Case IPR2016-01565
`Patent 8,853,156
`Paper No. 19
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v .
`
`BOEHRINGER INGELHEIM INTERNATIONAL GMBH,
`Patent Owner.
`
`Case IPR2016-01565
`Patent 8,853,156
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S MOTION FOR
`REHEARING UNDER 37 C.F.R. § 42.71
`
`
`Patent 8,853,156
`Paper No. 19
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v .
`
`BOEHRINGER INGELHEIM INTERNATIONAL GMBH,
`Patent Owner.
`
`Case IPR2016-01565
`Patent 8,853,156
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S MOTION FOR
`REHEARING UNDER 37 C.F.R. § 42.71
`
`
`
`Case IPR2016-01565
`Patent 8,853,156
`
`I.
`II.
`
`TABLE OF CONTENTS
`INTRODUCTION......................................................................................... 1
`ARGUMENT................................................................................................. 4
`A.
`Legal Standard for Rehearing.............................................................. 4
`B.
`Legal Standard for Establishing a Printed Publication at the
`Institution Stage................................................................................... 5
`Petitioner Established a Threshold Showing that the Januvia
`Label and Huettner were Printed Publications..................................... 8
`1.
`The Januvia Label ..................................................................... 8
`2.
`Huettner................................................................................... 13
`III. CONCLUSION ........................................................................................... 15
`
`C.
`
`ii
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`
`
`TABLE OF AUTHORITIES
`
`CASES
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`Case IPR2016-01565
`Patent 8,853,156
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`PAGE(S)
`
`Am. Megatrends, Inc. v. Kinglite Holdings, Inc.,
`IPR2015-01197, 2015 WL 9599216 (PTAB Nov. 23, 2015).......................... 6, 7
`Apple Inc. v. Virnetx, Inc.,
`IPR2016-00332, 2016 WL 5349402 (PTAB July 1, 2016)............................... 11
`Bld Servs., LLC, v. LMK Techs.,
`IPR2014-00772, 2014 WL 6666762, (PTAB Nov. 20, 2014)....................... 8, 10
`Captioncall, L.L.C., v. UltraTech, Inc.,
`IPR2013-00540, 2015 WL 1263028 (PTAB Mar. 3, 2015)................................ 7
`Cave Consulting Grp., LLC v. OptumInsight, Inc.,
`2015 WL 740379 (N.D. Cal. Feb. 20, 2015)..................................................... 12
`EMC Corp. v. PersonalWeb Techs, LLC,
`IPR2013-00085, 2013 WL 8595564 (May 17, 2013) ......................................... 6
`Ex Parte Hicks,
`2013 WL 5882933 (P.T.A.B. Oct. 31, 2013).................................................... 12
`Ex Parte Krivulka,
`2010 WL 3820666 (B.P.A.I. Sept. 28, 2010).................................................... 12
`FLIR Sys., Inc. v. Leak Surveys, Inc.,
`IPR2014-00411, Paper 9 (PTAB Sept. 5, 2014) ............................................... 10
`Fujian Newland Computer Co., Ltd. v. Hand Held Products, Inc.,
`IPR2013-00595, Paper 14 (PTAB Feb. 28, 2014) .............................................. 3
`Informatica Corp. v. Protegrity Corp.,
`CBM2015-00021, 2015 WL 3523401 (PTAB June 1, 2015) .................... passim
`Int’l Bus. Machs. Corp. v. Intellectual Ventures II LLC,
`IPR2014-00681, 2014 WL 5585264 (PTAB Oct. 30, 2014)............................. 12
`Intex Recreation Corp. v. Bestway Inflatables & Material Corp.,
`No. IPR2016-00180, Paper 6 (PTAB June 6, 2016) ....................................... 4, 9
`
`iii
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`Case IPR2016-01565
`Patent 8,853,156
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`LG Elecs., Inc. v. Advanced Micro Devices, Inc.,
`IPR2015-00329, Paper 13 (PTAB July 10, 2015)............................................. 10
`New England Braiding Co. v. A.W. Chesterton Co.,
`970 F.2d 878 (Fed. Cir. 1992)............................................................................. 5
`Oracle Am., Inc. v. Realtime Data LLC,
`IPR2016-00374, Paper 7 (PTAB June 27, 2016)........................................ 3, 6, 5
`Star Fruits S.N.C. v. United States,
`393 F.3d 1277 (Fed. Cir. 2005)........................................................................... 5
`Toshiba Corp. v. Optical Devices, LLC,
`IPR2014-01447, 2015 WL 1090309 (PTAB Mar. 10, 2015).................... 3, 7, 15
`TriVascular, Inc. v. Samuels,
`812 F. 3d 1056 (Fed. Cir. 2016).......................................................................... 5
`Under Armour, Inc. v. Adidas AG,
`IPR2015-00700, 2015 WL 4932209 (PTAB Aug. 14, 2015).................. 7, 12, 15
`STATUTES
`35 U.S.C. § 102........................................................................................................ 7
`35 U.S.C. § 316(e) ................................................................................................... 5
`OTHER AUTHORITIES
`37 C.F.R. § 42.71(c)................................................................................................. 4
`37 C.F.R. § 42.71(d) ................................................................................................ 4
`37 C.F.R. § 42.108(c)............................................................................................. 15
`37 C.F.R. § 42.123(a)............................................................................................... 7
`
`iv
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`Case IPR2016-01565
`Patent 8,853,156
`Petitioner Mylan Pharmaceuticals Inc. respectfully requests rehearing of the
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`Board’s February 9, 2017 decision denying inter partes review of claims 1, 2, 4–8,
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`10–18, and 23–25 (the “Challenged Claims”) of U.S. Patent No. 8,853,156 (the
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`“’156 patent”) as obvious based on Petitioner’s Ground 2.1 (Paper 17 at 22).
