Case 1:18-cv-00924-CFC-SRF Document 64 Filed 12/21/18 Page 1 of 18 PageID #:
`9219
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`GENENTECH, INC. and CITY OF HOPE,
`
`Plaintiffs,
`
`v.
`AMGEN INC.,
`
`Defendant and Counterclaim
`Plaintiff.
`
`Case No. 1:18-cv-00924-CFC
`
`NOTICE OF SUBPOENA DUCES TECUM
`
`TO ALL PARTIES AND THEIR ATTORNEYS OF RECORD:
`
`PLEASE TAKE NOTICE that pursuant to Rule 45 of the Federal Rules of Civil Procedure,
`
`Amgen Inc. will cause the attached subpoena to be served on Robert D. Mass, M.D.
`
`Dated: December 21, 2018
`
`SMITH, KATZENSTEIN & JENKINS, LLP
`/s/ Eve H. Ormerod
`
`Neal C. Belgam (No. 2721)
`Eve H. Ormerod (No. 5369)
`1000 West Street, Suite 1501
`Wilmington, DE 19801
`(302) 652-8400
`nbelgam@skjlaw.com
`eormerod@skjlaw.com
`Attorneys for Defendant Amgen Inc.
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 64 Filed 12/21/18 Page 2 of 18 PageID #:
`9220
`
`EXHIBIT 1
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 64 Filed 12/21/18 Page 3 of 18 PageID #:
`9221
`AO 88B (Rev. 12/13) Subpoena to Produce Documents, Information, or Objects or to Permit Inspection of Premises in a Civil Action
`
`UNITED STATES DISTRICT COURT
`for the
` District of Delaware
`__________ District of __________
`GENENTECH, INC. and CITY OF HOPE
`Plaintiff
`v.
`AMGEN, INC.
`
`Civil Action No.
`
`1:18-cv-00924-CFC
`
`Defendant
`
`))))))
`
`SUBPOENA TO PRODUCE DOCUMENTS, INFORMATION, OR OBJECTS
`OR TO PERMIT INSPECTION OF PREMISES IN A CIVIL ACTION
`
`To:
`
`Robert Mass, M.D.
`
`(Name of person to whom this subpoena is directed)
`✔
`(cid:117) Production: YOU ARE COMMANDED to produce at the time, date, and place set forth below the following
`documents, electronically stored information, or objects, and to permit inspection, copying, testing, or sampling of the
`See Attachment A
`material:
`
`Place:
`
`Cooley LLP (or zAmgenGenentech@cooley.com)
`4401 Eastgate Mall
`San Diego, CA 92121
`(cid:117) Inspection of Premises: YOU ARE COMMANDED to permit entry onto the designated premises, land, or
`other property possessed or controlled by you at the time, date, and location set forth below, so that the requesting party
`may inspect, measure, survey, photograph, test, or sample the property or any designated object or operation on it.
`
`Date and Time:
`
`01/11/2019 9:00 am
`
`Place:
`
`Date and Time:
`
`The following provisions of Fed. R. Civ. P. 45 are attached – Rule 45(c), relating to the place of compliance;
`Rule 45(d), relating to your protection as a person subject to a subpoena; and Rule 45(e) and (g), relating to your duty to
`respond to this subpoena and the potential consequences of not doing so.
`12/21/2018
`Date:
`
`CLERK OF COURT
`
`Signature of Clerk or Deputy Clerk
`
`OR
`
`/s/ Eve H. Ormerod
`Attorney’s signature
`
`Defendant
`The name, address, e-mail address, and telephone number of the attorney representing (name of party)
`, who issues or requests this subpoena, are:
`Amgen Inc.
`Eve H. Ormerod (No. 5369), Smith, Katzenstein & Jenkins, eormerod@skjlaw.com, (302) 652-8400
`
`Notice to the person who issues or requests this subpoena
`A notice and a copy of the subpoena must be served on each party in this case before it is served on the person to whom
`it is directed. Fed. R. Civ. P. 45(a)(4).
