UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`SLAYBACK PHARMA, LLC,
`Petitioner,
`
`v.
`
`SUMITOMO DAINIPPON PHARMA CO., LTD.,
`Patent Owner.
`
`__________________
`
`Case IPR2020-01053
`U.S. Patent 9,815,827
`
`__________________
`
`DECLARATION OF SCOTT STANCELL-CONDRON
`
`1
`
`Exhibit 2133
`Slayback v. Sumitomo
`IPR2020-01053
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`SLAYBACK PHARMA, LLC,
`Petitioner,
`
`v.
`
`SUMITOMO DAINIPPON PHARMA CO., LTD.,
`Patent Owner.
`
`__________________
`
`Case IPR2020-01053
`U.S. Patent 9,815,827
`
`__________________
`
`DECLARATION OF SCOTT STANCELL-CONDRON
`
`1
`
`Exhibit 2133
`Slayback v. Sumitomo
`IPR2020-01053
`
`
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`I, Scott Stancell-Condron, declare as follows:
`
`1.
`
`I am the Associate Director, Records & Information Management and
`
`Co-Chair Information Governance Office for Sunovion Pharmaceuticals, Inc.
`
`(“Sunovion”) and Sumitomo Dainippon Pharma America, Inc. (“SDPA”).
`
`2.
`
`I have been employed with Sunovion for approximately five years and
`
`have held the role described above during that time.
`
`3.
`
`4.
`
`I make this declaration based on my personal knowledge.
`
`As part of my role at Sunovion and SDPA, I have personal knowledge
`
`of Sunovion and SDPA’s regularly conducted business practices and activities for
`
`creating, recording, maintaining, and storing information and documents. The
`
`regular practice of Sunovion and SDPA when creating a record of an act, event,
`
`condition, or information is for an employee or representative of Sunovion or
`
`SDPA with knowledge of the respective act event, condition, or information to
`
`make the record or to transmit the information to be included in the record at or
`
`near the time of the act, event, condition, or information gathering or reasonably
`
`soon thereafter.
`
`5.
`
`Given my role at Sunovion and SDPA, I further have general
`
`familiarity with the regularly conducted business practices and activities for
`
`creating, recording, maintaining and storing information and documents of
`
`Sunovion and SDPA’s parent organization, Sumitomo Dainippon Pharma Co., Ltd.
`
`2
`
`
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`
`(“Sumitomo”). Like Sunovion and SDPA, Sumitomo’s regular practice when
`
`creating a record of an act, event, condition, or information is for an employee or
`
`representative of Sumitomo with knowledge of the respective act event, condition,
`
`or information to make the record or to transmit the information to be included in
`
`the record at or near the time of the act, event, condition, or information gathering
`
`or reasonably soon thereafter
`
`6.
`
`Attached hereto as Exhibit 2058 is a SDPA Clinical Study Report
`
`D1050231 dated October 23, 2009 titled “A Phase 3 Randomized, Placebo- and
`
`Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of
`
`Two Doses of Lurasidone HCl in Acutely Psychotic Patients with Schizophrenia.”
`
`Exhibit 2058 is a document included in Sunovion’s NDA No. 200603 for Latuda®.
`
`7.
`
`8.
`
`Exhibit 2058 is a true and accurate copy of the original document.
`
`The document attached as Exhibit 2058 is a copy of an original
`
`document that was created and/or kept by SDPA and Sunovion in the course of
`
`their regularly conducted business practices and activities.
`
`9.
`
`Attached hereto as Exhibit 2059 is a Sunovion Clinical Study Report
`
`D1050233 dated May 3, 2011 titled “A Phase 3 Randomized, Double-Blind,
`
`Placebo- and Active Comparator-Controlled Clinical Trial to Study the Efficacy
`
`and Safety of Two Doses of Lurasidone in Acutely Psychotic Patients with
`
`Schizophrenia.” Exhibit 2059 is a document included in Sunovion’s NDA No.
`
`
`
`3
`
`
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`
`200603 for Latuda®.
`
`10. Exhibit 2059 is a true and accurate copy of the original document.
`
`11. The document attached as Exhibit 2059 is a copy of an original
`
`document that was created and/or kept by Sunovion in the course of its regularly
`
`conducted business practices and activities.