`
`I.
`
`INTRODUCTION
`The Board erred by imposing a greater evidentiary burden than required to
`
`establish that a reference is a printed publication at the institution stage. As a
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`consequence of this legal error, the Board improperly found that Petitioner did not
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`sufficiently establish that the Januvia Label (Ex. 1006) and Huettner (Ex. 1004) were
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`printed publications for purposes of institution. While the Board acknowledged that
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`Petitioner need only make a “threshold showing” of public accessibility at the
`
`institution stage, the Board actually required more evidence—an amount similar to
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`that required at the close of evidence and the conclusion of trial. This is not the
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`proper standard. At this stage of the proceeding, Petitioner’s evidence should be
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`assessed while recognizing that this assessment is being done without the benefit of
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`a fully developed record. For that reason, Petitioner need only make a “threshold”
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`showing at institution. That is, Petitioner need only come forward with sufficient
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`credible evidence establishing a reasonable likelihood that Petitioner will fully meet
`
`1 The Board instituted inter partes review on claims 1, 2, 4, 5 and 23 based on
`Ground 1. (Paper 17 at 16–20).
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`1
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`Patent 8,853,156
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`its burden at trial—nothing more.
`
`Under the correct legal standard, Petitioner’s evidence was sufficient for
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`institution. For instance, the Januvia Label is conspicuously dated “2006” in at least
`
`two places on its face. On the back of the label, there is also a prominent copyright
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`notice dated “2006,” as well as Merck’s trademarks and patent number, contact
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`information for Merck and the FDA, and the statements “Printed in USA” and
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`“FDA-Approved Patient Labeling.” (Ex. 1006 at 1, 13). Moreover, Exhibit 1006
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`includes an Internet Archive printout showing the Januvia Label was publically
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`accessible in 2006. (Id. at 14). This evidence reasonably suggests only one thing: the
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`Januvia Label was publically accessible in 2006 when the FDA approved Januvia.
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`Likewise, Dr. Davidson testified that Huettner was published in 2007. (Ex.
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`1002 at ¶ 56). His testimony is entirely corroborated by Huettner’s facial indicia,
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`including the dates “22-26 June 2007,” poster number “0586P,” conference name,
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`Patent Owner’s logo, and a prominently displayed acknowledgment
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`to study
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`participants. (Ex. 1004). Further, nothing in Huettner indicates that the document is
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`a draft or confidential. (Id.). Everything about Huettner’s appearance and content
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`indicates it was published in 2007 and suggests Dr. Davidson’s testimony is correct.
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`Indeed, at the institution stage, the Board has routinely found a sufficient
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`threshold showing that a reference is a printed publication on similar evidence.
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`Moreover, the Board also erred by not only discounting Dr. Davidson’s testimony
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`2
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`Patent 8,853,156
`that the Januvia Label and Huettner were published as of the critical date, but also
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`by overlooking prominent facial indicia on these references, which taken alone or
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`together with Dr. Davidson’s testimony, sufficiently establish a threshold showing
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`at the institution stage that these references are printed publications.
