Carol Pitzel Cruz
`carol.pitzel.cruz@knobbe.com
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`925 Fourth Avenue, Suite 2500
`Seattle, WA 98104
`Telephone: 206-405-2000
`Facsimile: 206-405-2001
`
`Attorneys for Third Party
`INDIVIOR, INC.
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`ADAPT PHARMA OPERATIONS
`LIMITED ET AL.,
`
`Plaintiffs,
`
`-vs.-
`
`TEVA PHARMACEUTICALS USA,
`INC. and TEVA PHARMACEUTICALS
`INDUSTRIES LTD.
`Defendant.
`
`Case No. 2:16-cv-07721-JLL-LAD
`(Consolidated)
`
`INDIVIOR, INC.’S OBJECTIONS AND RESPONSES TO
`DEFENDANTS’ SUBPOENA TO PRODUCE DOCUMENTS
`
`Pursuant to Rules 26 and Rule 45 of the Federal Rules of Civil Procedure,
`
`third party Indivior, Inc. (“Indivior”), through its counsel of record, hereby objects
`
`to Defendants Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals Industries,
`
`Opiant Exhibit 2195
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 1
`
`
`carol.pitzel.cruz@knobbe.com
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`925 Fourth Avenue, Suite 2500
`Seattle, WA 98104
`Telephone: 206-405-2000
`Facsimile: 206-405-2001
`
`Attorneys for Third Party
`INDIVIOR, INC.
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`ADAPT PHARMA OPERATIONS
`LIMITED ET AL.,
`
`Plaintiffs,
`
`-vs.-
`
`TEVA PHARMACEUTICALS USA,
`INC. and TEVA PHARMACEUTICALS
`INDUSTRIES LTD.
`Defendant.
`
`Case No. 2:16-cv-07721-JLL-LAD
`(Consolidated)
`
`INDIVIOR, INC.’S OBJECTIONS AND RESPONSES TO
`DEFENDANTS’ SUBPOENA TO PRODUCE DOCUMENTS
`
`Pursuant to Rules 26 and Rule 45 of the Federal Rules of Civil Procedure,
`
`third party Indivior, Inc. (“Indivior”), through its counsel of record, hereby objects
`
`to Defendants Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals Industries,
`
`Opiant Exhibit 2195
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 1
`
`
`
`Ltd.’s Subpoena to Produce Documents, dated January 11, 2019 (“Third Party
`
`Subpoena”).
`
`GENERAL OBJECTIONS
`
`Indivior asserts the following General Objections to the Third Party
`
`Subpoena:
`
`1.
`
`Indivior objects to the Definitions and Instructions set forth in the
`
`Third Party Subpoena to the extent that they fail to comply with, or seek to impose
`
`obligations in excess of, the Federal Rules of Civil Procedure or any applicable
`
`local rules or court orders.
`
`2.
`
`Indivior objects to the Definitions set forth in the Third Party
`
`Subpoena to the extent that they make any individual request vague, ambiguous, or
`
`unintelligible, and/or not susceptible to any single meaning. Any term defined in
`
`the Third Party Subpoena that Indivior does not object to shall not be construed to
`
`mean that Indivior understands and/or agrees with the Definition.
`
`3.
`
`Indivior objects to the timing of the Third Party Subpoena’s requested
`
`production. Indivior also objects to any copying or sampling of produced material
`
`except as reasonably necessary to litigate issues relevant to the litigation.
`
`4.
`
`Indivior objects to the Third Party Subpoena to the extent that it seeks
`
`information protected by the attorney-client privilege, work-product immunity, or
`
`any other applicable privilege or immunity. Indivior has expressly stated privilege
`
`- 2 -
`
`Opiant Exhibit 2195
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 2
`
`
`
`objections to each document request that, in Indivior’s view, can be reasonably
`
`interpreted to encompass privileged information. To the extent that any other
`
`document request may encompass privileged information, however, Indivior
`
`hereby incorporates this General Objection.
`
`5.
