Case 1:18-cv-01025-CFC Document 38 Filed 11/16/18 Page 1 of 15 PageID #: 2857
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC., CITY OF HOPE, and
`HOFFMANN-LA ROCHE INC.,
`
`Plaintiffs,
`
`v.
`
`CELLTRION, INC., CELLTRION
`HEALTHCARE CO., LTD., TEVA
`PHARMACEUTICALS USA, INC., and
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH,
`
`Defendants.
`
`GENENTECH, INC., CITY OF HOPE, and
`HOFFMANN-LA ROCHE INC.,
`
`Plaintiffs,
`
`v.
`
`CELL TRION, INC., CELL TRION
`HEALTHCARE CO., LTD., TEVA
`PHARMACEUTICALS USA, INC., and
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH,
`
`Defendants.
`
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`C.A. No. 18-095-CFC
`
`C.A. No. I 8-1025-CFC
`
`-fl'ROPOSIJB~ER FOR DISCOVERY,
`INCLUDING DISCOVERY OF ELECTRONICALLY STORED INFORMATION
`("ESI")
`
`After conferring on these matters, the Parties hereby stipulate to the following protocol
`
`for electronic discovery:
`
`

`

`Case 1:18-cv-01025-CFC Document 38 Filed 11/16/18 Page 2 of 15 PageID #: 2858
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`1.
`
`General Provisions
`
`a.
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`Non-ESI. The Parties1 agree that, unless specified herein, nothing in this Order
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`changes the Parties' obligations under the Federal Rules of Civil Procedure to search for, collect,
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`and produce non-ESI information. Such non-ESI information, including but not limited to paper,
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`will be produced in electronic form, rendered text searchable to the extent possible, e.g., via
`
`OCR, by the Producing Party,2 and include any file folders and/or labels.
`
`b.
`
`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
`
`frequently as appropriate to negotiate in good faith to resolve any disputes that arise under this
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`Document Production Protocol.
`
`c.
`
`Proportionality.
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`Parties are expected to use reasonable, good faith and
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`proportional efforts to preserve, identify and produce relevant information. 3 This includes
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`identifying appropriate limits to discovery, including limits on custodians, identification of
`
`relevant subject matter, time periods for discovery and other parameters to limit and guide
`
`preservation and discovery issues.
`
`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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`1 "Parties" means or refers collectively to the named Plaintiffs and Defendants in the above(cid:173)
`captioned matter.
`2 "Producing Party" refers to a Party from which production of the information at issue is sought.
`3 Information can originate in any form, including ESI and paper, and is not limited to
`information created or stored electronically.
`
`2
`
`

`

`Case 1:18-cv-01025-CFC Document 38 Filed 11/16/18 Page 3 of 15 PageID #: 2859
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`(i)
`
`Absent a showing of good cause by the Requesting Party,4 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.
`
`e.
`
`Privilege.
`
`(i)
`
`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 that
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`Celltrion announced the filing of its aBLA, Parties are not required to include any such
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`information in privilege logs.
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`(iii) Unless otherwise agreed to by the Parties or ordered by the Court, the
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`Parties will exchange privilege logs no later than 30 days after the substantial completion of
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`document production.
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`(iv) With respect to information generated at the direction of Trial Counsel5 or
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`communications with Trial Counsel, parties are not required to include any such information or
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`communications in privilege logs.
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`4
`
`"Requesting Party" refers to a Party seeking production of the information at issue.
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`5
`
`"Trial Counsel" means, for Plaintiffs, Wilmer Cutler Pickering Hale & Dorr LLP, Durie
`Tangri LLP, and Morris Nichols Arsht & Tunnell LLP, and for Defendants, Goodwin Procter
`LLP and Shaw Keller LLP.
`
`3
`
`

