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`Paper No. ______
`Filed: August 25, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`FRESENIUS-KABI USA LLC
`
`Petitioner
`
`v.
`
`ASTRAZENECA AB
`
`Patent Owner
`
`
`
`
`
`Case IPR2017-01910
`
`U.S. Patent 6,774,122
`
`
`
`
`
`PATENT OWNER’S MANDATORY
`NOTICES PURSUANT TO 37 C.F.R. § 42.8
`
`
`
`

`

`Case IPR2017-01910
`U.S. Patent 6,774,122
`
`Pursuant to 37 C.F.R. § 42.8, the undersigned on behalf of and acting in a representative
`
`capacity for patent owner AstraZeneca AB, hereby submits the following mandatory notices in
`
`connection with the Petition for Inter Partes Review of United States Patent No. 6,774,122 (the
`
`“’122 patent”), Case No. IPR2017-01910.
`
`REAL PARTY-IN-INTEREST
`
`AstraZeneca AB is Patent Owner. AstraZeneca UK Limited is the beneficial owner of
`
`the ’122 patent and holder of approved New Drug Application (“NDA”) No. 21-344 for
`
`FASLODEX® (fulvestrant) intramuscular injection, in 50 mg/mL dosage forms. AstraZeneca
`
`Pharmaceuticals LP is the authorized agent for matters related to NDA No. 21-344 in the United
`
`States.
`
`RELATED MATTERS
`
`The ’122 patent has been asserted in the following actions: AstraZeneca Pharmaceuticals
`
`LP et al. v. Sandoz Inc., C.A. No. 1:14-cv-03547-RMB-KMW (D.N.J.) (dismissed); AstraZeneca
`
`Pharmaceuticals LP et al. v. Sagent Pharmaceuticals, Inc., C.A. No. 1:14-cv-05539-RMB-
`
`KMW (D.N.J.) (consolidated as 1:14-cv-03547) (dismissed); AstraZeneca Pharmaceuticals LP
`
`et al. v. Glenmark Pharmaceuticals Inc., USA, C.A. No. 1:15-cv-00615-RMB-KMW (D.N.J.)
`
`(consolidated as 1:14-cv-03547) (dismissed); AstraZeneca Pharmaceuticals LP et al. v. Agila
`
`Specialties, Inc. et al., C.A. No. 1:15-cv-06039-RMB-KMW (D.N.J.); AstraZeneca
`
`Pharmaceuticals LP et al. v. Mylan Pharmaceuticals Inc. et al., C.A. No. 1:15-cv-7009-RMB-
`
`KMW (consolidated as 1:15-cv-06039) (dismissed); AstraZeneca Pharmaceuticals LP et al. v.
`
`Teva Pharmaceuticals USA, Inc., C.A. No. 1:15-cv-7889-RMB-KMW (D.N.J.) (consolidated as
`
`1:15-cv-06039) (dismissed); AstraZeneca Pharmaceuticals LP et al. v. InnoPharma Licensing
`
`LLC, C.A. No. 1:16-cv-1962-RMB-KMW (D.N.J.) (consolidated as 1:15-cv-06039);
`
`AstraZeneca Pharmaceuticals LP et al. v. Teva Parenteral Medicines Inc. et al., C.A. No. 1:10-
`
`
`
`2
`
`

`

`Case IPR2017-01910
`U.S. Patent 6,774,122
`
`cv-00018 (D. Del.) (dismissed); AstraZeneca Pharmaceuticals LP et al. v. Sagent
`
`Pharmaceuticals, Inc., C.A. No. 1:14-cv-07358 (N.D. Ill.) (dismissed); AstraZeneca
`
`Pharmaceuticals LP et al. v. Mylan Pharmaceuticals Inc. et al., C.A. No. 1:15-cv-00183 (N.D.
`
`W. Va.) (dismissed); AstraZeneca Pharmaceuticals LP et al. v. InnoPharma, Inc., C.A. No.
`
`1:16-cv-00894-RMB-KMW (D.N.J.) (dismissed); AstraZeneca Pharmaceuticals LP et al. v.
`
`Mylan Institutional LLC, C.A. No. 1:16-cv-04612 (D.N.J.) (consolidated as 1:15-cv-06039)
`
`(dismissed); AstraZeneca Pharmaceuticals LP et al. v. Dr. Reddy’s Laboratories, Inc. et al.,
`
`C.A. No. 1:17-cv-00926 (D.N.J.) (dismissed); AstraZeneca Pharmaceuticals LP et al. v. HBT
`
`Labs, Inc., C.A. No. 1:17-cv-2652 (D.N.J.); AstraZeneca Pharmaceuticals LP et al. v. Teva
`
`Pharmaceuticals USA, Inc., C.A. No. 1:17-cv-02448 (D.N.J.); AstraZeneca Pharmaceuticals LP
`
`et al. v. Amneal Pharmaceuticals LLC, C.A. No. 1:17-cv-01968 (D.N.J.).
`
`Three related patents have been involved in district court proceedings: U.S. Patent Nos.
`
`7,456,160 (the “’160 patent”); 8,329,680 (the “’680 patent”); and 8,466,139 (the “’139 patent”).
`
`The ’122 patent and three related patents have been involved in inter partes review
`
`proceedings: IPR2016-01316 on the ’122 patent (terminated before institution); IPR2016-01324
`
`on the ’160 patent (terminated before institution); IPR2016-01325 on the ’680 patent (institution
`
`denied); IPR2016-01326 on the ’139 patent (terminated before institution); IPR2017-00904 on
`
`the ’122 patent (institution decision pending); IPR2017-00900 on the ’680 patent (institution
`
`decision pending); and IPR2017-00905 on the ’139 patent (institution decision pending).
`
`Concurrently with this petition, Petitioner submitted two other petitions for inter partes
`
`review: IPR2017-01912 on the ’139 patent and IPR2017-01913 on the ’680 patent.
`
`
`
`
`
`
`
`3
`
`

`

`Case IPR2017-01910
`U.S. Patent 6,774,122
`
`LEAD AND BACK-UP COUNSEL
`AND SERVICE INFORMATION
`
`Lead counsel:
`
`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
`
`Back-up counsel:
`
`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
`
`Other counsel:
`
`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
`
`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
`
`
`
`4
`
`

`

`Patent Owner may be served electronically using the following email addresses:
`
`Case IPR2017-01910
`U.S. Patent 6,774,122
`
`
`
`fprugo@omm.com
`chogan@omm.com
`mpensabene@omm.com
`cwall@omm.com
`
`
`
`
`
`
`Patent Owner may be served by mailing or hand-delivery to the following address:
`
`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
`
`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
`
`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
`
`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
`
`
`
`Respectfully submitted,
`
`
`
`/Filko Prugo/
`
`
`
`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
`
`
`
`
`
`5
`
`Dated: August 25, 2017
`
`
`
`
`
`

`

`Case IPR2017-01910
`U.S. Patent 6,774,122
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing Patent Owner’s Mandatory Notice Pursuant to
`
`37 C.F.R. § 42.8 was served on August 25, 2017 by causing it to be sent by email to counsel for
`
`Petitioner at the following email addresses:
`
`Imron T. Aly (Reg. No. 48,706): ialy@schiffhardin.com
`
`Jason G. Harp (Reg. No. 42,634): jharp@schiffhardin.com
`
`Dated: August 25, 2017
`
`
`
`/Kristin Godfrey/
`
`
`
`
`
`
`
`
`
`Kristin Godfrey
`Case Manager
`O’MELVENY & MYERS LLP
`
`6
`
`

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