IPR2015-00903 (Patent 8,129,431 B2)
` Paper No. __
`Filed: December 28, 2015
`
`
`
`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., and MYLAN INC.
`Petitioners,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.
`Patent Owner.
`__________________
`
`Case IPR2015-00903 (Patent 8,129,431 B2)
`__________________
`
`
`
`PATENT OWNER’S MOTION TO SEAL AND MOTION TO ENTER
`STIPULATED PROTECTIVE ORDER
`
`
`
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`
`
`
`
`
`
` Paper No. __
`Filed: December 28, 2015
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`
`
`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., and MYLAN INC.
`Petitioners,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.
`Patent Owner.
`__________________
`
`Case IPR2015-00903 (Patent 8,129,431 B2)
`__________________
`
`
`
`PATENT OWNER’S MOTION TO SEAL AND MOTION TO ENTER
`STIPULATED PROTECTIVE ORDER
`
`
`
`
`
`
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`
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`IPR2015-00903 (Patent 8,129,431 B2)
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`
`TABLE OF CONTENTS
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`
`I.
`Introduction ................................................................................................. 1
`Governing Rules and PTAB Guidance ......................................................... 2
`II.
`III. Background and Identification of Confidential Information ......................... 3
`IV. Good Cause Exists for Sealing Certain Confidential Information ................ 6
`A.
`Patent Owner’s New Drug Application (“NDA”) and Petitioner
`InnoPharma’s Abbreviated New Drug Application (“ANDA”)
`and Related Portions of Patent Owner’s Response, and the
`Williams, Trattler, and Jarosz Declarations Should Be Sealed ........... 6
`1.
`The NDA and ANDA Contain Highly Sensitive,
`Confidential Information to Their Respective Owners ............. 7
`Good Cause Exists to Seal the NDA and ANDA Exhibits
`as “BOARD’S EYES ONLY” Under the Proposed
`Stipulated Protective Order ...................................................... 8
`Patent Owner’s Confidential Presentations Related to its
`Research and Development and Related Jarosz Declaration and
`Pleadings Should Be Sealed ............................................................... 9
`Under the Rule on Witnesses, Transcript of Petitioner
`InnoPharma’s Expert Should Be Sealed Until Petitioner Lupin’s
`Expert Has Concluded Her Testimony in the Related IPR
`Proceedings.......................................................................................10
`Proposed Stipulated Protective Order..........................................................12
`V.
`VI. Conclusion ..................................................................................................13
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`2.
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`B.
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`C.
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`i
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`IPR2015-00903 (Patent 8,129,431 B2)
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`TABLE OF AUTHORITIES
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`FEDERAL CASES
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`Page(s)
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`Geders v. United States,
`425 U.S. 80 (1976) ........................................................................................... 11
`
`BOARD DECISIONS
`Sandoz, Inc. v. EKR Therapeutics, LLC,
`IPR2015-00005, Paper 21 ................................................................................. 8
`
`FEDERAL STATUTES
`35 U.S.C. § 316 ...................................................................................................... 2
`
`FEDERAL REGULATIONS
`37 C.F.R. § 42.14 ........................................................................................... 2, 7, 9
`37 C.F.R. § 42.20 ................................................................................................... 3
`37 C.F.R. § 42.54 ............................................................................................... 1, 3
`37 C.F.R. § 42.62 ................................................................................................. 11
`Office Patent Trial Practice Guide,
`77 Fed. Reg. 48756 (Aug. 14, 2012) ..................................................... 2-3, 8, 10
`
`
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`ii
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`IPR2015-00903 (Patent 8,129,431 B2)
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`I.
`
`
`Introduction
`Through this Motion to Seal and Motion to Enter Stipulated Protective Order,
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`Patent Owner requests that three categories of exhibits be sealed: (1) excerpts of
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`Patent Owner’s New Drug Application (“NDA”) (Exs. 2096, 2102, 2103, and
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`2110) and Petitioner InnoPharma Licensing’s Abbreviated New Drug Application
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`(“ANDA”) (Ex. 2109); (2) two confidential presentations related to Patent Owner’s
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`research and development of the patented formulation (Exs. 2220 and 2226); and
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`(3) the transcript of testimony of Petitioner InnoPharma’s expert, Dr. Paul Laskar
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`(Ex. 2114). In addition, Patent Owner also requests that portions of the
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`confidential versions of Patent Owner’s Response (Paper 34 (BOARD’S EYES
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`ONLY version, containing no redactions) and Paper 33 (FED. R. EVID. 615
`
`version, redacting BOARD’S EYES ONLY material, to be made public once FED.
