Paper No. ___
`Filed: April 12, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`
`
`ALTAIRE PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`PARAGON BIOTECK, INC.,
`Patent Owner.
`
`_____________________________
`
`Case PGR2015-00011
`Patent 8,859,623
`_____________________________
`
`
`
`PARAGON’S MOTION TO SEAL PAPER 20 AND EXHIBIT 2034
`
`
`Filed: April 12, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`
`
`ALTAIRE PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`PARAGON BIOTECK, INC.,
`Patent Owner.
`
`_____________________________
`
`Case PGR2015-00011
`Patent 8,859,623
`_____________________________
`
`
`
`PARAGON’S MOTION TO SEAL PAPER 20 AND EXHIBIT 2034
`
`
`
`Case PGR2015-00011
`Patent 8,859,623
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`I.
`
`STATEMENT OF PRECISE RELIEF REQUESTED
`
`Pursuant to 37 C.F.R. § 42.14, Patent Owner Paragon BioTeck, Inc.
`
`(“Paragon” or “Patent Owner”) respectfully moves to seal Patent Owner’s
`
`Response (Paper 20) and the deposition transcript of Assad Sawaya (Ex. 2034).
`
`This motion is supported by a declaration of Patrick Witham, President of Paragon.
`
`(Ex. 2041). Redacted versions of both documents are being filed concurrently with
`
`this motion. As described in more detail below, Paper 20 and Exhibit 2034 contain
`
`confidential and sensitive information related to a confidential agreement between
`
`the parties. Paragon has not and would not make the information it seeks to seal
`
`publicly available, and public disclosure would harm Paragon.
`
`Paragon previously moved for entry of the default protective order and to
`
`seal substantially the same information found in earlier filings. (Paper 6). Petitioner
`
`did not oppose. The Board granted the motion to seal and entered the default
`
`protective order. (Paper 12).
`
`On February 29, Petitioner filed a motion to seal portions of Paper 20 and
`
`Exhibit 2034. (Paper 24). Paragon did not oppose the motion only to the limited
`
`extent that it sought to seal information regarding certain specific terms of a non-
`
`public agreement between the parties. (Paper 26). On March 29, the Board denied
`
`Petitioner’s motion, but authorized Petitioner to file a renewed motion within five
`
`business days. (Paper 27). Petitioner has not filed a renewed motion. On April 8,
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`the Board issued a corresponding order. (Paper 30). On April 11, the Board
`
`authorized Paragon to file its own motion to seal Paper 20 and Exhibit 2034.
`
`(Paper 31).
`
`Accordingly, Paragon files this motion to seal portions of Paper 20 and
`
`Exhibit 2034, limited to the disclosure of certain specific terms of a non-public
`
`agreement between the parties.
`
`II. GOOD CAUSE EXISTS FOR SEALING CONFIDENTIAL
`INFORMATION
`
`The record of a proceeding is open and available for access by the public.
`
`See 37 C.F.R. § 42.14. The Board must find “good cause” to seal documents.
`
`Garmin v. Cuozzo, IPR2012-00001, Paper 36 at 3 (PTAB April 5, 2013). “The
`
`rules aim to strike a balance between the public’s interest in maintaining a
`
`complete and understandable file history and the parties’ interest in protecting truly
`
`sensitive information.” The Office Patent Trial Practice Guide, 77 Fed. Reg.
`
`48756, 48760 (Aug. 14, 2012).
`
`The information Paragon seeks to seal is limited to certain specific financial
`
`terms of a non-public agreement between the parties. Disclosure of this
`
`information would significantly harm Paragon at least because revealing the
`
`precise terms of the confidential agreement between Paragon and Petitioner to
`
`current or potential competitors, investors, or partners of Paragon could negatively
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`Case PGR2015-00011
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`impact Paragon in future negotiations with those third parties.
`
`First, per the terms of the agreement between the parties, the parties agreed
`
`“that any/all writings, documents, data and/or information that reveals the
`
`financial data and business information relating to a party are the proprietary and
`
`confidential information of such party, and may not be disclosed to any third
`
`party without the written consent of said party.” (See Ex. 2001 at 9 (emphases
`
`added)). Paper 20 and Exhibit 2034 reveal confidential business information
`
`relating to the relationship between Paragon and Altaire, and the terms of the
`
`agreement require that at least the portions of Paper 20 and Exhibit 2034 reflecting
`
`such information be kept confidential.
`
`Second, disclosure of the confidential business information contained in
`
`Paper 20 and Exhibit 2034 would allow current or potential competitors, investors,
`
`or partners to know the precise consideration provided pursuant to the agreement.
