Paper No. __
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________________
`
`LUPIN LTD., LUPIN PHARMACEUTICALS INC., INNOPHARMA
`LICENSING, INC., INNOPHARMA LICENSING LLC, INNOPHARMA
`INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.
`Petitioners
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner
`____________________
`
`IPR2015-01097 (US Patent No. 8,751,131)1
`____________________
`
`PETITIONERS’ MOTION TO EXPUNGE
`
`
`1 IPR2016-00089 has been joined with IPR2015-01097.
`
`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________________
`
`LUPIN LTD., LUPIN PHARMACEUTICALS INC., INNOPHARMA
`LICENSING, INC., INNOPHARMA LICENSING LLC, INNOPHARMA
`INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.
`Petitioners
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner
`____________________
`
`IPR2015-01097 (US Patent No. 8,751,131)1
`____________________
`
`PETITIONERS’ MOTION TO EXPUNGE
`
`
`1 IPR2016-00089 has been joined with IPR2015-01097.
`
`
`
`
`
`I.
`
`Introduction
`
`Pursuant to 37 C.F.R. § 42.56, Petitioner Lupin submits this motion to
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`expunge the previously-sealed versions of: (1) Exhibit 2109 and (2) Exhibit 2082.
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`Pursuant to the Board’s Order on September 15, 2016 (Paper 72), Petitioner is
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`authorized to file a motion to expunge confidential information from the records
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`within 35 days of the entry of the Final Written Decision.2 Patent Owner does not
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`oppose this motion.
`
`II. Legal Standard
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`“After denial of a petition to institute a trial or after final judgment in a trial,
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`a party may file a motion to expunge confidential information from the record.” 37
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`C.F.R. § 42.56. Under the rules, “information will be made public where the
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`existence of the information is referred to in a decision to grant or deny a request to
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`institute review or is identified in a final written decision following a trial.” Trial
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`Practice Guide, 77 Fed. Reg. at 48,761. Conversely, where confidential
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`information is not relied on by the Board, that information will generally be
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`expunged. Volkswagen Grp. of Am. v. Emerachem Holdings, LLC, IPR2014-
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`01556, Paper No. 61, at 2 (expunging confidential papers where “our consideration
`
`of the Subject Papers and Exhibits was not necessary for our determination of
`
`
`2 Sealed copies of Exhibit 2109 and Exhibit 2082 appear to have been
`already expunged by the Board, however, in an abundance of caution Petitioner
`hereby moves to expunge Exhibit 2109 and Exhibit 2082.
`
`1
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`
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`
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`whether the challenged claims of the ’911 patent were patentable.”). In other inter
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`partes review proceedings, the Board has held that confidential research,
`
`development, or commercial information should remain under seal. See Otter
`
`Products, LLC, Petr., IPR2014-01464, Paper No. 28, pp. 2-4 (PTAB Aug. 27,
`
`2015); Greene’s Energy Grp., LLC, Inc. v. Oil States Energy Svcs., LLC, IPR2014-
`
`00216, Paper 27, at 5 (PTAB Sept. 23, 2014); Gnosis, et al. v. South Alabama Med.
`
`Science Found., IPR2013-00117, Paper 39, at 2 (PTAB Oct. 31, 2013); Unified
`
`Patents Inc. v. Dragon Intellectual Property, LLC, IPR2014-01252, Paper 40, at 7
`
`(PTAB Feb. 27, 2015); Microsoft Corp. v. SurfCast, Inc., IPR2013- 00292, Paper
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`58, at 4 (PTAB Apr. 24, 2014). In Greene’s Energy Group, the Board held that
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`portions of an exhibit containing confidential financial information should remain
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`under seal where the proposed redactions were reasonable and the thrust of the
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`underlying argument or evidence was clearly discernible from the redacted
`
`versions. Greene’s Energy Grp., IPR2014-00216, Paper 27, at 5. Moreover, in
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`Otter Products, the Board held that it was appropriate to expunge select exhibits in
`
`support of redacted papers where the public release of such exhibits “has not been
`
`published or other made available to the public,” and where public disclosure of
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`the exhibits “would be commercially harmful.” Otter Products, IPR2014-01464,
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`Paper No. 28, at 4. Public disclosure of the information that the parties seek to
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`have expunged would be commercially harmful as explained further below.
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`2
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`
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`
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`Further, such information is unnecessary to understand the thrust of the Board’s
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`final written decision.
