throbber
IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`In the Inter Partes Review (IPR) of
`U.S. Patent No. 8,822,438
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`DECLARATION OF DEFOREST MCDUFF, Ph.D.
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`
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`I, DeForest McDuff, Ph.D., declare as follows:
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`I.
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`Introduction
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` Qualifications
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`1. My qualifications are generally described in Section I.A.1 of my initial
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`declaration submitted on December 4, 2015 (“Initial Declaration”).1 I incorporate
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`those qualifications by reference here. I have also provided an updated curriculum
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`vitae in Attachment A-1 to this declaration, which contains more details on my
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`background, experience, publications, and prior testimony.
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`
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`Scope of Work
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`2.
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`Intensity Corporation has been retained by McNeely, Hare & War, LLP
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`on behalf of Amerigen Pharmaceuticals Limited in connection with my work in this
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`matter. Intensity Corporation is being compensated at a rate of $700 per hour for
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`my work and at lower rates for time spent by others on my team. The compensation
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`1
`AMG 1017: McDuff Declaration, 12/4/2015.
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`Declaration of DeForest McDuff, Ph.D.
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`of Intensity Corporation is not dependent on the substance of my testimony or the
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`outcome of this matter.
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`3.
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`For this declaration, I was asked to review and discuss the declaration
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`of Dr. Christopher Vellturo relating to the alleged commercial success of Zytiga
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`(abiraterone acetate) and U.S. Patent No. 8,822,438 (“the ’438 patent”). This
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`declaration is a statement of my opinions in this matter and the basis and reasons for
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`those opinions. In forming the opinions expressed in this declaration, I have relied
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`upon my education, experience, and knowledge of the subjects discussed.
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`4.
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`This declaration summarizes only my current opinions, which are
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`subject to change depending upon additional information and/or analysis. The
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`entirety of my declaration, including attachments and referenced materials, supplies
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`the basis for my analysis and conclusions. The organizational structure of the
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`declaration is for convenience. To the extent that facts, economic analysis, and other
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`considerations overlap, I generally discuss such issues only once for the sake of
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`brevity. Neither the specific order in which each issue is addressed nor the
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`organization of my declaration or attachments affects the ultimate outcome of my
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`analysis.
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`Declaration of DeForest McDuff, Ph.D.
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`II. Analysis of the Vellturo Declaration
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` Overview
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`5.
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`Commercial success is a secondary consideration that a patent owner
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`may use to argue that its patent is not obvious based on the alleged commercial
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`success of an invention embodying that patent. I understand that commercial
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`success is relevant to the determination of a patent’s obviousness since the law
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`presumes that an idea would have been brought to market sooner in response to
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`market forces had it been obvious to persons skilled in the art.
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`6.
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`I understand that to show that commercial success demonstrates non-
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`obviousness, one must establish that (1) a product embodying the patented invention
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`is commercially successful (i.e., it achieved marketplace success), and (2) that the
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`marketplace success was driven by the advantages of the claimed invention (i.e.,
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`there must be proof of a causal nexus). I further understand that to establish a proper
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`nexus between a claimed invention and the commercial success of a product, a patent
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`owner must offer proof that the sales were a direct result of the unique characteristics
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`of the claimed invention, and not a result of economic and commercial factors
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`unrelated to the quality of the patented subject matter. Finally, I understand that if
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`commercial success is due to an element in the prior art, no nexus exists.
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`7.
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`In my opinion, the Vellturo Declaration has a number of shortcomings
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`and does not establish that Zytiga in combination with prednisone has been a
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`commercial success nor that there is a strong connection or nexus to the alleged
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`innovations of the ’438 patent. In addition, none of the opinions or evidence I have
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`reviewed from the Vellturo Declaration has caused me to change my primary
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`opinions from my Initial Declaration. These opinions are discussed in more detail
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`below.
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`
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`The Vellturo Declaration does not demonstrate that Zytiga is a
`commercial success
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`8.
