`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
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`MYLAN PHARMACEUTICALS INC.
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`Petitioner,
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`v.
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`YEDA RESEARCH & DEVELOPMENT CO. LTD.
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`Patent Owner
`______________
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`Case: PGR2016-00010
`Patent No. 9,155,776
`______________
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`
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`PATENT OWNER’S MANDATORY NOTICES
`PURSUANT TO 37 C.F.R. § 42.8(a)(2)
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`Pursuant to 37 C.F.R. § 42.8(a)(2), Patent Owner Yeda Research &
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`PGR2016-00010
`Patent Owner Mandatory Notices
`
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`Development, Co, Ltd., hereby submits the following mandatory notices. This
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`paper is timely filed within 21 days of service of the petition.
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`I.
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`REAL PARTY IN INTEREST (37 C.F.R. § 42.8(b)(1))
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`Yeda Research & Development Co., Ltd. is the patent owner of U.S. Pat.
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`No. 9,155,776 (“the ’776 patent”). Teva Pharmaceuticals Industries Ltd. is the
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`exclusive licensee of the ’776 patent. Teva Pharmaceuticals USA, Inc. is the
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`holder of the New Drug Application for Copaxone®, a drug for which the ’776
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`patent is listed in the FDA publication “Approved Drug Products with Therapeutic
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`Equivalence Evaluations,” commonly referred to as “the Orange Book.” Teva
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`Neuroscience, Inc. markets and sells Copaxone® in the United States. Yeda
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`Research & Development Co., Ltd., Teva Pharmaceuticals Industries Ltd., Teva
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`Pharmaceuticals USA, Inc., and Teva Neuroscience, Inc. are the real parties in
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`interest.
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`II. RELATED MATTERS (37 C.F.R. § 42.8(b)(2))
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`a. Judicial Matters
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`Patent Owner notes that the following proceedings may affect or be affected
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`by a decision in this proceeding:
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`1
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`PGR2016-00010
`Patent Owner Mandatory Notices
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`Case
`Teva Pharmaceuticals USA, Inc., et. al. v. Sandoz
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`Inc., et al.*
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`Teva Pharmaceuticals USA, Inc., et. al. v. Doctor
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`Reddy’s Laboratories, Ltd., et al.*
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`Teva Pharmaceuticals USA, Inc., et. al. v. Mylan
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`Pharmaceuticals Inc., et. al.*
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`Teva Pharmaceuticals USA, Inc., et. al. v.
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`Synthon Pharmaceuticals Inc., et. al.*
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`Teva Pharmaceuticals USA, Inc., et. al. v. Amneal
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`Pharmaceuticals LLC*
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`Teva Pharmaceuticals USA, Inc., et. al. v. Mylan
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`Pharmaceuticals, Inc., et. al.
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`Teva Pharmaceuticals USA, Inc., et. al. v.
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`Synthon Pharmaceuticals Inc., et. al. (dismissed)
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`Teva Pharmaceuticals USA, Inc., et. al. v. Doctor
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`Reddy’s Laboratories, Ltd., et. al. (dismissed)
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`Teva Pharmaceuticals USA, Inc., et. al. v. Doctor
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`Reddy’s Laboratories, Ltd., et. al.*
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`No.
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`Court
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`14-cv-1171
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`D.Del.
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`14-cv-1172
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`D.Del.
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`14-cv-1278
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`D.Del.
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`14-cv-1419
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`D.Del.
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`15-cv-00124
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`D.Del.
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`14-cv-00167
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`N.D.W.Va.
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`14-cv-00975
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`M.D.N.C.
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`14-cv-5672
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`D.N.J.
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`15-cv-00306
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`D.Del.
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`(*consolidated as In re Copaxone 40mg Cons. Cases)
`2
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`b. Administrative Matters
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`PGR2016-00010
`Patent Owner Mandatory Notices
`
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`The following pending patent applications are related to the ’776 patent:
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`14/630,326; 14/673,257.
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`Patent Owner is unaware of any other proceeding currently pending in the
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`United States Patent and Trademark Office for the ’776 patent.
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`The following proceedings are currently pending in the United States Patent
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`and Trademark Office for patents related to the ’776 patent: IPR2015-01976
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`(Patent No. 8,232,250); IPR2015-00643 (Patent No. 8,232,250); IPR2015-01980
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`(Patent No. 8,399,413); IPR2015-00644 (Patent No. 8,399,413); IPR2015-01981
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`(Patent No. 8,969,302); and IPR2015-00830 (Patent No. 8,969,302).
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`3
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`III. LEAD AND BACKUP COUNSEL (37 C.F.R. § 42.8(b)(3))
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`PGR2016-00010
`Patent Owner Mandatory Notices
`
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`Lead Counsel
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`Back-Up Counsel
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`Elizabeth J. Holland
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`(Reg. No. 47,657)
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`William G. James
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`(Reg. No. 55,931)
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`GOODWIN PROCTER LLP
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`GOODWIN PROCTER LLP
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`The New York Times Building
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`901 New York Ave. NW
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`620 Eighth Avenue
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`Washington, DC 20001
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`New York, NY 10018-1405
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`Tel: 202-346-4000
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`Tel: 212-813-8800
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`Fax: 212-355-3333
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`Fax: 202-346-4444
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`wjames@goodwinprocter.com
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`eholland@goodwinprocter.com
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`
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`IV. SERVICE INFORMATION (37 C.F.R. § 42.8(b)(4))
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`Please direct all correspondence to counsel at the contact information above.
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`Patent Owner consents to service by electronic mail at
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`eholland@goodwinprocter.com, wjames@goodwinprocter.com, and DG-
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`Copaxone@goodwinprocter.com.
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`4
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`PGR2016-00010
`Patent Owner Mandatory Notices
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`Respectfully Submitted,
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`/Elizabeth J. Holland/
`Elizabeth J. Holland
`(Reg. No. 47,657)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, New York 10018-1405
`Tel: 212-813-8800
`Fax: 212-355-3333
`
`
`Attorney for Patent Owner
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`5
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`Dated: March 8, 2016
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that the foregoing document captioned
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`“PATENT OWNER’S MANDATORY NOTICES PURSUANT TO 37 C.F.R. §
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`42.8(a)(2)” was served electronically via e-mail on this 8th day of March, 2016, as
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`follows:
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`Brandon M. White
`bmwhite@perkinscoie.com
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`Emily Greb
`egreb@perkinscoie.com
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`Lori P. Westin
`lwestin@wsgr.com
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`Jeffrey W. Guise
`jguise@wsgr.com
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`Richard Torczon
`rtorczon@wsgr.com
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`Dated: March 8, 2016 /April E. Weisbruch/