UNITED STATES PATENT AND TRADEMARK OFFICE
`___________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`WOCKHARDT BIO AG,
`TEVA PHARMACEUTICALS USA, INC.,
`AUROBINDO PHARMA U.S.A., INC.,
`SUN PHARMACEUTICAL INDUSTRIES, LTD.,
`SUN PHARMA GLOBAL FZE and
`AMNEAL PHARMACEUTICALS LLC
`Petitioners,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`
`
`
`
`
`Case: IPR2015-013401
`U.S. Patent No. RE 44,186
`____________________________________________
`
`ASTRAZENECA’S MOTION TO SEAL
`PORTIONS OF EXHIBIT 2220A
`
`
`1 Petitioner Wockhardt from IPR2016-01029, Petitioner Teva from IPR2016-
`01122, Petitioner Aurobindo from IPR2016-01117, and Petitioners Sun/Amneal
`from IPR2016-01104 have been added as Petitioners to this proceeding.
`
`
`
`
`___________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`WOCKHARDT BIO AG,
`TEVA PHARMACEUTICALS USA, INC.,
`AUROBINDO PHARMA U.S.A., INC.,
`SUN PHARMACEUTICAL INDUSTRIES, LTD.,
`SUN PHARMA GLOBAL FZE and
`AMNEAL PHARMACEUTICALS LLC
`Petitioners,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`
`
`
`
`
`Case: IPR2015-013401
`U.S. Patent No. RE 44,186
`____________________________________________
`
`ASTRAZENECA’S MOTION TO SEAL
`PORTIONS OF EXHIBIT 2220A
`
`
`1 Petitioner Wockhardt from IPR2016-01029, Petitioner Teva from IPR2016-
`01122, Petitioner Aurobindo from IPR2016-01117, and Petitioners Sun/Amneal
`from IPR2016-01104 have been added as Petitioners to this proceeding.
`
`
`
`
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`
`
`
`
`I.
`
`II.
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`
`
`
`Case No. IPR2015-01340
`Patent RE 44,186
`
`TABLE OF CONTENTS
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`Introduction and Statement of Relief Requested ............................................. 1
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`Standard for Granting a Motion to Seal .......................................................... 2
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`III. Good Cause Exists to Seal Portions of the Cross-Examination
`Transcript of Dr. McDuff, Exhibit 2220A ....................................................... 3
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`IV. Conclusion ....................................................................................................... 4
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`i
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`Case No. IPR2015-01340
`Patent RE 44,186
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Athena Automation Ltd. v. Husky Injection Molding Systems Ltd.,
`IPR2013-00167, Paper 25 (PTAB 2013) ......................................................... 3, 4
`
`Garmin Int’l Inc. v. Cuozzo Speed Techs. LLC,
`IPR2012-00001, Paper 34 (PTAB Mar. 14, 2013) ............................................... 2
`
`
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`Regulations and Statutes
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`35 U.S.C. 316(a) ........................................................................................................ 2
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`37 C.F.R. § 42.14 ................................................................................................... 1, 2
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`37 C.F.R. § 42.54 ............................................................................................... 1, 2, 3
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`Office Patent Trial Practice Guide,
`77 Fed. Reg. 48,756, 48,760 (Aug. 14, 2012) ...................................................... 2
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`ii
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`
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`Introduction and Statement of Relief Requested
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`Case No. IPR2015-01340
`Patent RE 44,186
`
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`I.
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`Pursuant to 37 C.F.R. §§ 42.14 and 42.54, Patent Owner AstraZeneca AB
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`(“AstraZeneca”) moves to seal portions of Exhibit 2220A, the cross-examination
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`of Dr. McDuff. Good cause to seal portions of this document exists because those
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`portions contain confidential and proprietary information from third-parties, which
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`had been previously designated confidential. See Paper 40. The third parties
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`identified their information as commercially sensitive, non-public information that
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`only retains its value when treated in accordance with laws that protect such
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`confidential information (e.g., trade secret law). The Board has previously granted
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`the motions to seal this information. Paper 56. Accordingly, AstraZeneca files
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`this motion to protect the third-party confidential information from public
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`disclosure, while allowing the parties access to that information in this proceeding.
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`AstraZeneca certifies that it conferred in good faith with Petitioners’ counsel
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`and that the parties previously agreed on the scope of the Protective Order (Ex
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`2192).
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`AstraZeneca consulted Mylan’s counsel, which stated it does not expect to
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`oppose this motion.
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`1
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`
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`II.
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`Standard for Granting a Motion to Seal
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`Case No. IPR2015-01340
`Patent RE 44,186
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`A motion to seal may be granted for good cause. 37 C.F.R. § 42.54. To
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`determine whether good cause exists, the Board must “strike a balance between the
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`public’s interest in maintaining a complete and understandable file history and the
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`parties’ interest in protecting truly sensitive information.” Garmin Int’l, Inc. v.
