`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________________________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________________________
`
`MYLAN PHARMACEUTICALS, INC., and
`MERCK SHARP & DOHME CORP.,
`Petitioners
`
`v.
`
`GENENTECH, INC. AND CITY OF HOPE,
`Patent Owners
`____________________________________________
`
`Case IPR2016-00710
`Patent 6,331,415
`____________________________________________
`
`
`
`EXPERT DECLARATION OF LOUIS G. DUDNEY, CPA, CFF
`
`April 7, 2017
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`PROTECTIVE ORDER MATERIAL
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`Mylan v. Genentech
`IPR2016-00710
`Merck Ex. 1092, Pg. 1
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`TABLE OF CONTENTS
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`Page
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`I.
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`Introduction ...................................................................................................... 2
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`II. Qualifications .................................................................................................... 2
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`III. Documents and Information Relied Upon ........................................................ 4
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`IV. AlixPartners’ Compensation ............................................................................ 5
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`V. Additional Analysis and Demonstrative Aids .................................................. 5
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`VI. Relevant Legal Standards ................................................................................. 5
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`VII. Summary of Ms. Davis’ Opinions .................................................................... 7
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`VIII. Summary of My Opinions ................................................................................ 8
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`IX. Ms. Davis Fails to Demonstrate that Licensing and Settlement Agreements
`that Include the Right to Use the Technology of the Cabilly II Patent are Indicative
`of Industry Recognition of the Cabilly II Patent........................................................ 9
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`X. Ms. Davis Fails to Demonstrate Commercial Success Because She Fails to
`Establish a Nexus Between the Cabilly II Patent and the Commercial Success of
`Products that Allegedly Incorporate the Technology of the Cabilly II Patent ........18
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`XI. Conclusion ......................................................................................................25
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` 1
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`Merck Ex. 1092, Pg. 2
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`I. Introduction
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`1.
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`On March 3, 2016, Mylan Pharmaceuticals Inc. (“Mylan”) filed a
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`petition for Inter Partes review of U.S. Patent No. 6,331,415 (the “Cabilly II”
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`patent) against Genentech, Inc. (“Genentech”) and City of Hope.1 On October 11,
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`2016, Merck Sharp & Dohme Corp. (“Merck”) also filed a petition for Inter Partes
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`review of the Cabilly II patent.2 On January 3, 2017, the Mylan and Merck
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`proceedings were joined. It is my understanding that Mylan has since settled its
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`dispute with Genentech and City of Hope. I was retained by Quinn Emanuel
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`Urquhart & Sullivan, LLP (“Quinn Emanuel”), counsel to Merck, to review and
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`respond to opinions presented on behalf of Genentech and City of Hope by Julie L.
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`Davis (“Ms. Davis”) in her declaration dated December 22, 2016 (the “Davis
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`Declaration”).
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`II. Qualifications
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`2.
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`I am a Managing Director with AlixPartners, LLP (“AlixPartners”),
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`an international financial and operational consulting firm with over 1,500 people
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`located in 27 offices worldwide. I am a member of the board of directors of
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`
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`1 It is my understanding that the Cabilly II patent is the second of three Cabilly
`patents. Cabilly I (U.S. Patent No. 4,816,567) was filed on April 8, 1983 and
`issued March 28, 1989 . Cabilly II (U.S. Patent No. 6,331,415) was filed on June
`10, 1988 and issued December 18, 2001. Cabilly III (U.S. Patent No. 7,923,221)
`was filed on April 13, 1995 and issued on April 12, 2011. Cabilly I and Cabilly II
`purport to claim priority to the April 8, 1983 filing date of Cabilly I.
`2 IPR No. 2017-00047.
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` 2
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`Merck Ex. 1092, Pg. 3
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`AlixPartners as well as its Management Committee and am the Americas Business
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`Unit leader. My experience covers broad types of operational, financial, valuation,
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`litigation, bankruptcy, and management consulting engagements.
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`3.
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`In the intellectual property area, I assist clients with the economic and
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`financial aspects of licensing, valuation, infringement and misappropriation
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`litigation. My experience in this area includes calculating lost profits, determining
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`incremental profitability rates for license transactions, evaluating commercial
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`success, calculating reasonable royalty rates, pricing alternative solutions,
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`calculating unjust enrichment damages, valuing intellectual property and
