Trials@uspto.gov
`Tel: 571-272-7822
`
`
`Paper: 83
`Entered: October 4, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS
`USA, INC., and AKORN INC.
`Petitioners,
`
`v.
`
`SAINT REGIS MOHAWK TRIBE,
`Patent Owner.
`____________
`
`Case IPR2016-01127 (8,685,930 B2)
`Case IPR2016-01128 (8,629,111 B2)
`Case IPR2016-01129 (8,642,556 B2)
`Case IPR2016-01130 (8,633,162 B2)
`Case IPR2016-01131 (8,648,048 B2)
`Case IPR2016-01132 (9,248,191 B2)1
`_______________
`
`
`Before SHERIDAN K. SNEDDEN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`PAULRAJ, Administrative Patent Judge.
`ORDER
`Conduct of the Proceedings
`37 C.F.R § 42.5
`
`
`1 Cases IPR2017-00576 and IPR2017-00594, IPR2017-00578 and IPR2017-
`00596, IPR2017-00579 and IPR2017-00598, IPR2017-00583 and IPR2017-
`00599, IPR2017-00585 and IPR2017-00600, and IPR2017-00586 and
`IPR2017-00601, have respectively been joined with the captioned
`proceedings.
`
`
`Tel: 571-272-7822
`
`
`Paper: 83
`Entered: October 4, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS
`USA, INC., and AKORN INC.
`Petitioners,
`
`v.
`
`SAINT REGIS MOHAWK TRIBE,
`Patent Owner.
`____________
`
`Case IPR2016-01127 (8,685,930 B2)
`Case IPR2016-01128 (8,629,111 B2)
`Case IPR2016-01129 (8,642,556 B2)
`Case IPR2016-01130 (8,633,162 B2)
`Case IPR2016-01131 (8,648,048 B2)
`Case IPR2016-01132 (9,248,191 B2)1
`_______________
`
`
`Before SHERIDAN K. SNEDDEN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`PAULRAJ, Administrative Patent Judge.
`ORDER
`Conduct of the Proceedings
`37 C.F.R § 42.5
`
`
`1 Cases IPR2017-00576 and IPR2017-00594, IPR2017-00578 and IPR2017-
`00596, IPR2017-00579 and IPR2017-00598, IPR2017-00583 and IPR2017-
`00599, IPR2017-00585 and IPR2017-00600, and IPR2017-00586 and
`IPR2017-00601, have respectively been joined with the captioned
`proceedings.
`
`
`
`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`
`A conference call for the above-captioned proceedings was held on
`September 26, 2017. Counsel for Petitioners Mylan Pharmaceuticals, Inc.
`(“Mylan”), Teva Pharmaceuticals USA, Inc. (“Teva”), and Akorn Inc.
`(“Akorn”) (collectively, “Petitioners”), Patent Owner Saint Regis Mohawk
`Tribe (“Tribe”), and exclusive licensee Allergan Inc. (“Allergan”)
`participated. A transcript of the call has been filed as Exhibit 1143.
`The primary purpose of the call was to discuss Mylan’s request for
`authorization to file a motion for additional discovery concerning any
`agreements between the Tribe and Allergan, as well as certain other
`settlement agreements referenced in the agreements that have already been
`made of record (Ex. 2086 and Ex. 2087). In particular, Mylan seeks:
`all agreements incorporating references to Allergan license
`grants, any side agreements, supplemental agreements,
`agreements to agree, term sheets, documents sufficient to show
`all drafts of the assignment, license agreement, [and] documents
`sufficient to show communications between Allegan and the
`Tribe or the Tribe’s attorneys regarding IPRs or patents
`including any marketing material.
`Ex. 1143, Tr. 12:18–13:4. Mylan further seeks “any documents showing
`good and valuable consideration that the Tribe gave to Allergan as part of
`this transaction.” Id. at 13:5–7. Mylan’s counsel indicated during the call
`that these documents are relevant to the question of whether the Tribe is the
`true owner of the challenged patents in these proceedings and whether
`Allergan has retained sufficient rights to the patents such that these
`proceedings can continue notwithstanding the Tribe’s assertion of sovereign
`immunity. Id. at 14:3–20.
`
` 2
`
`
`
`
`
`
`
`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`
`In response, the Tribe’s counsel represented during the call:
`Your Honor, first, there are no other agreements. Let me be
`unequivocal as I possibly can, there are no side agreements,
`there are no license-back agreements, there are no expansion of
`license rights agreements. There are no give-back agreements.
`There are no agreements at all in any way, shape, form, or
`fashion that have not already been produced in the case, none,
`zero, nada.
`Id. at 25:7–15. The Tribe’s counsel additionally represented “there are no
`term sheets, there never were any term sheets in the case.” Id. at 21:18–20.
`With respect to the prior settlement agreements referenced in the agreements
`made of record, the Tribe’s counsel indicated “[t]hey were simply listed as
`encumbrances and simply meaning that any time a patent owner takes
`ownership of a patent that they take it subject to prior license agreements.”