`

`Case 1:18-cv-01025-CFC Document 38 Filed 11/16/18 Page 4 of 15 PageID #: 2860
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`(v)
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`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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`2.
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`Initial Discovery Conference. On July 24, 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(t). (Case No. 18-cv-1025, D.I. 37; Case No. 1025, D.I. 10.)
`
`3.
`
`Notice. The Parties shall make a good faith effort to identify in a timely fashion any
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`issues that the Parties become aware of relating to:
`
`(i) any ESI (by type, date, custodian,
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`electronic system or other criteria) that a Party asserts is not reasonably accessible urider Fed. R.
`
`Civ. P. 26(b)(2)(C)(i); (ii) third-party discovery under Fed. R. Civ. P. 45 and otherwise,
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`including the timing and sequencing of such discovery; or (iii) production of information subject
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`to privacy protections, including information that may need to be produced from outside of the
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`United States and subject to foreign laws.
`
`4.
`
`Initial Discovery in Patent Litigation.
`
`a.
`
`As expressed in the Parties' Joint Status Report (Case No. 18-cv-95, D.I. 46),
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`given the Parties' exchanges under the BPCIA, the Parties shall forgo the initial discovery in
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`patent litigation provided under Delaware Default Discovery Standard Rule 4. Any final
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`supplementation of contentions shall occur by the close of fact discovery, or as otherwise
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`ordered by the Court.
`
`b.
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`Absent a showing of good cause, follow-up discovery shall be limited to a term of
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`6 years before the filing of the Complaint, except that discovery related to asserted prior art,
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`asserted objective indicia of non-obviousness, or the conception and reduction to practice of the
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`inventions claimed in any patent-in-suit shall not be so limited.
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`4
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`

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`Case 1:18-cv-01025-CFC Document 38 Filed 11/16/18 Page 5 of 15 PageID #: 2861
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`5.
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`Specific E-Discovery Issues.
`
`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.
`
`(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
`
`Requesting Party. Absent a showing of good cause, a Requesting Party
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`may request no more than ten ( I 0) additional terms in total to be used in
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`connection with the electronic search( es), with such additional terms to be
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`provided within seven (7) days of receipt of the Producing Party's
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`disclosure of search terms. The search terms proposed by the Requesting
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`Party shall be narrowly tailored to the particular issues in the case.
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`Focused terms, rather than over-broad terms (e.g., product and company
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`names), shall be employed. The Parties acknowledge that there may be
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`certain instances where the volume of ESI is particularly high. The Parties
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`agree that in the event of a claim that a particular search term or
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`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
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`information and
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`in excluding information that
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`is not
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`5
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`

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`Case 1:18-cv-01025-CFC Document 38 Filed 11/16/18 Page 6 of 15 PageID #: 2862
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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
`
`proposed search terms prior to committing to their use.
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`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") ~roadens 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 paragraph 5(b )(ii); and (ii) emails and other
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`ESI maintained by the custodian in accordance with paragraph 5(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 fourteen ( 14) days after the date of this
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`Order, Plaintiffs shall identify the 5 non-inventor custodians most likely to
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`have potentially responsive information in their possession, custody or
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`control. Within fourteen (14) days after the date of this Order, Defendants
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`shall identify the IO custodians most likely to have potentially responsive
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`information in their possession, custody or control. The custodians shall
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`be identified by name, title, role in the instant dispute, and a brief
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`6
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`

`

`Case 1:18-cv-01025-CFC Document 38 Filed 11/16/18 Page 7 of 15 PageID #: 2863
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`description of the nature of information expected to be located in the
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`custodian's ESI. The parties shall search the emails and other ESI of their
`
`respective custodians. Unless otherwise specifically requested and agreed
`
`to by the Parties or ordered by the Court, email and ESI of the inventors of
`
`the Asserted Patents need only be searched through the issue dates of the
`
`respective Asserted Patents. The Parties shall also make a good faith
`
`effort to identify and search non-custodial data sources6 likely to contain
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`non-duplicative responsive information. Each Producing Party shall
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`provide a list of the non-custodial data sources that such Producing Party
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`represents are most
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`likely
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`to contain non-duplicative discoverable
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`information for preservation and production consideration, along with a
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`brief description of the nature of information expected to be located within
`
`such sources, within fourteen (14) days after the date of this Order.
`
`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, except as provided in Sections 5 .d-e. When a text-searchable image file
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`is produced, the Producing Party must preserve the integrity of the underlying ESI, i.e., the
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`original formatting and metadata, to the extent such metadata exists (see infra Section 5.h). The
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`Parties shall produce their information in the following format: single page TIFF images and
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`associated multipage text files containing extracted text or OCR with Concordance and Opticon
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`load files containing all requisite information including relevant metadata.
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`6 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).
`
`7
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`

