UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`MYLAN PHARMACEUTICALS INC., 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.,
`
`Patent Owner
`
`Case IPR2016-013321
`Patent 8,822,438 B2
`
`
`
`
`
`DECLARATION OF BRYAN D. BEEL
`
`
`
`
`1 Case IPR2017-00853 has been joined with this proceeding.
`
`MYLAN PHARMS. INC. EXHIBIT 1152 PAGE 1
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`MYLAN PHARMACEUTICALS INC., 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.,
`
`Patent Owner
`
`Case IPR2016-013321
`Patent 8,822,438 B2
`
`
`
`
`
`DECLARATION OF BRYAN D. BEEL
`
`
`
`
`1 Case IPR2017-00853 has been joined with this proceeding.
`
`MYLAN PHARMS. INC. EXHIBIT 1152 PAGE 1
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`
`
`1.
`
`I, Bryan D. Beel, am over the age of eighteen and otherwise
`
`competent to make this Declaration. I have personal knowledge of the facts set
`
`forth in this Declaration and am competent to testify to the same.
`
`2.
`
`I am an attorney at Perkins Coie LLP, counsel for Petitioner Mylan
`
`Pharmaceuticals Inc. (“Mylan” or “Petitioner”) in connection with the above-
`
`captioned inter partes review (“IPR”).
`
`3.
`
`Exhibits MYL 1088 and 1141, filed April 19, 2017, are references
`
`cited in the Reply Declaration of Ivan T. Hofmann.
`
`4.
`
`Exhibit MYL 1088, filed on April 19, 2017, is a true and correct copy
`
`of a BTG press release entitled, “BTG Licenses New Prostate Cancer Drug to
`
`Cougar
`
`Biotechnology,”
`
`dated April
`
`20,
`
`2004,
`
`accessible
`
`at
`
`https://www.btgplc.com/media/press-releases/btg-licenses-new-prostate-cancer-
`
`drug-to-cougar-biotechnology/ (last visited April 3, 2017). An exhibit label was
`
`added to this exhibit upon its retrieval from the listed website, and a deposition
`
`exhibit label was added on April 5, 2017, during the deposition of Dr. Christopher
`
`Vellturo; no other alterations were made.
`
`5.
`
`Exhibit 1089 is a reference used during the deposition of Christopher
`
`Vellturo, Ph.D., on April 5, 2017.
`
`6.
`
`Exhibit MYL 1089, filed on April 19, 2017, is a true and correct copy
`
`of the Zytiga website page, “About Zytiga® (abiraterone acetate),” accessible at
`
`
`
`MYLAN PHARMS. INC. EXHIBIT 1152 PAGE 2
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`
`
`https://www.zytiga.com/choosing-zytiga/about-zytiga (last visited April 3, 2017).
`
`When scrolling down the page, the website URL changes from the above-listed
`
`URL to https://www.zytiga.com/choosing-zytiga/how-zytiga-works (middle of
`
`page) and then https://www.zytiga.com/choosing-zytiga/results-of-zytiga (end of
`
`page). An exhibit label was added to this exhibit, a deposition exhibit label was
`
`added on April 5, 2017, during the deposition of Dr. Christopher Vellturo, and no
`
`other alterations were made.
`
`7.
`
`Exhibits 1092–95, filed April 19, 2017, are references cited in the
`
`Reply Declaration of Ian McKeague, Ph.D.
`
`8.
`
`Exhibit MYL 1092, filed on April 19, 2017, is a true and correct copy
`
`of the American Cancer Society website page, “Hormone Therapy for Prostate
`
`Cancer,”
`
`accessible
`
`at
`
`https://www.cancer.org/content/cancer/en/cancer/
`
`prostate-cancer/treating/hormone-therapy (last visited April 10, 2017). An exhibit
`
`label was added to this exhibit and no other alterations were made.
`
`9.
`
`Exhibit MYL 1093, filed on April 19, 2017, is a true and correct copy
`
`of the NIH National Cancer Institute website page, “Metastatic Cancer,” accessible
`
`at https://www.cancer.gov/types/metastatic-cancer (last visited April 14, 2017).
`
`An exhibit label was added to this exhibit and no other alterations were made.
`
`10. Exhibit MYL 1094, filed on April 19, 2017, is a true and correct copy
`
`of the NIH National Cancer Institute website page, “Prostate-Specific Antigen
`
`
`
`MYLAN PHARMS. INC. EXHIBIT 1152 PAGE 3
`
`
`
`(PSA) Test,” accessible at https://www.cancer.gov/types/prostate/psa-fact-sheet
`
`(last visited April 11, 2017). An exhibit label was added to this exhibit and no
`
`other alterations were made.
