Case 1:18-cv-12029-ADB Document 381 Filed 06/02/22 Page 1 of 35
`Case 1:18-cv-12029-ADB Document 381 Filed 06/02/22 Page 1 of 35
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBHand
`TEVA PHARMACEUTICALS
`USA,INC.,
`
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`Plaintiffs,
`
`y
`
`Civil Action No.
`1:18-cv-12029-ADB
`
`ELI LILLY AND COMPANY,
`
`Defendant.
`
`[PROPOSED] STIPULATED PROTECTIVE ORDER
`
`WHEREASPlaintiffs Teva Pharmaceuticals International GmbH (“Teva GmbH”) and
`
`Teva Pharmaceuticals USA, Inc. (“Teva USA” and together with Teva GmbH,“Plaintiffs” or
`
`“Teva”’) and Defendant Eli Lilly and Company (“Lilly” or “Defendant”) (Teva and Lilly
`
`collectively, the “Parties”) expect that discovery in the above-captioned action (the “Litigation”)
`
`will entail the disclosure and production of documents,
`
`things,
`
`testimony, and information
`
`containing confidential, proprietary, personal,
`
`trade secret, and/or commercially sensitive
`
`information within the meaning of Rule 26(c) of the Federal Rules of Civil Procedure;
`
`WHEREAStheParties believe that such information must be protected by certain terms
`
`and conditions (the “Protective Order’’) to preserve the Parties’ legitimate businessinterests;
`
`WHEREASthe Parties have, through their undersigned counsel, stipulated to the entry of
`
`this Protective Order in order to expedite the flow of discovery material, facilitate the prompt
`
`resolution of any disputes over confidentiality, balance the Parties’ need for information to conduct
`
`

`

`Case 1:18-cv-12029-ADB Document 381 Filed 06/02/22 Page 2 of 35
`Case 1:18-cv-12029-ADB Document 381 Filed 06/02/22 Page 2 of 35
`
`confidential; and
`
`this Litigation against their need to maintain the confidentiality of information entitled to be kept
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`WHEREASthe Parties have established good cause for entry of this Protective Order;
`
`IT IS HEREBY ORDEREDthat this Protective Order shall govern discovery in the
`
`Litigation.
`
`1.
`
`Definitions. Words shall have their normally accepted meanings as employed in
`
`this Protective Order. The word “shall” is mandatory. The words “includes” and “including”are
`
`not limiting. The singular shall include the plural and vice versa. Additionally, the Parties hereby
`
`incorporate by reference the definitions set forth in Rule 26.5 of the Local Rules of the United
`
`States District Court for the District of Massachusetts (“Local Rules” or “L.R.”) as if fully set forth
`
`herein. Certain definitions from the Local Rules have been reproduced below for clarity.
`
`In
`
`addition, as used herein, the following wordsshall have the following meanings:
`
`(a)
`
`As used herein, the term “Document” is defined to be synonymous in
`
`meaning and equal
`
`in scope to the usage of the term “documents or electronically stored
`
`information” in Fed. R. Civ. P. 34(a)(1)(A) and Local Rule 26.5(c)(2). A draft or non-identical
`
`copy is a separate document within the meaningofthis term.
`
`(b)
`
`As used herein, the term “Information” includes information of any type,
`
`kind or character whether it be a document, information contained in a document, information
`
`revealed during a deposition, information revealed in an interrogatory or other discovery response,
`
`or otherwise.
`
`(c)
`
`Asused herein, the term “Litigation Material” shall mean Documents and
`
`Information produced, disclosed (as outlined in Paragraph 7, below), or filed in the Litigation by
`
`a Party or non-party, whether produced pursuant to formal or informal discovery requests or
`
`

