Case 1:18-cv-00924-CFC-SRF Document 115 Filed 04/01/19 Page 1 of 17 PageID #:
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`14521
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`Case No. 1:18-cv-00924-CFC
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`GENENTECH, INC. and CITY OF HOPE,
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`Plaintiffs and Counterclaim Defendants,
`v.
`AMGEN INC.,
`Defendant and Counterclaim Plaintiff.
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`DEFENDANT AMGEN INC.’S FIRST NOTICE OF DEPOSITION OF PLAINTIFFS
`PURSUANT TO FEDERAL RULE OF CIVIL PROCEDURE 30(b)(6)
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`PLEASE TAKE NOTICE that, pursuant to Rule 30(b)(6) of the Federal Rules of Civil
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`Procedure, counsel for Defendant Amgen Inc. (“Defendant”) will take the deposition by oral
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`examination of Plaintiffs Genentech, Inc. (“Genentech”), and City of Hope (collectively,
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`“Plaintiffs”), on the topics set forth in the attached Schedule A, through one or more officers,
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`directors, agents, or other persons designated by Plaintiffs to testify on their behalf.
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`The deposition will take place before an officer duly authorized by law to administer oaths,
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`at the office of Cooley LLP, 3175 Hanover St, Palo Alto, CA 94304, on a date or dates to be
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`determined as mutually convenient for both parties. The testimony will be recorded
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`stenographically and by videotape. The deposition will be taken for the purposes of discovery and
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`all other purposes permitted by the Federal Rules of Civil Procedure.
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`Case 1:18-cv-00924-CFC-SRF Document 115 Filed 04/01/19 Page 2 of 17 PageID #:
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`14522
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`SMITH, KATZENSTEIN & JENKINS LLP
`/s/ Neal C. Belgam
`
`Neal Belgam (No. 2721)
`Eve H. Ormerod (No. 5369)
`1000 West Street, Suite 1501
`Wilmington, DE 19801
`P 302-652-8400
`nbelgam@skjlaw.com
`eormerod@skjlaw.com
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`Attorneys for Defendant and Counterclaim
`Plaintiff Amgen Inc.
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`Dated: April 1, 2019
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`Of Counsel:
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`Michelle Rhyu
`Susan Krumplitsch
`Daniel Knauss
`COOLEY, LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
`P 650-843-5287
`rhyums@cooley.com
`skrumplitsch@cooley.com
`dknauss@cooley.com
`
`Eamonn Gardner
`COOLEY, LLP
`4401 Eastgate Mall
`San Diego, CA 92121-1909
`P 858-550-6086
`egardner@cooley.com
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`Orion Armon
`COOLEY, LLP
`380 Interlocken Crescent
`Suite 900
`Broomfield, CO 80021-8023
`P 720-566-4119
`oarmon@cooley.com
`
`Nancy Gettel
`Thomas Lavery, IV
`AMGEN, INC.
`One Amgen Center Drive
`Thousand Oaks, CA 91320-1799
`P 805-447-1000
`ngettel@amgen.com
`tlavery@amgen.com
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`2
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`Case 1:18-cv-00924-CFC-SRF Document 115 Filed 04/01/19 Page 3 of 17 PageID #:
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`14523
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`SCHEDULE A
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`DEFINITIONS
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`“Plaintiffs,” “You,” and “Your” mean Genentech, Inc.; F. Hoffmann-La Roche
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`1.
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`Ltd.; and City of Hope, individually and collectively, and includes their officers, directors,
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`partners, corporate parents, subsidiaries, affiliates, agents, employees, consultants, predecessors,
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`successors, predecessors-in-interest, successors-in-interest, representatives, all persons or entities
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`currently or previously under their control, and all persons or entities currently or previously acting
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`on their behalf.
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`2.
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`3.
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`subsidiaries.
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`“Genentech” means Genentech, Inc. and any and all affiliates and subsidiaries.
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`“Roche” means F. Hoffmann-La Roche, Inc. and any and all affiliates and
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`4.
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`“Concerning,” “relating to,” or “referring to” any given subject matter means,
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`without limitation, identifying, assessing, stating, constituting, containing, embodying, tending to
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`support or refute, referring directly or indirectly to, pertaining to, reflecting upon, evidencing,
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`concerning, discussing, describing, mentioning, summarizing or connecting, in any way, to the
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`particular subject matter.
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`5.