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`While Petitioner does not specifically call out all of these indicia in its
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`Petition, such indicia are nonetheless facts relevant to the Board’s inquiry and should
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`have been afforded proper evidentiary weight given their prominence and import to
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`the issue of public availability. Illumina, Inc. v. The Trustees of Columbia Univ. in
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`the City of New York, IPR2012-00007 (PTAB May 10, 2013) (It is the duty of the
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`Board to apply the pertinent law to the facts of the case). That is not to say that the
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`Board is expected to scour the evidence. However, the Board should not have
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`ignored these indicia in the Januvia Label and Huettner, particularly given that they
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`are readily apparent upon inspection and relevant to the issues here. See, e.g., Oracle
`
`Am., Inc., Paper 7 at 17 (despite not being raised by petitioner, the Board found, on
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`its own accord, indicia of public accessibility in prior art reference); Informatica
`
`Corp., 2015 WL 3523401, at *18 (same); Toshiba Corp, 2015 WL 1090309, at *17–
`
`*18 (same); Bld Servs., LLC, v. LMK Techs., IPR2014-00772, 2014 WL 6666762,
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`at *5 (PTAB Nov. 20, 2014) (same); Fujian Newland Computer Co., Ltd. v. Hand
`
`Held Products, Inc., IPR2013-00595, Paper 14 at 17 (PTAB Feb. 28, 2014) (same).
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`Further, in light of the evidence Petitioner has already presented regarding the
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`3
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`Patent 8,853,156
`Januvia Label and Huettner, and given that the Board decided to institute trial on
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`another ground, it need not decide the ultimate question of whether the references
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`are printed publications now. See Intex Recreation Corp. v. Bestway Inflatables &
`
`Material Corp., IPR2016-00180, Paper 13 at 13 (PTAB June 6, 2016) (instituting
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`despite “not reach[ing] the dispute regarding whether the [documents] have been
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`established properly to be ‘printed publications’” as trial would also proceed on a
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`separate ground). Therefore, deciding the issue on a more developed record will not
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`unduly burden the Board or the parties.
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`Accordingly, the Board’s decision not to institute on the purported grounds
`
`that the Petitioner failed to make a threshold showing that the Januvia Label or
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`Huettner is a printed publication was legal error and thus warrants rehearing.
`
`II.
`
`ARGUMENT
`A.
`Legal Standard for Rehearing
`Pursuant to 37 C.F.R. § 42.71(d), a party may request rehearing of a decision
`
`by the Board whether to institute a trial. “The request must specifically identify all
`
`matters the party believes the Board misapprehended or overlooked, and the place
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`where each matter was previously addressed in a motion, opposition, or reply.” Id.
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`The Board will review the previous decision for an abuse of discretion. 37 C.F.R. §
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`42.71(c). “An abuse of discretion occurs where the decision is based on an erroneous
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`interpretation of law, on factual findings that are not supported by substantial
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`4
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`Patent 8,853,156
`evidence, or represents an unreasonable judgment in weighing relevant factors.” Star
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`Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005).
`
`B.
`
`Legal Standard for Establishing a Printed Publication at the
`Institution Stage
`In an inter partes review, the petitioner bears the burden of establishing
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`unpatentability of the challenged claims by a preponderance of the evidence. 35
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`U.S.C. § 316(e). This burden, however, only applies at the conclusion of the trial
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`and the close of the evidence; the statute does not require a petitioner to meet its
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`ultimate burden based on the information in its petition alone. See TriVascular, Inc.
`
`v. Samuels, 812 F. 3d 1056, 1068 (Fed. Cir. 2016) (explaining that there is a
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`“significant difference between a petitioner’s burden to establish a ‘reasonable
`
`likelihood of success’ at
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`institution, and actually proving invalidity by a
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`preponderance of the evidence at trial”). To be clear, the “reasonable likelihood”
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`standard for instituting inter partes review is not a lower standard of proof than a
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`preponderance of the evidence, but instead asks whether the same preponderance
`
`standard is reasonably likely to be met at the close of evidence and conclusion of
`
`trial. The Board must therefore assess petitioner’s evidence while “recognizing that
`
`it is doing so without all evidence that may come out at trial.” New England Braiding
`
`Co. v. A.W. Chesterton Co., 970 F.2d 878, 883 (Fed. Cir. 1992). As such, the Board
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`has required only a “threshold showing” of public availability in order to institute
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`trial. See EMC Corp. v. PersonalWeb Techs, LLC, IPR2013-00085, 2013 WL
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`5
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`8595564, at *8 (PTAB May 17, 2013); Veeam Sw. Corp. v. Symantec Corp.,
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`IPR2014–00089, Paper 9 at 14 (PTAB Apr. 25, 2014).
