throbber
IPR2016-00710
`Patent Owners’ Motion for Pro Hac Vice Admission of David F. McGowan
`Filed on behalf of Patent Owners Genentech, Inc. and City of Hope by:
`
`David L. Cavanaugh
`Reg. No. 36,476
`Owen K. Allen
`Reg. No. 71,118
`Heather M. Petruzzi
`Reg. No. 71,270
`Robert J. Gunther, Jr.
`Pro Hac Vice
`Wilmer Cutler Pickering
`Hale and Dorr LLP
`1875 Pennsylvania Ave., NW
`Washington, DC 20006
`
`
`Adam R. Brausa
`Reg. No. 60,287
`Daralyn J. Durie
`Pro Hac Vice
`David F. McGowan
`Pro Hac Vice Pending
`Durie Tangri LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`
`
`Michael R. Fleming
`Reg. No. 67,933
`David I. Gindler
`Pro Hac Vice
`Joseph M. Lipner
`Pro Hac Vice
`Irell & Manella LLP
`1800 Avenue of the
`Stars, Suite 900
`Los Angeles, CA
`90067
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________________________
`
`MYLAN PHARMACEUTICALS, INC., AND
`MERCK SHARP & DOHME CORP.,
`Petitioners,
`v.
`
`GENENTECH, INC. AND CITY OF HOPE,
`Patent Owners.
`____________________________________________
`
`Case IPR2016-007101
`Patent 6,331,415 B1
`____________________________________________
`
`PATENT OWNERS’ UNOPPOSED MOTION FOR PRO HAC VICE
`ADMISSION OF DAVID F. MCGOWAN UNDER 37 C.F.R. § 42.10(C)
`
`1 Case IPR2017-00047 has been joined with this proceeding.
`
`
`
`
`
`

`
`IPR2016-00710
`Patent Owners’ Motion for Pro Hac Vice Admission of David F. McGowan
`
`
`RELIEF REQUESTED
`
`I.
`
`Pursuant to 37 C.F.R. § 42.10(c), Patent Owners Genentech, Inc.
`
`(“Genentech”) and City of Hope, by and through its attorneys, respectfully request
`
`that the Board admit David F. McGowan pro hac vice in this proceeding.
`
`Petitioners’ counsel have indicated that Petitioners do not oppose this motion.
`
`II. GOVERNING LAW, RULES, AND PRECEDENT
`Section 42.10(c) of 37 C.F.R. provides as follows:
`
`The Board may recognize counsel pro hac vice during a
`proceeding upon a showing of good cause, subject to the
`condition that lead counsel be a registered practitioner
`and to any other conditions as the Board may impose. For
`example, where the lead counsel is a registered
`practitioner, a motion to appear pro hac vice by counsel
`who is not a registered practitioner may be granted upon
`showing that counsel is an experienced litigating attorney
`and has an established familiarity with the subject matter
`at issue in the proceeding.
`
`The Board has specified that a motion for pro hac vice admission shall be
`
`filed in accordance with the “ORDER-AUTHORIZING MOTION FOR PRO HAC
`
`VICE ADMISSION – 37 C.F.R. § 42.10” in Unified Patents, Inc. v. Parallel Iron,
`
`LLC, Case No. IPR2013-00639 (“Representative Order”). The Representative
`
`Order states that the motion must “[c]ontain a statement of facts showing there is
`
`good cause for the Board to recognize counsel pro hac vice during the
`
`proceeding,” and “[b]e accompanied by an affidavit or declaration of the individual
`
`seeking to appear” which attests to a number of facts concerning the counsel
`
`1
`
`

`
`IPR2016-00710
`Patent Owners’ Motion for Pro Hac Vice Admission of David F. McGowan
`seeking admission pro hac vice specified in the Representative Order.
`
`Accompanying this motion as Exhibit 2138 is the Declaration of David F.
`
`McGowan in Support of this Motion for Admission Pro Hac Vice (“McGowan
`
`Decl.”).
`
`III. STATEMENT OF FACTS
`1.
`Patent Owners’ lead counsel, David L. Cavanaugh, is a registered
`
`practitioner (Reg. No. 36,476).
`
`2. Mr. McGowan is a Partner at the law firm Durie Tangri LLP.
`
`(McGowan Decl. ¶ 2) (Ex. 2138).
`
`3. Mr. McGowan is an experienced litigating attorney and has been
`
`litigating cases relating to patents for the past seven years. (Id. ¶ 2).
`
`4. Mr. McGowan is a member in good standing of the California State
`
`Bar, and among other courts, the United States Court of Appeals for the Federal
`
`Circuit. (Id. ¶ 3).
`
`5. Mr. McGowan has never been suspended or disbarred from practice
`
`before any court or administrative body. (Id. ¶ 5).
`
`6.
`
`No application filed under Mr. McGowan for admission to practice
`
`before any court or administrative body has ever been denied. (Id. ¶ 6).
`
`7.
`
`No sanctions or contempt citations have been imposed against Mr.
`
`McGowan by any court or administrative body. (Id. ¶ 7).
`
`2
`
`

