UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner
`
`v.
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`YEDA RESEARCH AND DEVELOPMENT CO. LTD.
`
`Patent Owner
`
`Case No. IPR2015-00644
`Patent No. 8,399,413
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`DECLARATION OF ELEANOR M. YOST
`IN RESPONSE TO PETITIONER’S OBJECTIONS
`TO PATENT OWNER’S EVIDENCE
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`YEDA EXHIBIT NO. 2150
`MYLAN PHARM. v YEDA
`IPR2015-00644
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`Page 1 of 11
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`
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner
`
`v.
`
`YEDA RESEARCH AND DEVELOPMENT CO. LTD.
`
`Patent Owner
`
`Case No. IPR2015-00644
`Patent No. 8,399,413
`
`DECLARATION OF ELEANOR M. YOST
`IN RESPONSE TO PETITIONER’S OBJECTIONS
`TO PATENT OWNER’S EVIDENCE
`
`
`
`
`
`
`
`
`
`
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`YEDA EXHIBIT NO. 2150
`MYLAN PHARM. v YEDA
`IPR2015-00644
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`Page 1 of 11
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`I, Eleanor M. Yost, declare, depose and state the following:
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`1.
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`I am counsel to Patent Owner Yeda Research & Development Co.
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`Ltd. in this proceeding.
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`2.
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`I am making this declaration in response to Petitioner’s Objections to
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`Patent Owner’s Exhibits in IPR2015-0644, dated November 30, 2015.
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`3. Exhibit 2028 is a true and accurate copy of slides from a presentation
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`entitled “Forte: Results from a phase III, 1-year, Randomized, Double-Blind,
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`Parallel-Group, Dose Comparison Study with Glatiramer Acetate in Relapse-
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`Remitting Multiple Sclerosis” authored by Giancarlo Comi. These slides were
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`presented at the World Congress on Treatment and Research in Multiple Sclerosis:
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`2008 Joint Meeting of the American, European, and Latin America Committees on
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`Treatment and Research in Multiple Sclerosis (ACTRIMS, ECTRIMS,
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`LACTRIMS). Petitioner objects to this exhibit as lacking authentication under
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`Fed. R. Civ. P. 901. Patent Owner has also submitted additional evidence
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`authenticating this document. See Ex. 2135 (Ziemssen Decl.) at ¶ 98.
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`4. Exhibit 2031 is a true and accurate copy of the article titled, “Multiple
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`Sclerosis: Transform Your Clinical Trial with PRA.” I, or those working under my
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`direction, downloaded a copy of this article on or about October 28, 2015 to a
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`Goodwin Procter LLP computer.
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`YEDA EXHIBIT NO. 2150
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`Page 2 of 11
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`5. To the extent Petitioner objects to Exhibit 2032 as “incomplete,” the
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`original will be made available for inspection and copying at the law offices of
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`Goodwin Procter LLP, 901 New York Avenue NW, Washington, D.C. 20001.
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`6. To the extent Petitioner objects to Exhibit 2037 as “incomplete,” a
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`complete copy of the public file history of U.S. Pat. Appl. 11/651,212 is available
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`for inspection and copying at the law offices of Goodwin Procter LLP, 901 New
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`York Avenue NW, Washington, D.C. 20001.
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`7. Exhibit 2097 is a true and accurate copy of the Avonex® (Interferon
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`beta-1a) IM injection (2008) prescribing information. I, or those working under
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`my direction, downloaded a copy of this document on or about November 14, 2015
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`to a Goodwin Procter LLP computer.
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`8. Exhibit 2098 is a true and accurate copy of the Rebif Prescribing
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`Information (2009). I, or those working under my direction, downloaded a copy of
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`this document on or about November 14, 2015 to a Goodwin Procter LLP
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`computer.
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`9. Exhibit 2099 is a true and accurate copy of the Extavia Highlights of
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`Prescribing Information (2009). I, or those working under my direction,
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`downloaded a copy of this document on or about November 14, 2015 to a
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`Goodwin Procter LLP computer.
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`YEDA EXHIBIT NO. 2150
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`Page 3 of 11
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`10. Exhibit 2100 is a true and accurate copy of the Curriculum Vitae of
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`Edward J. Fox M.D., Ph.D., FAAN.
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`11. Exhibit 2104 is a true and accurate copy of the Curriculum Vitae of
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`Dr. Henry George Grabowski.
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`12. Exhibit 2105 is a true and accurate copy of the List of Testimony of
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`Dr. Henry George Grabowski.
