`Paper No. _______
`Filed: February 8, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner
`
`v.
`
`JANSSEN ONCOLOGY, INC.
`
`Patent Owner
`____________________________
`
`Case No. IPR2016-01332
`U.S. Patent No. 8,822,438
`____________________________
`
`SECOND UPDATED LIST OF PETITIONER’S EXHIBITS
`
`Pursuant to 37 C.F.R. § 42.63(e), Petitioner submits the following current
`
`exhibit list.
`
`Exhibit
`
`MYL 1001
`
`Description
`
`U.S. Patent No. 8,822,438, Auerbach and Belldegrun, “Methods
`and Compositions for Treating Cancer” (“the ’438 patent”)
`
`MYL 1002
`
`Declaration of Marc B. Garnick, MD (“Garnick Decl.”)
`
`
`
`
`
`Exhibit
`
`MYL 1003
`
`MYL 1004
`
`Description
`
`O’Donnell, A. et al., “Hormonal impact of the 17α-
`hydroxylase/C17,20-lyase inhibitor abiraterone acetate (CB7630)
`in patients with prostate cancer,” Br. J. Cancer, (90):2317–2325
`(2004) (“O’Donnell”)
`
`Gerber, G.S. et al., “Prostate specific antigen for assessing
`response to ketoconazole and prednisone in patients with hormone
`refractory metastatic cancer,” J. Urology, 144(5):1177–9 (1990)
`(“Gerber”)
`
`MYL 1005
`
`U.S. Patent No. 5,604,213, Barrie S.E. et al., “17-Substituted
`Steroids Useful In Cancer Treatment” (“the ’213 patent”)
`
`MYL 1006
`
`Tannock, I. et al., “Chemotherapy with mitoxantrone plus
`prednisone or prednisone alone for symptomatic hormone-
`resistant prostate cancer: a Canadian randomized trial with
`palliative end points,” J. Clinical Oncology, 14:1756–1764 (1996)
`(“Tannock”)
`
`MYL 1007
`
`February 3, 2012 Office Action (excerpt from prosecution history
`of ’438 patent)
`
`MYL 1008
`
`July 3, 2012 Response (excerpt from prosecution history of ’438
`patent)
`
`MYL 1009
`
`Ryan, C.J. et al., “Abiraterone in metastatic prostate cancer
`without previous chemotherapy,” New Eng. J. Med., 368:138–148
`(2013).
`
`MYL 1010
`
`January 11, 2013 Response (excerpt from prosecution history of
`’438 patent)
`
`MYL 1011 March 4, 2013 Office Action (excerpt from prosecution history of
`’438 patent)
`
`MYL 1012
`
`June 4, 2013 Response (excerpt from prosecution history of ’438
`patent)
`
`MYL 1013
`
`July 3, 2013 Notice of Allowance (excerpt from prosecution
`history of ’438 patent)
`
`MYL 1014
`
`October 25, 2013 Notice of Allowance (excerpt from prosecution
`history of ’438 patent)
`
`
`
`2
`
`
`
`Exhibit
`
`MYL 1015
`
`Description
`
`February 11, 2014 Notice of Allowance (excerpt from prosecution
`history of ’438 patent)
`
`MYL 1016
`
`June 2, 2014 Notice of Allowance (excerpt from prosecution
`history of ’438 patent)
`
`MYL 1017
`
`Declaration of Ivan T. Hofmann (“Hofmann Declaration”)
`
`MYL 1018
`
`2011 Zytiga® Approval Prescribing Information
`
`MYL 1019
`
`2015 Zytiga® Prescribing Information, Co-administration
`Brochure
`
`MYL 1020
`
`Harris, K.A. et al., “Low dose ketoconazole with replacement
`doses of hydrocortisone in patients with progressive androgen
`independent prostate cancer,” J. Urology, 168:542–545 (August
`2002)
`
`MYL 1021
`
`Oh, W.K. “Secondary hormonal therapies in the treatment of
`prostate cancer,” Urology, 60(Supp. 3A):87–93 (2002)
`
`MYL 1022
`
`MYL 1023
`
`Tannock, I. et al., “Docetaxel plus prednisone or mitoxantrone
`plus prednisone for advanced prostate cancer,” N. Eng. J. Med.,
`351:1502–12 (2004)
`
`Attard, G. et al., “Selective blockade of androgenic steroid
`synthesis by novel lyase inhibitors as a therapeutic strategy for
`treating metastatic prostate cancer,” Br. J. Urol. 96(9): 1241–1246
`(2005)
`
`MYL 1024
`
`Hellerstedt, B.A. et al., “The current state of hormonal therapy for
`prostate cancer,” CA Cancer J. Clin., 52:154–179 (2002).
