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