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`13. Exhibit 2106 is a true and accurate copy of the Documents Relied
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`Upon by Dr. Henry George Grabowski. To the extent Petitioner objects to this
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`exhibit as “incomplete,” the original will be made available for inspection and
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`copying at the law offices of Goodwin Procter LLP, 901 New York Avenue NW,
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`Washington, D.C. 20001.
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`14. Exhibit 2107 is a true and accurate copy of Table: Approval Timeline,
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`Multiple Sclerosis Drugs. To the extent Petitioner objects to this exhibit as
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`“incomplete,” the original will be made available for inspection and copying at the
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`law offices of Goodwin Procter LLP, 901 New York Avenue NW, Washington,
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`D.C. 20001.
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`15. Exhibit 2108 is a true and accurate copy of Figure: Copaxone® 40
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`mg/mL Wholesale Dollar Sales (Q1 2014- Q3 2015). To the extent Petitioner
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`objects to this exhibit as “incomplete,” the original will be made available for
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`YEDA EXHIBIT NO. 2150
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`Page 4 of 11
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`
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`inspection and copying at the law offices of Goodwin Procter LLP, 901 New York
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`Avenue NW, Washington, D.C. 20001.
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`16. Exhibit 2109 is a true and accurate copy of Figure: Copaxone® 40
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`mg/mL Extended Units (Q1 2014- Q3 2015). To the extent Petitioner objects to
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`this exhibit as “incomplete,” the original will be made available for inspection and
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`copying at the law offices of Goodwin Procter LLP, 901 New York Avenue NW,
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`Washington, D.C. 20001.
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`17. Exhibit 2110 is a true and accurate copy of Figure: Copaxone® 40
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`mg/mL Total Prescriptions (Q1 2014- Q3 2015). To the extent Petitioner objects to
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`this exhibit as “incomplete,” the original will be made available for inspection and
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`copying at the law offices of Goodwin Procter LLP, 901 New York Avenue NW,
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`Washington, D.C. 20001.
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`18. Exhibit 2111 is a true and accurate copy of Figure: Copaxone® 40
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`mg/mL New Prescriptions (Q1 2014- Q3 2015). To the extent Petitioner objects to
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`this exhibit as “incomplete,” the original will be made available for inspection and
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`copying at the law offices of Goodwin Procter LLP, 901 New York Avenue NW,
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`Washington, D.C. 20001.
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`19. Exhibit 2112 is a true and accurate copy of Figure: Multiple Sclerosis
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`Drugs Share of Wholesale Dollar Sales (Q4 2009- Q3 2015). To the extent
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`Petitioner objects to this exhibit as “incomplete,” the original will be made
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`YEDA EXHIBIT NO. 2150
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`Page 5 of 11
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`
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`available for inspection and copying at the law offices of Goodwin Procter LLP,
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`901 New York Avenue NW, Washington, D.C. 20001.
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`20. Exhibit 2113 is a true and accurate copy of Figure: Multiple Sclerosis
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`Drugs Share of Total Prescriptions (Q4 2009- Q3 2015). To the extent Petitioner
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`objects to this exhibit as “incomplete,” the original will be made available for
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`inspection and copying at the law offices of Goodwin Procter LLP, 901 New York
`
`Avenue NW, Washington, D.C. 20001.
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`21. Exhibit 2114 is a true and accurate copy of Figure: Multiple Sclerosis
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`Drugs Share of New Prescriptions (Q4 2009- Q3 2015). To the extent Petitioner
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`objects to this exhibit as “incomplete,” the original will be made available for
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`inspection and copying at the law offices of Goodwin Procter LLP, 901 New York
`
`Avenue NW, Washington, D.C. 20001.
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`22. Exhibit 2115 is a true and accurate copy of Figure: Rationale for
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`Requesting Copaxone. To the extent Petitioner objects to this exhibit as
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`“incomplete,” the original will be made available for inspection and copying at the
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`law offices of Goodwin Procter LLP, 901 New York Avenue NW, Washington,
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`D.C. 20001.
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`23. Exhibit 2116 is a true and accurate copy of Figure: Perception of 3-
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`times-a-week Copaxone 40mg compared to Daily Copaxone 20 mg. To the extent
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`Petitioner objects to this exhibit as “incomplete,” the original will be made
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`YEDA EXHIBIT NO. 2150
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`Page 6 of 11
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`available for inspection and copying at the law offices of Goodwin Procter LLP,
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`901 New York Avenue NW, Washington, D.C. 20001.