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`The Vellturo Declaration concludes that Zytiga in combination with
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`prednisone is a commercial success based on: (1) a tabulation of abiraterone sales
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`and calculation of growth without any context for that tabulation and without a
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`comparison of that tabulation to a number of comparable mCRPC drugs in the
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`market, (2) a calculation of market share without defining a relevant market and
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`without including a number of comparable mCRPC drugs with which to compare
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`Zytiga in a market, and (3) a statement that Zytiga is a top 50 drug product without
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`providing other appropriate context.2 However, Dr. Vellturo’s analysis is
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`insufficient to establish the commercial success of the abiraterone-prednisone
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`2
`JSN 2044: Vellturo Declaration, 10/10/2016, ¶¶ 41–43.
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`combination subject to the ’438 patent claims. Specifically, it has several
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`shortcomings and fails to show one way or the other whether Zytiga in combination
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`with prednisone has been commercially successful in the context of an obviousness
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`inquiry.
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`9.
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`In general, a commercial success analysis can provide evidence of a
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`product’s absolute success (i.e., its sales and profitability) or its relative success (i.e.,
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`its market performance relative to its peers). On both accounts, for the reasons
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`described herein, Dr. Vellturo has failed to meet the burden to prove Zytiga’s alleged
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`commercial success.
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`10. First, at its core, the Vellturo Declaration fails to provide sufficient
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`context for determining whether abiraterone sales and sales growth are actually
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`substantial relative to the industry or to other potential benchmarks used for
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`evaluating commercial success. The Vellturo Declaration also provides no
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`benchmarks for success or comparison of the costs associated with bringing Zytiga
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`to market (see Section II.C. below). Dr. Vellturo provides limited comparisons only
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`to two other mCRPC drugs in his calculation of market share, but no comparisons
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`to other mCRPC drugs, such as Xofigo, Provenge, Taxotere, Casodex, and Lupron
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`Depot. Similarly, the Vellturo Declaration notes Zytiga’s position among top 50
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`drug products in terms of annual sales, but provides no context for Zytiga’s lifetime
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`sales and whether those are sufficient to show a commercially successful drug
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`product. On net, because Dr. Vellturo has not provided appropriate evidence of
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`points of comparison for Zytiga sales, he has not adequately demonstrated or proved
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`Zytiga’s alleged commercial success.
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`11. Second, the Vellturo Declaration provides no definition of a relevant
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`market or set of competition, a considerable deficiency of his analysis. Dr. Vellturo
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`simply provides Zytiga’s share of sales among two select mCRPC treatments, Xtandi
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`and Jevtana,3 without providing justification for the selection of these treatments as
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`relevant market competitors over other mCRPC treatments like Xofigo, Provenge,
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`Taxotere, Casodex, and Lupron Depot.4 It is a considerable shortcoming to omit
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`alternative mCRPC treatments in a market share analysis because they represent a
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`number of alternative treatment options to Zytiga, and are competitors in the market.
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`Similarly, Dr. Vellturo provides Zytiga’s share of extended units among only Xtandi
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`and Jevtana.5 In addition to ignoring other mCRPC treatments, the comparison of
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`extended units offers a skewed share calculation since it incorrectly compares
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`
`3
`JSN 2044: Vellturo Declaration, 10/10/2016, ¶ 42.
`4
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`See, e.g.: AMG 1061: Wells Fargo Securities, LLC., “Johnson & Johnson,”
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`6/29/2015, at 3-8.
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`5
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`JSN 2044: Vellturo Declaration, 10/10/2016, footnote 10.
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`milliliters of liquid (i.e., Jevtana extended unit) to tablets (i.e., Zytiga and Xtandi
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`extended unit), which are not used with the same frequency or in the same amounts.6
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`In other words, 1 millimeter of liquid does not equal 1 tablet, and an IV taken once
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`every 3 weeks is not comparable to tablets taken every day. In short, Dr. Vellturo
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`relies on a misleading apples-to-oranges comparison in his market share evaluation.