`
`IPR2016-00710
`Patent Owners’ Motion for Pro Hac Vice Admission of David F. McGowan
`8. Mr. McGowan has read and agrees to comply with the Office Patent
`
`Trial Practice Guide and the Board's Rules of Practice for Trials set forth in part 42
`
`of 37 C.F.R. (Id. ¶ 8).
`
`9. Mr. McGowan understands that he will be subject to the USPTO
`
`Rules of Professional Conduct set forth in 37 C.F.R. §§ 11.101 et seq. and
`
`disciplinary jurisdiction under 37 C.F.R. § 11.19(a). (Id. ¶ 9).
`
`10. Mr. McGowan has appeared Pro Hac Vice before the Patent Trial and
`
`Appeal Board once in the last three (3) years: Sanofi-Aventis U.S. LLC, Regeneron
`
`Pharmaceuticals, Inc., and Genzyme Corporation v. Genentech, Inc. and City of
`
`Hope, IPR2015-01624 (to which IPR2016-00460 was joined), in which U.S. Patent
`
`No. 6,331,415 (“the ’415 patent”) was the challenged patent. (Id. ¶ 10).
`
`11. Mr. McGowan has an established familiarity with the subject matter at
`
`issue in this proceeding. He has handled patent cases relating to recombinant
`
`antibodies for more than six years, including cases in which the ’415 patent was a
`
`patent-in-suit (e.g., IPR2015-01624, in which Mr. McGowan was admitted pro hac
`
`vice). (Id. ¶ 11). In all of these cases involving the ’415 patent, he has represented
`
`Genentech and in several of these cases, he also represented City of Hope. He has
`
`worked closely with Adam R. Brausa, counsel for Genentech and City of Hope in
`
`this matter. (Id.).
`
`12. Additionally, Mr. McGowan has carefully reviewed and has
`
`3
`
`

`
`IPR2016-00710
`Patent Owners’ Motion for Pro Hac Vice Admission of David F. McGowan
`developed extensive familiarity with the matters involved in and implicated by
`
`these proceedings, including the ’415 patent and its licensing history, and the legal
`
`and factual issues raised by the Petitioners in this proceeding. As a result, Mr.
`
`McGowan has acquired substantial understanding of the underlying legal and
`
`technological issues at stake in this proceeding. (Id. ¶ 12).
`
`IV. GOOD CAUSE EXISTS FOR PRO HAC VICE ADMISSION OF
`DAVID F. MCGOWAN
`
`The facts outlined above in the Statement of Facts, supported by the
`
`Declaration of David F. McGowan (Ex. 2038), establish there is good cause to
`
`admit Mr. McGowan pro hac vice in this proceeding under 37 C.F.R. § 42.10.
`
`Patent Owners’ lead counsel, David L. Cavanaugh, is a registered practitioner in
`
`good standing before the Board. Mr. McGowan is an attorney in good standing in
`
`the State Bar of California and the United States Court of Appeals for the Federal
`
`Circuit. Mr. McGowan has extensive experience litigating patents, including the
`
`’415 patent, which is the subject of this proceeding. As a result, Mr. McGowan is
`
`familiar with the subject matter at issue in this proceeding. Furthermore, Mr.
`
`McGowan has carefully reviewed the ’415 patent at issue in this proceeding, its
`
`licensing history, the grounds advanced by the Petitioners and other aspects of the
`
`record in this proceeding, and is familiar with these matters. Based on his
`
`experience and knowledge, there is good cause to admit Mr. McGowan pro hac
`
`vice in this proceeding.
`
`4
`
`

`
`IPR2016-00710
`Patent Owners’ Motion for Pro Hac Vice Admission of David F. McGowan
`V. CONCLUSION
`In light of the foregoing, Patent Owners respectfully request that the Board
`
`admit David F. McGowan pro hac vice in this proceeding.
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/David L. Cavanaugh/
`David L. Cavanaugh
`Registration No. 36,476
`
`Counsel for Patent Owners
`
`Date: January 18, 2017
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`WILMER CUTLER PICKERING HALE AND DORR LLP
`1875 PENNSYLVANIA AVENUE NW
`WASHINGTON, DC 20006
`TEL: 202-663-6000
`FAX: 202-663-6363
`EMAIL: david.cavanaugh@wilmerhale.com
`
`5
`
`

