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UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner,
`
`v.
`
`YEDA RESEARCH & DEVELOPMENT CO. LTD.
`
`Patent Owner
`______________
`
`Case: PGR2016-00010
`Patent No. 9,155,776
`______________
`
`
`
`PATENT OWNER’S MANDATORY NOTICES
`PURSUANT TO 37 C.F.R. § 42.8(a)(2)
`
`
`
`
`
`

`
`Pursuant to 37 C.F.R. § 42.8(a)(2), Patent Owner Yeda Research &
`
`PGR2016-00010
`Patent Owner Mandatory Notices
`
`
`Development, Co, Ltd., hereby submits the following mandatory notices. This
`
`paper is timely filed within 21 days of service of the petition.
`
`I.
`
`REAL PARTY IN INTEREST (37 C.F.R. § 42.8(b)(1))
`
`Yeda Research & Development Co., Ltd. is the patent owner of U.S. Pat.
`
`No. 9,155,776 (“the ’776 patent”). Teva Pharmaceuticals Industries Ltd. is the
`
`exclusive licensee of the ’776 patent. Teva Pharmaceuticals USA, Inc. is the
`
`holder of the New Drug Application for Copaxone®, a drug for which the ’776
`
`patent is listed in the FDA publication “Approved Drug Products with Therapeutic
`
`Equivalence Evaluations,” commonly referred to as “the Orange Book.” Teva
`
`Neuroscience, Inc. markets and sells Copaxone® in the United States. Yeda
`
`Research & Development Co., Ltd., Teva Pharmaceuticals Industries Ltd., Teva
`
`Pharmaceuticals USA, Inc., and Teva Neuroscience, Inc. are the real parties in
`
`interest.
`
`II. RELATED MATTERS (37 C.F.R. § 42.8(b)(2))
`
`a. Judicial Matters
`
`Patent Owner notes that the following proceedings may affect or be affected
`
`by a decision in this proceeding:
`
`1
`
`
`
`
`
`

`
`PGR2016-00010
`Patent Owner Mandatory Notices
`
`
`Case
`Teva Pharmaceuticals USA, Inc., et. al. v. Sandoz
`
`Inc., et al.*
`
`Teva Pharmaceuticals USA, Inc., et. al. v. Doctor
`
`Reddy’s Laboratories, Ltd., et al.*
`
`Teva Pharmaceuticals USA, Inc., et. al. v. Mylan
`
`Pharmaceuticals Inc., et. al.*
`
`Teva Pharmaceuticals USA, Inc., et. al. v.
`
`Synthon Pharmaceuticals Inc., et. al.*
`
`Teva Pharmaceuticals USA, Inc., et. al. v. Amneal
`
`Pharmaceuticals LLC*
`
`Teva Pharmaceuticals USA, Inc., et. al. v. Mylan
`
`Pharmaceuticals, Inc., et. al.
`
`Teva Pharmaceuticals USA, Inc., et. al. v.
`
`Synthon Pharmaceuticals Inc., et. al. (dismissed)
`
`Teva Pharmaceuticals USA, Inc., et. al. v. Doctor
`
`Reddy’s Laboratories, Ltd., et. al. (dismissed)
`
`Teva Pharmaceuticals USA, Inc., et. al. v. Doctor
`
`Reddy’s Laboratories, Ltd., et. al.*
`
`No.
`
`Court
`
`14-cv-1171
`
`D.Del.
`
`14-cv-1172
`
`D.Del.
`
`14-cv-1278
`
`D.Del.
`
`14-cv-1419
`
`D.Del.
`
`15-cv-00124
`
`D.Del.
`
`14-cv-00167
`
`N.D.W.Va.
`
`14-cv-00975
`
`M.D.N.C.
`
`14-cv-5672
`
`D.N.J.
`
`15-cv-00306
`
`D.Del.
`
`(*consolidated as In re Copaxone 40mg Cons. Cases)
`2
`
`
`
`

`
`b. Administrative Matters
`
`PGR2016-00010
`Patent Owner Mandatory Notices
`
`
`The following pending patent applications are related to the ’776 patent:
`
`14/630,326; 14/673,257.
`
`Patent Owner is unaware of any other proceeding currently pending in the
`
`United States Patent and Trademark Office for the ’776 patent.
`
`The following proceedings are currently pending in the United States Patent
`
`and Trademark Office for patents related to the ’776 patent: IPR2015-01976
`
`(Patent No. 8,232,250); IPR2015-00643 (Patent No. 8,232,250); IPR2015-01980
`
`(Patent No. 8,399,413); IPR2015-00644 (Patent No. 8,399,413); IPR2015-01981
`
`(Patent No. 8,969,302); and IPR2015-00830 (Patent No. 8,969,302).
`
`3
`
`
`
`
`
`

`
`III. LEAD AND BACKUP COUNSEL (37 C.F.R. § 42.8(b)(3))
`
`PGR2016-00010
`Patent Owner Mandatory Notices
`
`
`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
`
`901 New York Ave. NW
`
`620 Eighth Avenue
`
`Washington, DC 20001
`
`New York, NY 10018-1405
`
`Tel: 202-346-4000
`
`Tel: 212-813-8800
`
`Fax: 212-355-3333
`
`Fax: 202-346-4444
`
`wjames@goodwinprocter.com
`
`eholland@goodwinprocter.com
`
`
`
`IV. SERVICE INFORMATION (37 C.F.R. § 42.8(b)(4))
`
`Please direct all correspondence to counsel at the contact information above.
`
`Patent Owner consents to service by electronic mail at
`
`eholland@goodwinprocter.com, wjames@goodwinprocter.com, and DG-
`
`Copaxone@goodwinprocter.com.
`
`
`
`4
`
`
`
`
`
`

`
`PGR2016-00010
`Patent Owner Mandatory Notices
`
`
`
`Respectfully Submitted,
`
`/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
`
`5
`
`Dated: March 8, 2016
`
`
`
`
`
`
`
`

`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that the foregoing document captioned
`
`“PATENT OWNER’S MANDATORY NOTICES PURSUANT TO 37 C.F.R. §
`
`42.8(a)(2)” was served electronically via e-mail on this 8th day of March, 2016, as
`
`follows:
`
`Brandon M. White
`bmwhite@perkinscoie.com
`
`Emily Greb
`egreb@perkinscoie.com
`
`Lori P. Westin
`lwestin@wsgr.com
`
`Jeffrey W. Guise
`jguise@wsgr.com
`
`Richard Torczon
`rtorczon@wsgr.com
`
`
`Dated: March 8, 2016 /April E. Weisbruch/

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