UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WOCKHARDT BIO AG
`
`Petitioner,
`
`V.
`
`JANS SEN ONCOLOGY, INC.,
`Patent Owner.
`
`Case No. IPR2016—01582
`
`U.S. Patent No. 8,822,438
`
`DECLARATION OF BINDU DONOVAN
`
`JANSSEN EXHIBIT 2152
`
`Wockhardt v. Janssen lPR2016-01582
`
`JANSSEN EXHIBIT 2152
`Wockhardt v. Janssen IPR2016-01582
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WOCKHARDT BIO AG
`
`Petitioner,
`
`V.
`
`JANS SEN ONCOLOGY, INC.,
`Patent Owner.
`
`Case No. IPR2016—01582
`
`U.S. Patent No. 8,822,438
`
`DECLARATION OF BINDU DONOVAN
`
`JANSSEN EXHIBIT 2152
`
`Wockhardt v. Janssen lPR2016-01582
`
`JANSSEN EXHIBIT 2152
`Wockhardt v. Janssen IPR2016-01582
`
`
`
`Declaration of Bindu Donovan
`
`1.
`
`My name is Bindu Donovan.
`
`I am an attorney for Sidley Austin
`
`LLP, attorneys for Patent Owner J anssen Oncology, Inc. Unless otherwise stated,
`
`I have knowledge of all facts set forth in this declaration, and I would, and
`
`could, testify competently thereto if called upon to do so.
`
`2.
`
`Exhibits JSN 2010-2011, filed on December 19, 2016, are references
`
`cited in the Patent Owner Response filed March 17, 2017 in the above—captioned
`
`matter.
`
`3.
`
`Exhibits JSN 2012-2014, 2034-2035, 2050, 2070, 2073-2075, 2077-
`
`78, 2081-2084, 2089, 2091, 2098-2108, 2112-2113, 2132, 2137-38, 2151, 2154,
`
`and 2158, filed on March 17, 2017, are references cited in the Patent Owner
`
`Response filed March 17, 2017 in the above—captioned matter.
`
`4.
`
`Exhibit JSN 2010, filed on December 19, 2016, is a true and
`
`correct copy of the Opinion (Markman Patent Claim Construction) issued by
`
`the District Court for the District of New Jersey in BTG International Ltd. v.
`
`Actavis Laboratories FL, Ina, No. 2:15-cv-05909-KM-JBC, D.I. 239 (D.N.J.
`
`Nov. 10, 2016). An exhibit label has been added, but no other alterations have
`
`been made.
`
`IPR2016—01582
`
`Page 2 of 14
`
`
`
`5.
`
`Exhibit JSN 2011, filed on December 19, 2016, is a true and
`
`correct copy of the Order (Markman Patent Claim Construction) issued by the
`
`District Court for the District of New Jersey in BTG International Ltd. v.
`
`Actavis Laboratories FL, Inc., No. 2:15-cv-05909-KM—JBC, D1. 240 (D.N.J.
`
`Nov. 10, 2016). An exhibit label has been added, but no other alterations have
`
`been made.
`
`6.
`
`Exhibit JSN 2012, filed on March 17, 2017, is a true and correct
`
`copy of PM Live Top 50 Pharmaceuticals, available at
`
`http://www.pmlive.com/top_pharma_1ist/Top_50wpharmaceutica1_products_by__g1
`
`oba1_sa1es, last visited on or before March 17, 2017. An exhibit label has been
`
`added, but no other alterations have been made.
`
`7.
`
`Exhibit JSN 2013, filed on March 17, 2017, is a true and correct copy
`
`of the Johnson & Johnson January 26, 2016 Press Release, available at
`
`http://wvvw.investor.jnj.com/releasedetail.cfm?Re1easelD=951652, last visited on
`
`or before March 17, 2017. An exhibit label has been added, but no other
`
`alterations have been made.
`
`8.
`
`Exhibit JSN 2014, filed on March 17, 2017, is a true and correct copy
`
`of the Johnson & Johnson January 24, 2017 Press Release, available at
`
`IPR2016—0l 582
`
`Page 3 of 14
`
`
`
`http://www.investor.jnj.com/releasedetail.cfm?Release1D=1008867, last visited on
`
`or before March 17, 2017. An exhibit label has been added, but no other
`
`alterations have been made.
`
`9.
`
`Exhibit JSN 2034, filed on March 17, 2017, is a true and correct copy
`
`of the Johnson & Johnson January 21, 2014 Press Release, available at
`
`http://wwvv.investor.jnj.corn/releasedetail.cfm‘?releaseid=820215, last Visited on or
`
`before March 17, 2017. An exhibit label has been added, but no other alterations
`
`have been made.
