`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________
`
`WOCKHARDT BIO AG,
`Petitioner
`v.
`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`____________________________
`
`Case IPR: 2016-01582
`U.S. Patent No. 8,822,438
`____________________________
`
`
`
`
`SECOND SUPPLEMENTAL DECLARATION OF ROBERT D. STONER,
`Ph.D.
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-145
`
`WCK1124
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`IPR2016-01582
`
`
`
`Inter Partes Review of U.S. Patent No. 8,822,438
`Second Supplemental Declaration of Robert D. Stoner, Ph.D.
`I, Robert D. Stoner, Ph.D., declare and state that the following is true and accurate
`
`based on my personal knowledge, education, experience, study, and the
`
`information that has been made available to me to date:
`
`1.
`
`I am the same Robert D. Stoner who submitted declarations in this
`
`inter partes review proceeding IPR2016-01582 on August 10, 2016 (WCK1077),
`
`February 14, 2017 (Supplemental Declaration), and April 19, 2017 (WCK1103 and
`
`WCK1122), respectively. These declarations described the scope of my work, my
`
`background, my qualifications, my opinions, and/or the basis for certain Exhibits
`
`cited in my Initial and Reply Declarations.
`
`2.
`
`I understand from counsel that Patent Owner Janssen Oncology, Inc.
`
`("Janssen") filed a paper on April 26, 2017, which, in part, objected to certain
`
`Exhibits cited to and filed with my Reply Declaration.
`
`3.
`
`I understand from counsel that Janssen objected to Wockhardt
`
`Exhibits ("WCK") 1087, 1100, 1102, 1107, 1109, 1110, 1112, and 1114 cited in
`
`my Reply Declaration. I understand that Janssen asserted that Petitioner
`
`Wockhardt’s ("Wockhardt") Reply and my Reply Declaration did not establish the
`
`origin of those documents or that the documents are a true and correct copy of
`
`what they purport to be and hence inauthentic, or that the documents are either
`
`incomplete or an improper summary. I disagree with Janssen’s assertions and, in
`
`
`
`
`
`
`
`2
`
`WCK1124
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`IPR2016-01582
`
`
`
`Inter Partes Review of U.S. Patent No. 8,822,438
`Second Supplemental Declaration of Robert D. Stoner, Ph.D.
`response, submit this Second Supplemental Declaration to address certain of these
`
`objections.
`
`4. WCK1087, WCK1102, and WCK1100 are copies of publicly
`
`available informational materials from various websites regarding the development
`
`and market of abiraterone. Experts in economics and competition, and product and
`
`market valuation, routinely rely on materials such as WCK1087, WCK1102, and
`
`WCK1100 when analyzing a product’s use, characteristics, and development, as
`
`well as a product’s market and barriers to entry, such as in the opinions set forth in
`
`my Initial and Reply Declarations.
`
`5. WCK1087 is a true and correct copy of a document that I downloaded
`
`on April 3, 2017 from the "Press Releases" page on BTG plc’s website at:
`
`https://www.btgplc.com/media/press-releases/btg-licenses-new-prostate-cancer-
`
`drug-to-cougar-biotechnology/ ("BTG Licenses New Prostate Cancer Drug to
`
`Cougar Biotechnology").
`
`6. WCK1102 is a true and correct copy of a document that I downloaded
`
`on April 17, 2017 from the "Latest features" page, available under "Latest features"
`
`in the "News" section, on The Institute of Cancer Research’s website at:
`
`http://www.icr.ac.uk/news-features/latest-features/abiraterone-a-story-of-scientific-
`
`innovation-and-commercial-partnership ("Abiraterone: a story of scientific
`
`innovation and commercial partnership").
`
`
`
`
`
`
`
`3
`
`WCK1124
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`IPR2016-01582
`
`
`
`Inter Partes Review of U.S. Patent No. 8,822,438
`Second Supplemental Declaration of Robert D. Stoner, Ph.D.
`7. WCK1100 is a true and correct copy of a document that I downloaded
`
`on April 17, 2017 from the "Science blog" page, available under "Cancer news" in
`
`the "About us" section, on Cancer Research UK’s website at:
`
`http://scienceblog.cancerresearchuk.org/2015/09/21/our-milestones-the-birth-of-a-
`
`new-prostate-cancer-drug/ ("Our milestones: the birth of a new prostate cancer
`
`drug").
`
`8. WCK1107 and WCK1114 are copies of academic publications
`
`regarding applied economic principles to intellectual property. Experts in
`
`economics and competition, and product and market valuation, routinely rely on
`
`materials such as WCK1107 and WCK1114 when evaluating a product’s relevant
`
`market and expected upfront costs, revenues, and profits, particularly in the
`
`pharmaceutical industry, such as in the opinions set forth in my Initial and Reply
`
`Declarations.
`
`9. WCK1107 is a true and correct copy of an article authored by J.