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`evaluating the economics of substitute technologies.
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`4.
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`I have consulted with companies in a number of industries including,
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`but not limited to, pharmaceuticals, biotechnology, automotive, manufacturing,
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`consumer products, energy, healthcare, outsourcing, retail, professional services,
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`real estate, financial services, hospitality, entertainment, telecommunications,
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`environmental, and construction. In performing engagements in these industries, I
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`have analyzed damages, financial, accounting, operational, and economic issues
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`and testified in numerous cases before federal civil, criminal, and bankruptcy
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`courts, state courts, as well as in American Arbitration Association hearings,
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`international arbitrations, and state regulatory proceedings as an expert witness.
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`Merck Ex. 1092, Pg. 4
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`5.
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`Prior to joining AlixPartners, I was a Partner in the Financial
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`Advisory Services Group of PricewaterhouseCoopers. I hold a Bachelor of
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`Business Administration with a major in accounting from The College of William
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`& Mary, am a Certified Public Accountant, and am a Certified Financial Forensics
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`credential holder. I am a member of the Illinois Society of Certified Public
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`Accountants, the American Institute of Certified Public Accountants, the American
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`Bankruptcy Institute, the Licensing Executives Society, and the Turnaround
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`Management Association.
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`6.
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`Appendix A contains my curriculum vitae and a listing of testimony
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`that I have provided in the last four years.
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`7.
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`The opinions presented in this declaration are based on my analysis of
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`the available information and my experience, education, and expertise as a
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`financial consultant. As part of performing my analysis, I utilized a team of
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`professionals who worked under my direction and control.
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`III. Documents and Information Relied Upon
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`8.
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`Documents and information that I relied upon in conjunction with my
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`analysis are cited throughout this declaration and/or in Appendix B.
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` 4
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`Merck Ex. 1092, Pg. 5
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`IV. AlixPartners’ Compensation
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`9.
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`AlixPartners is being compensated at my normal and customary rate
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`of $870 per hour for my time and between $395 and $725 per hour for staff
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`working at my direction. The amount of AlixPartners’ fees is not contingent in any
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`way upon the opinions expressed herein or on the outcome of this matter.
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`V. Additional Analysis and Demonstrative Aids
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`10.
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`I reserve the right to amend and/or supplement this declaration based
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`upon any new and/or additional facts or other documents which may come to my
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`attention, or information, expert declarations, deposition testimony, and related
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`document exhibits thereto, which may be produced.
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`11.
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`I specifically reserve my ability to update and amend this declaration
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`based upon additional information.
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`12.
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`If I am called upon to testify, I may prepare demonstrative aids, such
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`as graphs, charts or tables.
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`VI. Relevant Legal Standards
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`13.
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`In order to conduct my work, I was instructed by counsel with respect
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`to the relevant legal standards applicable to evaluations of obviousness.
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`14.
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`I understand that an obviousness determination includes the
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`consideration of various factors including the existence of secondary
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`considerations such as commercial success, licensing, and long-felt but unresolved
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`needs, among other things.
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` 5
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`Merck Ex. 1092, Pg. 6
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`15.
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`I further understand that to have relevance and weight in an
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`obviousness analysis, the patentee must show that any asserted secondary
