Case 1:18-cv-01363-CFC Document 1-11 Filed 09/04/18 Page 1 of 29 PageID #: 457
`Case 1:18-cv-01363-CFC Document1-11
`Filed 09/04/18
`Page 1 of 29 PagelD #: 457
`
`
`
`EXHIBIT K
`EXHIBIT K
`
`
`
`

`

`Case 1:18-cv-01363-CFC Document 1-11 Filed 09/04/18 Page 2 of 29 PageID #: 458
`US009249218B2
`
`US009249218B2
`
`(ΐ2) United States Patent
`Basey et al.
`
`(ΐο) Patent No.:
`(45) Date of Patent:
`
`US 9,249,218 Β2
`*Feb. 2, 2016
`
`(54) PROTEIN PURIFICATION
`
`(75)
`
`Inventors: Carol D. Basey, Winters, CA (US);
`Greg S. Blank, Menlo Park, CA (US)
`
`(73) Assignee: GENENTECH, INC., South San
`Francisco, CA (US)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 214 days.
`This patent is subject to a terminal dis­
`claimer.
`
`(21) Αρρ1.Νο.: 13/313,931
`
`(22) Filed:
`
`Dec. 7, 2011
`
`(65)
`
`Prior Publication Data
`US 2014/0018523 Al Jan. 16, 2014
`
`Related U.S. Application Data
`(60) Continuation of application No. 12/418,905, filed on
`Apr. 6, 2009, now abandoned, which is a continuation
`of application No. 11/398,447, filed on Apr. 5, 2006,
`now Pat. No. 7,531,645, which is a continuation of
`application No. 10/949,683, filed on Sep. 24, 2004,
`now Pat. No. 7,074,404, which is a continuation of
`application No. 10/253,366, filed on Sep. 24, 2002,
`now abandoned, which is a division of application No.
`09/304,465, filed on May 3, 1999, now Pat. No.
`6,489,447.
`(60) Provisional application No. 60/084,459, filed on May
`6, 1998.
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`(51) Int.Cl.
`Α6IK 39/395
`Α61Κ 39/00
`Α6IK 39/40
`C07K16/28
`C07K1/18
`C07K16/06
`C07K16/32
`Α61Κ 38/00
`(52) U.S. Cl.
`CPC ............. .. C07K16/2863 (2013.01); CO7Κ1/18
`(2013.01); C07K16/065 (2013.01); C07K
`16/32 (2013.01); Α61Κ38/00 (2013.01); C07K
`2317/24 (2013.01); C07K 2317/56 (2013.01)
`(58) Field of Classification Search
`USPC .......... . 424/130.1, 133.1, 138.1, 141.1, 152.1
`See application file for complete search history.
`
`(56)
`
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`Primary Examiner — Rodney Ρ Swartz
`(74) Attorney, Agent, or Firm — Diane Marschang; Ginger
`R. Dreger; Arnold & Porter LLP
`(57)
`ABSTRACT
`A method for purifying a polypeptide by ion exchange chro­
`matography is described which involves changing the con­
`ductivity and/or pH of buffers in order to resolve a polypep­
`tide of interest from one or more contaminants.
`7 Claims, 7 Drawing Sheets
`
`

`

`Case 1:18-cv-01363-CFC Document 1-11 Filed 09/04/18 Page 3 of 29 PageID #: 459
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`US 9,249,218 Β2
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`
`

