Paper No. __
`Filed: July 29, 2016
`
`
`
`
`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., MYLAN INC., LUPIN LTD. and LUPIN PHARMACEUTICALS INC.,
`Petitioner
`v.
`
` SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner
`__________________
`
`Case IPR2015-00903 (Patent 8,129,431 B2) 1
`__________________
`
`RENEWED MOTION TO SEAL
`
`
`1 Case IPR2015-01871 has been joined with this proceeding.
`
`
`
`
`
`
`Filed: July 29, 2016
`
`
`
`
`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., MYLAN INC., LUPIN LTD. and LUPIN PHARMACEUTICALS INC.,
`Petitioner
`v.
`
` SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner
`__________________
`
`Case IPR2015-00903 (Patent 8,129,431 B2) 1
`__________________
`
`RENEWED MOTION TO SEAL
`
`
`1 Case IPR2015-01871 has been joined with this proceeding.
`
`
`
`
`
`
`
`
`
`
`
`I.
`
`II.
`
`TABLE OF CONTENTS
`
`Introduction ...................................................................................................... 1
`
`Procedural History ........................................................................................... 1
`
`III. Governing Rules and PTAB Guidance ............................................................ 3
`
`IV.
`
`Identification of Confidential Information ...................................................... 4
`
`V. Good Cause Exists for Sealing Certain Confidential Information .................. 5
`
`A.
`
`Patent Owner’s NDA and Related Portions of Patent Owner’s
`Response, the Williams, Trattler, and Jarosz Declarations and
`the Hoffman Transcript Should Be Sealed ............................................ 5
`
`1.
`
`2.
`
`The NDA Contains Patent Owner’s Highly Sensitive,
`Confidential Information ............................................................ 6
`
`Good Cause Exists to Seal the NDA Exhibits as
`“CONFIDENTIAL” Under the Proposed Stipulated
`Protective Order .......................................................................... 6
`
`VI. Conclusion ....................................................................................................... 8
`
`i
`
`
`
`
`
`
`
`
`
`
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`BOARD DECISIONS
`Sandoz, Inc. v. EKR Therapeutics, LLC,
`IPR2015-00005, Paper 21 .................................................................................... 7
`
`
`
`FEDERAL STATUTES
`
`35 U.S.C. § 316 .......................................................................................................... 3
`
`
`
`FEDERAL REGULATIONS
`
`37 C.F.R. § 42.14 .................................................................................................. 3, 5
`
`37 C.F.R. § 42.20 ...................................................................................................... 4
`
`37 C.F.R. § 42.54 ...................................................................................................... 4
`
`Office Patent Trial Practice Guide,
`77 Fed. Reg. 48756 (Aug. 14, 2012) ................................................................ 4, 7
`
`
`
`ii
`
`
`
`
`
`I.
`
`
`Introduction
`
`IPR2015-00903 (Patent 8,129,431 B2)
`
`
`Through this Renewed Motion to Seal, Patent Owner requests that the
`
`following exhibits be sealed: (1) excerpts of Patent Owner’s New Drug
`
`Application (“NDA”) (Exs. 2096, 2102, 2103, 2110). Patent Owner also requests
`
`that portions of its Patent Owner’s Response (Paper 34), expert declarations Exs.
`
`2082 (Williams), 2116 (Trattler), and 2130 (Jarosz), and the transcript of testimony
`
`Ex. 2273 (Hoffman) citing or substantially describing the above categories of
`
`documents be sealed. To the best of Patent Owner’s knowledge, the Patent Owner
`
`certifies that the information identified as confidential in this motion has not been
`
`published or otherwise made public. Petitioner Lupin does not oppose this motion.
`
`II.
`
`Procedural History
`
`Patent Owner has filed multiple Motions to Seal. On December 28, 2015,
`
`Patent Owner filed Motion to Seal and Motion to Enter Stipulated Protective Order
`
`(Paper 35), requesting that certain exhibits and pleadings be sealed, specifically:
`
`Exs. 2096, 2102, 2103, 2110 (related to Patent Owner’s NDA); Ex. 2086
`
`(Petitioner’s ANDA), Exs. 2220 and 2226 (Patent Owner’s presentations); Ex.
`
`2114 (transcript of expert testimony); portions of Patent Owner’s Response (Paper
`
`33); and Exs. 2082, 2105, 2116, 2130 (declarations of various experts citing or
`
`substantially describing the categories of documents sought to be sealed). On
`
`March 31, 2016 , Patent Owner filed a Motion to Seal (Paper 61) requesting that
`
`
`
`1
`
`
`
`
`
`transcripts of expert testimony (Ex. 2272 and 2273), Patent Owner’s Motion for
`
`IPR2015-00903 (Patent 8,129,431 B2)
`
`
`Observation Regarding Cross-Examination (Paper 58), be filed under seal.
