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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`ACRUX DDS PTY LTD. & ACRUX LIMITED
`Petitioners,
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`v.
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`KAKEN PHARMACEUTICAL CO., LTD. and
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`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.
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`Patent Owner and Licensee.
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`Case: IPR2017-00190
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`U.S. Patent No. 7,214,506
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`DECLARATION OF VINCENT A. THOMAS, CPA, CVA, CFF, ABV
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`Submitted August 1, 2017
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`________________________________________________________________
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`TABLE OF CONTENTS
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`I. EXPERIENCE AND CREDENTIALS ....................................................................... 1
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`II. SCOPE OF ASSIGNMENT ..................................................................................... 2
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`III. INFORMATION REVIEWED AND RELIED UPON .................................................. 3
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`IV. SUMMARY OF OPINIONS .................................................................................... 4
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`V. ANALYSIS OF JUBLIA®’S SUCCESS IN THE MARKETPLACE ................................................. 6
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`A. ONYCHOMYCOSIS ............................................................................................................ 6
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`B. TREATING ONYCHOMYCOSIS .......................................................................................... 8
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`C. THE ’506 PATENT .......................................................................................................... 10
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`D.
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`JUBLIA®......................................................................................................................... 11
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`E. CAUSAL LINK OF JUBLIA®’S SUCCESS TO THE ’506 PATENT ...................................... 12
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`I. EXPERIENCE AND CREDENTIALS
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`1.
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`I am a Senior Managing Director in the Forensic & Litigation
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`Consulting ("FLC") practice of FTI Consulting, Inc. ("FTI"), a multidisciplinary
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`international financial advisory and consulting firm. I am a Co-Leader of FTI’s
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`Dispute Advisory Practice and I also lead FTI’s National Intellectual Property
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`Practice. Before joining FTI, I was a partner with the international professional
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`services firm, KPMG, LLP.
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`2.
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`I have significant experience assisting companies and clients with
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`complex accounting, corporate finance and litigation issues. I focus on the
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`preparation of sophisticated economic analyses and the assessment of damages in
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`various types of commercial disputes. Over the course of my career, I have
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`analyzed economic and financial issues in more than one hundred commercial
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`disputes, many of which involved patent, copyright, trade secret, and trademark
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`infringement. Many of those assignments have also involved complex economic
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`analysis of commercial success of various products, sophisticated valuation
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`analysis, and damages in matters involving various pharmaceutical products,
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`biotechnology, and drug technologies. For the past three years I have been named
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`by Intellectual Asset Management magazine as one of the world’s leading patent
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`damages experts.
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`3.
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`I also have significant experience in corporate, financial, and
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`accounting management positions, including a role as an Analyst and Director as
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`well as Chief Financial Officer for a high-tech company, where I was responsible
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`for managing its intellectual property portfolio. In that capacity, as well as during
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`my consulting career, I have been involved in license negotiations, performing
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`royalty analysis, valuing intellectual property, and reviewing and analyzing license
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`agreements.
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`4.
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`I graduated cum laude from DePauw University with a Bachelor of
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`Arts degree in Economics and I subsequently received a Masters of Business
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`Administration degree from Indiana University. I am a Certified Public
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`Accountant, Certified Valuation Analyst, and I am Certified in Financial Forensics
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`and Accredited in Business Valuation. I am also a member of the American
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`Institute of Certified Public Accountants and the National Association of Certified
`Valuation Analysts. Appendix A contains a summary of my education,
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`experiences, prior testimony, and publications/seminars that I have authored. My
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`business address is FTI Consulting, Inc., 227 W. Monroe Street, Suite 900,
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`Chicago, Illinois 60606.
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`II. SCOPE OF ASSIGNMENT
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`5.
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` On November 2, 2016, Acrux DDS PTY Ltd. and Acrux Limited
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`(collectively, “Acrux” or “Petitioners”) filed a petition with the Patent Trial and
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`Appeal Board (“PTAB”) to institute an inter partes review of patent number
`7,214,506 (the “’506 patent”).1
`Pharmaceutical Co., Ltd. (“Kaken”) and it is licensed to Valeant Pharmaceuticals
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`is owned by Kaken
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` The ’506 patent
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`International, Inc. (“Valeant”) (collectively, “Patent Owners”). The PTAB
`instituted the inter partes review on May 1, 2017.2
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`1 Paper 01, Petition submitted November 2, 2016.