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`Indeed, numerous Board decisions have consistently held that a Petitioner
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`need not provide the same evidentiary showing that is ordinarily required after a full
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`record at trial. Even conclusory testimony from declarants and/or facial indicia on
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`challenged documents themselves have been found to be sufficient evidence of
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`public accessibility to meet the “reasonable likelihood” threshold for institution.
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`These indicia include, among other things, copyright notices, trademarks, patent
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`markings, dates, company logos, as well as the overall format and appearance of the
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`documents themselves. See, e.g., Informatica Corp. v. Protegrity Corp., CBM2015-
`
`00021, 2015 WL 3523401, at *18 (PTAB June 1, 2015) (declarant’s “conclusory
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`statement” that the reference was “published in 1971” corroborated only by “indicia”
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`in the document itself was sufficient evidence that the reference was a printed
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`publication for institution purposes); Am. Megatrends, Inc. v. Kinglite Holdings,
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`Inc., IPR2015-01197, 2015 WL 9599216, at *3 (PTAB Nov. 23, 2015) (copyright
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`notice on document evidence of public accessibility); Oracle Am., Inc. v. Realtime
`
`Data LLC, IPR2016-00374, Paper 7 at 17 (PTAB June 27, 2016) (“[p]etitioner has
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`made a threshold showing that [the document] is a ‘printed publication’” because
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`facial
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`indicia,
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`including the “format and appearance” of the document were
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`“consistent” with publication); Toshiba Corp. v. Optical Devices, LLC, IPR2014-
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`6
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`01447, 2015 WL 1090309, at *17–18 (PTAB Mar. 10, 2015) (presence of the “logo
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`of the manufacturer,” “product number,” and “date” “sufficient evidence at this stage
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`of the proceeding to establish that the [document] was publically available” at the
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`relevant time); Under Armour, Inc. v. Adidas AG, IPR2015-00700, 2015 WL
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`4932209, at *5 (PTAB Aug. 14, 2015) (copyright notice and “other factors” such as
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`date, company name, and submission of Internet Archive printout as well as the
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`absence of any indication that the document was a draft or confidential “weigh[ed]
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`in favor of finding [reference] was a printed publication” at institution stage).
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`Also, the very structure of inter partes review proceedings indicates that, at
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`the institution stage, the petitioner should not be required to go beyond a “threshold
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`showing.” Doing so would ignore that the C.F.R. provides mechanisms to resolve
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`issues concerning the sufficiency of the evidence after institution and before trial.
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`For example, “[o]nce a trial has been instituted, a party may file a motion to submit
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`supplemental information” if a “request . . . is made within one month of the date
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`the trial is instituted” and the supplemental information is “relevant to a claim for
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`which the trial has been instituted.” 37 C.F.R. § 42.123(a); see Captioncall, L.L.C.,
`
`v. UltraTech, Inc., IPR2013-00540, 2015 WL 1263028, at *18–21 (PTAB Mar. 3,
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`2015) (relying on supplemental information submitted after institution in finding
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`reference a printed publication under 35 U.S.C. § 102(b)).
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`Similarly,
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`the C.F.R. provides for discovery in an inter partes review,
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`7
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`including discovery into whether a reference is a “printed publication.” 37 C.F.R.
`
`§ 42.57; see, e.g., Am. Megatrends, 2015 WL 9599216, at *3 (instituting inter parts
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`review over argument that reference was not printed publication and explaining that
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`parties may take “appropriate discovery concerning the public availability of the
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`reference”). Thus, the nature of inter partes review is a further indication that the
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`“threshold showing” required at institution is not as high as the Board required here.
`
`C.
`
`Petitioner Established a Threshold Showing that the Januvia Label
`and Huettner were Printed Publications.
`1.
`The Januvia Label
`The Board found that Petitioner did not provide a threshold showing that the
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`Januvia Label constitutes a printed publication.
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`In doing so, the Board faults
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`Petitioner for not including a cite “to any information related to whether the Januvia
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`label was publically accessible in the relevant time frame, how one might have
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`obtained a copy of it, or whether it was reasonably accessible through generally
`
`available means.” (Paper 17 at 19–20). But there is no requirement that Petitioner
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`must establish each of these factors at the institution stage, and the Board erred by
`
`imposing one here. See Intex Recreation Corp., IPR2016-00180, Paper 13 at 13.