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 64 Filed 12/21/18 Page 4 of 18 PageID #:
`9222
`AO 88B (Rev. 12/13) Subpoena to Produce Documents, Information, or Objects or to Permit Inspection of Premises in a Civil Action (Page 2)
`
`Civil Action No.
`
`1:18-cv-00924-CFC
`
`PROOF OF SERVICE
`(This section should not be filed with the court unless required by Fed. R. Civ. P. 45.)
`
`I received this subpoena for (name of individual and title, if any)
`.
`
`on (date)
`
`(cid:117) I served the subpoena by delivering a copy to the named person as follows:
`
`(cid:117) I returned the subpoena unexecuted because:
`
`on (date)
`
`; or
`
`Unless the subpoena was issued on behalf of the United States, or one of its officers or agents, I have also
`tendered to the witness the fees for one day’s attendance, and the mileage allowed by law, in the amount of
`$
`.
`
`My fees are $
`
`for travel and $
`
`for services, for a total of $
`
`0.00
`
`.
`
`.
`
`I declare under penalty of perjury that this information is true.
`
`Date:
`
`Additional information regarding attempted service, etc.:
`
`Server’s signature
`
`Printed name and title
`
`Server’s address
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 64 Filed 12/21/18 Page 5 of 18 PageID #:
`9223
`AO 88B (Rev. 12/13) Subpoena to Produce Documents, Information, or Objects or to Permit Inspection of Premises in a Civil Action(Page 3)
`Federal Rule of Civil Procedure 45 (c), (d), (e), and (g) (Effective 12/1/13)
`(ii) disclosing an unretained expert’s opinion or information that does
`not describe specific occurrences in dispute and results from the expert’s
`study that was not requested by a party.
`(C) Specifying Conditions as an Alternative. In the circumstances
`described in Rule 45(d)(3)(B), the court may, instead of quashing or
`modifying a subpoena, order appearance or production under specified
`conditions if the serving party:
`(i) shows a substantial need for the testimony or material that cannot be
`otherwise met without undue hardship; and
`(ii) ensures that the subpoenaed person will be reasonably compensated.
`(e) Duties in Responding to a Subpoena.
` (1) Producing Documents or Electronically Stored Information. These
`procedures apply to producing documents or electronically stored
`information:
`(A) Documents. A person responding to a subpoena to produce documents
`must produce them as they are kept in the ordinary course of business or
`must organize and label them to correspond to the categories in the demand.
`(B) Form for Producing Electronically Stored Information Not Specified.
`If a subpoena does not specify a form for producing electronically stored
`information, the person responding must produce it in a form or forms in
`which it is ordinarily maintained or in a reasonably usable form or forms.
`(C) Electronically Stored Information Produced in Only One Form. The
`person responding need not produce the same electronically stored
`information in more than one form.
`(D) Inaccessible Electronically Stored Information. The person
`responding need not provide discovery of electronically stored information
`from sources that the person identifies as not reasonably accessible because
`of undue burden or cost. On motion to compel discovery or for a protective
`order, the person responding must show that the information is not
`reasonably accessible because of undue burden or cost. If that showing is
`made, the court may nonetheless order discovery from such sources if the
`requesting party shows good cause, considering the limitations of Rule
`26(b)(2)(C). The court may specify conditions for the discovery.
`(2) Claiming Privilege or Protection.
`(A) Information Withheld. A person withholding subpoenaed information
`under a claim that it is privileged or subject to protection as trial-preparation
`material must:
`(i) expressly make the claim; and
`(ii) describe the nature of the withheld documents, communications, or
`tangible things in a manner that, without revealing information itself
`privileged or protected, will enable the parties to assess the claim.