`2 Paper 12, Decision to Institute Inter Partes review, dated May 1, 2017.
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`6.
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`It is my understanding that Acrux seeks to have the ’506 patent
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`invalidated as obvious over several combinations of alleged prior art references. I
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`further understand that in the evaluation of obviousness, certain secondary
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`considerations may be contemplated, such as commercial success, long-felt but
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`unmet need, failure of others, and unexpected results. I have been retained by
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`Finnegan Henderson Farabow Garret & Dunner, counsel for the Patent Owners
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`(“Counsel”), to assess and provide opinions regarding secondary considerations
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`relating to the ’506 patent.
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`III.
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`INFORMATION REVIEWED AND RELIED UPON
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`7.
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`During the course of my work in this matter, I have examined
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`documents provided to me by Counsel and other information I have obtained from
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`public sources. This report and the opinions and conclusions reached herein are
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`based on my review of these documents as well as my knowledge, education,
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`experience, and training. A listing of the specific documents I considered and
`reviewed is contained in the attached Appendix B.
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`8. My opinions contained herein are the results of my investigations to
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`date. They are to be used for the specific purposes of this proceeding and are not
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`to be used for any other purpose without the express written consent of FTI. I
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`reserve the right to supplement, amend, or alter these opinions based on
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`information that hereafter becomes available, including information that becomes
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`available prior to and during the time this proceeding.
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`IV. SUMMARY OF OPINIONS
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`9.
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`In my opinion, Jublia®, a topical product FDA approved for treating
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`onychomycosis according to the methods claimed in the ’506 patent, has been a
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`commercial success. Not only did Jublia® have over two million prescriptions in
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`just its first two years on the market and sales revenue of more than $1 billion, but
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`it accounted for 60% of total market revenue in the first full year the product was
`on sale.3 In fact, Jublia® almost singlehandedly shifted the market for
`onychomycosis treatment from oral to topical therapy, with only 19% of patients
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`using topical treatments in 2013 to over 50% in 2015, Jublia®’s first full year on
`sale.4 Those patients receiving topical Jublia® treatment expanded the overall
`market, as prescriptions for oral treatments such as terbinafine remained relatively
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`stable before and after Jublia® launched.
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`10. Thus, after its launch, Jublia® quickly met with commercial success.
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`The drug rapidly became a market-leading prescription with prescription numbers
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`in its first full year on the market almost comparable to those of the long-
`established oral treatment.5 This rapid growth reflected market recognition of its
`topical efficacy against onychomycosis, ease of use, and lack of side effects
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`potentially associated with oral treatment. In other words, the success related to
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`the features I understand are claimed in the ’506 patent.
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`3 See Ex. 2098 (based on US_ _ _20170531 (2).xlsx).
`4 See Ex. 2099 (based on 012617 Jublia 4mEq Commercial Market
`Comparison.xlsx).
`5 See Ex. 2099 (based on 012617 Jublia 4mEq Commercial Market
`Comparison.xlsx).
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`11. The immediate and dramatic increase in prescriptions and sales for
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`topical treatments of onychomycosis after the release of Jublia® also highlights the
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`long-felt, unmet need for an effective topical anti-fungal treatment. Jublia®
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`brought new patients into the market rather than merely taking from the pool of
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`patients previously using oral treatments. This is evidenced by the continued rate
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`of prescription for oral terbinafine and the overall increase in the number of
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`prescriptions for onychomycosis treatments in the years after Jublia®’s launch. In
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`fact, prior to Jublia®, topical prescriptions for onychomycosis treatments in the
`U.S. stayed below or at 20% of total prescriptions for at least six straight years,6
`with the remainder of treatments being oral prescriptions. After Jublia® was
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`introduced to the U.S. market, not only did topical prescriptions become the
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`leading form of treatment for onychomycosis, but Jublia® effectively expanded the
`U.S. onychomycosis prescription market by 64%.7 Thus, rather than simply
`transition patients from oral to topical treatment, the increased overall number of
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`prescriptions suggests the entrance of many prospective patients who had
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`previously chosen to go untreated until Jublia® arrived to address their unmet
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`need. Jublia® did so by providing a therapeutically effective amount of
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`efinaconazole for topical treatment of onychomycosis, as claimed in the ’506
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`patent.