`
`Access to such sensitive business information could provide a competitor a
`
`business advantage over Paragon and could negatively impact negotiations
`
`between Paragon and current or potential investors and partners.
`
`Paragon has redacted only the very specific and very limited information
`
`that it considers confidential and highly sensitive. See Appendix infra. The Board
`
`has previously maintained information under seal when the moving party has
`
`proposed reasonable redactions such that the thrust of the argument or evidence
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`Case PGR2015-00011
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`can be reasonably understood from the redacted versions. Greene’s Energy Grp.,
`
`LLC, Inc. v. Oil States Energy Svs., LLC, IPR2014-00216, Paper 27 at pg. 5 (Sept.
`
`23, 2014). Indeed, the Board has previously sealed substantially the same
`
`information in this proceeding. (Paper 12). None of Paragon’s arguments in its
`
`Patent Owner Response rely on the specific content that Paragon proposes
`
`redacting. As such, there is little legitimate public interest in favor of disclosing
`
`this sensitive business information, and the public interest will not be harmed by
`
`filing Paper 20 and Exhibit 2034 under seal as “PROTECTIVE ORDER
`
`MATERIAL.”
`
`III. CONFIDENTIAL INFORMATION IS NOT PUBLICLY AVAILABLE
`
`Paragon certifies the information identified in Paper 20 and Exhibit 2034
`
`and sought to be sealed is not publicly available. In a related district court case,
`
`Petitioner’s counsel filed an unredacted version of the referenced agreement. The
`
`unredacted version was promptly removed from the public docket. Petitioner’s
`
`filing of the unredacted version was a violation of the agreement between the
`
`parties.
`
`IV. CERTIFICATION OF CONFERENCE WITH OPPOSING PARTY
`PURSUANT TO 37 C.F.R. §42.54
`
`Counsel for Paragon has conferred with counsel for Petitioner. Paragon
`
`understands that Petitioner does not oppose sealing the requested portions of Paper
`
`-4-
`
`
`
`20 and Exhibit 2034.
`
`
`
`
`
`Date: April 12, 2016
`
`
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`Case PGR2015-00011
`Patent 8,859,623
`
`Respectfully submitted,
`
`
`/ Michael T. Rosato /
`Michael T. Rosato, Lead Counsel
`Reg. No. 52,182
`
`
`
`
`
`-5-
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`
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`APPENDIX – PROPOSED REDACTIONS
`
`Case PGR2015-00011
`Patent 8,859,623
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`No.
`
`Exhibit Title
`
`Portions With Confidential
`Information
`
`p. 8, ll. 3-5, 7, 9
`
`p. 12, l. 9
`
`p. 19, ll. 4-5
`
`p. 21, ll. 17-18
`
`p. 23, ll. 11-13, 19, 21-22
`
`p. 24, ll. 2-3, 9
`
`p. 25, ll. 19-20
`
`p. 26, ll. 1-2, 4, 6
`
`p. 29, ll. 11-14, 16-17
`
`p. 30, ll. 3-4
`
`p. 31, ll. 9-13, 15-16, 19, 21, 23-24
`
`p. 32, ll. 2, 4-5, 8-9, 12-13
`
`p. 37, ll. 20, 25
`
`p. 38, ll. 2, 4-8, 14-15
`
`p. 39, ll. 5-7
`
`p. 49, l. 22
`
`p. 50, ll. 2, 5
`
`p. 51, ll. 6, 8
`
`p. 57, l. 11
`
`p. 60, ll. 3-4
`
`p. 72, ll. 2, 4, 11, 13-15, 19-21
`
`p. 73, l. 4
`
`p. 75, ll. 5, 16-19
`
`p. 77, ll. 15, 19, 21-22, 24-25
`
`Paper 20
`
`Patent Owner’s Response
`
`Ex. 2034 Sawaya Deposition Transcript
`
`
`
`
`
`-6-
`
`
`
`
`
`EXHIBIT
`NO.
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`Case PGR2015-00011
`Patent 8,859,623
`
`UPDATED LIST OF EXHIBITS
`
`DESCRIPTION
`
`Declaration of Assad Sawaya in Support of Altaire Pharmaceuticals,
`Inc. and Sawaya Aquebogue, LLC’s Motion to Dismiss or, in the
`Alternative, for Transfer of Venue; Paragon BioTeck, Inc. v. Altaire
`Pharmaceuticals, Inc. and Sawaya Aquebogue, LLC. (Case 3:15-cv-
`00189-PK; Document 21; Filed 3/23/15; U.S. District Court of OR)
`
`Proof of Service Summons and Complaint; Paragon BioTeck, Inc. v.