`
`IPR2016-00710
`Patent Owners’ Motion for Pro Hac Vice Admission of David F. McGowan
`Patent Owners’ Exhibit List
`IPR2016-00710
`
`Exhibit
`Number
`2001
`
`2002
`
`2003
`
`2004
`2005
`2006
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`2015
`
`Exhibit Name
`
`Declaration of Robert J. Gunther, Jr. in Support of Motion for
`Admission Pro Hac Vice (Sept. 22, 2016)
`Declaration of Daralyn J. Durie in Support of Motion for
`Admission Pro Hac Vice (Sept. 22, 2016)
`Institution of Inter Partes Review, Sanofi-Aventis U.S. LLC v.
`Genentech, Inc., IPR2015-01624, Paper 15 (Feb. 5, 2016)
`U.S. Patent No. 3,996,345
`EP 1 532 260 B1
`Withdrawn
`Declaration of Dr. Timothy John Roy Harris Under 37 C.F.R. §
`1.132 in Reexaminations 90/007,542 and 90/007,859 (Oct. 26,
`2006) (“Harris II Decl.”)
`Declaration of Joseph M. Lipner in Support of Motion for
`Admission Pro Hac Vice (Nov. 15, 2016)
`Declaration of David I. Gindler in Support of Motion for
`Admission Pro Hac Vice (Nov. 28, 2016)
`Transcript of Deposition of Dr. Kathryn Calame, Mylan Pharm.
`Inc. v. Genentech, Inc., IPR2016-00710 (Nov. 18, 2016) (“Calame
`Dep.”)
`Goeddel, D.V., et al., Expression in Escherichia coli of chemically
`synthesized genes for human insulin, Proc. Nat’l Acad. Sci. (USA)
`76:106-110 (1979) (“Goeddel 1979”)
`Frank, B.H., et al., Two Routes for Producing Human Insulin
`Utilizing Recombinant DNA Technology, Munch. Med. Wschr.,
`125, Suppl. 1:S14-S20 (1983) (“Frank 1983”)
`Kohler, G. and Milstein, C., Continuous Cultures of Fused Cells
`Secreting Antibody of Predefined Specificity, Nature 256:495-497
`(Aug. 7, 1975) (“Kohler and Milstein”)
`90/007,542 Office Action Response filed 2/13/2009
`Google Patents, U.S. Patent No. 6,331,415 and List of Patent
`Citations,
`https://www.google.com/patents/US6331415?dq=6331415&hl=en
`&sa=X&ved=0ahUKEwjPhr2C2dTMAhWBVSYKHfVRDtIQ6A
`EIHDAA (last visited Dec. 19, 2016)
`
`
`
`
`
`
`
`

`
`IPR2016-00710
`Patent Owners’ Motion for Pro Hac Vice Admission of David F. McGowan
`Exhibit
`Exhibit Name
`Number
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`Frommer, et al., Simple repeated sequences in human satellite
`DNA, Nuc. Acids Res. 10(2):547-563 (1982) (“Fromer 1982”)
`Israelewski, N., Structure and function of an AT-rich, interspersed
`repetitive sequence from Chironomus thummi: solenoidal DNA,
`142 bp palindrome-frame and homologes with the sequence for
`site-specific recombination of bacterial transposons, Nuc. Acids
`Res. 11(20):6985-6996 (1983)
`(“Israelewski 1983”)
`Bruce Alberts, et. al, Molecular Biology of the Cell, Chapter 1
`(1983)
`Expert Declaration of John Fiddes, Ph.D., Mylan Pharm. Inc. v.
`Genentech, Inc., IPR2016-00710 (“Fiddes Decl.”)
`Transcript of Deposition of Dr. Jefferson Foote, Sanofi-Aventis
`U.S. LLC v. Genentech, Inc., IPR2015-01624 (Apr. 21, 2016)
`(“Foote Dep.”)
`Expert Declaration of Reiner Gentz, Ph.D., Mylan Pharm. Inc. v.
`Genentech, Inc., IPR2016-00710 (“Gentz Decl.”)
`Falko G. Falkner & Hans G. Zachau, Expression of Mouse
`Immunoglobulin Genes in Monkey Cells, Nature, 298:286-288
`(1982)
`Expert Report of Sir Gregory Winter, CBE, FRS, Regarding
`Invalidity of U.S. Patent Nos. 6,331,415 and 7,923,221, Eli Lilly
`and Co. v. Genentech, Inc., No. 2:13-cv-07248-MRP-JEMx (C.D.
`Cal.) (Oct. 13, 2014) (“Winter Rep.”)
`Transcript of Deposition of Sir Gregory Winter, Eli Lilly and Co.
`v. Genentech, Inc., No. 2:13-cv-07248-MRP-JEMx (C.D. Cal.)
`(Jan. 19, 2015) (“Winter Dep.”)
`Keiichi Itakura et al., Expression of Escherichia coli of a
`Chemically Synthesized Gene for the Hormone Somatostatin,
`Science, New Series, 198:1056-1063 (1977)
`Declaration of Arthur Riggs, Cabilly v. Boss, Interference No.
`102,572 (Oct. 28, 1991)
`Declaration of Ronald Wetzel, Cabilly v. Boss, Interference No.
`102,572 (Oct. 28, 1991)
`Declaration of Jeanne Perry, Cabilly v. Boss, Interference No.
`102,572 (Oct. 27, 1991)
`
`
`
`
`
`

