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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC. and MYLAN LABORATORIES
`LIMITED,
`Petitioners,
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`v.
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`UCB PHARMA GMBH,
`Patent Owner.
`
`Case IPR2016-005101
`Patent 6,858,650 B1
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`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`UNDER 37 C.F.R. § 42.64(c)
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`
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`1 Petitioners Alembic Pharmaceuticals Limited from IPR2016-01596, Torrent
`Pharmaceuticals Limited from IPR2016-01636, and Amerigen Pharmaceuticals
`Limited from IPR2016-01665 have been joined as Petitioners to this proceeding.
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`IPR2016-00510
`Patent 6,858,650 B1
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`I.
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`INTRODUCTION
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`Pursuant to 37 C.F.R. § 42.64(c), Patent Owner UCB Pharma GmbH
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`(“UCB” or “Patent Owner”) moves to exclude from evidence, in their entirety,
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`Exhibit Nos. 1033 and 1034 (the Declaration and CV of economist DeForest
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`McDuff) and Exhibit Nos. 1036-1049 (related to sales, costs, and/or market share
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`of Toviaz®), which were submitted by Mylan Pharmaceuticals Inc. and Mylan
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`Laboratories Limited (“Petitioner”). This motion is timely pursuant to the
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`Consolidated Scheduling Order entered in this proceeding on July 26, 2016.2
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`II.
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`STATEMENT OF MATERIAL FACTS
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`Petitioner filed the Exhibits challenged herein with its Petition dated January
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`28, 2016. Petitioner relies on the challenged Exhibits on pages 54-56 of its
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`Corrected Petition.3 See Paper 5. Following institution on July 20, 2016 (Paper
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`12), UCB timely objected to Exhibit Nos. 1033, 1034, and 1036-1049 by filing
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`Patent Owner’s Notice of Objections to Evidence Pursuant to 37 C.F.R. § 42.64 on
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`August 3, 2016. See Paper 16. Petitioner served a Response and Supplemental
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`Evidence on August 17, 2016. See Paper 17.
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`2 See IPR2016-00516 (Paper 13) (consolidating the schedule in this case with the
`schedule of related cases: IPR2016-00512, IPR2016-00514, IPR2016-00516, and
`IPR2016-00517).
`3 Exhibits 1039 and 1049 are not cited in the Corrected Petition or in Petitioner’s
`Declarations.
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`IPR2016-00510
`Patent 6,858,650 B1
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`III.
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`LEGAL STANDARDS
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`A.
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` Only Relevant Evidence Is Admissible
`The Federal Rules of Evidence govern the admissibility of evidence and
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`expert testimony in an inter partes review. 37 C.F.R. § 42.62(a). Irrelevant
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`evidence is not admissible. FED. R. EVID. 402. Additionally, relevant evidence
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`may be excluded “if its probative value is substantially outweighed by a danger of
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`… unfair prejudice, [or] confusing the issues.” FED. R. EVID. 403.
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`Further, expert opinion “testimony is admissible only if it is both relevant
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`and reliable.” Kumho Tire Co. v. Carmichael, 526 U.S. 137, 141 (1999).
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`B.
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`It Is Patent Owner’s Burden To Produce Commercial Success Evidence
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`The legal conclusion as to obviousness is based on an underlying factual
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`inquiry into the “Graham factors:” (1) the level of ordinary skill in the art, (2) the
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`scope and content of the prior art, (3) the differences between the claimed subject
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`matter and the prior art, and (4) any objective evidence of nonobviousness. Eisai
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`Co. v. Dr. Reddy’s Labs., Ltd., 533 F.3d 1353, 1356 (Fed. Cir. 2008) (citing
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`Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966)). The Fourth Graham
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`Factor, objective evidence, may include, inter alia, evidence that the claimed
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`invention has been a commercial success. See, e.g., Procter & Gamble Co. v. Teva
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`Pharm. USA, Inc., 566 F.3d 989, 998 (Fed. Cir. 2009).
