Case IPR2017-00047
`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 IPR 2017-00047
`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. 1059, pg 1315
`
`
`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 IPR 2017-00047
`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. 1059, pg 1315
`
`
`
`Case IPR2017-00047
`Patent 6,331,415
`
`I, Katherine A. Helm, declare as follows:
`
`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
`
`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
`
`States District Courts for the Southern and Eastern Districts of New York
`
`2.
`
`I am a senior associate in the law firm of Simpson Thacher & Bartlett
`
`LLP and a member of the Litigation Department and the Intellectual Property
`
`Group in the New York Office. I have over eight years of experience as a patent
`
`litigator and trial lawyer, appearing and acting as counsel in numerous patent
`
`litigation matters before various United States District Courts and the United States
`
`Courts of Appeals, including the U.S. Court of Appeals for the Federal Circuit.
`
`The majority of these cases have been within the pharmaceutical and
`
`biotechnology industries. In addition, I spent five years prior to and during law
`
`school working as a technical advisor in the Intellectual Property Group of a large
`
`New York law firm, where I focused on pharmaceutical and biotechnology patent
`
`prosecution and a variety of contested proceedings in the United States Patent and
`
`Trademark Office and the European Patent Office.
`
`3.
`
`I am a member in good standing in all jurisdictions and courts where I
`
`have been admitted to practice.
`
`Merck Ex. 1059, pg 1316
`
`
`
`Case IPR2017-00047
`Patent 6,331,415
`
`4.
`
`I have never been suspended or disbarred from practice before any
`
`court or administrative body.
`
`5.
`
`I have never had a court or administrative body deny my application
`
`for admission to practice.
`
`6.
`
`I have never been sanctioned or cited for contempt by any court or
`
`administrative body.
`
`7.
`
`I have read and will 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.
`
`8.
`
`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
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`disciplinary jurisdiction under 37 C.F.R. § 11.19(a).
`
`9.
`
`I have not appeared pro hac vice before the Patent Trial and Appeal
`
`Board (“Board”) in the last three years. However, as discussed in ¶ 13 below,
`
`Merck, Sharp & Dohme Corp. (“Merck”) has a motion pending before the Board
`
`for my admission pro hac vice in connection with inter partes review number
`
`IPR2016-01373. See Merck Sharp & Dohme Corp. v. Genentech, Inc. and City of
`
`Hope, Case IPR2016-01373, Paper 4 (Petitioner Merck Sharp & Dohme Corp.’s
`
`Motion for Pro Hac Vice Admission of Katherine A. Helm) (July 28, 2016) (“the
`
`’1373 Petition”).
`
`10.
`
`I have an established familiarity with the subject matter at issue in this
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`2
`
`Merck Ex. 1059, pg 1317
`
`
`
`Case IPR2017-00047
`Patent 6,331,415
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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
`
`(“Eli Lilly”) in litigations involving the ’415 patent in Human Genome Sciences
`
`Inc. v. Genentech, Inc. et al., Case No. 2:11-cv-06519 (C.D. Cal.); Human Genome
`
`Sciences Inc. v. Genentech, Inc., Case No. 2:11-cv-06546 (C.D. Cal.); Human
`
`Genome Sciences Inc. v. Genentech, Inc. et al., Case No. 11-082-LPS (D. Del.);
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`Human Genome Sciences Inc. v. Genentech, Inc., Case No. 11-156-LPS (D. Del.);
`
`and Eli Lilly & Co. et al. v. Genentech, Inc., et al., Case No. 13-cv-07248 (C.D.
`
`Cal.).
`
`11.
`
`In addition, I served as counsel for HGS in related district court patent
`
`litigation matters, entitled Human Genome Sciences Inc. v. Genentech, Inc. et al.,
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`Case No. 11-328-LPS (D. Del.); Human Genome Sciences Inc. v. Genentech, Inc.
`
`et al., Case No. 2:11-cv-6594 (C.D. Cal.); Genentech, Inc. et al. v. Glaxo Group
`
`Limited et al., Case No. 2:11-cv-3065 (C.D. Cal.). These litigations all involved
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`U.S. Patent No. 7,923,221 (“the ’221 patent”), which was filed as a continuation of
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`the application that issued as the challenged ’415 patent and involved the same
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`recombinant antibody technology claimed by the ’415 patent.
`
`12.
`
`I also presently serve as counsel for Merck in a patent litigation matter
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`also relating to the ’221 patent, entitled Merck Sharp & Dohme Corp. v.
`
`Genentech, Inc. and City of Hope, Case No. 16-cv-04992-GW (C.D. Cal.) (“Merck
`
`3
`
`Merck Ex. 1059, pg 1318
`
`
`
`Case IPR2017-00047
`Patent 6,331,415
`
`District Court Litigation”). The Merck District Court Litigation was filed on July
`
`7, 2016.
`
`13. Merck has also moved for my pro hac vice admission on its behalf in
`
`connection with the ’1373 Petition currently before the Board for an inter partes
`
`review of the ’415 patent. ’1373 Petition, Paper 4 (Petitioner Merck Sharp &
`
`Dohme Corp.’s Motion for Pro Hac Vice Admission of Katherine A. Helm) (July
`
`28, 2016).
`
`14. Given my prior experience as counsel for HGS and Eli Lilly, and my
`
`current role as counsel for Merck in the Merck District Court Litigation and the
`
`’1373 Petition, I have carefully reviewed, developed an extensive familiarity with,
`
`and acquired a substantial understanding of the ’415 patent and file history, the
`
`legal subject matter, the factual and technical subject matter, and the prior art and
`
`expert testimony presented in Merck’s request for inter partes review of the ’415
`
`patent, which forms the basis of this proceeding.
`
`4
`
`Merck Ex. 1059, pg 1319
`
`
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`Case IPR2017-00047
`Patent 6,331,415
`
`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;
`
`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
`
`statements may jeopardize the validity of the ’415 patent.
`
`Dated: November 1, 2016
`
`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
`
`5
`
`Merck Ex. 1059, pg 1320
`
`
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