`
`IPR2016-00710
`Patent Owners’ Motion for Pro Hac Vice Admission of David F. McGowan
`Exhibit
`Exhibit Name
`Number
`2029
`
`Declaration of William Holmes, Cabilly v. Boss, Interference No.
`102,572 (Oct. 28, 1991)
`Declaration of Michael Rey, Cabilly v. Boss, Interference No.
`102,572 (Oct. 28, 1991)
`Declaration of Michael Mumford, Cabilly v. Boss, Interference
`No. 102,572 (Oct. 28, 1991)
`Declaration of Shmuel Cabilly, Cabilly v. Boss, Interference No.
`102,572 (Oct. 28, 1991)
`Declaration of Julie L. Davis, Mylan Pharm. Inc. v. Genentech,
`Inc., IPR2016-00710 (“Davis Decl.”)
`PROTECTIVE ORDER MATERIAL
`United States Patent and Trademark Office, Patent Bibliographic
`Data (Patent Number: 4,495,280)
`File History of U.S. Patent No. 4,495,280
`U.S. Patent No. 4,351,760
`U.S. Patent No. 4,439,356
`U.S. Patent No. 4,287,300
`U.S. Patent No. 4,174,384
`U.S. Patent No. 4,299,916
`Second Declaration of Steven Lanier McKnight Under 37 C.F.R.
`§ 1.132 in Reexaminations 90/007,542 and 90/007,859 (June 3,
`2008) (“McKnight Decl. II”)
`U.S. Patent No. 4,199,559
`U.S. Patent No. 4,277,437
`U.S. Patent No. 4,391,904
`U.S. Patent No. 4,374,925
`U.S. Patent No. 4,328,311
`U.S. Patent No. 4,281,061
`U.S. Patent No. 4,366,241
`U.S. Patent No. 4,318,846
`U.S. Patent No. 4,233,402
`U.S. Patent No. 4,261,968
`U.S. Patent No. 4,275,149
`U.S. Patent No. 4,272,506
`U.S. Patent No. 4,256,834
`U.S. Patent No. 4,220,722
`U.S. Patent No. 4,235,869
`
`2030
`
`2031
`
`2032
`
`2033
`
`2034
`
`2035
`2036
`2037
`2038
`2039
`2040
`2041
`
`2042
`2043
`2044
`2045
`2046
`2047
`2048
`2049
`2050
`2051
`2052
`2053
`2054
`2055
`2056
`
`
`
`
`
`