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`2
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`IPR2016-00510
`Patent 6,858,650 B1
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`“Patent Owners bear a burden of production with respect to evidence of
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`commercial success.” Torrent Pharm. Ltd. v. Novartis AG, IPR2014-00784
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`(P.T.A.B. Sept. 24, 2015) (Paper 112) at 27 (citing Ecolochem, Inc. v. S. Cal.
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`Edison Co., 227 F.3d 1361, 1377 (Fed. Cir. 2000). “If Patent Owners make such a
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`showing, Petitioners may rebut the evidence of commercial success by showing
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`that the commercial success was instead due to other factors extraneous to the
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`patented invention.” Id. (internal quotations omitted) (emphasis added); see also
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`Lupin Ltd. v. Senju Pharm. Co., IPR2015-01099 (P.T.A.B. Sept. 12, 2016) (Paper
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`69) at 36 (“Once a patentee makes the required showing, the burden shifts to the
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`challenger to prove that the commercial success is instead due to other factors
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`extraneous
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`to
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`the patented
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`invention, such as advertising or superior
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`workmanship.”) (internal quotation omitted) (emphasis added).
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`IV.
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`ARGUMENT
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`A.
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`
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`Petitioner’s Exhibits Related to Commercial Success (Exhibits 1033-
`1034 and 1036-1049) Are Not Relevant and Are Inadmissible
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`UCB, as Patent Owner, bears the burden of production with respect to
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`evidence related to commercial success. See Torrent, IPR2014-00784 (Paper 112)
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`at 27. Only after UCB makes a showing of commercial success would the burden
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`shift to Petitioner to present evidence to challenge such a showing. Id.; Lupin,
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`IPR2015-01099 (Paper 69) at 36. UCB has not introduced as a secondary
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`3
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`IPR2016-00510
`Patent 6,858,650 B1
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`consideration of nonobviousness, the commercial success of Toviaz®. Petitioner’s
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`evidence, in the form of expert testimony and exhibits, intended to rebut such a
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`showing of commercial success, is entirely irrelevant and should be excluded.
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`FED. R. EVID. 401-402; Kumho Tire Co., 526 U.S. at 141. The Exhibits that are the
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`subject of this motion are cited, if at all, only in the section of the Corrected
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`Petition related to commercial success (Paper 5 at 54-56) or in the Declaration of
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`Petitioner’s economist (Exhibit 1033).
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`Exhibits 1039 and 1049 should additionally be excluded because Petitioner
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`has not cited them in its papers, nor made no attempt to explain their relevance to
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`its arguments.
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`B.
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`
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`Petitioner’s Improperly Filed Supplemental Evidence (Exhibits 1050-
`1072) Did Not Resolve UCB’s Objections and Should Be Expunged
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`After UCB objected to Petitioner’s Exhibits 1033, 1034, and 1036-1049
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`(Paper 16), Petitioner filed a Response to Patent Owner’s Objections and
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`Supplemental Evidence Pursuant to 37 C.F.R. § 42.64(b)(2). See Paper 17. With
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`its Response, Petitioner filed 23 additional Exhibits (Exhibit Nos. 1050 – 1072) as
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`supplemental evidence, intended to “provide additional foundation and authenticity
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`support” and to resolve the objections to the Exhibits that are the subject of this
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`motion. Paper 17 at 10. As supplemental evidence, Exhibits 1050-1072 “may be
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`relied upon to support admissibility arguments but not arguments on the merits.”
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`4
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`IPR2016-00510
`Patent 6,858,650 B1
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`Valeo N. Am., Inc. v. Magna Elecs., Inc., IPR2014-01208 (P.T.A.B. Dec. 21, 2015)
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`(Paper 49) at 13 n.18. Petitioner’s supplemental evidence does not resolve UCB’s
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`relevance objections, but rather compounds them, as the supplemental evidence is
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`similarly not relevant.
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`In any event, supplemental evidence is to be served, not filed, following an
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`objection. 37 C.F.R. § 42.64(b)(2); see also Symantec Corp. v. Trustees of
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`Columbia Univ., IPR2015-00372 (P.T.A.B. Sept. 29, 2015) (Paper 30) at 2-3
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`(“Under 37 C.F.R. § 42.64(b)(2), a party may respond to an objection to evidence
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`by serving supplemental evidence within ten business days of service of the
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`objection. Patent Owner prematurely filed supplemental evidence before a motion
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`to exclude, and thus the exhibits filed as supplemental evidence will be expunged
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`from the record of these proceedings.”) (emphasis in original).