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`6 See Ex. 2099 (based on 012617 Jublia 4mEq Commercial Market
`Comparison.xlsx).
`7 See Ex. 2099 (based on 012617 Jublia 4mEq Commercial Market
`Comparison.xlsx).
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`V. ANALYSIS OF JUBLIA®’S SUCCESS IN THE MARKETPLACE
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`A. ONYCHOMYCOSIS
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`12.
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` I understand that onychomycosis is a fungal infection of the nail
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`affecting humans and animals. Symptoms include opacity, tylosis (i.e. thickening),
`and destruction and deformation of the nail plate.8 The disease is caused by fungal
`agents known as dermatophytes, most commonly Trichophyton rubrum and
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`Trichophyton mentagrophytes, invading and proliferating in the nail bed and/or
`nail plate.9 The infection occurs more often within or under the toenail than in the
`fingernails. Onychomycosis is not life threatening, but the disease is prevalent in
`about 10% of the overall U.S. population.10 I understand that the disease is most
`common in older individuals, existing in about 20% of adults over 60 and 50% of
`adults over 70.11 People that have either diabetes mellitus or HIV are also at
`greater risk of contracting the disease.12
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`13. Historically, I understand the disease has been difficult to treat
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`because of factors that are intrinsic to the nail itself. I understand the hard,
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`protective nail plate, the deep infection in the underlying nail bed, and slow growth
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`of the nail itself make it particularly difficult to treat as compared to fungal
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`8 Ex. 1001 (US Patent Number 7,214,506), 2:21-25.
`9 Ex. 2071 (http://www.merckmanuals.com/professional/dermatologic-
`disorders/nail-disorders/onychomycosis); Petition, p. 6.
`10 Ex. 2010
`(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC88888/pdf/cm000415.pdf).
`11 Ex. 2072 (http://www.aafp.org/afp/2013/1201/p762.pdf).
`12 Ex. 2072 (http://www.aafp.org/afp/2013/1201/p762.pdf).
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`infections located at other body sites.13 I understand that, due to the nature of the
`disease, onychomycosis can also pose long-term significant negative effects on
`one’s social, emotional, and occupational functioning.14 I understand it can also
`cause pain and limited mobility, especially in older patients.15
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`14. Because of the difficulty treating the disease and the limited efficacy
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`of antifungal treatments prior to Jublia®, many patients willingly or unwillingly let
`onychomycosis go untreated.16
` Before the release of Jublia®, 85% of
`onychomycosis patients went untreated.17 By letting the infection go untreated,
`patients risk having the infection cause serious damage to the nail and possibly
`spreading to other areas of the body.18 I understand some patients ultimately
`elected to undergo complete nail removal, which can lead to permanent
`disfigurement.19
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`13 Ex. 2010
`(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC88888/pdf/cm000415.pdf).
`14 Ex. 2010
`(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC88888/pdf/cm000415.pdf).
`15 Ex. 2079 (http://lermagazine.com/article/onychomycosis-remains-a-major-
`clinical-challenge).
`16 Ex. 2080 (https://well.blogs.nytimes.com/2013/10/11/ask-well-leaving-nail-
`fungus-untreated/).
`17 Exhibit 1003.
`18 Ex. 2081 (http://www.everydayhealth.com/hs/toenail-fungal-infection-
`guide/dangers-of-ignoring-toenail-fungal-infections/).
`19 Ex. 2072 (http://www.aafp.org/afp/2013/1201/p762.pdf).
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`B. TREATING ONYCHOMYCOSIS
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`15. Because of the intractability of this fungal infection, I understand
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`treating onychomycosis has historically been challenging. Before the ’506 patent,
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`I understand that the most common therapy was oral treatment using antifungal
`agents such as terbinafine HCL.20 When faced with unpleasant or dangerous side
`effects such as gastrointestinal disorders and hepatotoxicity, many patients either
`took the drug irregularly or completely abandoned the treatment.21 Oral drugs can
`also have negative drug-drug interactions which can especially harm patients who
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`are the most at risk for onychomycosis: people with diabetes or HIV and patients
`over age 60.22
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`16.
