`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`GENENTECH, INC. AND CITY OF HOPE,
`Patent Owners.
`____________________________________________
`
`Case IPR2016-00710
`U.S. Patent 6,331,415
`____________________________________________
`
`DECLARATION OF ROBERT J. GUNTHER, JR. IN SUPPORT OF
`MOTION FOR ADMISSION PRO HAC VICE
`
`
`
`
`
`
`
`
`
`
`
`Mylan v. Genentech
`IPR2016-00710
`Genentech Exhibit 2001
`
`
`
`
`
`
`I, Robert J. Gunther, Jr. declare as follows:
`
`Case No. IPR2016-00710
`Gunther Declaration
`
`1.
`
`I was admitted to the New York Bar in February of 1985 and have been
`
`practicing law for over 30 years. During the entire time that I have been
`
`practicing law, my practice has focused on the field of intellectual property,
`
`and particularly, patent litigation.
`
`2.
`
`I am a member in good standing of the Bar of New York, and am admitted
`
`to practice before District Courts of the Southern District of New York the
`
`Eastern District of New York, the Western District of New York, the
`
`Northern District of California, the District of Colorado, the Eastern District
`
`of Michigan, the Western District of Michigan, and the Northern District of
`
`Illinois. I am also admitted to practice before the U.S. Courts of Appeals for
`
`the Second, Ninth, Tenth, and Federal Circuits. I am a fellow of The
`
`American College of Trial Lawyers.
`
`3. My New York Bar membership number is 1967652.
`
`4.
`
`Over the course of my career, I have been counsel in dozens of patent
`
`litigations. Several of these cases have concerned Patent Office rules and
`
`regulations. For example, I have litigated a number of cases concerning the
`
`duty of candor to the Patent Office embodied in 37 C.F.R. § 1.56. Cases that
`
`I have been involved in which implicate this rule include Apotex, Inc. v.
`
`
`
`
`1
`
`
`
`
`
`
`
`Case No. IPR2016-00710
`Gunther Declaration
`
`Cephalon, Inc., et al., Civ. No. 2:06-cv-02768-MSG (E.D. Pa.); Anascape
`
`Ltd. V. Nintendo of America Inc., Civ. No. 9:06-CV-158-RC (E.D. Tex.) and
`
`Nintendo of America Inc. v. The Magnavox Company et al, Civ. No. 86 Civ.
`
`1606 (LBS) (S.D.N.Y.).
`
`5.
`
`I have never been suspended or disbarred from practice before any court or
`
`administrative body.
`
`6.
`
`I have never had a court or administrative body deny my application for
`
`admission to practice.
`
`7.
`
`I have never had any sanctions or contempt citations imposed on me by any
`
`court or administrative body.
`
`8.
`
`I have read and will comply with Office Patent Trial Practice Guide and the
`
`Board’s Rules of Practice for Trials, as set forth in 37 C.F.R. Part 42.
`
`9.
`
`I agree to be subject to the United States Patent and Trademark Office 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).
`
`10.
`
`I was admitted pro hac vice in IPR2014-01093 before the United States
`
`Patent Trial and Appeal Board on May 28, 2015 and presented the argument
`
`for Petitioner at the oral hearing on August 24, 2015. I was admitted pro
`
`hac vice in IPR2015-01624 on February 17, 2016 and represented Patent
`
`Owners Genentech, Inc. and City of Hope in that matter, which was
`
`
`
`
`2
`
`
`
`
`
`
`
`Case No. IPR2016-00710
`Gunther Declaration
`
`terminated due to settlement. I also represented Genentech, Inc. and City of
`
`Hope in IPR2016-00460 (pro hac vice motion filed), which was joined with
`
`IPR2015-01624 (which was terminated due to settlement); IPR2016-00383
`
`(pro hac vice motion filed), which was not instituted; and IPR2016-01373
`
`(pro hac vice motion filed and pending), which is pending. I also represent
`
`Genentech, Inc. in IPR2016-01693 and IPR2016-01694 (pro hac vice
`
`motions to be filed).
`
`11.