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`Finally, the Vellturo Declaration fails to consider the prostate treatment market more
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`broadly, where Zytiga represents a share of only 3% to 6%.7 Because Dr. Vellturo
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`has not defined a relevant market and because his evidence of market share is
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`otherwise flawed, he again has not adequately demonstrated or proved Zytiga’s
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`alleged commercial success.
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`12. Third, while Dr. Vellturo notes that Zytiga is a top 50 drug product, Dr.
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`Vellturo fails to evaluate a number of other relevant factors that appropriately
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`contextualize Zytiga’s sales. For example, as discussed in my Initial Declaration,
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`Zytiga has been losing market share due to competition from Xtandi, evidence
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`6
`Jevtana label, 9/2016.
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`Zytiga label, 5/2016.
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`Xtandi label, 10/2016.
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`AMG 1049: Jevtana Website, Dosing and Administration,
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`http://www.jevtana.com/hcp/dosing/default.aspx (accessed 8/20/2015).
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`7
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`AMG 1017: McDuff Declaration, 12/4/2015, ¶ 24.
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`indicates that Xtandi earns premium pricing relative to Zytiga, and analyst coverage
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`of the prostate cancer market demonstrates a market perception that Xtandi is
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`superior to Zytiga and will likely become the premier treatment.8 In light of these
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`market conditions, Zytiga’s sales are not as impressive as Dr. Vellturo suggests.
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` The Vellturo Declaration does not evaluate profits
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`13. A fundamental consideration of commercial success is whether the
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`sales and profits are large enough that the market would have brought a product or
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`products to market sooner if the claimed subject matter were obvious. Consistent
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`with this, an evaluation of commercial success should involve an evaluation of
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`profits in relation to costs of bringing a product to market. The Vellturo
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`Declaration tabulates and analyzes Zytiga sales,9 but provides no information or
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`analysis by which to evaluate profits. An evaluation of sales alone does not
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`demonstrate commercial success (i.e., that there were incentives to bring a product
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`to market), since firms seek to maximize profits, not sales. As such, he fails to
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`demonstrate commercial success.
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`14. A fundamental economic question in the pharmaceutical industry (and
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`more generally) involves comparing the expected costs of commercialization and
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`
`8
`AMG 1017: McDuff Declaration, 12/4/2015, § III.E.
`9
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`JSN 2044: Vellturo Declaration, 10/10/2016, ¶ 41.
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`FDA approval to potential sales and profits, occurring with uncertainty and many
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`years into the future.10 Published research shows that the costs of
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`commercialization and FDA approval are substantial, with fully capitalized and
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`risk-adjusted expenses associated with development and commercialization now
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`exceeding $2.5 billion, on average.11 These estimates of the total economic cost of
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`bringing a drug to market account for the out-of-pocket costs, opportunity cost, and
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`10
`For a variety of sources and discussion, see:
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`Mestre-Ferrandiz, Jorge, Jon Sussex, and Adrian Towse (2012), “The R&D
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`Cost of a New Medicine,” Office of Health Economics, London UK, 1–86.
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`DiMasi, Joseph, Henry Grabowski, and Ronald Hansen (2016), "Innovation
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`in the pharmaceutical industry: New estimates of R&D costs," Journal of
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`Health Economics 47: 20–33.
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`David, Jesse and Marion B. Stewart (2005), “Commercial Success:
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`Economic Principles Applied to Patent Litigation,” in Gregory K. Leonard
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`and Lauren J. Stiroh, ed., Economic Approaches to Intellectual Property
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`Policy, Litigation, and Management, White Plains, NY: National Economic
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`Research Associates, Inc., at 196 (“From an economic perspective,
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`commercial success could in principle be defined by a single criterion: Does
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`the patented invention earn a positive net return (risk-adjusted) on invested
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`capital after accounting for all relevant costs associated with developing and
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`commercializing the patent as well as any alternatives available to the patent
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`holder?”).
