UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`WOCKHARDT BIO AG, TEVA PHARMACEUTICALS USA, INC.
`and AUROBINDO PHARMA U.S.A. INC.,
`Petitioners,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`
`_____________________________
`
`Case IPR2015-01340
`Patent RE44,186 E1
`_____________________________
`
`
`
`PETITIONERS’ MOTION TO SEAL
`37 C.F.R. §§42.14 & 42.54(a)
`
`
`
`1 Wockhardt (IPR2016-01209), Teva (IPR2016-01122) and Aurobindo (IPR2016-
`
`01117) have each been joined to this proceeding.
`
`
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`WOCKHARDT BIO AG, TEVA PHARMACEUTICALS USA, INC.
`and AUROBINDO PHARMA U.S.A. INC.,
`Petitioners,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`
`_____________________________
`
`Case IPR2015-01340
`Patent RE44,186 E1
`_____________________________
`
`
`
`PETITIONERS’ MOTION TO SEAL
`37 C.F.R. §§42.14 & 42.54(a)
`
`
`
`1 Wockhardt (IPR2016-01209), Teva (IPR2016-01122) and Aurobindo (IPR2016-
`
`01117) have each been joined to this proceeding.
`
`
`
`TABLE OF CONTENTS
`TABLE OF CONTENTS
`
`I.
`I.
`
`II.
`II.
`
`Statement of requested relief ......................................................................... 1
`Statement of requested relief....................................................................... ..1
`
`Discussion .................................................................................................... 2
`Discussion .................................................................................................. ..2
`
`III. Conclusion .................................................................................................... 4
`III.
`Conclusion .................................................................................................. ..4
`
`Certificate of Compliance ....................................................................................... 5
`Certificate of Compliance ..................................................................................... ..5
`
`Certificate of Service .............................................................................................. 6
`Certificate of Service ............................................................................................ ..6
`
`
`
`
`
`
`
`
`
`-i-
`
`
`
`
`
`I.
`
`STATEMENT OF REQUESTED RELIEF
`
`Petitioners (collectively, Mylan) move to seal exhibits EX1035, EX1060A,
`
`EX1062A and EX1066-EX1071. Patent Owner (“AstraZeneca”) previously filed a
`
`motion to seal exhibits EX2059A and EX2117-EX2119 and for entry of the
`
`Default Protective Order. Paper 30; EX2192. Good cause exists to seal exhibits
`
`EX1035, EX1060A, EX1062A because they contain confidential information
`
`produced by AstraZeneca and information sought by AstraZeneca to be filed under
`
`seal in EX2059A and EX2117-EX2119, and thus should be protected to the same
`
`extent the Board protects the AstraZeneca exhibits. Similarly, good cause exists to
`
`seal exhibits EX1066-EX1071 because these exhibits contain confidential and
`
`proprietary information from third-party analysts. These analysts maintain that
`
`their information is commercially sensitive, non-public information that only
`
`retains its value when treated in accordance with laws that protect confidential
`
`information (e.g., trade secret laws). These analysts restrict use of their
`
`confidential information to avoid public disclosure. Accordingly, Mylan files this
`
`motion to protect the third-party analyst’s confidential information from public
`
`disclosure. Mylan has consulted AstraZeneca, which stated it would not take a
`
`position on the motion to seal until after it had reviewed the motion in the context
`
`of the exhibits.
`
`-1-
`
`
`
`
`
`II. DISCUSSION
`
`The Board will grant a motion to seal upon a showing of good cause.
`
`37 CFR §42.54(a). The Director has prescribed regulations “providing for
`
`protective orders governing the exchange and submission of confidential
`
`information”. 35 U.S.C. 316(a)(7). The Office Trial Practice Guide specifies that
`
`confidential information subject to protection under the protective order includes
`
`trade secret or other confidential research, development, or commercial
`
`information. 77 Fed. Reg. 48756, 48760 (Aug. 14, 2012); see also 37 CFR
`
`§42.54(a)(7).
`
`According to AstraZeneca:
`
`Exhibits 2117-2119 and 2059A contain confidential and proprietary
`
`information from third-party, IMS Health Inc. (“IMS”). IMS
`
`maintains that its information is commercially sensitive, non-public
`
`information that only retains its value when treated in accordance with
`
`laws that protect such confidential information (e.g., trade secret law).
`
`IMS restricts the use of its confidential information to avoid public
`
`disclosure.
