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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
`
`v.
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`JANSSEN ONCOLOGY, INC.
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`Patent Owner
`____________________________
`
`Case No. IPR2016-01332
`U.S. Patent No. 8,822,438
`____________________________
`
`DECLARATION OF SHANNON M. BLOODWORTH
`IN SUPPORT OF MOTION FOR PRO HAC VICE ADMISSION OF
`SHANNON M. BLOODWORTH
`
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 1
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`
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`I, Shannon M. Bloodworth, declare as follows:
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`1.
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`2.
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`I am a partner in the patent litigation group at Perkins Coie LLP.
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`I am a member in good standing of the Bar of the States of Maryland
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`and Wisconsin, the Commonwealth of Virginia and the District of Columbia. I am
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`also admitted to practice before the United States Courts of Appeals for the Fourth
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`Circuit, D.C. Circuit, and the Federal Circuit. I am admitted to practice before the
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`United States District Courts for D.C. and Maryland, and the Supreme Courts of
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`Virginia and Wisconsin.
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`3. My Bar membership numbers are VA 46671, DC 474925 and WI
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`1088470.
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`4.
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`I have been practicing law for more than 15 years, during which time I
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`have focused on litigating patent cases, specifically pharmaceutical patent cases.
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`5. More generally, I have represented the Petitioner and/or its various
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`related entities in litigating significant pharmaceutical patent cases, such as the
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`following infringement cases:
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`•
`
`•
`
`BTG Int’l Ltd. v. Actavis Labs. FL, Inc., Civil Action No. 2:15-cv-
`
`05909 (U.S. District Court for the District of New Jersey);
`
`Teva Pharmaceuticals USA Inc. v. Mylan Pharmaceuticals Inc., Civil
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`Action No. 1:14-cv-01278 (U.S. District Court for the District of
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`Delaware);
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 2
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`
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`Teva Pharmaceuticals USA Inc. v. Sandoz Inc., Civil Action No.
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`17-1575 (U.S. Court of Appeals for the Federal Circuit);
`
`Yeda Research and Development Co. v. Mylan Pharmaceuticals Inc.,
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`Civil Action Nos. 17-1594, 17-1595, 17-1596 (U.S. Court of Appeals
`
`for the Federal Circuit);
`
`The Medicines Co. v. Mylan Inc., Civil Action No. 1:11-cv-01285
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`(U.S. District Court for the Northern District of Illinois);
`
`The Medicines Co. v. Mylan Inc., Civil Action Nos. 15-1113,
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`15-1151, 15-1181 (U.S. Court of Appeals for the Federal Circuit);
`
`AstraZeneca AB v. Mylan Laboratories Ltd., Civil Action No.
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`3:12-cv-01378 (U.S. District Court for the District of New Jersey);
`
`AstraZeneca AB v. Mylan Laboratories Ltd., Civil Action No.
`
`15-1889 (U.S. Court of Appeals for the Federal Circuit);
`
`Teva Pharmaceuticals USA Inc. v. Mylan Pharmaceuticals Inc., Civil
`
`Action No. 1:09-cv-08824 (U.S. District Court for the Southern
`
`District of New York);
`
`•
`
`Teva Pharmaceuticals USA Inc. v. Sandoz Inc., Civil Action Nos.
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`12-1567, 12-1568, 12-1569, 12-1570 (U.S. Court of Appeals for the
`
`Federal Circuit);
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 3
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`
`
`•
`
`•
`
`Teva Pharmaceuticals USA Inc. v. Sandoz Inc., Civil Action No.
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`13-854 (Supreme Court of the United States);
`
`Novo Nordisk Inc. v. Mylan Pharmaceutical Inc., Civil Action No.
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`3:09-cv-02445 (United States District Court for the District of New
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`Jersey);
`
`•
`
`Teva Pharmaceuticals USA Inc. v. Mylan Pharmaceuticals Inc., Civil
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`Action No. 10-cv-7246 (U.S. District Court for the Southern District
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`of New York);
`
`•
`
`•
`
`•
`
`•
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`Teva Neuroscience,
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`Inc. v. Mylan
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`Inc., Civil Action No.