`

`Case 1:18-cv-01363-CFC Document 1-11 Filed 09/04/18 Page 4 of 29 PageID #: 460
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`US 9,249,218 Β2
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`1 308 455, Approved Judgment. Date: Jan. 30, 2014. (6 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Approved Judgment. Date: Apr. 10, 2014 (47 pages).
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`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Judgment Costs. Date: May 16, 2014 (10 pages).
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`1 308 455, Order for Directions, Date: Nov. 22, 2012 (5 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Consent Order. Date: Dec. 2, 2012 (3 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Order Dispensing with Expert Meetings and Joint Reports.
`Date: Jan. 14, 2014 (2 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Order From Pre-Trial Review. Date: Jan. 30, 2015 (6
`pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Order for a Declaration of Non-Infingement for ΕΡ (UK)
`1 308 455 (8 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Order Declaring ’155 and ’455 invalid and revoked. Date:
`May 16, 2014 (4 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Amended Particulars of Claim under CPR 17.1(2)(a).
`Date: Jun. 24, 2013 (3 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Re-Amended Grounds of Invalidity under CPR 17. l(2)(a).
`Date: Dec. 13, 2013 (8 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Re-Amended Defence under CPR 17.1(2)(a). Date: Jan.
`10, 2014 (3 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Confidential Statement of Case Served Pursuant to Court
`Order. Date: Dec. 12, 2012 (7 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Claimant’s Notice to Admit Facts and Part 18 Request for
`Further Information from the Defendant, Date: Feb. 15, 2013 (7
`pages).
`
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308455, Defendant’s Notice to AdmitFacts. Date: Feb. 15,2013 (2
`pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Defendant’s Response to the Claimant’s Notice to Admit
`Facts and Part 18 Request for Further Information. Date: Mar. 1,2013
`(3 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Claimant’s Response to the Defendant’s Notice to Admit
`Facts. Date: Mar. 1, 2013 (3 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Supplemental Claimant’s Notice to Admit Facts and Part
`18 Request for Further Information. Date: Jul. 4, 2013 (3 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Defendant’s Response to the Claimant’s Supplemental
`Notice to Admit Facts and Part 18 Request for Further Information.
`Date: Jul. 15, 2013.
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Claimant’s Pleading of Matters Falling within the Com­
`mon General Knowledge. Date: Sep. 27, 2013. (7 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Defendant’s Reply to the Claimant’s Pleading of Matters
`Falling within Common General Knowledge, Date: Oct. 29,2013 (17
`pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Defendant’s Statement of Case on Independent Validity,
`Date: Feb. 10, 2014 (4 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308455, Claimant’s Response to Defendant’s Statement of Case on
`Independent Validity, Date: Feb. 17, 2014 (3 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Confidential Witness Statement of Michael John Gilbert,
`Date: Nov. 21, 2012 (7 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit MJG-1, Fetter between Taylor Wessing and
`Mewburn Ellis FFP dated Sep. 5, 2012, in Confidential Witness
`Statement of Michael John Gilbert, Date: Nov. 21, 2012 (9 pages).
`Hospira ν. Genentech trial in the High Court of Justice Division 2
`Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK) 1 308 455,
`Exhibit MJG-2, news release dated Oct. 9,2009, “Hospira, Celltrion,
`Enter Business Cooperation Agreement to Develop and Market
`Biogeneric Drags” in Confidential Witness Statement of Michael
`John Gilbert, Date: Nov. 21, 2012 (3 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit MJG-3, “About Hospira” in Confidential Witness
`Statement of Michael John Gilbert, Date: Nov. 21, 2012 (3 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit MJG-4, United States Security and Exchange
`Commission Form 10-Q filed Aug. 1, 2012, in Confidential Witness
`Statement of Michael John Gilbert, Date: Nov. 21, 2012 (69 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit MJG-5, Product Pipeline section of Cellitron 2nd
`Quarter 2012 report, in Confidential Witness Statement of Michael
`John Gilbert, Date: Nov. 21, 2012 (15 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit MJG-6, Product Pipeline section of Cellitron 3rd
`Quarter 2012 report, in Confidential Witness Statement of Michael
`John Gilbert, Date: Nov. 21, 2012 (16 pages).
`
`

