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`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
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`_______________
`
`Case IPR2017-001901
`Patent 7,214,506 B2
`_______________
`
`
`DECLARATION OF LISA N. PHILLIPS IN SUPPORT OF PETITIONER’S
`RESPONSE TO PATENT OWNER’S OBJECTIONS TO EVIDENCE
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`1
`Case IPR2017-01429 has been joined with the instant proceeding.
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`Page 1 of 61
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`ACRUX DDS PTY LTD. et al.
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`EXHIBIT 1672
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`IPR Petition for
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`U.S. Patent No. 7,214,506
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`
`
`I, Lisa N. Phillips, declare and state as follows:
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`I am a member of the Bar of the District of Columbia and a Partner with
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`the firm Rothwell, Figg, Ernst & Manbeck, PC, attorneys for Acrux DDS Pty.
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`Ltd. and Acrux Limited ("Petitioner"). I submit this declaration in support of the
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`Response to Patent Owner's Objections to Evidence. I have personal knowledge
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`of the facts stated in this declaration and have personally reviewed each of the
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`attached documents. If called upon to do so, I could, and would, competently
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`testify on the matters set forth herein.
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`1.
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`Originally filed Exhibit 1515 is a true and accurate copy of Label for
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`Kerydin® (tavaborole) topical solution, 5%, Anacor Pharmaceuticals, Inc., NDA
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`204-427, available at
`
`http://www.accessdata. f da. gov/ drugsatf da docs/label/2014/2044 2 7 sOOOlbl. pdf, last
`
`accessed November 15, 2017. I obtained this document by going to the United
`
`States Food and Drug Administration ("FDA") website at https://www.fda.gov/;
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`clicking on the tab labeled "Drugs" at the top of the page; under "Spotlight" on the
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`right side of the page, clicking "Search Drugs@FDA;" entering "Kerydin" into the
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`search prompt and clicking "Search;" clicking on the drop-down tab labeled
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`"Approval Date(s) and History, Letters, Labels, Reviews for NDA 203567;" and
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`under "Original Approvals or Tentative Approvals," clicking the link for "Label."
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`2
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`Exhibit 1515 is a true and accurate copy of the PDF document that appeared at that
`
`link.
`
`2.
`
`Originally filed Exhibit 1516 is a true and accurate copy of Label for
`
`Diflucan® (fluconazole)
`
`tablets, Pfizer
`
`Inc., NDA 19-949, available at
`
`http://www.accessdata.fda.gov/drugsatfda docs/label/2008/0l9949s041,019950s0
`
`43,020090s022lbl.pdf, last accessed November 15, 2017. I obtained this document
`
`by going to the FDA website at https://www.fda.gov/; clicking on the tab labeled
`
`"Drugs" at the top of the page; under "Spotlight" on the right side of the page,
`
`clicking "Search Drugs@FDA;" entering "Diflucan" into the search prompt and
`
`clicking "Search;" clicking on "Diflucan" and then "Diflucan (FLUCONAZOLE)"
`
`for the oral tablet; clicking on the drop-down tab labeled "Approval Date(s) and
`
`History, Letters, Labels, Reviews for NDA 203567;" and in the line for "SUPPL-
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`67" under "Supplements," clicking the link for "Label." Exhibit 1516 is a true and
`
`accurate copy of the PDF document that appeared at that link.
`
`3.
`
`Originally filed Exhibit 1517 is a true and accurate copy of Label for
`
`Sporanox® (itraconazole) capsules, Janssen Pharmaceutical Company, NDA 20-
`
`083, available at
`
`http://www.accessdata.fda.gov/ drugsatfda docs/label/2012/020083s048s049s0 501b
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`1.pdf, last accessed November 15, 2017. I obtained this document by going to the
`
`FDA website at https://www.fda.gov/; clicking on the tab labeled "Drugs" at the
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`3
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`Page 3 of 61
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`Patent 7,214,506 B2
`top of the page; under "Spotlight" on the right side of the page, clicking "Search
`
`Drugs@FDA;" entering "Sporanox" into the search prompt and clicking "Search;"
`
`clicking on "Sporanox" and then "SPORANOX (ITRACONAZOLE)" for the oral
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`capsule, NDA 20083; clicking on the drop-down tab labeled "Approval Date(s)
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`and History, Letters, Labels, Reviews for NDA 203567;" and in the line for
`
`"SUPPL-60" under "Supplements," clicking the link for "Label." Exhibit 1517 is
`
`a true and accurate copy of the PDF document that appeared at that link.
