UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALSINC.,
`
`Petitioner
`
`Vv.
`
`BIOGEN MA INC.,
`
`Patent Owner
`
`IPR2018-01403
`Patent 8,399,514 B2
`
`DECLARATION OF EMILY J. GREB
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE1
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 1
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 1
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALSINC.,
`
`Petitioner
`
`Vv.
`
`BIOGEN MA INC.,
`
`Patent Owner
`
`IPR2018-01403
`Patent 8,399,514 B2
`
`DECLARATION OF EMILY J. GREB
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE1
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 1
`
`MYLAN PHARMS. INC. EXHIBIT 1134 PAGE 1
`
`
`
`1.
`
`I, Emily J. Greb, am overthe age of eighteen and otherwise competent
`
`to make this Declaration.
`
`I have personal knowledge of the facts set forth in this
`
`Declaration and am competentto 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 mydirection before these exhibits were filed on July
`
`13, 2018. No other changes were madeto either Exhibit 1010 or Exhibit 1054 before
`
`they werefiled on July 13, 2018.
`
`4.
`
`IPR2015-01993 Exhibit 1022 was relied upon by the Board in the
`
`1
`
`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) at8,
`
`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 attachmentto this Declaration. Replacement Exhibit
`
`1010 was obtained by me or at my direction on February 26, 2019 on the
`
`Clinicaltrials.gov 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/NCT00168701, clicking on the hyperlinked text
`
`“History of Changes” near the bottom of the page, which took me to the URL
`
`https://clinicaltrials.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://clinicaltrials.gov/ct2/history/ NCT00168701,
`
`selecting
`
`Version 1 (September 9, 2005) in both columns A and B ofthe table, and clicking
`
`the blue button titled “Compare”at the bottom ofthe page.
`
`Exhibit 1011
`
`5.
`
`Exhibit 1011 is a reference cited in the Petition and the Expert
`
`Declaration of John R. Corboy, M.D. in Support of Petition for Inter Partes Review
`
`of U.S. 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 wasoriginally
`
`filed as Exhibit 1004 in IPR2015-01993 andretrieved 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 meor 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,
`
`2018.
`
`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 1011, is being provided as an attachmentto 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 attachmentto this Declaration.
`
`Ex. 1042
`
`9.
`
`Exhibit 1042 is a reference cited in the Expert Declaration of John R.
`
`Corboy, M.D. in Support of Petition for Inter Partes Review of U.S. 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-
`
`Society/MS-Prevalence. Exhibit 1042 was printed by meor at my direction on July
`
`9, 2018, and an exhibit label was addedto 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, M.D. in Support of Petition for Inter Partes Review
`
`ofU.S. 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 Kapposetal.
`
`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/PublicView.jsp?identifier=106023
`
`&identifier2=null&tabSel=7&action=displayexhibits&replyTo=PublicView.jsp.
`
`An exhibit label was added by meor at my direction before Exhibit 1046 wasfiled
`
`on July 13, 2018. No other changes were made to Exhibit 1046 before it wasfiled
`
`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 U.S. 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 U.S. 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
`
`1049
`
`is
`
`accessible
`
`from
`
`the
`
`FDA
`
`website,
`
`at
`
`https://www.fda.gov/downloads/Drugs /Guidances/UCM202140.pdf. Exhibit 1049
`
`wasretrieved 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 meor 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 attachmentto 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 wasfiled 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 attachmentof 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 submitted
`
`
`
`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
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
