UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ACRUX DDS PTY LTD., ACRUX LIMITED,
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`KAKEN PHARMACEUTICAL CO., LTD. and
`V ALEANT PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`
`Case IPR2017-001901
`Patent 7,214,506 B2
`
`DECLARATION OF CAITLIN M. WILMOT IN SUPPORT OF
`PETITIONER'S RESPONSE TO PATENT OWNER'S
`OBJECTIONS TO EVIDENCE
`
`Case IPR2017-01429 has been joined with the instant proceeding.
`
`Page 1 of 11
`
`ACRUX DDS PTY LTD. et al.
`
`EXHIBIT 1669
`
`IPR Petition for
`
`U.S. Patent No. 7,214,506
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ACRUX DDS PTY LTD., ACRUX LIMITED,
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`KAKEN PHARMACEUTICAL CO., LTD. and
`V ALEANT PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`
`Case IPR2017-001901
`Patent 7,214,506 B2
`
`DECLARATION OF CAITLIN M. WILMOT IN SUPPORT OF
`PETITIONER'S RESPONSE TO PATENT OWNER'S
`OBJECTIONS TO EVIDENCE
`
`Case IPR2017-01429 has been joined with the instant proceeding.
`
`Page 1 of 11
`
`ACRUX DDS PTY LTD. et al.
`
`EXHIBIT 1669
`
`IPR Petition for
`
`U.S. Patent No. 7,214,506
`
`
`
`I, Caitlin M. Wilmot, declare and state as follows:
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`
`I am a law clerk with the firm Rothwell, Figg, Ernst & Manbeck, PC,
`
`attorneys for Acrux DDS Pty. Ltd. and Acrux Limited ("Petitioner"). I submit
`
`this declaration in support of the Response to Patent Owner's Objections to
`
`Evidence. I have personal knowledge of the facts stated in this declaration and
`
`have personally reviewed each of the attached documents. If called upon to do
`
`so, I could, and would, competently testify on the matters set forth herein.
`
`1.
`
`Attached hereto as Exhibit 1513(a) is a library-stamped, true and
`
`accurate copy of "Antibacterial activity of topical antifungal agent in the infected
`
`sites- study- skin permeability and absorption to horny materials," Tadashi Arika et
`
`al., Nishi Nihon Journal of Dermatology, 52 (3): 545-549 (1990). Exhibit 1513(a)
`
`was obtained from
`
`the vendor Reprints Desk/Research Associates. The
`
`unnumbered pages between the journal cover and the article starting on page 545
`
`of the journal, as well as pages 649-652 of the journal (understood to include the
`
`copyright and/or publication data, as well as a table of contents), have not been
`
`translated from Japanese into English, as they do not include the relevant portions
`
`of the exhibit cited by Petitioner. Exhibit 1513(a) is served in response to Patent
`
`Owner's objections to Exhibit 1513.
`
`2.
`
`Attached hereto as Exhibit 1518(a) is a library-stamped, true and
`
`accurate copy of "Risk factors and comorbidities for onychomycosis: implications
`
`2
`
`Page 2 of 11
`
`
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`for treatment with topical therapy," Boni E. Elewski et al., Journal of Clinical
`
`Aesthetic Dermatology, 8(11): 38-42 (2015), obtained from the National Library of
`
`Medicine. Exhibit 1518(a) is served in response to Patent Owner's objections to
`
`Exhibit 1518.
`
`3.
`
`Attached hereto as Exhibit 1522(a) is a true and accurate copy of
`
`"Antifungal drugs for onychomycosis: efficacy, safety, and mechanisms of action,"
`
`Theodore Rosen et al., Seminars in Cutaneous Medicine and Surgery:
`
`Onychomycosis~ Diagnosis, Treatment, and Prevention Strategies (Supp. 3), 35
`
`(3S): S51-S55 (2016), available at
`
`http://www.globalacademycme.com/fileadmin/images/supplement image/ onycho
`
`mycosisl6/SCMS™Onycho0316.pdf, accessed on November 16, 2017. I obtained
`
`this document by going to the homepage for the Global Academy for Medical
`
`Education at https:Uwww.globalacademycme.com/; entering "onychomycosis" into
`
`the search prompt in the top right comer of the webpage and clicking "Search;"
`
`clicking on the link for "Onychomycosis: Diagnosis, Treatment, and Prevention
`
`Strategies;" and at the bottom of the right hand column on the webpage, under
`
`"Download PDF(s)," clicking the pdf link for "Seminars in Cutaneous Medicine
`
`and Surgery." Exhibit 1522(a) is a true and accurate copy of the PDF at that link.