`11 DiMasi, Joseph, Henry Grabowski, and Ronald Hansen (2016), "Innovation
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`in the pharmaceutical industry: New estimates of R&D costs," Journal of
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`Health Economics 47: 20–33, at 20.
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`uncertainty of failed research and development, which are common and expected
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`in the pharmaceutical industry.12
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`15. The Vellturo Declaration fails to consider profits of any sort, not only
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`economic profits more generally but even accounting profits earned over time by
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`Zytiga (i.e., no evaluation of Zytiga cost of sales, marketing, or any other
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`expenditures). This is a significant shortcoming of his analysis, without which he
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`has failed to demonstrate commercial success.
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` The Vellturo Declaration does not establish a nexus to the ’438
`patent
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`16. The Vellturo Declaration argues that Zytiga’s commercial success is
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`due “in significant part to the claims of the ’438 patent,”13 because: (1) the ’438
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`patent covers the only FDA-approved use of Zytiga;14 (2) physicians value Zytiga –
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`12 Mestre-Ferrandiz, Jorge, Jon Sussex, and Adrian Towse (2012), “The R&D
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`Cost of a New Medicine,” Office of Health Economics, London UK, 1–86, at
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`5.
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`DiMasi, Joseph, Henry Grabowski, and Ronald Hansen (2016), "Innovation
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`in the pharmaceutical industry: New estimates of R&D costs," Journal of
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`Health Economics 47: 20–33, at 28.
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`JSN 2044: Vellturo Declaration, 10/10/2016, § IV.B.
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`That the ’438 patent covers the “only FDA-approved use of Zytiga” is of no
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`moment, as the Patent Owner (owner of both the abiraterone acetate patent
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`(’213 patent) and the ’438 patent), dictating the sequence of approvals sought
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`13
`14
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`the combination of abiraterone acetate and prednisone – for its therapeutic survival
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`benefit; (3) Zytiga’s commercial success is not attributable to excessive marketing
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`spend levels; and (4) Zytiga’s commercial success is not due to aggressively low
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`pricing.15 However, Dr. Vellturo’s analysis does not show a nexus to the ’438 patent;
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`rather, he incorrectly evaluates and omits evidence that shows a lack of nexus. In
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`contrast, as described in Section III.F of my Initial Declaration16 and further
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`described herein, I find a lack of nexus to the ’438 patent.
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`from the FDA, elected initially to seek approval in the U.S. of only the
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`abiraterone acetate and prednisone combination. Of course, it is the only FDA
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`approved use of Zytiga. The ’438 patent describes numerous steroid agents
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`in combination with abiraterone (for each of which Patent Owner could, at
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`least in theory, seek regulatory approval for the treatment of prostate cancer.
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`Notably, Patent Owner sought and received approval abroad for abiraterone
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`acetate co-administered with either prednisone or prednisolone (separately
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`described as a glucocorticoid suitable according to the “invention” of the ’438
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`patent (AMG 1001, col. 10:25-31) (https://www.jnj.com/media-center/press-
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`releases/zytiga-approved-in-the-eu-for-use-in-the-treatment-of-metastatic-
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`castration-resistant-prostate-cancer-before-chemotherapy)). I additionally
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`understand that Patent Owner is currently collaborating in a clinical trial
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`evaluating abiraterone acetate monotherapy to treat mCRPC, NCT 02025010
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`(AMG 1139).
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`15
`JSN 2044: Vellturo Declaration, 10/10/2016, § IV.B.
`16 AMG 1017: (McDuff Declaration, 12/4/2015), § III.F.