`

`Case 1:18-cv-12029-ADB Document 381 Filed 06/02/22 Page 3 of 35
`Case 1:18-cv-12029-ADB Document 381 Filed 06/02/22 Page 3 of 35
`
`motion practice, by agreement or otherwise, and whether revealed in a document, deposition
`
`(including testimony and deposition exhibits), an interrogatory answer, a response to a request for
`
`production or for admission(s), a submission to the court or otherwise, and including all
`
`Documents and Information produced or disclosed by non-parties in this Litigation pursuant to
`
`subpoenaand/or deposition notice.
`
`(d)
`
`As used herein, the term “Producing Party” shall mean any Party to the
`
`Litigation or any non-party or third party, including its counsel, retained experts, directors, officers,
`
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`employees, business partners, or agents, who produces,discloses, or files any Litigation Material.
`
`(e)
`
`As used herein, the term “Receiving Party” shall mean any Party to the
`
`Litigation, including its counsel, retained experts, directors, officers, employees, businesspartners,
`
`or agents, who receives any Litigation Material.
`
`(f)
`
`Asused herein, the term “Confidential Health Information” (“CHI”)shall
`
`mean anypatient health information protected by any state or federal law. CHI includes, without
`
`limitation, information relating to: the past, present, or future physical health, mental health,
`
`condition, or medical treatment of an individual which identifies or reasonably could be expected
`
`to identify the individual. It also includes, butis not limited to, medical bills, claims forms, charges
`
`sheets, medical records, medical charts, test results, notes, dictation, invoices, itemized billing
`
`statements, remittance advice forms, explanation of benefits, checks, notices, and requests, and
`
`includes all notes, summaries, compilations, extracts, abstracts or oral communications that are
`
`based on or derived from CHI, regardless of form or format. CHI does not include any document
`
`or information in which the Producing Party has redacted the identifiers listed and does not have
`
`actual knowledge that information could be used alone or in combination with other information
`
`to identify an individual whois subject of the information. A Producing Party may, but is not
`
`

`

`Case 1:18-cv-12029-ADB Document 381 Filed 06/02/22 Page 4 of 35
`Case 1:18-cv-12029-ADB Document 381 Filed 06/02/22 Page 4 of 35
`
`required to, perform such redactions before producing documents that originally contained CHI so
`
`long as the redactions do notresult in prejudice to anotherparty.
`
`(g)|Asused herein, the term “Final Resolution of the Litigation” shall mean the
`
`date thirty (30) calendar days following:
`
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`to FDA or for communications with FDA involving fremanezumab, galcanezumab,or any other
`
`(i)
`
`the Court’s entry of a stipulated dismissal disposing of all claims
`
`and counterclaimsin the Litigation,
`
`(ii)
`
`the Court’s entry ofa voluntary dismissal disposing ofall claims and
`
`counterclaimsin the Litigation, or
`
`(iii)
`
`‘the entry of a final, non-appealable order disposing of the case.
`
`(h)
`
` Asused herein, the term “In-House Counsel” shall mean attorneys who are
`
`employeesof a Party, licensed patent attorneys admitted to practice before a national or European
`
`patent office who are employeesof a Party, or scientific litigation advisors who are employees of
`
`a Party working in the Party’s legal department who are responsible for overseeing this Litigation
`
`for a Party and who do notand shall not have direct responsibility for prosecuting or filing any
`
`patent applications involving fremanezumab, galcanezumab,or any other anti-CGRP antagonist
`
`antibody, and do not and shall not have direct responsibility for submitting regulatory documents
`
`anti-CGRP antagonist antibody,
`
`including without
`
`limitation any Citizen Petition, with the
`
`exception of the preparation of a notification under 42 U.S.C. § 262(1)(6)(C)(i).
`
`2.
`
`Scope of Protective Order. This Protective Order includes within its scope any and
`
`all Litigation Material.
`
`3.
`
`Scope and Designation of Confidentiality. “Protected Information”shall include
`
`Litigation Material designated either “CONFIDENTIAL” or “HIGHLY CONFIDENTIAL—
`
`