`
`R. EVID. 615 has been lifted, as explained herein)), and portions of confidential
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`versions of Patent Owner’s expert declarations (Exs. 2082 (Williams), 2105
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`(Davies), 2116 (Trattler), and 2130 (Jarosz)) citing or substantially describing the
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`above categories of documents be sealed. Finally, under 37 C.F.R. § 42.54, Patent
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`Owner further requests entry of the Proposed Stipulated Protective Order,
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`submitted concurrently herewith. To the best of Patent Owner’s knowledge, the
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`Patent Owner certifies that the information identified as confidential in this motion
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`1
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`IPR2015-00903 (Patent 8,129,431 B2)
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`have not been published or otherwise made public. Petitioner does not oppose this
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`motion.
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`II. Governing Rules and PTAB Guidance
`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 but a party may
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`file a concurrent motion to seal and the information at issue is sealed pending the
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`outcome of the motion.
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`Similarly, 37 C.F.R. § 42.14 provides:
`
`The record of a proceeding, including documents and
`things, shall be made available to the public, except as
`otherwise ordered. A party intending a document or thing
`to be sealed shall file a motion to seal concurrent with the
`filing of the document or thing to be sealed. The
`document or thing shall be provisionally sealed on
`receipt of the motion and remain so pending the outcome
`of the decision on the motion.
`
`It is, however, only “confidential information” that is protected from disclosure. 35
`
`U.S.C. § 316(a)(7)(“The Director shall prescribe regulations -- . . . providing for
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`protective orders governing the exchange and submission of confidential
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`information”). In that regard, the Office Trial Practice Guide, 77 Fed. Reg. 48756,
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`48760 (Aug. 14, 2012) provides:
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`2
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`IPR2015-00903 (Patent 8,129,431 B2)
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`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.
`
`* * *
`
`Confidential Information: The rules identify confidential
`information in a manner consistent with Federal Rule of
`Civil Procedure 26(c)(1)(G), which provides for
`protective orders for trade secret or other confidential
`research, development, or commercial information.
`§ 42.54.
`
`The standard for granting a motion to seal is “for good cause,” 37 C.F.R.
`
`§ 42.54, and the moving party has the burden of proof in showing entitlement to
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`the requested relief, 37 C.F.R. § 42.20(c).
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`A motion to seal is also required to include a proposed protective order and a
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`certification that the moving party has in good faith conferred or attempted to
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`confer with the opposing party in an effort to come to an agreement as to the scope
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`of the proposed protective order for this inter partes review. 37 C.F.R. § 42.54.
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`III. Background and Identification of Confidential Information
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`As discussed with the Board on November 17, 2015, this IPR is related to
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`nine other IPR proceedings, specifically, IPR2015-00902, IPR2016-00089,
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`IPR2016-00090, and IPR2016-00091 (filed by Petitioner InnoPharma Licensing,
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`3
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`IPR2015-00903 (Patent 8,129,431 B2)
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`Inc. et al.) and IPR2015-01871, IPR2015-01099, IPR2015-01097, IPR2015-01100,
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`and IPR2015-01105 (filed by Petitioner Lupin Ltd. et al.) (“Related IPR
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`Proceedings”). Collectively, these ten proceedings involve five patents (U.S.
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`Patent Nos. 8,669,290; 8,129,431; 8,754,131; 8,927,606; and 8,871,813)
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`(collectively, the “Patents-at-Issue”), which all share the same specification and are
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`owned by Patent Owner. There are also four pending Motions for Joinder to join
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`four pairs of petitions involving the same Patent-at-Issue.