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`17. First, Dr. Vellturo’s mere assertion that the ’438 patent covers Zytiga
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`is not sufficient to establish nexus.17 As an Orange Book listed patent, the ’438
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`patent necessarily is alleged to cover FDA-approved use of Zytiga. However, in
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`order to establish nexus, I understand that there must be a direct and demonstrable
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`connection between the innovative aspects of the claimed technology and what is
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`driving sales of Zytiga, as opposed to what is known as prior art. As described in
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`Section III.F of my Initial Declaration and throughout this declaration, there is no
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`such connection between the innovative aspects of the claimed technology and the
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`sales of Zytiga. The Vellturo Declaration has provided no evidence to the contrary.
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`18. Second, the Vellturo Declaration provides no convincing evidence that
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`physicians “overwhelmingly prescribe the combination” of abiraterone acetate and
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`prednisone.18 In an attempt to support this notion, Dr. Vellturo relies on a single
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`17
`JSN 2044: Vellturo Declaration, 10/10/2016, § IV.B.1.
`18
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`JSN 2044: Vellturo Declaration, 10/10/2016, § IV.B.2.a.
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`Even if physicians do “overwhelmingly” prescribe the combination, apart
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`from new testimony evidence from Dr. Rettig, Dr. Vellturo points to no
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`evidence that the reason for prescribing the combination is due to any
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`perception that the efficacy of abiraterone acetate in treating prostate cancer
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`is maximized through its concomitant administration of prednisone. In fact,
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`I understand from Dr. Serels that when the abiraterone acetate and prednisone
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`are prescribed, the prescriptions are written based on Zytiga prescribing
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`document summarizing physician intent for Zytiga prescriptions from IBM Explorys
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`EHR data from August 2013 to July 2016.19 Dr. Vellturo argues that “at least 89%
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`of patients prescribed Zytiga between mid-2013 and mid-2016 were prescribed the
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`combination of abiraterone acetate and prednisone,”20 but does not appropriately
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`contextualize the underlying data. The study finds that 89% of patients received
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`Zytiga and any dosage and form (oral, IV, etc.) of prednisone at least once during
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`the last three years.21 That is, there is no indication of how frequently those 89% of
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`information that indicates that abiraterone acetate and prednisone perform
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`according to their individual known properties, as opposed to any maximized
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`effect of abiraterone acetate through the concomitant administration of
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`prednisone. AMG 1095, Serels Declaration, ¶ 19; Vellturo Declaration,
`10/10/2016, § IV.B.2.a.
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`19
`JSN 2095: Zytiga Usage – Zytiga patients who had prednisone (2016).
`20 Vellturo Declaration, 10/10/2016, ¶ 47.
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`21
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`Chris Vellturo, Ph.D., Dep. Tr., 12/20/2016, at 37:3–38:4.
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`JSN 2095: Zytiga Usage – Zytiga patients who had prednisone (2016).
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`Chris Vellturo, Ph.D., Dep. Tr., 12/20/2016, at 39:2–24.
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`A second interpretation of the study, which would similarly establish the
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`lack of relevance of its findings, is that the study omits patients that never
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`received the combination. That is, 100% of the patients in the study have
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`received the combination at some point in their life, and 89% have received
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`the combination in the last three years. Either way, Dr. Vellturo did not
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`appropriately investigate and could not provide basic information regarding
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`the patient population or prescribers in the study. See, e.g.:
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`patients were prescribed the combination (although it is clear that 11% never
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`received the combination in the last three years). Dr. Vellturo has admitted that the
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`study states: “Data represents more of physicians’ prescribing intent than actual
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`treatment,” that the study does not state whether the patients were taking prednisone
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`for the treatment of prostate cancer, that he does not know how many doctors were
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`involved in this study, and that he does not recall whether each patient is reported
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`only once in the dataset.22 Dr. Vellturo then also cites the personal prescribing habits
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`of Dr. Serels and Dr. Rettig, which is too small a sample to draw any significant
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`conclusions beyond these physicians’ individual experiences.23
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`19. Third, even if Zytiga is most commonly used with prednisone (as Dr.