`
`On June 21, 2016, the Board denied the parties request to enter the
`
`Stipulated Protective Order (Paper 77) and denied all pending requests to seal
`
`exhibits and pleadings without prejudice (Papers 77, 79). As noted in the Second
`
`Motion for Entry of Stipulated Protective Order (Paper 81) filed on July 25, 2016,
`
`the parties modified the previously Stipulated Protective Order as directed by the
`
`Board. Among other things, the parties removed the category of confidential
`
`information that may be marked as “PROTECTIVE ORDER MATERIAL-FED R.
`
`EVID 615” (Paper 77 at 3) because this category is no longer necessary now that
`
`discovery has been completed. Accordingly, in this Motion, Patent Owner will not
`
`be seeking to seal portions of Patent Owner’s Response (Paper 33), Petitioner’s
`
`Reply to Patent’s Owner’s Response to Petition (Ex. 2271), Patent Owner’s
`
`Motion for Observations (Paper 58) and of the declarations or testimony of Dr.
`
`Paul Lasker (Exs. 2114 and 2272), Ivan Hoffman (Ex. 2273), Robert O. Williams
`
`(Ex. 2082), and Stephen G. Davies (Ex. 2105) that were previously marked as
`
`Confidential under FRE 615. Patent Owner will be refiling these exhibits without
`
`the “PROTECTIVE ORDER MATERIAL-FED R. EVID 615” marking.
`
`As to the research and development presentations (Exs. 2220 and 2226), the
`
`Board noted that, in its view, the Patent Owner had “not identified what portions of
`
`
`
`2
`
`
`
`
`
`the Patent Owner’s Response contain the asserted confidential material.” (Paper
`
`IPR2015-00903 (Patent 8,129,431 B2)
`
`
`77 at 7.) Patent Owner did not request that any portions of the Patent Owner’s
`
`Response be sealed, because the information from Exs. 2220 and 2226 was not
`
`directly quoted in the Patent Owner’s Response. Nonetheless, Patent Owner’s
`
`Response relied on the testimony of Dr. Jarosz (Ex. 2130) regarding the benefits of
`
`the invention (Paper 33 at 59 (citing Ex. 2130 at ¶¶ 85, 135)) and Dr. Jarosz
`
`supported his testimony with citations to Patent Owner’s research and development
`
`presentations (see e.g., Ex. 2130 at ¶ 95 (citing Ex. 2220), Ex. 2130 at ¶¶ 82, 96
`
`(citing Ex. 2226)). Thus Patent Owner’s original request was not deficient in this
`
`regard. Upon further consideration, Patent Owner will not request that Exs. 2220
`
`or 2226 be sealed. Public versions of Exs. 2220 and 2226 will be filed.
`
`III. Governing Rules and PTAB Guidance
`Under 35 U.S.C. § 316(a)(1), the default rule is that all papers filed in an
`
`inter partes review are open and available for access by the public but a party may
`
`file a concurrent motion to seal and the information at issue is sealed pending the
`
`outcome of the motion. See also 37 C.F.R. § 42.14. 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 protective
`
`orders governing the exchange and submission of confidential information”). In
`
`
`
`3
`
`
`
`
`
`that regard, the Office Trial Practice Guide, 77 Fed. Reg. 48756, 48760 (Aug. 14,
`
`IPR2015-00903 (Patent 8,129,431 B2)
`
`
`2012) provides:
`
`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
`
`the requested relief, 37 C.F.R. § 42.20(c).
`
`IV.
`
`
`Identification of Confidential Information
`
` In this Second Motion to Seal, Patent Owner requests that excerpts of Patent
`
`Owner’s NDA (Exs. 2096, 2102, 2103, and 2110) be sealed as “PROTECTIVE
`
`ORDER MATERIAL” under the Stipulated Protective Order that the parties
`
`requested be entered on July 25, 2016. As noted by the Board in its Decision,
`
`Patent Owner will provide a redacted version of Ex. 2096.
`
`
`
`4
`
`
`
`
`
`V. Good Cause Exists for Sealing Certain Confidential Information
`
`As noted above, Patent Owner requests that excerpts of Patent Owner’s
`
`IPR2015-00903 (Patent 8,129,431 B2)
`
`
`NDA2 and portions of its Response and supporting declarations citing or
`
`substantially describing those exhibits be sealed. As explained herein, good cause
`
`exists for sealing each category of information.
`
`A.
`
`Patent Owner’s NDA and Related Portions of Patent Owner’s
`Response, the Williams, Trattler, and Jarosz Declarations and the
`Hoffman Transcript Should Be Sealed
`
`
`
`Patent Owner requests that certain excerpts from Patent Owner’s NDA (Exs.
`
`2102, 2103, and 2110) be sealed in their entirety, portions of Ex. 2096 be sealed,
`
`and portions of Patent Owner’s Response (Paper 34), specifically pages 3, 55-57,
`
`59, the Declarations of Patent Owner’s experts, including: Dr. Robert O. Williams
`
`(Ex. 2082), specifically: paragraph nos. 152, 153, 177, 178, 180, 181, 185, 186,
`
`187; Dr. William Trattler (Ex. 2116), specifically paragraph nos. 16, 41, and 49; Dr.