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`I understand that a topical treatment of onychomycosis is preferable
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`because it can improve patient compliance, be applied directly to the infected area,
`and have lower side effects.23 However, prior to Jublia®, only one topical agent,
`ciclopirox 8% nail lacquer, was approved for use in the United States.24 Ciclopirox
`has limited effectiveness.25 I understand it has disappointing mycologic cure
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`20 Ex. 2099 (based on 012617 Jublia 4mEq Commercial Market Comparison.xlsx).
`21 Ex. 2085 (http://www.medscape.com/viewarticle/821083); Ex. 2079
`(http://lermagazine.com/article/onychomycosis-remains-a-major-clinical-
`challenge).
`22 Ex. 2085 (http://www.medscape.com/viewarticle/821083);
`Ex. 2079 (http://lermagazine.com/article/onychomycosis-remains-a-major-clinical-
`challenge).
`23 Ex. 2086 (https://www.ncbi.nlm.nih.gov/pubmed/25271773).
`24 Ex. 2064
`(https://www.sec.gov/Archives/edgar/data/807198/000104746904006848/
`a2128888z20-f.htm).
`25 Ex. 2060 (http://www.aafp.org/afp/2001/0215/p663.html).
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`rates26 ranging from 29% to 36%, and in most cases, it was given only in response
`to the mildest cases or in conjunction with other treatments.27 I also understand
`other earlier efforts to develop topical treatments did not sufficiently permeate the
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`thick keratin that makes up the nail plate and exhibit persistent efficacy at the site
`of infection in the nail plate and nail bed.28
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`17.
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`In order to address the lack of efficacy seen with topical treatments,
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`physicians developed other treatments such as nail trimming, nail debridement,
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`nail avulsion, and laser therapies, but they are also often ineffective, disfiguring,
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`and frequently need to be used in conjunction with other treatments such as oral
`antifungal therapy.29 Some of the methods, especially laser and light based
`therapies, are also expensive and are not covered by insurance.30
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`18. Before the FDA approval of Jublia®, many podiatrists noted that there
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`was a “conspicuous absence of medical therapies approved in the United States”
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`and that the treatment options in most cases were limited, especially topical
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`26 I understand many studies surrounding onychomycosis refer to both mycologic
`and clinical cure rates. I reference mycologic cure rates within my report. Ex.
`2017
`(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4106353/pdf/jcad_7_7_10.pdf, p.
`12).
`27 Ex. 2017
`(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4106353/pdf/jcad_7_7_10.pdf,
`pp. 12-13). This cure rate range using this drug was used in conjunction with nail
`debridement.
`28 Ex. 2017
`(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4106353/pdf/jcad_7_7_10.pdf).
`29 Ex. 2072 (http://www.aafp.org/afp/2013/1201/p762.pdf).
`30 Ex. 2080 (https://well.blogs.nytimes.com/2014/03/14/ask-well-laser-treatments-
`for-nail-fungus/).
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`treatments.31 In the decades before the approval, research and development
`programs had repeatedly failed to identify effective topical antifungal treatments
`for onychomycosis.32 I understand that existing treatments did not have the
`pharmacologic/pharmacokinetic profile to allow for adequate nail unit penetration,
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`persistence in the nail plate and underlying nail bed, and ultimate efficacy against
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`the fungal infection in these locations. Thus, the use of topical agent against
`onychomycosis was severely limited.33
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`C. THE ’506 PATENT
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`19. The ’506 patent titled “Method for Treating Onychomycosis” was
`issued to Kaken on May 8, 2007.34 I understand that claim 1 of the patent recites a
`method for treating onychomycosis by topically applying to the nail a
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`therapeutically effective amount of a compound defined by a particular triazole
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`formula. I also understand that claim 2 uses a particular compound from the genus
`in claim 1, and that compound is known as KP-103 (a.k.a. efinaconazole).35
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`31 Ex. 2017
`(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4106353/pdf/jcad_7_7_10.pdf).
`See also, Ex. 2088 (http://www.podiatrytoday.com/blogged/closer-look-new-
`topical-option-onychomycosis) and Ex. 2089
`(http://www.podiatrytoday.com/files/Valeant_Supplement.pdf).
