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`Paper No. ______
`Filed: August 25, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`FRESENIUS-KABI USA LLC
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`Petitioner
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`v.
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`ASTRAZENECA AB
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`Patent Owner
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`Case IPR2017-01912
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`U.S. Patent 8,466,139
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`PATENT OWNER’S MANDATORY
`NOTICES PURSUANT TO 37 C.F.R. § 42.8
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`Case IPR2017-01912
`U.S. Patent 8,466,139
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`Pursuant to 37 C.F.R. § 42.8, the undersigned on behalf of and acting in a representative
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`capacity for patent owner AstraZeneca AB, hereby submits the following mandatory notices in
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`connection with the Petition for Inter Partes Review of United States Patent No. 8,466,139 (the
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`“’139 patent”), Case No. IPR2017-01912.
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`REAL PARTY-IN-INTEREST
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`AstraZeneca AB is Patent Owner. AstraZeneca UK Limited is the beneficial owner of
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`the ’139 patent and holder of approved New Drug Application (“NDA”) No. 21-344 for
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`FASLODEX® (fulvestrant) intramuscular injection, in 50 mg/mL dosage forms. AstraZeneca
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`Pharmaceuticals LP is the authorized agent for matters related to NDA No. 21-344 in the United
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`States.
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`RELATED MATTERS
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`The ’139 patent has been asserted in the following actions: AstraZeneca Pharmaceuticals
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`LP et al. v. Sandoz Inc., C.A. No. 1:14-cv-03547-RMB-KMW (D.N.J.) (dismissed); AstraZeneca
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`Pharmaceuticals LP et al. v. Sagent Pharmaceuticals, Inc., C.A. No. 1:14-cv-05539-RMB-
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`KMW (D.N.J.) (consolidated as 1:14-cv-03547) (dismissed); AstraZeneca Pharmaceuticals LP
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`et al. v. Glenmark Pharmaceuticals Inc., USA, C.A. No. 1:15-cv-00615-RMB-KMW (D.N.J.)
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`(consolidated as 1:14-cv-03547) (dismissed); AstraZeneca Pharmaceuticals LP et al. v. Agila
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`Specialties, Inc. et al., C.A. No. 1:15-cv-06039-RMB-KMW (D.N.J.); AstraZeneca
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`Pharmaceuticals LP et al. v. Mylan Pharmaceuticals Inc. et al., C.A. No. 1:15-cv-7009-RMB-
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`KMW (consolidated as 1:15-cv-06039) (dismissed); AstraZeneca Pharmaceuticals LP et al. v.
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`Teva Pharmaceuticals USA, Inc., C.A. No. 1:15-cv-7889-RMB-KMW (D.N.J.) (consolidated as
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`1:15-cv-06039) (dismissed); AstraZeneca Pharmaceuticals LP et al. v. InnoPharma Licensing
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`LLC, C.A. No. 1:16-cv-1962-RMB-KMW (D.N.J.) (consolidated as 1:15-cv-06039);
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`AstraZeneca Pharmaceuticals LP et al. v. Sagent Pharmaceuticals, Inc., C.A. No. 1:14-cv-07358
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`2
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`Case IPR2017-01912
`U.S. Patent 8,466,139
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`(N.D. Ill.) (dismissed); AstraZeneca Pharmaceuticals LP et al. v. Mylan Pharmaceuticals Inc. et
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`al., C.A. No. 1:15-cv-00183 (N.D. W. Va.) (dismissed); AstraZeneca Pharmaceuticals LP et al.
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`v. InnoPharma, Inc., C.A. No. 1:16-cv-00894-RMB-KMW (D.N.J.) (dismissed); AstraZeneca
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`Pharmaceuticals LP et al. v. Mylan Institutional LLC, C.A. No. 1:16-cv-04612 (D.N.J.)
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`(consolidated as 1:15-cv-06039) (dismissed); AstraZeneca Pharmaceuticals LP et al. v. Dr.
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`Reddy’s Laboratories, Inc. et al., C.A. No. 1:17-cv-00926 (D.N.J.) (dismissed); AstraZeneca
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`Pharmaceuticals LP et al. v. HBT Labs, Inc., C.A. No. 1:17-cv-2652 (D.N.J.); AstraZeneca
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`Pharmaceuticals LP et al. v. Teva Pharmaceuticals USA, Inc., C.A. No. 1:17-cv-02448 (D.N.J.);
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`AstraZeneca Pharmaceuticals LP et al. v. Amneal Pharmaceuticals LLC, C.A. No. 1:17-cv-
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`01968 (D.N.J.).
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`Three related patents have been involved in district court proceedings: U.S. Patent Nos.
