Paper No. __
`Filed: March 31, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
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`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., and MYLAN INC.,
`Petitioners,
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`v.
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`SENJU PHARMACEUTICAL CO., LTD.
`Patent Owner.
`__________________
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`Case IPR2015-00902 (Patent 8,669,290 B2)
`__________________
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`PATENT OWNER’S MOTION TO SEAL
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`Filed: March 31, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
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`INNOPHARMA LICENSING, INC., INNOPHARMA LICENSING LLC,
`INNOPHARMA INC., INNOPHARMA LLC,
`MYLAN PHARMACEUTICALS INC., and MYLAN INC.,
`Petitioners,
`
`v.
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`SENJU PHARMACEUTICAL CO., LTD.
`Patent Owner.
`__________________
`
`Case IPR2015-00902 (Patent 8,669,290 B2)
`__________________
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`PATENT OWNER’S MOTION TO SEAL
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`Case IPR2015-00902 (Patent 8,669,290 B2)
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`TABLE OF CONTENTS
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`Introduction ...................................................................................................... 1
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`Governing Rules and PTAB Guidance ............................................................ 1
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`I.
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`II.
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`III. Background and Identification of Confidential Information ........................... 3
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`IV. Good Cause Exists for Sealing Certain Confidential Information .................. 5
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`A.
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`B.
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`Patent Owner’s Confidential Information Contained in the
`Testimony of Mr. Hofmann Should Be Sealed ..................................... 5
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`Under the Rule on Witnesses, Transcript of Petitioner
`InnoPharma’s Experts Should Be Sealed Until Petitioner
`Lupin’s Expert Has Concluded Her Testimony in the Related
`IPR Proceedings .................................................................................... 7
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`V.
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`Conclusion ....................................................................................................... 9
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`Case IPR2015-00902 (Patent 8,669,290 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) ................................................................................................ 7
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`BOARD DECISIONS
`Sandoz, Inc. v. EKR Therapeutics, LLC,
`IPR2015-00005, Paper 21 .................................................................................... 6
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`
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`FEDERAL STATUTES
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`35 U.S.C. § 316 ...................................................................................................... 1, 2
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`FEDERAL REGULATIONS
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`37 C.F.R. § 42.14 ...................................................................................................... 2
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`37 C.F.R. § 42.20 ...................................................................................................... 3
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`37 C.F.R. § 42.54 .................................................................................................. 1, 3
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`37 C.F.R. § 42.62 ...................................................................................................... 7
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`Office Patent Trial Practice Guide,
`77 Fed. Reg. 48756 (Aug. 14, 2012) .................................................................... 2
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`ii
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`Case IPR2015-00902 (Patent 8,669,290 B2)
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`Introduction
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`Through this Motion to Seal, Patent Owner requests that two categories of
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`I.
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`exhibits be sealed: (1) Patent Owner’s confidential information from Patent
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`Owner’s New Drug Application (“NDA”) (EX2273); (2) the transcript of
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`testimony of Petitioner InnoPharma’s experts, Dr. Paul Laskar (EX2272) and Mr.
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`Ivan Hofmann (EX2273). In addition, Patent Owner also requests that the
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`confidential version of Patent Owner’s Motion for Observation Regarding Cross-
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`Examination of Reply Witnesses Dr. Paul A. Laskar, Ph.D., and Ivan T. Hofmann,
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`CPA/CFF, CLP (“Observations”) (Paper 64 (FED. R. EVID. 615 version to be
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`made public once FED. R. EVID. 615 has been lifted, as explained herein)) citing
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`or substantially describing the second category of documents be sealed. Finally,
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`under 37 C.F.R. § 42.54, Patent Owner renews its request for entry of the Proposed
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`Stipulated Protective Order, Paper 36, filed on December 28, 2015. To the best of
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`Patent Owner’s knowledge, the Patent Owner certifies that the information
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`identified as confidential in this motion have not been published or otherwise made
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`public. Petitioner does not oppose this 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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`Case IPR2015-00902 (Patent 8,669,290 B2)
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`outcome of the motion.
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`Similarly, 37 C.F.R. § 42.14 provides:
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`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.
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`It is, however, only “confidential information” that is protected from disclosure. 35
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`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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`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.