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`2:10-cv-05078 (U.S. District Court for the District of New Jersey);
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`Teva Neuroscience, Inc. v. Mylan Inc., Civil Action No. 14-1166
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`(U.S. Court of Appeals for the Federal Circuit);
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`Apotex, Inc. v. Daiichi Sankyo, Inc., Civil Action No. 1:15-cv-03695
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`(U.S. District Court for the Northern District of Illinois);
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`Apotex, Inc. v. Daiichi Sankyo, Inc., Civil Action Nos. 16-2073,
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`16-2075, 16-2076, 16-2078 (U.S. Court of Appeals for the Federal
`
`Circuit);
`
`•
`
`AstraZeneca Pharmaceuticals LP v. Agila Specialties Inc.., Civil
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`Action No. 1:15-cv-06039 (U.S. District Court for the District of New
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`Jersey);
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 4
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`
`
`•
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`•
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`AstraZeneca AB v. Mylan Pharmaceuticals Inc., No. 3:13-cv-04022
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`(U.S. District Court for the District of New Jersey);
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`Horizon Pharma, Inc. v. Mylan Pharmaceuticals Inc., Civil Action
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`No. 15-cv-03327 (U.S. District Court for the District of New Jersey);
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`and
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`•
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`Horizon Pharma, Inc. v. Mylan Pharmaceuticals Inc., Civil Action
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`No. 16-cv-04921 (U.S. District Court for the District of New Jersey).
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`6.
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`I have never been disbarred, sanctioned or cited for contempt by any
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`court or administrative body. I am not currently suspended in any bar or by any
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`court or administrative body.1
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`7.
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`I have never had a court deny my application for admission to
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`practice.
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`8.
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`I am familiar with the subject matter of this proceeding. In addition to
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`U.S. Patent No. 8,822,438 (“the ’438 patent”) and its prosecution history, I am
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`familiar with the technology at issue and Zytiga, the pharmaceutical product for
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`which the ’438 patent is listed by Janssen in FDA’s publication, Approved Drug
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`1 In May 2004, during transition to a new law firm, my DC bar dues were
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`inadvertently not paid. As soon as I discovered the non-payment, I immediately
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`paid all outstanding dues and was reinstated. I have been a member in good
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`standing ever since.
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`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 5
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`
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`Products with Therapeutic Equivalence Evaluations, commonly referred to as the
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`“Orange Book.” I have been litigating issues surrounding Zytiga for more than a
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`year in BTG Int’l Ltd. v. Actavis Labs. FL, Inc., Civil Action No. 2:15-cv-05909
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`(D.N.J.), on behalf of Mylan Pharmaceuticals and Mylan Inc.
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`9.
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`In connection with my work on the Zytiga litigation, I have become
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`familiar with the prior art references that are the subject of this proceeding.
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`10. Given my familiarity with the underlying facts and my litigation
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`experience with the Federal Rules of Evidence, I have experience and expertise
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`important to representing Mylan’s interests in this matter.
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`11.
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`I have read and will comply with Office Patent Trial Practice guide
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`and the Board's Rules of Practice for Trials, as set forth in Part 42 of 37 C.F.R.
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`12.
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`I agree to be subject to the United States Patent and Trademark Office
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`Code of Professional Responsibility 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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`13.
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`I have previously applied for, and been granted, admission pro hac
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`vice before the United States Patent and Trademark Office in IPR2015-643,
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`IPR2015-644 and IPR2015-830.
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`14.
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`I hereby declare 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 are made with the knowledge
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`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 6
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`
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`that 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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`
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`Dated: March 27, 2017
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`
`
`
`/s/ Shannon M. Bloodworth
`Shannon M. Bloodworth
`
`MYLAN PHARMS. INC. EXHIBIT 1084 PAGE 7
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`
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