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`“Communication” means any exchange or transmittal of information in the form
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`of facts, ideas, inquiries, or otherwise, whether written, oral, electronic, or in any other form.
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`6.
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`“Person” means any natural person or any business, legal or governmental entity,
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`or association.
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`7.
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`8.
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`9.
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` “’213 patent” means U.S. Patent No. 6,407,213.
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` “’918 patent” means U.S. Patent No. 6,620,918.
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`“’196 patent” means U.S. Patent No. 6,627,196.
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`3
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`14524
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`10.
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`11.
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`12.
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`13.
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`14.
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`15.
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`16.
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`17.
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`18.
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`19.
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`“’379 patent” means U.S. Patent No. 7,371,379.
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` “’834 patent” means U.S. Patent No. 7,993,834
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`“’066 patent” means U.S. Patent No. 8,076,066.
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` “’983 patent” means U.S. Patent No. 8,512,983.
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`“’869 patent” means U.S. Patent No. 8,574,869.
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` “’293 patent” means U.S. Patent No. 9,714,293.
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`“’811 patent” means U.S. Patent No. 10,160,811.
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`“’744 patent” means U.S. Patent No. 9,493,744.
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`“’106 patent” means U.S. Patent No. 10,184,106.
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`“Patents-in-Suit” means collectively the ’213 patent, the ’918 patent, the ’196
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`patent, the ’379 patent, the ’834 patent, the ’066 patent, the ’983 patent, the ’869 patent, the ’293
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`patent, the ’811 patent, and any additional patents that Plaintiffs may assert in this litigation.
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`20.
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`“Prior Art” means all documents, information, acts, or things that qualify as prior
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`art under any subsection of 35 U.S.C. §§ 102 and 103, including all systems, methods, apparatus,
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`publications, patents, or uses.
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`21.
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`“Related Patents and Applications” means any and all applications related to the
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`Patents-in-Suit, including any continuations, continuations-in-part, divisionals, interferences,
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`reexaminations, reissues, parents, foreign counterpart applications, and any other applications
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`disclosing, describing, or claiming any invention disclosed, described, or claimed in the Patents-
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`in-Suit, or claiming the benefit of the filing date of any applications whose benefit is claimed in
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`the Patents-in-Suit, whether or not abandoned and whether or not issued.
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`22.
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`23.
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`“FDA” means the U.S. Food and Drug Administration.
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`The term “Herceptin®” means the trastuzumab antibody product approved by the
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`4
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`Case 1:18-cv-00924-CFC-SRF Document 115 Filed 04/01/19 Page 5 of 17 PageID #:
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`14525
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`FDA under Biologic License Application No. 103792.
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`24.
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`25.
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`“Including” shall be construed broadly as “including without limitation.”
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`The connectors “and,” “or,” and “and/or” shall be construed either disjunctively or
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`conjunctively as necessary in order to give the broadest meaning to the request.
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`26.
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`The use of the singular form of any word includes the plural and vice versa, and the
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`past tense shall include the present tense and vice versa, as necessary, to bring within the scope of
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`the discovery request all responses that might otherwise be construed to be outside of its scope.
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`TOPICS FOR EXAMINATION
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`The identity and inventive contributions, and the nature and existence of evidence
`1.
`corroborating such inventive contributions of each person who conceived any aspect of any claim
`of the following patents:
`a. ’213 patent;
`b. ’918 patent;
`c. ’196 patent, ’379 patent, and ’811 patent;
`d. ’834 patent, and ’066 patent;
`e. ’983 patent, and ’293 patent;
`f. ’869 patent; and
`g. ’744 and ’106 patent,
`as well as the identity and location of persons most knowledgeable about this topic, and the identity
`and location of documents concerning this topic
`Reduction to practice of any invention embodying any claim of the following
`2.
`patents, and the nature and existence of evidence corroborating diligent reduction to practice:
`a. ’213 patent;
`b. ’918 patent;
`c. ’196 patent, ’379 patent, and ’811 patent;
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`5
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`Case 1:18-cv-00924-CFC-SRF Document 115 Filed 04/01/19 Page 6 of 17 PageID #:
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`d. ’834 patent, and ’066 patent;
`e. ’983 patent, and ’293 patent;
`f. ’869 patent; and
`g. ’744 and ’106 patent,
`as well as the identity and location of persons most knowledgeable about this topic, and the identity
`and location of documents concerning this topic.
