`
`
`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: IPR2015-00644
`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
`
`
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.8(a)(2), Patent Owner Yeda Research &
`
`IPR2015-00644
`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 the ’413
`
`patent. Teva Pharmaceuticals Industries Ltd. is the exclusive licensee of the ’413
`
`patent. Teva Pharmaceuticals USA, Inc. is the holder of the New Drug
`
`Application for Copaxone®, a drug for which the ’413 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
`
`
`
`IPR2015-00644
`Patent Owner Mandatory Notices
`
`
`Number
`
`Court
`
`Case
`
`Teva Pharmaceuticals USA, Inc., et. al. v. Sandoz Inc.,
`
`et al.
`
`14-cv-1171 DED
`
`Teva Pharmaceuticals USA, Inc., et. al. v. Doctor
`
`Reddy’s Laboratories, Ltd., et al.
`
`14-cv-1172 DED
`
`Teva Pharmaceuticals USA, Inc., et. al. v. Mylan
`
`Pharmaceuticals Inc., et. al.
`
`14-cv-1278 DED
`
`Teva Pharmaceuticals USA, Inc., et. al. v. Synthon
`
`Pharmaceuticals Inc., et. al.
`
`14-cv-1419 DED
`
`Teva Pharmaceuticals USA, Inc., et. al. v. Amneal
`
`Pharmaceuticals LLC
`
`15-cv-00124 DED
`
`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)
`
`14-cv-00167 NDWVa
`
`14-cv-00975 M.D.N.C.
`
`14-cv-5672 D.N.J.
`
`
`
`
`
`
`2
`
`
`
`IPR2015-00644
`Patent Owner Mandatory Notices
`
`
`
`
`b. Administrative Matters
`
`The following patent applications claim the benefit of the ’413 patent:
`
`13/770,677; 14/630,326.
`
`The following proceeding is currently pending in the United States Patent
`
`and Trademark Office for Patent No. 8,232,250, which is related to the ’413 patent:
`
`IPR2015-00643.
`
`
`
`III. LEAD AND BACKUP COUNSEL (37 C.F.R. § 42.8(b)(3))
`
`Lead Counsel
`
`Elizabeth J. Holland
`
`(Reg. No. 47,657)
`
`Back-up Counsel
`
`William G. James
`
`(Reg. No. 55,931)
`
`GOODWIN PROCTER LLP
`
`GOODWIN PROCTER LLP
`
`The New York Times Building
`
`901 New York Avenue NW
`
`620 Eighth Avenue
`
`Washington, DC 20001
`
`New York, New York 10018-1405
`
`Tel: 202-346-4000
`
`Tel: 212-813-8800
`
`Fax: 212-355-3333
`
`Fax: 202-346-4444
`
`wjames@goodwinprocter.com
`
`eholland@goodwinprocter.com
`
`
`
`
`
`
`3
`
`
`
`IV. SERVICE INFORMATION (37 C.F.R. § 42.8(b)(4))
`
`IPR2015-00644
`Patent Owner Mandatory Notices
`
`
`Please direct all correspondence to counsel at the contact information above.
`
`Petitioner consents to service by electronic mail at eholland@goodwinprocter.com,
`
`wjames@goodwinprocter.com and DG-Copaxone@goodwinprocter.com.
`
`
`
`Dated: February 27, 2015
`
`
`
`
`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
`
`
`
`
`4
`
`
`
`IPR2015-00644
`Patent Owner Mandatory Notices
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that the foregoing document captioned
`
`
`
`“PATENT OWNER’S MANDATORY NOTICES” was served electronically via
`
`e-mail on this 27th day of February, 2015, as follows:
`
`Jeffrey W. Guise
`jguise@wsgr.com
`WILSON SONSINI GOODRICH & ROSATI
`
`Brandon M. White
`BMWhite@perkinscoie.com
`PERKINS COIE LLP
`
`
`
`Dated: February 27, 2015 /Elizabeth J. Holland/
` Elizabeth J. Holland (Reg. No. 47,657)
` GOODWIN PROCTER LLP
`
`
`
`
`
`
`
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