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`Vellturo argues in § IV.B.2–3), an important inquiry for purposes of demonstrating
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`nexus whether is whether the sales are due specifically to the unique and novel
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`characteristics of the patented invention, which the Patent Owner has stated is the
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`purported unexpected maximizing of the anti-cancer effect of abiraterone acetate in
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`treating prostate treat when abiraterone acetate and prednisone are co-administered
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`Rettig Decl. (JSN 2038), ¶177); PO Response 1-2, 55-56], not what is known in the
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`Chris Vellturo, Ph.D., Dep. Tr., 12/20/2016, at 40:22–45:16.
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`22
`23
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`Chris Vellturo, Ph.D., Dep. Tr., 12/20/2016, at 40:22–45:16.
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`JSN 2044: Vellturo Declaration, 10/10/2016, ¶ 48.
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`art. In other words, I understand that the mere existence of abiraterone use with
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`prednisone does not prove that additional anti-cancer effects derive from the
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`combination.
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`20. Furthermore, evidence indicates that Zytiga would have achieved
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`largely similar commercial performance without the specific abiraterone /
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`prednisone combination, indicating that sales are not driven by the claimed
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`technology. Several factors indicate that the impact of the co-administration with
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`prednisone on sales is limited: (1) the ’438 patent specification describes co-
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`administration with a number of glucocorticoids beyond prednisone;24 (2) Zytiga is
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`approved in the EU for co-administration with prednisone or prednisolone;25
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`(3) abiraterone can be prescribed with prednisolone (separately identified in the ’438
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`patent specification as another glucocorticoid suitable for administration with
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`24 AMG 1001: Methods and Compositions for Treating Cancer, U.S. Patent
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`No. 8,822,438, col. 10 l.25–41 (filed 2/24/2011, issued 9/2/2014).
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`Chris Vellturo, Ph.D., Dep. Tr., 12/20/2016, at 57:22–58:12, 108:20–109:11.
`25 AMG 1150: Johnson & Johnson, “Zytiga Approved in the EU for Use in the
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`Treatment of Metastatic Castration-Resistant Prostate Cancer Before
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`Chemotherapy,” 1/11/2013; see also AMG 1151: EMA – Zytiga information
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`-- http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
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`_Product_Information/human/002321/WC500112858.pdf; compare AMG
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`1019.
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`abiraterone);26 (4) abiraterone is marketed by Janssen in the EU with either
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`prednisone or prednisolone;27 and (5) Janssen is currently participating in clinical
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`trials for an abiraterone product without prednisone co-administration, and has a
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`pending patent application including claims directed to co-administration of
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`abiraterone and dexamethasone.28 I am aware of no evidence set forth by Dr.
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`Vellturo or otherwise that physicians prescribe abiraterone with prednisone for any
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`reason other than the labeling and FDA approval, or that the combination of
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`abiraterone and prednisone drives sales above and beyond what would be the
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`demand for abiraterone acetate alone if co-administration of a glucocorticoid were
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`26 AMG 1089: Dizdar (2015), “Is Dexamethasone a Better Partner for
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`Abiraterone than Prednisolone?” The Oncologist 20(13).
`
`Chris Vellturo, Ph.D., Dep. Tr., 12/20/2016, at 105:5–107:10.
`
`AMG 1001: Methods and Compositions for Treating Cancer, U.S. Patent
`
`No. 8,822,438, col.10 l.25–41 (filed 2/24/2011, issued 9/2/2014).
`
`27
`
`Johnson & Johnson, “Zytiga Approved in the EU for Use in the Treatment
`
`of Metastatic Castration-Resistant Prostate Cancer Before Chemotherapy,”
`
`1/11/2013, 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.
`
`28
`
`Chris Vellturo, Ph.D., Dep. Tr., 12/20/2016, at 140:23–25.
`
`AMG 1091: Ratain Declaration, 1/16/2017, ¶ 67; AMG 1146 (dex and AA
`
`application).
`
`Declaration of DeForest McDuff, Ph.D.