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`III. Confidential Documents that Should be Expunged from the Record
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`Lupin moves to expunge the sealed versions of (1) Exhibit 2109 that
`
`contains Lupin’s Abbreviated New Drug Application (“ANDA”) and (2) Exhibit
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`2082 (Declaration of Robert O. Williams, III, Ph.D.) that cite to or substantially
`
`describe the confidential information in Exhibit 2109. Because public disclosure of
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`the contents of these documents, or descriptions of those contents, would disclose
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`confidential business information in a highly competitive market, Petitioner
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`requests that the sealed versions of Exhibit 2109 and Exhibit 2082 be expunged.
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`This information has not been published and is not publicly available.
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`A. Exhibit 2109
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`As explained in Petitioner’s motion to seal (Paper 65) the sealed version of
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`Exhibit 2109 is Lupin’s ANDA, which was filed confidentially with the FDA in
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`order to obtain FDA approval to market Lupin’s generic pharmaceutical product.
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`The information the parties seek to seal contains Lupin’s highly sensitive,
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`confidential development information and technical, business information. Lupin’s
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`product has not yet been marketed and remains confidential.
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`This exhibit is not cited or discussed in the Board’s Final Written Decision
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`(Paper 70), therefore, the public can understand the thrust of the Board’s decision
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`3
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`
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`
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`without resorting to the information contained in Exhibit 2109. If Lupin’s
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`confidential information is made public, Lupin’s competitors could exploit its
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`confidential information and gain an unfair competitive advantage over Lupin.
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`Accordingly, Petitioner requests that Exhibit 2109 be expunged.
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`B.
`
`Exhibit 2082
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`As explained in Petitioner’s motion to seal (Paper 65), the Williams
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`Declaration (Exhibit 2082) describes the confidential information contained in the
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`ANDA (Exhibit 2109) in connection with secondary considerations of
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`nonobviousness. In particular, paragraph 206 cites to Exhibit 2109, and the chart at
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`paragraph 240 shows the generic bromfenac product components described in
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`Exhibit 2109, and the Final Written Decision (Paper 70) does not cite or rely on
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`paragraphs 206 or 240 of Exhibit 2082. If Lupin’s confidential information is made
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`public, Lupin’s competitors could exploit its confidential information and gain an
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`unfair competitive advantage over Lupin. A redacted copy of Exhibit 2082 has
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`been filed and will remain in the record, so expunging the aforementioned
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`confidential information will not impede public understanding of the underlying
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`arguments and evidence. Accordingly, Petitioner requests that the sealed copy of
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`Exhibit 2082 be expunged.
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`4
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`
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`IV. Conclusion
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`For the foregoing reasons, Petitioner respectfully requests that the Board
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`expunge the sealed version of Exhibit 2109 and Exhibit 2082. The previously filed
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`redacted version of Exhibit 2082 should remain publicly available. Expungement
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`will protect the parties’ confidential and competitively sensitive technical and
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`commercial information without comprising the public’s ability to understand the
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`underlying arguments and evidence, because (1) redacted copies of Exhibit 2082
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`would remain in the record and because (2) the information contained in the
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`redacted paragraphs of Exhibit 2082 and the information in Exhibit 2109 is
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`unnecessary to understanding the Board’s rationale in its Final Written Decision.
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`Respectfully submitted,
`
`/Deborah Yellin/
`Deborah Yellin, Lead Counsel
`Reg. No. 45,904
`CROWELL & MORING LLP
`Intellectual Property Group
`1001 Pennsylvania Avenue, N.W.
`Washington, DC 20004-2595
`Telephone: (202) 624-2947
`Fax: (202) 628-8844
`
`Counsel for Petitioners
`
`
`
`
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`5
`
`Date: October 17, 2016
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`CERTIFICATION OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4) and 42.105, the undersigned
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`certifies that on the 17th day of October, 2016, a complete copy of the foregoing
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`Petitioners’ Motion to Expunge was served on Patent Owner’s counsel of record
`
`and counsel of record for Petitioners InnoPharma at the following:
`
`Patent Owner
`Bryan.Diner@finnegan.com
`Justin.Hasford@finnegan.com
`Joshua.Goldberg@finnegan.com
`
`Petitioners InnoPharma
`jitty.malik@alston.com;
`bryan.skelton@alston.com;
`lance.soderstrom@alston.com;
`james.abe@alston.com; and
`Joe.janusz@alston.com
`
`Respectfully submitted,
`
`
`
`/Shannon M. Lentz/
`Shannon M. Lentz
`Reg. No. 65,382
`CROWELL & MORING LLP
`Intellectual Property Group
`P.O. Box 14300
`Washington, DC 20044-4300
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`6
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`October 17, 2016
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