`(B) Information Produced. If information produced in response to a
`subpoena is subject to a claim of privilege or of protection as
`trial-preparation material, the person making the claim may notify any party
`that received the information of the claim and the basis for it. After being
`notified, a party must promptly return, sequester, or destroy the specified
`information and any copies it has; must not use or disclose the information
`until the claim is resolved; must take reasonable steps to retrieve the
`information if the party disclosed it before being notified; and may promptly
`present the information under seal to the court for the district where
`compliance is required for a determination of the claim. The person who
`produced the information must preserve the information until the claim is
`resolved.
`(g) Contempt.
`The court for the district where compliance is required—and also, after a
`motion is transferred, the issuing court—may hold in contempt a person
`who, having been served, fails without adequate excuse to obey the
`subpoena or an order related to it.
`
`(c) Place of Compliance.
` (1) For a Trial, Hearing, or Deposition. A subpoena may command a
`person to attend a trial, hearing, or deposition only as follows:
` (A) within 100 miles of where the person resides, is employed, or
`regularly transacts business in person; or
` (B) within the state where the person resides, is employed, or regularly
`transacts business in person, if the person
` (i) is a party or a party’s officer; or
` (ii) is commanded to attend a trial and would not incur substantial
`expense.
` (2) For Other Discovery. A subpoena may command:
` (A) production of documents, electronically stored information, or
`tangible things at a place within 100 miles of where the person resides, is
`employed, or regularly transacts business in person; and
` (B) inspection of premises at the premises to be inspected.
`(d) Protecting a Person Subject to a Subpoena; Enforcement.
` (1) Avoiding Undue Burden or Expense; Sanctions. A party or attorney
`responsible for issuing and serving a subpoena must take reasonable steps
`to avoid imposing undue burden or expense on a person subject to the
`subpoena. The court for the district where compliance is required must
`enforce this duty and impose an appropriate sanction—which may include
`lost earnings and reasonable attorney’s fees—on a party or attorney who
`fails to comply.
` (2) Command to Produce Materials or Permit Inspection.
`(A) Appearance Not Required. A person commanded to produce
`documents, electronically stored information, or tangible things, or to
`permit the inspection of premises, need not appear in person at the place of
`production or inspection unless also commanded to appear for a deposition,
`hearing, or trial.
`(B) Objections. A person commanded to produce documents or tangible
`things or to permit inspection may serve on the party or attorney designated
`in the subpoena a written objection to inspecting, copying, testing, or
`sampling any or all of the materials or to inspecting the premises—or to
`producing electronically stored information in the form or forms requested.
`The objection must be served before the earlier of the time specified for
`compliance or 14 days after the subpoena is served. If an objection is made,
`the following rules apply:
`(i) At any time, on notice to the commanded person, the serving party
`may move the court for the district where compliance is required for an
`order compelling production or inspection.
` (ii) These acts may be required only as directed in the order, and the
`order must protect a person who is neither a party nor a party’s officer from
`significant expense resulting from compliance.
` (3) Quashing or Modifying a Subpoena.
`(A) When Required. On timely motion, the court for the district where
`compliance is required must quash or modify a subpoena that:
` (i) fails to allow a reasonable time to comply;
`(ii) requires a person to comply beyond the geographical limits
`specified in Rule 45(c);
`(iii) requires disclosure of privileged or other protected matter, if no
`exception or waiver applies; or
`(iv) subjects a person to undue burden.
`(B) When Permitted. To protect a person subject to or affected by a
`subpoena, the court for the district where compliance is required may, on
`motion, quash or modify the subpoena if it requires:
`(i) disclosing a trade secret or other confidential research,
`development, or commercial information; or
`
`For access to subpoena materials, see Fed. R. Civ. P. 45(a) Committee Note (2013).
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 64 Filed 12/21/18 Page 6 of 18 PageID #:
`
`9224
`
`ATTACHMENT A
`
`The words and phrases used in these Requests shall have the meanings ascribed to them
`
`under the Federal Rules of Civil Procedure and the Local Rules of the United States District Court
`
`for the District of Delaware. In addition, the following terms shall have the meanings set forth
`
`below whenever used in any Request:
`
`DEFINITIONS
`
`1.