`
`4.
`
`Originally filed Exhibit 1523 is a true and accurate copy ofKaken
`
`Research & Development Division: R&D Pipeline, available at
`
`http://www.kaken.co.jp/english/business/rd pipeline.html, last accessed on
`
`October 30, 2017. I obtained this document by going to the Kaken website at
`
`http://www.kaken.co.jp/english/; clicking on the tab labeled "Business" in the top
`
`right comer of the page; clicking on the tab labeled "Research & Development
`
`Division;" and then clicking on "R&D Pipeline." Exhibit 1523 is a true and
`
`accurate copy of the webpage that appeared.
`
`5.
`
`Originally filed Exhibit 1524 is a true and accurate copy of "Leaked
`
`Documents Shed Light on the Defunct Pharmacy that Brought Valeant to its
`
`Knees." M. Turner and L. Lopez, Business Insider, Nov. 8, 2016, available at
`
`http://www. businessinsider. com/leaked-valeant-documents-show-philidor(cid:173)
`
`strategy-2016-11 , last accessed on October 30, 2017.
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`4
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`Originally filed Exhibit 1525 is a true and accurate copy of
`
`6.
`
`"Pharmacy's Sales Tactics Disclosed," J. Rockoff and J. Whalen, Oct. 28, 2015,
`
`available
`
`at
`
`https://www.wsj.com/articles/pharmacys-sales-tactics-disclosed-
`
`1446075817, last accessed on October 30, 2017.
`
`7.
`
`Originally filed Exhibit 1526 is a true and accurate copy of Valeant
`
`Pharmaceuticals International, Inc., Investor Conference Call Presentation, October
`
`26, 2015, available at http://ir.valeant.com/~/media/Files/V /Valeant-IR/reports(cid:173)
`
`and-presentations/1 0-26-15-investor-presentation.pdf, last accessed on October 28,
`
`201 7. I obtained this document by going to the Valeant Investor Relations website
`
`at http://ir.valeant.com/; hovering the mouse over the tab on the top of the page
`
`labeled "Investor Relations" and then clicking the link below for "EVENTS AND
`
`PRESENTATIONS;" clicking on the tab for "2015" under the heading "Past
`
`Events;" and, finally, clicking the PDF link for "Valeant Investor Call" dated
`
`10/26/2015. Exhibit 1526 is a true and accurate copy of the PDF that appeared at
`
`that link.
`
`8.
`
`Originally filed Exhibit 1527 is a true and accurate copy of "Valeant
`
`and Pharmacy More Intertwined than Thought." J. Rockoff and J. Whalen, Wall
`
`Street Journal, October 25 , 2015, available at
`
`https://www.wsj.com/articles/valeants-ties-to-pharmacy-scrutinized-l 445817449,
`
`last accessed on October 30, 2017.
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`5
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`Originally filed Exhibit 1528 is a true and accurate copy of "Valeant
`
`9.
`
`Under Criminal Investigation." J. McNish and C.M. Matthews, Wall Street
`
`Journal, August 10, 2016, available at https://www.wsj.com/articles/valeant-under(cid:173)
`
`criminal-investigation-1470868752, last accessed on October 30, 2017.
`
`10. Originally filed Exhibit 1529 is a true and accurate copy of Thomson
`
`Reuters StreetEvents, Edited Transcript, VRX.TO - Q3 2015 Valeant
`
`Pharmaceuticals International Inc. Earnings Call, dated October 19, 2015. I
`
`obtained this document by purchasing it on http://www.alacrastore.com/, owned
`
`and operated by Alacra, Inc. Exhibit 1529 is a true and accurate copy of the
`
`document that was received. It is reported that Alacra, Inc. is a global provider of
`
`business and financial information from several providers, including earnings call
`
`transcripts from Thomson Reuters StreetEvents. See
`
`http://www.alacrastore.com/help/about, last accessed on November 21, 2017.
`
`11. Originally filed Exhibit 1530 is a true and accurate copy of "Valeant,
`
`Philidor RX, and the Uninformed Attack on Specialty Pharmacy," A.J. Fein, Drug
`
`Channels, October 27, 2015, available at
`
`http://www.drugchannels.net/2015/10/valeant-philidor-rx-and-uninformed.html ( as
`
`noted under the article's title), last accessed on October 30, 2017.
`
`12. Originally filed Exhibit 1531 is a true and accurate copy of "Drug
`
`Makers Sidestep Barriers on Pricing." A. Pollack, New York Times, October 19,
`
`6
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`2015, available at https://www .nytimes.com/2015/10/20/business/ drug-makers-
`
`sidestep-barriers-on-pricing.html? r=l , last accessed on October 30, 2017.