`
`
`
`16
`
`AMG 1152
`
`
`
`
`
`
`
`
`

`

`not required. In fact, the evidence above indicates the opposite may be true and thus
`
`there is lack of nexus. Said another way, Zytiga’s FDA approval with prednisone
`
`may drive its market performance to some degree but does not, by itself, indicate a
`
`nexus to the claimed invention.
`
`21. Fourth, Dr. Vellturo’s commercial success analysis does not consider
`
`the impact of dosage form on Zytiga’s sales. Zytiga is a tablet for oral
`
`administration, while other leading competitors like Jevtana require IV infusion or
`
`injection,29 which is less convenient or otherwise more costly for mCRPC patients.30
`
`The contribution of Zytiga’s oral form to earning prescriptions and sales further
`
`substantiates the lack of nexus to the ’438 patent since the alleged innovation is
`
`unrelated to that benefit.
`
`22. Fifth, Dr. Vellturo fails to respond to other factors examined in my
`
`Initial Declaration that show a lack of nexus to the ’438 patent. These include: (1)
`
`Zytiga’s compound and primary active ingredient (abiraterone acetate) is alleged to
`
`be covered by the ’213 patent, not the ’438 patent (to which Dr. Vellturo apparently
`
`
`29
`Jevtana label, 9/2016.
`
`
`
`AMG 1049: Jevtana Website, Dosing and Administration,
`
`http://www.jevtana.com/hcp/dosing/default.aspx (accessed 8/20/2015).
`30 AMG 1091: Ratain Declaration, 1/16/2017, ¶ 71.
`
`
`
`
`
`
`Declaration of DeForest McDuff, Ph.D.
`
`
`
`17
`
`AMG 1152
`
`

`

`accords no weight in the marketplace success of Zytiga);31 (2) methods of treating
`
`patients with combinations of drugs are known and common in the marketplace for
`
`cancer treatment;32 for example, Jevtana and docetaxel (both of which are indicated
`
`for the treatment of mCRPC) are often prescribed in combination with prednisone;33
`
`and (3) the incremental contribution of the alleged innovation of the ’438 patent
`
`beyond existing treatment is relatively low.34 As discussed, Dr. Vellturo offers no
`
`meaningful rebuttal to any of these points in his rebuttal declaration.
`
`23. Lastly, consistent with the Vellturo Declaration, I have seen no
`
`evidence that marketing and pricing have been particularly impactful one way or the
`
`other. However, I am not aware of any marketing materials that emphasize the
`
`antitumoral benefits of prednisone, and Dr. Vellturo does not offer any evidence of
`
`such materials, indicating further lack of nexus to the claimed subject matter.35
`
`
`31 AMG 1017: McDuff Declaration, 12/4/2015, ¶ 32.
`32 AMG 1017: McDuff Declaration, 12/4/2015, ¶ 33.
`33
`
`Chris Vellturo, Ph.D., Dep. Tr., 12/20/2016, at 80:10–81:3.
`
`
`
`AMG 1149: Jevtana label, 9/2016.
`
`
`AMG 1032: Taxotere label.
`34 AMG 1017: McDuff Declaration, 12/4/2015, ¶ 35.
`35
`
`Chris Vellturo, Ph.D., Dep. Tr., 12/20/2016, at 47:24–48:4.
`
`
`
`
`
`
`Declaration of DeForest McDuff, Ph.D.
`
`
`
`18
`
`AMG 1152
`
`

`

` Dr. Vellturo’s arguments and evidence on the ’213 patent are
`unpersuasive
`
`24.
`
`In Section III.B. of my Initial Declaration, I state that the ’213 patent is
`
`a blocking patent that limits the economic relevance of commercial success.36 In
`
`response, the Vellturo Declaration argues that the ’213 patent, or “Barrie Patent,” as
`
`a blocking patent does not invalidate a commercial success assessment.37 In
`
`particular, Dr. Vellturo claims that the ’213 patent “did not serve as a disincentive
`
`to the industry to discover the invention claimed in the ’438 patent, as numerous
`
`opportunities arose that provided access to the Barrie patent.”38 However, Dr.