`
`Indivior objects to each document request as overly broad and unduly
`
`burdensome to the extent that it seeks information that is neither relevant to the
`
`subject matter of the present action nor proportional to the needs of the case.
`
`6.
`
`Indivior objects to each request to the extent it seeks the identification
`
`of “all documents” or “all information” concerning a particular subject on the
`
`grounds that Indivior could not possibly represent that its responses reflect or
`
`include “all” potentially responsive documents located anywhere within its
`
`possession, custody, or control, as that would require it to undertake an
`
`unreasonably broad search. Indivior objects to performing searches and responses
`
`of such breadth on the grounds of undue burden and expense.
`
`7.
`
`Indivior objects to the Third Party Subpoena to the extent that it seeks
`
`documents that are not within Indivior’s possession, custody, or control, or
`
`requests that Indivior create documents that are not currently in Indivior’s
`
`possession. By responding to the Third Party Subpoena, Indivior does not
`
`represent that it knows or is otherwise in possession of any relevant information or
`
`documents.
`
`- 3 -
`
`Opiant Exhibit 2195
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 3
`
`
`
`8.
`
`Indivior objects to the Third Party Subpoena to the extent that it
`
`purports to require Indivior to reach legal conclusions about any document.
`
`9.
`
`Indivior objects to each document request to the extent it seeks
`
`disclosure of Indivior’s highly confidential and/or proprietary information without
`
`regard for the potential commercial risk to Indivior associated with such disclosure
`
`and/or the relative necessity (or lack thereof) of such information to the underlying
`
`action. Indivior further objects to the Third Party Subpoena to the extent that the
`
`Discovery Confidentiality Order [DI 40] in the underlying action is insufficient to
`
`protect Indivior’s highly confidential and/or proprietary information from the risk
`
`of subsequent disclosure or use.
`
`10.
`
`Indivior objects to each request to the extent it seeks information
`
`and/or documents and things that are subject to one or more confidentiality
`
`agreements with non-parties to this action, which agreements restrict its ability to
`
`disclose such information and/or documents and things.
`
`The foregoing General Objections shall be deemed continuous throughout
`
`and are hereby incorporated by reference in the Responses set forth below.
`
`- 4 -
`
`Opiant Exhibit 2195
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 4
`
`
`
`SPECIFIC OBJECTIONS AND RESPONSES
`
`DOCUMENT REQUEST NO. 1:
`
`
`
`The Complete Response Letter received from the FDA concerning Indivior,
`
`Inc.’s New Drug Application for an intranasal naloxone hydrochloride product
`
`(“Indivior’s NDA”).
`
`RESPONSE TO DOCUMENT REQUEST NO. 1:
`
`
`
`Indivior incorporates by reference its General Objections as if set forth in
`
`full herein. Indivior objects to this request to the extent it seeks information
`
`protected by the attorney-client privilege, the work product immunity, the common
`
`interest privilege, or other applicable grounds of privilege or immunity. Indivior is
`
`not a party to this action and objects to this request as overly broad and unduly
`
`burdensome. Indivior also objects to producing Indivior’s highly confidential
`
`documents under the terms of the Discovery Confidentiality Order [DI 40]
`
`(“DCO”) currently in place in the above-captioned action to the extent that such
`
`production would be accessible to the parties’ IP Personnel.
`
`
`
`Subject to and without waiving its general and specific objections, Indivior
`
`responds as follows: provided that the parties to the above-identified action agree
`
`to maintain the confidentiality of Indivior’s highly confidential documents subject
`
`to the DCO in this action, with the additional condition that said documents will be
`
`kept on an outside counsel only basis, Indivior will produce relevant documents
`
`- 5 -
`
`Opiant Exhibit 2195
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 5
`
`
`
`responsive to this request to the extent they exist and are in Indivior’s possession,
`
`custody, or control, and can be located after a reasonable search.
`
`DOCUMENT REQUEST NO. 2:
`
`
`
`Documents from Indivior’s NDA sufficient to show the formulation and
`
`delivery device of the subject intranasal naloxone hydrochloride product.