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`considerations, including licensing and commercial success, have a nexus between
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`the factor being considered and the merits of the claimed invention.
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`16. Specifically, I understand that the mere fact that a patentee has been
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`able to sell a large quantity of its invention will not suffice to demonstrate
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`commercial success if the patentee does not also show that its sales were
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`attributable to the desire for the claimed invention and not to other factors such as
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`the patentee’s marketing acumen or position in the market.
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`17. With respect to licensing as a secondary consideration of
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`obviousness, I have been informed that in order for licenses to the patent-at-issue
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`to overcome a strong case of obviousness, the patentee must show a nexus between
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`the merits of the invention and the licenses themselves, and not just a desire to
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`avoid the costs of litigation.
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`18. With respect to the secondary consideration of commercial success, it
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`is my understanding that only if the alleged commercially successful product
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`embodies the claimed features, and is coextensive with them, then a nexus is
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`presumed. A commercially successful product is not necessarily coextensive with
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`the patented invention when the invention is only a component of a commercially
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` 6
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`Merck Ex. 1092, Pg. 7
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`successful product. Moreover, I understand that where the subject products are
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`covered by multiple patents, the patentee is not entitled to a presumption of nexus.
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`Merck Ex. 1092, Pg. 8
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`Merck Ex. 1092, Pg. 9
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`Merck Ex. 1092, Pg. 10
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`Merck Ex. 1092, Pg. 10
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`Merck Ex. 1092, Pg. 11
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`Merck Ex. 1092, Pg. 11
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`Merck Ex. 1092, Pg. 12
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`Merck Ex. 1092, Pg. 12
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`Merck Ex. 1092, Pg. 13
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`Merck Ex. 1092, Pg. 13
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`Merck Ex. 1092, Pg. 14
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`Merck Ex. 1092, Pg. 14
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`Merck Ex. 1092, Pg. 15
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`p—t 4;
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`Merck Ex. 1092, Pg. 15
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`Merck Ex. 1092, Pg. 16
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`Merck Ex. 1092, Pg. 17
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`Merck Ex. 1092, Pg. 17
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`Merck Ex. 1092, Pg. 18
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`Merck Ex. 1092, Pg. 20
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`Merck Ex. 1092, Pg. 20
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`Merck Ex. 1092, Pg. 21
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`Merck Ex. 1092, Pg. 21
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`Merck Ex. 1092, Pg. 22
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`Merck Ex. 1092, Pg. 22
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`III—I-I-I-
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`Merck Ex. 1092, Pg. 23
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`Merck Ex. 1092, Pg. 23
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`Merck Ex. 1092, Pg. 24
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`Merck Ex. 1092, Pg. 24
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`Merck Ex. 1092, Pg. 25
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`XI. Conclusion
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`49.
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`It is my opinion that the information upon which Ms. Davis bases her
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`opinions do not support the secondary considerations of non-obviousness of
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`industry recognition by licensing or commercial success.
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`49 Sources summarized in Appendix C.
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`Merck Ex. 1092, Pg. 26
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`50.
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`I declare that all statements made herein of my own knowledge are
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`true and that all statements made on information and belief are believed to be true,
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`and further that these statements were made with the knowledge that willful false
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`statements and the like so made are punishable by fine or imprisonment, or both,
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`under Section 1001 of Title 18 of the United States Code.
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`Executed this 7th day of April 2017. I declare under penalty of perjury that
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`the foregoing is true and correct.
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`______________________
`Louis G. Dudney
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` 26
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`Merck Ex. 1092, Pg. 27
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`APPENDIX A
`APPENDIX A
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`Merck Ex. 1092, Pg. 28
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`Merck Ex. 1092, Pg. 28
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`