`
`10.
`
`Exhibit JSN 2035, filed on March 17, 2017, is a true and correct copy
`
`of the Johnson & Johnson January 20, 2015 Press Release, available at
`
`http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=891937, last visited on
`
`or before March 17, 2017. An exhibit label has been added, but no other
`
`alterations have been made.
`
`11.
`
`Exhibit JSN 2050, filed on March 17, 2017, is a true and correct copy
`
`of article Med1inePlus, “ACTH stimulation test,” available at
`
`https://medlineplus.gov/ency/article/003696.htm, last visited on or before March
`
`17, 2017. An exhibit label has been added, but no other alterations have been
`
`made.
`
`lPR20 16-01582
`
`Page 4 of 14
`
`
`
`12.
`
`Exhibit JSN 2070, filed on March 17, 2017, is a true and correct copy
`
`of the FDA Press Release (201 1), available at
`
`http://www.fda.gov/NewsEvents/Newsroom/Press/Xnnouncements/ucm253 05 5 .ht
`
`m, last visited on or before March 17, 2017. An exhibit label has been added, but
`
`no other alterations have been made.
`
`13.
`
`Exhibit JSN 2073, filed on March 17, 2017, is a true and correct copy
`
`of the Tokai July 26, 2016 Press Release, available at
`
`http://wWw.businesswire.corn/news/horne/20160726005553/en/, last visited on or
`
`before March 17, 2017. An exhibit label has been added, but no other alterations
`
`have been made.
`
`14.
`
`Exhibit JSN 2074, filed on March 17, 2017, is a true and correct copy
`
`of the Active/Ipsen April 16, 2015 Press Release, available at
`
`http://activebiotech.com/press—re1eases?pressid=1911619, last visited on or before
`
`March 17, 2017. An exhibit label has been added, but no other alterations have
`
`been made.
`
`15.
`
`Exhibit JSN 2075, filed on March 17, 2017, is a true and correct copy
`
`of the Takeda June 19, 2014 Press Release, available at
`
`https://www.takeda.com/news/2014/20140619_66l5.html, last visited on or before
`
`IPR2016—01582
`
`Page 5 of 14
`
`
`
`March 17, 2017. An exhibit label has been added, but no other alterations have
`
`been made.
`
`16.
`
`Exhibit JSN 2077, filed on March 17, 2017, is a true and correct copy
`
`of the OneoGenex (April 28, 2014) Press Release, available at
`
`http2//ir.oncogenex.com/releasedetail.cfin?Release1D=842949, last visited on or
`
`before March 17, 2017. An exhibit label has been added, but no other alterations
`
`have been made.
`
`17.
`
`Exhibit JSN 2078, filed on March 17, 2017, is a true and correct copy
`
`of the BMS Sept. 12, 2013 Press Release, available at
`
`http://investor.bms.com/investors/news-and—events/press—releases/press—release—
`
`details/2013/Bristol—Myers-Squibb—Reports—Results—for—Phase—3 —Trial—of—Yervoy—
`
`Ipilimumab—in—Previously—Treated-Castration-Resistant—Prostate—
`
`Cancer/defaultaspx, last visited on or before March 17, 2017. An exhibit label has
`
`been added, but no other alterations have been made.
`
`18.
`
`Exhibit JSN 2081, filed on March 17, 2017, is a true and correct copy
`
`of the Genentech March 12, 2010 Press Release, available at
`
`http://www.businesswire.com/news/home/201003 1 1007023/en/Genentech—Update—
`
`IPR20l6-01582
`
`Page 6 of 14
`
`
`
`Phase—1I1—Study—Avastin—Men, last visited on or before March 17, 2017. An exhibit
`
`label has been added, but no other alterations have been made.
`
`19.
`
`Exhibit JSN 2082, filed on March 17, 2017, is a true and correct copy
`
`of the Mulcahy, Medscape October 17, 2008 Press Release, available at
`
`http://www.medscape.com/viewarticle/582220, last visited on or before March 17,
`
`2017. An exhibit label has been added, but no other alterations have been made.
`
`20.
`
`Exhibit JSN 2083, filed on March 17, 2017, is a true and correct copy
`
`of Novacea Form 8-K at 1.02, available at
`
`https://Www.sec.gov/Archives/edgar/data/117871 1/000119312508077953/d8k.htm
`
`, last visited on or before March 17, 2017. An exhibit label has been added, but no
`
`other alterations have been made.
`
`21.
`
`Exhibit J SN 2084, filed on March 17, 2017, is a true and Correct copy
`
`of IrnmunoGen, Inc., Form 8—K, Item 8.01, available at
`
`https://www.sec.gov/Archives/edgar/data/855654/000085565406000002/form8-
`
`k.htm, last visited on or before March 17, 2017. An exhibit label has been added,
`
`but no other alterations have been made.
