throbber
Case 1:18-cv-01363-CFC Document 100 Filed 04/12/19 Page 1 of 16 PageID #:
`13823
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. 18-1363-CFC
`
`)))))))))
`
`GENENTECH, INC., AND CITY OF HOPE,
`
`Plaintiffs,
`
`v.
`
`SAMSUNG BIOEPIS CO., LTD.,
`
`Defendant.
`
`SAMSUNG BIOEPIS’S NOTICE OF RULE 30(b)(6) DEPOSITION OF
`GENENTECH, INC.
`
`PLEASE TAKE NOTICE that, pursuant to Federal Rule of Civil Procedure 30(b)(6),
`
`counsel for Defendant Samsung Bioepis Co., Ltd. (“Samsung”) will take the oral deposition of
`
`Plaintiffs Genentech, Inc. (“Genentech”) and City of Hope (collectively “Plaintiffs”) on the
`
`topics set forth in the attached Schedule A on a date or dates to be determined as mutually
`
`convenient for both parties and will continue the deposition day-to-day until completed. The
`
`deposition will take place at White & Case LLP, 1221 Avenue of the Americas, New York, NY
`
`10020, or at a mutually convenient location to be agreed upon by the parties. The deposition will
`
`be taken before a notary public or other officer duly authorized to administer oaths and take
`
`testimony and will be recorded by stenographic means and by videotape. The deposition will be
`
`taken for the purposes of discovery and all other purposes permitted by the Federal Rules of
`
`Civil Procedure.
`
`Genentech is required to designate and produce one or more officers, directors, managing
`
`agents, or other persons to testify on its behalf with respect to each of the topics set forth in
`
`Schedule A. The persons designated are required to testify on each of those matters known or
`
`reasonably available to Genentech.
`
`

`

`Case 1:18-cv-01363-CFC Document 100 Filed 04/12/19 Page 2 of 16 PageID #:
`13824
`
`Samsung requests that, no later than seven business days before the date of the
`
`deposition, Genentech (1) provide Samsung with written notice of the name and position of
`
`employment of each designee testifying on behalf of Genentech and the topics on which each
`
`such designee will testify; and (2) produce all documents in the possession, custody, or control of
`
`Genentech or any of its designees relating to each topic to the extent all such documents have not
`
`previously been produced. If Genentech fails to comply with either request for any of the
`
`noticed topics, Samsung reserves the right to recall Genentech and each designee for further
`
`depositions on such topics.
`
`OF COUNSEL:
`
`Dimitrios T. Drivas
`Scott T. Weingaertner
`Amit H. Thakore
`Holly Tao
`John P. Padro
`WHITE & CASE LLP
`1221 Avenue of the Americas
`New York, New York 10020-1095
`Tel: (212) 819-8200
`
`POTTER ANDERSON & CORROON LLP
`
`By: /s/ David E. Moore
`David E. Moore (#3983)
`Bindu A. Palapura (#5370)
`Stephanie E. O’Byrne (#4446)
`Jennifer Penberthy Buckley (#6264)
`Hercules Plaza, 6th Floor
`1313 N. Market Street
`Wilmington, DE 19801
`Tel: (302) 984-6000
`dmoore@potteranderson.com
`bpalapura@potteranderson.com
`sobyrne@potteranderson.com
`
`Dated: April 12, 2019
`6154018 / 45001
`
`Attorneys for Defendant Samsung Bioepis Co.,
`Ltd.
`
`2
`
`

`

`Case 1:18-cv-01363-CFC Document 100 Filed 04/12/19 Page 3 of 16 PageID #:
`13825
`
`SCHEDULE A
`
`DEFINITIONS AND INSTRUCTIONS
`
`Samsung incorporates by reference the definitions and instructions set forth in Defendant
`
`Samsung Bioepis Co., Ltd.’s First Set of Interrogatories to Plaintiffs Genentech, Inc., and City of
`
`Hope dated March 11, 2019. The definitions and instructions incorporated by reference shall
`
`have the same force as if fully stated herein.
`
`TOPICS
`
`1.
`
`All facts relating to the conception, diligence, reduction to practice, design,
`
`research and development, testing, marketing, and sale of any invention described, disclosed,
`
`claimed, or enabled in the Asserted Patents, including the present location of any related
`
`documents and all persons knowledgeable about these subjects.
`
`2.
`
`The policies, procedures, and persons involved in the preparation, submission,
`
`review, evaluation, and/or analysis of any invention disclosure submissions that may relate to
`
`any asserted claim of the Asserted Patents, including the present location of any related
`
`documents and all persons knowledgeable about these subjects.
`
`3.
`
`All facts relating to the preparation, prosecution, filing, and allowance of any
`
`application related to the Asserted Patents.
`
`4.
`
`Any proceeding in the United States Patent and Trademark Office concerning
`
`Genentech or any Related Patent or related patent application.
`
`5.
`
`Any Prior Art to the Asserted Patents of which You are aware, including the facts
`
`and circumstances related to your first awareness of each instance, reference, event, or other
`
`evidence of the aforementioned Prior Art.
`
`

