UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., MYLAN INC., LUPIN LTD., and LUPIN
`PHARMACEUTICALS, INC.
`Petitioner,
`v.
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner.
`
`Case IPR2015-00903 (Patent 8,129,431 B2)1
`
`Filed: September 21, 2016
`
`PETITIONER’S MOTION TO EXPUNGE
`
`1 IPR2015-01871 has been joined with IPR2015-00903.
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., MYLAN INC., LUPIN LTD., and LUPIN
`PHARMACEUTICALS, INC.
`Petitioner,
`v.
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC., and
`BAUSCH & LOMB PHARMA HOLDINGS CORP.
`Patent Owner.
`
`Case IPR2015-00903 (Patent 8,129,431 B2)1
`
`Filed: September 21, 2016
`
`PETITIONER’S MOTION TO EXPUNGE
`
`1 IPR2015-01871 has been joined with IPR2015-00903.
`
`
`
`I.
`
`Introduction
`Pursuant to 37 C.F.R. § 42.56, Petitioner InnoPharma submits this motion to
`
`expunge the previously-sealed versions of: (1) Exhibit 2109 and (2) Exhibit 2082.
`
`Pursuant to the Board’s Order on September 19, 2016 (Paper 95), Petitioner is
`
`authorized to file a motion to expunge confidential information from the records by
`
`September 21, 2016.2 Patent Owner does not oppose this motion.
`
`II.
`
`Legal Standard
`“After denial of a petition to institute a trial or after final judgment in a trial,
`
`a party may file a motion to expunge confidential information from the record.” 37
`
`C.F.R. section 42.56. Under the rules, “information will be made public where the
`
`existence of the information is referred to in a decision to grant or deny a request to
`
`institute review or is identified in a final written decision following a trial.” Trial
`
`Practice Guide, 77 Fed. Reg. at 48,761. Conversely, where confidential
`
`information is not relied on by the Board, that information will generally be
`
`expunged. Volkswagen Grp. of Am. v. Emerachem Holdings, LLC, IPR2014-
`
`01556, Paper No. 61, at 2 (expunging confidential papers where “our consideration
`
`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
`
`
`
`of the Subject Papers and Exhibits was not necessary for our determination of
`
`whether the challenged claims of the ’911 patent were patentable.”).
`
`In other inter 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 58, at 4 (PTAB Apr. 24, 2014). In Greene’s Energy Group, the
`
`Board held that portions of an exhibit containing confidential financial information
`
`should remain under seal where the proposed redactions were reasonable and the
`
`thrust of the underlying argument or evidence was clearly discernable from the
`
`redacted versions. Greene’s Energy Grp., IPR2014-00216, Paper 27, at 5.
`
`Moreover, in 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 the exhibits “would be commercially harmful.” Otter
`
`Products, IPR2014-01464, Paper No. 28, at 4. Public disclosure of the information
`
`2
`
`
`
`that the parties seek to have expunged would be commercially harmful as
`
`explained further below. Further, such information is unnecessary to understand
`
`the thrust of the Board’s final written decision.
`
`III. Confidential Documents that Should be Expunged from the Record
`InnoPharma moves to expunge the sealed versions of (1) Exhibit 2109 that
`
`contains InnoPharma’s Abbreviated New Drug Application (“ANDA”) and (2)
`
`Exhibit 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 the contents of these documents, or descriptions of those contents,
`
`would disclose confidential business information in a highly competitive market,
`
`Petitioner requests that the sealed versions of Exhibit 2109 and Exhibit 2082 be
`
`expunged. This information has not been published and is not publicly available.
`
`Exhibit 2109
`1.
`As explained in Petitioner’s motion to seal (Paper 88) the sealed version of
`
`Exhibit 2109 is InnoPharma’s ANDA, which was filed confidentially with the
`
`FDA in order
`
`to obtain FDA approval
`
`to market
`
`InnoPharma’s generic
`
`pharmaceutical product.
`
`The information the parties seek to seal contains
`
`InnoPharma’s highly sensitive,
`
`confidential development
`
`information and
`
`technical, business information. InnoPharma’s product has not yet been marketed
`
`and remains confidential.
`
`3
`
`
`
`This exhibit is not cited or discussed in the Board’s Final Written Decision
`
`(Paper 83), therefore, the public can understand the thrust of the Board’s decision
`
`without resorting to the information contained in Exhibit 2109.