`
`IPR2016-01582
`
`Page 7 of 14
`
`
`
`22.
`
`Exhibit JSN 2089, filed on March 17, 2017, is a true and correct copy
`
`of NCI—SEER Stat 1*‘ act Sheets: Prostate Cancer, available at
`
`http2//seer.cancer.gov/statlacts/html/prost.html, last visited on or before March 17,
`
`2017. An exhibit label has been added, but no other alterations have been made.
`
`23.
`
`Exhibit JSN 2091, filed on March 17, 2017, is a true and correct copy
`
`of the What You Need to Know About Prostate Cancer article, NIH Publication
`
`No. 12-1576 (2012), available at https://www.cancer.gov/publications/patient-
`
`education/prostatepdf, last visited on or before March 17, 2017. An exhibit label
`
`has been added, but no other alterations have been made.
`
`24.
`
`Exhibit JSN 2098, filed on March 17, 2017, is a true and correct copy
`
`of the ACS article ~ “What is Prostate Cancer? Topics” available at
`
`http://vvww.cancer.org/cancer/prostatecancer/detailedguide/prostate—cancer-what-
`
`is—prostate—cancer, last visited on or before March 17, 2017. An exhibit label has
`
`been added, but no other alterations have been made.
`
`25.
`
`Exhibit J SN 2099, filed on March 17, 2017, is a true and correct copy
`
`of the Cancer.Net — September 8, 2014 article, “Treatment of Metastatic Castration
`
`Resistant Prostate Cancer”, available at http2//www.cancer.net/research-and-
`
`advocacy/asco-care—and—treatment-recommendations—patients/treatment-metastatic-
`
`1PR2016—01582
`
`Page 8 of 14
`
`
`
`castration—resistant—prostate—cancer, last visited on or before March 17, 2017. An
`
`exhibit label has been added, but no other alterations have been made.
`
`26.
`
`Exhibit JSN 2100, filed on March 17, 2017, is a true and correct copy
`
`of the CDC article — “Prostate Cancer” available at
`
`https://www.cdc.gov/cancer/prostate/, last visited on or before March 17, 2017.
`
`An exhibit label has been added, but no other alterations have been made.
`
`27.
`
`Exhibit JSN 2101, filed on March 17, 2017, is a true and correct copy
`
`of the Johnson & Johnson May 21, 2009 Press Release, available at
`
`http://www.investor.jnj.com/releasedetail.cfm?releaseid=385634, last visited on or
`
`before March 17, 2017. An exhibit label has been added, but no other alterations
`
`have been made.
`
`28.
`
`Exhibit JSN 2102, filed on March 17, 2017, is a true and correct copy
`
`of the Mayo Clinic article - Prednisone and other corticosteroids available at
`
`http://wwwmayoclinic.org/steroids/art—20045692, last visited on or before March
`
`17, 2017. An exhibit label has been added, but no other alterations have been
`
`made. A
`
`1PR2016—01582
`
`Page 9 of 14
`
`
`
`29.
`
`Exhibit JSN 2103, filed on March 17, 2017, is a true and correct copy
`
`of the Medical Dictionary —— refractory cancer definition available at http://medical-
`
`dictionarythefreedictionary.com/refiractory+cancer, last visited on or before March
`
`17, 2017. An exhibit label has been added, but no other alterations have been
`
`made.
`
`30.
`
`Exhibit JSN 2104, filed on March 17, 2017, is a true and correct copy
`
`of the NCI article — Docetaxel available at https://www.cancer.gov/about-
`
`cancer/treatment/drugs/docetaxel, last visited on or before March 17, 2017. An
`
`exhibit label has been added, but no other alterations have been made.
`
`31.
`
`Exhibit JSN 2105, filed on March 17, 2017, is a true and correct copy
`
`of the NCI article - Metastatic Cancer available at
`
`https://www.cancer.gov/types/metastatic-cancer, last visited on or before March
`
`17,2017.
`
`32.
`
`Exhibit JSN 2106, filed on March 17, 2017, is a true and correct copy
`
`of the FDA “Orange Book” entry - Xofigo available at
`
`http://wwwaccessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl__Type=N
`
`&Appl_No=20397l, last visited on or before March 17, 2017. An exhibit label has
`
`been added, but no other alterations have been made.
`
`IPR20l6—0l582
`
`Page 10 of 14
`
`
`
`33.