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`24. Exhibit 2117 is a true and accurate copy of Figure: Rationale for
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`Discussing 20 mg and 40 mg for First Line Patients. To the extent Petitioner
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`objects to this exhibit as “incomplete,” the original will be made available for
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`inspection and copying at the law offices of Goodwin Procter LLP, 901 New York
`
`Avenue NW, Washington, D.C. 20001.
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`25. Exhibit 2118 is a true and accurate copy of Figure: Perceptions of
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`Copaxone® 40 mg compared to Daily Generic GA. To the extent Petitioner
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`objects to this exhibit as “incomplete,” the original will be made available for
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`inspection and copying at the law offices of Goodwin Procter LLP, 901 New York
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`Avenue NW, Washington, D.C. 20001.
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`26. Exhibit 2119 is a true and accurate copy of Figure: Perceptions of
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`Copaxone® 40 mg vs. 20 mg. To the extent Petitioner objects to this exhibit as
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`“incomplete,” the original will be made available for inspection and copying at the
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`law offices of Goodwin Procter LLP, 901 New York Avenue NW, Washington,
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`D.C. 20001.
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`27. Exhibit 2120 is a true and accurate copy of Figure: Copaxone® Total
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`Prescriptions (Q4 2009- Q3 2015). To the extent Petitioner objects to this exhibit
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`as “incomplete,” the original will be made available for inspection and copying at
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`YEDA EXHIBIT NO. 2150
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`Page 7 of 11
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`
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`the law offices of Goodwin Procter LLP, 901 New York Avenue NW, Washington,
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`D.C. 20001.
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`28. Exhibit 2121 is a true and accurate copy of Figure: Copaxone® 20
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`mg/mL, Copaxone® 40 mg/mL, and Glatopa™ Net Prescriptions Flow (10/26/12-
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`10/9/15). To the extent Petitioner objects to this exhibit as “incomplete,” the
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`original will be made available for inspection and copying at the law offices of
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`Goodwin Procter LLP, 901 New York Avenue NW, Washington, D.C. 20001.
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`29. Exhibit 2122 is a true and accurate copy of Table: Total Promotional
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`Spending to Sales Ratio. To the extent Petitioner objects to this exhibit as
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`“incomplete,” the original will be made available for inspection and copying at the
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`law offices of Goodwin Procter LLP, 901 New York Avenue NW, Washington,
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`D.C. 20001.
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`30. Exhibit 2129 is a true and accurate copy of the Declaration of Edward
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`J. Fox M.D., Ph.D.
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`31. Exhibit 2130 is a true and accurate copy of the Curriculum Vitae of
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`Robert William Gristwood, Ph.D.
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`32. Exhibit 2131 (Corrected) is a true and accurate copy of the
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`Curriculum Vitae of Tjalf Ziemssen.
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`33. Exhibit 2132 is a true and accurate copy of Ziemssen’s MS Clinical
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`Trials.
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`YEDA EXHIBIT NO. 2150
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`Page 8 of 11
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`34. Exhibit 2133 is a true and accurate copy of the Declaration of Henry
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`G. Grabowski, Ph.D.
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`35. Exhibit 2134 is a true and accurate copy of the Declaration of Robert
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`William Gristwood, Ph.D.
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`36. Exhibit 2135 is a true and accurate copy of the Declaration of Tjalf
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`Ziemssen, M.D., Ph.D.
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`YEDA EXHIBIT NO. 2150
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`Page 9 of 11
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`I declare that all statements made herein of my own knowledge are true and
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`that all statements made on information and belief are believed to be true; and
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`further that these statements 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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`I declare under penalty of perjury that the foregoing is true and correct.
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`Executed in Washington, D.C. on December 14, 2015.
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`Eleanor M. Yost
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`YEDA EXHIBIT NO. 2150
`MYLAN PHARM. v YEDA
`IPR2015-00644
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`Page 10 of 11
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`CERTIFICATE OF SERVICE
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`The undersigned certifies service of the foregoing Declaration on December
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`14, 2015 pursuant to 37 C.F.R. § 42.6(e) on the Petitioner via email as follows:
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`Jeffrey W. Guise
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`jguise@wsgr.com
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`Brandon M. White
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`BMWhite@perkinscoie.com
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`Shannon Bloodworth
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`Sbloodworth@perkinscoie.com
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`David Anstaett
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`DAnstaett@perkinscoie.com
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`Richard Torczon
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`rtorczon@wsgr.com
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`/Eleanor Yost/
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`Eleanor M. Yost
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`YEDA EXHIBIT NO. 2150
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`Page 11 of 11
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