UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SANDOZ INC.,
`Petitioner,
`
`v.
`
`EKR THERAPEUTICS, LLC (F/K/A EKR THERAPEUTICS, INC.),
`Patent Owner.
`
`Patent No. 8,455,524
`
`Inter Partes Review No. IPR2015-00005
`
`UNOPPOSED MOTION UNDER 37 C.F.R. § 42.56 FOR
`EXPUNGEMENT OF CONFIDENTIAL INFORMATION
`
`la-1288150
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SANDOZ INC.,
`Petitioner,
`
`v.
`
`EKR THERAPEUTICS, LLC (F/K/A EKR THERAPEUTICS, INC.),
`Patent Owner.
`
`Patent No. 8,455,524
`
`Inter Partes Review No. IPR2015-00005
`
`UNOPPOSED MOTION UNDER 37 C.F.R. § 42.56 FOR
`EXPUNGEMENT OF CONFIDENTIAL INFORMATION
`
`la-1288150
`
`
`
`IPR2015-00005
`
`Docket No.: 129352800700
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`I.
`
`INTRODUCTION AND STATEMENT OF REQUESTED RELIEF
`
`On April 24, 2015, the Patent Trial and Appeal Board (“PTAB”) entered
`
`Paper No. 20 denying institution of inter partes review under 37 C.F.R. § 42.108.
`
`Petitioner Sandoz Inc. (“Petitioner”) now requests that the record be expunged of
`
`the confidential version of Patent Owner’s Preliminary Response (Paper 9),
`
`Petitioner’s Reply to Preliminary Response (Paper 12) and Patent Owner’s Sur-
`
`Reply (Paper 16), and confidential Exhibits 1018, 1019, 1025, 2002 and 2014.
`
`EKR Therapeutics, LLC (“Patent Owner”) does not oppose this motion.
`
`II.
`
`BACKROUND AND RELEVANT FACTS
`
`On October 1, 2014, Petitioner filed a petition requesting inter partes review
`
`of U.S. Patent No. 8,455,524 (the “Petition”). Patent Owner filed under seal a
`
`confidential Preliminary Response with two confidential exhibits on January 26,
`
`2015. Papers 9 & 11, Exhibits 2002 and 2014. On February 20, 2015, Petitioner
`
`filed under seal a Reply to Patent Owner’s Preliminary Response with certain
`
`confidential exhibits. Papers 12 & 14, Exhibits 1018, 1019 and 1025. Patent
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`Owner also filed a confidential Sur-Reply on February 27, 2015. Paper 16.
`
`On April 24, 2015, the PTAB issued three decisions granting Petitioner’s
`
`Motion to Seal (Paper 21), Patent Owner’s Motion to Seal (Paper 22), and Patent
`
`Owner’s Second Motion to Seal (Paper 23). Also on April 24, the PTAB issued a
`
`decision denying the Petition. Paper 20.
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`IPR2015-00005
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`Docket No.: 129352800700
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`III. LEGAL STANDARD
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`Pursuant to 37 C.F.R. § 42.20(c), the moving party has the burden to
`
`establish that it is entitled to the requested relief. A party moving to expunge
`
`information must show that the information is confidential and that the party’s
`
`“interest in expunging it outweighs the public’s interest in maintaining a complete
`
`and understandable history of this inter partes review.” Atlanta Gas Light Co. v.
`
`Bennett Regulator Guards, Inc., IPR2013-00453, slip op. at 2 (Apr. 15, 2015)
`
`(Paper 97).
`
`IV. GOOD CAUSE EXISTS FOR GRANTING THIS MOTION TO
`EXPUNGE
`
`This standard is met for the limited information Sandoz seeks to have
`
`expunged from the record. The material in question relates to confidential
`
`commercial documents or regulatory submissions that are treated as proprietary by
`
`Sandoz. The PTAB did not rely upon any of the confidential portions of the
`
`parties’ submissions or the confidential exhibits in its decision not to institute.
`
`And with respect to the parties’ submissions, public versions have been filed with
`
`selected redactions for the confidential information. Accordingly, the reasoning
`
`for the Board’s decision will remain complete and clear even without the
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`information in these materials. The specific papers subject to this motion are
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`discussed below.