`
`IPR2016-00710
`Patent Owners’ Motion for Pro Hac Vice Admission of David F. McGowan
`Exhibit
`Exhibit Name
`Number
`2057
`2058
`2059
`2060
`
`U.S. Patent No. 4,208,479
`U.S. Patent No. 4,220,450
`U.S. Patent No. 4,193,983
`Reiner Gentz et al., Cloning and Analysis of Strong Promoters Is
`Made Possible By the Downstream Placement of a RNA
`Termination Signal, Proc. Nat’l Acad. Sci. (USA) 78:4936-4940
`(1981)
`Christie et al., Selective Amplification of Variants of a Complex
`Repeating Unit in DNA of a Crustacean, Proc. Nat’l Acad. Sci.
`(USA) 77(5):2786-2790 (1980)
`Orr-Weaver et al., Multiple, Tandem Plasmid Integration in
`Saccharomyces cerevisiae, Molecular and Cellular Biology 3:747-
`49 (1983)
`Takahashi et al., Mechanism of pBR322 Transduction Mediated by
`Cytosine-Substituting T4 Bacteriophage, Mol. Gen. Genet.
`186:497-500 (1982)
`Marrero et al., SP02 Particles Mediating Transduction of a
`Plasmid Containing SP02 Cohesive Ends, J. Bacteriology 147:1-8
`(1981)
`Bastin, Molecular Cloning in Plasmid pBR322 Giving Altered
`Expression of the Tetracycline Resistance Gene, J. General
`Microbiology 123:187-191 (1981)
`Potter et al., On the Mechanism of Genetic Recombination: The
`Maturation of Recombination Intermediates, Proc. Nat’l Acad.
`Sci. (USA) 74:4168-4172 (1977)
`Annie C. Y. Chang and Stanley N. Cohen, Construction and
`Characterization of Amplifiable Multicopy DNA Cloning Vehicles
`Derived from the P15A Cryptic Miniplasmid, J. Bacteriology,
`134(3): 1141-1156 (1978)
`Declaration of Dr. Timothy Roy Harris Under 37 C.F.R. § 1.132
`in Reexaminations 90/007,542 and 90/007,859 (Nov. 23, 2005)
`(“Harris Decl.”)
`National Library of Medicine, Medical Subject Headings –
`Annotated Alphabetic List (1983)
`Shi-Hsiang Shen, Multiple Joined Genes Prevent Product
`Degradation in Escherichia coli, Proc. Nat’l Acad. Sci. (USA)
`81:4627-4631 (1984)
`
`2061
`
`2062
`
`2063
`
`2064
`
`2065
`
`2066
`
`2067
`
`2068
`
`2069
`
`2070
`
`
`
`
`
`

`
`IPR2016-00710
`Patent Owners’ Motion for Pro Hac Vice Admission of David F. McGowan
`Exhibit
`Exhibit Name
`Number
`2071
`
`Brigitte von Wilcken-Bergmann et al., A Synthetic Operon
`Containing 14 Bovine Pancreatic Trypsin Inhibitor Genes Is
`Expressed in E. coli, EMBO J. 5(12):3219-3225 (1986)
`Expert Report of Carlo M. Croce, M.D., Bristol-Myers Squibb Co.
`v. Genentech, Inc., No. 2:13-cv-05400 (C.D. Cal Nov. 9, 2014)
`Matthias Wabl and Charles Steinberg, A Theory of Allelic and
`Isotypic Exclusion for Immunoglobulin Genes, Proc. Nat’l Acad.
`Sci. (USA) 79:6976-6978 (1982)
`Wolfgang Kammerer et al., Functional Dissection of Escherichia
`coli Promoters: Information in the Transcribed Region Is
`Involved in Late Steps of the Overall Process, EMBO J.
`5(11):2995-3000 (1986)
`Ulrich Deuschle et al., Promoters of Escherichia coli: A
`Hierarchy of In Vivo Strength Indicates Alternate Structures,
`EMBO J. 5(11):2987-94 (1986)
`Ulrich Deuschle et al., lac Repressor Blocks Transcribing RNA
`Polymerase and Terminates Transcription, Proc. Natl. Acad. Sci.
`(USA) 83(12):4134-37 (1986)
`Ursula Peschke et al., Efficient Utilization of Escherichia coli
`Transcriptional Signals in Bacillus subtilis, J. Mol. Biol.
`186(3):547-55 (1985)
`Reiner Gentz and Hermann Bujard, Promoters Recognized By
`Escherichia coli RNA Polymerase Selected By Function: Highly
`Efficient Promoters From Bacteriophage T5, J. Bacteriol.
`164(1):70-77 (1985)
`Hermann Bujard et al., Insertion of Transcriptional Elements
`Outside the Replication Region Can Interfere with Replication,
`Maintenance, and Stability of Co1E1-derived Plasmids, Basic
`Life Sci. 30:45-52 (1985)
`Declaration of Dr. Douglas A. Rice Under 37 C.F.R. § 1.132 in
`Reexaminations 90/007,542 and 90/007,859 (Oct. 26, 2006)
`(“Rice Decl.”)
`Bruce Alberts et al., Essential Cell Biology, Chapter 1 (3rd ed.
`2009)
`G. N. Godson et al., Nucleotide Sequence of Bacteriophage G4
`DNA, Nature 276:236-47 (1978)
`
`2072
`
`2073
`
`2074
`
`2075
`
`2076
`
`2077
`
`2078
`
`2079
`
`2080
`
`2081
`
`2082
`
`
`
`
`
`