`The policies, procedures, and persons involved in the preparation, submission,
`3.
`review, evaluation, and/or analysis of any invention disclosure submissions that may relate to any
`asserted claim of the following patents:
`a. ’213 patent;
`b. ’918 patent;
`c. ’196 patent, ’379 patent, and ’811 patent;
`d. ’834 patent, and ’066 patent;
`e. ’983 patent, and ’293 patent;
`f. ’869 patent; and
`g. ’744 and ’106 patent,
`as well as the identity and location of persons or committees most knowledgeable about this topic,
`and the identity and location of documents concerning this topic—including but not limited to the
`identity and location of any documents identifying the policies, procedures, and composition of
`any committees that evaluate invention disclosure submissions.
`The identity, contributions, and the nature and existence of evidence corroborating
`4.
`such contributions of each person who conceived the clinical trials identified as BO15935,
`WO16229, MO16982, MO16419, and any other clinical trial protocol that may relate to any
`asserted claim of the following patents:
`a. ’213 patent;
`b. ’918 patent;
`c. ’196 patent, ’379 patent, and ’811 patent;
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`6
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`Case 1:18-cv-00924-CFC-SRF Document 115 Filed 04/01/19 Page 7 of 17 PageID #:
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`d. ’834 patent, and ’066 patent;
`e. ’983 patent, and ’293 patent;
`f. ’869 patent; and
`g. ’744 and ’106 patent,
`as well as the identity and location of persons most knowledgeable about this topic, and the identity
`and location of documents concerning this topic.
`Details of each clinical trial proposed by or to You since 1992, involving
`5.
`Herceptin®, or any other products concerning anti-ErbB2 monoclonal antibodies, including the
`date of proposal, the Person who proposed the trial, the terms of the trial, whether the trial was
`approved, whether the trial was conducted, who conducted the trial, who funded the trial, and the
`clinical results of the trial, as well as the identity and location of persons most knowledgeable
`about this topic, and the identity and location of documents concerning this topic.
`Communications with Brian Leyland-Jones, Karen Gelmon, Jean-Pierre Ayoub,
`6.
`Andrew Arnold, Shail Verma, Parviz Gharamani, Luca Gianni, or Merrill Egorin concerning any
`clinical trial or study involving any trastuzumab product, including Herceptin®, or any other
`product containing an anti-erbB2 monoclonal antibody, as well as the identity and location of
`persons most knowledgeable about this topic, and the identity and location of documents
`concerning this topic.
`The work described in each of the Examples of the ‘196 patent, as well as the
`7.
`identity and location of persons most knowledgeable about this topic, and the identity and location
`of documents concerning this topic .
`Your understanding of the pharmacokinetic characteristics of trastuzumab over
`8.
`time, including all dosing regimens considered or proposed by You for trastuzumab over time, as
`well as the identity and location of persons most knowledgeable about this topic, and the identity
`and location of documents concerning this topic.
` Documents and communications exchanged with the FDA concerning the
`9.
`pharmacokinetic characteristics of trastuzumab over time, including all dosing regimens
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`7
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`Case 1:18-cv-00924-CFC-SRF Document 115 Filed 04/01/19 Page 8 of 17 PageID #:
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`14528
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`considered by You for trastuzumab over time, as well as the identity and location of persons most
`knowledgeable about this topic, and the identity and location of documents concerning this topic.
`Your medical or sales communications with third parties concerning selection of
`10.
`patients for trastuzumab therapy using assays that test HER2 gene amplification or HER2 protein
`overexpression, as well as the identity and location of persons most knowledgeable about this
`topic, and the identity and location of documents concerning this topic.
`Your collection and analysis of clinical trial data relating to patient selection for
`11.
`trastuzumab therapy using assays that test HER2 gene amplification or HER2 protein
`overexpression, as well as the identity and location of persons most knowledgeable about this
`topic, and the identity and location of documents concerning this topic.
`Facts and data in Your possession concerning the biological attributes of cancer
`12.
`cells that have a 0 or 1+ score of HER2 protein overexpression by immunohistochemistry and
`HER2 gene amplification by FISH, as well as the identity and location of persons most
`knowledgeable about this topic, and the identity and location of documents concerning this topic.
`Documents and communications exchanged with the FDA concerning Your
`13.
`selection of patients for trastuzumab therapy using assays that test HER2 gene amplification or
`HER2 protein overexpression, as well as the identity and location of persons most knowledgeable
`about this topic, and the identity and location of documents concerning this topic.