`
`13. Originally filed Exhibit 1532 is a true and accurate copy of "U.S.
`
`Drug Benefit Managers Clamp Down on Specialty Pharmacies," C. Rumer and D.
`
`Beasley, Reuters, Health News, November 16, 2015, available at
`
`http://www.reuters.com/article/us-healthcare-pharmacies-terminations(cid:173)
`
`ex/exclusive-u-s-drug-benefit-managers-clamp-down-on-specialty-pharmacies(cid:173)
`
`idINKCNOT40WF20151 l 15, last accessed on October 30, 2017.
`
`14. Originally filed Exhibit 1533 is a true and accurate copy of "Beyond
`
`Valeant, U.S. Payers Scrutinize Other Drugmaker Ties to Pharmacies," D. Beasley,
`
`Reuters, Health News, October 30, 2015, available at
`
`http://www.reuters.com/article/us-valeant-pharmacies-expressscripts-
`
`exc/ exclusi ve-beyond-valeant-u-s-payers-scrutinize-other-drugmaker-ties-to-
`
`pharmacies-idUSKCNOS02NE20151031 , last accessed on October 30, 2017.
`
`15. Originally filed Exhibit 1534 is a true and accurate copy of "Valeant
`
`Plunges on Report U.S. Attorney Pursuing Criminal Charges against the
`
`Company," A. Gara, Forbes, August 11 , 2016, available at
`
`https://www.forbes.com/sites/antoinegara/2016/08/ l l /valeant-plunges-on-report-u(cid:173)
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`s-attomey-pursuing-criminal-charges-against-company/#54 228 8297 806, last
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`accessed on October 30, 2017.
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`7
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`16. Attached hereto as Exhibit 1535(a) is a true and accurate copy of
`
`"Pharmacy Benefit Management: Are Reporting Requirements Pro- or
`
`Anticompetitive?" P.M. Danzon, International Journal of the Economics of
`
`Business, 22(2):245-261 (2015). I obtained this document by going to the
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`International Journal of the Economics of Business website at
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`http://www.tandfonline.com/loi/cijb20; clicking on the tab labeled "Browse List of
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`Issues;" clicking on "Volume 22 2015" to expand it; clicking on "Issue 2;" locating
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`the article entitled "Pharmacy Benefit Management: Are Reporting Requirements
`
`Pro- or Anticompetitive?" and clicking on the link; clicking the orange "get
`
`access" tab; and purchasing access to the article. Exhibit l 535(a) is a true and
`
`correct copy of the article that was purchased and downloaded. Exhibit 1535(a) is
`
`served in response to Patent Owner's objections to Exhibit 1535.
`
`17. Originally filed Exhibit 1536 is a true and accurate copy of "Prior
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`Authorization," The Academy of Managed Care Pharmacy's Concepts in Managed
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`Care Pharmacy, available at http://www.amcp.org/prior authorization/, last
`
`accessed on October 30, 2017.
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`18. Originally filed Exhibit 1537 is a true and accurate copy of
`
`"Adventures in 'Prior Authorization,"' D. Ofri, New York Times, August 3, 2014,
`
`available at https://www.nytimes.com/2014/08/04/opinion/adventures-in-prior(cid:173)
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`authorization.html, last accessed on October 30, 2017.
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`8
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`19. Originally filed Exhibit 1538 is a true and accurate copy of "Curing
`
`the Prior Authorization Headache," J. Bendix, Medical Economics, October 10,
`
`2013, available at http://medicaleconomics.modernmedicine.com/medical(cid:173)
`
`economics/content/tags/americas-health-insurance-plans/curing-prior(cid:173)
`
`authorization-headache, last accessed on October 30, 2017.
`
`20. Originally filed Exhibit 1539 is a true and accurate copy of
`
`"Pharmacist at Center ofValeant Scandal Accuses Drugmaker of 'Massive
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`Fraud'," M. Petersen and S. Pfeifer, Los Angeles Times, October 31, 2015,
`
`available at http://www.latimes.com/business/la-fi-1101-valeant-pharmacy-
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`2015110 I-story.html, last accessed on October 30, 2017.
`
`21. Originally filed Exhibit 1540 is a true and accurate copy of "The
`
`Valeant Executive Who Could've Saved Bill Ackman's Investment Just Walked
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`Out the Door," L. Lopez, Business Insider, March 3, 2016, available at
`
`http://www.businessinsider.com/valeant-two-top-drugs-are-face-big-risks-2016-3 ,
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`last accessed on October 30, 2017.