`

`Exhibit 1
`
`Louis G. Dudney, CPA, CFF
`Managing Director
`ldudney@alixpartners.com
`
`Phone
`
`+1 (312)551-3269 (o)
`+1 (312)961-1078 (m)
`
`Louis’ experience covers broad types of operational, financial,
`valuation, litigation, bankruptcy and management consulting
`engagements, including financing, mergers and acquisitions,
`intellectual property valuations and damages analysis, lost profit
`determinations, business valuations, solvency determinations,
`debtor advisory assistance, credit advisory assistance, and
`corporate investigations.
`
`Louis leads AlixPartners’ Americas Business Unit which includes
`Financial Advisory Services, Turnaround and Restructuring
`Services, Enterprise Improvement, Digital, and Leadership and
`Organizational Effectiveness. Prior to joining AlixPartners, Mr.
`Dudney was a partner with PricewaterhouseCoopers in its
`Financial Advisory Services Group.
`
`Relevant experience
`In the intellectual property area, Louis assists clients with the
`•
`economic and financial aspects of licensing, valuation,
`infringement and misappropriation litigation. Louis’
`experience in this area includes calculating lost profits,
`determining incremental profitability rates for license
`transactions, evaluating commercial success, calculating
`reasonable royalty rates, pricing alternative solutions,
`calculating unjust enrichment damages, valuing intellectual
`property and evaluating the economics of substitute
`technologies.
`• Louis has consulted with companies in a number of industries
`including, but not limited to, pharmaceuticals, biotechnology,
`automotive, manufacturing, consumer products, energy,
`healthcare, outsourcing, retail, professional services, real
`estate, financial services, hospitality, entertainment,
`telecommunications, environmental, and construction.
`In performing engagements in these industries, he has
`analyzed economic, accounting and financial issues and
`testified in federal civil, criminal and bankruptcy courts, state
`courts, American Arbitration Association hearings and state
`regulatory proceedings as an expert witness.
`
`•
`
`LOUIS' EXPERTISE COVERS: Damages, Valuation, Forensic Accounting, Litigation, Bankruptcy and
`Management Consulting Engagements
`
`1
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`alixpartners.com
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`Merck Ex. 1092, Pg. 29
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`

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`Exhibit 1
`
`
`
`
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`
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`
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`
`
`Louis G. Dudney – Testimony Experience Last 4 Years
`Massachusetts Mutual Life Insurance Company,
`Monterey Bay Military Housing LLC, et al. v.
`v. Countrywide Financial, et al., United States
`Pinnacle Monterey LLC, et al., Superior Court of
`the State of California, For the County of
`District Court, District of Massachusetts
`Monterey
`Massachusetts Mutual Life Insurance Company
`Opry Mills Mall Limited Partnership, et al. v.
`v. DB Structured Products, Inc. et al., United
`Arch Insurance Company, et al., Chancery Court
`States District Court, District of Massachusetts
`for Davidson County, Tennessee
`RC/PB, Inc. v. The Ritz-Carlton Hotel Co. LLC,
`2003 Non-Participating Manufacturers
`Marriott Int’l Inc. and Avendra LLC, In the
`Circuit Court of the 15th Judicial Circuit, In and
`Adjustment Proceedings before an Arbitration
`For Palm Beach County, Florida.
`Panel for the State of Kentucky.
`UBS Securities LLC and UBS AG, London Branch
`Activist Special Advisory Services LLC, et al. v.
`v. Highland Capital Management, L.P., et al. In
`Phoenix Real Estate Solutions LTD, American
`the Supreme Court of the State of New York,
`Arbitration Association, International Centre for
`County of New York.
`Dispute Resolution, New York, NY
`Morningstar, Inc. v. The Mills Corporation and
`Right Field Rooftops, LLC, d/b/a Skybox on
`Block 37 Office LLC, Circuit Court of Cook
`Sheffield; et al. v. Chicago Baseball Holdings,
`County, IL, County Department, Chancery
`LLC, et al.; United States District Court,
`Division.
`Northern District of Illinois, Eastern Division
`Carlson, Inc. v. International Business Machines
`Monterey Bay Military Housing, LLC, et al. v.
`Corporation. United States District Court,
`Pinnacle Monterey LLC, Pinnacle Irwin, LLC,
`District of Minnesota.
`American Management Services California, Inc.,
`American Management Services LLC, Goodman
`Massachusetts Mutual Life Insurance Company
`Real Estate, Inc., Goodman Financial Services,
`v. Countrywide Financial Corporation, et al.,
`Inc., Stanley Harrelson and John Goodman;
`United States District Court, Central District of
`United States District Court, Northern District of
`California.
`California, San Jose Division.
`Immunomedics, Inc. v. Nycomed Gmbh, Takeda
`H.B. Fuller Company v. Accenture, LLP. American
`Pharmaceutical Limited, et al., International
`Arbitration Association, Minneapolis, MN
`Centre for Dispute Resolution
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`2
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`alixpartners.com
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`Merck Ex. 1092, Pg. 30
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`

