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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`Sawai USA Inc., and Sawai Pharmaceutical Co., Ltd,
`Petitioners,
`
`v.
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`Nissan Chemical Industries, Ltd.,
`Patent Owner
`
`U.S. Patent No. 5,856,336
`
`Issue Date: January 5, 1999
`
`Title: Quinoline Type Mevalonolactones
`
`Inter Partes Review No. IPR2015-01648
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`DECLARATION OF THOMAS H. WINTNER
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`Page 1 of 6
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` Nissan Chemical Industries, Ltd.
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`NCI Exhibit 2001
`Case IPR2015-01648
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`I, Thomas H. Wintner, do hereby declare:
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`1.
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`I am a member in the law firm of Mintz, Levin, Cohn, Ferris, Glovsky
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`and Popeo P.C. ("Mintz Levin"). Lead counsel in this inter partes review
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`proceeding is David G. Conlin, who is also a member at Mintz Levin. Back up
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`counsel is Kathleen B. Carr who is also a member at Mintz Levin. Mr. Conlin and
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`Ms. Carr are registered to practice before the United States Patent and Trademark
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`Office and hold Registration Nos. 27,026 and 41,658 respectively. With respect to
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`this proceeding, I will work closely with Mr. Conlin and Ms. Carr.
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`2.
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`I am a member in good standing of the Bar of the Commonwealth of
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`Massachusetts (see current Certificate, appended hereto). My Massachusetts Bar
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`membership is 667329. I am admitted to practice before the Supreme Court of the
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`United States, the United States Courts of Appeals for the Federal, First, Fourth,
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`Sixth, and Ninth Circuits, and the United States District Court for the District of
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`Massachusetts.
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`3.
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`In my almost ten years of litigation practice I currently represent or
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`have represented clients in numerous chemical and pharmaceutical patent litigation
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`cases in various United States courts. Those actions include:
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`• Kowa Company, Ltd., et al. v. Aurobindo Pharma Limited, et al.
`(S.D.N.Y. No. 14-2497)
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`• Kowa Company, Ltd., et al. v. Amneal Pharmaceuticals LLC
`(S.D.N.Y. No. 14-2758)
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`2
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`• Kowa Company, Ltd., et al. v. Mylan Inc., et al. (S.D.N.Y. No. 14-
`2647)
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`• Kowa Company, Ltd., et al. v. Orient Pharma Co., Ltd. (S.D.N.Y.
`No. 14-2759)
`
`• Kowa Company, Ltd., et al. v. Sawai USA, Inc., et al. (S.D.N.Y.
`No. 14-5575)
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`• Kowa Company, Ltd., et al. v. Zydus Pharmaceuticals (USA) Inc.,
`et al. (S.D.N.Y. No. 14-2760)
`
`• Kowa Company, Ltd., et al. v. Apotex, Inc., et al. (S.D.N.Y. No.
`14-7934)
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`• Kowa Company, Ltd., et al. v. Zydus Pharmaceuticals (USA) Inc.,
`et al. (S.D.N.Y. 15-07136)
`
`• Takeda Pharmaceutical Co. v. Mylan, Inc., et al., (S.D.N.Y. No.
`12-00024)
`
`• Mitsubishi Chemical Corp. v. Barr Laboratories, Inc., 718 F.
`Supp. 2d 382 (S.D.N.Y. 2010), affirmed, No. 2010-1432, 2011 WL
`3288394 (Fed. Cir. Aug. 2, 2011).
`
`• Roquette Fr6-es v. SPI Pharma, Inc., No. 06-540 (D. Del. Oct. 4,
`2010)
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`4.
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`In addition to my J.D. obtained from the University of Virginia
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`School of Law, I hold a B.A. in chemistry, summa cum laude, from Williams
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`College, and an M.A. in bioorganic chemistry from Harvard University, where I
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`was a National Science Foundation Fellow. Accordingly, I am comfortable and
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`experienced with technically and legally complex matters such as those raised in
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`this inter partes review proceeding. In particular, I am experienced with
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`technically and legally complex matters in the fields of synthetic organic chemistry
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`and biochemistry.
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`3
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`5.
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`I am familiar with U.S. Patent No. 5,856,336 ("the '336 patent"), its
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`prosecution history, and the legal subject matter, technical subject matter, and prior
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`art discussed in Petitioner's request for inter panes review of the '336 patent.
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`6.
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`I am also familiar with Livalo , the FDA-approved drug product for
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`which the '336 patent is listed in the Orange Book.
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`7.
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`I am currently serving as trial counsel in the co-pending district court
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`litigation involving Patent Owner Nissan Chemical Industries, Ltd. ("NCI") and
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`Petitioners, Sawai USA Inc. and Sawai Pharmaceutical Co., Ltd ("Sawai"). That
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`litigation involves the '336 patent, and I have been actively involved throughout
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`that litigation, including investigating and analyzing infringement and validity
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`issues raised by Sawai in connection with that litigation. In connection with my
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`work in relation to the '336 patent and Livalo , I have become familiar with the
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`prior art references that are the subject of this inter partes review proceeding. I
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`was substantially involved with the preparation of the Patent Owner's Preliminary
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`Response in connection with this IPR 2015-01648 proceeding.
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`8.
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`I have never been suspended or disbarred from practice before any
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`court or administrative body, nor has a court or administrative body denied my
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`application for admission to practice. I have not been sanctioned or cited for
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`contempt by any court or administrative body.
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`4
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`9.
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`I have read and will comply with the Patent Office 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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`10. 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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`11. I am simultaneously applying to appear pro hac vice in two additional
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`proceedings before the U.S. Patent and Trademark Office, both involving the same
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`claims of the same '336 patent: Sawai USA Inc. and Sawai Pharmaceutical Co.,
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`Ltd v. Nissan Chemical Industries, Ltd., IPR2015-01647, and Mylan
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`Pharmaceuticals Inc. v. Nissan Chemical Industries, Ltd., IPR2015-01069.
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`12. I 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 are punishable by fine, imprisonment, or both, under
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`Section 1001 of Title 18 of the United States Code.
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`5
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`NCI Exhibit 2001
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`Respectfully submitted,
`
`Thomas H. Wintner
`MINTZ, LEVIN, COHN, FERRIS,
`GLOVSKY AND POPEO P.C.
`One Financial Center
`Boston, MA 02111
`(617) 542-6000
`
`Dated: October 13, 2015
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`6
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`Page 6 of 6
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`NCI Exhibit 2001
`Case IPR2015-01648