`
`“Plaintiffs” means Genentech, Inc.; F. Hoffmann-La Roche Ltd.; and City of
`
`Hope, individually and collectively, and includes their officers, directors, partners, corporate
`
`parents, divisions, subsidiaries, affiliates, agents, employees, consultants, predecessors,
`
`successors, predecessors-in-interest, successors-in-interest, representatives, all persons or entities
`
`
`
`currently or previously under their control, and all persons or entities currently or previously acting
`
`on their behalf.
`
`2.
`
`3.
`
`4.
`
`“Amgen” means Amgen Inc.
`
`“Robert Mass” or “You” or “Your” means Robert D. Mass, M.D.
`
`“F. Hoffmann-La Roche Ltd.” or “Roche” means any and all corporate parents,
`
`divisions, subsidiaries, affiliates, agents, employees, consultants, predecessors, successors,
`
`predecessors-in-interest, successors-in-interest, representatives, all persons or entities currently or
`
`previously under their control, and all persons or entities currently or previously acting on their
`
`behalf,
`
`including without
`
`limitation Roche Holding AG, Roche Diagnostics, Roche
`
`Pharmaceuticals (“Roche Pharma”), Roche Pharmaceuticals Research and Early Development
`
`(pRED), Genentech Research and Early Development (gRED), Chugai, and any other corporate
`
`entity operating under the Roche name.
`
`5.
`
`“This Litigation” means the action Genentech, Inc. and City of Hope v. Amgen
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 64 Filed 12/21/18 Page 7 of 18 PageID #:
`
`9225
`
`Inc., Case No. 1:18-cv-00924-CFC, filed on June 21, 2018 and pending in the United States
`
`District Court for the District of Delaware.
`
`6.
`
`“Document(s)” is used in the broadest sense possible under Rule 34 of the Federal
`
`Rules of Civil Procedure and means all written, recorded, and graphic material or medium,
`
`however produced or reproduced, upon which information or intelligence is recorded or from
`
`which information or intelligence can be recorded, which is or has been in the possession, custody
`
`or control of Plaintiffs, or of which Plaintiffs have knowledge. This definition includes all
`
`originals, copies, and drafts, including, but not limited to the following: literature, records, notes,
`
`summaries, bank records or statements, brochures, booklets, calendars, charts, coding forms,
`
`communications (intra-company or intercompany), compilations, data, databases, schedules,
`
`contracts, agreements, electronic mail, magnetic media of all kinds (including discs, tapes or other
`
`
`
`media), drawings, sketches, orders, acknowledgments, diaries, reports, memoranda of all
`
`conversations by or with any person, telephone messages, all other memoranda, letters, telegrams,
`
`telexes, facsimiles and cables prepared, drafted, received or sent, tapes, transcripts, and recordings,
`
`photographs, pictures, and films, computer programs and data, all other graphic, symbolic,
`
`recorded, and written materials of any nature, whatsoever, and any other documents and tangible
`
`items subject to discovery under the Federal Rules of Civil Procedure. Any document which
`
`contains any comment, notation, addition, insertion, or marking of any kind constitutes a document
`
`separate from the unmarked version.
`
`7.
`
`“Thing” means any tangible object, including without limitation devices, designs,
`
`plans, physical objects, samples, products, components, prototypes, models, specimens,
`
`photographs, and any audio, video, or digital recordings.
`
`8.
`
`“Concerning,” “relating to,” or “referring to” any given subject matter means,
`
`
`
`
`
`2
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 64 Filed 12/21/18 Page 8 of 18 PageID #:
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`9226
`
`without limitation, identifying, assessing, stating, constituting, containing, embodying, tending to
`
`support or refute, referring directly or indirectly to, pertaining to, reflecting upon, evidencing,
`
`concerning, discussing, describing, mentioning, summarizing or connecting, in any way, to the
`
`particular subject matter.
`
`9.