`
`11. Exhibit MYL 1095, filed on April 19, 2017, is a true and correct copy
`
`of the Cougar Biotechnology, Inc., Clinical Study Report: COU-AA-001 and
`
`COU-AA-001 EXT dated November 17, 2010, accessible through https://clinical
`
`trials.gov. The document was obtained by (1) searching clinicaltrials.gov for the
`
`“COU-AA-001” study, (2) clicking on the first result, (3) scrolling down to the
`
`bottom of the page and clicking on the link provided under the “More Information”
`
`heading, (4) clicking on the URL provided, and (5) clicking on the downloaded
`
`PDF. See the following screenshots for a depiction of how Exhibit MYL 1095 was
`
`obtained:
`
`1:
`
`
`
`________________________________________________________________
`
`
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`MYLAN PHARMS. INC. EXHIBIT 1152 PAGE 4
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`
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`2:
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`
`
`________________________________________________________________
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`3:
`
`________________________________________________________________
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`4:
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`________________________________________________________________
`
`
`
`
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`5:
`
`
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`An exhibit label was added to this exhibit and no other alterations were made.
`
`12. Exhibits 1117 and 1125, filed April 19, 2017, are references cited in
`
`the Reply Declaration of Marc B. Garnick, M.D.
`
`13. Exhibit MYL 1117, filed on April 19, 2017, is a true and correct copy
`
`
`
`MYLAN PHARMS. INC. EXHIBIT 1152 PAGE 5
`
`
`
`of Abiraterone Acetate: Abbreviated Clinical Study Report Synopsys COU-AA-
`
`BE, issued October 14, 2010, document no. EDMS-ERI-13494974:2.0, accessible
`
`through https://www.clinicaltrials.gov. The document was obtained by (1)
`
`searching clinicaltrials.gov for the “COU-AA-BE” study, (2) clicking on the search
`
`result, (3) scrolling down to the bottom of the page and clicking on the link
`
`provided under the “More Information” heading, (4) clicking on the URL
`
`provided, and (5) clicking on the downloaded PDF. See the following screenshots
`
`for a depiction of how Exhibit MYL 1117 was obtained:
`
`1:
`
`________________________________________________________________
`
`2:
`
`________________________________________________________________
`
`3:
`
`
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`MYLAN PHARMS. INC. EXHIBIT 1152 PAGE 6
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`
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`________________________________________________________________
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`4:
`
`
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`________________________________________________________________
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`5:
`
`
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`An exhibit label was added to this exhibit and, on page 4, a vertical red annotation
`
`was added in the margin to denote a relevant paragraph.
`
`14. Exhibit MYL 1125, filed on April 19, 2017, is substantively the same
`
`as Ex. 1120 filed in IPR2016-00286.2 MYL 1125 is a compilation of several
`
`documents available in the archives of the FDA website, accessible through
`
`https://www.fda.gov at the following URLs:
`
`https://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsa
`
`ndtobacco/cder/ucm120851.pdf;
`
`https://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsa
`
`
`2 Janssen did not move to exclude Ex. 1120 in IPR2016-00286 on the basis of lack
`
`of authenticity. See IPR2016-00286, Paper 70.
`
`
`
`MYLAN PHARMS. INC. EXHIBIT 1152 PAGE 7
`
`
`
`ndtobacco I cder lucml 20 8 5 3 .Pdf;
`
`htçs://www.fda.gov/downloads laboutfda/centersoffices/officeofmedicalproductsa
`
`ndtobacco I cder I ucml 20 8 5 5 .Pdf;
`
`https://www.fda.gov/downloads laboutfdalcentersoffices/officeofmedicalproductsa
`
`ndtob acco I cder I ucml 208 5 7 .p df;
`
`https://www.fda.gov/downloads laboutfdalcentersoffrces/officeofmedicalproductsa
`
`ndtobacco I cder fucml 2085 8.pdf; and
`
`htçs://www.fda.gov/downloads laboutfdalcentersofftces/officeofmedicalproductsa
`
`ndtobacco I cder I ucml 20 8 5 9.pdf.
`
`The compilation does not include each document's cover page (noting the
`
`document is archived on the FDA website for reference purposes only). An MYL
`
`exhibit label was added.
`
`May 10,2017
`
`bmi
`
`D. Beel
`
`MYLAN PHARMS. INC. EXHIBIT 1152 PAGE 8
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`
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