`
`IPR2016-00710
`Patent Owners’ Motion for Pro Hac Vice Admission of David F. McGowan
`Exhibit
`Exhibit Name
`Number
`2083
`
`Protein Structure, Boundless,
`https://www.boundless.com/biology/textbooks/boundless-biology-
`textbook/biological-macromolecules-3/proteins-56/protein-
`structure-304-11437 (last visited Dec. 17, 2016)
`RCSB Protein Databank, Molecular Machinery: A Tour of the
`Protein Data Bank, Protein Data Bank,
`http://cdn.rcsb.org/pdb101/learn/resources/2014-mol-mach-
`poster.pdf (last visited Dec. 17, 2016)
`Paulina Balbas, et al., Vectors: A Survey of Molecular Cloning
`Vectors and Their Uses, Chapter 1: The Plasmid, pBR322
`(Rodriguez, R.L. and Denhardt, D.T. eds., 1988)
`Gilbert, Expression of active polypeptides in E. coli, Recomb.
`DNA Tech. Bull. 4(1):4-5 (1981)
`Jürg Meyer and Shigeru Iida, Amplification of Chloramphenicol
`Resistance Transposons Carried by Phage P1Cm in Escherichia
`coli, Molec. Gen. Genet. 176:209-219 (1979)
`Linscott’s Directory of Immunological and Biological Reagents
`(2d ed. 1982-83)
`Annie Solomon, Bence Jones Proteins and Light Chains of
`Immunoglobulins, Scand. J. Immunol. 5:685-695 (1976)
`Deposition Transcript of James H. Sabry, M.D., Sanofi-Aventis
`U.S. LLC v. Genentech, Inc., No. 2:15-cv-05685 (C.D. Cal) (Mar.
`16, 2016)
`PROTECTIVE ORDER MATERIAL
`Deposition Transcript of Timothy R. Schwartz, Sanofi-Aventis
`U.S. LLC v. Genentech, Inc., No. 15-cv-05685 (C.D. Cal) (Mar. 1,
`2016)
`PROTECTIVE ORDER MATERIAL
`Karen Talmadge et al., Eukaryotic Signal Sequence Transports
`Insulin Antigen in Escherichia coli, Proc. Nat’l Acad. Sci. (USA)
`77:3369-3373 (1980)
`Expert Report of Robert C. Rickert, Ph.D., Bristol-Myers Squibb
`Co. v. Genentech, Inc., No. 2:13-cv-05400-MRP-JEM (C.D. Cal.
`Oct. 13, 2014)
`PROTECTIVE ORDER MATERIAL
`Gilbert, W. & Villa-Komaroff, L., Useful Proteins from
`Recombinant Bacteria, Scientific American, 242:74-94 (1980)
`
`2084
`
`2085
`
`2086
`
`2087
`
`2088
`
`2089
`
`2090
`
`2091
`
`2092
`
`2093
`
`2094
`
`
`
`
`
`

`
`IPR2016-00710
`Patent Owners’ Motion for Pro Hac Vice Admission of David F. McGowan
`Exhibit
`Exhibit Name
`Number
`2095
`
`2096
`
`2097
`
`2098
`
`2099
`2100
`
`2101
`
`2102
`
`2103
`
`2104
`
`2105
`
`2106
`
`West Virginia Secretary of State Business Organization Detail for
`Mylan Pharmaceuticals Inc.,
`http://apps.sos.wv.gov/business/corporations/organization.aspx?or
`g=20402 (last visited Dec. 17, 2016)
`Mylan N.V., United States Securities and Exchange Commission
`Form 10-K at 4, 97 (for fiscal year ended Dec. 31, 2015),
`available at
`https://www.sec.gov/Archives/edgar/data/1623613/000162361316
`000046/myl10k_20151231xdoc.htm
`Mylan Fact Sheet, http://www.mylan.com/-
`/media/mylancom/files/company/20161123_85x11%20mylan%20
`fact%20sheet.pdf (last visited Dec. 17, 2016)
`Modified Default Standing Protective Order and Patent Owners’
`Certification of Agreement to Terms
`Modified Default Standing Protective Order (Redline)
`Certificate of Third Amendment of Amended and Restated
`Certificate of Incorporation (Apr. 16, 2004), available at
`http://www.sec.gov/Archives/edgar/data/318771/0000318771040
`00010/dna-ex3_5.htm
`Genentech, Visit Us, https://www.gene.com/contact-us/visit-us
`(last visited Dec. 17, 2016)
`Genentech, “Roche Completes Acquisition of Genentech” (Mar.
`26, 2009), available at http://www.gene.com/media/press-
`releases/12007/2009-03-26/roche-completes-acquisition-of-
`genentech (last visited Dec. 17, 2016)
`Genentech, About Us, http://www.gene.com/about-us (last visited
`Dec. 17, 2016)
`Genentech, Genentech Fast Facts,
`http://www.gene.com/media/company-information/fast-facts (last
`visited Dec. 17, 2016)
`Genentech, Company Information,
`http://www.gene.com/media/company-information (last visited
`Dec. 17, 2016)
`City of Hope and Affiliates, Consolidated Financial Statements
`(years ended Sept. 30, 2015 and 2014), available at
`http://www.cityofhope.org/doc/1430376104234-wcc_031604.pdf
`(last visited Dec. 17, 2016)
`
`
`
`
`
`