`

`Case 1:18-cv-01025-CFC Document 38 Filed 11/16/18 Page 8 of 15 PageID #: 2864
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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.,
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`.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 presents 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.
`
`e.
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`Appearance and Content.
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`Subject
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`to any necessary redaction, each
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`Document's7 TIFF image file shall contain the same
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`information and same physical
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`representation as the Document did in its original format, whether paper or electronic, consistent
`
`with the processing specifications set forth in Paragraph c. If a produced Document presents
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`imaging or formatting problems that the Producing Party was not able to resolve at the time of
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`production, the Receiving Party, upon discovery, may request a replacement copy from the
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`Producing Party of the problematic Document and such requests shall not be unreasonably
`
`denied and shall be promptly satisfied if possible.
`
`f.
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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
`
`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).
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`In addition, a
`
`Receiving Party may make reasonable, good faith, and proportional requests for color versions of
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`"Documents" shall have the same definition as set forth in Federal Rule of Civil Procedure
`
`7
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`34.
`
`8
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`

`

`Case 1:18-cv-01025-CFC Document 38 Filed 11/16/18 Page 9 of 15 PageID #: 2865
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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
`
`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.
`
`g.
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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
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`(e.g., "AMGKAN00000000"). Each Plaintiff and Defendant shall have a unique identifying
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`name. The confidentiality designation, if any, should also be electronically "burned" onto the
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`image at a place on the Document that does not obscure, conceal, or interfere with any
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`information originally appearing on the document.
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`h.
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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: Custodian, File
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`Path, Email subject, Conversation Index, From, To, CC, BCC, Date Sent, Time Sent, Date
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`Received, Time Received, Filename, Author, Date Created, Date Last Modified, MD5 Hash or
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`SHA Hash, File Size, File Extension, Control Number Begin, Control Number End, Attachment
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`Range, Attachment Begin, Attachment End, Redaction, and Confidentiality.
`
`9
`
`

`

`Case 1:18-cv-01025-CFC Document 38 Filed 11/16/18 Page 10 of 15 PageID #: 2866
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`i.
`
`Redactions. Documents may be subject to redaction, in good faith by the
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`Producing Party, of information that is neither relevant to the subject matters of this litigation nor
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`reasonably calculated to lead to the discovery of admissible evidence, or is subject to the
`
`attorney-client privilege, to work-product immunity, or any other applicable privilege or
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`immunity. For avoidance of doubt, no information contained in regulatory correspondence or
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`submissions may be redacted or withheld on relevance grounds if it directly relates to the
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`patents-in-suit and to trastuzumab or any trastuzumab biosimilar product. Each such redaction,
`
`regardless of size, shall be clearly labeled "Redacted." The Parties further agree that non(cid:173)
`
`responsive attachments to responsive parent documents need not be produced and a placeholder
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`slip-sheet endorsed "Withheld Non-Responsive" will be produced
`
`to capture
`
`the
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`relationship. This Paragraph shall not be construed as a waiver of any Party's right to seek
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`disclosure of redacted or withheld information. All documents redacted based on attorney-client
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`privilege, work-product immunity, or any other privilege or immunity shall be listed on a
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`privilege log stating the basis for such redaction, pursuant to section 1 ( e) above, and any
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`subsequent agreement of the Parties.
`
`j.
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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.i), but nonresponsive attachments in the family need not be produced.
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`k.
`
`Corrupt or Inaccessible Files. Certain files may be inaccessible due to
`
`password protection, corruption, or unreadable document formats. If reasonable efforts to obtain
`
`10
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`

