UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner
`
`v.
`
`YEDA RESEARCH AND DEVELOPMENT CO. LTD.
`
`Patent Owner
`
`Case No. IPR2015-00643
`Patent No. 8,232,250
`
`DECLARATION OF ELEANOR M. YOST
`IN RESPONSE TO PETITIONER’S OBJECTIONS
`TO PATENT OWNER’S EVIDENCE
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`
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`YEDA EXHIBIT NO. 2149
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`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. IPR2015-00643
`Patent No. 8,232,250
`
`DECLARATION OF ELEANOR M. YOST
`IN RESPONSE TO PETITIONER’S OBJECTIONS
`TO PATENT OWNER’S EVIDENCE
`
`
`
`
`
`
`
`
`
`
`
`YEDA EXHIBIT NO. 2149
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`Page 1 of 11
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`
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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. Ltd. in this proceeding.
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`2.
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`I am making this declaration in response to Petitioner’s
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`Objections to Patent Owner’s Exhibits in IPR2015-0643, dated November 30,
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`2015.
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`3.
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`Exhibit 2028 is a true and accurate copy of slides from a
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`presentation entitled “Forte: Results from a phase III, 1-year, Randomized,
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`Double-Blind, Parallel-Group, Dose Comparison Study with Glatiramer Acetate in
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`Relapse-Remitting Multiple Sclerosis” authored by Giancarlo Comi. These slides
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`were presented at the World Congress on Treatment and Research in Multiple
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`Sclerosis: 2008 Joint Meeting of the American, European, and Latin America
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`Committees on Treatment and Research in Multiple Sclerosis (ACTRIMS,
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`ECTRIMS, LACTRIMS). Petitioner objects to this exhibit as lacking
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`authentication under Fed. R. Civ. P. 901. Patent Owner has also submitted
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`additional evidence authenticating this document. See Ex. 2135 (Ziemssen Decl.)
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`at ¶ 98.
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`4.
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`Exhibit 2031 is a true and accurate copy of the article titled,
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`“Multiple Sclerosis: Transform Your Clinical Trial with PRA.” I, or those working
`
`YEDA EXHIBIT NO. 2149
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`Page 2 of 11
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`
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`under my direction, downloaded a copy of this article on or about October 28,
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`2015 to a Goodwin Procter LLP computer.
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`5.
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`To the extent Petitioner objects to Exhibit 2032 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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`6.
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`To the extent Petitioner objects to Exhibit 2037 as
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`“incomplete,” a complete copy of the public file history of U.S. Pat. Appl.
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`11/651,212 is available for inspection and copying at the law offices of Goodwin
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`Procter LLP, 901 New York Avenue NW, Washington, D.C. 20001.
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`7.
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`Exhibit 2097 is a true and accurate copy of the Avonex®
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`(Interferon beta-1a) IM injection (2008) prescribing information. I, or those
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`working under my direction, downloaded a copy of this document on or about
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`November 14, 2015 to a Goodwin Procter LLP computer.
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`8.
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`Exhibit 2098 is a true and accurate copy of the Rebif
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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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`9.
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`Exhibit 2099 is a true and accurate copy of the Extavia
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`Highlights of Prescribing Information (2009). I, or those working under my
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`YEDA EXHIBIT NO. 2149
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`Page 3 of 11
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`direction, downloaded a copy of this document on or about November 14, 2015 to
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`a Goodwin Procter LLP computer.
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`10. Exhibit 2100 is a true and accurate copy of the Curriculum
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`Vitae of Edward J. Fox M.D., Ph.D., FAAN.
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`11. Exhibit 2104 is a true and accurate copy of the Curriculum
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`Vitae of Dr. Henry George Grabowski.
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`12. Exhibit 2105 is a true and accurate copy of the List of
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`Testimony of Dr. Henry George Grabowski.