`
`Exhibit 1522(a) is served in response to Patent Owner's objections to Exhibit 1522.
`
`3
`
`Page 3 of 11
`
`
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`Attached hereto as Exhibit 1561(a) is a library-stamped, true and
`
`4.
`
`accurate copy of Durie, D. et al., A Realistic Approach to the Obviousness of
`
`Inventions, 50 (3) Wm. & Mary L. Rev. 989-1020 (2008), obtained from the
`
`University of California Berkeley, Law Library. Exhibit 1561(a) is served in
`
`response to Patent Owner's objections to Exhibit 1561.
`
`5.
`
`Attached hereto as Exhibit 1562(a) is a library-stamped, true and
`
`accurate copy of "The Pharmaceutical Industry - Prices and Progress," F .M.
`
`Scherer, The New England Journal of Medicine, 351 (9):927-932 (August 26,
`
`2004), obtained from the University of Minnesota Bio-Medical Library. Exhibit
`
`1562(a) is served in response to Patent Owner's objections to Exhibit 1562.
`
`6.
`
`Attached hereto as Exhibit 1564(a) are true and accurate copies of
`
`chapters 1 and 3 from the Pharmaceutical Industry Antitrust Handbook, American
`
`Bar Association Section of Antitrust Law, 2009. Exhibit 1564(a) is served in
`
`response to Patent Owner's objections to Exhibit 1564.
`
`7.
`
`Attached hereto as Exhibit 1565(a) is a true and accurate copy of
`
`"Health Insurance and the Growth in Pharmaceutical Expenditures." P.M. Danzon
`
`and M.V. Pauly, Journal of Law and Economics, Vol. XLV: 587- 613 (October
`
`2002), obtained from the vendor Reprints Desk/Research Associates. Exhibit
`
`1565(a) is served in response to Patent Owner's objections to Exhibit 1565.
`
`4
`
`Page 4 of 11
`
`
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`Attached hereto as Exhibit 1567(a) is a true and accurate copy of
`
`8.
`
`Chapter 3 ( entitled "The Life Cycle of a Pharmaceutical Brand") from T. Ellery
`
`and N. Hansen, Pharmaceutical Lifecycle Management, (Wiley: New Jersey),
`
`2012. Exhibit 1567(a) is served in response to Patent Owner's objections to
`
`Exhibit 1567.
`
`9.
`
`Originally filed Exhibit 1580 is a true and accurate copy of "Inside
`
`the Secret World of Drug Company Rebates," M. Herper, Forbes, May 10, 2012,
`
`available at https:Uwww .forbes.com/sites/matthewherper/2012/05/10/why(cid:173)
`
`astrazeneca-gives-insurers-60-discounts-on-nexi ums-list-price/2/#7f d663de6ec5,
`
`last accessed on October 30, 2017.
`
`10. Attached hereto as Exhibit 1589(a) is a true and accurate copy of
`
`Chapter 16, entitled "Product Differentiation, Market Structure, and Competition,"
`
`pp. 572-611, from, F.M. Scherer and D. Ross, Industrial Market Structure and
`
`Economic Performance, (Houghton Mifflin: Boston) 1990. Exhibit 1589(a) is
`
`served in response to Patent Owner's objections to Exhibit 1589.
`
`11. Attached hereto as Exhibit 1601(a) is a library-stamped, true and
`
`accurate copy of "Returns on Research and Development for 1990s New Drug
`
`Introductions," H. Grabowksi, J. Vernon, and J. A. DiMasi, PharmacoEconomics,
`
`20 (Supp. 3): 11-29 (2002), obtained from the University of Wisconsin, Pharmacy
`
`5
`
`Page 5 of 11
`
`
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`Library. Exhibit 1601(a) is served in response to Patent Owner's objections to
`
`Exhibit 1601.
`
`12. Attached hereto as Exhibit 1606(a) is a true and accurate copy of
`
`"Secondary Considerations of Nonobviousness Analysis: The Use of Objective
`
`Indicia Following KSR v. Teleflex," 86 N.Y.U. L. Rev. 2070 (2011), supplied by
`
`the British Library. Exhibit 1606(a) is served in response to Patent Owner's
`
`objections to Exhibit 1606.