`32 Ex. 2017
`(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4106353/pdf/jcad_7_7_10.pdf).
`33 Ex. 2017
`(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4106353/pdf/jcad_7_7_10.pdf).
`34 Ex. 1001 (US Patent Number 7,214,506).
`35 Ex. 1001 (US Patent Number 7,214,506), 9:11-14.
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`D. JUBLIA®
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`20. Efinaconazole (a.k.a. KP-103) is sold under the Jublia® brand name.36
`Jublia® is sold by Valeant in the U.S. as a topical 10% efinaconazole solution used
`to treat fungal toenail infections.37 Jublia® was approved by the FDA on June 9,
`2014.38 Efinaconazole has been sold by Kaken in Japan under the brand name
`Clenafin® since September 2014.39
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`21. Valeant acquired the nascent drug through its purchase of Dow
`Pharmaceutical Sciences in 2008.40 Valeant itself advanced Jublia® from the pre-
`IND phase through clinical phases 1, 2, and 3, and eventually approval.41 As
`Valeant stated in a press release announcing Jublia®’s FDA approval, Jublia®
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`became the “first topical triazole approved for the treatment of onychomycosis of
`the toenails.”42 Jublia® is now the market share leader in all pharmaceutical
`treatments of onychomycosis, representing over 70% of total U.S. sales.43
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`22. From June 2014 through March 2017, Jublia® generated over $1
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`billion in revenue in the U.S. and increased the use of topical treatments for
`onychomycosis four-fold over pre-launch levels.44 Physicians prescribed Jublia®
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`36 Ex. 2090 (http://www.kaken.co.jp/english/business/top12.html).
`37 Ex. 2091 (http://www.Jubliarx.com/).
`38 Exhibit 1003.
`39 Ex. 2090 (http://www.kaken.co.jp/english/business/top12.html).
`40 Ex. 2092 (http://ir.valeant.com/news-releases/2014/09-06-2014).
`41 Ex. 2092 (http://ir.valeant.com/news-releases/2014/09-06-2014).
`42 Exhibit 1003.
`43 See Ex. 2098 (based on US_ _ _20170531 (2).xlsx).
`44 See Ex. 2099 (based on 012617 Jublia 4mEq Commercial Market
`Comparison.xlsx).
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`over two million times in just its first two years on the market, rapidly approaching
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`the numbers seen for well-established oral treatments such as terbinafine. Prior to
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`Jublia®, the U.S. market for treating onychomycosis either decreased or remained
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`relatively flat; however, after the drug’s launch, the U.S. onychomycosis market
`increased overall by 64%45. Jublia® has not only proven its commercial success
`through high prescription numbers, but also in attracting new patients that were
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`otherwise not seeking
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`treatment,
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`thereby expanding
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`the overall market
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`dramatically.
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`E. CAUSAL LINK OF JUBLIA®’S SUCCESS TO THE ’506 PATENT
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`23. The immediate and dramatic increase in prescriptions and sales for
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`topical treatments of onychomycosis after the release of Jublia® highlights its
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`commercial success. It also reflects the long-felt, unmet need for a topical anti-
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`fungal treatment that Jublia® addressed by bringing in new patients who in the
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`past had preferred to go untreated. I understand it did so by providing a
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`therapeutically effective amount of efinaconazole for topical treatment of
`onychomycosis, as claimed in the ’506 patent.46 I understand that the features
`claimed in the ’506 patent contributed directly and were responsible for Jublia®’s
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`success — its superior efficacy in treating onychomycosis derives from topical
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`application of a therapeutically effective amount of efinaconazole to the nail. I
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`understand Jublia® provided the ease of application of a topical agent and efficacy
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`45 See Ex. 2099.
`46 Ex. 2017, 17 (stating that Jublia® “appears to represent an important advance in
`the initial treatment and long-term management” of onychomycosis).
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`comparable to an oral treatment, while also lacking the undesirable side effects of
`an oral antifungal agent.47
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`24.
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`I understand
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`that, prior
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`to
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`the ’506 patent, KP-103 (a.k.a.