`
`12. Attached hereto as Exhibit 2060 is a SDPA Clinical Study Report
`
`D1050249 dated October 5, 2009 titled “A Double-Blind, Double-Dummy, Active
`
`Controlled, Randomized, 3-Arm, Parallel Study to Evaluate the Effects of
`
`Therapeutic and Supratherapeutic Doses of MK-3756 on QTC Interval in Male and
`
`Female Schizophrenic or Schizoaffective Patients.” Exhibit 2060 is a document
`
`included in Sunovion’s NDA No. 200603 for Latuda®.
`
`13. Exhibit 2060 is a true and accurate copy of the original document.
`
`14. The document attached as Exhibit 2060 is a copy of an original
`
`document that was created and/or kept by SDPA and Sunovion in the course of
`
`their regularly conducted business practices and activities.
`
`15. Attached hereto as Exhibit 2069 is a PowerPoint presentation dated
`
`October 1, 2009 titled “Lurasidone, Strategic Business Plan”.
`
`16. Exhibit 2069 is a true and accurate copy of the original document.
`
`17. The document attached as Exhibit 2069 is a copy of an original
`
`document that was created and/or kept by Sunovion in the course of its regularly
`
`
`
`4
`
`
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`
`conducted business practices and activities.
`
`18. Attached hereto as Exhibit 2074 is a document entitled “Latuda
`
`Financial Information FY11-FY20 YTD” that contains Latuda® financial
`
`information for fiscal year 2011 through December 2020 prepared on or around
`
`February 3, 2020.
`
`19. Exhibit 2074 is a true and accurate copy of the original document.
`
`20. The document attached as Exhibit 2074 is a copy of an original
`
`document that was created and/or kept by Sunovion in the course of its regularly
`
`conducted business practices and activities.
`
`21. Attached hereto as Exhibit 2075 is a PowerPoint presentation dated
`
`June 2016 titled “LATUDA Monthly Commercial Analytics Meeting”.
`
`22. Exhibit 2075 is a true and accurate copy of the original document.
`
`23. The document attached as Exhibit 2075 is a copy of an original
`
`document that was created and/or kept by Sunovion in the course of its regularly
`
`conducted business practices and activities.
`
`24. Attached hereto as Exhibit 2076 is a PowerPoint presentation dated
`
`August 2, 2020 titled “LATUDA Situational Assessment – FY 2020, Sunovion
`
`Commercial Insights & Analytics”.
`
`25. Exhibit 2076 is a true and accurate copy of the original document.
`
`26. The document attached as Exhibit 2076 is a copy of an original
`
`
`
`5
`
`
`
`
`document that was created and/or kept by Sunovion in the course of its regularly
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`conducted business practices and activities.
`
`27. Attached hereto as Exhibit 2078 is a PowerPoint presentation dated
`
`December 13, 2012 titled “Latuda® (lurasidone HCl) 2013 Brand Plan, Final
`
`Brand Plan”.
`
`28. Exhibit 2078 is a true and accurate copy of the original document.
`
`29. The document attached as Exhibit 2078 is a copy of an original
`
`document that was created and/or kept by Sunovion in the course of its regularly
`
`conducted business practices and activities.
`
`30. Attached hereto as Exhibit 2080 is PowerPoint presentation dated
`
`October 14, 2011 titled “Latuda Physician ATU Tracker Findings Q3’11 Insights
`
`Reports”.
`
`31. Exhibit 2080 is a true and accurate copy of the original document.
`
`32. The document attached as Exhibit 2080 is a copy of an original
`
`document that was created and/or kept by Sunovion in the course of its regularly
`
`conducted business practices and activities.
`
`33. Attached hereto as Exhibit 2082 is a PowerPoint presentation dated
`
`March 20, 2017 titled “LATUDA – Bipolar Depression HCP ATU FY16-Q4
`
`Commercial Analytics”.
`
`34. Exhibit 2082 is a true and accurate copy of the original document.
`
`
`
`6
`
`
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`
`
`35. The document attached as Exhibit 2082 is a copy of an original
`
`document that was created and/or kept by Sunovion in the course of its regularly
`
`conducted business practices and activities.
`
`36. Attached hereto as Exhibit 2083 is a PowerPoint Presentation dated
`
`June 22, 2020 titled “The Bipolar Disorder Patient Journey, Sunovion Commercial
`
`Insights & Analytics June 2020”.