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`6,774,122 (the “’122 patent”); 7,456,160 (the “’160 patent”); and 8,329,680 (the “’680 patent”).
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`The ’139 patent and three related patents have been involved in inter partes review
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`proceedings: IPR2016-01316 on the ’122 patent (terminated before institution); IPR2016-01324
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`on the ’160 patent (terminated before institution); IPR2016-01325 on the ’680 patent (institution
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`denied); IPR2016-01326 on the ’139 patent (terminated before institution); IPR2017-00904 on
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`the ’122 patent (institution decision pending); IPR2017-00900 on the ’680 patent (institution
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`decision pending); and IPR2017-00905 on the ’139 patent (institution decision pending).
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`Concurrently with this petition, Petitioner submitted two other petitions for inter partes
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`review: IPR2017-01910 on the ’122 patent and IPR2017-01913 on the ’680 patent.
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`Case IPR2017-01912
`U.S. Patent 8,466,139
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`LEAD AND BACK-UP COUNSEL
`AND SERVICE INFORMATION
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`Lead counsel:
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`Filko Prugo (Reg. No. 73,092)
`O’MELVENY & MYERS LLP
`Times Square Tower
`7 Times Square
`New York, NY 10036
`Phone: (212) 326-2000
`Fax: (212) 326-2061
`Email: fprugo@omm.com
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`Back-up counsel:
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`Caitlin Hogan (Reg. No. 61,515)
`O’MELVENY & MYERS LLP
`Times Square Tower
`7 Times Square
`New York, NY 10036
`Phone: (212) 326-2000
`Fax: (212) 326-2061
`Email: chogan@omm.com
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`Other counsel:
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`Marc Pensabene (Reg. No. 37,416)
`O’MELVENY & MYERS LLP
`Times Square Tower
`7 Times Square
`New York, NY 10036
`Phone: (212) 326-2000
`Fax: (212) 326-2061
`Email: mpensabene@omm.com
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`Carolyn Wall (Reg. No. 75,737)
`O’MELVENY & MYERS LLP
`Times Square Tower
`7 Times Square
`New York, NY 10036
`Phone: (212) 326-2000
`Fax: (212) 326-2061
`Email: cwall@omm.com
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`Patent Owner may be served electronically using the following email addresses:
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`Case IPR2017-01912
`U.S. Patent 8,466,139
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`fprugo@omm.com
`chogan@omm.com
`mpensabene@omm.com
`cwall@omm.com
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`Patent Owner may be served by mailing or hand-delivery to the following address:
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`Filko Prugo (Reg. No. 73,092)
`O’MELVENY & MYERS LLP
`Times Square Tower
`7 Times Square
`New York, NY 10036
`Phone: (212) 326-2000
`Fax: (212) 326-2061
`Email: fprugo@omm.com
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`Marc Pensabene (Reg. No. 37,416)
`O’MELVENY & MYERS LLP
`Times Square Tower
`7 Times Square
`New York, NY 10036
`Phone: (212) 326-2000
`Fax: (212) 326-2061
`Email: mpensabene@omm.com
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`Caitlin Hogan (Reg. No. 61,515)
`O’MELVENY & MYERS LLP
`Times Square Tower
`7 Times Square
`New York, NY 10036
`Phone: (212) 326-2000
`Fax: (212) 326-2061
`Email: chogan@omm.com
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`Carolyn Wall (Reg. No. 75,737)
`O’MELVENY & MYERS LLP
`Times Square Tower
`7 Times Square
`New York, NY 10036
`Phone: (212) 326-2000
`Fax: (212) 326-2061
`Email: cwall@omm.com
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`Respectfully submitted,
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`/Filko Prugo/
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`Filko Prugo (Reg. No. 73,092)
`O’MELVENY & MYERS LLP
`Times Square Tower
`7 Times Square
`New York, NY 10036
`Phone: (212) 326-2000
`Fax: (212) 326-2061
`Email: fprugo@omm.com
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`5
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`Dated: August 25, 2017
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`Case IPR2017-01912
`U.S. Patent 8,466,139
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`CERTIFICATE OF SERVICE
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`I certify that a copy of the foregoing Patent Owner’s Mandatory Notice Pursuant to
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`37 C.F.R. § 42.8 was served on August 25, 2017 by causing it to be sent by email to counsel for
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`Petitioner at the following email addresses:
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`Imron T. Aly (Reg. No. 48,706): ialy@schiffhardin.com
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`Jason G. Harp (Reg. No. 42,634): jharp@schiffhardin.com
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`Dated: August 25, 2017
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`/Kristin Godfrey/
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`Kristin Godfrey
`Case Manager
`O’MELVENY & MYERS LLP
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