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`efinaconazole) was a known antifungal, but only for its use in treating skin
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`conditions – not toenail fungus. The first product to embody the claims of the ’506
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`patent, Jublia®, was not only a commercial success in gaining market share, but it
`also rapidly expanded the overall market.48 This expansion of the market
`represents the capture of patients who had forgone treatment of onychomycosis
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`until the availability of an effective topical method using KP-103, Jublia®. In fact,
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`prior to Jublia®, U.S. topical prescriptions for onychomycosis treatments stayed
`below or at 20% of total prescriptions for at least six straight years,49 and these
`earlier topical treatments did not practice the ’506 patent. Thus, the ability to treat
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`onychomycosis according to the methods claimed in the ’506 patent via Jublia®
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`allowed Kaken and Valeant to fulfil an unmet need in the market, addressing these
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`previously untreated patients. It also reflected commercial success as the market
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`recognized the surprising topical efficacy of the product, and that has translated
`into sales on the order of over $1 billion in less than three years.50
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`25.
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`I have seen no evidence that the commercial success of Jublia® was
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`primarily driven by any other factor than its embodiment of the methods claimed in
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`the ’506 patent. The marketing spend for Jublia® is consistent with other
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`47 Ex. 2017
`(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4106353/pdf/jcad_7_7_10.pdf).
`48 See Ex. 2099.
`49 See Ex. 2099.
`50 See Ex. 2098.
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`companies’ advertising costs on comparable branded topical onychomycosis
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`treatments such as Lamisil® (more than $100 million in advertising to date) and
`Penlac® (more than $10 million annually).51
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`26. For example, in 2003, Aventis described Penlac® in its annual report
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`as “the first and so far only prescription topical therapy approved in the U.S. for
`the treatment of onychomykosis [sic] (nail fungus).”52 Even as the only topical
`prescription on the market, Aventis spent more than $10 million in 2002 and $11
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`television, radio, newspaper, and magazine
`million in 2003 on national
`advertising.53 This level of advertising in 2003 ranked Penlac® in the top 2000 for
`U.S. brands by marketing spend, next to brands such as Cascade dishwashing
`detergent and Best Western Hotels.54 Even with this level of national advertising
`and no topical competition on the market, Penlac® did not achieve nearly the
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`success of Jublia®. By 2008, the active ingredient of Penlac®, ciclopirox,
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`51 Novartis International AG (“Novartis”), sells Lamisil® and has spent over $100
`million on marketing. It appears additional sources calculate its spending as high
`as $236 million. Ex. 2029 (https://www.forbes.com/forbes/2006/0508/094a.html).
`Penlac advertising was only found for 2002 and 2003. Ex. 2063
`(http://brandautopsy.typepad.com/superbrands_2004_brandweek.pdf).
`52 Ex. 2064
`(https://www.sec.gov/Archives/edgar/data/807198/000104746904006848/
`a2128888z20-f.htm).
`53 Ex. 2064
`(https://www.sec.gov/Archives/edgar/data/807198/000104746904006848/
`a2128888z20-f.htm); Ex. 2063
`(http://brandautopsy.typepad.com/superbrands_2004_
`brandweek.pdf).
`54 Ex. 2063 (http://brandautopsy.typepad.com/superbrands_2004_brandweek.pdf).
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`represented less than 20% of prescriptions in the U.S. onychomycosis market, with
`the remaining portion going to the oral drug Terbinafine HCL.55
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`27. Thus, despite its national advertising of Penlac®, Aventis was not
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`able to shift the market from oral to topical treatment. However, after the release
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`of Jublia®, the market switched to majority topical treatments in less than one
`year.56 Thus, I have seen no evidence indicating that the volume of advertisement
`primarily drove the sales of Jublia®. Rather, the evidence supports the conclusion
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`that Jublia®’s commercial success depended on its use of the method claimed in
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`the ’506 patent.
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`28. Further, even when Jublia® was advertised, the advertisements
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`highlighted its use of the method claimed in the ’506 patent. For example, in
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`Valeant’s 2016 Super Bowl commercial, a banner is prominently shown stating,
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`“Jublia® (efinaconazole) Topical Solution 10%” and the voice over includes
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`statements such as “Jublia® is a prescription medicine used to treat toenail
`fungus” (emphasis added).57 Similarly, the main page of the website promoting
`Jublia® states that it is “[a]n FDA-approved prescription topical solution proven to
`treat toenail fungus (onychomycosis).”58
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`29.
