`Date Filed: March 11, 2015
`
`Filed On Behalf Of:
`
`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.,
`Petitioner
`
`v.
`
`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`Inter Partes Review No. 2014-00549
`
`U.S. Patent 6,316,023
`
`UNOPPOSED MOTION TO FILE CORRECTED PATENT OWNERS’
`RESPONSE, CORRECTED AND SUPPLEMENTAL EXHIBITS, AND
`CORRECTED EXHIBIT LIST
`
`
`
`Patent Owners Novartis AG and LTS Lohmann Therapie-Systeme AG
`
`respectfully move the Board for leave to submit a corrected Patent Owners’
`
`Response (Paper 25), corrected Exhibits 2012, 2023, 2035, 2044, 2050, 2051 and
`
`supplemental Exhibit 2054, and for leave to submit an amended Patent Owners’
`
`Exhibit List 3 as set forth below.
`
`On January 27, 2015, Noven Pharmaceuticals (“Petitioner”) served
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`objections pursuant to 37 C.F.R § 42.64(b)(1) to all of Patent Owners’ filed
`
`exhibits. Petitioner’s objections included (i) general evidentiary objections and (ii)
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`specific objections due to clerical and typographical errors addressed herein. On
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`February 10, 2015, pursuant to 37 C.F.R § 42.64(b)(2), Patent Owners provided a
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`list of corrections and supplemental evidence to address certain errors raised in
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`Petitioner’s objections. In a communication dated February 18, 2015, Petitioner
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`agreed that the proposed corrections and supplemental evidence cured the defects
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`to which they were addressed but maintained all remaining objections. Patent
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`Owners have provided the corrected and supplemental exhibits and amended
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`Exhibit List 3 to the Petitioner, and Petitioner has stated that it does not oppose this
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`motion.
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`In addition, after submitting their Patent Owners’ Response (Paper 25) on
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`January 20, 2015, Patent Owners noticed that the response inadvertently referenced
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`the prosecution history of related patent 6,335,031 (Exhibit 2029) on pages 21 and
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`1
`
`
`
`24 rather than the prosecution history of patent 6,316,023 (Exhibit 2028.) In a
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`communication on February 10, 2015 Patent Owners advised Petitioner of this
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`discrepancy and on February 18, 2015 Petitioner confirmed that it would not
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`oppose a motion to correct.
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`Patent Owners sought permission to file this motion, which was granted in
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`an email from the Board on March 10, 2015.
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`I.
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`Motion To File Corrected Patent Owners’ Response
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`To facilitate the Board’s review of this matter and to cure a clerical error,
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`Patent Owners seek permission to file a corrected Patent Owners’ Response (Paper
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`25) with the following changes:
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` Page 21: Change “Ex. 2029 at N0001063” to “Ex. 2028 at N0000914”
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` Page 24: Change “Ex. 2029 at N0001083” to “Ex. 2028 at N0000914”
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`II. Motion To File Corrected And Supplemental Exhibits And
`Corrected Exhibit List 3
`
`To facilitate the Board’s review of this matter, Patent Owners further seek
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`permission to file the following exhibits and amended exhibit list to correct clerical
`
`and typographical errors:
`
`Exhibit 2012
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`To correct the following clerical and typographical errors in paragraph 85
`
`and Appendix A paragraph 1 of Exhibit 2012, Patent Owners provide the
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`Supplemental Declaration of Alexander M. Klibanov, Ph.D., dated February 10,
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`2
`
`
`
`2015, making the following corrections to Dr. Klibanov’s January 20, 2015
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`Declaration:
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` Paragraph 85: Change “(Ex. 2040, USP XX (1979) at 1079; Ex. 2041,
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`USP XXII (1989) at 624.)” to “(Ex. 2040, United States Pharmacopeia and
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`National Formulary (USP 20-NF 15), Rockville, MD: United States
`
`Pharmacopeial Convention, 1980 at 624; Ex. 2041, United States
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`Pharmacopeia and National Formulary (USP 22-NF 17), Rockville, MD:
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`United States Pharmacopeial Convention, 1990 at 1079.)”
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` Appendix A, Paragraph 1: Change “(Ex. 40, Rosin, col. 4, ll. 21-53.)” to
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`“(Ex. 1008, Rosin, col. 4, ll. 21-53.)”
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`Exhibits 2023, 2035, 2044 and 2050
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`To address, in part, Petitioner’s objections, Patent Owners provide
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`replacement exhibits 2023, 2035, 2044, and 2050 with associated cover pages.
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`Patent Owners request permission to file an amended Exhibit List 3 to
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`clarify the entry for Exhibit 2023:
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` Change “U.S. Pharmacopeial Convention, Revision Bulletin, Clonidine
`
`Transdermal System (Jan. 1, 2011)” to “U.S. Pharmacopeial Convention,
`
`Revision Bulletin, Clonidine Transdermal System (Jan. 1, 2011)
`
`incorporated into United States Pharmacopeia and National Formulary (USP
`
`3
`
`
`
`34-NF 29) Supplement 2, 5407-5410, Rockville, MD: United States
`
`Pharmacopeial Convention, 2011”
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`Exhibits 2040 and 2041
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`To address, in part, Petitioner’s objections to Exhibits 2040 and 2041, Patent
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`Owners request permission to file an amended Exhibit List 3 with the following
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`corrections:
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` The entry for Exhibit 2040 change “The United States Pharmacopeia, 624-
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`625 (20th ed., 1979) (Entry for Physostigmine Salicylate Injection)” to
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`“United States Pharmacopeia and National Formulary (USP 20-NF 15),
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`624-625, Rockville, MD: United States Pharmacopeial Convention, 1980”
`
` The entry for Exhibit 2041 change “The United States Pharmacopeia, 1078-
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`1079 (22nd ed., 1989) (Entry for Physostigmine Salicylate Injection)” to
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`“United States Pharmacopeia and National Formulary (USP 22-NF 17),
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`1078-1079, Rockville, MD: United States Pharmacopeial Convention,
`
`1990”
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`Exhibit 2047
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`To address, in part, Petitioner’s objections to Exhibit 2047, Patent Owners
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`provide the Declaration of Lisa Butler (supplemental Exhibit 2054), dated
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`February 10, 2015.
`
`4
`
`
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`Exhibit 2051
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`To address, in part, Petitioner’s objections to Exhibit 2051, Patent Owners
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`provide a clean replacement copy of the exhibit.
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`Dated: March 11, 2015
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`Respectfully submitted,
`
`/Raymond R. Mandra/
`Raymond R. Mandra
`Registration No. 34,382
`Lead Counsel for Patent Owner
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`5
`
`
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`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing UNOPPOSED MOTION TO FILE
`CORRECTED PATENT OWNERS’ RESPONSE, CORRECTED AND
`SUPPLEMENTAL EXHIBITS, AND CORRECTED EXHIBIT LIST
`was served on March 11, 2015 by causing it to be sent by email to counsel for
`Petitioner at the following email addresses:
`
`Steven J. Lee (slee@kenyon.com)
`
`Michael K. Levy (mlevy@kenyon.com)
`
`Chris Coulson (ccoulson@kenyon.com)
`
`Dated: March 11, 2015
`
`/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
`
`6
`
`