`
`13. Attached hereto as Exhibit 1615(a) is a library-stamped, true and
`
`accurate copy of "Creating Demand for Prescription Drugs: A Content Analysis of
`
`Television Direct-to-Consumer Advertising," D.L. Frosch, et. al., Annals of
`
`Family Medicine, 5(1):6-14 (January/February 2007), obtained from the National
`
`Library of Medicine. Exhibit 1615(a) is served in response to Patent Owner's
`
`objections to Exhibit 1615.
`
`14. Attached hereto as Exhibit 1616(a) is a library-stamped, true and
`
`accurate copy of "Direct to Consumer Advertising and Prescription Choice," T.
`
`Iizuka, and G.Z. Jin, The Journal of Industrial Economics, LV(4): 771, Notes &
`
`Comments (December 2007), obtained from the British Library. A true and
`
`correct copy of pages 1-10 of the corresponding online note is attached. Exhibit
`
`1616(a) is served in response to Patent Owner's objections to Exhibit 1616.
`
`6
`
`Page 6 of 11
`
`
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`Case IPR2017-00190
`Patent 7,214,506 B2
`15. Attached hereto as Exhibit 1620(a) is a library-stamped, true and
`
`accurate copy of "Following the Script: How Drug Reps Make Friends and
`
`Influence Doctors," A. Fugh-Berman, S. Ahari, PLOS Medicine, 4(4): 621-625
`
`(April 2007), obtained from the National Library of Medicine. Exhibit 1620(a) is
`
`served in response to Patent Owner's objections to Exhibit 1620.
`
`16. Attached hereto as Exhibit 1622(a) is a library-stamped, true and
`
`accurate copy of "Promotion and Market Share in the Proton Pump Inhibitor
`
`Market: A Case Study," Y.J. Lu, J.F. Farley, R.A. Hansen, Journal of
`
`Pharmaceutical Marketing & Management, 17 (3/4): 39-59 (2006), obtained from
`
`the Nova Southeastern University, Health Professions Division Library. Exhibit
`
`1622(a) is served in response to Patent Owner's objections to Exhibit 1622.
`
`17. Attached hereto as Exhibit 1624(a) is a library-stamped, true and
`
`accurate copy of "Physician Awareness of Drug Cost: A Systematic Review." G.
`
`Michael Allan et al., Plos Medicine, 4(9):1486- 1496 (2007), obtained from the
`
`National Library of Medicine. Exhibit 1624(a) is served in response to Patent
`
`Owner's objections to Exhibit 1624.
`
`18. Attached hereto as Exhibit 1625(a) is a library-stamped, true and
`
`accurate copy of "Physicians' Perceptions of Relevant Prescription Drug Costs:
`
`Do Costs to the Individual Patient or to the Population Matter Most?" W.H. Shank,
`
`et. al, The American Journal of Managed Care, 12(9):545-551 (September 2006),
`
`7
`
`Page 7 of 11
`
`
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`obtained from the National Library of Medicine. Exhibit 1625(a) is served in
`
`response to Patent Owner's objections to Exhibit 1625.
`
`19. Originally filed Exhibit 1638 is a true and accurate copy of "Top 200
`
`Brand-Name Drugs by Retail Sales in 2000," available at
`
`http://www.modernmedicine.com/modern-medicine/content/top-200-brand-name(cid:173)
`
`drugs-retail-sales-2000, last accessed on October 31, 2017. I obtained this
`
`document by going to the Modern Medicine Network homepage at
`
`http://www.modernmedicine.com; entering "Top 200 brand name drugs in 2000"
`
`in the search prompt in the top right corner of the page and clicking the search
`
`icon; and clicking on the result for "Top 200 Brand-Name Drugs By Retail Sales in
`
`2000" dated January O 1, 2001. Exhibit 1638 is a true and accurate copy of the
`
`webpage that appeared.
`
`20. Originally filed Exhibit 1639 is a true and accurate copy of "Top 200
`
`Brand-Name Drugs by Retail Sales in 2001," available at
`
`http://www.modernmedicine.com/modern-medicine/content/top-200-brand-name(cid:173)
`
`drugs-retail-sales-2001, last accessed on October 31, 2017. I obtained this
`
`document by going to the Modern Medicine Network homepage at
`
`http://www.modernmedicine.com; entering "Top 200 brand name drugs in 2001"
`
`in the search prompt in the top right corner of the page and clicking the search
`
`icon; and clicking on the result for "Top 200 Brand-Name Drugs By Retail Sales in
`
`8
`
`Page 8 of 11
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`
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`Case IPR2017-00190
`Patent 7,214,506 B2
`200 l" dated January O 1, 2002. Exhibit 1639 is a true and accurate copy of the
`
`webpage that appeared.