`

`Case 1:18-cv-01363-CFC Document 100 Filed 04/12/19 Page 4 of 16 PageID #:
`13826
`
`6.
`
`Any investigations, analyses, or searches conducted by or for Plaintiffs or the
`
`inventors of the Asserted Patents concerning the patentability and validity of the Asserted
`
`Patents, including concerning any Prior Art.
`
`7.
`
`Any decision to cite or not cite any given Prior Art reference during the
`
`prosecution of any application leading to the Asserted Patents, including all facts relating to any
`
`decision to incorporate by reference any given Prior Art during the prosecution of any
`
`application leading to the Asserted Patents.
`
`8.
`
`All purported evidence of secondary considerations or objective indicia of non-
`
`obviousness of each claim of the Asserted 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.
`
`9.
`
`The identity and role of each person involved in the prosecution or enforcement
`
`of the Asserted Patents, and the identity of each person with a financial, legal, or other interest in
`
`the outcome of the above-captioned litigation.
`
`10.
`
`The relationship, agreements, and communications between Genentech and each
`
`of the named inventors of the Asserted Patents, including communications and agreements
`
`concerning ownership or assignment of the Asserted Patents, development strategies, Prior Art,
`
`validity, invalidity, enforceability, scope, and infringement of the claims of the Asserted Patents.
`
`11.
`
`The identity and inventive contributions, and the nature and existence of evidence
`
`corroborating such inventive contributions, of each person who conceived any aspect of any
`
`claim of the Asserted Patents.
`
`2
`
`

`

`Case 1:18-cv-01363-CFC Document 100 Filed 04/12/19 Page 5 of 16 PageID #:
`13827
`
`12.
`
`The identity, the contributions, and the nature and existence of evidence
`
`corroborating such contribution 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 in the Asserted Patents.
`
`13.
`
`Details of each clinical trial proposed by or to You since 1992 involving
`
`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.
`
`14.
`
`Communications with Brian Leyland-Jones, Karen Gelmon, Jean-Pierre Ayoub,
`
`Andrew Arnold, Shail Verma, Parviz Gharamani, or Luca Gianni 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.
`
`15.
`
`The work described in each of the Examples of the ’196 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.
`
`16.
`
`Your understanding of the pharmacokinetic characteristics of Your Trastuzumab
`
`Product over time, including all dosing regimens considered or proposed by You for Your
`
`Trastuzumab Product 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.
`
`3
`
`

`

`Case 1:18-cv-01363-CFC Document 100 Filed 04/12/19 Page 6 of 16 PageID #:
`13828
`
`17.
`
`Documents and communications exchanged with the FDA concerning the
`
`pharmacokinetic characteristics of Your Trastuzumab Product over time, including all dosing
`
`regimens considered by You for Your Trastuzumab Product 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.
`
`18.
`
`Patient and/or physician surveys that You are aware of or were conducted by, on
`
`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 persons most knowledgeable about this topic, and the identity and location of
`
`documents concerning this topic.
`
`19.
`
`Your medical or sales communications with third parties concerning 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.
`
`20.
`
`Your collection and analysis of clinical trial data relating to patient selection 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.
`
`21.
`
`Facts and data in your possession concerning the biological attributes of cancer
`
`cells that have a 0 or 1+ score of HER2 protein overexpression by immunohistochemistry and
`
`4
`
`

`

`Case 1:18-cv-01363-CFC Document 100 Filed 04/12/19 Page 7 of 16 PageID #:
`13829
`
`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.
`
`22.
`
`Documents and communications exchanged with the FDA concerning your
`
`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.
`
`23.
`
`Your business records concerning, and communications (including but not limited
`
`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 Your Trastuzumab Product or analysis of test results, as well as
`
`the identity and location of persons most knowledgeable about this topic, and the identity and
`
`location of documents concerning this topic.
`
`24.
`
`The date, circumstances, and factual basis of your first knowledge that patients
`
`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.
`
`25.
`
`The products or processes that embody the Asserted Patents, including but not
`
`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
`
`5
`
`

