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UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`
`Petitioner
`
`V.
`
`BIOGEN MA INC.,
`
`Patent Owner
`
`IPR2018—01403
`
`Patent 8,399,514 B2
`
`DECLARATION OF EMILY J. GREB
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 1
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 1
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 1
`
`

`

`1.
`
`I, Emily J. Greb, am over the age of eighteen and otherwise competent
`
`to make this Declaration.
`
`I have personal knowledge of the facts set forth in this
`
`Declaration and am competent to testify to the same.
`
`2.
`
`I am an attorney at Perkins Coie LLP, counsel for Petitioner Mylan
`
`Pharmaceuticals Inc. (“Mylan” or “Petitioner”) in connection with the above-
`
`captioned inter partes review (“IPR”).
`
`Exs. 1010 and 1054
`
`3.
`
`Exhibit 1010 is a true and correct copy of a Clinicaltrials. gov record as
`
`filed in IPR2015—01993. Exhibit 1054 is a true and correct copy of the Declaration
`
`of Robert Mihail, attorney for the Coalition For Affordable Drugs V LLC, as filed
`
`in IPR2015-01993. Exhibit 1054 includes a description of the process by which Mr.
`
`Mihail originally obtained Exhibit 1010 (referred to as Exhibit 1022 in the Mihail
`
`Declaration). Exhibits 1010 and 1054 were originally filed as Exhibits 1022 and
`
`1024A in IPR2015—01993, respectively, and retrieved by me or at my direction from
`
`the
`
`Patent
`
`Trial
`
`and
`
`Appeal
`
`Board
`
`E2E
`
`portal,
`
`located
`
`at
`
`https://ptab.uspto.gov/#/login. An exhibit label was added to each of Exhibit 1010
`
`and Exhibit 1054 by me or at my direction before these exhibits were filed on July
`
`13, 2018. No other changes were made to either Exhibit 1010 or Exhibit 1054 before
`
`they were filed on July 13, 2018.
`
`4.
`
`IPR2015—01993 Exhibit 1022 was relied upon by the Board in the
`
`l
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 2
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 2
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 2
`
`

`

`IPR2015-01993 proceeding, and neither IPR2015-01993 Exhibit 1022 nor 1024A
`
`were excluded. See, e.g., IPR2015—01993, Paper 63 (Final Written Decision) at 8,
`
`11—12. In addition, Exhibit 1010 still exists in its substantively identical form on the
`
`Internet, and Replacement Exhibit 1010, a substantively identical copy of Exhibit
`
`1010, is being provided as an attachment to this Declaration. Replacement Exhibit
`
`1010 was obtained by me or at my direction on February 26, 2019 on the
`
`Clinicaltrialsgov website and is available at https://clinicaltrials.gov/ct2/history/
`
`NCT00168701?A=1&B=1&C=merged. Replacement Exhibit 1010 was obtained
`
`by
`
`me
`
`or
`
`at
`
`my
`
`direction
`
`by
`
`accessing
`
`the
`
`URL
`
`https://clinicaltrials.gov/show/NCTOO168701, clicking on the hyperlinked text
`
`“History of Changes” near the bottom of the page, which took me to the URL
`
`https://c1inicaltrials.gov/ct2/archive/NCT00168701, clicking on the hyperlinked text
`
`“ClinicalTrials.gov Archive Site” located near the bottom of the page, which took
`
`me to the URL https://clinica1trials.gov/ct2/history/ NCT00168701,
`
`selecting
`
`Version 1 (September 9, 2005) in both columns A and B of the table, and clicking
`
`the blue button titled “Compare” at the bottom of the page.
`
`Exhibit 1011
`
`5.
`
`Exhibit 1011 is a reference cited in the Petition and the Expert
`
`Declaration of John R. Corboy, MD. in Support of Petition for Inter Partes Review
`
`of US. Patent No. 8,399,514 (Exhibit 1002).
`
`2
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 3
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 3
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 3
`
`

`

`6.
`
`Exhibit 1011, filed on July 13, 2018, is a true and correct copy of an
`
`ICH Harmonised Tripartite Guideline entitled, “Dose-Response Information to
`
`Support Drug Registration: E4,” dated March 10, 1994. Exhibit 1011 was originally
`
`filed as Exhibit 1004 in IPR2015-01993 and retrieved by me or at my direction from
`
`the
`
`Patent
`
`Trial
`
`and
`
`Appeal
`
`Board
`
`E2E
`
`portal,
`
`located
`
`at
`
`https://ptab.uspto.gov/#/login. An exhibit label from IPR2015-01993 was removed
`
`by me or at my direction, and an exhibit label was added by me or at my direction
`
`pertaining to the above-captioned IPR, before Exhibit 1011 was filed on July 13,
`
`2018. No other changes were made to Exhibit 1011 before it was filed on July 13,
`
`201 8.
`
`7.
`
`IPR2015—01993 Exhibit 1004 was relied upon by the Board in the
`
`IPR2015-01993 proceeding, and it was not excluded. See, e.g., IPR2015-01993,
`
`Paper 63 (Final Written Decision) at 8, 12—14. In addition, Exhibit 1011 still exists
`
`in its current form on the Internet, and Replacement Exhibit 1011, an identical copy
`
`ofExhibit 101 1, is being provided as an attachment to this Declaration. Replacement
`
`Exhibit 1011 was obtained by me or at my direction on February 25, 2019 on the
`
`ICH website and is available at https://www.ich.org/fileadmin/Public_Web_Site
`
`/ICH_Products/ Guidelines/Efficacy/E4/Step4/E4_Guideline.pdf.
`
`3
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 4
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 4
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 4
`
`