`
`37. Exhibit 2083 is a true and accurate copy of the original document.
`
`38. The document attached as Exhibit 2083 is a copy of an original
`
`document that was created and/or kept by Sunovion in the course of its regularly
`
`conducted business practices and activities.
`
`39. Attached hereto as Exhibit 2089 is a PowerPoint presentation dated
`
`December 10, 2010 titled “Senior Leadership Budget Presentation, Latuda Brand
`
`Strategy and Budget”.
`
`40. Exhibit 2089 is a true and accurate copy of the original document.
`
`41. The document attached as Exhibit 2089 is a copy of an original
`
`document that was created and/or kept by Sunovion in the course of its regularly
`
`conducted business practices and activities.
`
`42. Attached hereto as Exhibit 2090 is a PowerPoint presentation dated
`
`November 7, 2011 titled “2012 Budget Presentation Meeting LATUDA”.
`
`43. Exhibit 2090 is a true and accurate copy of the original document.
`
`
`
`7
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`
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`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`
`
`44. The document attached as Exhibit 2090 is a copy of an original
`
`document that was created and/or kept by Sunovion in the course of its regularly
`
`conducted business practices and activities.
`
`45. Attached hereto as Exhibit 2092 is a document titled “Covance
`
`Cardiac Safety Services, Phase III Repolarization Assessment Plan, Lurasidone”
`
`dated Feb. 13, 2007.
`
`46. Exhibit 2092 is a true and accurate copy of the original document.
`
`47. The document attached as Exhibit 2092 is a copy of an original
`
`document that was created and/or kept by Sumitomo, SDPA, and Sunovion in the
`
`course of their regularly conducted business practices and activities.
`
`48. Attached hereto as Exhibit 2093 is a document titled “Medifacts
`
`International, Review of the Preliminary Results from MK-3756 Protocol 023”
`
`dated February 7, 2007.
`
`49. Exhibit 2093 is a true and accurate copy of the original document.
`
`50. The document attached as Exhibit 2093 is a copy of an original
`
`document that was created and/or kept by Sumitomo, SDPA, and Sunovion in the
`
`course of their regularly conducted business practices and activities.
`
`51. Attached hereto as Exhibit 2094 is a document titled “Clinical
`
`Pharmacology and Biopharmaceutics Review Aid, Dainippon Sumitomo Pharma
`
`America, Inc., Lurasidone.” Exhibit 2094 is a document included in Sunovion’s
`
`
`
`8
`
`
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`
`NDA No. 200603 for Latuda®.
`
`52. Exhibit 2094 is a true and accurate copy of the original document.
`
`53. The document attached as Exhibit 2094 is a copy of an original
`
`document that was created and/or kept by SDPA and Sunovion in the course of
`
`their regularly conducted business practices and activities.
`
`54. Attached hereto as Exhibit 2095 is an FDA Contact Report dated
`
`October 25, 2010 with the subject “Labeling Negotiations with FDA.” Exhibit
`
`2095 is a document included in Sunovion’s NDA No. 200603 for Latuda®.
`
`55. Exhibit 2095 is a true and accurate copy of the original document.
`
`56. The document attached as Exhibit 2095 is a copy of an original
`
`document that was created and/or kept by Sunovion in the course of its regularly
`
`conducted business practices and activities.
`
`57. Attached hereto as Exhibit 2138 is a May 2007 memorandum titled
`
`“Memorandum With Respect to Lurasidone Development Handover Status.”
`
`58. Exhibit 2138 is a true and accurate copy of the original document.
`
`59. The document attached as Exhibit 2138 is a copy of an original
`
`document that was created and/or kept by Sumitomo in the course of its regularly
`
`conducted business practices and activities.
`
`
`
`9
`
`
`
`Attorney Docket No.: 46094-0002IP1
`Case No.: IPR2020-01053
`
`
`
`I hereby declare under penalties of perjury that all statements made herein of
`
`my own knowledge are true and that all statements made on information and belief
`
`are believed to be true; and further that these statements were made with the
`
`knowledge that willful false statements and the like so made are punishable by fine
`
`or imprisonment, or both, under Section 1001 of Title 18 of the United States
`
`Code.
`
`
`
`Dated: ____________
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`_______________________
`Scott Stancell-Condron
`
`
`
`10
`
`03/09/2021
`
`
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