UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
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`v.
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`COSMO TECHNOLOGIES LIMITED,
`Patent Owner.
`
`
`Case IPR2017-01035
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`Patent 9,320,716
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`
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`PETITIONER’S MOTION TO SEAL
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`COSMO TECHNOLOGIES LIMITED,
`Patent Owner.
`
`
`Case IPR2017-01035
`
`Patent 9,320,716
`
`
`
`PETITIONER’S MOTION TO SEAL
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`I.
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`Introduction
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`Pursuant to the Board’s authorization via email on July 7, 2017, Petitioner
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`hereby moves to seal a few sentences of the Patent Owner’s Preliminary Response
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`(“Preliminary Response”) (Paper 7) under 37 C.F.R. §§ 42.14 and 42.54. The
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`information identified as confidential in this Motion has not been published or
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`otherwise made public. The Parties have met and conferred and Patent Owner
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`opposes this motion.1
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`II. Legal Standard
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`Under 35 U.S.C. § 316(a)(1), the default rule is that all papers filed in an
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`inter partes review are open and available for access by the public and a party may
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`file a motion to seal and that the information at issue is sealed pending the outcome
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`of the motion. 37 C.F.R. § 42.14 provides that “[a] party intending a document or
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`thing to be sealed shall file a motion to seal concurrent with the filing of the
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`document or thing to be sealed.” The moving party has the burden of establishing
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`“good cause” for sealing documents containing confidential information. Garmin
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`Int’l, Inc. v. Cuozzo Speed Techs. LLC, IPR2012-00001, Paper 37 at 4 (PTAB,
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`Apr. 5, 2013); see also 37 C.F.R. §§ 42.20(c), 42.54.
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`1 Patent Owner also filed a public redacted Preliminary Response (Paper 8),
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`which is the subject of Petitioner’s concurrently filed motion to expunge.
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`1
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`The Board’s rules identify confidential information in a manner consistent
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`with Federal Rule of Civil Procedure 26(c)(1)(G), which provides for protective
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`orders for trade secret or other confidential research, development, or commercial
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`information. Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,760; see also
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`Illumina, Inc. v. Trustees of Columbia University in the City of New York,
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`IPR2013-00011, Paper 66 at 6 (PTAB Aug. 12, 2013) (granting a motion to seal
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`“technical and business information”).
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`III.
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`Identification of Confidential Information
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`In this Motion to Seal, Petitioner requests limited portions of the Preliminary
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`Response be sealed as “PROTECTIVE ORDER MATERIAL” under the Default
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`Protective Order for revealing Petitioner’s confidential information pertaining to
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`Petitioner’s ANDA product. Petitioner’s ANDA was filed confidentially with the
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`Food and Drug Administration (“FDA) in order to obtain FDA approval to market
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`a generic pharmaceutical product. No information from the ANDA has been made
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`public by Petitioner or by the FDA, and it is not otherwise available to the public.
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`Sandoz, Inc. v. EKR Therapeutics, LLC, IPR2015-00005, Paper 21 at 2 (PTAB
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`Apr. 24, 2014) (sealing entire ANDA). Indeed, Patent Owner admits in its
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`Preliminary Response that Petitioner has claimed that its ANDA information is
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`confidential information, and that such information is subject to the District
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`Court’s Protective Order. Preliminary Response at 6 fn. 3; Sandoz, Inc., IPR2015-
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`2
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`00005, Paper 21 at 3 (PTAB Apr. 24, 2014) (discussing relevance of considering
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`the Protective Order in the Board’s determination).
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`The following passages of the Preliminary Response contain confidential
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`information that Petitioner seeks to redact:
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`The portion of the sentence on page 6, footnote 2, the parenthetical at
`line 6 that is between the phrases “prove infringement” and “is
`nevertheless”;
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`The portion of the sentence on page 36 lines 6-8 that is between the
`phrases “in district court litigation—” and “—should be rejected”; and
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`The portion of the sentence on page 51 lines 9-11 that is between the
`phrases “in district court litigation—” and “—should be rejected.”
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`The identified portions reveal confidential information regarding Petitioner’s
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`ANDA product—specifically how the active ingredient in Petitioner’s ANDA
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`product is distributed.
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`IV. Good Cause Exists for Sealing the Confidential Information
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`Petitioner requests that the above identified three (3) statements revealing
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`confidential information about Petitioner’s ANDA product be sealed. Public
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`disclosure of information regarding the arrangement of a component in Petitioner’s
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`ANDA product, or how it is created/tested, would reveal confidential business
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`information and is trade secret and/or confidential commercial information. It
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`therefore qualifies as confidential information under 37 CFR § 42.2. Public
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`disclosure of the information that Petitioner seeks to seal would be commercially
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`harmful to Petitioner.