`
`If InnoPharma’s
`
`confidential information is made public, InnoPharma’s competitors could exploit
`
`its confidential
`
`information and gain an unfair competitive advantage over
`
`InnoPharma. Accordingly, Petitioner requests that Exhibit 2109 be expunged.
`
`Exhibit 2082
`2.
`As explained in Petitioner’s motion to seal (Paper 83), the Williams
`
`Declaration (Exhibit 2082) describes the confidential information contained in the
`
`ANDA (Exhibit 2109) in connection with secondary considerations of non-
`
`obviousness. In particular, the chart at paragraph 187 shows the generic
`
`bromfenac product components described in Exhibit 2109, and the Final Written
`
`Decision (Paper 83) does not cite or rely on paragraph 187 of Exhibit 2082.
`
`If InnoPharma’s confidential information is made public, InnoPharma’s
`
`competitors could exploit its confidential information and gain an unfair
`
`competitive advantage over InnoPharma. A redacted copy of Exhibit 2082 has
`
`been filed and will remain in the record, so expunging the aforementioned
`
`confidential information will not impede public understanding of the underlying
`
`arguments and evidence. Accordingly, Petitioner requests that the sealed copy of
`
`Exhibit 2082 be expunged.
`
`4
`
`
`
`IV. CONCLUSION
`For the foregoing reasons, Petitioner respectfully requests that the Board
`
`expunge the sealed version of Exhibit 2109 and Exhibit 2082. The previously filed
`
`redacted version of Exhibit 2082 should remain publicly available. Expungement
`
`will protect the parties’ confidential and competitively sensitive technical and
`
`commercial information without comprising the public’s ability to understand the
`
`underlying arguments and evidence, because redacted copies of the above exhibits
`
`would remain in the record and because this information is unnecessary to
`
`understanding the Board’s rationale in its Final Written Decision.
`
`Date: September 21, 2016
`
`Respectfully submitted,
`
`Alston & Bird LLP
`
`By: /Jitendra Malik/
`
`Jitendra Malik, Ph.D.
`Reg. No. 55823
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`jitty.malik@alston.com
`
`Lead Counsel for Petitioner
`
`5
`
`
`
`CERTIFICATION OF SERVICE
`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4) and 42.105, the undersigned
`
`certifies that on the 21st day of September, 2016, a complete copy of the foregoing
`
`Petitioner’s Motion to Expunge was served on counsel of record for the Patent
`
`Owner:
`
`Senju Pharmaceutical Co., Ltd., et al.
`
`Bryan C. Diner
`bryan.diner@finnegan.com
`
`Justin J. Hasford
`justin.hasford@finnegan.com
`
`Joshua L. Goldberg
`Joshua.goldberg@finnegan.com
`
`Lupin Ltd. et al.
`
`Deborah Yellin
`dyellin@crowell.com
`
`Jonathan Lindsay
`jLindsay@Crowell.com
`
`Shannon Lentz
`SLentz@Crowell.com
`
`Respectfully submitted,
`
`Alston & Bird LLP
`
`By: /Jitendra Malik/
`
`Jitendra Malik, Ph.D.
`Reg. No. 55823
`
`1
`
`
`
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`jitty.malik@alston.com
`
`Bryan Skelton, Ph.D.
`Reg. No. 50893
`Alston & Bird LLP
`4721 Emperor Blvd., Suite 400
`Durham, NC 27703-8580
`bryan.skelton@alston.com
`
`Lance Soderstrom
`Reg. No. 65405
`Alston & Bird LLP
`90 Park Avenue
`15th Floor
`New York, NY 10016-1387
`lance.soderstrom@alston.com
`
`Hidetada James Abe
`Reg. No. 61,182
`Alston & Bird LLP
`333 South Hope Street
`16th Floor
`Los Angeles, CA 90071
`james.abe@alston.com
`
`Joseph M. Janusz
`Reg. No. 70396
`ALSTON & BIRD LLP
`101 S. Tryon Street, Suite 4000
`Charlotte, NC 28205
`Telephone: 704-444-1000
`Fax: 704-444-1111
`joe.janusz@alston.com
`
`2
`
`
`
`Attorneys for Petitioners InnoPharma
`Licensing, Inc., InnoPharma Licensing
`LLC, InnoPharma Inc., InnoPharma
`LLC, Mylan Pharmaceuticals Inc., and
`Mylan Inc.
`
`3
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