`

`Ex. 1029
`
`8.
`
`Replacement Exhibit 1029, a replacement of Exhibit 1029, is being
`
`provided as an attachment to this Declaration.
`
`EX. 1042
`
`9.
`
`Exhibit 1042 is a reference cited in the Expert Declaration of John R.
`
`Corboy, MD. in Support of Petition for Inter Partes Review of US. Patent No.
`
`8,399,514 (Exhibit 1002).
`
`10.
`
`Exhibit 1042 is a true and correct copy of a website titled “MS
`
`Prevalence”
`
`and accessible
`
`at https://www.nationalmssociety.org/About—the—
`
`SocietyflVlS—Prevalence. Exhibit 1042 was printed by me or at my direction on July
`
`9, 2018, and an exhibit label was added to this exhibit by me or at my direction upon
`
`its retrieval from the listed website. No other alterations were made.
`
`Ex. 1046
`
`11.
`
`Exhibit 1046 is a reference cited in the Petition and the Expert
`
`Declaration of John R. Corboy, MD. in Support of Petition for Inter Partes Review
`
`of US. Patent No. 8,399,514 (Exhibit 1002). Exhibit 1046 is a true and correct copy
`
`of an excerpt of the Declaration of Katherine T. Dawson, M.D. Under 37 C.F.R.
`
`§ 1.132, dated October 13, 2011, filed with the United States Patent and Trademark
`
`Office (“USPTO”), enclosing as an exhibit a slide presentation by Kappos et a1.
`
`given on May 30, 2006. Exhibit 1046 is an excerpt of an exhibit originally filed as
`
`4
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 5
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 5
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 5
`
`

`

`Forward Pharma Exhibit 1018 in Interference No. 106,023 before the Patent Trial
`
`and Appeal Board and retrieved by me or at my direction from acts.uspto.gov,
`
`located
`
`at
`
`https://acts.uspto.gov/ifiling/PublicViewjsp?identifier=106023
`
`&identifier2=null&tabSel=7&action=displayexhibits&replyTo=PublicView.j sp.
`
`An exhibit label was added by me or at my direction before Exhibit 1046 was filed
`
`on July 13, 2018. No other changes were made to Exhibit 1046 before it was filed
`
`on July 13, 2018. The entirety of the Declaration of Katherine T. Dawson, M.D.
`
`Under 37 C.F.R. § 1.132, dated October 13, 2011, including all exhibits enclosed
`
`therein, as well as a copy of the entire unofficial file history of US. Patent No.
`
`8,399,514, can be found and accessed through the USPTO’S Public Pair portal,
`
`located at https://portal.uspto.gov/pair/PublicPair.
`
`Ex. 1049
`
`12.
`
`Exhibit 1049 is a reference cited in the Expert Declaration of Ian
`
`McKeague, Ph.D. in Support of Petition for Inter Partes Review of US. Patent No.
`
`8,399,514 (Exhibit 1004). Exhibit 1049 is a true and correct copy of a Guidance
`
`Document issued by the Food and Drug Administration (“FDA”) titled “Non—
`
`Inferiority Clinical Trials to Establish Effectiveness,” dated November 2016.
`
`Exhibit
`
`1 049
`
`is
`
`accessible
`
`from
`
`the
`
`FDA
`
`website,
`
`at
`
`https ://www.fdagov/downloads/Drugs /Guidances/UCM202140.pdf. Exhibit 1049
`
`was retrieved by me or at my direction on or before July 13, 2018. An exhibit label
`
`5
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 6
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 6
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 6
`
`

`

`was added by me or at my direction before Exhibit 1049 was filed on July 13, 2018.
`
`No other changes were made to Exhibit 1049 before it was filed on July 13, 2018.
`
`Ex. 1055
`
`13.
`
`Exhibit 1055 is a declaration by Ms. Jennifer Rock at West Publishing
`
`Company. Without conceding that 37 C.F.R. § 1.4(d) applies to Exhibit 1055 or that
`
`the signature affixed to Exhibit 1055 is insufficient in any way, a Replacement
`
`Exhibit 1055 is provided as an attachment to this Declaration, which includes a hand
`
`signature by Ms. Rock. Replacement Exhibit 1055 also attaches previously-filed
`
`Exhibits 1026, 1005, and 1016, respectively, at the end of Replacement Exhibit
`
`1055. These three exhibits were not attached to Exhibit 1055 when it was filed on
`
`July 13, 2018 but instead were filed concurrently as Exhibits 1026, 1005 , and 1016.
`
`Replacement Exhibit 1055 includes no changes from Exhibit 1055, other than the
`
`affixation of a hand signature and the attachment of the three exhibits previously not
`
`attached to Exhibit 1055 which are identical to those filed as Exhibits 1026, 1005,
`
`and 1016.
`
`March 6, 2019
`
`
`Respectfully subm'
`d
`
`
`
`Emily J. Greb
`
`6
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 7
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 7
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 7
`
`

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