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`Paper No. ___
`Date Filed: Feb. 21, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`
` ACTAVIS LABORATORIES FL, INC., AMNEAL PHARMACEUTICALS LLC,
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC, DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD., SUN
`PHARMACEUTICALS INDUSTRIES, LTD., SUN PHARMACEUTICALS
`INDUSTRIES, INC., TEVA PHARMACEUTICALS USA, INC., WEST-WARD
`PHARMACEUTICAL CORP., and HIKMA PHARMACEUTICALS, LLC,
`
`Petitioners
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
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`Patent Owner
`
`________________
`
`Case IPR2017-00853
`Patent 8,822,438
`
`________________
`
`
`JANSSEN ONCOLOGY, INC.’S MANDATORY NOTICES
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`
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`
`
`IPR2017-00853
`Patent 8,822,438
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`Janssen Oncology, Inc. submits the following mandatory notices pursuant to
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`37 C.F.R. §42.8.
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`REAL PARTY-IN-INTEREST
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`Janssen Oncology, Inc., a wholly-owned subsidiary of Johnson & Johnson
`
`(“J&J”), is a real party-in-interest. J&J, a publicly held company, is also a real
`
`party-in-interest. In addition, BTG International Limited, a subsidiary of BTG plc,
`
`is a real party-in-interest.
`
`RELATED MATTERS
`
`U.S. Patent 8,822,438 (the “’438 Patent”) issued from U.S. Application No.
`
`13/034,340 (the “’340 Application”). U.S. Patent Application No. 15/019,353,
`
`which is now abandoned, claims the benefit of the ’340 Application. U.S. Patent
`
`Application No. 15/419,148 filed on January 30, 2017, which is pending, claims
`
`the benefit of the ’340 Application.
`
`The ’438 Patent was the subject of ex parte reexamination request No.
`
`90/020,096 (the “’096 reexamination”). On June 14, 2016, the Office issued a
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`Notice of Termination of Preprocessing of the ’096 reexamination. As a result, the
`
`’096 reexamination will not be granted a filing date for failure to comply with the
`
`requirements of 37 C.F.R. § 1.501(a). See Ex. 2001.
`
`The ’438 Patent is the subject of the following inter partes reviews:
`
`2
`
`
`
`IPR2017-00853
`Patent 8,822,438
`
` IPR2016-00286, which was instituted on May 31, 2016 and was filed
`
`by Amerigen Pharmaceuticals Limited;
`
` IPR2016-01317, which was filed by Argentum Pharmaceuticals LLC
`
`on June 29, 2016 (now joined with IPR2016-00286);
`
` IPR2016-01332, which was filed by Mylan Pharmaceuticals Inc., on
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`June 30, 2016 and instituted on January 10, 2017; and
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` IPR2016-01582, which was filed by Wockhardt BIO AG on August
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`10, 2016 and instituted on January 19, 2017.
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`The ’438 Patent is being asserted in the following patent infringement
`
`lawsuits:
`
` BTG International Limited, et al. v. Actavis Laboratories FL, Inc., et
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`al., C.A. No. 2:15-cv-05909-KM-JBC (D.N.J.) (the “District of New
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`Jersey Action”);
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` Janssen Biotech, Inc., et al. v. Mylan Pharmaceuticals Inc., et al.,
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`C.A. No. 1:15-cv-00130-IMK (N.D. W. Va.) (stayed; conditional trial
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`date set for February 2018);
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` BTG International Limited, et al. v. Amerigen Pharmaceuticals, Inc.,
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`et al., C.A. No. 2:16-cv-02449-KM-JBC (D.N.J.); and
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` BTG International Limited, et al. v. Glenmark Pharmaceuticals Inc.,
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`USA et al., C.A. No. 2:16-cv-05909 (D.N.J.).
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`3
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`IPR2017-00853
`Patent 8,822,438
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`The ’438 Patent was asserted in the following patent infringement lawsuits
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`that have now been terminated:
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` Janssen Biotech, Inc., et al. v. Par Pharmaceutical, Inc., et al., C.A.
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`No. 1:15-cv-00679-SLR (D. Del.); and
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` BTG International Limited, et al. v. Actavis Laboratories FL, Inc., et
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`al., C.A. No. 9:15-cv-81076-DMM (S.D. Fla.).
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`
`LEAD AND BACKUP COUNSEL
`
`Lead Counsel
`
`
`Dianne B. Elderkin
`AKIN GUMP STRAUSS HAUER
`& FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel.: (215) 965-1340
`Fax: (215) 965-1210
`delderkin@akingump.com
`USPTO Registration No. 28,598
`
`
`
`
`Backup Counsel
`
`
`
`
`Barbara L. Mullin
`AKIN GUMP STRAUSS HAUER
`& FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel.: (215) 965-1243
`Fax: (215) 965-1210
`bmullin@akingump.com
`USPTO Registration No. 38,250
`
`Ruben H. Munoz
`AKIN GUMP STRAUSS HAUER
`& FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel.: (215) 965-1263
`Fax: (215) 965-1210
`rmunoz@akingump.com
`USPTO Registration No. 66,998
`
`
`4
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`
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`IPR2017-00853
`Patent 8,822,438
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`SERVICE INFORMATION
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`Janssen consents to electronic service at the following email address:
`
`JANS-ZYTIGA@akingump.com
`ZytigaIPRTeam@sidley.com
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`
`
`Janssen may be served courtesy copies by postal mailing or hand-delivery as
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`follows:
`
`
`
`Dianne B. Elderkin
`AKIN GUMP STRAUSS HAUER & FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel.: (215) 965-1340
`Fax: (215) 965-1210
`
`
`
`Respectfully submitted,
`
`
`
`/Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
`
`
`
`
`
`
`
`
`
`Date: Feb. 21, 2017
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`
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`5
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`IPR2017-00853
`Patent 8,822,438
`
`
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Janssen
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`Oncology, Inc.’s Mandatory Notices was served on counsel of record on February
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`21, 2017 by filing this document through the End-to-End System, as well as
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`delivering a copy via electronic mail to counsel of record for the Petitioner at the
`
`Samuel S. Park – spark@winston.com
`Ryan B. Hauer – rhauer@winston.com
`Jovial Wong – jwong@winston.com
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`Respectfully submitted,
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`By: /Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
`
`following addresses:
`
`Date: Feb. 21, 2017
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`6
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