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`Finally, an “exhibit must be filed with the first document in which it is cited
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`except as the Board may otherwise order.” 37 C.F.R. 42.6(c). At least some of
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`Petitioner’s supplemental evidence was expressly cited in the McDuff Declaration
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`(Exhibit 1033), but was not filed at the time the Declaration was filed.4 See, e.g.,
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`Exhibit Nos. 1052, 1064-1066, and 1069-1071. Petitioner did not seek the
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`permission of the Board before later filing Exhibits 1050-1072 in response to
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`4 Many of the other references cited in the McDuff Declaration have never been
`filed or served on UCB.
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`5
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`IPR2016-00510
`Patent 6,858,650 B1
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`UCB’s objections. Instead, it filed Exhibits 1050-1072 as supplemental evidence,
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`which may not be used to support its arguments on the merits. See Valeo,
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`IPR2014-01208 (Paper 49) at 13 n.18. Accordingly, UCB requests that Exhibits
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`1050-1072 be expunged from the record.
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`V.
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`CONCLUSION
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`For the foregoing reasons, UCB requests that Exhibit Nos. 1033, 1034, and
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`1036-1049 be excluded from evidence in their entirety and that Exhibit Nos. 1050-
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`72 be expunged from the record.
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`Respectfully submitted,
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`WHITE & CASE LLP
`/Jeffrey J. Oelke/ (Electronically signed)
`Jeffrey J. Oelke, Reg. No. 37,409
`joelke@whitecase.com
`James S. Trainor, Jr., Reg. No. 52,297
`jtrainor@whitecase.com
`Robert E. Counihan, Reg. No. 61,382
`rcounihan@whitecase.com
`White & Case LLP
`1155 Avenue of the Americas
`New York, NY 10036
`(212) 819-8200
`Attorneys for UCB Pharma GmbH
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`6
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`Date: March 8, 2017
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`IPR2016-00510
`Patent 6,858,650 B1
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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 Exclude Evidence Pursuant to 37 C.F.R. § 42.64(c) was served
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`on March 8, 2017, by filing this document through the Patent Trial and Appeal
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`Board End to End system as well as delivering a copy via electronic mail upon the
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`following attorneys of record for the Petitioners:
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`Mitchell G. Stockwell, Reg. No. 39,389
`mstockwell@kilpatricktownsend.com
`D. Clay Holloway, Reg. No. 58,011
`cholloway@kilpatricktownsend.com
`Alyson L. Wooten, Reg. No. 58,045
`awooten@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, NE Suite 2800
`Atlanta, Georgia 30309
`(404) 815-6500
`
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`William Hare, Reg. No. 44,739
`bill@miplaw.com
`Gabriela Materassi, Reg. No. 47,774
`materassi@miplaw.com
`Renita S. Rathinam, Reg. No. 53,502
`rathinam@miplaw.com
`MCNEELY, HARE & WAR LLP
`5335 Wisconsin Ave., NW
`Suite 440
`Washington, DC 20015
`(202) 640-1801
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`IPR2016-00510
`Patent 6,858,650 B1
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`Neal Seth, Reg. No. 67,075
`nseth@wileyrein.com
`Lawrence Sung, Reg. No. 38,330
`lsung@wileyrein.com
`WILEY REIN LLP
`1776 K Street NW
`Washington, DC 20006
`(202) 719-7000
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`
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`Manish Mehta, Reg. No. 64, 570
`mmehta@sheppardmulllin.com
`Laura Burson, Reg. No. 40,929
`lburson@sheppardmullin.com
`SHEPPARD MULLIN
`Three First National Plaza
`70 West Madison Street, 48th Floor
`Chicago, Illinois 60602
`(312) 499-6300
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`/Jeffrey J. Oelke/ (Electronically signed)
`Jeffrey J. Oelke
`Reg. No. 37,409
`Phone: (212) 819-8936
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`Date: March 8, 2017
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`8
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