`
`“Communication” means any exchange or transmittal of information in the form
`
`of facts, ideas, inquiries, or otherwise, whether written, oral, electronic, or in any other form.
`
`10.
`
`“Person” means any natural person, corporation, limited liability company,
`
`association, partnership, governmental or other agency or body, and each and every other entity,
`
`however formed.
`
`11.
`
`“Herceptin” or “Herceptin®” or “trastuzumab” means the anti-HER2/neu/ErbB2
`
`
`
`monoclonal antibody also known as trastuzumab, and includes any products or formulations
`
`comprising the monoclonal antibody known as trastuzumab.
`
`12.
`
`13.
`
`14.
`
`15.
`
`16.
`
`17.
`
`18.
`
`19.
`
`“’196 patent” means U.S. Patent No. 6,627,196.
`
`“’379 patent” means U.S. Patent No. 7,371,379.
`
`“Dosing Patents” means the ’196 patent and the ’379 patent.
`
`“’659 application” means U.S. App. No. 14/073,659.
`
`“’834 patent” means U.S. Patent No. 7,993,834.
`
`“’066 patent” means U.S. Patent No. 8,076,066.
`
`“Gene Detection Patents” means the ’834 patent and the ’066 patent.
`
`“Prior Art” means any patent, published patent application, reference, apparatus,
`
`device, system, public knowledge, public use, sale, offer of sale, or invention, in the United States
`
`or any other country, relating to the subject matter of the claims of the Patents-in-Suit that is dated
`
`or may have occurred prior to any filing date of a Patent-in-Suit, or encompasses, by way of
`
`
`
`
`
`3
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 64 Filed 12/21/18 Page 9 of 18 PageID #:
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`9227
`
`example and without limitation, the subject matter described in each and every subdivision of 35
`
`U.S.C. § 102 and 35 U.S.C. § 103.
`
`20.
`
`21.
`
`22.
`
`“FDA” means the U.S. Food and Drug Administration.
`
`“Including” shall be construed broadly as “including without limitation.”
`
`“Herceptin” means the anti-HER2/neu/ErbB2 monoclonal antibody, also known
`
`as trastuzumab.
`
`23.
`
`“Vysis” means Vysis Inc. and any and all corporate parents, divisions, subsidiaries,
`
`affiliates, agents, employees, consultants, predecessors, successors, predecessors-in-interest,
`
`successors-in-interest, representatives, all persons or entities currently or previously under their
`
`control, and all persons or entities currently or previously acting on their behalf, including without
`
`
`
`limitation, Abbott Laboratories and Abbott Molecular.
`
`24.
`
`“ONCOR” means Oncor Inc. and any and all corporate parents, divisions,
`
`subsidiaries, affiliates, agents, employees, consultants, predecessors, successors, predecessors-in-
`
`interest, successors-in-interest, representatives, all persons or entities currently or previously under
`
`their control, and all persons or entities currently or previously acting on their behalf.
`
`25.
`
`“DAKO” means Dako, Dako North America, Inc., and any and all corporate
`
`parents, divisions, subsidiaries, affiliates, agents, employees, consultants, predecessors,
`
`successors, predecessors-in-interest, successors-in-interest, representatives, all persons or entities
`
`currently or previously under their control, and all persons or entities currently or previously acting
`
`on their behalf, including without limitation, Agilent Technologies.
`
`26.
`
`“Ventana Medical Systems” means Ventana Medical System, Inc. and any and all
`
`corporate parents, divisions, subsidiaries, affiliates, agents, employees, consultants, predecessors,
`
`successors, predecessors-in-interest, successors-in-interest, representatives, all persons or entities
`
`
`
`
`
`4
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 64 Filed 12/21/18 Page 10 of 18 PageID #:
`
`9228
`
`currently or previously under their control, and all persons or entities currently or previously acting
`
`on their behalf, including without limitation, Roche.
`
`27.