`
`Exhibit JSN 2107, filed on March 17, 2017, is a true and correct copy
`
`of the “Orange Book” entry ~ Xtandi available at
`
`http2//wwwaccessdata.fda.gov/scripts/cder/ob/results_product.cfrn?Appl__Type=N
`
`&Appl__No=203415, last visited on or before March 17, 2017. An exhibit label has
`
`been added, but no other alterations have been made.
`
`34.
`
`Exhibit JSN 2108, filed on March 17, 2017, is a true and correct Copy
`
`of the “Orange Book” entry — Jevtana available at
`
`http://wwwaccessdata.fda.gov/scripts/cder/ob/results___product.Cfm?Appl_Type=N
`
`&Appl_No=201023, last visited on or before March 17, 2017. An exhibit label has
`
`been added, but no other alterations have been made.
`
`35.
`
`Exhibit JSN 2112, filed on March 17, 2017, is a true and correct copy
`
`of the Boehringer-Inge1heim—BTG Press Release — “NEW TREATMENT FOR
`
`PROSTATE CANCER UNDER DEVELOPMENT,” dated May 22, 1996,
`
`available at http://Web.archive.org/web/ 199701 18070207/http://www.boehringer—
`
`ingelheim.com/prO52296.htm, last visited on or before March 17, 2017. An
`
`exhibit label has been added, but no other alterations have been made.
`
`36.
`
`Exhibit JSN 2113, filed on March 17, 2017, is a true and correct copy
`
`of the Public Citizen Press Room Release — “Antifungal Treatment Should Be
`
`IPR2016—01582
`
`Page 11 of14
`
`
`
`Taken Off the Market, Public Citizen Tells FDAD,” dated February 24, 2015,
`
`accessible at http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=5423,
`
`last Visited on or before March 17, 2017. An exhibit label has been added, but no
`
`other alterations have been made.
`
`37.
`
`Exhibit JSN 2132, filed on March 17,2017, is a true and correct
`
`copy ofthe Order Granting Janssen’s Motion to Set a Hearing and Correct
`
`lnventorship ofthe “438 Patent Pursuant to 35 U.S.C. § 256 and Authorizing
`
`the Filing ofa Second Amended Complaint issued by the District Court for the
`
`District of New Jersey in BTG International Ltd. v. Actavis Laboratories FL,
`
`Inc., No. 2:15—cv—05909-KM—JBC, D.I. 270 (D.N.J. Jan. 24, 2017). An exhibit
`
`label has been added, but no other alterations have been made.
`
`38.
`
`Exhibit JSN 2137, filed on March 17, 2017, is a true and correct copy
`
`of BTG plc Annual report and accounts for the year ended 31 March 2003
`
`available at http1//quote.morningstar.com/stock—tiling/Annual-
`
`Report/2003/3/31/t.aspx?t=:BTGGF&ft=&d=b2310ebce3f8ee5l, last visited on or
`
`before March 17, 2017. An exhibit label has been added, but no other alterations
`
`have been made.
`
`IPR2016—O1582
`
`Page 12 of 14
`
`
`
`39.
`
`Exhibit JSN 2138, filed on March 17,2017, is a true and correct copy
`
`of BTG plc Annual report and accounts for the year ended 31 March 2004
`
`available at http://quote.morningstar.com/stock—filing/Annual-
`
`Report/2004/3/31/t.aspx?t=:BTGGF&ft=&d=ac2f13da52c10e66, last visited on or
`
`before March 17, 2017. An exhibit label has been added, but no other alterations
`
`have been made.
`
`40.
`
`Exhibit JSN 2151, filed on March 17, 2017, is a true and correct copy
`
`of the Patent Owner Response submitted in IPR2016—00286 on October 4, 2016.
`
`An exhibit label has been added, but no other alterations have been made.
`
`41.
`
`Exhibit JSN 2154, filed on March 17, 2017, is a true and correct copy
`
`of the Patent Owner Response submitted in IPR2016—01332 on March 8, 2017. An
`
`exhibit label has been added, but no other alterations have been made.
`
`42.
`
`Exhibit JSN 2158, filed on March 17, 2017, is a true and correct copy
`
`of ECOG Performance Status, available at http://ecog—acrin.org/resources/ecog—
`
`performance—status, last Visited on or before March 17, 2017. An exhibit label has
`
`been added, but no other alterations have been made.
`
`IPR2016—01582
`
`Page 13 of 14
`
`
`
`I hereby declare that all statements made herein of my own knowledge are
`
`true and that all statements made on information or belief are believed to be
`
`true; and further that these statements were made with the knowledge that willful
`
`false statements and the like so made are punishable by fine or imprisonment, or
`
`both, under Section 1001 of Title 18 ofthe United States Code.
`
`Dated: March 17, 2017
`
`Bindu Donovan
`
`IPR20l6-01582
`
`Page 14 ofl4
`
`
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