native file (at the producing party’s discretion). In addition, a
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`Receiving Party may make reasonable, good faith, and proportional requests for color versions of
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`documents by notifying the Producing Party of the Bates number of the documents that it
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`reasonably anticipates may be needed for filing, discovery response, deposition, or trial, or that it
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`contends is illegible in black-and-white. In response to reasonable, good faith, and proportional
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`requests, a Producing Party shall produce the requested color documents as a single page TIFF
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`image, JPEG, or native file (at the Producing Party’s discretion) within five (5) business days of
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`the request or within a timeframe that is mutually agreeable to the Parties.
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`h.
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`Document Unitization: If a Document is more than one page, to the extent
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`possible, the unitization of the Document and any attachments or affixed notes shall be
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`maintained as it existed when collected by the Producing Party. The Producing Party should
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`determine logical Document breaks, and attachments should be preserved. Physical bindings,
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`such as staples and clips, should be considered but should not be used exclusively for
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`determining Document boundaries and attachments. The Producing Party’s efforts should
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`emphasize analyzing the stand-alone value of the Document as a measurement of whether the
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`Document should have its own database record or be included within the same record of another
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`Document. For example, a lab notebook will be produced as a single Document. If unitization
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`cannot be maintained, the original unitization shall be documented in a load file or otherwise
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`electronically tracked in the DocumentBreak field in the .OPT file in accordance with Section
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`6.c.iii.
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`i.
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`Document Numbering and Confidentiality Designation for TIFF Images.
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`Each page of a Document produced in TIFF file format shall have a legible, unique numeric
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`identifier (“Document Number;” a/k/a Bates number) not less than eight (8) digits electronically
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`“burned” onto the image at a place on the Document that does not obscure, conceal or interfere
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`with any information originally appearing on the Document. The Document Number for each
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`Document shall be created so as to identify the Producing Party and the Document Number (e.g.,
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`“AMGKAN00000000”). Each Plaintiff and Defendant shall have a unique identifying name.
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`The confidentiality designation, if any, should also be electronically “burned” onto the image at a
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`place on the Document that does not obscure, conceal, or interfere with any information
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`originally appearing on the document.
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`j.
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`Metadata fields. The Parties are obligated to provide the following metadata for
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`all ESI produced (or the equivalent thereof), to the extent such metadata exists: Volume,
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`Custodian, Duplicate Custodian, File Path, Email subject, Conversation Index, From, To, CC,
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`BCC, Date Sent, Time Sent, Date Received, Time Received, Filename, File Extension, Author,
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`Date Created, Date Last Modified, Modified By, MD5 Hash or SHA Hash, File Size, File
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`Extension, Control Number Begin, Control Number End, Full Text, Attachment Range,
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`Attachment Begin, Attachment End, Redaction, and Confidentiality.
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`k.
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`Production Media: The Producing Party shall produce Document images, load
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`files and metadata on hard drives, CDs, DVDs, FTP, or other mutually agreeable media
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`(“Production Media”). Each piece of Production Media shall include a unique identifying label
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`corresponding to the identity of the Producing Party, the date of the production of Documents on
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`the Production Media, the Production Volume, and the Document Number ranges of the
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`Documents in that production (e.g., “Amgen Production March 1, 2018, AMG0000123 -
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`AMG0000456”). To the extent that the Production Media includes any information designated
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`as “CONFIDENTIAL” or any similar type of designation under any Stipulated Protective Order
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`filed with the Court, or other order or agreement, the label on such Production Media shall
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`prominently indicate that the Production Media includes information so designated. Production
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`Media shall include text referencing the case name and number. Further, any replacement
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`Production Media shall cross-reference the original Production Media, clearly identify that it is a
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`replacement and cross-reference the Document Number range that is being replaced. All
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`Production Media that is capable of write protection should be write-protected before production.
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`All Production Media shall be encrypted, with the Parties to agree on a decryption key prior to
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`production. If any piece of Production Media is known to have any physical defect, electronic
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`defect or damaged data or is infected with any virus or other harmful software of any kind, it
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`should be clearly labeled so that appropriate care can be taken during its examination.
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`Alternatively, a Party may remove any virus or defect before production but must inform any
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`Receiving Party of any such efforts. If any piece of Production Media is unusable by the
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`Receiving Party, the Producing Party must provide a replacement Production Media as soon as
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`reasonably practicable.
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`l.
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`Redactions. The Producing Party may redact, from any TIFF image, metadata
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`field, and/or native file, information that is protected from disclosure by any applicable privilege
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`or immunity law or regulation, including but not limited to information protected by attorney-
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`client privilege, work product doctrine, joint defense work product doctrine, individually
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`identifiable health information, personal identifying information, or confidential information that
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`does not relate to ABP 980, Herceptin, or the patents-in-suit and that is otherwise non-responsive
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`to a discovery request. Each redaction, regardless of size, shall be clearly labeled “Redacted –
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`Privileged,” “Redacted – Protected Data,” or “Redacted – Non-Responsive” as appropriate. In
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`the event that a native file is redacted, the corresponding TIFF image shall indicate on its face
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`that the native file has been redacted, and the redaction in the native file shall identify the basis
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`for withholding the redacted information. The Producing Party may also redact information that
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`is not responsive and if so, the redaction shall identify the basis for withholding the redacted
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`information.
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`m.
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`Production Rules. Due to the contextual relationship of electronic documents,
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`the Parties will maintain family relationships for electronic data. If any document in a document
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`family is responsive (e.g., an attachment to an email), the cover email in the family shall be
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`produced without regard to whether it is independently responsive (subject to the redaction
`
`provisions of 5.k), but nonresponsive attachments in the family need not be produced. The
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`Parties will make relevancy and production determinations for hard copy documents at the
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`document level.
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`n.
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`Corrupt or Inaccessible Files. Certain files may be inaccessible due to
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`password protection, corruption, or unreadable document formats.