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`
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`Thus, while the Board has yet to rule on these Motions for Joinder, the
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`parties (including Lupin) have crafted the Proposed Stipulated Protective Order
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`contemplating that this proceeding (IPR2015-00903) and Lupin’s petition in
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`IPR2015-01871 may be joined. If joined, then there are certain exhibits (see, e.g.,
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`Ex. 2109) containing confidential information belonging to one petitioner that
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`Petitioners InnoPharma and Lupin would like to keep confidential from the other
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`petitioner. To accomplish this goal, Patent Owner is filing these Exhibits as
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`“PROTECTIVE ORDER MATERIAL - BOARD’S EYES ONLY” under the
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`Proposed Stipulated Protective Order.
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`
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`In addition, in support of their respective petitions in the Related IPR
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`Proceedings, Petitioner InnoPharma has relied on the opinions of Dr. Laskar and
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`Petitioner Lupin has relied on the opinions of Dr. Jayne Lawrence. Although their
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`declarations are not identical, Drs. Laskar and Lawrence rely on the same
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`IPR2015-00903 (Patent 8,129,431 B2)
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`references to support their opinions regarding the validity of the Patents-at-Issue.
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`Because the petitions are proceeding on various timelines, Senju has already cross
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`examined Dr. Laskar in some of these petitions (see e.g., IPR2015-00902,
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`IPR2015-00903), but has not yet cross examined Dr. Lawrence in related petitions
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`(see, e.g., IPR2015-01099, IPR2015-01097). As explained herein, under Federal
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`Rule of Evidence 615, Patent Owner requests that the transcript of testimony of Dr.
`
`Laskar be sealed from Dr. Lawrence until the cross examination on Petitioner
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`Lupin’s petitions has concluded. To that end, the parties have crafted the Proposed
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`Stipulated Protective Order contemplating that the transcript of testimony of an
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`expert may be sealed for a limited period of time under FRE 615. To do so, Patent
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`Owner is filing the Laskar Transcript, Ex. 2114, as “PROTECTIVE ORDER
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`MATERIAL - FED R. EVID 615” under the Proposed Stipulated Protective Order.
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`
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`Moreover, in support of its Response, Patent Owner’s expert Dr. John Jarosz
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`relies on two confidential, proprietary presentations from Patent Owner (Exs. 2220
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`and 2226) related to Patent Owner’s research and development of the patented
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`formulation. To protect the information contained in these presentations, Patent
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`Owner is filing these exhibits as “PROTECTIVE ORDER MATERIAL” under the
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`Proposed Stipulated Protective Order.
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`
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`Finally, Patent Owner and Petitioner InnoPharma are also currently litigating
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`the patent-at-issue in this IPR before the United States District Court for the
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`IPR2015-00903 (Patent 8,129,431 B2)
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`District of New Jersey in Senju Pharmaceutical Co., Ltd., Bausch & Lomb, Inc.,
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`and Bausch & Lomb Pharma Holdings Corp. v. InnoPharma Licensing, Inc.,
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`InnoPharma Licensing, LLC, InnoPharma, Inc., and InnoPharma, LLC, C.A. No.
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`1:14-cv-06893-JBS-KMW (D.N.J. filed Nov. 3, 2014) (hereinafter “the
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`Litigation”). The Court has entered a Stipulated Discovery Confidentiality Order in
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`the Litigation, and Patent Owner and InnoPharma have exchanged certain
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`confidential discovery under that Order.
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`IV. Good Cause Exists for Sealing Certain Confidential Information
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`As noted above, Patent Owner requests that three categories of exhibits and
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`portions of its Response and supporting declarations citing or substantially
`
`describing those exhibits be sealed. As explained herein, good cause exists for
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`sealing each category of information.
`
`A.
`
`Patent Owner’s New Drug Application (“NDA”) and Petitioner
`InnoPharma’s Abbreviated New Drug Application (“ANDA”) and
`Related Portions of Patent Owner’s Response, and the Williams,
`Trattler, and Jarosz Declarations Should Be Sealed
`Patent Owner requests that certain excerpts from Patent Owner’s NDA (Exs.