`
`RESPONSE TO DOCUMENT REQUEST NO. 2:
`
`
`
`Indivior incorporates by reference its General Objections as if set forth in
`
`full herein. Indivior objects to this request to the extent it seeks information
`
`protected by the attorney-client privilege, the work product immunity, the common
`
`interest privilege, or other applicable grounds of privilege or immunity. Indivior is
`
`not a party to this action and objects to this request as overly broad and unduly
`
`burdensome. Indivior also objects to producing Indivior’s highly confidential
`
`documents under the terms of the DCO currently in place in the above-captioned
`
`action to the extent that such production would be accessible to the parties’ IP
`
`Personnel.
`
`
`
`Subject to and without waiving its general and specific objections, Indivior
`
`responds as follows: provided that the parties to the above-identified action agree
`
`to maintain the confidentiality of Indivior’s highly confidential documents subject
`
`to the DCO in this action, with the additional condition that said documents will be
`
`kept on an outside counsel only basis, Indivior will produce relevant documents
`
`- 6 -
`
`Opiant Exhibit 2195
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 6
`
`
`
`responsive to this request to the extent they exist and are in Indivior’s possession,
`
`custody, or control, and can be located after a reasonable search.
`
`DOCUMENT REQUEST NO. 3:
`
`
`
`The Pharmaceutical Development Report from Indivior’s NDA.
`
`RESPONSE TO DOCUMENT REQUEST NO. 3:
`
`
`
`Indivior incorporates by reference its General Objections as if set forth in
`
`full herein. Indivior objects to this request to the extent it seeks information
`
`protected by the attorney-client privilege, the work product immunity, the common
`
`interest privilege, or other applicable grounds of privilege or immunity. Indivior is
`
`not a party to this action and objects to this request as overly broad and unduly
`
`burdensome. Indivior also objects to producing Indivior’s highly confidential
`
`documents under the terms of the DCO currently in place in the above-captioned
`
`action to the extent that such production would be accessible to the parties’ IP
`
`Personnel.
`
`
`
`Subject to and without waiving its general and specific objections, Indivior
`
`responds as follows: provided that the parties to the above-identified action agree
`
`to maintain the confidentiality of Indivior’s highly confidential documents subject
`
`to the DCO in this action, with the additional condition that said documents will be
`
`kept on an outside counsel only basis, Indivior will produce relevant documents
`
`- 7 -
`
`Opiant Exhibit 2195
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 7
`
`
`
`responsive to this request to the extent they exist and are in Indivior’s possession,
`
`custody, or control, and can be located after a reasonable search.
`
`DOCUMENT REQUEST NO. 4:
`
`
`
`Documents
`
`from
`
`Indivior’s NDA
`
`sufficient
`
`to
`
`show
`
`summary
`
`pharmacokinetic properties of the subject intranasal naloxone hydrochloride
`
`product, including but limited to Cmax, AUC, and Tmax after administration to
`
`human subjects.
`
`RESPONSE TO DOCUMENT REQUEST NO. 4:
`
`
`
`Indivior incorporates by reference its General Objections as if set forth in
`
`full herein. Indivior objects to this request to the extent it seeks information
`
`protected by the attorney-client privilege, the work product immunity, the common
`
`interest privilege, or other applicable grounds of privilege or immunity. Indivior is
`
`not a party to this action and objects to this request as overly broad and unduly
`
`burdensome. Indivior also objects to producing Indivior’s highly confidential
`
`documents under the terms of the DCO currently in place in the above-captioned
`
`action to the extent that such production would be accessible to the parties’ IP
`
`Personnel.
`
`
`
`Subject to and without waiving its general and specific objections, Indivior
`
`responds as follows: provided that the parties to the above-identified action agree
`
`to maintain the confidentiality of Indivior’s highly confidential documents subject
`
`- 8 -
`
`Opiant Exhibit 2195
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 8
`
`
`
`to the DCO in this action, with the additional condition that said documents will be
`
`kept on an outside counsel only basis, Indivior will produce relevant documents
`
`responsive to this request to the extent they exist and are in Indivior’s possession,
`
`custody, or control, and can be located after a reasonable search.