`
`MYL 1025
`
`Kasper, D.L. et al. (Eds.), Harrison’s Principles of Internal
`Medicine, 16th Edition (2005), 549.
`
`MYL 1026
`
`MYL 1027
`
`Auchus, R.J. “The genetics, pathophysiology, and management of
`human deficiencies of P450c17,” Endocrinol. Metab. Clin. North
`Am. 30(1):101–119 (2001)
`
`Costa-Santos, M. et al., “Two prevalent CYP17 mutations and
`genotype-phenotype correlations in 24 Brazilian patients with 17-
`hydroxylase deficiency,” J. Clin. Endocrin. & Metabol. 89(1):49–
`60 (2004)
`
`
`
`3
`
`
`
`Exhibit
`
`MYL 1028
`
`Description
`
`Jubelirer, S.J., et al., “High dose ketoconazole for the treatment of
`hormone refractory metastatic prostate carcinoma,” J. Urol.,
`142(1):89–91 (1989)
`
`MYL 1029
`
`U.S. Patent 5,688,977, Sisti, N.J. et al., “Method for Docetaxel
`Synthesis”
`
`MYL 1030
`
`MYL 1031
`
`U.S. Food and Drug Administration (“FDA”) FDA News Release
`dated May 19, 2004, “FDA Approves New Indication for
`Taxotere-Prostate Cancer”
`
`Tannock, I. et al., “Treatment of metastatic prostatic cancer with
`low-dose prednisone: evaluation of pain and quality of life as
`pragmatic indices of response,” J. Clin. Oncology, 7:590–7 (1989)
`
`MYL 1032
`
`Intentionally left blank
`
`MYL 1033
`
`MYL 1034
`
`Scher, H.I. et al., “Increased survival with enzalutamide in
`prostate cancer after chemotherapy,” New Eng. J. Med.,
`367:1187–97 (2012)
`
`de Bono, J.S. et al., “Abiraterone and increased survival in
`metastatic prostate cancer,” New Engl. J. Med., 364:1995–2005
`(2011)
`
`MYL 1035
`
`Orange Book listing for Zytiga®
`
`MYL 1036
`
`Initial Application (excerpt from prosecution history of ’438
`patent)
`
`MYL 1037
`
`Intentionally left blank
`
`MYL 1038
`
`Intentionally left blank
`
`MYL 1039
`
`September 11, 2012 Office Action (excerpt from prosecution
`history of ’438 patent)
`
`MYL 1040
`
`Cancer.net (ASCO Patient Website), Treatment of Metastatic
`Castration-Resistant Prostate Cancer,
`http://www.cancer.net/research-and-advocacy/asco-care-and-
`treatment-recommendations-patients/treatment-metastatic-
`castration-resistant-prostate-cancer (accessed 6/28/2016).
`
`
`
`4
`
`
`
`Exhibit
`
`MYL 1041
`
`Description
`
`Cancer.org (ACS), “What are the key statistics about prostate
`cancer?”
`http://www.cancer.org/cancer/prostatecancer/detailedguide/prostat
`e-cancer-key-statistics (accessed 6/28/2016).
`
`MYL 1042
`
`Intentionally left blank
`
`MYL 1043
`
`Intentionally left blank
`
`MYL 1044
`
`Intentionally left blank
`
`MYL 1045
`
`MYL 1046
`
`MYL 1047
`
`FDA News Release, “FDA expands Zytiga’s use for late-stage
`prostate cancer,” 12/10/2012
`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements
`/ucm331492.htm (access 6/30/2016).
`
`FDA Website, Drugs@FDA – Zytiga,
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?
`fuseaction=Search.DrugDetails (accessed 6/28/2016).
`
`FDA Website, Orange Book, Zytiga (NDA 202379),
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cf
`m?Appl_No=202379&Product_No=001&table1=OB_Rx
`(accessed 6/30/2016).
`
`MYL 1048
`
`Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 740–41 (Fed.
`Cir. 2013).
`
`MYL 1049
`
`MYL 1050
`
`Jevtana Website, Dosing and Administration,
`http://www.jevtana.com/hcp/dosing/default.aspx (accessed
`6/28/2016).
`
`Kirby, M. et al., “Characterising the castration-resistant prostate
`cancer population: A systematic review,” Int’l J. Clinical Practice
`65(11):1180–1192 (2011).
`
`MYL 1051 Mayo Clinic Website, Prostate cancer,
`http://www.mayoclinic.org/diseasesconditions/prostate-
`cancer/basics/definition/con-20029597?p=1 (accessed 6/28/2016).