`Your business records concerning, and communications (including but not limited
`14.
`to communications involving Robert Mass, Mark Sliwkowski, Robert Cohen, Leonard Presta, Paul
`Carter, Noel Dybdal, Alex Bajamonde, Gracie Lieberman, or Steve Shak) exchanged with,
`employees at The University of California, Los Angeles (including but not limited to Mark
`Pegram, John Glaspy, or Dennis Slamon), The University of Southern California (including but
`not limited to Michael Press), or LabCorp., Inc. (including but not limited to Steve Anderson)
`concerning tests for diagnosing HER2 gene amplification or HER2 protein overexpression to
`select patients for treatment with trastuzumab or analysis of test results, as well as the identity and
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`8
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`Case 1:18-cv-00924-CFC-SRF Document 115 Filed 04/01/19 Page 9 of 17 PageID #:
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`14529
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`location of persons most knowledgeable about this topic, and the identity and location of
`documents concerning this topic.
`Your business records and communications with Andrew D. Seidman, MD,
`15.
`employees of Memorial Sloan-Kettering Cancer Center, or employees of M.D. Anderson Cancer
`Center, concerning the Phase II study (alternately referred to as H0833s, BB-IND 7720, MSKCC-
`98028, NCI-G98-1473, NCT00003539, and CDR0000066593) titled “Paclitaxel Plus Monoclonal
`Antibody Therapy in Treating Women With Recurrent or Metastatic Breast Cancer,” that began
`on or around 1998, as well as the identity and location of persons most knowledgeable about this
`topic, and the identity and location of documents concerning this topic.
`The date, circumstances, and factual basis of Your first knowledge that patients
`16.
`whose tumors test as FISH (+) and either IHC 0 or 1+ benefit from trastuzumab therapy, as well
`as the identity and location of persons most knowledgeable about this topic, and the identity and
`location of documents concerning this topic.
`Your use and Your contract manufacturers’ use of high temperature short time
`17.
`(“HTST”) treatment, as well as the identity and location of persons most knowledgeable about this
`topic, and the identity and location of documents concerning this topic.
`The facts and circumstances relating to the sale or offer for sale of each product
`18.
`You made using any process that included HTST treatment, as well as the identity and location of
`persons most knowledgeable about this topic, and the identity and location of documents
`concerning this topic.
`Your reasons for, processes, and product quality and manufacturing outcomes
`19.
`associated with manufacturing Herceptin® (including but not limited to manufacturing by Wyeth
`Pharmaceuticals and Your Penzberg facility) with and without HTST treatment, as well as the
`identity and location of persons most knowledgeable about this topic, and the identity and location
`of documents concerning this topic.
`Documents and communications exchanged with the FDA concerning Your (or
`20.
`Your contract manufacturers’) use or non-use of HTST treatment in the manufacture of
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`Case 1:18-cv-00924-CFC-SRF Document 115 Filed 04/01/19 Page 10 of 17 PageID
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`#: 14530
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`Herceptin®, as well as the identity and location of persons most knowledgeable about this topic,
`and the identity and location of documents concerning this topic.
`Communications and the terms of each commercial agreement that You entered
`21.
`into with any third-party regarding sharing of know-how relating to HTST treatment prior to June
`20, 2012, as well as the identity and location of persons most knowledgeable about this topic, and
`the identity and location of documents concerning this topic.
`Your deployment of HTST at Your South San Francisco City and Vacaville
`22.
`facilities, including but not limited to the HTST system You implemented at South San Francisco
`City for Your PULMOZYME® (dornase alfa) product, as well as the identity and location of
`persons most knowledgeable about this topic, and the identity and location of documents
`concerning this topic.
`Your implementation of HTST treatment at Your Lonza and Oceanside facilities,
`23.
`as well as the identity and location of persons most knowledgeable about this topic, and the identity
`and location of documents concerning this topic.
`The identity and circumstances of the 2000 runs of HTST treatment producing 6-8
`24.
`products that You performed prior to August 2006 without Mouse Minute Virus (“MMV”)
`contamination at any of Your facilities, as well as the identity and location of persons most
`knowledgeable about this topic, and the identity and location of documents concerning this topic.
`The design and operation of each HTST system that You implemented prior to June
`25.
