Paper No. ___
`Filed: May 20, 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 IDENTIFICATION OF
`IMPROPER NEW REPLY MATERIALS THAT
`SHOULD BE STRUCK FROM THE RECORD
`
`
`Filed: May 20, 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 IDENTIFICATION OF
`IMPROPER NEW REPLY MATERIALS THAT
`SHOULD BE STRUCK FROM THE RECORD
`
`
`
`Case PGR2015-00011
`Patent 8,859,623
`
`I.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`
`Petitioner’s Reply advances new argument and evidence exceeding the
`
`proper scope of reply. See 37 CFR §42.23; 77 Fed. Reg. 48,756, 48,767. The new
`
`evidence and argument is an improper attempt to cure (1) the lack of any expert
`
`testimony submitted with the Petition; and (2) the failure to disclose test
`
`methodology and information corresponding to the original test data submitted
`
`with the Petition, as required per 37 CFR 42.65(b). Ex. 2042. Pursuant to the
`
`Board’s authorization (Paper 38), Paragon submits this paper identifying materials
`
`that are untimely and/or outside the scope of a proper reply. These materials
`
`should be struck and expunged from the record pursuant to 37 CFR § 42.12.
`
`II.
`
`STATEMENT OF THE REASONS FOR THE RELIEF REQUESTED
`
`Assad Sawaya Newly Appearing as an Expert Witness: The entirety of
`
`Ex. 1025 (Declaration No. 3 of Assad Sawaya) and Paper 35, § II purport to
`
`qualify Assad Sawaya as an expert witness. Assad Sawaya was not previously
`
`presented or qualified as an expert witness under FRE 702. The Board already
`
`assessed this issue and agreed. See Paper 14 at 14 (Assad Sawaya “is not shown to
`
`be an expert witness” and the Board “accord[ed] no weight to his opinion in that
`
`capacity.”). Accordingly, the materials represent a departure from the Petition.
`
`New Experimental Protocols and Test Data: The entirety of Exs. 1027
`
`(TMQC# 247-01), 1028 (TMQC# 247-00), and 1030 (STU0346) present details of
`
`
`
`-1-
`
`
`
`Case PGR2015-00011
`Patent 8,859,623
`
`HPLC methods and validation experiments never previously submitted by
`
`Petitioner. The entirety of Ex. 1029 (Declaration of Rashid Zaman) presents
`
`testimony regarding the method and validation experiments. The entirety of
`
`Exs. 1031, 1032 (Declaration No. 2 of Michael Sawaya), and 1033 allegedly show
`
`that a Paragon employee was mailed a paper copy of some version of STU-0346.
`
`Paper 35, §§ III.A-B presents arguments regarding this new evidence.
`
`It is undeniable that, prior to the Reply, no HPLC method or validation
`
`experiments had ever been submitted by Petitioner—either in the petition
`
`materials or by motion under 37 C.F.R. 42.123. Paragon’s Response pointed out
`
`that the test data provided with the Petition did not comply with 37 C.F.R.
`
`§ 42.65(b). See Paper 20 at 31-36. The petition materials were confusing at best as
`
`to methodologies utilized, making different references to “proprietary” materials
`
`with no corresponding detail (see Ex. 1003 ¶¶ 21, 47; Pet. at 20, 49-50, 61), as well
`
`as USP standard protocol methods (see Ex. 1003 p. 21, n.5). Paragon and the
`
`Board reasonably concluded that the test method in the Petition presumably
`
`corresponded to “the USP standard HPLC method.” Paper 14 at 12; Paper 7 at 12-
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`13. Petitioner now alleges it used a “proprietary” method (not the USP method),
`
`which the newly submitted exhibits present for the first time. The methodologies
`
`are unquestionably new to the case, and represent a departure from the Petition.
`
`-2-
`
`
`
`
`Date: May 20, 2016
`
`
`
`Case PGR2015-00011
`Patent 8,859,623
`Respectfully submitted,
`
`
`/ Michael T. Rosato /
`Michael T. Rosato, Lead Counsel
`Reg. No. 52,182
`
`
`
`
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`-3-
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`
`
`
`
`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
`
`-4-
`
`
`
`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
`
`-5-
`
`
`
`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)
`
`-6-
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`
`
`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)
`
`-7-
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`
`
`EXHIBIT
`NO.
`
`2041
`
`2042
`
`Case PGR2015-00011
`Patent 8,859,623
`
`DESCRIPTION
`
`Declaration of Patrick Witham in Support of Paragon’s Motion to Seal
`Paper 20 and Exhibit 2034
`
`Email from Michael T. Rosato to the Patent Trial and Appeal Board,
`May 12, 2016
`
`
`
`
`
`
`
`-8-
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`
`
`Case PGR2015-00011
`Patent 8,859,623
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that the foregoing PARAGON’S
`
`IDENTIFICATION OF IMPROPER NEW REPLY MATERIALS and Exhibit
`
`2042 were served on May 20, 2016 on the Petitioner at the correspondence address
`
`of the 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: May 20, 2016
`
`
`
`
`
`-9-
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