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`* * *
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`Confidential Information: The rules identify confidential
`information in a manner consistent with Federal Rule of
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`Civil Procedure 26(c)(1)(G), which provides for
`protective orders for trade secret or other confidential
`research, development, or commercial information.
`§ 42.54.
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`The standard for granting a motion to seal is “for good cause,” 37 C.F.R.
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`§ 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, IPR2015-00903, IPR2016-00089,
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`IPR2016-00090, and IPR2016-00091 (filed by Petitioner InnoPharma Licensing,
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`Inc. et al.), and IPR2015-01871, IPR2015-010967, IPR2015-01099, IPR2015-
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`01100, and IPR2015-1105 (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. On January 25, 2016, the Board granted institution in
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`IPR2015-01871 and joined that proceeding to IPR2015-00903, both involving
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`Case IPR2015-00902 (Patent 8,669,290 B2)
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`the ’431 patent. IPR2015-01871, Paper 13. On February 25, 2016, the Board: (1)
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`granted institution in IPR2016-00089 and joined that proceeding to IPR2015-
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`01097, both involving the ’131 patent, see IPR2016-0089, Paper 22; (2) granted
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`institution in IPR2016-00090 and joined that proceeding to IPR2015-01105, both
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`involving the ’813 patent, see IPR2016-0090, Paper 13; and (3) granted institution
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`in IPR2016-00091 and joined that proceeding to IPR2015-01100, both involving
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`the ’606 patent, see IPR2016-0089, Paper 14.
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`In anticipation of the Board’s possible joinder order, the parties (including
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`Lupin) have crafted the Proposed Stipulated Protective Order (filed December 28,
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`2015) contemplating that this proceeding (IPR2015-00903) and Lupin’s petition in
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`IPR2015-01871 may be joined.
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`In support of their respective petitions in the Related IPR Proceedings,
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`Petitioner InnoPharma has relied on the opinions of Dr. Laskar and Petitioner
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`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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`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 twice in some of these petitions (see e.g., IPR2015-00902,
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`IPR2015-00903), but has only cross examined Dr. Lawrence once in related
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`petitions (see, e.g., IPR2015-01099, IPR2015-01097) and expects to cross examine
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`Dr. Lawrence again in connection with any reply declaration that she executes. As
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`explained herein, under Federal Rule of Evidence 615, Patent Owner requests that
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`the transcripts of testimony of Dr. Laskar and Mr. Hofmann be sealed from Dr.
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`Lawrence and other potential reply witnesses that Petitioner Lupin may offer until
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`the cross examination on Petitioner Lupin’s petitions has concluded. To that end,
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`the parties have crafted the Proposed Stipulated Protective Order contemplating
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`that the transcript of testimony of an expert may be sealed for a limited period of
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`time under FRE 615. To do so, Patent Owner is filing the Laskar Transcript, Ex.
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`2272, and the Hofmann Transcript, Ex. 2273, as “PROTECTIVE ORDER
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`MATERIAL - FED R. EVID 615” under the Proposed Stipulated Protective 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 two exhibits and the Patent
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`Owner’s Observations which citing or substantially describing those exhibits be
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`sealed. As explained herein, good cause exists for sealing this information.
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`A.
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`Patent Owner’s Confidential Information Contained in the
`Testimony of Mr. Hofmann Should Be Sealed
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`Patent Owner requests that several excerpts from the cross-examination
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`transcript (EX 2273) of Mr. Hofmann be sealed (24:21-25:4; 33:8-9; 33:19-21;
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`34:3-4; 36:2-3; 37:6; 37:22-38:1; 38:3-4; 38:19-20; 39:13-14; 48:21-22; 52:11-12).
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`In this testimony, Mr. Hofmann discloses Patent Owner’s highly sensitive,
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`confidential, technical information. This confidential information has not been
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`Case IPR2015-00902 (Patent 8,669,290 B2)
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`made public by either party or by the Food and Drug Administration (“FDA”), and
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`is not otherwise available to the public. This information was filed as part of
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`Patent Owner’s NDA that was filed confidentially with the FDA in order to obtain
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`FDA approval to market its innovative pharmaceutical product. Accordingly,
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`Patent Owner requests that this discrete portion of Mr. Hofmann’s transcript be
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`sealed.