`20, 2012, including the processes and procedures You used before or after HTST treatment to
`adjust pH, or remove or add any process nutrient, mineral, substance or ingredient to decrease
`precipitation or to maintain the suitability of cell culture media, as well as the identity and location
`of persons most knowledgeable about this topic, and the identity and location of documents
`concerning this topic.
`The business requirements that You implemented regarding the use of HTST for
`26.
`Your commercial processes, as well as the identity and location of persons most knowledgeable
`about this topic, and the identity and location of documents concerning this topic.
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`10
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`Case 1:18-cv-00924-CFC-SRF Document 115 Filed 04/01/19 Page 11 of 17 PageID
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`#: 14531
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`The design, process parameters, and specifications for each HTST system that You
`27.
`implemented or had implemented at any contract manufacturing organization (“CMO”) site,
`including but not limited to the Wyeth Pharmaceuticals site at Andover, Massachusetts, as well as
`the identity and location of persons most knowledgeable about this topic, and the identity and
`location of documents concerning this topic.
`All testing and experiments related to suppression of precipitates that form as a
`28.
`result of High Temperature Short Time (“HTST”) treatment, including the tests and experiments
`on the effects of temperature, pH, process nutrients, minerals, substances or ingredients on
`precipitation that are referenced in the specification of U.S. Patent Nos. 9,493,744 and 10,184,106,
`as well as the identity and location of persons most knowledgeable about this topic, and the identity
`and location of documents concerning this topic.
`Your policies and practices regarding the licensing of technology to or from other
`29.
`parties, and all facts and circumstances relating to any ownership or licensing interest in any of the
`Patents-in-Suit or Related Patents and Applications, or offer to license any of the Patents-in-Suit
`or Related Patents and Applications, as well as the identity and location of persons most
`knowledgeable about this topic, and the identity and location of documents concerning this topic.
`Terms of any settlement agreement, patent license, or covenant not to sue that You
`30.
`entered into with any third party concerning any Patent-in-Suit or any drug product embodied by
`any Patent-in-Suit, as well as the identity and location of persons most knowledgeable about this
`topic, and the identity and location of documents concerning this topic.
`Annual financial data since January 1, 2015, including unit sales, revenues, gross
`31.
`and net profits, losses, costs, and promotional expenditures (including expenditures for direct and
`indirect marketing, sales force/detailing, rebates, and discounts), relating to making and selling
`Your trastuzumab products, including Herceptin®, or any other product containing an anti-erbB2
`monoclonal antibody, as well as the identity and location of persons most knowledgeable about
`this topic, and the identity and location of documents concerning this topic.
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`11
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`Case 1:18-cv-00924-CFC-SRF Document 115 Filed 04/01/19 Page 12 of 17 PageID
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`#: 14532
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`Past, present, and projected market data (including market share and market
`32.
`demand by disease state or indication or dosing schedule) concerning Your trastuzumab products,
`including Herceptin®, or any other product containing an anti-erbB2 monoclonal antibody, as well
`as the identity and location of persons most knowledgeable about this topic, and the identity and
`location of documents concerning this topic.
`Your business plans for Your breast cancer therapeutic drug portfolio, including
`33.
`Your lifecycle management plan for Herceptin®, as well as the identity and location of persons
`most knowledgeable about this topic, and the identity and location of documents concerning this
`topic.
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`Your business plans for responding to any biosimilar competition with Your
`34.
`trastuzumab products, including Herceptin®, or any other product containing an anti-erbB2
`monoclonal antibody, as well as the identity and location of persons most knowledgeable about
`this topic, and the identity and location of documents concerning this topic.
`Analyses, projections, and forecasts of alleged lost sales or profits that You contend
`35.
`You will incur as a result of market entry by each seller of a biosimilar trastuzumab product, as
`well as the identity and location of persons most knowledgeable about this topic, and the identity
`and location of documents concerning this topic.
`The prices (including wholesale acquisition cost and the existence and amount of
`36.
`any rebates or discounts) and pricing strategies (including, but not limited to, any price
`determinations or changes in pricing and rebates and discounts) for Your trastuzumab products,
`including Herceptin®, from January 1, 2015 until the present, and any projections, expectations,
`or forecasts for same for the next five years, as well as the identity and location of persons most
`knowledgeable about this topic, and the identity and location of documents concerning this topic.
`Your business plans for Herceptin® after You lose patent exclusivity in the United
`37.