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`Cuozzo Speed Techs. LLC, IPR2012-00001, Paper 34, at 2 (PTAB Mar. 14, 2013)
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`(quoting Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,760 (Aug.
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`14, 2012)). To that end, only “confidential information” may be sealed. 35 U.S.C.
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`§ 316(a)(7) (“The Director shall prescribe regulations . . . providing for protective
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`orders governing the exchange and submission of confidential information”);
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`Garmin Int’l, IPR2012-00001, Paper 34, at 2. The Office Trial Practice Guide
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`defines confidential information as follows:
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`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.
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`77 Fed. Reg. 48756, 48760 (Aug. 14, 2012).
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`Under 35 U.S.C. § 316(a)(1), a party may file a document with a concurrent
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`motion to seal, and the document will be sealed pending the outcome of the
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`motion. See also 37 C.F.R. § 42.14. A motion to seal must include a proposed
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`2
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`
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`protective order and certify that the moving party has conferred in good faith with
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`Case No. IPR2015-01340
`Patent RE 44,186
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`the opposing party regarding the scope thereof. 37 C.F.R. § 42.54.
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`III. Good Cause Exists to Seal Portions of the Cross-Examination
`Transcript of Dr. McDuff, Exhibit 2220A
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`The cross-examination transcript, Exhibit 2220A, contains information
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`obtained from third-parties. See Ex. 2220A at pp. 114 & 131. During the cross-
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`examination of Dr. McDuff, AstraZeneca relied on previously-designated
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`confidential information obtained by Mylan from third-parties. Id.
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`Because public disclosure of certain questions and answers would disclose
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`third party confidential commercial and financial information, AstraZeneca
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`requests that portions of Exhibit 2220A, i.e., pages 114 and 131, that cite or
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`substantially describe third party confidential information be designated
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`“PROTECTIVE ORDER MATERIAL” and be sealed for the duration of this
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`proceeding. AstraZeneca has concurrently filed a redacted version of this exhibit.
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`The Board has granted a motion to seal under similar circumstances. In
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`Athena Automation Ltd. v. Husky Injection Molding Systems Ltd., IPR2013-00167,
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`paper 25 at 2 (PTAB 2013), the Board granted a motion to seal and permitted
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`Patent Owner to file redacted versions of third-party exhibits. Like here, the third
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`parties did not want the exhibits entering the public domain, because they
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`contained their confidential information. The Board stated that as long as the
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`3
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`documents were under seal, “we see no reason why the entirety of these
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`Case No. IPR2015-01340
`Patent RE 44,186
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`documents, which are being relied on by Patent Owner, should not be available for
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`Petitioner to use in these proceedings.” Id. Accordingly, the Board permitted the
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`third-party exhibit to be sealed, shielding the information from the public, while
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`still making it available to the parties under the terms of a Protective Order. The
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`same should be done here.
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`IV. Conclusion
`For these reasons, AstraZeneca respectfully requests that the Board grant
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`AstraZeneca’s motion to seal portions of Exhibit 2220A.
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`Dated: December 12, 2016
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`Respectfully submitted,
`
`By: /Anthony A. Hartmann /
`
`Anthony A. Hartmann, Reg. No. 43,662
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`Counsel for Patent Owner in
`IPR2015-01340
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`4
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that copies of the foregoing ASTRAZENECA’S
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`MOTION TO SEAL PORTIONS OF EXHIBIT 2220A was served
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`electronically via e-mail on December 12, 2016, in its entirety to the following:
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`Counsel for Petitioner Mylan Pharmaceuticals Inc.:
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`Steven W. Parmelee
`sparmelee@wsgr.com
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`Richard Torczon
`rtorczon@wsgr.com
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`Jad A. Mills
`jmills@wsgr.com
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`Douglas H. Carsten
`dcarsten@wsgr.com
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`Counsel for Petitioner Wockhardt BIO AG.:
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`Patrick Gallagher
`PCGallagher@duanemorris.com
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`Gary Speier
`gspeier@carlsoncaspers.com
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`Iain McIntyre
`imcintyre@carlsoncaspers.com
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`Counsel for Petitioner Teva Pharmaceuticals U.S.A., Inc..:
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`Counsel for Petitioner Aurobindo Pharma U.S.A., Inc..:
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`Case No. IPR2015-01340
`Patent RE 44,186
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`Sailesh K. Patel
`SPatel@schiffhardin.com
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`Counsel for Petitioners Sun/Amneal:
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`George Yu
`GYu@schiffhardin.com
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`Samuel Park
`SPark@winston.com
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`Andrew Sommer
`ASommer@winston.com
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`By: /Lauren K. Young/
`Lauren K. Young
`Litigation Legal Assistant
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
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`Dated: December 12, 2016
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