`
`
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`2096, 2102, 2103, and 2110) and Petitioner’s ANDA (Ex. 2109) be sealed in their
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`entirety, and portions of Patent Owner’s Response (Paper 34), specifically pages 3,
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`55-57, and 59, the Declaration of Patent Owner’s expert Dr. Robert O. Williams
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`(Ex. 2082), specifically paragraph nos. 152, 153, 177, 178, 180, 181, 186, and 187,
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`the Declaration of Patent Owner’s expert Dr. William Trattler (Ex. 2116),
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`IPR2015-00903 (Patent 8,129,431 B2)
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`specifically paragraph nos. 16, 41, and 49, and the Declaration of Patent Owner’s
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`expert Dr. Jarosz (Ex. 2130), specifically paragraph nos. 17, 56, 82, and 134,
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`which cite or substantially describe the excerpts from the NDA and ANDA be
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`sealed under 37 C.F.R. § 42.14. Based on Patent Owner’s representations about
`
`these documents, Petitioner does not oppose sealing these Exhibits and related
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`materials.
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`1.
`
`The NDA and ANDA Contain Highly Sensitive,
`Confidential Information to Their Respective Owners
`The information Patent Owner seeks to seal has not been made public by
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`
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`either party or by the Food and Drug Administration (“FDA”), and is not otherwise
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`available to the public. Patent Owner’s NDA was filed confidentially with the
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`FDA in order to obtain FDA approval to market its innovative pharmaceutical
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`product. Likewise, InnoPharma’s ANDA was filed confidentially with the FDA in
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`order to obtain FDA approval to market its generic pharmaceutical product.
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`The information Patent Owner seeks to seal contains each parties’ highly sensitive,
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`confidential development information and technical, business information.
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`Petitioner InnoPharma’s product has not yet been marketed and remains
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`confidential. If Petitioner’s confidential information is made public, Petitioner’s
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`competitors could exploit the Petitioner’s confidential information and gain an
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`unfair competitive advantage over Petitioner. The Exhibits listed above are only
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`excerpts of the much larger NDA and ANDA and redaction would not be practical;
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`7
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`IPR2015-00903 (Patent 8,129,431 B2)
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`therefore, Patent Owner requests that these Exs. 2096, 2102, 2103, 2109, and 2110
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`be sealed in their entirety.
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`
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`Moreover, Patent Owner’s Response and the Williams declaration (Ex.
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`2082) describe the confidential information contained in the NDA and ANDA in
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`connection with secondary considerations of non-obviousness. Patent Owner
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`relies on limited excerpts of its own NDA in part to establish Patent Owner’s
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`commercial success. In addition, Patent Owner relies on a limited excerpt of
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`Petitioner’s ANDA in part to establish Petitioner’s copying. Accordingly, Patent
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`Owner requests that these portions of the Patent Owner’s Response and the
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`Williams declaration be sealed.
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`2. Good Cause Exists to Seal the NDA and ANDA Exhibits as
`“BOARD’S EYES ONLY” Under the Proposed Stipulated
`Protective Order
`The Board’s rules identify confidential information in a manner consistent
`
`with Federal Rule of Civil Procedure 26(c)(1)(G), which provides for protective
`
`orders for trade secret or other confidential research, development, or commercial
`
`information. Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,760 (Aug.
`
`14, 2012). Accordingly, the Board has recognized that New Drug Applications
`
`(“NDA”) and Abbreviated New Drug Applications (“ANDA”) contain confidential
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`commercial information that should be protected from public disclosure. See
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`Sandoz, Inc. v. EKR Therapeutics, LLC, IPR2015-00005, paper 21. In sum, here,
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`IPR2015-00903 (Patent 8,129,431 B2)
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`the public’s interest in the instant proceeding does not outweigh the parties’
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`interest in protecting their sensitive business information.
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`Because public disclosure of the contents of these documents, or
`
`descriptions of those contents, would disclose confidential business terms in a
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`highly competitive market, even to potential co-Petitioner Lupin in the Related IPR
`
`Proceedings, Patent Owner requests that Exhibits 2096, 2102, 2103, 2110, and
`
`2109 and the portions of Patent Owner’s Response and the Williams, Trattler, and
`
`Jarosz declarations that cite or substantially describe the NDA and ANDA exhibits
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`be sealed, as “PROTECTIVE ORDER MATERIAL - BOARD’S EYES ONLY”,
`
`for the duration of this proceeding.
