Case IPR2016-01373
`Patent 6,331,415
`
`
`Filed on behalf of: Merck Sharp & Dohme Corp.
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________________
`
`MERCK SHARP & DOHME CORP.,
`Petitioner
`
`v.
`
`GENENTECH, INC. AND CITY OF HOPE,
`Patent Owners
`________________________
`
`Case IPR2016-01373
`Patent 6,331,415
`
`________________________
`
`DECLARATION OF KATHERINE A. HELM IN SUPPORT OF
`
`MOTION FOR PRO HAC VICE ADMISSION ON BEHALF OF
`
`PETITIONER MERCK SHARP & DOHME CORP.
`
`Merck Ex. 1075, pg 1605
`
`
`Patent 6,331,415
`
`
`Filed on behalf of: Merck Sharp & Dohme Corp.
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________________
`
`MERCK SHARP & DOHME CORP.,
`Petitioner
`
`v.
`
`GENENTECH, INC. AND CITY OF HOPE,
`Patent Owners
`________________________
`
`Case IPR2016-01373
`Patent 6,331,415
`
`________________________
`
`DECLARATION OF KATHERINE A. HELM IN SUPPORT OF
`
`MOTION FOR PRO HAC VICE ADMISSION ON BEHALF OF
`
`PETITIONER MERCK SHARP & DOHME CORP.
`
`Merck Ex. 1075, pg 1605
`
`
`
`Case IPR2016-01373
`Patent 6,331,415
`
`
`I, Katherine A. Helm, declare as follows:
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`1.
`
`I am an attorney licensed to practice law in the State of New York, the
`
`Commonwealth of Massachusetts, and the District of Columbia. I am also
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`admitted to practice before the United States Court of Appeals for the Federal
`
`Circuit, the United States Court of Appeals for the Third Circuit, and the United
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`States District Courts for the Southern and Eastern Districts of New York
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`2.
`
`I am a senior associate in the law firm of Simpson Thacher & Bartlett
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`LLP and a member of the Litigation Department and the Intellectual Property
`
`Group in the New York Office. I have approximately eight years of experience as
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`a patent litigator and trial lawyer, appearing and acting as counsel in numerous
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`patent litigation matters in various United States District Courts and the United
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`States Courts of Appeals, including the U.S. Court of Appeals for the Federal
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`Circuit. The majority of these cases have been within the pharmaceutical and
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`biotechnology industries. In addition, I spent five years prior to and during law
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`school working as a technical advisor in the Intellectual Property Group of a large
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`New York law firm, where I focused on pharmaceutical and biotechnology patent
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`prosecution and a variety of contested proceedings in the United States Patent and
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`Trademark Office (“USPTO”) and the European Patent Office.
`
`3.
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`I am a member in good standing in all jurisdictions and courts where I
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`have been admitted to practice.
`
`Merck Ex. 1075, pg 1606
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`
`
`Case IPR2016-01373
`Patent 6,331,415
`
`4.
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`I have never been suspended or disbarred from practice before any
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`court or administrative body.
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`5.
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`I have never had a court or administrative body deny my application
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`for admission to practice.
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`6.
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`I have never been sanctioned or cited for contempt by any court or
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`administrative body.
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`7.
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`I have read and will comply with the Office Patent Trial Practice
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`Guide and the Board’s Rules of Practice for Trials set forth in Part 42 of 37 C.F.R.
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`8.
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`I agree to be subject to the USPTO Rules of Professional Conduct set
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`forth in 37 C.F.R. §§ 11.101 et seq. and disciplinary jurisdiction under 37 C.F.R.
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`§ 11.19(a).
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`9.
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`I have not appeared pro hac vice before the Patent Trial and Appeal
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`Board in the last three years.
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`10.
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`I have an established familiarity with the subject matter at issue in this
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`proceeding, specifically U.S. Patent No. 6,331,415 (“the ’415 patent”). I served as
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`counsel for Human Genome Sciences Inc. (“HGS”) and Eli Lilly and Company
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`(“Eli Lilly”) in litigations involving the ’415 patent in Human Genome Sciences
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`Inc. v. Genentech, Inc. et al., Case No. 2:11-cv-06519 (C.D. Cal.); Human Genome
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`Sciences Inc. v. Genentech, Inc., Case No. 2:11-cv-06546 (C.D. Cal.); Human
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`Genome Sciences Inc. v. Genentech, Inc. et al., Case No. 11-082-LPS (D. Del);
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`
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`2
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`Merck Ex. 1075, pg 1607
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`
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`Case IPR2016-01373
`Patent 6,331,415
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`Human Genome Sciences Inc. v. Genentech, Inc., Case No. 11-156-LPS (D. Del.);
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`and Eli Lilly & Co. et al. v. Genentech, Inc., et al., Case No. 13-cv-07248 (C.D.
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`Cal).
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`11.
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`In addition, I served as counsel for HGS in related district court patent
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`litigation matters, entitled Human Genome Sciences Inc. v. Genentech, Inc.et al.,
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`Case No. C.A. No. 11-328-LPS (D. Del); Human Genome Sciences Inc. v.
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`Genentech, Inc.et al., Case No. 2:11-cv-6594 (C.D. Cal.); Genentech, Inc. et al., v.
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`Glaxo Group Limited et al., Case No. 2:11-cv-3065 (C.D. Cal.). These litigations
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`all involved U.S. Patent No. 7,923,221 (“the ’221 patent”), which was filed as a
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`continuation of the application that issued as the challenged ’415 patent and
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`involves the same recombinant antibody technology claimed by the ’415 patent.
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`12.
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`I also presently serve as counsel for Merck Sharp & Dohme Corp.
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`(“Merck”) in a patent litigation matter also relating to the ’221 patent, entitled
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`Merck Sharp & Dohme Corp. v. Genentech, Inc. and City of Hope, Case No. 16-
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`cv-04992-GW (C.D. Cal.) (“Merck District Court Litigation”). The Merck District
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`Court Litigation was filed on July 7, 2016.
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`13. Given my prior involvement in HGS and Eli Lilly cases, and my
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`current involvement with the Merck District Court Litigation, I have carefully
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`reviewed, developed an extensive familiarity with, and acquired a substantial
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`understanding of the ’415 patent and file history, the legal subject matter, the
`
`
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`3
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`Merck Ex. 1075, pg 1608
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`
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`Case IPR2016-01373
`Patent 6,331,415
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`factual and technical subject matter, and the prior art and expert testimony
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`presented in Merck’s request for inter partes review of the ’415 patent, which
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`forms the basis of this proceeding.
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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 be true;
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`and further that these statements are made with the knowledge that willful false
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`statements and the like so made are punishable by fine or imprisonment, or both,
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`under Section 1001 of Title 18 of the United States Code and that such willful false
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`statements may jeopardize the validity of the ’415 patent.
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`Dated: July 28, 2016
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`Respectfully submitted,
`
`By: /s/ Katherine A. Helm
` Katherine A. Helm
` SIMPSON THACHER & BARTLETT LLP
` 425 Lexington Avenue
` New York, NY 10017
` Tel: (212) 455-2000
` Fax: (212) 455-2502
`
`
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`4
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`
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`Merck Ex. 1075, pg 1609
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