`

`Case 1:18-cv-01025-CFC Document 38 Filed 11/16/18 Page 11 of 15 PageID #: 2867
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`useful TIFF images or accessible native versions of these files are unsuccessful, such documents
`
`may be withheld.
`
`I.
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`De-duplication. To the extent identical copies of Documents (i.e., Documents
`
`with identical hash values) appear in the files produced in this case, the Producing Party need
`
`only produce one such identical copy for that source. De-duplication may be done across
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`custodians, provided, however, that the name of each custodian who had the Document being de(cid:173)
`
`duped shall be provided in the "Duplicate Custodian" metadata field, as known at the time of
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`production of that record. Email and their attachments shall be treated as a single file for
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`purposes of de-duplication. The Custodian field shall be supplemented on a timely basis when
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`additional duplicates are identified and not produced. The parties may de-duplicate stand-alone
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`documents against stand-alone documents and may de-duplicate top-level email documents
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`against top-level email documents using the calculated hash of the native produced file
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`(e.g. MD5 Hash Code or SHA-I). Electronic files will be de-duplicated based upon the
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`calculated hash values for binary file content ( e.g. MD5 Hash Code or SHA- I). File contents
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`will only be used for hash value calculation and will not include operating system metadata
`
`values.
`
`m.
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`Parent-Child Relationships. Parent-child relationships (the association between
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`an attachment and its parent document) shall be preserved and reflected in the ProdBegAttach /
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`ProdEndAttach metadata fields. Original document orientation shall be maintained (i.e., portrait
`
`to portrait and landscape to landscape).
`
`n.
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`Third-Party Software. To the extent that Documents produced pursuant to this
`
`Document Production Protocol cannot be rendered or viewed without the use of proprietary non(cid:173)
`
`commercially available third-party software or software developed by the Parties, the Parties
`
`11
`
`

`

`Case 1:18-cv-01025-CFC Document 38 Filed 11/16/18 Page 12 of 15 PageID #: 2868
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`shall meet and confer to minimize any expense or burden associated with the production of such
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`Documents in an acceptable format and review of the Documents by the Receiving Party,
`
`including issues as may arise with respect to obtaining access to any such software and operating
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`manuals which are the property of a third party or the Parties.
`
`o.
`
`Processing Specifications. The Producing Party shall use the following
`
`specifications when converting ESI from its Native Format into TIFF image files prior to its
`
`production:
`
`(i)
`
`Tracked changes, author comments, hidden columns and hidden rows
`
`shall be turned "on" before production.
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`(ii)
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`Presenter notes will be made visible and Microsoft PowerPoint files shall
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`be produced in notes view.
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`(iii) Compressed Files. Compression file types (i.e., .CAB, .GZ, .TAR, .Z,
`
`.ZIP) shall be decompressed in a reiterative manner to ensure that a zip
`
`within a zip is decompressed into the lowest possible compression
`
`resulting in individual folders and/or files.
`
`p.
`
`Manner of Service:
`
`(i)
`
`Pursuant to Fed. R. Civ. P. 5(b)(2)(E), all discovery requests shall be
`
`served by Email in .pdf format. Upon a request by the receiving party, the
`
`serving party will provide a courtesy copy of the requests in Word format.
`
`(ii)
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`All responses and objections thereto (but not necessarily Documents
`
`produced pursuant to any such request) shall be served by Email in a
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`searchable .pdf format.
`
`12
`
`

`

`Case 1:18-cv-01025-CFC Document 38 Filed 11/16/18 Page 13 of 15 PageID #: 2869
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`(iii) All discovery requests, responses, and objections served by Email by
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`6 PM Eastern time on given day shall constitute timely service on that day.
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`(iv) All produced Documents shall be served either by .ftp site or by hand
`
`delivery or by Federal Express (or similar means) for next day delivery.
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`When serving produced Documents by hand delivery or next day delivery,
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`such delivery shall be made on electronic media with encryption or other
`
`similar means of security. Where service is made by next day delivery,
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`service shall be effective on the day sent.
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`(v)
`
`For service of discovery requests, discovery responses and objections, and
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`Documents by .ftp, the parties designate the following counsel to receive
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`ftp instructions and passwords at the Email addresses identified below.
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`For hand delivery or overnight delivery of Documents, the parties
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`designate the following counsel to receive the Documents at the addresses
`
`identified below with a copy of production cover letters to be sent to the
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`Email addresses identified below.
`
`Party
`
`Service by E-mail
`
`Service by
`Hand/Overnight
`Mail
`Anita Gulino
`jblumenfeld@mnat.com
`Wilmer Hale
`kjacobs@mnat.com
`60 State St.
`WHGNE-
`CelltrionHercegtinServiceList@wilmerhale Boston, MA 02109
`.com
`Celltrion and Teva DG-
`Cynthia Hardman
`CelltrionTMABBPCIALit@goodwinlaw.c Goodwin Procter LLP
`New York Times Building
`om; ahfitzgerald@goodwinlaw.com
`620 Eighth A venue
`New York, NY 10018
`
`Gen en tech
`
`13
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`