`
`21. Originally filed Exhibit 1640 is a true and accurate copy of "Top 200
`
`Brand-Name Drugs by Retail Sales in 2002," available at
`
`http://www.modernmedicine.com/modern-medicine/ content/top-200-brand-name(cid:173)
`
`drugs-retail-sales-2002, last accessed on October 31, 2017. I obtained this
`
`document by going to the Modern Medicine Network homepage at
`
`http://www.modernmedicine.com; entering "Top 200 brand name drugs in 2002"
`
`in the search prompt in the top right corner of the page and clicking the search
`
`icon; and clicking on the result for "Top 200 Brand-Name Drugs By Retail Sales in
`
`2002" dated January 01, 2003. Exhibit 1640 is a true and accurate copy of the
`
`webpage that appeared.
`
`22. Originally filed Exhibit 1641 is a true and accurate copy of '~Top 200
`
`Brand-Name Drugs by Retail Sales in 2003," available at
`
`http://www.modernmedicine.com/modern-medicine/content/top-200-brand-name(cid:173)
`
`drugs-retail-sales-2003, last accessed on October 31, 2017. I obtained this
`
`document by going to the Modern Medicine Network homepage at
`
`http://www.modernmedicine.com; entering "Top 200 brand name drugs in 2003"
`
`in the search prompt in the top right corner of the page and clicking the search
`
`icon; and clicking on the result for "Top 200 Brand-Name Drugs By Retail Sales in
`
`9
`
`Page 9 of 11
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`
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`Case IPR2017-00190
`Patent 7,214,506 B2
`2003" dated January 01, 2004. Exhibit 1641 is a true and accurate copy of the
`
`webpage that appeared.
`
`23. Originally filed Exhibit 1642 is a true and accurate copy of "Top 200
`
`Drugs for 2004 by Sales," available at https:Uwww.drugs.com/top200-2004.html,
`
`last accessed on October 31, 2017. I obtained this document by going to the Drugs
`
`homepage at https://www.drugs.com/; entering "Top 200 brand name drugs in
`
`2004" in the search prompt at the top of the page and clicking the search icon; and
`
`clicking on the result for "Top 200 Prescribed Drugs by Sales in 2004." Exhibit
`
`1642 is a true and accurate copy of the webpage that appeared.
`
`24. Originally filed Exhibit 1643 is a true and accurate copy of "Top 200
`-
`
`Drugs for 2005 by Sales," available at https://www.drugs.com/top200 2005.html,
`
`last accessed on October 31, 2017. I obtained this document by going to the Drugs
`
`homepage at https://www.drugs.com/; entering "Top 200 brand name drugs in
`
`2005" in the search prompt at the top of the page and clicking the search icon; and
`
`clicking on the result for "Top 200 Prescribed Drugs by Sales in 2005." Exhibit
`
`1643 is a true and accurate copy of the webpage that appeared.
`
`25. Originally filed Exhibit 1644 is a true and accurate copy of "Top 200
`
`Drugs for 2006 by Sales," available at https://www.drugs.com/top200_2006.html,
`
`last accessed on October 31, 2017. I obtained this document by going to the Drugs
`
`homepage at https:Uwww.drugs.com/; entering "Top 200 brand name drugs in
`
`10
`
`Page 10 of 11
`
`
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`2006" in the search prompt at the top of the page and clicking the search icon; and
`
`clicking on the result for "Top 200 Prescribed Drugs by Sales in 2006." Exhibit
`
`1644 is a true and accurate copy of the webpage that appeared.
`
`26. Originally filed Exhibit 1645 is a true and accurate copy of "Top 200
`
`Drugs for 2007 by Sales," available at https://www.drugs.com/top200_2007.html,
`
`last accessed on October 31, 2017. I obtained this document by going to the Drugs
`
`homepage at https://www.drugs.com/; entering "Top 200 brand name drugs in
`
`2007" in the search prompt at the top of the page and clicking the search icon; and
`
`clicking on the result for "Top 200 Prescribed Drugs by Sales in 2007." Exhibit
`
`1645 is a true and accurate copy of the webpage that appeared.
`
`I declare under penalty of perjury that the foregoing is true and correct. Executed
`
`this 22nd day of November, 2017, in Washington, D.C.
`
`Caitlin M. Wilmot
`
`11
`
`Page 11 of 11
`
`
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