`

`(a)
`
`if it is in the public domain at the time of disclosure, as evidenced by a
`
`document, electronically stored information, or tangible thing;
`
`(b)
`
`if it becomespart of the public domain through no fault of the Receiving
`
`Party, as evidenced by a document, electronically stored information, or tangible thing;
`
`(c)
`
`if it was in the rightful and lawful possession of the Receiving Party prior
`
`to the time of the disclosure, without any applicable obligation of confidentiality, as evidenced by
`
`a document, electronically stored information, or tangible thing; or
`
`(d)
`
`if it is received lawfully by the Receiving Party at a later date from a third
`
`party withoutrestriction as to disclosure, provided that such third party has the right to make such
`
`unrestricted disclosure to the Receiving Party.
`
`4.
`
`Designation as “CONFIDENTIAL”. The designation “CONFIDENTIAL”shall
`
`mean information that
`
`the Producing Party in good faith believes is of a proprietary or
`
`commercially sensitive nature and/or information that is required to be treated as confidential
`
`pursuant to statute or common law,including applicable foreign data privacy laws, including, but
`
`not limited to, information that the Producing Party in good faith believes constitutes a trade secret
`
`in the possession of the Producing Party, including the trade secrets of the Producing Party’s
`
`faith believes constitutes other highly sensitive proprietary information that is entitled to additional
`
`protections, or that is not generally available in the public domain and for which Paragraphs 3(a)-
`
`(d) do not apply. Information designated “CONFIDENTIAL”mayinclude,but is not limited to,
`
`Case 1:18-cv-12029-ADB Document 381 Filed 06/02/22 Page 5 of 35
`Case 1:18-cv-12029-ADB Document 381 Filed 06/02/22 Page 5 of 35
`
`OUTSIDE COUNSEL ONLY,”as defined below. No information shall be regarded as Protected
`
`Information:
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`customers, vendors, accountants, underwriters, or other party, that the Producing Party in good
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`Case 1:18-cv-12029-ADB Document 381 Filed 06/02/22 Page 6 of 35
`Case 1:18-cv-12029-ADB Document 381 Filed 06/02/22 Page 6 of 35
`
`is non-public and confidential or proprietary, the value of which arises from its secrecy.
`
`5.
`
`Designation as “HIGHLY CONFIDENTIAL—OUTSIDE COUNSEL ONLY”.
`
`The designation “HIGHLY CONFIDENTIAL—OUTSIDE COUNSEL ONLY”is limited to
`
`information that the Producing Party in good faith believes constitutes technical or business
`
`information of a most sensitive nature that might be of significant value to an actual or potential
`
`competitor of the Producing Party and which mustbe protected from disclosure as set forth herein.
`
`Information designated “HIGHLY CONFIDENTIAL—OUTSIDE COUNSEL ONLY” may
`
`include CHI, documents detailing highly sensitive research and development for any indications
`
`or products that were not approved as ofthe filing of the Complaint in this Litigation, projections
`
`related to FDA regulatory approval for indications or products that were not approved as of the
`
`filing of the Complaintin this Litigation, future business plansor strategy, financial analyses and
`
`projections, P&L statements, pricing, revenue, cost, contractual relationships with third parties,
`
`and the identification of customers and suppliers.
`
`6.
`
`Limited Use of Discovery.
`
`materials relating to research, development, commercial, personnel, or marketing information that
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`(a)
`
`All Protected Information shall be used solely for this Litigation and the
`
`preparation andtrial in this Litigation (including anyretrials and any appellate proceedingresulting
`
`from this Litigation), and not for any other purpose whatsoever, including without limitation, any
`
`other litigation; patent prosecution; post grant proceedings before the United States Patent and
`
`Trademark Office, including without limitation, patent reexamination and reissue proceedings;
`
`acquisition; or any communication with any U.S. or foreign regulatory agency including, but not
`
`limited to, the FDA, or any business, research, development or competitive purpose or function.
`
`Protected Information must not be distributed, disclosed, or made available to anyone except as
`
`