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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. 48,756, 48,760 (Aug.
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`14, 2012). Accordingly, the Board has recognized that New Drug Applications
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`(“NDA”) contain confidential commercial information that should be protected
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`from public disclosure. See Sandoz, Inc. v. EKR Therapeutics, LLC, IPR2015-
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`00005, paper 21. In sum, here, the public’s interest in the instant proceeding does
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`not outweigh the parties’ interest in protecting their sensitive business information.
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`Because public disclosure of the contents of these documents, or
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`descriptions of those contents, would disclose confidential business terms in a
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`highly competitive market, Patent Owner requests that portions of Exhibit 2273 be
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`sealed, as “PROTECTIVE ORDER MATERIAL - BOARD’S EYES ONLY”, for
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`Case IPR2015-00902 (Patent 8,669,290 B2)
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`the duration of this proceeding.
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`B. Under the Rule on Witnesses, Transcript of Petitioner
`InnoPharma’s Experts Should Be Sealed Until Petitioner Lupin’s
`Expert Has Concluded Her Testimony in the Related IPR
`Proceedings
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`Patent Owner further requests that the transcript of Dr. Paul A. Laskar’s
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`testimony (Ex. 2272) and the transcript of Ivan T. Hofmann’s testimony (Ex. 2273)
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`be sealed in entirety under Federal Rule of Evidence 615 (“FRE”) (Excluding
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`Witnesses) until such time as the cross examination of Petitioner Lupin’s expert Dr.
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`Lawrence in connection with Lupin’s petition in the Related IPR Proceedings, as
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`well as any other reply witness offered by Lupin, has been concluded. Dr.
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`Lawrence has not yet been cross examined in those related proceedings, but has
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`relied on the same references as Dr. Laskar in rendering her opinions regarding
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`validity of the patent at issue. Petitioner does not oppose sealing these Exhibits
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`and materials that cite to or substantially describe these Exhibits.
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`The Federal Rules of Evidence (“FRE”) generally apply to inter partes
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`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’
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`testimony.” The U.S. Supreme Court has long-recognized the goal of sequestering
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`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
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`Case IPR2015-00902 (Patent 8,669,290 B2)
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`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 and Mr. Hofmann for a
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`limited time, until Dr. Lawrence has been cross-examined in connection with
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`Lupin’s petition on the patent at issue. Once expert testimony has been completed,
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`then the transcripts of both experts can be unsealed and made public.
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`Similarly, Patent Owner requests that Patent Owner’s Observations be
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`likewise sealed for the same duration, because they quote, cite or substantially
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`describe portions of Dr. Laskar’s and Mr. Hofmann’s testimony that should be
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`sealed under FRE 615. Patent Owner has not provided a redacted version of the
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`Observations, because of the extensive nature of the material to be filed under FRE
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`615 cited therein.
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`Because public disclosure of the contents of the Laskar or Hofmann
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`testimony, or descriptions of those contents, would risk the harms described by the
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`Supreme Court in Gedars, Patent Owner requests that the testimony of Dr. Laskar
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`(EX2272), Mr. Hofmann (EX2273), and the Observations (Paper 64) be sealed in
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`their entirety, under Federal Rule of Evidence 615, as “PROTECTIVE ORDER
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`MATERIAL - FED R. EVID 615” until such time as Dr. Lawrence’s testimony in
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`the Related Proceedings has concluded.
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`Case IPR2015-00902 (Patent 8,669,290 B2)
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`V. 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: March 31, 2016
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`By:
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`Respectfully submitted,
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`
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`/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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`Case IPR2015-00902 (Patent 8,669,290 B2)
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Patent
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`Owner’s Motion to Seal was served on March 31, 2016, via email directed to
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`counsel of record for the Petitioner at the following:
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`Jitendra Malik
`jitty.malik@alston.com
`
`Bryan Skelton
`bryan.skelton@alston.com
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`Lance Soderstrom
`lance.soderstrom@alston.com
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`Hidetada James Abe
`james.abe@alston.com
`
`Joseph Janusz
`Joe.janusz@alston.com
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`
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`Date: March 31, 2016
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`
`
`/Bradley J. Moore/
`Bradley J. Moore
`Litigation Legal Assistant
`
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, LLP
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