`Id. at 27:12–16.
`Upon considering the parties’ arguments, we do not authorize Mylan
`to file a Motion for Additional Discovery. Additional discovery is
`warranted only when granting the discovery is “necessary in the interest of
`justice.” 35 U.S.C. § 316(a)(5); Office Patent Trial Practice Guide, 77 Fed.
`Reg. 48,756, 48,761 (Aug. 14, 2012). The Board has outlined several
`factors (the “Garmin factors”) useful in evaluating whether granting
`additional discovery would be in the interests of justice, including the
`requirement that the request is based on “more than a possibility and mere
`allegation”:
`The mere possibility of finding something useful, and mere
`allegation that something useful will be found, are insufficient
`to demonstrate that the requested discovery is necessary in the
`interest of justice. The party requesting discovery should
`
` 3
`
`
`
`
`
`
`
`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`
`already be in possession of evidence tending to show beyond
`speculation that in fact something useful will be uncovered.
`Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC, IPR2012-00001, Paper 26,
`6–7 (PTAB Mar. 5, 2013) (precedential) (emphases added).
`Mylan has not demonstrated that the additional discovery it seeks
`satisfies this first Garmin factor. In particular, Mylan has not identified any
`specific basis to suggest that there exist additional agreements between Tribe
`and Allergan relating to the challenged patents that have not already been
`produced. To the contrary, the Tribe’s counsel represented unequivocally
`during the call that no such agreements or term sheets exist. Moreover, to
`the extent that there may have been any other communications or draft
`agreements, Mylan has not shown why those documents would be “useful”
`to the issue of the Tribe’s ownership in the patents. As further noted by
`Allergan’s counsel during the call, the license agreement between Tribe and
`Allergan indicates that “the license agreement represents the entire
`agreement and understanding between the parties.” Ex. 1143, Tr. 31:18–
`32:8. Likewise, Mylan has not shown why any prior settlement agreements
`between Allergan and other third parties would be relevant to the issue of the
`Tribe’s ownership.
`During the call, Allergan’s counsel also sought leave to withdraw as
`counsel in this proceeding on the basis that Allergan is not the patent owner.
`Id. at 19:14–21. Given the current dispute concerning the true ownership of
`the challenged patents, we denied that request at this point. We indicated
`that Allergan’s counsel may renew that request after briefing on the Tribe’s
`motion to dismiss is completed.
`
` 4
`
`
`
`
`
`
`
`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`
`The parties also discussed a request the Board received via email on
`September 26, 2017, from the Association for Accessible Medicines
`(“AAM”) to file an amicus brief supporting Petitioners’ opposition to the
`Tribe’s motion to terminate. The Tribe’s counsel stated that if AAM is
`permitted to file an amicus brief, then other tribes should be permitted to file
`amicus briefs in support of the Tribe’s motion. Petitioners stated they did
`not support the filings if they would result in further delay of these
`proceedings. Having considered AAM’s request and the parties’ arguments,
`we deny AAM’s request to file an amicus brief. An email will be sent to
`AAM to notify them of our decision.
`Accordingly, based on the foregoing, it is:
`ORDERED that Mylan’s request for authorization to file a motion for
`additional discovery is denied;
`FURTHER ORDERED that Allergan’s counsel’s request to withdraw
`in this proceeding is denied without prejudice; and
`FURTHER ORDERED that the parties are to notify the Board by
`joint email within five business days of entering this Order whether this
`Order contains any confidential information that should remain under seal.
`Otherwise, this Order shall be opened to the public after five business days.
`.
`
`
`
`
`
` 5
`
`
`
`
`
`
`
`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`PETITIONER MYLAN:
`
`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`WILSON SONSINI GOODRICH & ROSATI
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`
`PETITIONER TEVA:
`
`Donald R. Steinberg
`David L. Cavanaugh
`Michael H. Smith
`Wilmer Cutler Pickering Hale and Dorr LLP
`6 don.steinberg@wilmerhale.com
`david.cavanaugh@wilmerhale.com
`michaelh.smith@wilmerhale.com
`
`PETITIONER AKORN:
`
`Mark Nikolsky
`Vadim Cherkasov
`mnikolsky@mccarter.com
`vcherkasov@mccarter.com
`
`PATENT OWNER:
`
`Dorothy P. Whelan
`Michael Kane
`FISH & RICHARDSON P.C.
`whelan@fr.com
`PTABInbound@fr.com
`
`
`
`
`
` 6
`
`
`
`
`
`
`
`IPR2016-01127 (8,685,930 B2); IPR2016-01128 (8,629,111 B2);
`IPR2016-01129 (8,642,556 B2); IPR2016-01130 (8,633,162 B2);
`IPR2016-01131 (8,648,048 B2); IPR2016-01132 (9,248,191 B2)
`
`Alfonso Chan
`Joseph DePumpo
`SHORE CHAN DEPUMPO LLP
`achan@shorechan.com
`jdepumpo@shorechan.com
`
`
` 7
`
`
`
`
`
`
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