`

`Case 1:18-cv-12029-ADB Document 381 Filed 06/02/22 Page 7 of 35
`Case 1:18-cv-12029-ADB Document 381 Filed 06/02/22 Page 7 of 35
`
`Producing Party’s use or disclosure of its own Protected Information.
`
`(b)
`
`Any person who receives or reviews HIGHLY CONFIDENTIAL—
`
`OUTSIDE COUNSEL ONLYinformation produced by any party other than his or her client shall
`
`not thereafter, during the pendency of the instant litigation and for one year after the final
`
`conclusionofthislitigation, including appeals:
`
`(i)
`
`Amend, draft, or otherwise substantively assist in the drafting or
`
`amending of patent claims in any patent prosecution, reexamination, post-grant review (“PGR”),
`
`or inter partes review (“IPR”) proceeding pertaining to fremanezumab, galcanezumab,or any other
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`anti-CGRP antagonist antibody.
`
`expressly provided in this Protective Order. This Protective Order places no limitation on a
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`(ii)
`
`Participate in or aid in the filing of any FDA Citizen Petition related
`
`to the technology that is the subject matter of the instant litigation.
`
`(iii)
`
`The foregoing restrictions of this Paragraph 6(b) shall apply only to
`
`individuals, and not to the firms or organizations by which they are employed,nor to individuals
`
`whoreceived access to Protected Information solely in their capacity as clerical staff.
`
`(c)
`
`Protected Information and the information derived from such Protected
`
`Information shall be kept confidential and shall not be given, shown, made available, discussed,
`
`or otherwise directly communicated in any manner to any person not authorized to receive the
`
`information underthe termsof this Protective Order.
`
`(d)
`
`All Protected Information, including,but not limited to electronically stored
`
`data, shall be maintained by the Receiving Party at a location and under circumstances to ensure
`
`that accessis limited to those persons entitled to have access under this Protective Order.
`
`

`

`Case 1:18-cv-12029-ADB Document 381 Filed 06/02/22 Page 8 of 35
`Case 1:18-cv-12029-ADB Document 381 Filed 06/02/22 Page 8 of 35
`
`7.
`
`Access to Protected Information
`
`Unless otherwise ordered by the Court or permitted in writing by a Producing Party,
`
`Protected Information may be disclosed only as follows:
`
`(a)
`
`Materials
`
`designated
`
`as
`
`“HIGHLY CONFIDENTIAL—OUTSIDE
`
`COUNSEL ONLY”pursuantto this Protective Order, including copies thereof, extracts therefrom,
`
`compilations and/or summaries thereof and information therein, may be disclosed only to the
`
`following persons:
`
`(i)
`
`Any attorney whoserves as outside counsel of record to any Party
`
`to this Litigation and all attorneys, legal assistants, stenographic and clerical employees working
`
`under the supervision of such attorney in this Litigation;
`
`(ii)
`
`The Parties’ independent expert(s) or consultant(s) in accordance
`
`with Paragraphs 10 and 13 herein;
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`witness for the Producing Party, or where counsel for the Producing Party has, either before or
`
`(iii)|Any person with prior knowledge of the Protected Information
`
`designated “HIGHLY CONFIDENTIAL—OUTSIDE COUNSEL ONLY”in accordance with
`
`Paragraph 13 herein;
`
`(iv)
`
`Any person from whom testimonyis taken, where such person was
`
`the author or specified recipient of the Protected Information or is the present employee or expert
`
`during the deposition, approved the disclosure of such materials to that person, except that such
`
`person may notretain any such Protected Information;
`
`(v)
`
`The Court and court personnel in this Litigation, including any
`
`Court-appointed Special or Discovery Master, any Court-appointed mediator, any mediator agreed
`
`

`

`Case 1:18-cv-12029-ADB Document 381 Filed 06/02/22 Page 9 of 35
`Case 1:18-cv-12029-ADB Document 381 Filed 06/02/22 Page 9 of 35
`
`to by the Parties, and any Court reporter or videographer transcribing or recording testimony,
`
`whetherat a deposition, hearing,or trial in accordance with Paragraph 21 herein;
`
`(vi)|Any person designated by the Court, in the interest ofjustice, upon
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`such terms as the Court may deem proper;
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`Protected Information regardless of the mannerin whichit is disclosed, including but not limited
`
`(vii) Any interpreters, or court or other shorthand reporters or typists
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`translating, recording or transcribing testimony;
`
`(viii) Any employee of outside counsel of record or service contractors
`
`(such as document copy services) involved in organizing, filing, coding, converting, storing or
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`retrieving data or in designing programs for handling documents or data connected with these
`
`actions, including the performance of such duties in relation to a computerizedlitigation support
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`system in accordance with Paragraph 13 herei