`
`Jarosz (Ex. 2130), specifically paragraph nos. 17, 56, 82, and 134; and the
`
`transcript of Mr. Hoffman (Ex. 2273), specifically on pages 25, 26, 34, 35, 37-40,
`
`49, and 53 which cite or substantially describe the excerpts from the NDA be
`
`sealed under 37 C.F.R. § 42.14. Petitioner Lupin does not oppose sealing these
`
`Exhibits and related materials.
`
`2 Patent Owner understands that Petitioner will be requesting that Ex. 2086
`
`(Petitioner’s ANDA excerpt) be filed under seal in a separate pleading.
`
`
`
`5
`
`
`
`
`
`
`
`IPR2015-00903 (Patent 8,129,431 B2)
`
`
`The NDA Contains Patent Owner’s Highly Sensitive,
`Confidential Information
`
`1.
`
`The information Patent Owner seeks to seal has not been made public by
`
`either party or by the Food and Drug Administration (“FDA”), and is not otherwise
`
`available to the public. Patent Owner’s NDA was filed confidentially with the
`
`FDA in order to obtain FDA approval to market its innovative pharmaceutical
`
`product. The information Patent Owner seeks to seal contains Patent Owner’s
`
`highly sensitive, confidential development information and technical, business
`
`information. The Exhibits listed above are only excerpts of the much larger NDA
`
`and redaction (or further redaction in the case of Ex. 2096) would not be practical;
`
`therefore, Patent Owner requests that these Exs. 2102, 2103, and 2110 be sealed in
`
`their entirety and portions Ex. 2096 be filed under seal. Moreover, the Patent
`
`Owner’s Response and the supporting declarations (Ex. 2082, 2116, 2130) and
`
`transcript (Ex. 2273) describe the confidential information contained in the NDA.
`
`Accordingly, Patent Owner requests that these portions of the Patent Owner’s
`
`Response and the supporting declarations be sealed.
`
`2. Good Cause Exists to Seal the NDA Exhibits as
`“CONFIDENTIAL” 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
`6
`
`
`
`
`
`
`
`IPR2015-00903 (Patent 8,129,431 B2)
`
`information. Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,760 (Aug.
`
`14, 2012). The Board has recognized that NDAs contain confidential commercial
`
`information that should be protected from public disclosure. See Sandoz, Inc. v.
`
`EKR Therapeutics, LLC, IPR2015-00005, paper 21. In sum, here, the public’s
`
`interest in the instant proceeding does not outweigh the parties’ interest in
`
`protecting their sensitive business information.
`
`Because public disclosure of the contents of these documents, or
`
`descriptions of those contents, would disclose confidential business terms in a
`
`highly competitive market, Patent Owner requests that Exhibits 2096, 2102, 2103,
`
`2110, and the portions of the Trattler, and Jarosz declarations and the Hoffman
`
`transcript that cite or substantially describe the NDA exhibits be sealed, as
`
`“PROTECTIVE ORDER MATERIAL”, for the duration of this proceeding.
`
`Because Petitioner’s ANDA, portions of Patent Owner’s Response and the
`
`Williams declaration cite Ex. 2082 , Patent Owner requests that this pleading and
`
`exhibit be sealed, as “PROTECTIVE ORDER MATERIAL-BOARD’S EYES
`
`ONLY.” These exhibits will be refiled with this marking.
`
`
`
`
`
`
`
`7
`
`
`
`
`
`VI. Conclusion
`For the reasons set forth above, Patent Owner respectfully requests that the
`
`IPR2015-00903 (Patent 8,129,431 B2)
`
`
`Board grant this motion to seal.
`
`Respectfully,
`
`
`
`
` /Bryan C. Diner/
`By:
`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
`
`Counsel for Patent Owner
`
`
`
`
`8
`
`
`
`
`
`
`
`
`
`IPR2015-00903 (Patent 8,129,431 B2)
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Renewed
`
`Motion to Seal was served on July 29, 2016, via email directed to counsel of
`
`record for the Petitioner at the following:
`
`
`
`
`
`Jitendra Malik
`jitty.malik@alston.com
`
`Bryan Skelton
`bryan.skelton@alston.com
`
`Lance Soderstrom
`lance.soderstrom@alston.com
`
`Hidetada James Abe
`James.abe@alston.com
`
`Joseph Janusz
`joe.janusz@alston.com
`
`Deborah Yellin
`dyellin@crowell.com
`
`Jonathan Lindsay
`jlindsay@crowell.com
`
`Shannon Lentz
`slentz@crowell.com
`
`
`Date: July 29, 2016
`
`
`
`9
`
`
`
`
`
`
`
`
`
`IPR2015-00903 (Patent 8,129,431 B2)
`
`
`
`/Bradley J. Moore/
`Bradley J. Moore
`Litigation Legal Assistant
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, LLP
`
`
`10
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
