`
`Novartis AG and LTS Lohmann Therapie-Systeme AG
`
`By:
`
`Raymond R. Mandra
`ExelonPatchIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NOVEN PHARMACEUTICALS INC.
`AND MYLAN PHARMACEUTICALS INC.,
`Petitioners
`
`v.
`
`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`Inter Partes Review No. 2014-005501
`
`U.S. Patent 6,335,031
`
`CERTIFICATION PURSUANT TO FED. R. EVID. 902(11)
`
`1 Case IPR2015-00268 has been joined with this proceeding.
`
`Noven Exhibit 1052
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`1 of 4
`
`
`
`
`
`
`I, Peter McArdle, declare pursuant to 28 U.S.C. § 1746:
`
`1.
`
`I am an Executive Director of Drug Regulatory Affairs at Novartis
`
`Pharmaceuticals Corporation (“Novartis”). I make this certification to establish
`
`that the record referenced herein and attached hereto is a record of a regularly
`
`conducted activity or business record within the meaning of Federal Rule of
`
`Evidence 803(6) and so that it may be offered as evidence of the truth of the
`
`matters stated in the record at the trial of this matter.
`
`2.
`
`I certify that it is part of my duty as an Executive Director of Drug
`
`Regulatory Affairs to maintain the following record pursuant to law and for the
`
`purpose of documenting the pharmaceutical regulatory approval process:
`
`Bates Range
`N0002374-N0002403
`
`
`Description
`Excerpt from NDA 22-038, Rivastigmine (ENA713-
`NXA Base) Drug substance (Ex. 2059 in the above
`captioned proceeding is Bates page N0002403 of the
`attached record)
`
`
`3.
`
`I am familiar with the manner and process in which this record is
`
`maintained by virtue of my duties and responsibilities.
`
`4.
`
`Documents maintained in the Novartis archives (hard copy and/or
`
`electronic), are true and correct copies of records made by Novartis as a regular
`
`business practice and as part of the regularly conducted business of Novartis.
`
`
`
`1
`
`Noven Exhibit 1052
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`2 of 4
`
`
`
`5.
`
`In accordance with the regular practice at Novartis, this record would
`
`have been generated at or near the time of the activity described therein by a
`
`person with knowledge of those matters.
`
`6.
`
`This document was collected from the regulatory records archives at
`
`Novartis. Novartis kept the record in the regulatory records archives as part of its
`
`regularly conducted business activity.
`
` declare under penalty of perjury under the laws of the United States of America
`
` I
`
`that the foregoing is true and correct.
`
`
`
`
`Dated: April 28, 2015
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Mc Ardle Peter
`____________________________
`
`
`Digitally signed by Mc Ardle Peter
`DN: SERIALNUMBER=590103 + CN=Mc Ardle Peter,
`OU=PH, OU=people, DC=novartis, DC=com
`Reason: I attest to the accuracy and integrity of this
`document.
`Date: 2015.04.28 05:37:53 +03:00
`
`
`
`
`
`Noven Exhibit 1052
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`3 of 4
`
`
`
`
`
`I certify that a copy of the foregoing CERTIFICATION PURSUANT TO
`
`FED. R. EVID. 902(11) was served on April 28, 2015 by causing them to be sent
`
`by email to counsel for Petitioners at the following email addresses:
`
`
`
`Dated: April 28, 2015
`
`
`
`
`
`
`
`
`
`
`
`Steven J. Lee (slee@kenyon.com)
`
`Michael K. Levy (mlevy@kenyon.com)
`
`Chris Coulson (ccoulson@kenyon.com)
`
`Joseph M. Reisman (BoxMylan2@knobbe.com)
`
`Jay R. Deshmukh (BoxMylan2@knobbe.com)
`
`William R. Zimmerman (BoxMylan@knobbe.com)
`
`
`
`
`
`
`
`
` /s/ Raymond R. Mandra
`
`Raymond R. Mandra
`Registration No. 34,382
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`
`FCHS_WS 11426594v1.doc
`
`
`
`Noven Exhibit 1052
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`4 of 4
`
`
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