UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Sawai USA Inc., and Sawai Pharmaceutical Co., Ltd,
`Petitioners,
`
`v.
`
`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
`
`DECLARATION OF THOMAS H. WINTNER
`
`Page 1 of 6
`Sawai USA, Inc., et al. v.
`
` Nissan Chemical Industries, Ltd.
`
`NCI Exhibit 2001
`Case IPR2015-01648
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Sawai USA Inc., and Sawai Pharmaceutical Co., Ltd,
`Petitioners,
`
`v.
`
`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
`
`DECLARATION OF THOMAS H. WINTNER
`
`Page 1 of 6
`Sawai USA, Inc., et al. v.
`
` Nissan Chemical Industries, Ltd.
`
`NCI Exhibit 2001
`Case IPR2015-01648
`
`
`
`I, Thomas H. Wintner, do hereby declare:
`
`1.
`
`I am a member in the law firm of Mintz, Levin, Cohn, Ferris, Glovsky
`
`and Popeo P.C. ("Mintz Levin"). Lead counsel in this inter partes review
`
`proceeding is David G. Conlin, who is also a member at Mintz Levin. Back up
`
`counsel is Kathleen B. Carr who is also a member at Mintz Levin. Mr. Conlin and
`
`Ms. Carr are registered to practice before the United States Patent and Trademark
`
`Office and hold Registration Nos. 27,026 and 41,658 respectively. With respect to
`
`this proceeding, I will work closely with Mr. Conlin and Ms. Carr.
`
`2.
`
`I am a member in good standing of the Bar of the Commonwealth of
`
`Massachusetts (see current Certificate, appended hereto). My Massachusetts Bar
`
`membership is 667329. I am admitted to practice before the Supreme Court of the
`
`United States, the United States Courts of Appeals for the Federal, First, Fourth,
`
`Sixth, and Ninth Circuits, and the United States District Court for the District of
`
`Massachusetts.
`
`3.
`
`In my almost ten years of litigation practice I currently represent or
`
`have represented clients in numerous chemical and pharmaceutical patent litigation
`
`cases in various United States courts. Those actions include:
`
`• Kowa Company, Ltd., et al. v. Aurobindo Pharma Limited, et al.
`(S.D.N.Y. No. 14-2497)
`
`• Kowa Company, Ltd., et al. v. Amneal Pharmaceuticals LLC
`(S.D.N.Y. No. 14-2758)
`
`2
`
`Page 2 of 6
`Sawai USA, Inc., et al. v.
`
` Nissan Chemical Industries, Ltd.
`
`NCI Exhibit 2001
`Case IPR2015-01648
`
`
`
`• Kowa Company, Ltd., et al. v. Mylan Inc., et al. (S.D.N.Y. No. 14-
`2647)
`
`• 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)
`
`• 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)
`
`• 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)
`
`4.
`
`In addition to my J.D. obtained from the University of Virginia
`
`School of Law, I hold a B.A. in chemistry, summa cum laude, from Williams
`
`College, and an M.A. in bioorganic chemistry from Harvard University, where I
`
`was a National Science Foundation Fellow. Accordingly, I am comfortable and
`
`experienced with technically and legally complex matters such as those raised in
`
`this inter partes review proceeding. In particular, I am experienced with
`
`technically and legally complex matters in the fields of synthetic organic chemistry
`
`and biochemistry.
`
`3
`
`Page 3 of 6
`Sawai USA, Inc., et al. v.
`
` Nissan Chemical Industries, Ltd.
`
`NCI Exhibit 2001
`Case IPR2015-01648
`
`
`
`5.
`
`I am familiar with U.S. Patent No. 5,856,336 ("the '336 patent"), its
`
`prosecution history, and the legal subject matter, technical subject matter, and prior
`
`art discussed in Petitioner's request for inter panes review of the '336 patent.
`
`6.
`
`I am also familiar with Livalo , the FDA-approved drug product for
`
`which the '336 patent is listed in the Orange Book.
`
`7.
`
`I am currently serving as trial counsel in the co-pending district court
`
`litigation involving Patent Owner Nissan Chemical Industries, Ltd. ("NCI") and
`
`Petitioners, Sawai USA Inc. and Sawai Pharmaceutical Co., Ltd ("Sawai"). That
`
`litigation involves the '336 patent, and I have been actively involved throughout
`
`that litigation, including investigating and analyzing infringement and validity
`
`issues raised by Sawai in connection with that litigation. In connection with my
`
`work in relation to the '336 patent and Livalo , I have become familiar with the
`
`prior art references that are the subject of this inter partes review proceeding. I
`
`was substantially involved with the preparation of the Patent Owner's Preliminary
`
`Response in connection with this IPR 2015-01648 proceeding.
`
`8.
`
`I have never been suspended or disbarred from practice before any
`
`court or administrative body, nor has a court or administrative body denied my
`
`application for admission to practice. I have not been sanctioned or cited for
`
`contempt by any court or administrative body.
`
`4
`
`Page 4 of 6
`Sawai USA, Inc., et al. v.
`
` Nissan Chemical Industries, Ltd.
`
`NCI Exhibit 2001
`Case IPR2015-01648
`
`
`
`9.
`
`I have read and will comply with the Patent Office Trial Practice
`
`Guide and the Board's Rules of Practice for Trials set forth in Part 42 of 37 C.F.R.
`
`10. 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
`
`disciplinary jurisdiction under 37 C.F.R. § 11.19(a).
`
`11. I am simultaneously applying to appear pro hac vice in two additional
`
`proceedings before the U.S. Patent and Trademark Office, both involving the same
`
`claims of the same '336 patent: Sawai USA Inc. and Sawai Pharmaceutical Co.,
`
`Ltd v. Nissan Chemical Industries, Ltd., IPR2015-01647, and Mylan
`
`Pharmaceuticals Inc. v. Nissan Chemical Industries, Ltd., IPR2015-01069.
`
`12. I declare that all statements made herein of my own knowledge are
`
`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
`
`statements and the like are punishable by fine, imprisonment, or both, under
`
`Section 1001 of Title 18 of the United States Code.
`
`5
`
`Page 5 of 6
`Sawai USA, Inc., et al. v.
`
` Nissan Chemical Industries, Ltd.
`
`NCI Exhibit 2001
`Case IPR2015-01648
`
`
`
`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
`
`6
`
`Page 6 of 6
`Sawai USA, Inc., et al. v.
`
` Nissan Chemical Industries, Ltd.
`
`NCI Exhibit 2001
`Case IPR2015-01648
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