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`13. Exhibit 2106 is a true and accurate copy of the Documents
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`Relied Upon by Dr. Henry George Grabowski. 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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`14. Exhibit 2107 is a true and accurate copy of Table: Approval
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`Timeline, Multiple Sclerosis Drugs. 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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`the 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®
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`40 mg/mL Wholesale Dollar Sales (Q1 2014- Q3 2015). To the extent Petitioner
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`YEDA EXHIBIT NO. 2149
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`Page 4 of 11
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`
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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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`16. Exhibit 2109 is a true and accurate copy of Figure: Copaxone®
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`40 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
`
`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®
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`40 mg/mL Total Prescriptions (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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`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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`18. Exhibit 2111 is a true and accurate copy of Figure: Copaxone®
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`40 mg/mL New Prescriptions (Q1 2014- Q3 2015). To the extent Petitioner objects
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`to this exhibit as “incomplete,” the original will be made available for inspection
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`and copying at the law offices of Goodwin Procter LLP, 901 New York Avenue
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`NW, Washington, D.C. 20001.
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`19. Exhibit 2112 is a true and accurate copy of Figure: Multiple
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`Sclerosis Drugs Share of Wholesale Dollar Sales (Q4 2009- Q3 2015). To the
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`YEDA EXHIBIT NO. 2149
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`Page 5 of 11
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`
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`extent Petitioner objects to this exhibit as “incomplete,” the original will be made
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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
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`Sclerosis Drugs Share of Total Prescriptions (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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`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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`21. Exhibit 2114 is a true and accurate copy of Figure: Multiple
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`Sclerosis Drugs Share of New Prescriptions (Q4 2009- Q3 2015). To the extent
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`Petitioner objects to this exhibit as “incomplete,” the original will be made
`
`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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`22. Exhibit 2115 is a true and accurate copy of Figure: Rationale
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`for 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
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`of 3-times-a-week Copaxone 40mg compared to Daily Copaxone 20 mg. To the
`
`YEDA EXHIBIT NO. 2149
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`Page 6 of 11
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`
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`extent Petitioner objects to this exhibit as “incomplete,” the original will be made
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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
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`for 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
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`Avenue NW, Washington, D.C. 20001.
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`25. Exhibit 2118 is a true and accurate copy of Figure: Perceptions
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`of 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
`
`Avenue NW, Washington, D.C. 20001.
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`26. Exhibit 2119 is a true and accurate copy of Figure: Perceptions
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`of 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®
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`Total Prescriptions (Q4 2009- Q3 2015). To the extent Petitioner objects to this
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`YEDA EXHIBIT NO. 2149
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`Page 7 of 11
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`
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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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`28. Exhibit 2121 is a true and accurate copy of Figure: Copaxone®
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`20 mg/mL, Copaxone® 40 mg/mL, and Glatopa™ Net Prescriptions Flow
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`(10/26/12- 10/9/15). 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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`29. Exhibit 2122 is a true and accurate copy of Table: Total
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`Promotional Spending to Sales Ratio. 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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`30. Exhibit 2129 is a true and accurate copy of the Declaration of
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`Edward J. Fox M.D., Ph.D.
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`31. Exhibit 2130 is a true and accurate copy of the Curriculum
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`Vitae of Robert William Gristwood, Ph.D.
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`32. Exhibit 2131 is a true and accurate copy of the Curriculum
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`Vitae of Tjalf Ziemssen.
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`YEDA EXHIBIT NO. 2149
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`Page 8 of 11
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`33. Exhibit 2132 is a true and accurate copy of Ziemssen’s MS
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`Clinical Trials.
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`34. Exhibit 2133 is a true and accurate copy of the Declaration of
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`Henry G. Grabowski, Ph.D.
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`35. Exhibit 2134 is a true and accurate copy of the Declaration of
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`Robert William Gristwood, Ph.D.
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`36. Exhibit 2135 is a true and accurate copy of the Declaration of
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`Tjalf Ziemssen, M.D., Ph.D.
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`YEDA EXHIBIT NO. 2149
`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. 2149
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`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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`
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`/Eleanor Yost/
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`Eleanor M. Yost
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`YEDA EXHIBIT NO. 2149
`MYLAN PHARM. v YEDA
`IPR2015-00644
`
`Page 11 of 11
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