`

`Case 1:18-cv-01363-CFC Document 100 Filed 04/12/19 Page 8 of 16 PageID #:
`13830
`
`changes to products or processes that affected whether those products or processes embodied
`
`claims of the Asserted Patents, as well as the identity and location of persons most
`
`knowledgeable about this topic, and the identity and location of documents concerning this topic.
`
`26.
`
`The manufacturing processes from the cell culture production stage, through
`
`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.
`
`27.
`
`Documents and communications exchanged with the FDA regarding (i) the use of
`
`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.
`
`28.
`
`Any evaluations, testing, or analysis to evaluate the effect of sparging and/or any
`
`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
`
`Genentech prior to July 9, 2007, including but not limited to Herceptin® (trastuzumab), Rituxan
`
`6
`
`

`

`Case 1:18-cv-01363-CFC Document 100 Filed 04/12/19 Page 9 of 16 PageID #:
`13831
`
`(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.
`
`29.
`
`All testing and experiments related to sparging referenced in the specification of
`
`the ’869 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.
`
`30.
`
`The components and/or ingredients used in the cell culture production stage for
`
`any 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, (iii) the concentration of
`
`aspartic acid, (iv) the concentration of citric acid or citrate not bound in a chelate complex with
`
`iron or another transition metal ion, and (v) the concentration of chelated citrate, as well as the
`
`identity and location of persons most knowledgeable about this topic, and the identity and
`
`location of documents concerning this topic.
`
`31.
`
`Documents and communications exchanged with the FDA regarding the
`
`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, (iii) the concentration of aspartic
`
`acid, (iv) the concentration of citric acid or citrate not bound in a chelate complex with iron or
`
`7
`
`

`

`Case 1:18-cv-01363-CFC Document 100 Filed 04/12/19 Page 10 of 16 PageID #:
`13832
`
`another transition metal ion, and (v) the concentration of chelated citrate, as well as the identity
`
`and location of persons most knowledgeable about this topic, and the identity and location of
`
`documents concerning this topic.
`
`32.
`
`Any evaluations, testing, or analysis regarding the 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 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
`
`(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, (iii)
`
`the concentration of aspartic acid, (iv) the concentration of citric acid or citrate not bound in a
`
`chelate complex with iron or another transition metal ion, and (v) the concentration of chelated
`
`citrate, as well as the identity and location of persons most knowledgeable about this topic, and
`
`the identity and location of documents concerning this topic.
`
`33.
`
`The processes relating to Protein A chromatography used to manufacture any
`
`antibody product by or on behalf of Genentech, the antibody product including but not limited to
`
`Herceptin® (trastuzumab), Rituxan (rituximab), Xolair (omalizumab), Raptiva (efalizumab),
`
`Avastin (bevacizumab), Ocrevus (ocrelizumab), and Lucentis (ranibuzumab), and the processes
`
`including but not limited to (i) any measurements or analyses of leached Protein A in the
`
`harvested cull culture fluid, and (ii) any steps taken to change the temperature of the room,
`
`column, or harvested culture fluid, including but not limited to any steps taken to change the
`
`temperature following measurements or analysis of leached Protein A in the harvested cell
`
`8
`
`

`

`Case 1:18-cv-01363-CFC Document 100 Filed 04/12/19 Page 11 of 16 PageID #:
`13833
`
`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.
`
`34.
`
`Documents and communications exchanged with FDA regarding (i) use of Protein
`
`A chromatography during the purification stage, (ii) any measurements or analyses of leached
`
`Protein A in the harvested cull culture fluid, and (iii) any steps taken to change the temperature
`
`of the room, column, or harvested culture fluid, including but not limited to any steps taken to
`
`change the temperature following measurements or analysis of leached Protein A in the
`
`harvested 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.
`
`35.
`
`Any evaluations, testing, or analysis to evaluate Protein A chromatography 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
`
`(rituximab), Xolair (omalizumab), Raptiva (efalizumab), Avastin (bevacizumab), Ocrevus
`
`(ocrelizumab), and Lucentis (ranibuzumab), including but not limited to any evaluation, testing,
`
`or analysis related to the effect of temperature on the leaching of Protein A during Protein A
`
`chromatography, as well as the identity and location of persons most knowledgeable about this
`
`topic, and the identity and location of documents concerning this topic.
`
`36.
`
`All testing and experiments referenced in the specification of the ’704 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.
`
`37.
`
`Annual financial data since January 1, 2015, including unit sales, revenues, gross
`
`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
`
`9
`
`

