UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN LABORATORIES LIMITED,
`
`Petitioner,
`
`v.
`
`AVENTIS PHARMA S.A.,
`
`Patent Owner.
`
`Case IPR2016-00712
`
`Patent No. 8,927,592
`
`
`
`SECOND EVIDENTIARY DECLARATION OF PATRICK M. MEDLEY
`
`MYLAN -EXHIBIT 1095
`
`
`
`Mylan Laboratories Limited v. Aventis Pharma S.A.
`IPR2016-00712
`AVENTIS EXHIBIT 2262
`Mylan v. Aventis IPR2016-00712
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN LABORATORIES LIMITED,
`
`Petitioner,
`
`v.
`
`AVENTIS PHARMA S.A.,
`
`Patent Owner.
`
`Case IPR2016-00712
`
`Patent No. 8,927,592
`
`
`
`SECOND EVIDENTIARY DECLARATION OF PATRICK M. MEDLEY
`
`MYLAN -EXHIBIT 1095
`
`
`
`Mylan Laboratories Limited v. Aventis Pharma S.A.
`IPR2016-00712
`AVENTIS EXHIBIT 2262
`Mylan v. Aventis IPR2016-00712
`
`
`
`I, Patrick M. Medley, declare as follows:
`
`1.
`
`I am the same Patrick M. Medley who previously submitted an
`
`evidentiary declaration (EX1038) in this Inter Partes Review (“IPR”) proceeding.
`
`2.
`
`I provide this Declaration in connection with the above-identified
`
`Inter Partes Review proceeding that was requested at the United States Patent and
`
`Trademark Office by Mylan Laboratories Ltd. under 35 U.S.C. §§ 311-319, 37
`
`C.F.R. § 42. Unless otherwise stated, the facts stated in this Declaration are based
`
`on my personal knowledge.
`
`3.
`
`Exhibit 1052 is a true and correct copy of Exhibit 1022A in Coal. For
`
`Affordable Drugs V LLC v. Biogen MA Inc., IPR2015-01136, as downloaded from
`
`the PTAB E2E website for that case.
`
`4.
`
`I have reviewed the affidavits of Christopher Butler (EX1026 and
`
`EX2142) submitted by Mylan and Aventis, respectively in this proceeding. I
`
`understand based on these affidavits that the Internet Archive records copies of
`
`web files published on the internet, and makes these files available through the
`
`Wayback Machine service. EX1026, 1; EX2142, 1. I understand that these files are
`
`copied automatically by web crawlers and preserved as they exist at the time of
`
`capture. Id. I further understand that the time of capture is encoded in the format of
`
`the URL for each file stored in the Internet Archive, as follows:
`
`“http://web.archive.org/web/[Year in yyyy][Month in mm][Day in dd][Time code
`
`-1-
`
`
`
`in hh:mm:ss]/[Archived URL].” Id. I further understand that both HTML and PDF
`
`files are archived in the same manner. EX2142, 1; see also EX1025, 1.
`
`5.
`
`Exhibit 1045 is a true and correct copy of the NCCN Antiemesis
`
`Guidelines, downloaded from the Internet Archive at the URL
`
`http://web.archive.org/web/20081001233326/http://www.nccn.org/professionals/p
`
`hysician_gls/PDF/antiemesis.pdf. I understand based on the Affidavits of
`
`Christopher Butler (EX1026 and EX2142, discussed above in ¶4) that the URL of
`
`this file indicates that it was recorded and preserved automatically by the web
`
`crawlers of the Internet Archive on October 1, 2008.
`
`6.
`
`Exhibit 1053 is a true and correct copy of Michael et al., “Prostate
`
`cancer chemotherapy in the era of targeted therapy” (“Michael”), as obtained from
`
`the URL http://www.nature.com/pcan/journal/v12/n1/pdf/pcan200832a.pdf. The
`
`article states on its face that it was published online on June 3, 2008. The online
`
`table of contents of Prostate Cancer and Prostatic Diseases
`
`(http://www.nature.com/pcan/journal/v12/n1/index.html) indicates that Michael
`
`was published in print in the March 2009 issue (Volume 12, Issue 1), and that it
`
`received “advance online publication” on June 3, 2008.