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`22. Originally filed Exhibit 1541 is a true and accurate copy of "Valeant
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`Shares Fall After Sales and Earnings Targets Cut," D. Crow and P. Kwan Yuk,
`
`Financial Times, November 8, 2016, available at
`
`https://www.ft.com/content/8efd1 dl 8-a5b0-11 e6-8b69-02899e8bd9dl ?mhq5j=e7,
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`last accessed on October 30, 2017.
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`9
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`23. Originally filed Exhibit 1542 is a true and accurate copy of "Suit
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`Alleges Valeant Ran Secret Prescription Refill Scam," C. Dometsch and D.
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`Voreacos, Insurance Journal, August 19, 2016, available at
`
`http://www.insurancejoumal.com/news/national/2016/08/19/423867.htm, last
`
`accessed on October 30, 2017.
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`24. Attached hereto as Exhibit 1543(a) is a true and accurate copy of "Is
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`Walgreens Valeant's New Philidor?" D. A. Hussar, The Pharmacist Activist, vol.
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`11, no. 2 (February 2016), available at
`
`http://www.pharmacistactivist.com/2016/February 2016.shtml, last accessed on
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`November 16, 2017. I obtained this document by going to The Pharmacist Activist
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`homepage at http://www.pharmacistactivist.com/; clicking "2016" under "Back
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`Issues" in the left column of the page; and clicking the link for "February 2016
`
`Issue." Exhibit 1543(a) is a true and accurate copy of the webpage that appeared
`
`in that link. Exhibit 1543, the PDF version of the webpage, was obtained by
`
`clicking on the link for "Download PDF format" on the webpage for Exhibit
`
`1543(a). Exhibit 1543 is a true and accurate copy of the PDF that appeared at the
`
`"Download PDF format" link of Exhibit 1543(a). Exhibit 1543(a) is served in
`
`response to Patent Owner's objections to Exhibit 1543.
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`25. Attached hereto as Exhibit 1544(a) is a true and accurate copy of
`
`"The King's Gambit: Valeant's Big Secret," R. Boyd, Southern Investigative
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`10
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`Reporting Foundation, October 19, 2015, available at http://sirf-
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`online.org/2015/10/19/hidden-in-plain-sight-valeants-big-crazy-sort-of-secret(cid:173)
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`story/, last accessed on November 16, 2017, obtained by printing the webpage to
`
`PDF format to include the website address at the top of each page. Exhibit 1544 is
`
`also a true and accurate copy of "The King's Gambit: Valeant's Big Secret," R.
`
`Boyd, Southern Investigative Reporting Foundation, October 19, 2015, available at
`
`http://sirf-online.org/2015/10/19/hidden-in-plain-sight-valeants-big-crazy-sort-of(cid:173)
`
`secret-story/, last accessed on October 30, 2017, obtained as a screenshot of the
`
`webpage. Exhibit 1544(a) is served in response to Patent Owner's objections to
`
`Exhibit 1544.
`
`26. Originally filed Exhibit 1545 is a true and accurate copy of "Valeant
`
`Slumps Again After Rebutting Critical Report," J. D. Rockoff and M. Farrell, Wall
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`Street Journal, October 21, 2015, available at
`
`https://www.wsj.com/articles/valeant-rebuffs-critical-report-that-pummels-stock-
`
`1445452695, last accessed on October 30, 2017.
`
`27. Originally filed Exhibit 1546 is a true and accurate copy of "Valeant
`
`Pharmaceuticals Under Investigation by Federal Prosecutors," J. D. Rockoff, Wall
`
`Street Journal, October 15, 2015 https://www.wsj.com/articles/valeant(cid:173)
`
`pharmaceuticals-under-investigation-by-federal-prosecutors-1444874 710, last
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`accessed on October 30, 2017.