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`B.
`
`Patent Owner’s Confidential Presentations Related to its
`Research and Development and Related Jarosz Declaration and
`Pleadings Should Be Sealed
`For similar reasons, Patent Owner requests that its confidential presentations
`
`
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`(Exs. 2220 and 2226), related to Patent Owner’s commercial embodiment of the
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`patent at issue and the portions of the Declaration of Patent Owner’s expert Dr.
`
`John Jarosz (Ex. 2130), specifically paragraph nos. 44, 45 (at note 5), 47, 56, 82,
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`95, 96 and 97, citing these presentations be sealed under 37 C.F.R. § 42.14. These
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`presentations contain Patent Owner’s proprietary information related to Patent
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`Owner’s methods of conducting confidential discussion groups related to its
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`commercial embodiment of the Patents-at-Issue. Patent Owner and Dr. Jarosz rely
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`9
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`IPR2015-00903 (Patent 8,129,431 B2)
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`on these presentations to show Patent Owner’s commercial success. Petitioner
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`does not oppose sealing these Exhibits and related materials.
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`The Board’s rules provide for the protection of trade secret or other
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`confidential commercial information. See 77 Fed. Reg. at 48,760. Here, the
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`public’s interest in the instant proceeding does not outweigh the parties’ interest in
`
`protecting this limited sensitive business information.
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`Because public disclosure of the contents of these document, or descriptions
`
`of those contents, would disclose confidential business methods, Patent Owner
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`requests that Exhibits 2220 and 2226 and the portions of Patent Owner’s Response
`
`and the Jarosz declaration (Ex. 2130) that cite or substantially describe these
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`confidential presentation exhibits be sealed, as “PROTECTIVE ORDER
`
`MATERIAL”, for the duration of this proceeding.
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`C. Under the Rule on Witnesses, Transcript of Petitioner
`InnoPharma’s Expert Should Be Sealed Until Petitioner Lupin’s
`Expert Has Concluded Her Testimony in the Related IPR
`Proceedings
`Patent Owner further requests that the transcript of Dr. Paul A. Laskar’s
`
`
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`testimony (Ex. 2114) be sealed in its entirety under Federal Rule of Evidence 615
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`(“FRE”) (Excluding Witnesses) until such time as the cross examination of
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`Petitioner Lupin’s expert Dr. Lawrence in connection with Lupin’s petition in the
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`Related IPR Proceedings has been concluded. Dr. Lawrence has not yet been cross
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`examined in those related proceedings, but has relied on the same references as Dr.
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`10
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`IPR2015-00903 (Patent 8,129,431 B2)
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`Laskar in rendering her opinions regarding validity of the patent at issue.
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`Petitioner does not oppose sealing this Exhibit and materials that cite to or
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`substantially describe this Exhibit.
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`The Federal Rules of Evidence (“FRE”) generally apply to inter partes
`
`reviews. See 37 C.F.R. § 42.62(a). Under FRE 615, “[a]t a party’s request, the
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`court must order witnesses excluded so that they cannot hear other witnesses’
`
`testimony.” The U.S. Supreme Court has long-recognized the goal of sequestering
`
`witnesses, known as the “rule on witnesses,” is two-fold. Geders v. United States,
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`425 U.S. 80, 87 (1976). First, the rule “exercises a restraint on witnesses
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`‘tailoring’ their testimony to that of earlier witnesses.” Id. Second, the rules “aids
`
`in detecting testimony that is less than candid.” Id. (internal citation omitted). For
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`the same reasons, given the similarity of their positions on validity of the patent at
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`issue, good cause exists to seal the testimony of Dr. Laskar for a limited time, until
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`Dr. Lawrence has been cross-examined in connection with Lupin’s petition on the
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`patent at issue. Once expert testimony has been completed, then the transcripts of
`
`both experts can be unsealed and made public.