`
`7.
`
`Exhibit 1046 is a true and correct copy of Takenaka et al.,
`
`“Combination chemotherapy with weekly docetaxel and estramustine for hormone
`
`refractory prostate cancer in Japanese patients” (“Takenaka”). The article states on
`
`-2-
`
`
`
`its face that it was published in 2008 in volume 15 of the International Journal of
`
`Urology. The Wiley Online Library provides copies of articles of the International
`
`Journal of Urology, and the online table of contents for volume 15, issue 1
`
`indicates that Takenaka was published online on January 1, 2008 (See
`
`http://onlinelibrary.wiley.com/doi/10.1111/iju.2008.15.issue-1/issuetoc).
`
`8.
`
`Exhibit 1047 is a true and correct copy of Trudeau et al., “Docetaxel
`
`in Patients with Metastatic Breast Cancer: A Phase II Study of the National Cancer
`
`Institute of Canada-Clinical Trials Group” (“Trudeau”). The article states on its
`
`face that it was published in 1996 in volume 14, issue 2 of the Journal of Clinical
`
`Oncology. I have confirmed that the table of contents for volume 14, issue 2 of the
`
`Journal of Clinical Oncology indicates that Trudeau was published on February 1,
`
`1996.
`
`9.
`
`Exhibit 1048 is a true and correct copy of Hudis et al., “Phase II and
`
`Pharmacologic Study of Docetaxel as Initial Chemotherapy for Metastatic Breast
`
`Cancer” (“Hudis”). The article states on its face that it was published in 1996 in
`
`volume 14, issue 1 of the Journal of Clinical Oncology. I have confirmed that the
`
`table of contents for volume 14, issue 1 of the Journal of Clinical Oncology
`
`indicates that Hudis was published on January 1, 1996.
`
`10.
`
` Exhibit 1049 is a true and correct copy of Doenicke et al.,
`
`“Premedication with H1 and H2 blocking agents reduces the incidence of
`
`-3-
`
`
`
`postoperative nausea and vomiting” (“Doenicke”). The article states on its face that
`
`it was published in 2004 in volume 53, supplement 2 of Inflammation Research. I
`
`have confirmed that the table of contents for volume 53, supplement 2 of
`
`Inflammation Research indicates that Doenicke was published in August of 2004.
`
`11.
`
`Exhibit 1050 is a true and correct copy of Cabrespine et al.,
`
`“Randomized phase II study comparing paclitaxel and carboplatin versus
`
`mitoxantrone in patients with hormone-refractory prostate cancer” (“Cabrespine”).
`
`The article states in its footer that it was published in 2006 in volume 67, issue 2 of
`
`Urology. I have confirmed that the table of contents for volume 67, issue 2 of
`
`Urology indicates that Cabrespine was published online on January 25, 2006.
`
`12.
`
`Exhibit 1051 is a true and correct copy of Padhani et al., “The
`
`RECIST criteria: implications for diagnostic radiologists” (“Padhani”). The article
`
`states on its face that it was published in November of 2001 in volume 74 of The
`
`British Institute of Radiology. I have confirmed that the table of contents for
`
`volume 74, issue 887 of The British Institute of Radiology indicates that Padhani
`
`was published in issue 887 in 2001.
`
`13.
`
`I declare that all statements made herein of my knowledge are true,
`
`and that all statements made on information and belief are believed to be true, and
`
`that these statements were made with the knowledge that willful false statements
`
`-4-
`
`
`
`and the like so made are punishable by fine or imprisonment, or both, under
`
`Section 1001 of Title 18 of the United States Code.
`
`Dated: April 4, 2017
`
`By:
`
` / Patrick Medley/
`Patrick M. Medley
`Reg. No. 74,735
`
`-5-
`
`
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