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`28. Attached hereto as Exhibit 1547(a) is a true and accurate copy of
`
`"Citron Research, Valeant: Could this be the Pharmaceutical Enron?," For the Rest
`
`of the Story, Click Here, available at http://www.citronresearch.com/valeant-could(cid:173)
`
`this-be-the-pharmaceutical-enron/, last accessed on November 16, 2017. I obtained
`
`this document by going to the Citron Research website at
`
`http://www.citronresearch.com/; clicking on the search icon in the top right comer
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`of the page; entering "Valeant" in the search prompt and clicking the search icon
`
`again; and clicking on the search result entitled "V ALEANT- COULD THIS BE
`
`THE PHARMACEUTICAL ENRON?." Exhibit 1547(a) is a true and accurate
`
`copy of the webpage that appeared. Exhibit 154 7 is a true and accurate copy of
`
`the PDF document that appeared after I clicked on "For the Rest of the Story, Click
`
`Here:," as shown in Exhibit 1547(a) and is available at
`
`http://www.citronresearch.com/wp-content/uploads/2015/10/Valeant-Philador-and(cid:173)
`
`RandO-final-a.pdf, last accessed on October 30, 2017. Exhibit 1547(a) is served in
`
`response to Patent Owner's objections to Exhibit 1547.
`
`29. Originally filed Exhibit 1548 is a true and accurate copy of "The
`
`Fraud Allegations Against Valeant Exposed an Industry Secret that's going to
`
`Infuriate Washington," L. Lopez, Business Insider, October 21, 2015, available at
`
`http://www. businessinsider. com/valeant-accusations-highlight-special-pharmacies-
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`2015-10, last accessed on October 30, 2017.
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`30. Originally filed Exhibit 1549 is a true and accurate copy of "CVS,
`
`Express Scripts, UnitedHealth Group Cut Off Philidor, Pharmacy Used by
`
`Valeant," A.W. Mathews, J. Whalen, R. Copeland, Wall Street Journal, October
`
`29, 2015, available at https://www.wsj.com/articles/cvs-cuts-off-philidor(cid:173)
`
`pharmacy-used-by-valeant-pharmaceuticals-1446151453 , last accessed on October
`
`30, 2017.
`
`31. Originally filed Exhibit 1550 is a true and accurate copy of the Label
`
`for Lamisil® (terbinafine) tablets, Novartis Pharmaceuticals Corporation, NDA 20-
`
`539, available at
`
`http://www.accessdata. f <la.gov/ drugsatf da docs/label/2014/2044 2 7 sOOO lbl. pdf, last
`
`accessed on November 16, 2017. I obtained this document by going to the FDA
`
`website at https://www.fda.gov/; clicking on the tab labeled "Drugs" at the top of
`
`the page; under "Spotlight" on the right side of the page, clicking "Search
`
`Drugs@FDA;" entering "Lamisil" into the search prompt and clicking "Search;"
`
`clicking on "Lamisil" and then "LAMISIL (TERBINAFINE
`
`HYDROCHLORIDE)" for the oral capsule, NDA 20539; clicking on the drop(cid:173)
`
`down tab labeled "Approval Date(s) and History, Letters, Labels, Reviews for
`
`NDA 203567;" and in the line for "SUPPL-24" under "Supplements," clicking the
`
`link for "Label." Exhibit 1550 is a true and accurate copy of the PDF document
`
`that appeared at that link.
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`13
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`32. Originally filed Exhibit 1551 is a true and accurate copy of Yahoo
`
`Finance, Valeant Pharmaceuticals International, Inc., Stock Price Historical Values
`
`(Daily), dated from October 1, 2015 through December 31, 2015, available at
`
`https://finance.yahoo.com/quote/VRX/history?period1=1443672000&period2=145
`
`1538000&interval=ld&filter=history&frequency=ld, last accessed on October 30,
`
`2017. I obtained this document by going to the Yahoo Finance website at
`
`https://finance.yahoo.com/; typing "Valeant" into the search prompt and clicking
`
`the search icon on the top of the page; clicking the tab labeled "Historical Data;"
`
`selecting the time period as October 1, 2015 through December 31, 2015; and,
`
`finally, clicking "Apply." Exhibit 1551 is a true and accurate copy of the webpage
`
`that appeared.
`
`33. Originally filed Exhibit 1552 is a true and accurate copy of Valeant
`
`Press Release, "Valeant to Terminate Relationship with Philidor," dated October
`
`30, 2015, available at, http://ir.valeant.com/tools/viewpdf.aspx?page= {D20805D9-
`
`D640-40D9-BBFO-FC808DA4A 7B2}, last accessed on October 30, 2017. I
`
`obtained this document by going to the Valeant Investor Relations website at
`
`http://ir.valeant.com/; hovering the mouse over the tab on the top of the page
`
`labeled "Investor Relations" and then clicking the link below for "NEWS
`
`RELEASES;" clicking on the tab for "2015" just above the heading "Archive;"
`
`and, finally, clicking the PDF link for "Valeant to Terminate Relationship with
`
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`Philidor" dated 10/30/2015. Exhibit 1552 is a true and accurate copy of the PDF
`
`that appeared.