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`
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`Similarly, Patent Owner requests that portions of Patent Owner’s Response
`
`(Paper 33, specifically pages 8-15, 17-18, 22, 23, 25, 29, 32, 35, 36, 39, 43, 52, 55,
`
`and 57), the declarations of Patent Owner’s experts Dr. Williams (Ex. 2082,
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`specifically paragraph nos. 46, 51, 53, 55, 56, 60, 62-65, 69-71, 77, 81, 84-85, 88-
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`11
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`IPR2015-00903 (Patent 8,129,431 B2)
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`90, 95, 98-99, 104, 107, 108, 113, 116, 124, 125, 128, 129, 132, 135, 136, 140,
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`142, 147, 153, 156, 165, 168, 178, and 182-184), Dr. Stephen Davies (Exs. 2105,
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`specifically paragraphs nos. 37, 38, 47, 48, 57, 66, 71, 72, 74, 76-79, 87, 90, 96 (at
`
`note 3), and 97), and Dr. Trattler (Ex. 2216, specifically paragraph no. 40), citing
`
`or substantially describing Dr. Laskar’s testimony be likewise sealed for the same
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`duration. Patent Owner has provided redacted versions of the Patent Owner’s
`
`Response and the related declarations to be publicly available in the meantime.
`
`Because public disclosure of the contents of the Laskar testimony, or
`
`descriptions of those contents, would risk the harms described by the Supreme
`
`Court in Gedars, Patent Owner requests that the testimony of Dr. Laskar (Ex.
`
`2114) be sealed in its entirety and the portions of Patent Owner’s Response (Paper
`
`33) and the Williams, Trattler, and Davies declarations (Exs. 2082, 2216, 2105,
`
`portions noted specifically above) that cite or substantially describe Dr. Laskar’s
`
`testimony be sealed, under Federal Rule of Evidence 615, as “PROTECTIVE
`
`ORDER MATERIAL - FED R. EVID 615” until such time as Dr. Lawrence’s
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`testimony in the Related Proceedings has concluded.
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`V.
`
`Proposed Stipulated Protective Order
`The parties have agreed to the terms of the Proposed Stipulated Protective
`
`Order as described above and as located in attached Appendix A. In accordance
`
`with the terms of the Proposed Stipulated Protective Order, confidential versions
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`12
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`IPR2015-00903 (Patent 8,129,431 B2)
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`(marked “PROTECTIVE ORDER MATERIAL - BOARD’S EYES ONLY”,
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`“PROTECTIVE ORDER MATERIAL - FED R. EVID 615”, or “PROTECTIVE
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`ORDER MATERIAL” as appropriate), and non-confidential versions of the
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`documents have been filed.
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`VI. Conclusion
`For the reasons set forth above, Patent Owner respectfully requests that the
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`Board grant this motion to seal.
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`Date: December 28, 2015
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`
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`
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`Respectfully submitted,
`
`
`
`
`By: /Bryan C. Diner/
`Bryan C. Diner, Lead Counsel
`Reg. No. 32,409
`Justin J. Hasford, Back-up Counsel
`Reg. No. 62,180
`Joshua L. Goldberg, Back-up Counsel
`Reg. No. 59,369
`Finnegan, Henderson, Farabow,
`Garrett
` & Dunner, L.L.P.
`901 New York Ave. NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`Counsel for Patent Owner
`
`
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`13
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`IPR2015-00903 (Patent 8,129,431 B2)
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`APPENDIX A
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`IPR2015-00902 (Patent 8,669,290 B2)
`IPR2015-00903 (Patent 8,129,431 B2)
` Paper No. __
`Filed: December 28, 2015
`
`
`
`
`
`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., and MYLAN INC.
`Petitioners,
`
`v.
`
`SENJU PHARMACEUTICAL CO., LTD.
`Patent Owner.
`__________________
`Case IPR2015-00902 (Patent 8,669,290 B2)
`Case IPR2015-00903 (Patent 8,129,431 B2)1
`__________________
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`PROPOSED STIPULATED PROTECTIVE ORDER
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`1 The word-for-word identical paper is filed in each proceeding identified in the
`heading.
