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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`____________________________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________________________________________
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
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`v.
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`GENENTECH, INC. AND CITY OF HOPE,
`Patent Owners.
`____________________________________________
`
`Case IPR2016-00710
`U.S. Patent 6,331,415
`____________________________________________
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`DECLARATION OF ROBERT J. GUNTHER, JR. IN SUPPORT OF
`MOTION FOR ADMISSION PRO HAC VICE
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`Mylan v. Genentech
`IPR2016-00710
`Genentech Exhibit 2001
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`I, Robert J. Gunther, Jr. declare as follows:
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`Case No. IPR2016-00710
`Gunther Declaration
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`1.
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`I was admitted to the New York Bar in February of 1985 and have been
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`practicing law for over 30 years. During the entire time that I have been
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`practicing law, my practice has focused on the field of intellectual property,
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`and particularly, patent litigation.
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`2.
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`I am a member in good standing of the Bar of New York, and am admitted
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`to practice before District Courts of the Southern District of New York the
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`Eastern District of New York, the Western District of New York, the
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`Northern District of California, the District of Colorado, the Eastern District
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`of Michigan, the Western District of Michigan, and the Northern District of
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`Illinois. I am also admitted to practice before the U.S. Courts of Appeals for
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`the Second, Ninth, Tenth, and Federal Circuits. I am a fellow of The
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`American College of Trial Lawyers.
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`3. My New York Bar membership number is 1967652.
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`4.
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`Over the course of my career, I have been counsel in dozens of patent
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`litigations. Several of these cases have concerned Patent Office rules and
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`regulations. For example, I have litigated a number of cases concerning the
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`duty of candor to the Patent Office embodied in 37 C.F.R. § 1.56. Cases that
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`I have been involved in which implicate this rule include Apotex, Inc. v.
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`1
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`Case No. IPR2016-00710
`Gunther Declaration
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`Cephalon, Inc., et al., Civ. No. 2:06-cv-02768-MSG (E.D. Pa.); Anascape
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`Ltd. V. Nintendo of America Inc., Civ. No. 9:06-CV-158-RC (E.D. Tex.) and
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`Nintendo of America Inc. v. The Magnavox Company et al, Civ. No. 86 Civ.
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`1606 (LBS) (S.D.N.Y.).
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`5.
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`I have never been suspended or disbarred from practice before any court or
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`administrative body.
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`6.
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`I have never had a court or administrative body deny my application for
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`admission to practice.
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`7.
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`I have never had any sanctions or contempt citations imposed on me by any
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`court or administrative body.
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`8.
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`I have read and will comply with Office Patent Trial Practice Guide and the
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`Board’s Rules of Practice for Trials, as set forth in 37 C.F.R. Part 42.
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`9.
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`I agree to be subject to the United States Patent and Trademark Office Rules
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`of Professional Conduct set forth in 37 C.F.R. §§ 11.101 et seq. and
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`disciplinary jurisdiction under 37 C.F.R. § 11.19(a).
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`10.
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`I was admitted pro hac vice in IPR2014-01093 before the United States
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`Patent Trial and Appeal Board on May 28, 2015 and presented the argument
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`for Petitioner at the oral hearing on August 24, 2015. I was admitted pro
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`hac vice in IPR2015-01624 on February 17, 2016 and represented Patent
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`Owners Genentech, Inc. and City of Hope in that matter, which was
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`Case No. IPR2016-00710
`Gunther Declaration
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`terminated due to settlement. I also represented Genentech, Inc. and City of
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`Hope in IPR2016-00460 (pro hac vice motion filed), which was joined with
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`IPR2015-01624 (which was terminated due to settlement); IPR2016-00383
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`(pro hac vice motion filed), which was not instituted; and IPR2016-01373
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`(pro hac vice motion filed and pending), which is pending. I also represent
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`Genentech, Inc. in IPR2016-01693 and IPR2016-01694 (pro hac vice
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`motions to be filed).
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`11.
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`In addition to this matter, I represent Genentech in certain matters related to
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`biosimilars, including IPR2016-01693 and IPR2016-01694, which are
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`pending. I have also represented Genentech in Inter Partes Review
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`IPR2016-01624 (joined with IPR2016-00460) involving U.S. Patent No.
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`6,331,415 (the “ʼ415 Patent”), which was terminated due to settlement;
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`IPR2016-00460, which was joined with IPR2015-01624 (which is now
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`terminated); IPR2016-00383, which was not instituted; and IPR2016-01373,
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`which is pending. I have also represented Genentech’s corporate parent,
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`Roche, in many patent litigation matters since 2004. Patent and patent
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`related cases in which I represent or have represented Roche Molecular
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`Systems, Inc. or its affiliates include: Roche Diagnostics GmbH et al. v.
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`Enzo Biochem, Inc. et al., Civ. No. 1:04 Civ. 4046 (RJS) (S.D.N.Y.); Enzo
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`Life Sciences, Inc. v. Roche Molecular Systems, Inc., Civ. No. 1:2012-cv-
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`3
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`Case No. IPR2016-00710
`Gunther Declaration
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`00106 (D. Del.); Digene Corp. v. F. Hoffmann-La Roche Ltd. and Roche
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`Molecular Systems, Inc., Case No. 50 181 T00502 06 (International Centre
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`for Dispute Resolution, American Arbitration Association, NY, NY); Roche
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`Molecular Systems, Inc., et al. v. One Lambda Inc., ICC Case No. 17613/FM
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`(International Chamber of Commerce, Zurich, Switzerland); Roche
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`Molecular Systems, Inc., et al. v. Cepheid, ICC Case No.
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`18130/FM/MHM/EMT (International Chamber of Commerce, Zurich,
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`Switzerland).
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`12.
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`I am intimately familiar with the subject matter of the ʼ415 Patent and the
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`prior art at issue in this proceeding. While at a prior firm, I was one of the
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`attorneys who litigated on behalf of Genentech against Medimmune with
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`respect to validity and infringement issues relating to the ʼ415 patent. I am
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`also intimately familiar with antibody technology as a result of my
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`participation as counsel in prior antibody-related patent cases such as Abbott
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`GMBH & Co., et al. v. Centocor Ortho Biotech, Inc., Civ. No. 09-11340-
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`FDS (D. Mass.) In addition, I have represented life sciences and
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`pharmaceutical companies, including AbbVie, Cephalon, Chugai
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`Pharmaceuticals, GSK, Genentech, Novartis and Roche in many patent
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`litigation matters before federal district courts and arbitration tribunals. The
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`technology involved in these disputes includes fully human and humanized
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`4
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`Case No. IPR2016-00710
`Gunther Declaration
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`monoclonal antibodies generated in transgenic mice and by phage display,
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`antibody/antigen binding affinity and measurement of same through
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`techniques such as surface plasmon resonance, epitope mapping,
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`crystallography, amplification of nucleic acids through techniques such as
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`polymerase chain reaction, antibody/antigen diagnostic assays and the
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`production and use of labeled hybridization probes.
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`13.
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`I hereby declare that all statements made herein of my own knowledge are
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`true and that all statements made on information and belief are believed to
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`be true; and further that these statements are made with the knowledge that
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`willful false statements and the like are punishable by fine, imprisonment, or
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`both, under Section 1001 of Title 18 of the United States Code.
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`Respectfully submitted,
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`
`
`/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
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`5
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`Dated: September 22, 2016
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