`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`
`
`AMNEAL PHARMACEUTICALS LLC
`Petitioner,
`
`v.
`
`YEDA RESEARCH & DEVELOPMENT CO. LTD.
`Patent Owner
`______________
`
`Case: IPR2015-01980
`Patent No. 8,399,413
`______________
`
`
`
`PATENT OWNER’S MANDATORY NOTICES
`PURSUANT TO 37 C.F.R. § 42.8(a)(2)
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`
`
`Pursuant to 37 C.F.R. § 42.8(a)(2), Patent Owner Yeda Research &
`
`IPR2015-01980
`Patent Owner Mandatory Notices
`
`
`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 the ’413
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`patent. Teva Pharmaceuticals Industries Ltd. is the exclusive licensee of the ’413
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`patent. Teva Pharmaceuticals USA, Inc. is the holder of the New Drug
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`Application for Copaxone®, a drug for which the ’413 patent is listed in the FDA
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`publication “Approved Drug Products with Therapeutic Equivalence Evaluations,”
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`commonly referred to as “the Orange Book.” Teva Neuroscience, Inc. markets and
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`sells Copaxone® in the United States. Yeda Research & Development Co., Ltd.,
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`Teva Pharmaceuticals Industries Ltd., Teva Pharmaceuticals USA, Inc., and Teva
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`Neuroscience, Inc. are the real parties in 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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`
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`IPR2015-01980
`Patent Owner Mandatory Notices
`
`
`Number
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`14-cv-1171
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`Court
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`DED
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`14-cv-1172
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`DED
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`14-cv-1278
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`DED
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`14-cv-1419
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`DED
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`15-cv-00124
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`DED
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`14-cv-00167
`
`NDWVa
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`Case
`Teva Pharmaceuticals USA, Inc., et. al. v.
`
`Sandoz Inc., et al.
`
`Teva Pharmaceuticals USA, Inc., et. al. v.
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`Doctor Reddy’s Laboratories, Ltd., et al.
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`Teva Pharmaceuticals USA, Inc., et. al. v.
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`Mylan 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.
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`Amneal Pharmaceuticals LLC
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`Teva Pharmaceuticals USA, Inc., et. al. v.
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`Mylan 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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`14-cv-00975
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`M.D.N.C.
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`(dismissed)
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`Teva Pharmaceuticals USA, Inc., et. al. v.
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`Doctor Reddy’s Laboratories, Ltd., et. al.
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`14-cv-5672
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`D.N.J.
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`2
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`(dismissed)
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`
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`
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`b. Administrative Matters
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`IPR2015-01980
`Patent Owner Mandatory Notices
`
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`The following pending patent applications are related to the ’413 patent:
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`14/630,326; 14/673,257.
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`The following proceeding is currently pending in the United States Patent
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`and Trademark Office for the ’413 patent: IPR2015-00644.
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`The following proceedings are currently pending in the United States Patent
`
`and Trademark Office for patents related to the ’413 patent: IPR2015-01976
`
`(Patent No. 8,232,250); IPR2015-00643 (Patent No. 8,232,250); IPR2015-01981
`
`(Patent No. 8,969,302); and IPR2015-00830 (Patent No. 8,969,302).
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`III. LEAD AND BACKUP COUNSEL (37 C.F.R. § 42.8(b)(3))
`
`Lead Counsel
`
`Back-Up Counsel
`
`Elizabeth J. Holland
`
`(Reg. No. 47,657)
`
`William G. James
`
`(Reg. No. 55,931)
`
`GOODWIN PROCTER LLP
`
`GOODWIN PROCTER LLP
`
`The New York Times Building
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`901 New York Ave. NW
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`620 Eighth Avenue
`
`Washington, DC 20001
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`New York, NY 10018-1405
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`Tel: 202-346-4000
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`Fax: 202-346-4444
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`wjames@goodwinprocter.com
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`3
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`Tel: 212-813-8800
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`Fax: 212-355-3333
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`
`
`
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`eholland@goodwinprocter.com
`
`IPR2015-01980
`Patent Owner Mandatory Notices
`
`
`Daryl L. Wiesen
`
`(To seek pro hac vice admission)
`
`Exchange Place
`
`53 State Street
`
`Boston, MA 02109
`
`Tel: 617-570-1000
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`Fax: 617-523-1231
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`dwiesen@goodwinprocter.com
`
`
`
`John T. Bennett
`
`(To seek pro hac vice admission)
`
`Exchange Place
`
`53 State Street
`
`Boston, MA 02109
`
`Tel: 617-570-1000
`
`Fax: 617-523-1231
`
`jbennett@goodwinprocter.com
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`
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`4
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`IPR2015-01980
`Patent Owner Mandatory Notices
`
`
`Eleanor M. Yost
`
`(Reg. No. 58,013)
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`GOODWIN PROCTER LLP
`
`901 New York Avenue NW
`
`Washington, DC 20001
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`Tel: 202-346-4000
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`Fax: 2022-346-4444
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`eyost@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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`Petitioner consents to service by electronic mail at eholland@goodwinprocter.com,
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`wjames@goodwinprocter.com, dwiesen@goodwinprocter.com,
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`jbennett@goodwinprocter.com, eyost@goodwinprocter.com, and DG-
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`Copaxone@goodwinprocter.com.
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`5
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`IPR2015-01980
`Patent Owner Mandatory Notices
`
`
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`Respectfully Submitted,
`GOODWIN PROCTER LLP
`
`/Elizabeth J. Holland/
`(Reg. No. 47,657)
`The New York Times Building
`620 Eighth Avenue
`New York, New York 10018-1405
`Tel: 212-813-8800
`Fax: 212-355-3333
`
`
`Attorneys for Patent Owner
`
`Dated: October 16, 2015
`
`
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`6
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`IPR2015-01980
`Patent Owner Mandatory Notices
`
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that the foregoing document captioned
`
`
`
`“PATENT OWNER’S MANDATORY NOTICES” was served electronically via
`
`e-mail on this 16h day of October, 2015, as follows:
`
`Vincent L. Capuano
`vcapuano@duanemorris.com
`DUANE MORRIS LLP
`
`Christopher S. Kroon
`cskroon@duanemorris.com
`DUANE MORRIS LLP
`
`
`
`Dated: October 16, 2015 /Elizabeth J. Holland/
` Elizabeth J. Holland (Reg. No. 47,657)
` GOODWIN PROCTER LLP