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`1
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`IPR2015-00902 (Patent 8,669,290 B2)
`IPR2015-00903 (Patent 8,129,431 B2)
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`This joint protective order governs the treatment and filing of confidential
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`information, including documents and testimony.2
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`1. Marking of Confidential Information. Confidential information shall be
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`clearly marked as either “PROTECTIVE ORDER MATERIAL - BOARD’S EYES
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`ONLY” or “PROTECTIVE ORDER MATERIAL - FED R. EVID 615” or
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`“PROTECTIVE ORDER MATERIAL”.
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`2.
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`Persons Having Access to Confidential Information Marked
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`“PROTECTIVE ORDER MATERIAL - BOARD’S EYES ONLY”. For the
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`confidential information marked “PROTECTIVE ORDER MATERIAL -
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`BOARD’S EYES ONLY”, access to confidential information is limited to the
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`Employees and representatives of the Office who have a need for access to the
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`confidential information. Such employees and representatives shall have such
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`access without the requirement to sign an Acknowledgement. Such employees and
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`representatives shall include the Director, members of the Board and their clerical
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`staff, other support personnel, court reporters, and other persons acting on behalf of
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`the Office.
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`3.
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`Persons Having Access to Confidential Information Marked
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`“PROTECTIVE ORDER MATERIAL - FED R. EVID 615”. For the
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`2 Nothing in this Order prevents any Party from challenging a confidentiality
`designation to any Exhibit by raising the matter with the Board.
`2
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`IPR2015-00902 (Patent 8,669,290 B2)
`IPR2015-00903 (Patent 8,129,431 B2)
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`confidential information marked, “PROTECTIVE ORDER MATERIAL - FED R.
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`EVID 615”, access to confidential information about one expert’s deposition
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`testimony is limited to the following individuals who have executed the
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`acknowledgment appended to this order and shall not be disclosed to any other
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`expert in any Related Proceeding3 (unless the information is already known to that
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`expert) until after such time as the Board has lifted the Rule on Witnesses under
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`Fed. R. Evid. 615, and then only upon the formal request of any Party to the Board,
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`or upon a joint request by the Parties to the Board’s administrative staff to do so
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`without raising the matter with the Board:4
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`(A) Parties. Persons who are owners of a patent involved in the
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`proceeding and other persons who are identified as a real party-in-interest in
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`any Related Proceeding.
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`(B) Outside Counsel. Outside counsel of record for a party in any Related
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`Proceeding.
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`3 Related Proceeding is defined as “any other IPR proceeding or district court
`proceeding involving the patent at issue, the patent owners, and any one of
`Petitioners InnoPharma Licensing, Inc., InnoPharma Licensing LLC, InnoPharma
`Inc., InnoPharma LLC, Mylan Pharmaceuticals Inc., Mylan Inc., Lupin, Ltd., or
`Lupin Pharmaceuticals, Inc.”).
`4 Upon termination of the “PROTECTIVE ORDER MATERIAL - FED R. EVID
`615” designation, any party may, in good faith, request that the Information be re-
`designated to “PROTECTIVE ORDER MATERIAL.”
`3
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`
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`IPR2015-00902 (Patent 8,669,290 B2)
`IPR2015-00903 (Patent 8,129,431 B2)
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`(C)
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`In-house counsel. In-house counsel of a party or in-house counsel of a
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`real party-in-interest.
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`(D) Other Employees of a Party. Employees, other than in-house counsel
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`and in-house counsel’s support staff, who sign the Acknowledgement shall
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`be extended access to confidential information only upon agreement of the
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`parties or by order of the Board upon a motion brought by the party seeking
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`to disclose confidential information to that person. The party opposing
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`disclosure to that person shall have the burden of proving that such person
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`should be restricted from access to confidential information.
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`(E) The Office. Employees and representatives of the Office who have a
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`need for access to the confidential information shall have such access
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`without the requirement to sign an Acknowledgement. Such employees and
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`representatives shall include the Director, members of the Board and their
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`clerical staff, other support personnel, court reporters, and other persons
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`acting on behalf of the Office.