`
`“Abbott” means Abbott Molecular, Abbott Laboratories, and any and all corporate
`
`parents, divisions, subsidiaries, affiliates, agents, employees, consultants, predecessors,
`
`successors, predecessors-in-interest, successors-in-interest, representatives, all persons or entities
`
`currently or previously under their control, and all persons or entities currently or previously acting
`
`on their behalf.
`
`28.
`
`The connectors “and,” “or,” and “and/or” shall be construed either disjunctively or
`
`conjunctively as necessary in order to give the broadest meaning to the request.
`
`29.
`
`The use of the singular form of any word includes the plural and vice versa, and the
`
`
`
`past tense shall include the present tense and vice versa, as necessary, to bring within the scope of
`
`the discovery request all responses that might otherwise be construed to be outside of its scope.
`
`INSTRUCTIONS
`
`1.
`
`2.
`
`Each page or sheet shall be marked with a consecutive document control number.
`
`Documents, communications, or information created or conveyed subsequent to the
`
`filing of This Litigation that are protected by attorney-client privilege or work product doctrine,
`
`including any applicable common interest or joint defense privileges, do not have to be identified.
`
`3.
`
`For documents, communications, or information created or conveyed before the
`
`filing of This Litigation, please provide the following information for any responsive document or
`
`thing withheld from production on the grounds that it is protected from disclosure by the attorney-
`
`client privilege, the work product doctrine, or any other relevant privilege:
`
`4.
`
`5.
`
`
`
`
`
`The author of the document;
`
`The person(s) for whom the document was prepared, to whom it was sent, and who
`
`5
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 64 Filed 12/21/18 Page 11 of 18 PageID #:
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`9229
`
`received copies;
`
`6.
`
`7.
`
`8.
`
`9.
`
`10.
`
`11.
`
`The date of the document;
`
`The subject matter of the document;
`
`The type of document (e.g., letter, memorandum, note, report, etc.);
`
`The number of pages and attachments; and
`
`The nature and the basis for the claim of privilege.
`
`All documents or things requested herein shall be produced in the same sequence
`
`as they are contained or found and with the file folders and other identifying documents or
`
`containers (e.g., copy of envelope, file cabinet market, binder tab) in which such documents were
`
`located when these requests were served. If You do not produce each document requested herein
`
`
`
`as kept in the usual course of business, You are requested to organize and label the documents or
`
`things produced to correspond with the particular document request to which the document or
`
`thing is responsive.
`
`12.
`
`If any document or thing requested herein is no longer in Your possession, custody,
`
`or control, You are requested to identify each such requested document or thing by date, type of
`
`document or thing, person(s) from whom sent, person(s) to whom sent, and person(s) receiving
`
`copies, and to provide a summary of its pertinent contents.
`
`13.
`
`Electronic and computerized materials must be produced in an intelligible format
`
`or together with a description of the system from which it was derived sufficient to permit review
`
`of the material.
`
`14.
`
`If You object to a request, or any part of a request, please produce all documents to
`
`which Your objection does not apply.
`
`
`
`
`
`6
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 64 Filed 12/21/18 Page 12 of 18 PageID #:
`
`9230
`
`DOCUMENTS AND THINGS TO BE PRODUCED
`
`1.
`
`All documents and things related to the conception, reduction to practice, design,
`
`and research and development of any subject matter claimed in the Dosing Patents and the ’659
`
`application, including, but not limited to, invention disclosures, notebooks, workbooks, laboratory
`
`notebooks, investigations, summaries, meeting notes or minutes, reports, presentations,
`
`evaluations, analyses, test data, and analytical data.
`
`2.
`
`All documents concerning investigations or analyses regarding the subject matter
`
`of the Dosing Patents and the ’659 application.
`
`3.
`
`All documents related to the ownership of the Dosing Patents and the ’659
`
`application, including the assignment, transfer, title, licensing or other retention or conveyance of
`
`
`
`rights or ownership of each of the Patents-in-Suit.
`
`4.