`

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`
`(56)
`
`References Cited
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`OTHER PUBLICATIONS
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`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, First Witness Statement of Nigel Martin Stoate, Date: Dec.
`3, 2012 (4 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Witness Statement of Rekha Patel, Date: May 23, 2013 (2
`pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Second Witness Statement of Simon Charles Cohen, Date:
`Jan. 27, 2014 (12 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit SCC-2, Inter-Partes Correspondence between
`Marks & Clerk Solicitors LLP and Taylor Wessing LLP, in Second
`Witness Statement of Simon Charles Cohen, Date: Jan. 27, 2014 (3
`pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit SCC-3, Inter-Partes Correspondence between
`Marks & Clerk Solicitors LLP and Taylor Wessing LLP, in Second
`Witness Statement of Simon Charles Cohen, Date: Jan. 27, 2014 (29
`pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit SCC-4, Application Notice filed by Marks & Clerk
`Solicitors LLP on Nov. 22, 2012, in Second Witness Statement of
`Simon Charles Cohen, Date: Jan. 27, 2014 (6 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit SCC-5, Consent Order dated May 12, 2012, in
`Second Witness Statement of Simon Charles Cohen, Date: Jan. 27,
`2014 (4 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit SCC-6, Confidential Statement of Case Served
`Pursuant to Court Order Dated Dec. 12, 2012, in Second Witness
`Statement of Simon Charles Cohen, Date: Jan. 27, 2014 (8 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit SCC-7, Excerpt of Expert Report of Professor
`Zhaohui Sunny Zhou dated Dec. 18, 2013, in Second Witness State­
`ment of Simon Charles Cohen, Date: Jan. 27, 2014 (5 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit SCC-8, Excerpts of Expert Report of Dr. Uwe
`Gottschalk dated Dec. 18, 2013, in Second Witness Statement of
`Simon Charles Cohen, Date: Jan. 27, 2014 (4 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit SCC-9, Second Expert Report of Dr. Uwe
`Gottschalk, in Second Witness Statement of Simon Charles Cohen,
`Date: Jan. 27, 2014 (4 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit SCC-10, Inter-Partes Correspondence between
`Marks & Clerk Solicitors LLP and Taylor Wessing LLP, in Second
`Witness Statement of Simon Charles Cohen, Date: Jan. 27, 2014 (15
`pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit SCC-11, letter from UKIPO regarding Amend­
`ment filed in ΕΡ1308455 dated Nov. 26, 2013, in Second Witness
`Statement of Simon Charles Cohen, Date: Jan. 27, 2014 (4 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`
`1 308 455, Exhibit SCC-12, draft trial running order, in Second
`Witness Statement of Simon Charles Cohen, Date: Jan. 27, 2014 (2
`pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit SCC-13, Inter-Partes Correspondence between
`Marks & Clerk Solicitors LLP and Taylor Wessing LLP, in Second
`Witness Statement of Simon Charles Cohen, Date: Jan. 27, 2014 (4
`pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit SCC-14, Inter-Partes Correspondence between
`Marks & Clerk Solicitors LLP and Taylor Wessing LLP, in Second
`Witness Statement of Simon Charles Cohen, Date: Jan. 27, 2014 (16
`pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Defendant’s Skeleton Argument—Case Management
`Conference, Date: Nov. 22, 2012 (4 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308455, Skeleton Argument of the Claimantfor Case Management
`Conference, Date: Nov. 22, 2012 (5 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Supplemental Skeleton Argument of the Claimant for
`Case Management Conference, Date: Nov. 22, 2012 (1 page).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Hospira’s Skeleton Argument for the Pre-Trial Review,
`Date: Jan. 29, 2014 (15 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Genentech’s Skeleton Argument forthe Pre-Trial Review,
`Date: Jan. 29, 2014 (8 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455,Genentech’s Skeleton Argument, Date: Feb. 27, 2014 (37
`pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455,Hospira’s Skeleton Argument, Date: Feb. 27, 2014 (61
`pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455,Genentech’s Supplemental Skeleton Argument, Date:
`Mar. 4, 2014 (4 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Hospira’s Written Closing, Date: Mar. 17, 2014 (60
`pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Genentech’s Closing Submissions, Date: Mar. 17, 2014
`(86 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Transcript of Case Management Conference, Date: Nov.
`22, 2012 (21 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Transcript of Pre-Trial Review, Date: Jan. 29, 2014 (63
`pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Transcript of Proceedings, Date: Mar. 6-19, 2014 (487
`pages).
`Guelat, et. al., “Simulation model for overloaded monoclonal anti­
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`Chromatogr. A, 2012, vol. 1253, ρρ. 32-43.
`Muller-Spath, et. al., “Chromatographic Separation of Three
`Monoclonal Antibody Variants Using Multicolumn Countercurrent
`
`

`

`Case 1:18-cv-01363-CFC Document 1-11 Filed 09/04/18 Page 6 of 29 PageID #: 462
`
`US 9,249,218 Β2
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`Page 5
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`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit RHE-10, Excerpt from Robert Earhart’s Third
`Expert Report dated Feb. 10, 2014 (1 page).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Chronology of Clinical Trials of trastuzumab, Date: Feb.
`28, 2014(2 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Expert Report of Professor Zhaohui Sunny Zhou, Date:
`Dec. 18, 2013 (54 pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit ZSZ-1, Curriculum Vitae of Professor Zhaohui
`Sunny Zhou, in Expert Report of Professor Zhaohui Sunny Zhou,
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`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit ZSZ-2, List of Publications Authored and Co-
`Authored by Professor Zhaohui Sunny Zhou, Date: Dec. 18, 2013 (7
`pages).
`Hospira ν. Genentech trial in the High Court of Justice Chancery
`Division 2 Patents Court, Case No. HC12 C03487 regarding ΕΡ (UK)
`1 308 455, Exhibit ZSZ-3, List of patent in which Zhaohui Sunny
`Zhou is a named inventor, Date: Dec. 18, 2013 (2 pages).
`Hospira ν. Genentech trial in the High Court of J