`Patent 6,331,415
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`Filed on behalf of: Merck Sharp & Dohme Corp.
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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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`MERCK SHARP & DOHME CORP.,
`Petitioner
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`v.
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`GENENTECH, INC. AND CITY OF HOPE,
`Patent Owners
`________________________
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`Case IPR 2017-00047
`Patent 6,331,415
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`________________________
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`DECLARATION OF KATHERINE A. HELM IN SUPPORT OF
`MOTION FOR PRO HAC VICE ADMISSION ON BEHALF OF
`PETITIONER MERCK SHARP & DOHME CORP.
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`Merck Ex. 1059, pg 1315
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`Case IPR2017-00047
`Patent 6,331,415
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`I, Katherine A. Helm, declare as follows:
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`1.
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`I am an attorney licensed to practice law in the State of New York, the
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`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
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`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.
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`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
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`Group in the New York Office. I have over eight years of experience as a patent
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`litigator and trial lawyer, appearing and acting as counsel in numerous patent
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`litigation matters before various United States District Courts and the United States
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`Courts of Appeals, including the U.S. Court of Appeals for the Federal Circuit.
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`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 and the European Patent Office.
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`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.
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`Merck Ex. 1059, pg 1316
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`Case IPR2017-00047
`Patent 6,331,415
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`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 United States Patent and Trademark Office
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`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).
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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 (“Board”) in the last three years. However, as discussed in ¶ 13 below,
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`Merck, Sharp & Dohme Corp. (“Merck”) has a motion pending before the Board
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`for my admission pro hac vice in connection with inter partes review number
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`IPR2016-01373. See Merck Sharp & Dohme Corp. v. Genentech, Inc. and City of
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`Hope, Case IPR2016-01373, Paper 4 (Petitioner Merck Sharp & Dohme Corp.’s
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`Motion for Pro Hac Vice Admission of Katherine A. Helm) (July 28, 2016) (“the
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`’1373 Petition”).
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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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`2
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`Merck Ex. 1059, pg 1317
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`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
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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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`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. 11-328-LPS (D. Del.); Human Genome Sciences Inc. v. Genentech, Inc.
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`et al., Case No. 2:11-cv-6594 (C.D. Cal.); Genentech, Inc. et al. v. Glaxo Group
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`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.
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`12.
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`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.
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`Genentech, Inc. and City of Hope, Case No. 16-cv-04992-GW (C.D. Cal.) (“Merck
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`3
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`Merck Ex. 1059, pg 1318
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`District Court Litigation”). The Merck District Court Litigation was filed on July
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`7, 2016.
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`13. Merck has also moved for my pro hac vice admission on its behalf in
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`connection with the ’1373 Petition currently before the Board for an inter partes
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`review of the ’415 patent. ’1373 Petition, Paper 4 (Petitioner Merck Sharp &
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`Dohme Corp.’s Motion for Pro Hac Vice Admission of Katherine A. Helm) (July
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`28, 2016).
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`14. Given my prior experience as counsel for HGS and Eli Lilly, and my
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`current role as counsel for Merck in the Merck District Court Litigation and the
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`’1373 Petition, I have carefully reviewed, developed an extensive familiarity with,
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`and acquired a substantial understanding of the ’415 patent and file history, the
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`legal subject matter, the factual and technical subject matter, and the prior art and
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`expert testimony presented in Merck’s request for inter partes review of the ’415
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`patent, which forms the basis of this proceeding.
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`4
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`Merck Ex. 1059, pg 1319
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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: November 1, 2016
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`Respectfully submitted,
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`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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`5
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`Merck Ex. 1059, pg 1320
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