`
`IPR2016-00710
`Patent Owners’ Motion for Pro Hac Vice Admission of David F. McGowan
`Exhibit
`Exhibit Name
`Number
`2107
`
`2108
`
`2109
`
`2110
`2111
`
`2112
`
`2113
`2114
`
`2115
`
`2116
`
`2117
`
`2118
`
`2119
`
`City of Hope, Locations, http://www.cityofhope.org/about-city-of-
`hope/locations (last visited Dec. 17, 2016)
`City of Hope, Who We Are, http://www.cityofhope.org/about-
`city-of-hope/who-we-are (last visited Dec. 17, 2016)
`City of Hope, About Us, http://www.cityofhope.org/about-city-of-
`hope (last visited Dec. 17, 2016)
`City of Hope, Form 990 (year ending Sept. 30, 2013)
`Exhibit 17 to Deposition Timothy R. Schwartz, Sanofi-Aventis
`U.S. LLC v. Genentech, Inc., No. 2:15-cv-05685 (C.D. Cal) (Mar.
`1, 2016), Selected Historical Financial Data
`PROTECTIVE ORDER MATERIAL
`Order Denying Plaintiffs’ Motion for Summary Judgment on
`Double Patenting, Eli Lilly and Co. and ImClone Systems LLC v.
`Genentech, Inc. and City of Hope, Case No. 2:13-cv-07248-MRP-
`JEM (C.D. Cal. Mar. 5, 2015)
`U.S. Patent No. 7,923,221
`Appendix A to Declaration of Julie L. Davis, Mylan Pharm. Inc. v.
`Genentech, Inc., IPR2016-00710
`PROTECTIVE ORDER MATERIAL
`Appendix B to Declaration of Julie L. Davis, Mylan Pharm. Inc. v.
`Genentech, Inc., IPR2016-00710
`PROTECTIVE ORDER MATERIAL
`Appendix C to Declaration of Julie L. Davis, Mylan Pharm. Inc. v.
`Genentech, Inc., IPR2016-00710
`PROTECTIVE ORDER MATERIAL
`Appendix D to Declaration of Julie L. Davis, Mylan Pharm. Inc. v.
`Genentech, Inc., IPR2016-00710
`PROTECTIVE ORDER MATERIAL
`Appendix E to Declaration of Julie L. Davis, Mylan Pharm. Inc. v.
`Genentech, Inc., IPR2016-00710
`PROTECTIVE ORDER MATERIAL
`Janssen Biotech, Inc., Our History,
`https://www.janssenbiotech.com/company/history (last visited
`May 9, 2016)
`
`
`
`
`
`

`
`IPR2016-00710
`Patent Owners’ Motion for Pro Hac Vice Admission of David F. McGowan
`Exhibit
`Exhibit Name
`Number
`2120
`
`Johnson & Johnson, United States Securities and Exchange
`Commission Form 10-K (for fiscal year ended Jan. 3, 2016),
`available at
`https://www.sec.gov/Archives/edgar/data/200406/0000200406160
`00071/form10-k20160103.htm (last visited Dec. 17, 2016)
`Sanofi, “Sanofi-aventis to Acquire Genzyme for $74.00 in Cash
`per Share Plus Contingent Value Right” (Feb. 16, 2011), available
`at
`http://en.sanofi.com/Images/28367_20110216_Deal_Genzyme_en
`.pdf (last visited Dec. 17, 2016)
`Maryann P. Feldman et al., Lessons from the Commercialization
`of the Cohen-Boyer Patents: The Stanford University Licensing
`Program, In Intellectual Property Management in Health and
`Agricultural Innovation: A Handbook of Best Practices 1797-1807
`(A Krattiger et al., eds., 2007)
`Ann Gibbons, Molecular Scissors: RNA Enzymes Go Commercial,
`Science, New Series, 251:521 (1991)
`Lita Nelsen, The Rise of Intellectual Property Protection in the
`American University, Science, New Series, 279:1460-61 (1998)
`Frederic M. Scherer, The Size Distribution of Profits from
`Innovation, The Economics and Econometrics of Innovation, No.
`49/50:495-516 (1998)
`Emily Waltz, Industry Waits for Fallout from Cabilly, Nature
`Biotechnology, 25(7):699-700 (2007)
`Letter from Jay P. Siegel, M.D., FACP, to M. David MacFarlane,
`Ph.D. (Nov. 26, 1997), available at
`http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProc
`ess/HowDrugsareDevelopedandApproved/ApprovalApplications/
`TherapeuticBiologicApplications/ucm107740.pdf (last visited
`Dec. 17, 2016)
`Laura Lorenzetti, “7 New Blockbuster Drugs to Watch in 2016,”
`Fortune (Mar. 25, 2016), available at
`http://fortune.com/2016/03/25/new-blockbuster-drugs-to-watch/
`(last visited Dec. 17, 2016)
`
`2121
`
`2122
`
`2123
`
`2124
`
`2125
`
`2126
`
`2127
`
`2128
`
`
`
`
`
`