`
`MYL 1052
`
`Intentionally left blank
`
`MYL 1053 Merck & Co. v. Teva Pharms. USA, Inc., 395 F.3d 1364 (Fed. Cir.
`2005).
`
`
`
`5
`
`
`
`Exhibit
`
`Description
`
`MYL 1054 Murphy, W.J., J.L. Orcutt & P.C. Remus (2012), Patent
`Valuation: Improving Decision Making through Analysis,
`Hoboken, NJ: Wiley.
`
`MYL 1055
`
`PMLiVe Website, “Top 50 Pharmaceutical Products by Global
`Sales,”
`http://www.pmlive.com/top_pharma_list/Top_50_pharmaceutical
`_products_by_global_sales (accessed 6/30/2016).
`
`MYL 1056
`
`Intentionally left blank
`
`MYL 1057
`
`Syntex (U.S.A.) LLC v. Apotex, Inc., 407 F.3d 1371 (Fed. Cir.
`2005).
`
`MYL 1058-
`MYL 1063
`
`Intentionally left blank
`
`MYL 1064
`
`Zytiga Brochure, Putting Prednisone in Perspective, 3/2015.
`
`MYL 1065
`
`Zytiga Label, 5/20/2015.
`
`MYL 1066
`
`Zytiga Website, How Zytiga® (abiraterone acetate) Works,
`https://www.zytiga.com/print/about-zytiga/how-zytiga-works
`(accessed 6/28/2016).
`
`MYL 1067
`
`Intentionally left blank
`
`MYL 1068
`
`November 25, 2011 Office Action (excerpt from prosecution
`history of ’438 patent)
`
`MYL 1069
`
`December 21, 2011 Response (excerpt from prosecution history
`of ’438 patent)
`
`MYL 1070
`
`September 11, 2012 Office Action (excerpt from prosecution
`history of ’438 patent)
`
`MYL 1071
`
`October 3, 2013 IDS (excerpt from prosecution history of ’438
`patent)
`
`MYL 1072
`
`October 3, 2013 IDS (excerpt from prosecution history of ’438
`patent)
`
`MYL 1073
`
`January 10, 2014 IDS (excerpt from prosecution history of ’438
`patent)
`
`
`
`6
`
`
`
`Exhibit
`
`Description
`
`MYL 1074 May 9, 2014 IDS (excerpt from prosecution history of ’438
`patent)
`
`MYL 1075 May 9, 2014 IDS (excerpt from prosecution history of ’438
`patent)
`
`MYL 1076 May 30, 2014 IDS (excerpt from prosecution history of ’438
`patent)
`
`MYL 1077 May 30, 2014 IDS (excerpt from prosecution history of ’438
`patent)
`
`MYL 1078
`
`MYL 1079
`
`Barrie et al., “Pharmacology of novel steroidal inhibitors of
`Cytochrome P45017α (17α-hydroxylase/C17,20 lyase),”
`J. Steroid Biochem. Molec. Biol. 50:267-73 (1994)
`
`Fakih, M. et al., “Glucocorticoids and treatment of prostate
`cancer: A preclinical and clinical review,” Urology 60:553-561
`(2002)
`
`MYL 1080
`
`Lam, J.S. et al., “Secondary hormonal therapy for advanced
`prostate cancer,” J. Urology 175:28-34 (2006)
`
`MYL 1081
`
`Declaration of Bryan D. Beel in Support of Motion for Pro Hac
`Vice Admission
`
`MYL 1082
`
`Declaration of Ivan T. Hofmann, CPA/CFF, CLP
`
`MYL 1083
`
`Declaration of Marc B. Garnick, M.D.
`
`
`Dated: February 8, 2017
`
`
`
`
`
`
`
`/Brandon M. White/
`Brandon M. White
`Reg. No. 52,354
`
`PERKINS COIE LLP
`700 13th Street, NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6204
`Facsimile: (202) 654-6211
`Email: bmwhite@perkinscoie.com
`
`Attorney for Mylan Pharmaceuticals Inc.
`
`
`
`7
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that the foregoing Second Updated List of
`
`Petitioner’s Exhibits was served electronically via email as follows:
`
`Patent Owners:
`
`Dianne B. Elderkin
`Barbara L. Mullin
`Ruben H. Munoz
`Akin Gump Strauss Hauer & Feld LLP
`JANS-ZYTIGA@akingump.com
`
`David T. Pritikin
`Bindu Donovan
`Sidley Austin LLP
`ZytigaIPRTeam@sidley.com
`
`
`
`Dated: February 8, 2017
`
`
`
`/Brandon M. White/
`Brandon M. White
`
`Attorney for Mylan Pharmaceuticals Inc.
`
`
`
`
`
`
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