`
`DOCUMENT REQUEST NO. 5:
`
`Documents from Indivior’s NDA sufficient to show the spray characteristics
`
`of the subject intranasal naloxone hydrochloride product, including the ovality
`
`ratio, droplet size distribution, and percentage of droplets with a diameter less than
`
`10 microns.
`
`RESPONSE TO DOCUMENT REQUEST NO. 5:
`
`Indivior incorporates by reference its General Objections as if set forth in
`
`full herein. Indivior objects to this request to the extent it seeks information
`
`protected by the attorney-client privilege, the work product immunity, the common
`
`interest privilege, or other applicable grounds of privilege or immunity. Indivior is
`
`not a party to this action and objects to this request as overly broad and unduly
`
`burdensome. Indivior also objects to producing Indivior’s highly confidential
`
`documents under the terms of the DCO currently in place in the above-captioned
`
`action to the extent that such production would be accessible to the parties’ IP
`
`Personnel.
`
`- 9 -
`
`Opiant Exhibit 2195
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 9
`
`
`
`Subject to and without waiving its general and specific objections, Indivior
`
`responds as follows: provided that the parties to the above-identified action agree
`
`to maintain the confidentiality of Indivior’s highly confidential documents subject
`
`to the DCO in this action, with the additional condition that said documents will be
`
`kept on an outside counsel only basis, Indivior will produce relevant documents
`
`responsive to this request to the extent they exist and are in Indivior’s possession,
`
`custody, or control, and can be located after a reasonable search.
`
`DOCUMENT REQUEST NO. 6:
`
`Documents sufficient to show the formulation and delivery device for
`
`“NALSCUE®” that is sold or distributed by or on behalf of Indivior, Inc. in
`
`Europe.
`
`RESPONSE TO DOCUMENT REQUEST NO. 6:
`
`Indivior incorporates by reference its General Objections as if set forth in
`
`full herein. Indivior objects to this request to the extent it seeks information
`
`protected by the attorney-client privilege, the work product immunity, the common
`
`interest privilege, or other applicable grounds of privilege or immunity. Indivior is
`
`not a party to this action and objects to this request as overly broad and unduly
`
`burdensome. Indivior also objects to producing Indivior’s highly confidential
`
`documents under the terms of the DCO currently in place in the above-captioned
`
`- 10 -
`
`Opiant Exhibit 2195
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 10
`
`
`
`action to the extent that such production would be accessible to the parties’ IP
`
`Personnel.
`
`Subject to and without waiving its general and specific objections, Indivior
`
`responds as follows: provided that the parties to the above-identified action agree
`
`to maintain the confidentiality of Indivior’s highly confidential documents subject
`
`to the DCO in this action, with the additional condition that said documents will be
`
`kept on an outside counsel only basis, Indivior will produce relevant documents
`
`responsive to this request to the extent they exist and are in Indivior’s possession,
`
`custody, or control, and can be located after a reasonable search.
`
`January 25, 2019
`
`s/ Carol Pitzel Cruz
`Carol Pitzel Cruz
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`925 Fourth Avenue, Suite 2500
`Seattle, WA 98104
`Telephone: 206-405-2000
`Facsimile: 206-405-2001
`carol.pitzel.cruz@knobbe.com
`
`Attorneys for Third Party
`INDIVIOR, INC.
`
`- 11 -
`
`Opiant Exhibit 2195
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 11
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that, on January 25, 2019, a true and correct copy of
`
`the foregoing was served via email on the following counsel of record:
`
`Michael Bruns
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1100 New York Avenue NW, Suite 600
`Washington D.C. 20005
` mbruns@sternekessler.com
`
`29746646
`
`Consuelo Durand
`
`- 12 -
`
`Opiant Exhibit 2195
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 12
`
`
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