`

`Louis G. Dudney – Testimony Experience Last 4 Years
`Bracket Holding Corp. v. Darwin Select
`Baker McKenzie, LLP v. TCS Solutions.
`Insurance Company; Allied World Assurance
`American Arbitration Association
`Co., (US) Inc. American Arbitration Association,
`LoggerHead Tools, LLC v. Sears Holdings
`Washington, DC
`Corporation, et al., United States District Court,
`The Boeing Company and Boeing Commercial
`Northern District of Illinois, Eastern Division
`Space Company v. KB Yuzhnoye, et al., United
`Infinity Sales Group, LLC v. Valassis
`States District Court, Central District of
`Communications, Inc., United States District
`California
`Court, Southern District of Florida, West Palm
`Miller UK Ltd. and Miller International Ltd. v.
`Beach Division
`Caterpillar Inc., United States District Court,
`Bedford Med, LLC v. The Arie Zweig Self
`Northern District of Illinois, Eastern Division
`Declaration of Trust dated June 28, 1990.
`Curatus Trust Company (Mauritius) Limited, as
`American Arbitration Association
`Trustee of the Polo Settlement Trust and the
`Massachusetts Mutual Life Insurance Company
`Solleric Settlement Trust v. American Leisure
`v. DLJ Mortgage Capital, Inc., et al. United
`Group Ltd., et al., In the Circuit Court of Ninth
`States District Court, District of Massachusetts.
`Judicial Circuit in and for Orange County Florida
`Massachusetts Mutual Life Insurance Company
`TCV VI, L.P., et al. v. TradingScreen Inc., et al.,
`v. Credit Suisse First Boston Mortgage Securities
`Court of Chancery for the State of Delaware
`Corp., et al., United States District Court,
`District of Massachusetts.
`New Jersey Department of Environmental
`Regulation, et al. v. Occidental Chemical
`Bridgestone Americas, Inc. v. International
`Corporation, Tierra Solutions, Inc., Maxus
`Business Machines Corporation, United States
`Energy Corporation, Maxus International Energy
`District Court, Middle District of Tennessee,
`Corporation, Repsol YPF, S.A., YPF, S.A., YPF
`Nashville Division.
`Holdings, Inc., YPF International S.A., and CLH
`Guarantee Trust Life Insurance Company v.
`Holdings. Superior Court of New Jersey – Law
`Platinum Services, Inc. n/k/a Platinum
`Division – Essex County
`Supplemental Insurance, Inc. American
`Ascension Health Alliance v. Ascension Insurance, Inc.
`Arbitration Association, Chicago, IL.
`United States District Court for the Eastern District of
`Missouri. Eastern Division
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`Exhibit 1
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`
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`3
`
`alixpartners.com
`
`Merck Ex. 1092, Pg. 31
`
`

`

`
`
`APPENDIX B
`APPENDIX B
`
`Merck Ex. 1092, Pg. 32
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`
`
`Merck Ex. 1092, Pg. 32
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`

`

`APPENDIX B: DOCUMENTS CONSIDERED
`
` Declaration of Julie L. Davis dated December 22, 2016 and cited materials
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` Deposition of Julie L. Davis dated March 7, 2017 and related exhibits
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`1
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`Merck Ex. 1092, Pg. 33
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`

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`IPR2016-00710
`Appendix B to the Declaration of L. Dudney
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`Merck Ex. 1092, Pg. 34
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`
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`IPR2016-00710
`Appendix B to the Declaration of L. Dudney
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`3
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`Merck Ex. 1092, Pg. 35
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`

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`APPENDIX C
`APPENDIX C
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`Merck Ex. 1092, Pg. 36
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`Merck Ex. 1092, Pg. 36
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`

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`APPENDIX C:
`APPENDIX C:
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`1
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`Merck Ex. 1092, Pg. 37
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`Merck Ex. 1092, Pg. 37
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`

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`IPR2016-00710
`Appendix C to Declaration of L. Dudney
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`Merck Ex. 1092, Pg. 38
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`IPR2016-00710
`Appendix C to Declaration of L. Dudney
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`3
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`Merck Ex. 1092, Pg. 39
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