`

`Case 1:18-cv-01025-CFC Document 38 Filed 11/16/18 Page 14 of 15 PageID #: 2870
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`6.
`
`Miscellaneous Provisions
`
`a.
`
`City of Hope. Notwithstanding anything to the contrary herein, except upon a
`
`showing of good cause, City of Hope shall not be obligated to produce documents in this
`
`litigation, except for documents previously produced in one or more litigations relating to
`
`U.S. Patent No. 6,331,415 and/or U.S. Patent No. 7,923,221.
`
`b.
`
`Modification. This Document Production Protocol may be modified by a
`
`Stipulated Order of the Parties or by the Court for good cause shown.
`
`MORRIS, NICHOLS, ARSHT & TuNNELL LLP
`
`SHAW KELLER LLP
`
`/s/ Jae{ <B. <B{umenfelii
`
`/s/ 7(/lren 'E. 'l(J{{er
`
`Jack B. Blumenfeld (#1014)
`Karen Jacobs (#2881)
`1201 North Market Street, 16th Floor
`Wilmington, DE 19899
`(302) 351-9291
`jblumenfeld@mnat.com
`kjacobs@mnat.com
`
`Attorneys for Plaintiffs
`
`November 14, 2018
`
`John W. Shaw (#3362)
`Karen E. Keller (#4489)
`Nathan R. Hoeschen (#6232)
`I.M. Pei Building
`1105 North Market Street, 12th Floor
`Wilmington, DE 19801
`(302) 298-0700
`jshaw@shawkeller.com
`kkeller@shawkeller.com
`nhoeschen@shawkeller.com
`
`Attorneys for Defendants
`
`SO ORDERED this~day ofNovember, 2018.
`
`14
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`

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`Case 1:18-cv-01025-CFC Document 38 Filed 11/16/18 Page 15 of 15 PageID #: 2871
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`1.
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`2.
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`3.
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`4.
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`5.
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`6.
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`7.
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`8.
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`9.
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`10.
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`11.
`
`12.
`
`SCHEDULE A
`
`Deleted, slack, fragmented, or other data only accessible by forensics.
`
`Random access memory (RAM), temporary files, or other ephemeral data that are
`difficult to preserve without disabling the operating system.
`
`On-line access data such as temporary internet files, history, cache, cookies, and the like.
`
`Data in metadata fields that are frequently updated automatically, such as last-opened
`dates.
`
`Back-up data that are substantially duplicative of data that are more accessible elsewhere.
`
`Voice messages.
`
`Instant messages that are not ordinarily printed or maintained in a server dedicated to
`instant messaging.
`
`Electronic mail or pin-to-pin messages sent to or from mobile devices (e.g., iPhone and
`Blackberry devices), provided that a copy of such mail is routinely saved elsewhere.
`
`Other electronic data stored on a mobile device, such as calendar or contact data or notes,
`provided that a copy of such information is routinely saved elsewhere.
`
`Logs of calls made from mobile devices.
`
`Server, system or network logs.
`
`Electronic data temporarily stored by laboratory equipment or attached electronic
`equipment, provided that such data is not ordinarily preserved as part of a laboratory
`report.
`
`13.
`
`Data remaining from systems no longer in use that is unintelligible on the systems in use.
`
`