`Filed: July 20, 2016
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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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`MYLAN PHARMACEUTICALS INC.
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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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`
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`Case IPR2016-01316
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`U.S. Patent 6,774,122
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`PATENT OWNER’S MANDATORY
`NOTICES PURSUANT TO 37 C.F.R. § 42.8
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`Case IPR2016-01316
`U.S. Patent 6,774,122
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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. 6,774,122 (the
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`“’122 patent”), Case No. IPR2016-01316.
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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 ’122 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 ’122 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.); 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); AstraZeneca Pharmaceuticals LP et al. v.
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`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); AstraZeneca Pharmaceuticals LP et al. v. Agila Specialties,
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`Inc. et al., C.A. No. 1:15-cv-06039-RMB-KMW (D.N.J.); AstraZeneca Pharmaceuticals LP et
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`al. v. Mylan Pharmaceuticals Inc. et al., C.A. No. 1:15-cv-7009-RMB-KMW (consolidated as
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`1:15-cv-06039); AstraZeneca Pharmaceuticals LP et al. v. Teva Pharmaceuticals USA, Inc.,
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`C.A. No. 1:15-cv-7889-RMB-KMW (D.N.J.) (consolidated as 1:15-cv-06039); AstraZeneca
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`Pharmaceuticals LP et al. v. InnoPharma Licensing LLC, C.A. No. 1:16-cv-1962-RMB-KMW
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`(D.N.J.) (consolidated as 1:15-cv-06039); AstraZeneca Pharmaceuticals LP et al. v. Teva
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`Parenteral Medicines Inc. et al., C.A. No. 1:10-cv-00018 (D. Del.) (dismissed); AstraZeneca
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`2
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`Case IPR2016-01316
`U.S. Patent 6,774,122
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`Pharmaceuticals LP et al. v. Sagent Pharmaceuticals, Inc., C.A. No. 1:14-cv-07358 (N.D. Ill.)
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`(dismissed); AstraZeneca Pharmaceuticals LP et al. v. Mylan Pharmaceuticals Inc. et al., C.A.
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`No. 1:15-cv-00183 (N.D. W. Va.) (stayed); AstraZeneca Pharmaceuticals LP et al. v.
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`InnoPharma, Inc., C.A. No. 1:16-cv-00894-RMB-KMW (D.N.J.) (dismissed).
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`Three related patents have been involved in district court proceedings: U.S. Patent Nos.
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`7,456,160 (the “’160 patent”); 8,329,680 (the “’680 patent”); and 8,466,139 (the “’139 patent”).
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`Concurrently with this petition, Petitioner submitted three other petitions for inter partes
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`review: IPR2016-01324 on the ’160 patent; IPR2016-01325 on the ’680 patent; and IPR2016-
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`01326 on the ’139 patent.
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`Lead counsel:
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`LEAD AND BACK-UP COUNSEL
`AND SERVICE INFORMATION
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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
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`3
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`Case IPR2016-01316
`U.S. Patent 6,774,122
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`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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`Kevin Murray (Reg. No. 69,529)
`O’MELVENY & MYERS LLP
`400 South Hope Street
`Los Angeles, CA 90071
`Phone: (213) 430-6100
`Email: kmurray2@omm.com
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`Patent Owner may be served electronically using the following email addresses:
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`
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`fprugo@omm.com
`chogan@omm.com
`mpensabene@omm.com
`kmurray2@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
`
`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
`
`Kevin Murray (Reg. No. 69,529)
`O’MELVENY & MYERS LLP
`400 South Hope Street
`Los Angeles, CA 90071
`Phone: (213) 430-6100
`Email: kmurray2@omm.com
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`Respectfully submitted,
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`Dated: July 20, 2016
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`/s/ Filko Prugo
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`Filko Prugo (Reg. No. 73,092)
`O’MELVENY & MYERS LLP
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`4
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`Case IPR2016-01316
`U.S. Patent 6,774,122
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`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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`Case IPR2016-01316
`U.S. Patent 6,774,122
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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 July 20, 2016 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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`Brandon M. White (Reg. No. 52,354): BMWhite@PerkinsCoie.com
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`Crystal R. Canterbury (Reg. No. 69,853): CCanterbury@PerkinsCoie.com
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`/Shari Gordon/
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`Shari Gordon
`Case Manager
`O’MELVENY & MYERS LLP
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`Dated: July 20, 2016
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