`Altaire Pharmaceuticals, Inc., et al (Case 3:15-cv-00189-PK;
`Document 17; Filed 3/20/15; U.S. District Court of OR)
`
`Proof of Service Summons and Complaint; Paragon BioTeck, Inc. v.
`Altaire Pharmaceuticals, Inc., et al (Case 3:15-cv-00189-PK;
`Document 18; Filed 3/20/15; U.S. District Court of OR)
`
`Paragon’s Response to Defendants’ Motion to Dismiss or for Transfer
`of Venue; Paragon BioTeck, Inc. v. Altaire Pharmaceuticals, Inc. and
`Sawaya Aquebogue, LLC. (Case 3:15-cv-00189-PK; Document 27;
`Filed 4/15/15; U.S. District Court of OR)
`
`Air State Facility Permit Under the Environmental Conservation Law
`Issued to Sawaya Aquebogue, LLC for an Altaire Pharmaceuticals
`Facility on behalf of Michael Sawaya, Altaire Pharmaceuticals; New
`York State Department of Environmental Conservation (Effective
`Date April 27, 2010)
`
`Altaire Pharmaceuticals, Inc. and Sawaya Aquebogue, LLC’s Motion
`to Dismiss or, in the Alternative, for Transfer of Venue. Paragon
`BioTeck, Inc. v. Altaire Pharmaceuticals, Inc. and Sawaya
`Aquebogue, LLC. (Case 3:15-cv-00189-PK; Document 20; Filed
`3/23/15; U.S. District Court of OR)
`
`2007
`
`Letter from Michael Sawaya, General Counsel of Altaire
`Pharmaceuticals, Inc. to Travis Sydow of Paragon BioTeck, Inc. Dated
`June 12, 2015
`
`-7-
`
`
`
`EXHIBIT
`NO.
`
`2008
`
`2009
`
`2010
`
`2011
`
`Case PGR2015-00011
`Patent 8,859,623
`
`DESCRIPTION
`
`USP Monographs: Phenylephrine Hydrochloride Injection,
`Pharmacopeia online,
`http://uspbpep.com/usp31/v31261/usp31nf26s1_m64170.asp#usp31nf
`26s1_m64170s3 (last visited August 11, 2015)
`
`USP Monographs: Phenylephrine Hydrochloride Nasal Jelly,
`Pharmacopeia online,
`http://uspbpep.com/usp031/v31261/usp31nf26s1_m64180.asp (last
`visited August 11, 2015)
`
`USP: General Chapters: <621> Chromatography, U.S. Pharmacopeia,
`http://www.pharmacopeia.cn/v29240/usp29nf24s0_c621_viewall.html
`(last visited August 24, 2015)
`
`USP: General Chapters: <1225> Validation of Compendial Methods,
`U.S. Pharmacopeia,
`http://pharmacopeia.cn/v29240/usp29nf24s0_c1225.html (last visited
`August 24, 2015)
`
`2012
`
`Protective Order in PGR2015-00011
`
`2013
`
`2014
`
`2015
`
`Email from Roy Bryant to Patrick Witham and Lauren MC Bluett,
`October 18, 2013.
`
`Paragon’s Analysis of R-Phenylephrine Solutions Using Currently
`Published USP Methods (dated October 11, 2013; October 17, 2013
`and October 18, 2013)
`
`Paragon BioTeck, Inc.’s Answer, Affirmative Defenses,
`Counterclaims, and Third-Party Complaint; Altaire Pharmaceuticals,
`Inc. v. Paragon BioTeck, Inc.; Paragon BioTeck, Inc. v. Sawaya
`Aquebogue, LLC. (Case 2:15-cv-02416-LDW-AYS; Document 22;
`Filed 08/14/15; U.S. District Court of NY)
`
`2016
`
`Declaration of Dr. Gojko Lalic
`
`2017
`
`Curriculum vitae of Dr. Gojko Lalic
`
`-8-
`
`
`
`EXHIBIT
`NO.