`

`Case 1:18-cv-01363-CFC Document 100 Filed 04/12/19 Page 12 of 16 PageID #:
`13834
`
`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.
`
`38.
`
`Past, present, and projected market data (including market share and market
`
`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.
`
`39.
`
`Annual financial data since January 1, 2015, including unit sales, revenues, gross
`
`and net profits, losses, costs, and promotional expenditures (including expenditures for direct and
`
`indirect marketing, sales force/detailing, rebates, and discounts), relating to Your licensing of
`
`any invention described, disclosed, claimed, or enabled in the Asserted Patents, including but not
`
`limited to the ’869 Patent, the ’983 Patent, the ’293 Patent, the ’660 Patent, and the ’704 Patent.
`
`40.
`
`Your business plans for your breast cancer therapeutic drug portfolio, including
`
`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.
`
`41.
`
`Your business plans for responding to any biosimilar competition with 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.
`
`42.
`
`Analyses, projections, and forecasts of alleged lost sales or profits that You
`
`contend You will incur as a result of market entry by each seller of a biosimilar trastuzumab
`
`10
`
`

`

`Case 1:18-cv-01363-CFC Document 100 Filed 04/12/19 Page 13 of 16 PageID #:
`13835
`
`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.
`
`43.
`
`The prices (including wholesale acquisition cost and the existence and amount of
`
`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.
`
`44.
`
`Your business plans for Herceptin® after You lose patent exclusivity in the
`
`United 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.
`
`45.
`
`Business impacts You have experienced, or expect to experience in the future,
`
`from 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.
`
`46.
`
`Your public statements regarding biosimilars, including impacts on your business,
`
`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.
`
`47.
`
`All infringement-related harms You allege You will suffer due to market entry
`
`and sales of Defendant’s trastuzumab biosimilar, including but not limited to economic and non-
`
`11
`
`

`

`Case 1:18-cv-01363-CFC Document 100 Filed 04/12/19 Page 14 of 16 PageID #:
`13836
`
`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 Asserted 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.
`
`48.
`
`The marketing and promotion of each of Your trastuzumab products, including:
`
`(a) 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.
`
`49.
`
`The products that Genentech contends compete with Herceptin® products,
`
`including any information regarding budgets, forecasts, marketing, sales, revenue, profits, and
`
`the entities responsible for the manufacture and sale of such products.
`
`50.
`
`Any evaluations or analyses of any products that compete or may compete with
`
`Herceptin® products, including any analyses of the physical characteristics or the strengths or
`
`weaknesses of any competing products.
`
`51.
`
`The development, manufacture, marketing, sale, revenue, and profits related to
`
`Herceptin® products and the inventions claimed in the Asserted Patents, including any
`
`agreement for revenue sharing, transfer, or reporting between Genentech and any other company.
`
`52.
`
`Any enforcement or defense of the Asserted Patents in any domestic or foreign
`
`civil action or administrative proceeding.
`
`12
`
`

`

`Case 1:18-cv-01363-CFC Document 100 Filed 04/12/19 Page 15 of 16 PageID #:
`13837
`
`53.
`
`Any evaluation or analysis related to assertion or enforcement of the Asserted
`
`Patents.
`
`54.
`
`55.
`
`Any decision to assert or enforce the Asserted Patents against potential infringers.
`
`Any quality problems associated with Genentech’s products that had any effect on
`
`the ability to market or sell such products, including any recall of such products.
`
`56.
`
`Communications, negotiations, and agreements with defendants in the Related
`
`Litigation regarding the Asserted Patents.
`
`57.
`
`Terms of any settlement agreement, patent license, or covenant not to sue that
`
`You entered into with any third party concerning any Asserted Patent or any drug product
`
`embodied by any Asserted Patent, or as to which manufacturing processes associated with such
`
`drug product are embodied by any Asserted Patent.
`
`58.
`
`Your policies and practices regarding the licensing of technology to or from other
`
`parties, and all facts and circumstances relating to any ownership or licensing interest in any of
`
`the Asserted Patents or Related Patents and applications, or any offer to license any of the
`
`Asserted Patents 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.
`
`59.
`
`Genentech’s corporate structure, including its relationship to any corporate
`
`parents, subsidiaries, or affiliates, including F. Hoffman – La Roche AG.
`
`60.
`
`The valuation of Genentech, including Genentech’s sales, profits, assets,
`
`liabilities, and net worth from September 25, 1998, to present, both as a whole for Genentech and
`
`for any business unit within Genentech related to Herceptin® products.
`
`13
`
`

`

`Case 1:18-cv-01363-CFC Document 100 Filed 04/12/19 Page 16 of 16 PageID #:
`13838
`
`61.
`
`Your document retention policies from 1995 to the present, as well as the identity
`
`and location of persons most knowledgeable about this topic, and the identity and location of
`
`documents concerning this topic.
`
`14
`
`

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