`
`Paper 30, 1. According to AstraZeneca, its economist-expert Dr. Meyers uses
`
`confidential IMS data in EX2117-EX2119 in support of her testimony in the
`
`unredacted version of her declaration, EX2059A. Paper 30, 4. Pursuant to a
`
`stipulation between the parties (Paper 35, 4), Mylan relies on Dr. Meyer’s cross-
`
`examination testimony from the collateral litigation in lieu of cross examination in
`
`-2-
`
`
`
`
`
`this proceeding and is required by stipulation of the parties to file Dr. Meyer’s
`
`cross-examination testimony as well as all documents referenced therein.
`
`Paper 35, ¶¶4-5
`
`Mylan uses data from these same exhibits to rebut AstraZeneca testimony
`
`based on the exhibits. Specifically, Mylan’s economist-expert Dr. McDuff relies on
`
`these exhibits in preparing the unredacted version of his declaration (EX1060A)
`
`and his supporting exhibit (EX1062A).
`
`The third-party analyst reports in EX1066-EX1071 are proprietary materials
`
`that, like the IMS data, are third-party proprietary commercial information that
`
`would lose their value if publicly available. To the best of Mylan’s knowledge, the
`
`information to be sealed is not otherwise publicly available. The Board has
`
`previously granted a motion to seal under similar circumstances. See Athena
`
`Automation Ltd. v. Husky Injection Molding Systems Ltd., IPR2013-00167, Paper
`
`32 at 2.
`
`
`
`Mylan proposes adoption of the Default Protective Order that AstraZeneca
`
`has already submitted (EX2192). To balance between the public interest in an open
`
`record and the needs of IMS and the third-party analysts to protect their proprietary
`
`data, Mylan submits redacted versions of EX1060A and EX1062A (EX1060 and
`
`EX1062). EX1035 and EX1066-EX1071 should be sealed in their entirety because
`
`they contain material that is confidential to a party or third-party other than Mylan
`
`-3-
`
`
`
`
`
`and, in each case, redaction to protect confidential information would render the
`
`remaining document meaningless.
`
`III. CONCLUSION
`
`For the reasons provided above, Mylan requests that the Board seal exhibits
`
`EX1035, EX1060A, EX1062A and EX1066-EX1071.
`
`Respectfully,
`
`
`
`/ Richard Torczon /
`Richard Torczon, Reg. No. 34,448
`
`
`
`
`
`
`
`
`Date: 7 November 2016
`
`
`
`
`
`
`
`-4-
`
`
`
`
`
`CERTIFICATE OF COMPLIANCE
`37 CFR §42.54(a)
`
`Mylan certifies that it conferred in good faith with AstraZeneca’s counsel
`
`and that the parties agree on the scope of the proposed Protective Order (EX2192).
`
`Respectfully,
`
`
`/ Richard Torczon /
`Richard Torczon, Reg. No. 34,448
`
`
`
`
`
`
`Date: 7 November 2016
`
`
`
`
`
`
`
`-5-
`
`
`
`
`
`CERTIFICATE OF SERVICE
`37 CFR §42.6(e)(i)
`
`I certify that, on 7 November 2016, this PETITIONERS’ MOTION TO
`
`SEAL was served on AstraZeneca at the following service electronic addresses:
`
`Charles E. Lipsey
`
`charles.lipsey@finnegan.com
`
`Eric E. Grondahl
`
`egrondahl@mccarter.com
`
`John D. Livingstone
`
`john.livingstone@finnegan.com
`
`Anthony A. Hartmann
`
`anthony.hartmann@finnegan.com
`
`M. David Weingarten
`
`david.weingarten@finnegan.com
`
`
`
`on Wockhardt at the following service electronic addresses:
`
`Frederick R. Ball
`
`FRBall@duanemorris.com
`
`Patrick C. Gallagher
`
`PCGallagher@duanemorris.com
`
`
`
`on Teva at the following service electronic addresses:
`
`Iain A. McIntyre
`
`IMcIntyre@carlsoncaspers.com
`
`Gary J. Speier
`
`GSpeier@carlsoncaspers.com
`
`
`
`and on Aurobindo at the following service electronic addresses:
`
`Sailesh K. Patel
`
`SPatel@schiffhardin.com
`
`-6-
`
`
`
`
`
`Joel Wallace
`
`JWallace@schiffhardin.com
`
`George Yu
`
`GYu@schiffhardin.com
`
`
`
`Dated: 7 November 2016
`
`
`
`
`/ Richard Torczon /
` Richard Torczon, Reg. No. 34,448
`
`-7-
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