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`Indeed, Petitioner correctly established a threshold showing through Dr. Davidson’s
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`Declaration and the Januvia Label itself, which contains prominent facial indicia of
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`public accessibility in 2006.
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`First, Dr. Davidson testified that Januvia had been commercially available
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`8
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`since 2006 and that the Januvia Label published in 2006. (Ex. 1002 at ¶ 52); see
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`Informatica Corp., 2015 WL 3523401, at *18 (even allegedly conclusory testimony
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`and facial indicia held sufficient at institution stage). Patent Owner provides no
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`factual
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`information in its Preliminary Response that disputes Dr. Davidson’s
`
`testimony that the label was published in 2006. (See generally Paper 11). These
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`unrebutted facts are sufficient at this stage to satisfy Petitioner’s initial burden of
`
`establishing a “reasonable likelihood” that, at the close of trial, Petitioner will meet
`
`its burden of showing that the Januvia Label was publically available as of 2006.
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`See, e.g., Informatica Corp., 2015 WL 3523401, at *18.
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`Second, Dr. Davidson’s testimony is not an unsupported “conclusory
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`assertion.” (Paper 17 at 18). It is a statement of fact supported by the label itself,
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`which indicates that the FDA approved “Januvia” in 2006. (Ex. 1006 at 1). The face
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`of the label also bears the product name Januvia and date “Revised: 10/2006,” which
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`is entirely consistent with Dr. Davidson’s testimony that Januvia was commercially
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`available in 2006 and that the Januvia Label had published at that time. Id.; see Bld
`
`Servs., 2014 WL 6666762, at *5 (“revision date of 3/2006” and title “Installation
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`Instructions,” suggested that the disputed document “may have been made available
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`with sold product,” which was sufficient for threshold showing at institution stage).
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`Third, the Board overlooked that the Januvia Label includes a prominently
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`dated copyright notice—“COPYRIGHT © 2006 MERCK & CO., Inc.” (Ex. 1006,
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`9
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`at 13)—which the Board has treated as prima facie evidence of public accessibility.
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`See, e.g., FLIR Sys., Inc. v. Leak Surveys, Inc., IPR2014-00411, Paper 9 at 18–19
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`(PTAB Sept. 5, 2014) (“On the record before us, we are persuaded that the Copyright
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`notice prima facie establishes a prior art date of 2002”); LG Elecs., Inc. v. Advanced
`
`Micro Devices, Inc., IPR2015-00329, Paper 13 at 10–13 (PTAB July 10, 2015)
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`(accepting, for purposes of institution, a copyright notice as “some evidence of
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`public accessibility as of a particular date”). Thus, by prominently placing a
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`copyright notice on the Januvia Label, Merck represented that it first distributed the
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`Januvia Label to the public in 2006. Thus, the Januvia Label’s copyright notice is
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`evidence of its public distribution, not only generally, but in 2006.
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`Fourth, the Januvia Label includes other indicia of public accessibility,
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`namely a trademark (“JanuviaTM”); product use instructions; FDA phone numbers
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`and a website; safety warnings; and Merck’s U.S. and Italian contact addresses. (Ex.
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`1006 at 1, 13). The Board overlooked all of these indicia of public accessibility
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`prominently displayed on the Januvia Label. Moreover, the label includes the
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`statement that it was “Printed in USA” (Id. at 13), and a U.S. Patent marking (“US
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`Patent No.: 6,699,871”); as well as the bolded statement “FDA-Approved Patient
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`Labeling.” (Id.). These indicia constitute credible evidence establishing the Januvia
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`Label’s public accessibility as of 2006. See Apple Inc. v. Virnetx, Inc., IPR2016-
`
`00332, 2016 WL 5349402, at *5 (PTAB July 1, 2016) (copyright, trademark, contact
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`10
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`information, website, and statement “[p]rinted in the United States of America”
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`sufficient evidence of publically dissemination at institution stage).
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`Fifth, separate and apart from the label’s indicia, Petitioner also submitted a
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`printout from the Internet Archive showing the website from which the Januvia
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`Label was obtained. (Ex. 1006 at 14). This printout was submitted with the label and
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`is further evidence that the label was publically accessible in 2006. (See id.)
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`(showing vertical black marks in timeline indicating label was available in 2006).