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`3
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`
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`The Board has recognized such information, especially if it reveals
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`information from the ANDA, should be protected from public disclosure. See
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`Sandoz, Inc., IPR2015-00005, Paper 21 at 2 (PTAB Apr. 24, 2014) (sealing entire
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`the ANDA); InnoPharma Licensing, Inc. v. Senju Pharm. Co., Ltd., IPR2015-
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`00902, Paper 100 at 2-3 (PTAB Aug. 29, 2016) (sealing portions of the ANDA).
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`Even though Patent Owner did not submit Petitioner’s ANDA itself as an
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`exhibit, the assertions made by Patent Owner in its Preliminary Response with
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`respect to the arrangement of a component in Petitioner’s ANDA product is based
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`on information Patent Owner gained because it has access to Petitioner’s ANDA,
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`and the related defenses being asserted by Petitioner, in the related District Court
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`litigation. The information Petitioner seeks to seal is directly derived from
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`Petitioner’s ANDA.
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`In its Motion to Seal (Paper 9), Patent Owner asserts that the sole basis to
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`seal the Preliminary Response is because it quotes Exhibit 2025, excerpts of a trial
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`transcript from another district court litigation. Paper 9 at 3. Petitioner, however,
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`was not a party to that other litigation and no information about Petitioner’s ANDA
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`product was revealed in that litigation. Nevertheless, the Preliminary Response
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`reveals information regarding Petitioner’s ANDA product. Tellingly, several of
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`the redactions made by Patent Owner do not even cite or reference Exhibit 2025,
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`4
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`but instead pertain to Petitioner’s non-infringement defenses 2 and/or ANDA
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`product. See, e.g., Preliminary Response at 5, 7, 34, 36, 51.3
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`Petitioner understands that the rules promulgated by the USPTO “aim to
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`strike a balance between the public’s interest in maintaining a complete and
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`understandable file history and the parties’ interest in protecting truly sensitive
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`information.” Office Trial Practice Guide, 77 Fed. Reg. 48,756, 48,760 (Aug. 14,
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`2012). Petitioner contends that its redactions—constituting only portions of three
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`sentences—are minimal and are far less than those proposed by Patent Owner in its
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`Motion to Seal (Paper 9). Even with Petitioner’s proposed redactions the public
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`will be left with a complete and understandable file history, only being unaware of
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`the distribution of ingredient component in Petitioner’s ANDA product and details
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`2 Indeed, Patent Owner makes assertions regarding Petitioner’s non-
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`infringement contentions and arguments from the related District Court action. See
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`id. at 5-6, 36. By their very nature, Petitioner’s non-infringement contentions and
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`defenses are based on Petitioner’s actual ANDA product.
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`3 Petitioner reserves the right to respond to Patent Owner’s Motion to Seal
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`(Paper 9) in accordance with 37 C.F.R. § 42.25.
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`5
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`about Petitioner’s non-infringement defenses.4 Sandoz, Inc, IPR2015-00005, Paper
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`21 at 4 (PTAB Apr. 24, 2014) (“The redactions to the Petitioner’s Reply appear to
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`be limited to isolated passages that consist entirely of confidential commercial
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`information. The redactions made to the Petitioner’s Reply would not inhibit a
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`reader’s understanding of the substance of the Petitioner’s position.”). Petitioner
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`contends that such information would not impede the public’s understanding of
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`Patent Owner’s Preliminary Response and strikes the appropriate balance between
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`the public’s interest and Petitioner’s interest in protecting its confidential
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`information.
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`4 Indeed, coupled with the statements in this paper, the public will
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`understand what the redacted information generally relates to, left only without
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`information about the distribution of ingredient component in Petitioner’s ANDA
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`product.
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`6
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`V. Conclusion
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`For the foregoing reasons, Petitioner respectfully requests that the Board
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`grant the instant Motion to Seal Patent Owner’s Preliminary Response.
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`Date: July 13, 2017
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`Respectfully submitted,
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`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
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`7
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`CERTIFICATION OF SERVICE
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`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 13th day of July, 2017, a complete copy of the foregoing
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`Petitioner’s Motion to Seal was served on counsel of record for the Patent Owner:
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`Gary N. Frischling (Reg. No. 35,515)
`gfrischling@irell.com
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`Yite John Lu (Reg. No. 63,158)
`yjlu@irell.com
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`CosmoIPR@irell.com
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`Respectfully submitted,
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`Alston & Bird LLP
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`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
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`1
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