`
`Mestre-Ferrandiz, J. Sussex, and A. Towse, published by the Office of Health
`
`Economics that I downloaded on April 17, 2017 from the "Publications" section on
`
`the Office of Health Economics’ website at: https://www.ohe.org/publications/rd-
`
`cost-new-medicine (“The R&D Cost of a New Medicine”). Though WCK1107
`
`provides an executive summary on pages 8-12, WCK1107 is a well-cited 80+ page
`
`publication that, as stated on page 4, "has undergone a rigorous peer review by the
`
`
`
`
`
`
`
`4
`
`WCK1124
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`IPR2016-01582
`
`
`
`Inter Partes Review of U.S. Patent No. 8,822,438
`Second Supplemental Declaration of Robert D. Stoner, Ph.D.
`independent OHE Editorial Board and other experts in the field," and which
`
`thoroughly provides the sources of the referenced original data and information
`
`underlying the disclosed figures and tables. For instance, pages 93-98 of
`
`WCK1107 lists all references cited therein.
`
`10. WCK1114 is a true and correct copy of an article authored by Jesse
`
`David and Marion B. Stewart (“Commercial Success: Economic Principles
`
`Applied to Patent Litigation”) that I obtained on April 17, 2017 with the assistance
`
`of my employer Economists Incorporated’s library, extracted from a 399 page
`
`compilation of multiple articles published by the National Economic Research
`
`Associates, Inc. and edited by Drs. Gregory K. Leonard and Lauren J. Stiroh (titled
`
`"Economic Approaches to Intellectual Property: Policy, Litigation, and
`
`Management").
`
`11.
`
`I understand from counsel that Janssen objected to WCK1114 cited in
`
`my Reply Declaration for allegedly being incomplete. I have supplied the entirety
`
`of WCK1114 in this proceeding as an attachment to this Declaration.
`
`12. WCK1109, WCK1110, and WCK1112 are copies of publicly
`
`available background and informational materials concerning Janssen’s U.S. and
`
`EU abiraterone product(s) and/or development thereof. Experts in economics and
`
`competition, and product and market valuation, routinely rely on materials such as
`
`WCK1109, WCK1110, and WCK 1112 when analyzing a product’s use,
`
`
`
`
`
`
`
`5
`
`WCK1124
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`IPR2016-01582
`
`
`
`Inter Partes Review of U.S. Patent No. 8,822,438
`Second Supplemental Declaration of Robert D. Stoner, Ph.D.
`development, characteristics, and marketplace success, such as in the opinions set
`
`forth in my Initial and Reply Declarations.
`
`13. WCK1109 is a true and correct copy of a webpage, regarding clinical
`
`trial NCT0205010, which I printed on April 17, 2017 from the "Study Record
`
`Details" section on the ClinicalTrials.gov website at:
`
`https://clinicaltrials.gov/ct2/show/NCT02025010 ("Phase II Clinical Trial of
`
`Abiraterone Acetate Without Exogenous Glucocorticoids in Men with Castration-
`
`resistant Prostate Cancer with Correlative Assessment of Hormone Intermediates").
`
`14. WCK1110 is a true and correct copy of an article that I downloaded
`
`on April 18, 2017 from the "Press Releases" page, available under the "Media
`
`Center" section, of Johnson & Johnson’s website at: https://www.jnj.com/media-
`
`center/press-releases/zytiga-approved-in-the-eu-for-use-in-the-treatment-of-
`
`metastatic-castration-resistant-prostate-cancer-before-chemotherapy ("Zytiga®
`
`Approved in the EU for Use in the Treatment of Metastatic Castration-Resistant
`
`Prostate Cancer Before Chemotherapy").
`
`15. WCK1112 was submitted in IPR2016-00286 as Amerigen Exhibit
`
`1151 by Dr. McDuff. I obtained WCK1112 on April 18, 2017 from the United
`
`States Patent Trial and Appeal Board’s End to End (E2E) system at
`
`https://ptab.uspto.gov/#/login. It is my understanding that a true and correct
`
`updated version of WCK1112 can be obtained from the "Document Library"
`
`
`
`
`
`
`
`6
`
`WCK1124
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`IPR2016-01582
`
`
`
`Inter Partes Review of U.S. Patent No. 8,822,438
`Second Supplemental Declaration of Robert D. Stoner, Ph.D.
`section on the European Medicines Agency’s website at:
`
`http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
`
`_Product_Information/human/002321/WC500112858.pdf ("EMA – Zytiga Product
`
`Information"). I have supplied a replacement of WCK1112 in this proceeding as an
`
`attachment to this Declaration.
`
`16.
`
`I confirm that to the best of my knowledge, the Exhibits cited in my
`
`Reply Declaration (WCK1103 and WCK1122) are true and accurate copies, and
`
`that an expert in the field would typically and reasonably rely on them to formulate
`
`opinions such as those set forth in my Initial and Reply Declarations.
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`7
`
`WCK1124
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`IPR2016-01582
`
`
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`8
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`WCK1124
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`IPR2016-01582
`
`
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