`
`In addition to this matter, I represent Genentech in certain matters related to
`
`biosimilars, including IPR2016-01693 and IPR2016-01694, which are
`
`pending. I have also represented Genentech in Inter Partes Review
`
`IPR2016-01624 (joined with IPR2016-00460) involving U.S. Patent No.
`
`6,331,415 (the “ʼ415 Patent”), which was terminated due to settlement;
`
`IPR2016-00460, which was joined with IPR2015-01624 (which is now
`
`terminated); IPR2016-00383, which was not instituted; and IPR2016-01373,
`
`which is pending. I have also represented Genentech’s corporate parent,
`
`Roche, in many patent litigation matters since 2004. Patent and patent
`
`related cases in which I represent or have represented Roche Molecular
`
`Systems, Inc. or its affiliates include: Roche Diagnostics GmbH et al. v.
`
`Enzo Biochem, Inc. et al., Civ. No. 1:04 Civ. 4046 (RJS) (S.D.N.Y.); Enzo
`
`Life Sciences, Inc. v. Roche Molecular Systems, Inc., Civ. No. 1:2012-cv-
`
`
`
`
`3
`
`
`
`
`
`
`
`Case No. IPR2016-00710
`Gunther Declaration
`
`00106 (D. Del.); Digene Corp. v. F. Hoffmann-La Roche Ltd. and Roche
`
`Molecular Systems, Inc., Case No. 50 181 T00502 06 (International Centre
`
`for Dispute Resolution, American Arbitration Association, NY, NY); Roche
`
`Molecular Systems, Inc., et al. v. One Lambda Inc., ICC Case No. 17613/FM
`
`(International Chamber of Commerce, Zurich, Switzerland); Roche
`
`Molecular Systems, Inc., et al. v. Cepheid, ICC Case No.
`
`18130/FM/MHM/EMT (International Chamber of Commerce, Zurich,
`
`Switzerland).
`
`12.
`
`I am intimately familiar with the subject matter of the ʼ415 Patent and the
`
`prior art at issue in this proceeding. While at a prior firm, I was one of the
`
`attorneys who litigated on behalf of Genentech against Medimmune with
`
`respect to validity and infringement issues relating to the ʼ415 patent. I am
`
`also intimately familiar with antibody technology as a result of my
`
`participation as counsel in prior antibody-related patent cases such as Abbott
`
`GMBH & Co., et al. v. Centocor Ortho Biotech, Inc., Civ. No. 09-11340-
`
`FDS (D. Mass.) In addition, I have represented life sciences and
`
`pharmaceutical companies, including AbbVie, Cephalon, Chugai
`
`Pharmaceuticals, GSK, Genentech, Novartis and Roche in many patent
`
`litigation matters before federal district courts and arbitration tribunals. The
`
`technology involved in these disputes includes fully human and humanized
`
`
`
`
`4
`
`
`
`
`
`
`
`Case No. IPR2016-00710
`Gunther Declaration
`
`monoclonal antibodies generated in transgenic mice and by phage display,
`
`antibody/antigen binding affinity and measurement of same through
`
`techniques such as surface plasmon resonance, epitope mapping,
`
`crystallography, amplification of nucleic acids through techniques such as
`
`polymerase chain reaction, antibody/antigen diagnostic assays and the
`
`production and use of labeled hybridization probes.
`
`13.
`
`I hereby declare that all statements made herein of my own knowledge are
`
`true and that all statements made on information and belief are believed to
`
`be true; and further that these statements are made with the knowledge that
`
`willful false statements and the like are punishable by fine, imprisonment, or
`
`both, under Section 1001 of Title 18 of the United States Code.
`
`
`
`
`Respectfully submitted,
`
`
`
`/Robert J. Gunther, Jr./
`Robert J. Gunther, Jr.
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`7 World Trade Center
`New York, New York 10007
`robert.gunther@wilmerhale.com
`Tel.: 212-230-8830
`Fax: 212-230-8888
`
`5
`
`
`
`
`Dated: September 22, 2016
`
`
`
`
`
`