`
`Vellturo’s claims are largely unsupported and do not support a notion of the ’213
`
`patent being broadly available or accessible. As such, he provides little to no
`
`evidence that other parties were able to access the ’213 patent and then had the
`
`incentives to develop the claimed technology in the ’438 patent. Thus, the existence
`
`of the ’213 patent, which covers abiraterone acetate, as a blocking patent indicates
`
`
`36 AMG 1017: McDuff Declaration, 12/4/2015, § III.B.
`37
`38
`
`JSN 2044: Vellturo Declaration, 10/10/2016, § III.B.
`
`JSN 2044: Vellturo Declaration, 10/10/2016, ¶ 28.
`
`
`
`
`
`
`Declaration of DeForest McDuff, Ph.D.
`
`
`
`19
`
`AMG 1152
`
`

`

`limited, if any, relevance of any alleged success on inferences of obviousness of the
`
`’438 patent.39
`
`25. First, Dr. Vellturo could not identify a single alleged licensing
`
`opportunity relating to the ’213 patent. Dr. Vellturo acknowledged that he did not
`
`study any terms of any proposed partnering, development, or license agreements
`
`involving the ’213 patent and has seen no evidence of the identities of the parties
`
`approached in the alleged “numerous opportunities” that arose to access the ’213
`
`patent.40 As such, there is no direct evidence indicating that the ’213 patent was
`
`actively shopped. In fact, for his claims regarding the patent holder’s search for a
`
`
`39 Merck v. Teva Phams. USA, Inc., 395 F.3d 1364, 1376-77 (Fed. Cir. 2005)
`
`(“Commercial success is relevant because the law presumes an idea would
`
`successfully have been brought to market sooner, in response to market forces,
`
`had the idea been obvious to persons skilled in the art… In this case Merck
`
`had a right to exclude others from practicing the weekly-dosing of alendronate
`
`specified in claims 23 and 37, given (1) another patent covering the
`
`administration of alendronate sodium to treat osteoporosis, U.S. Pat. No.
`
`4,621,077 (issued Nov. 4, 1986); and (2) its exclusive statutory right, in
`
`conjunction with FDA marketing approvals, to offer Fosamax at any dosage
`
`for the next five years. 21 U.S.C. § 355(c)(3)(D)(ii) (2000). Because market
`
`entry by others was precluded on those bases, the inference of non-
`
`obviousness of weekly-dosing, from evidence of commercial success, is
`
`weak.”).
`
`40
`
`Chris Vellturo, Ph.D., Dep. Tr., 12/20/2016, at 126:7–131:17, 134:9–24.
`
`
`
`
`
`
`Declaration of DeForest McDuff, Ph.D.
`
`
`
`20
`
`AMG 1152
`
`

`

`commercial partner through 2004, Dr. Vellturo relies solely on the Judson
`
`Declaration.41
`
`26. Second, even Dr. Vellturo’s claims themselves do not support a notion
`
`of the ’213 patent being broadly available or accessible. Between the patent owner’s
`
`alleged search for a commercial partner beginning in 1999 and the decision to
`
`execute a license with Cougar in 2004, I am aware only of the limited claims made
`
`by Professor Ian Judson and cited by Dr. Vellturo, without any information on
`
`specific terms of license.42 In addition, regardless of the early opportunities to access
`
`the ’213 patent (which may or may not have been widely available), once the ’213
`
`patent was held by Plaintiffs, the patent was not available or accessible, and there
`
`were reduced incentives to develop the claimed technology in the ’438 patent. As
`
`the Vellturo Declaration notes, the ’213 patent was licensed to Cougar
`
`Biotechnology, Inc. in 2004,43 and the priority date of

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