`
`Documents sufficient to show the first public disclosure, first public use or
`
`demonstration, first offer for sale, first sale, and/or first commercial use of the subject matter
`
`claimed by the Dosing Patents and the ’659 application and/or each product that purportedly
`
`practices, or the manufacture of which purportedly practices, any claimed subject matter of the
`
`Dosing Patents and the ’659 application.
`
`5.
`
`All documents and things relating to inventorship of the subject matter claimed in
`
`the Dosing Patents and the ’659 application, including but not limited to all disclosure statements
`
`made at any time concerning the inventions claimed in the Patents-in-Suit.
`
`6.
`
`All documents and things concerning any communication by You any other Person
`
`about the Dosing Patents and the ’659 application or the subject matter of the Dosing Patents and
`
`the ’659 application.
`
`7.
`
`All documents concerning Your obligation to cooperate or assist in enforcement of,
`
`
`
`
`
`7
`
`
`
`

`

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`or litigation relating to, the Dosing Patents and the ’659 application.
`
`8.
`
`All documents and things concerning the development program that led to
`
`trastuzumab, the properties of trastuzumab, or the use of trastuzumab including but not limited to
`
`or any other products concerning anti-ErbB2 monoclonal antibodies.
`
`9.
`
`All documents and things concerning the research, development, and/or testing of
`
`trastuzumab, or any other products concerning anti-ErbB2 monoclonal antibodies, discussed with
`
`or conducted by Dr. Brian Leyland-Jones, including, but not limited to, any correspondence,
`
`research proposals, or protocols regarding trastuzumab.
`
`10.
`
`All documents and things concerning the research, development, and/or testing of
`
`trastuzumab, or any other products concerning anti-ErbB2 monoclonal antibodies, discussed with
`
`
`
`or conducted by Dr. Mark Pegram, including, but not limited to, any correspondence, research
`
`proposals, or protocols regarding trastuzumab.
`
`11.
`
`All documents and things relating to correspondence with Brian Leyland-Jones,
`
`Luca Gianni, or Merrill Egorin relating to methods of use of trastuzumab, including without
`
`limitation methods of dosing trastuzumab and trastuzumab pharmacokinetics.
`
`12.
`
`All documents and things, including, but not limited to, key presentations and
`
`meeting minutes, concerning any internal Genentech/IDEC meetings, including, but not limited
`
`to, Product Development Committee Meetings, in which clinical trials or proposals using an anti-
`
`ErbB2 monoclonal antibody were discussed.
`
`13.
`
`All proposals relating to trastuzumab submitted to the Genentech/IDEC Clinical
`
`Trials Review Committee (CTRC), all communications by committee members concerning the
`
`proposals, and all communications between Genentech/IDEC and third parties who proposed
`
`clinical trials using trastuzumab.
`
`
`
`
`
`8
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`
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`

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`Case 1:18-cv-00924-CFC-SRF Document 64 Filed 12/21/18 Page 14 of 18 PageID #:
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`9232
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`14.
`
`All documents and things relating to any proposed or actual clinical trials (including
`
`without limitation the trials coded as BO15935, WO16229, WO16982, and MO16419) involving
`
`any trastuzumab product(s) or any other products concerning anti-ErbB2 monoclonal antibodies,
`
`including, but not limited to, protocols, consent forms, agreements, efforts to publicize the trials,
`
`efforts to recruit patients, clinical trial brochures, and communications with enrolled patients or
`
`any other third parties, including but not limited to communications with Larry Norton, Mark
`
`Pegram, Dennis Slamon, Melody Cobleigh, Karen Gelmon, Jean-Pierre Ayoub, Andrew Arnold,
`
`Shail Verma, Parviz Ghahramani, Brian Leyland-Jones, Luca Gianni, and Merrill Egorin.
`
`15.
`
`All documents and things concerning scientific advisory board meetings or other
`
`meetings with key opinion leaders (“KOLs”) held between 1992 and 2001, including, but not
`
`limited to, agendas, materials disseminated to the Board members, meeting notes, presentations,
`
`
`
`and correspondence regarding any trastuzumab product(s), including but not limited to
`
`Herceptin®, or any other products concerning anti-ErbB2 monoclonal antibodies.