`
`34. Originally filed Exhibit 1553 is a true and accurate copy of Valeant
`
`Pharmaceuticals International, Inc., U.S. Securities and Exchange Commission
`
`Form 10-K, for the Fiscal Year Ended December 31, 2015, available at
`
`https://www.sec.gov/ Archives/edgar/data/885590/000088559016000101 /valeant20
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`15form10-k.htm, last accessed on October 30, 2017. I obtained this document by
`
`going to the United States Securities and Exchange Commission ("SEC") website
`
`at https://www.sec.gov/; clicking "COMPANY FILINGS" under the search prompt
`
`in the top right corner of the page; typing "Valeant" into the search prompt and
`
`clicking "Search;" clicking on CIK number 0000885590 for Valeant
`
`Pharmaceuticals; clicking on the "Next 40" button at the bottom of the page;
`
`clicking "Documents" for the 10-K form filed on 04-29-2016; and, finally, clicking
`
`on the document link "valeant2015form10-k.htm" under the heading "Document
`
`Format Files." Exhibit 1553 is a true and accurate copy of the webpage that
`
`appeared.
`
`35. Attached hereto as Exhibit 1553(a) is a true and accurate copy of
`
`Valeant Pharmaceuticals International, Inc., U.S. Securities and Exchange
`
`Commission Form 10-K, for the Fiscal Year Ended December 31, 2015, available
`
`at http://otp.investis.com/clients/us/valeant pharmaceuticals 1/SEC/sec-
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`Case IPR2017-00190
`Patent 7,214,506 B2
`show.aspx?Type=html&Filingid=l 1344612&CIK=0000885590&Index=lOOOO,
`
`accessed November 16, 2017. I obtained this document by going to the Valeant
`
`Investor Relations website at http://ir.valeant.com/; hovering the mouse over the
`
`tab on the top of the page labeled "Investor Relations" and then clicking the link
`
`below for "SEC FILINGS;" using the search pages below the results to get to page
`
`19; clicking the link for "Annual Report," form 10-K, dated 04/29/2016; and,
`
`finally, clicking on the link for "Form 10-K (Entire Filing)." Exhibit 1553(a) is a
`
`true and accurate copy of the webpage that appeared at that link. Exhibit 1553(a)
`
`is served in response to Patent Owner's objections to Exhibit 1553.
`
`36. Originally filed Exhibit 1554 is a true and accurate copy ofValeant
`
`Pharmaceuticals International, Inc., U.S. Securities and Exchange Commission
`
`Form 10-K, for the Fiscal Year Ended December 31, 2016, available at
`
`https://www.sec.gov/Archives/edgar/data/885590/000088559017000015/valeant20
`
`16forml0-k.htm, last accessed on October 30, 2017. I obtained this document by
`
`going to the SEC website at https://www.sec.gov/; clicking "COMPANY
`
`FILINGS" under the search prompt in the top right comer of the page; typing
`
`"Valeant" into the search prompt and clicking "Search;" clicking on CIK number
`
`0000885590 for Valeant Pharmaceuticals; clicking "Documents" for the 10-K form
`
`filed on 03-01-2017; and, finally, clicking on the document link
`
`16
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`Page 16 of 61
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`"valeant2016form10-k.htm" under the heading "Document Format Files." Exhibit
`
`1554 is a true and accurate copy of the webpage that appeared.
`
`37. Attached hereto as Exhibit 1554(a) is a true and accurate copy of
`
`Valeant Pharmaceuticals International, Inc., U.S. Securities and Exchange
`
`Commission Form 10-K, for the Fiscal Year Ended December 31, 2016, available
`
`at http://otp.investis.com/clients/us/valeant pharmaceuticals 1/SEC/sec-
`
`show .aspx?Type=html&Filingid= 118 97971&CIK=0000885 590&Index= 10000,
`
`accessed November 16, 2017. I obtained this document by going to the Valeant
`
`Investor Relations website at http://ir.valeant.com/; hovering the mouse over the
`
`tab on the top of the page labeled "Investor Relations" and then clicking the link
`
`below for "SEC FILINGS;" using the search pages below the results to get to page
`
`8; clicking the link for "Annual Report," form 10-K, dated 03/01 /2017; and,
`
`finally, clicking on the link for "Form 10-K (Entire Filing)." Exhibit l 554(a) is a
`
`true and accurate copy of the webpage that appeared at that link. Exhibit 1554(a)
`
`is served in response to Patent Owner's objections to Exhibit 1554.