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`IPR2015-00005
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`Docket No.: 129352800700
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`Portions of Patent Owner’s Preliminary Response (Paper 9) contain
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`confidential commercial information that should be protected from public
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`disclosure. Those portions primarily relate to the Patent Owner’s position on the
`
`Petition’s real party in interest, which was not reached by the Board. See paper 20
`
`at 6. In particular, they discuss and characterize a confidential “Manufacture and
`
`Supply Agreement” (Ex. 2002), which is confidential commercial information and
`
`is subject to a protective order entered in a related case before the United States
`
`District Court for the District of New Jersey in Chiesi USA, Inc. et al. v. Sandoz
`
`Inc. et al., No. 1:13-cv-05723-NLH-AMD (D.N.J.). A redacted version of Paper 9
`
`is found in the record at Paper 8. The redactions made to the Patent Owner’s
`
`Preliminary Response would not inhibit a reader’s understanding of the substance
`
`of the Patent Owner’s position. Petitioner respectfully submits that the scope of
`
`the redactions to Paper 9 are reasonable given the type and extent of information
`
`Petitioner seeks to protect. On April 24, 2015, the PTAB found good cause to seal
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`Paper 9 (see Paper 22, at 3), and Petitioner now requests that confidential Paper 9
`
`be expunged.
`
`Portions of the Petitioner’s Reply (Paper 12) on the real party in interest
`
`issue likewise consist entirely of confidential commercial information that should
`
`be protected from public disclosure. A redacted version of Paper 12 is found in the
`
`record at Paper 13. The redactions made to the Petitioner’s Reply would not
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`Docket No.: 129352800700
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`inhibit a reader’s understanding of the substance of the Petitioner’s position.
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`Petitioner respectfully submits that the scope of the redactions to Paper 12 are
`
`reasonable given the type and extent of information Petitioner seeks to protect. On
`
`April 24, 2015, the PTAB found good cause to seal Paper 12 (see Paper 21, at 3-4),
`
`and Petitioner now requests that confidential Paper 12 be expunged.
`
`Portions of Patent Owner’s Sur-Reply (Paper 16) on the real party in interest
`
`issue likewise consist entirely of confidential commercial information. A redacted
`
`version of Paper 16 is found in the record at Paper 17. The redactions made to the
`
`Patent Owner’s Sur-Reply would not inhibit a reader’s understanding of the
`
`substance of the Patent Owner’s position. Petitioner respectfully submits that the
`
`scope of the redactions to Paper 16 are reasonable given the type and extent of
`
`information Petitioner seeks to protect. On April 24, 2015, the PTAB found good
`
`cause to seal Paper 16 (see Paper 23), and Petitioner now requests that confidential
`
`Paper 16 be expunged.
`
`Exhibit 1018 is an excerpt from Sandoz Inc.’s Abbreviated New Drug
`
`Application (“ANDA”) containing confidential commercial information that
`
`should be protected from public disclosure. Petitioner filed its ANDA
`
`confidentially with the Food and Drug Administration (“FDA”) in order to obtain
`
`FDA approval to market a generic pharmaceutical product. This excerpt has not
`
`been made public by Petitioner or by the FDA, and is not otherwise available to the
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`Docket No.: 129352800700
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`public. On April 24, 2015, the PTAB found good cause to seal Exhibit 1018 (see
`
`Paper 21, at 2), and Petitioner now requests that Exhibit 1018 be expunged.
`
`Exhibit 1019 is Sandoz Inc.’s Notice of Certification Letter under 21 U.S.C.
`
`§ 355(j)(2)(B) (§ 505(j)(2)(B)) and 21 C.F.R § 314.95 and contains confidential
`
`commercial information that should be protected from public disclosure. The
`
`information in Exhibit 1019 has not been made public. On April 24, 2015, the
`
`PTAB found good cause to seal Exhibit 1019 (see Paper 21, at 2), and Petitioner
`
`now requests that Exhibit 1019 be expunged.
`
`Portions of Exhibit 1025, the Declaration of Sergio Dusci, contain
`
`confidential commercial information that should be protected from public
`
`disclosure. Those portions of Exhibit 1025 discuss and characterize a confidential
`
`“Manufacture and Supply Agreement” (Ex. 2002), which contains confidential
`
`commercial information and is subject to a protective order entered in a related
`
`case before the United States District Court for the District of New Jersey in Chiesi
`
`USA, Inc. et al. v. Sandoz Inc. et al., No. 1:13-cv-05723-NLH-AMD (D.N.J.). A
`
`redacted version of Exhibit 1025 has been made available on the public record.