`
`16.
`
`All documents and things related to BLA No. 103792 for Herceptin®, including
`
`without limitation the complete file of BLA No. 103792 for Herceptin®, and any supplemental
`
`applications and/or amendments thereto, including, but not limited to, all related investigational
`
`new drug (“IND”) applications, regardless of whether they were filed with the FDA.
`
`17.
`
`All documents and things relating to the disclosures in the ʼ196 patent at 43:39-
`
`46:3, under the heading “Example 5,” including any communications related to this disclosure,
`
`experimental work or modeling related to this disclosure, clinical trial designs discussed in the
`
`disclosure, results of clinical trials discussed in the disclosure, and drafts of the disclosure.
`
`18.
`
`All documents and things relating to the disclosures in the ʼ196 patent at 46:5-
`
`48:15, under the heading “Example 6,” including any communications related to this disclosure,
`
`
`
`
`
`9
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 64 Filed 12/21/18 Page 15 of 18 PageID #:
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`9233
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`experimental work or modeling related to this disclosure, clinical trial designs discussed in the
`
`disclosure, results of clinical trials discussed in the disclosure, drafts of the disclosure, and
`
`including any documents or things relating to the statement therein that “Simulation of the
`
`proposed treatment regimen suggests that the trough serum concentrations will be 17 mcg/ml, in
`
`the range (10-20mcg/ml) of the targeted trough serum concentrations from previous
`
`HERCEPTIN® IV clinical trials.”
`
`19.
`
`All documents and things relating to Your understanding of the pharmacokinetics
`
`of trastuzumab over time, including all documents and things relating to trastuzumab
`
`pharmacokinetics data and modeling of trastuzumab pharmacokinetics.
`
`20.
`
`All documents and things relating to Your communications with the FDA or like
`
`
`
`regulatory agencies concerning trastuzumab pharmacokinetics, including communications relating
`
`to your request to amend the trastuzumab label to recite three-weekly dosing regimens for
`
`trastuzumab and the pharmacokinetic data, models, and concepts related to any such labeling
`
`changes.
`
`21.
`
`All documents and things, relating to scientific meetings attended by You during
`
`1995 through 2000, inclusive, including for example any scientific meetings discussing
`
`trastuzumab clinical trials or development, including documents such as abstract books, meeting
`
`programs, meeting agenda, slide presentations, poster presentations, notes taken during scientific
`
`meetings, and documents prepared reflecting information disclosed at scientific meetings.
`
`22.
`
`All documents and things prior to 2002 concerning diagnostic methods used or
`
`considered for use in identifying patients for whom any trastuzumab product(s), including but not
`
`limited to Herceptin®, or any other products concerning anti-ErbB2 monoclonal antibodies, would
`
`be effective.
`
`
`
`
`
`10
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 64 Filed 12/21/18 Page 16 of 18 PageID #:
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`9234
`
`23.
`
`All documents and things prior to 2002, including communications with the FDA,
`
`clinicians, pathologists, Michael Press, Kerry J. Flom, Dennis Slamon, Vysis, ONCOR, DAKO,
`
`Ventana Medical Systems, or Abbott, related to assays and/or diagnostic testing for gene
`
`amplification.
`
`24.
`
`Documents sufficient to show that patients who were IHC0/1+ and tested positive
`
`for HER2 Gene amplification responded positively to anti-ErbB2 antibody.
`
`25.
`
`All documents and things concerning the total number or proportion of patients
`
`treated annually with an anti-ErbB2 antibody who were IHC0/1+ and who tested positive for
`
`HER2 Gene amplification.
`
`26.
`
`All documents and things related to the disclosures in the ’834 patent and ’066
`
`
`
`patent, under the heading “EXAMPLE 1,” including any communications related to this
`
`disclosure, experimental work, or modeling related to this disclosures, clin