`
`38. Originally filed Exhibit 1555 is a true and accurate copy of "Valeant
`
`Under Investigation by SEC," J. McNish and M. Rapoport, Wall Street Journal,
`
`February 29, 2016, available at https://www.wsj.com/articles/valeant-under(cid:173)
`
`investigation-by-sec-1456779650, last accessed on October 30, 2017.
`
`17
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`Page 17 of 61
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`39. Originally filed Exhibit 1556 is a true and accurate copy ofValeant
`
`Press Release, "Valeant Announces CEO Succession Plan And Changes To Board
`
`Of Directors; Provides Accounting And Financial Reporting Update," dated March
`
`21, 2016, available at http://ir.valeant.com/news-releases/2016/03-2l-2016-
`
`l25936508?ncid=txtlnkusaolp00000618, last accessed on October 30, 2017. I
`
`obtained this document by going to the Valeant Investor Relations website at
`
`http://ir.valeant.com/; hovering the mouse over the tab on the top of the page
`
`labeled "Investor Relations" and then clicking the link below for "NEWS
`
`RELEASES;" clicking on the tab for "2016" just above the heading "Archive;"
`
`and, finally, clicking the PDF link for "Valeant Announces CEO Succession Plan
`
`and Changes to Board of Director~," dated 3/21/16. Exhibit 1556 is a true and
`
`accurate copy of the PDF that appeared.
`
`40. Originally filed Exhibit 1557 is a true and accurate copy of "Mike
`
`Pearson is on His Way Out ofValeant, Former CFO Refuses to Leave Board," N.
`
`Vardi, Forbes, March 21, 2016, available at
`
`https://www.forbes.com/sites/nathanvardi/2016/03/21 /mike-pearson-is-on-his(cid:173)
`
`way-out-of-valeant-amid-more-drama-former-cfo-refuses-to-leave-
`
`board/#1695d6c5275c, last accessed on October 30, 2017.
`
`41. Originally filed Exhibit 1558 is a true and accurate copy of "Valeant
`
`Sold Some Drugs Twice," M. Levine, Bloomberg, March 21, 2016, available at
`
`18
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`Page 18 of 61
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`https://www.bloomberg.com/view/artic1es/2016-03-21 /valeant-sold-some-drugs-
`
`twice?ncid=txtlnkusaolp00000618, last accessed on October 30, 2017.
`
`42. Originally filed Exhibit 1559 is a true and accurate copy of "Valeant
`
`Ex-CEO, Ex-CFO Are a Focus of U.S. Criminal Probe," C. Berthelsen, G. Farrell,
`
`N. Weinberg, and C. Koons, Bloomberg, October 31, 2016, available at
`
`https://www.bloomberg.com/news/articles/2016-10-31 /valeant-ex-ceo-ex-cfo-said(cid:173)
`
`to-be-a-focus-of-u-s-criminal-probe, last accessed on October 30, 2017.
`
`43. Originally filed Exhibit 1560 is a true and accurate copy of "Two are
`
`Charged in Fraud and Kickback Scheme Against Valeant Pharmaceuticals," A.
`
`Gara, Forbes, November 17, 2016, available at
`
`https://www.forbes.com/sites/antoinegara/2016/11 /17 /two-are-charged-in-fraud(cid:173)
`
`and-kickback-scheme-against-valeant-pharmaceuticals/#6b86c356494d, last
`
`accessed on October 30, 2017.
`
`44. Originally filed Exhibit 1563 is a true and accurate copy of "How
`
`Increased Competition From Generic Drugs has Affected Prices and Returns in the
`
`Pharmaceutical Industry: a CBO Study," Congressional Budget Office (1998),
`
`available at https://www.cbo.gov/sites/default/files/1 OSth-congress-1997-
`
`1998/reports/pharm.pdf, last accessed on October 30, 2017. I obtained this
`
`document by going to the Congressional Budget Office website at
`
`https://www.cbo.gov/; clicking on the search icon in the top right comer of the
`
`19
`
`Page 19 of 61
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`page; entering "How Increased Competition from Generic Drugs" into the search
`
`prompt and hit Enter on my keypad; clicking on the link for "How Increased
`
`Competition From Generic Drugs has Affected Prices and Returns in the
`
`Pharmaceutical Industry;" and then clicking "View Document." Exhibit 1563 is a
`
`true and accurate copy of the PDF that appeared.