`States, as well as the identity and location of persons most knowledgeable about this topic, and the
`identity and location of documents concerning this topic.
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`12
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`Case 1:18-cv-00924-CFC-SRF Document 115 Filed 04/01/19 Page 13 of 17 PageID
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`#: 14533
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`Business impacts You have experienced, or expect to experience in the future, from
`38.
`trastuzumab biosimilar market entry in Europe, including price erosion, loss of market share, and
`any other economic or non-economic impact that You have measured or identified in Your
`business planning and strategy documents, as well as the identity and location of persons most
`knowledgeable about this topic, and the identity and location of documents concerning this topic.
`Your public statements regarding biosimilars, including impacts on Your business,
`39.
`on Your oncology portfolio, and any benefits or drawbacks of biosimilar market entry to the U.S.
`healthcare system, as well as the identity and location of persons most knowledgeable about this
`topic, and the identity and location of documents concerning this topic.
`All infringement-related harms You allege You will suffer due to market entry and
`40.
`sales of Defendant’s trastuzumab biosimilar, including, but not limited to economic and non-
`economic harms; any evidence supporting an allegation that such harm will be irreparable and
`incalculable; and any evidence tying any alleged harm You allege You will suffer to infringement
`of any patent-in-suit, as well as the identity and location of persons most knowledgeable about this
`topic, and the identity and location of documents concerning this topic.
`The marketing and promotion of each of Your trastuzumab products, including: (a)
`41.
`annual budgets for marketing and promotion; (b) sales and marketing strategies related to the
`product; (c) development of sales and marketing materials relating to the product; (d) content of
`sales and marketing materials relating to the product; and (e) Your plans to phase out, or to reduce
`marketing expenditures for, any trastuzumab product, as well as the identity and location of
`persons most knowledgeable about this topic, and the identity and location of documents
`concerning this topic.
`Patient and/or physician surveys that You are aware of, or were conducted by, on
`42.
`behalf of, at the request of, or with funding from, Plaintiffs regarding Herceptin®, or any other
`product containing an anti-erbB2 monoclonal antibody, and responses to same that concern the
`prescribing habits of physicians, including how physicians have written, or may write prescriptions
`for Herceptin® or any biosimilar trastuzumab product, as well as the identity and location of
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`Case 1:18-cv-00924-CFC-SRF Document 115 Filed 04/01/19 Page 14 of 17 PageID
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`#: 14534
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`persons most knowledgeable about this topic, and the identity and location of documents
`concerning this topic.
`The products or processes that embody the Patents-in-Suit, including but not
`43.
`limited to the products and processes for manufacturing Your trastuzumab products, including
`Herceptin®, or any other product containing an anti-erbB2 monoclonal antibody, including any
`changes to products or processes that affected whether those products or processes embodied
`claims of the Patents-in-Suit, as well as the identity and location of persons most knowledgeable
`about this topic, and the identity and location of documents concerning this topic.
`The manufacturing processes from the cell culture production stage, through
`44.
`harvest, to the treatment or storage of the harvested cell culture fluid used or in use to manufacture
`any antibody product by or on behalf of Genentech including but not limited to Herceptin®
`(trastuzumab), Rituxan (rituximab), Xolair (omalizumab), Raptiva (efalizumab), Avastin
`(bevacizumab), Ocrevus (ocrelizumab), and Lucentis (ranibuzumab), including but not limited to
`(i) any use of sparging and/or any bubbling of a gas into a liquid in the bioreactor tank, (ii) the
`methods used for agitation of the cell culture or harvested cell culture fluid, and (iii) any steps
`taken to change the temperature of the cell culture fluid, as well as the identity and location of
`persons most knowledgeable about this topic, and the identity and location of documents
`concerning this topic.
`Documents and communications exchanged with the FDA regarding (i) use of
`45.
`sparging and/or bubbling of a gas into a liquid in the bioreactor tank during the cell culture and
`harvest operations, (ii) the methods used for agitation of the cell culture or harvested cell culture
`fluid, and (iii) any steps taken to change the temperature of the cell culture fluid in the manufacture
`of Herceptin®, as well as the identity and location of persons most knowledgeable about this topic,
`and the identity and location of documents concerning this topic.
`Any evaluations, testing, or analysis to evaluate the effect of sparging and/or any
`46.