`
`IPR2016-00710
`Patent Owners’ Motion for Pro Hac Vice Admission of David F. McGowan
`Exhibit
`Exhibit Name
`Number
`2129
`
`Ben Hirschler, “Seven $1 Billion-plus Drugs Seen Reaching
`Market in 2016”, Reuters (Feb. 3, 2016), available at
`http://www.reuters.com/article/us-pharmaceuticals-blockbusters-
`idUSKCN0VC0CG (last visited Dec. 17, 2016)
`Cabilly License Agreements
`PROTECTIVE ORDER MATERIAL
`Cabilly Settlement Agreements
`PROTECTIVE ORDER MATERIAL
`Cabilly Royalty Statements
`PROTECTIVE ORDER MATERIAL
`Karen Talmadge et al., Bacteria Mature Preproinsulin to
`Proinsulin, Proc. Nat’l Acad. Sci. (USA) 77:3988-3992 (1980)
`Nancy Lee et al., Cloning with Tandem Gene Systems for High
`Level Gene Expression, Nucleic Acids Res. 12(17):6797-6812
`(1984)
`Dawn M. Ecker, et al., The therapeutic monoclonal antibody
`market, mAbs 7:1, 9-14 (2015)
`Summary of Genentech’s Licensing Deals for the Cabilly II and
`Cabilly III Patents
`PROTECTIVE ORDER MATERIAL
`Genentech Selected Historical Financial Data
`PROTECTIVE ORDER MATERIAL
`Declaration of David F. McGowan in Support of Motion for
`Admission Pro Hac Vice
`
`2130
`
`2131
`
`2132
`
`2133
`
`2134
`
`2135
`
`2136
`
`2137
`
`2138
`
`
`
`
`
`
`
`

`
`IPR2016-00710
`Patent Owners’ Motion for Pro Hac Vice Admission of David F. McGowan
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that, on January 18, 2017, I caused a true and correct copy of
`
`
`
`the following materials:
`
` Patent Owners’ Unopposed Motion for Pro Hac Vice Admission of David F.
`McGowan Under 37 C.F.R. § 42.10(C)
` Exhibit 2138 – Declaration of David F. McGowan in Support of Motion for
`Admission Pro Hac Vice
` Patent Owners’ Updated List of Exhibits
`
`to be served via electronic mail as previously agreed by the parties on the
`
`following attorneys of record:
`
`
`Deanne M. Mazzochi
`Paul J. Molino
`William A. Rakoczy
`Eric Hunt
`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`dmazzochi@rmmslegal.com
`paul@rmmslegal.com
`wrakoczy@rmmslegal.com
`ehunt@rmmslegal.com
`Mylan_IPR_Service@rmmslegal.com
`
`Raymond N. Nimrod
`Matthew A. Traupman
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`51 Madison Ave., 22nd Floor
`New York, NY 10010
`raynimrod@quinnemanuel.com
`matthewtraupman@quinnemanuel.com
`
`
`
`
`
`
`

`
`IPR2016-00710
`Patent Owners’ Motion for Pro Hac Vice Admission of David F. McGowan
`
`
`
`Katherine A. Helm
`SIMPSON THACHER & BARTLETT LLP
`425 Lexington Avenue
`New York, NY 10017
`khelm@stblaw.com
`
`/Owen K. Allen/
`Owen K. Allen
`Reg. No. 71,118
`Wilmer Cutler Pickering Hale and Dorr LLP
`950 Page Mill Road
`Palo Alto, CA 94304

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