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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`BRECKENRIDGE PHARMACEUTICAL, INC.,
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`Petitioner,
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`v.
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`NOVARTIS PHARMACEUTICALS CORPORATION,
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`Patent Owner.
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`Case IPR2017-01592
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`Patent No. 8,410,131
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`DECLARATION IN SUPPORT OF PATENT OWNER NOVARTIS’S
`MOTION FOR PRO HAC VICE ADMISSION OF CHRISTINA SCHWARZ
`UNDER 37 C.F.R. § 42.10
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`NOVARTIS EXHIBIT 2020
`Breckenridge v Novartis, IPR 2017-01592
`Page 1 of 5
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`1.
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`I, Christina Schwarz, am more than twenty-one years of age, am
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`competent to present this declaration, and have personal knowledge of the facts set
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`forth herein.
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`2.
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`This declaration is given in support of Patent Owner Novartis’s
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`Motion for Pro Hac Vice Admission.
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`3.
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`I am a partner at the law firm of Fitzpatrick, Cella, Harper & Scinto,
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`in the firm’s New York office.
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`4.
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`I have been a patent litigation attorney for more than nine years. I
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`have been litigating patent cases for this entire time period and have been involved
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`in numerous cases involving patent validity and infringement, at both the District
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`Court and the Federal Circuit. I have also been involved in inter partes review
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`proceedings and patent interference proceedings before the Board. A significant
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`portion of my work has involved biological and chemical arts, with particular
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`emphasis on pharmaceuticals. I am, therefore, an experienced litigating attorney.
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`5.
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`I am a member in good standing of the State Bar of New York and the
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`Province of Ontario. I have never been suspended or disbarred from practice before
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`any court or administrative body.
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`6.
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`No court or administrative body has ever denied my application for
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`admission to practice before it.
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`7.
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`No court or administrative body has ever imposed sanctions or
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`contempt citations on me.
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`8.
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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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`9.
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`I understand that I will be subject to the Office’s Rules of Professional
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`Conduct set forth in 37 C.F.R. §§ 11.101 et seq. and disciplinary jurisdiction under
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`37 C.F.R. § 11.19(a).
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`10.
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`I have applied to appear pro hac vice in two other proceedings before
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`the Office in the last three (3) years: IPR2016-00084 and IPR2016-01096.
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`11.
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`I have an established familiarity with the subject matter at issue in this
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`proceeding. I have been involved consistently and substantively in the instant
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`matter since its inception in June 2017. I have read in detail and understand the
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`Petition filed by Petitioner and the challenged patent, U.S. Patent 8,410,131 (“the
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`’131 patent”). I have also reviewed in detail all the exhibits relied upon by
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`Petitioner in this proceeding, including Ex. 1002 (Wasik et al., PCT Published
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`App. No. WO 01/51049 A1); Ex. 1003 (Navarro et al., PCT Published App. No.
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`WO 00/33878 A2); Ex. 1004 (Crowe et al., “Absorption and Intestinal Metabolism
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`of SDZ-RAD and Rapamycin in Rats,” Drug Metab. Disp, 27(5): 627-632 (1999));
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`Ex. 1005 (Luan et al., “Sirolimus Prevents Tumor Progression: mTOR Targeting
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`for the Inhibition of Neoplastic Progression,” Am. J. Transplant. 1 Suppl 1, 243
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`(Abstr. No. 428) (2001)); Ex. 1006 (Hidalgo et al., “The Rapamycin-sensitive
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`Signal Transduction Pathway as a Target for Cancer Therapy,” Oncogene 19(56):
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`6680-6686 (2000)); Ex. 1007 (Alexandre et al., “CCI-779, A new Rapamycin
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`Analog, Has Antitumor Activity at Doses Including Only Mild Cutaneous Effects
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`and Mucositis: Early Results of an Ongoing Phase I Study,” Clin. Cancer Res.
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`Suppl. 5: 3730s, Abstr. No. 7 (1999)); Ex. 1008 (Schuler et al., “SDZ RAD, A
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`New Rapamycin Derivative,” Transplantation 64(1): 36-42 (1997)); Ex. 1009
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`(Neumayer et al., “Entry-into-human Study with the Novel Immunosuppressant
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`SDZ RAD in Stable Renal Transplant Patients,” Br. J. Clin. Pharmacol. 48(5):
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`694-703 (1999)).
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`12.
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`I have engaged in extensive strategic and substantive discussions
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`regarding this proceeding with Nicholas N. Kallas, who is the lead counsel for
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`Patent Owner in this proceeding and a registered practitioner (Reg. No. 31,530).
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`13. Therefore, I have an established familiarity with the subject matter at
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`issue in this proceeding.
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`14.
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`I declare further that all statements made herein of my own
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`knowledge are true and that all statements made on information and belief are
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`believed to be true and further that these statements were made with the knowledge
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`that willful false statements and the like so made are punishable by fine or
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`imprisonment, or both, under Section 1001 of Title 18 of the United States Code,
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`and that such willful false statements may jeopardize the validity of the ’131
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`patent.
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`Dated: October 30, 2017
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`_. / r
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`Lflrxfl v
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`“L
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`Christina Schw:
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`"
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`-
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