`
`Petitioner respectfully submits that the scope of the redactions to Exhibit 1025 are
`
`limited to isolated passages that consist entirely of confidential commercial
`
`information. On April 24, 2015, the PTAB found good cause to seal Exhibit 1025
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`IPR2015-00005
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`Docket No.: 129352800700
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`(see Paper 21, at 3), and Petitioner now requests that confidential Exhibit 1025 be
`
`expunged.
`
`Exhibit 2002 is a “Manufacture and Supply Agreement” between Sandoz
`
`AG and ACS Dobfar Info SA, dated July 27, 2011, and contains confidential
`
`commercial information that should be protected from public disclosure. Exhibit
`
`2002 is subject to a protective order entered in a related case before the United
`
`States District Court for the District of New Jersey in Chiesi USA, Inc. et al. v.
`
`Sandoz Inc. et al., No. 1:13-cv-05723-NLH-AMD (D.N.J.). On April 24, 2015, the
`
`PTAB found good cause to seal Exhibit 2002 (see Paper 22, at 2), and Petitioner
`
`now requests that Exhibit 2002 be expunged.
`
`Portions of Exhibit 2014, which is an excerpt from “Plaintiffs’ Responses to
`
`Defendant’s Invalidity Contentions,” contain confidential commercial information
`
`that should be protected from public disclosure. Exhibit 2014 is subject to a
`
`protective order entered in a related case before the United States District Court for
`
`the District of New Jersey in Chiesi USA, Inc. et al. v. Sandoz Inc. et al., No. 1:13-
`
`cv-05723-NLH-AMD (D.N.J.). A redacted version of Exhibit 2014 has been made
`
`available on the public record. Petitioner respectfully submits that the scope of the
`
`redactions to Exhibit 2014 are reasonable given the type and extent of information
`
`Petitioner seeks to protect. On April 24, 2015, the PTAB found good cause to seal
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`6
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`IPR2015-00005
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`Docket No.: 129352800700
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`Exhibit 2014 (see Paper 22, at 2-3), and Petitioner now requests that confidential
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`Exhibit 2014 be expunged.
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`Petitioner’s interest in expunging the confidential information in these
`
`documents and exhibits outweighs any public interest in maintaining the
`
`information as part of the official record. The PTAB did not rely upon any of the
`
`confidential portions of the parties’ submissions or the confidential exhibits in its
`
`decision not to institute a proceeding. Accordingly, the reasoning for the Board’s
`
`decision will remain complete and clear even without the information in these
`
`materials.
`
`V.
`
`CONCLUSION
`
`Because Petitioner has demonstrated that Petitioner has an interest in
`
`maintaining the confidentiality of its information, the Board’s decision did not rely
`
`on any confidential information or cite to any of the exhibits to be expunged, and
`
`redacted versions of the parties’ submissions will remain publicly available,
`
`Petitioner respectfully requests that the Board grant this Motion to Expunge
`
`Confidential Information.
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`la-1288150
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`7
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`IPR2015-00005
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`Docket No.: 129352800700
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`Dated: June 8, 2015
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`Respectfully submitted,
`
`/Matthew I. Kreeger/
`Matthew I. Kreeger
`Registration No. 56,398
`Attorneys for Petitioner
`Morrison & Foerster LLP
`425 Market Street
`San Francisco, CA 94105-2482
`Telephone: 415.268.7000
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`IPR2015-00005
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`Docket No.: 129352800700
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`Certificate of Service (37 C.F.R. § 42.6(e)(4))
`
`I hereby certify that the attached UNOPPOSED MOTION UNDER 37
`
`C.F.R. § 42.56 FOR EXPUNGEMENT OF CONFIDENTIAL INFORMATION
`
`was served as of the below date by e-mail on the Patent Owner at the following
`
`correspondence address(es):
`
`Edgar H. Haug
`Nicholas F. Giove
`Angus Chen
`FROMMER LAWRENCE & HAUG LLP
`745 Fifth Avenue
`New York, NY 10151
`ipr.chiesi@flhlaw.com
`
`Dated: June 8, 2015
`
`/David J. Austin/
`David J. Austin
`
`la-1288150
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`9
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