`
`45. Originally filed Exhibit 1566 is a true and accurate copy of "100
`
`Best-Selling, Most Prescribed Branded Drugs through March," T. Brown,
`
`Medscape (May 6, 2015), available at
`
`http://www.medscape.com/viewarticle/844317#vp 3, last accessed on October 31,
`
`2017.
`
`46. Originally filed Exhibit 1568 is a true and accurate copy of
`
`"Prescription Drug Pricing in the Private Sector: a CBO Paper." Congressional
`
`Budget Office, CBO Publication No. 2703 (2007), available at
`
`https://www.cbo.gov/publication/18275 , last accessed on October 30, 2017. I
`
`obtained this document by going to the Congressional Budget Office website at
`
`https://www.cbo.gov/; clicking on the search icon in the top right comer of the
`
`page; entering "Prescription Drug Pricing" into the search prompt and hitting Enter
`
`on my keypad; clicking on the link for "Prescription Drug Pricing in the Private
`
`Sector;" and then clicking "View Document." Exhibit 1568 is a true and accurate
`
`copy of the PDF that appeared.
`
`20
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`4 7. Originally filed Exhibit 1569 is a true and accurate copy of Thomson
`
`Reuters StreetEvents, Edited Transcript, VRX.TO - Q3 2016 Valeant
`
`Pharmaceuticals International Inc. Earnings Call, dated November 8, 2016. I
`
`obtained this document by purchasing it on http://www.alacrastore.com/, owned
`
`and operated by Alacra, Inc. Exhibit 1569 is a true and accurate copy of the
`
`document that was received. It is reported that Alacra, Inc. is a global provider of
`
`business and financial information from several providers, including earnings call
`
`transcripts from Thomson Reuters StreetEvents. See
`
`http://www.alacrastore.com/help/about, last accessed on November 21, 2017.
`
`48. Originally filed Exhibit 1570 is a true and accurate copy ofValeant
`
`Pharmaceuticals International, Inc. Q2 2015 Financial Results Presentation, dated
`
`July 23, 2015, available at http://ir.valeant.com/~/media/Files/V/Valeant(cid:173)
`
`IR/reports-and-presentations/Q22015-earnings-deck-final-august-11-revised.pdf,
`
`last accessed on October 30, 2017. I obtained this document by going to the
`
`Valeant Investor Relations website at http://ir.valeant.com/; hovering the mouse
`
`over the tab on the top of the page labeled "Investor Relations" and then clicking
`
`the link below for "EVENTS AND PRESENTATIONS;" clicking on the tab for
`
`"2015" under the heading "Past Events;" and, finally, clicking the PDF link for
`
`"Q2 2015 Earnings Call Conference Call," dated 07/23/2015. Exhibit 1570 is a
`
`true and accurate copy of the PDF that appeared at that link.
`
`21
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`Page 21 of 61
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`Case IPR2017-00190
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`49. Originally filed Exhibit 1571 is a true and accurate copy of Valeant
`
`Pharmaceuticals International, Inc. First Quarter 2016 Conference Call
`
`Presentation, dated June 7, 2016, available at
`
`http://ir.valeant.com/~/media/Files/V /Valeant-IR/reports-and-presentations/ q 1-
`
`2016-earnings-presentation.pdf, last accessed on October 30, 2017. I obtained this
`
`document by going to the Valeant Investor Relations website at
`
`http://ir.valeant.com/; hovering the mouse over the tab on the top of the page
`
`labeled "Investor Relations" and then clicking the link below for "EVENTS AND
`
`PRESENTATIONS;" clicking on the tab for "2016" under the heading "Past
`
`Events;" and, finally, clicking the PDF link for "Valeant Ql 2016 Earnings" dated
`
`06/07/16. Exhibit 1571 is a true and accurate copy of the PDF that appeared at that
`
`link.
`
`50. Originally filed Exhibit 1572 is a true and accurate copy of Valeant
`
`Pharmaceuticals International, Inc. Fourth Quarter and Full Year 2015
`
`Supplemental Information Presentation, dated April 29, 2016, available at
`
`http://ir.valeant.com/~/media/Files/V/Valeant-IR/reports-and-presentations/q4-and(cid:173)
`
`fy2015-financials-presentation-final-v4.pdf, last accessed on October 30, 2017. I
`
`obtained this document by going to the Valeant Investor Relations website at
`
`http://ir.valeant.com/; hovering the mouse over the tab on the top of the page
`
`labeled "Investor Relations" and then clicking the link below for "EVENTS AND
`
`22
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`Page 22
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