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`(F) Support Personnel. Administrative assistants, clerical staff, court
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`reporters and other support personnel of the foregoing persons who are
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`reasonably necessary to assist those persons in the proceeding shall not be
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`required to sign an Acknowledgement, but shall be informed of the terms
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`4
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`IPR2015-00902 (Patent 8,669,290 B2)
`IPR2015-00903 (Patent 8,129,431 B2)
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`and requirements of the Protective Order by the person they are supporting
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`who receives confidential information.
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`4.
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`Persons Having Access to Confidential Information Marked
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`“PROTECTIVE ORDER MATERIAL”. For the confidential information
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`marked, “PROTECTIVE ORDER MATERIAL”, access to confidential
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`information is limited to the following individuals who have executed the
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`acknowledgment appended to this order:
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`(A) Parties. Persons who are owners of a patent involved in the
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`proceeding and other persons who are identified as a real party-in-interest in
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`any Related Proceeding.
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`(B) Outside Counsel. Outside counsel of record for a party in any Related
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`Proceeding.
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`(C) Experts. Retained experts of a party in any Related Proceeding who
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`sign the Acknowledgement.
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`(D)
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`In-house counsel of a party or in-house counsel of a real party-in-
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`interest.
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`(E) Other Employees of a Party. Employees, consultants or other persons
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`performing work for a party, other than in-house counsel and in-house
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`counsel’s support staff, who sign the Acknowledgement shall be extended
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`access to confidential information only upon agreement of the parties or by
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`5
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`
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`IPR2015-00902 (Patent 8,669,290 B2)
`IPR2015-00903 (Patent 8,129,431 B2)
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`order of the Board upon a motion brought by the party seeking to disclose
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`confidential information to that person. The party opposing disclosure to that
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`person shall have the burden of proving that such person should be restricted
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`from access to confidential information.
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`(F) The Office. Employees and representatives of the Office who have a
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`need for access to the confidential information shall have such access
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`without the requirement to sign an Acknowledgement. Such employees and
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`representatives shall include the Director, members of the Board and their
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`clerical staff, other support personnel, court reporters, and other persons
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`acting on behalf of the Office.
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`(G) Support Personnel. Administrative assistants, clerical staff, court
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`reporters and other support personnel of the foregoing persons who are
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`reasonably necessary to assist those persons in the proceeding shall not be
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`required to sign an Acknowledgement, but shall be informed of the terms
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`and requirements of the Protective Order by the person they are supporting
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`who receives confidential information.
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`5. Maintaining Confidentiality. Persons receiving confidential information
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`shall use reasonable efforts to maintain the confidentiality of the information,
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`including:
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`6
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`
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`IPR2015-00902 (Patent 8,669,290 B2)
`IPR2015-00903 (Patent 8,129,431 B2)
`
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`(A) Maintaining such information in a secure location to which persons
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`not authorized to receive the information shall not have access;
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`(B) Otherwise using reasonable efforts to maintain the confidentiality of
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`the information, which efforts shall be no less rigorous than those the
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`recipient uses to maintain the confidentiality of information not received
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`from the disclosing party;
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`(C) Ensuring that support personnel of the recipient who have access to
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`the confidential information understand and abide by the obligation to
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`maintain the confidentiality of information received that is designated as
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`confidential; and
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`(D) Limiting the copying of confidential information to a reasonable
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`number of copies needed for conduct of the proceeding and maintaining a
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`record of the locations of such copies.
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`6.
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`Filing and Exchange of Confidential Materials. Persons receiving
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`confidential information shall use the following procedures to maintain the
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`confidentiality of the information:
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`(A) Documents and Information Filed With the Board.
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`(i) A party may file documents or information with the Board under
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`seal, together with a non-confidential description of the nature of the
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`confidential information that is under seal and the reasons why the
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`7
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`
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`IPR2015-00902 (Patent 8,669,290 B2)
`IPR2015-00903 (Patent 8,129,431 B2)
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`information is confidential and should not be made available to the
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`public. The submission shall be treated as confidential and remain
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`under seal, unless, upon motion of a party and after a hearing on t
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