`
`2018
`
`2019
`
`2020
`
`Case PGR2015-00011
`Patent 8,859,623
`
`DESCRIPTION
`
`USP reference standard certificate for phenylephrine LOT M0L504
`(2012)
`
`Sigma-Aldrich® Product Specification for phenylephrine product
`number P6126
`
`USP Monographs: Phenylephrine Hydrochloride, U.S. Pharmacopeia,
`http://www.pharmacopeia.cn/v29240/usp29nf24s0_m64160.html (last
`visited January 4, 2016)
`
`2021
`
`Declaration of Sailaja Machiraju
`
`2022
`
`Ernest L. Eliel et al., Stereochemistry of Organic Compounds (1994)
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`Sterile Phenylephrine Hydrochloride Opthalmic Solution 2.5% USP
`Rx Only, distributed by HUB Pharmaceuticals, LLC. U.S. National
`Library of Medicine,
`http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21525f9e-
`f3a2-4871-81bf-90a0686968f0 (last visited February 5, 2016)
`
`Remington: The Science and Practice of Pharmacy, 21st Edition, Part
`5: Pharmaceutical Manufacturing, page 860 (Beringer et al. eds. 2006)
`
`ATCC, Product sheet for Bacillus subtilis subsp. Subtilis (ATCC®
`6051TM) (2013)
`
`ATCC, Product sheet for Aspergillus fumigatus (ATCC® 1022TM)
`(2016)
`
`ATCC, Product sheet for Pseudomonas aeruginosa (ATCC® 10145TM)
`(2015)
`
`ATCC, Product sheet for Staphylococcus aureus subsp. Aureus
`(ATCC® 12600TM) (2014)
`
`Food and Drug Administration, Appendix 4: Bacterial Pathogen
`Growth and Inactivation,
`http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM25244
`7.pdf (last visited February 3, 2016)
`
`-9-
`
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`Case PGR2015-00011
`Patent 8,859,623
`
`2030
`
`Certificate of Incorporation of Altaire Pharmaceuticals, Inc.
`
`2031
`
`Articles of Organization of Sawaya Aquebogue, LLC
`
`2032
`
`2033
`
`Results of public records search for properties owned by Sawaya
`Aquebogue, LLC as of January 22, 2016
`
`Letter to the Honorable Leonard D. Wexler from counsel to Altaire
`Pharmaceuticals, Inc.and Sawaya Aquebogue, LLC, Case 2:15-cv-
`02416-LDW-AYS, Document 34, Filed 10/15/15 in the Eastern
`District of New York
`
`2034
`
`Transcript of Assad Sawaya deposition, January 20, 2016
`
`2035
`
`Carol Lakkis et al., “Infection control guidelines for optometrists,”
`Clin Exp Optom 90(6):434-444, 2007
`
`2036
`
`Curriculum vitae of Sailaja Machiraju
`
`2037
`
`2038
`
`2039
`
`2040
`
`Sigma-Aldrich® catalog entries for phenylephrine hydrochloride,
`http://www.sigmaaldrich.com/catalog/search?interface=All&term=phe
`nylephrine&N=0&mode=match+partialmax&focus=product&lang=en
`®ion=US (last visited February 7, 2016)
`
`Sigma-Aldrich® Product Portfolio - Description of quality control tests
`performed on Sigma-Aldrich products according to quality grade
`(2010)
`
`Image of Drs. Steeg and Reuter Optical Polarimeter Model SR-6
`obtained from, http://easytechsell.com/products/polyscience-sr6-fc-
`polarimeter-full-circle-scale-sr-6-steeg-reuter-warranty-free-domestic-
`shipping (last visited February 8, 2016)
`
`HPLC chromatograms obtained by Paragon for phenylephrine
`hydrochloride enantiomers and controls run under the USP
`Compendium method, Project Name: PPHcl_NasalJ_Sys4_160118_NJ
`(2016)
`
`-10-
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`Case PGR2015-00011
`Patent 8,859,623
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`2041
`
`Declaration of Patrick Witham in Support of Paragon’s Motion to Seal
`Paper 20 and Exhibit 2034
`
`-11-
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`Case PGR2015-00011
`Patent 8,859,623
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that PARAGON’S MOTION TO SEAL PAPER 20 AND
`
`EXHIBIT 2034, as well as the supporting declaration of Patrick Witham (Exhibit
`
`2041) and redacted copies of Paper 20 and Exhibit 2034, were served on April 12,
`
`2016 on Petitioner at the correspondence address of Petitioner as follows:
`
`Dipu A. Doshi
`Jonathan W.S. England
`Mark J. Thronson
`BLANK ROME LLP
`1825 Eye Street NW
`Washington, DC 20006
`Tel: (202)420-2604
`Fax: (202)420-2201
`Email: ddoshi@blankrome.com
`Email: jwengland@blankrome.com
`Email: mthronson@blankrome.com
`
`
`Respectfully submitted,
`
`
`/ Michael T. Rosato /
`Michael T. Rosato, Lead Counsel
`Reg. No. 52,182
`
`
`
`
`
`Date: April 12, 2016
`
`
`
`
`
`-12-
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