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`I understand that the Petitioner in this IPR argues that “Valeant has
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`spent hundreds of millions of dollars to promote Jublia®” and insinuates that this
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`is the reason for Jublia’s success. However, these advertisements contained
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`55 Ex. 2099 (based on 012617 Jublia 4mEq Commercial Market Comparison.xlsx).
`56 Ex. 2099 (based on 012617 Jublia 4mEq Commercial Market Comparison.xlsx).
`57 https://www.youtube.com/watch?v=AXCCmCwzRPs.
`58 Ex. 2091 (http://www.jubliarx.com/).
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`promotion consistent with Jublia®’s embodiment of the method claimed in the
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`’506 patent. Thus, if anything, these advertisements reinforce the link between the
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`elements claimed in the ’506 patent and the commercial success of the product in
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`providing an effective topical treatment for onychomycosis.
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`30. Overall, in my opinion, Jublia® has been a commercial success, and
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`has addressed an unmet need in the market, due to its embodiment of the method
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`claimed in the ’506 patent, not other factors.
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` PAGE 16
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`*****
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`My report, with supporting appendices, is contained herein, and presents my
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`opinion and the bases and reasons therefor. To the extent any additional
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`information is produced by either party, I reserve the right to incorporate such
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`additional information into my report. This report was prepared solely for the
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`above-captioned matter and should not be used for any other purpose without prior
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`written authorization.
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`I hereby declare that all statements made herein of my own knowledge are true and
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`that statements made on information and belief are, to the best of my knowledge,
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`believed to be true; and further that these statements are made with the knowledge
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`that willful false statement and the like so made are punishable by fine or
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`imprisonment, or both, under Section 1001 of Title 18 of the United States Code.
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`Respectfully,
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` ________________________
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`Vincent A. Thomas
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`August 1, 2017
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` PAGE 17
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`Appendix A
`Appendix A
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`Page 20 of 35
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`

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`Vincent A. Thomas, CPA/ABV/CFF, CVA
`Senior Managing Director — Intellectual Property Practice Leader
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`
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`vince.thomas@fticonsulting.com
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`227 West Monroe Street
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`Suite 900
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`Chicago, IL 60606
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`Tel: +1 317 432 5160
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`
`
`CERTIFICATIONS
`
`Certified Public Accountant
`
`Certified Valuation Analyst
`
`Accredited in Business
`Valuation
`
`Certified in Financial Forensics
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`
`
`PROFESSIONAL AFFILIATIONS
`
`AICPA
`
`American Society of Appraisers
`
`National Association of Certified
`Valuation Analysts
`
`
`
`EDUCATION
`
`M.B.A. – Finance – Indiana
`University
`
`B.A. – Economics (Cum Laude)
`– DePauw University
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`Vince Thomas is a Senior Managing Director and Co-Leader of FTI’s Dispute
`Advisory Services Practice and also leads FTI’s Intellectual Property Practice. Prior to
`joining FTI Consulting, he was a partner with KPMG LLP. Mr. Thomas is nationally
`recognized consultant and expert with more than 25 years of experience assisting
`companies and clients with complex accounting, finance and valuation issues. For
`the past three years, he has been named by Intellectual Asset Management
`magazine as one of the world’s leading damages experts.
`
`Mr. Thomas specializes in matters involving intellectual property and has analyzed
`economic and financial issues in hundreds of disputes. He has also testified as an
`expert witness on economic, financial and valuation issues in over eighty
`proceedings in state and federal courts across the country; and, he has provided
`expert testimony for various International Trade Commission 337 investigations on
`issues related to domestic industry, remedy, bonding and exclusion orders. Mr.
`Thomas has assisted in negotiations to determine appropriate licensing rates and
`payments as well as to determine royalty payments under Fair Reasonable and
`Non-Discriminatory (FRAND) terms and obligations.
`
`Mr. Thomas has conducted seminars to various groups across the country and has
`participated in various panel discussions on topics involving economic damages,
`valuation methods and techniques for increasing shareholder value. He has also
`published articles on valuation and damage issues, co-authored a book on
`economic damages and served as a gues