`bubbling of a gas into a liquid in the bioreactor tank on the pre-harvest or harvested cell culture
`fluid in the manufacture of any antibody product developed or commercialized by or on behalf of
`
`
`
`
`
`14
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`
`

`

`
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`Case 1:18-cv-00924-CFC-SRF Document 115 Filed 04/01/19 Page 15 of 17 PageID
`
`#: 14535
`
`Genentech prior to July 9, 2007, including but not limited to Herceptin® (trastuzumab), Rituxan
`(rituximab), Xolair (omalizumab), Raptiva (efalizumab), Avastin (bevacizumab), Ocrevus
`(ocrelizumab), and Lucentis (ranibuzumab), including but not limited to any evaluation, testing,
`or analysis related to whether sparging has an effect on preventing the reduction of disulfide bonds,
`as well as the identity and location of persons most knowledgeable about this topic, and the identity
`and location of documents concerning this topic.
`All testing and experiments related to sparging referenced in the specification of
`47.
`U.S. Patent No. 8,574,869, as well as the identity and location of persons most knowledgeable
`about this topic, and the identity and location of documents concerning this topic.
`The components and/or ingredients used in the cell culture production stage for any
`48.
`cell culture, feed, and/or supplemental mediums used or in use to manufacture any antibody
`product by or on behalf of Genentech including but not limited to Herceptin® (trastuzumab),
`Rituxan (rituximab), Xolair (omalizumab), Raptiva (efalizumab), Avastin (bevacizumab), Ocrevus
`(ocrelizumab), and Lucentis (ranibuzumab), including but not limited to (i) the concentration of
`glutamine, (iii) the concentration of asparagine, and (iii) the concentration of aspartic acid, as well
`as the identity and location of persons most knowledgeable about this topic, and the identity and
`location of documents concerning this topic.
` Documents and communications exchanged with the FDA regarding the
`49.
`components and/or ingredients used in the cell culture production stage for any cell culture, feed,
`and/or supplemental mediums used in the manufacture of Herceptin®, including (i) the
`concentration of glutamine, (ii) the concentration of asparagine, and (iii) the concentration of
`aspartic acid, as well as the identity and location of persons most knowledgeable about this topic,
`and the identity and location of documents concerning this topic.
`Any evaluations, testing, or analysis regarding the components and/or ingredients
`50.
`used in the cell culture production stage for any cell culture, feed, and/or supplemental mediums
`used in the manufacture of any antibody product developed or commercialized by or on behalf of
`Genentech prior to July 9, 2007, including but not limited to Herceptin® (trastuzumab), Rituxan
`
`
`
`
`
`15
`
`
`
`

`

`
`
`Case 1:18-cv-00924-CFC-SRF Document 115 Filed 04/01/19 Page 16 of 17 PageID
`
`#: 14536
`
`(rituximab), Xolair (omalizumab), Raptiva (efalizumab), Avastin (bevacizumab), Ocrevus
`(ocrelizumab), and Lucentis (ranibuzumab), including but not limited to any evaluation, testing,
`or analysis related to (i) the concentration of glutamine, (ii) the concentration of asparagine, and
`(iii) the concentration of aspartic acid, as well as the identity and location of persons most
`knowledgeable about this topic, and the identity and location of documents concerning this topic.
`Any evaluations, testing, analysis, methods, or techniques You use to evaluate the
`51.
`monomer purity and/or yield of the following polypeptides: anti-IgE, anti-IgG, anti-Her-2, anti-
`CD11a, anti-CD18, anti-CD20, anti-VEGF, or IgE, as well as the identity and location of persons
`most knowledgeable about this topic, and the identity and location of documents concerning this
`topic.
`
`All Prior Art of which You are aware, including the facts and circumstances relating
`52.
`to your first awareness of each item of Prior Art, as well as the identity and location of persons
`most knowledgeable about this topic, and the identity and location of documents concerning this
`topic.
`
`All purported evidence of secondary considerations or objective indicia of non-
`53.
`obviousness of each claim of the following patents, including, but not limited to, unexpected
`results, commercial success, long-felt but unsolved need, failure of others, and copying, and the
`nexus between the subject matter claimed in each claim of the following patents and Herceptin®,
`as well as all purported evidence of teachings away in a reference or combination of references:
`a. ’213 patent;
`b. ’918 patent;
`c. ’196 patent, ’379 patent, and ’811 patent;
`d. ’834 patent, and ’066 patent;
`e. ’983 patent, and ’293 patent;
`f. ’869