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`Indeed, the Board’s decision to discount this evidence ignored its own long-standing
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`practice to recognize date stamps from the Internet Archive as demonstrating public
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`accessibility.2 See Cave Consulting Grp., LLC v. OptumInsight, Inc., 2015 WL
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`740379, at *9 & n.95 (N.D. Cal. Feb. 20, 2015) (“The PTO will accept date stamps
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`from the Internet Archive as evidence of when a given Web page was accessible to
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`the public” and “to determine if a Web page is available as prior art.”); see also Ex
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`Parte Hicks, 2013 WL 5882933, at *4 (PTAB Oct. 31, 2013) (examiner’s reliance
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`on Internet Archive sufficient to establish reference as prior art); Ex Parte Krivulka,
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`2 Patent Owner makes a factual misrepresentation in arguing that because the March
`16, 2015 Internet Archive update is highlighted, Exhibit 1006 is a 2015 version of
`the label. (Paper 11 at 15–16). The revision date on the March 16, 2015 version of
`the Januvia label lists a “03/2015” date—not “3/2006” as is found on the Januvia
`Label submitted as Exhibit 1006. Compare March 16, 2015 version, available at:
`https://web.archive.org/web/20150316190534/http://www.merck.com/product/usa/
`pi_circulars/j/januvia/januvia_pi.pdf with 2006 version (Ex. 1006), available at:
`https://web.archive.org/web/20061108173741/http://www.merck.com/product/usa/
`pi_circulars/j/januvia/januvia_pi.pdf.
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`11
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`2010 WL 3820666, at *4 (BPAI Sept. 28, 2010) (evidence from Internet Archive
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`sufficient to show public availability).
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`Sixth, nothing in the Januvia Label suggests that it was a draft or that it was
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`not meant to be publically disseminated. This is also an indication of public
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`accessibility. See Under Armour, 2015 WL 4932209, at *5 (the absence of any
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`suggestion that document was a draft is evidence of public accessibility); Int’l Bus.
`
`Machs. Corp. v. Intellectual Ventures II LLC, IPR2014-00681, 2014 WL 5585264,
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`at *9 (PTAB Oct. 30, 2014) (Patent Owner “has not pointed to any other indication,
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`in [manual] itself, that it is anything other than what it appears to be—a User’s Guide
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`that was published and accessible to users of the corresponding product on or around
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`the disclosed 1997 copyright date”).
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`Accordingly, the Board erred in requiring Petitioner to meet an evidentiary
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`standard that is more applicable at the conclusion of trial than at institution. Under
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`the proper standard, Petitioner made a threshold showing that the Januvia Label is a
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`printed publication through Dr. Davidson’s testimony, together with indicia on
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`Januvia Label itself. Accordingly, the Board should grant Petitioner’s motion for
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`rehearing and institute inter partes review on Petitioner’s Ground 2.3
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`3 Should the Board institute on Ground 2 based only on the Januvia Label, the claims
`implicated by this decision include claims 1, 2, 4, 5, 10, 14–18, and 23. (See Paper
`2 at 26–31).
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`12
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`Huettner
`2.
`Petitioner likewise made a threshold showing that Huettner is a printed
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`publication. As with the label, the Board erred by imposing an evidentiary burden
`
`that goes beyond what is needed to make a threshold showing at the institution stage.
`
`Specifically, Patent Owner alleged that Petitioner did not meet its burden because it
`
`presented no evidence that Huettner was displayed or, if it was displayed, for not
`
`establishing a multitude of factors “relevant to determining whether a temporarily
`
`displayed reference constitutes a ‘printed publication,’” including how long Huettner
`
`was displayed, the expertise of the audience, and the ability of others to copy it.
`
`(Paper 17 at 19).4 The Board agreed. (Id. at 20). But there is no requirement for
`
`Petitioner to establish these factors in order to make a threshold showing at the
`
`institution stage. Indeed, the declaration testimony of Dr. Davidson and the facial
`
`indicia on Huettner itself are sufficient.
`
`Dr. Davidson testifies that “Huettner was published in June 2007.” (Ex. 1002
`
`at ¶ 56). Patent Owner does not dispute this statement—nor can it. (See Paper 11).
`
`Moreover, the Board overlooked Huettner’s facial indicia (e.g., the format and
`
`appearance) of the document’s public accessibility that corroborate Dr. Davidson’s
`
`4 To the extent this information is necessary for Petitioner to meet its ultimate burden
`in showing that Huettner was a printed publication, a further developed record would
`no doubt reveal that Patent Owner’s use of Huettner will satisfy each one of these
`factors, as was already discovered in the pending district court litigation, Boehringer
`Ingelheim Pharms. Inc. v. HEC Pharm Co., et al., C.A. No. 15-5982 (D.N.J.).
`
`13
`
`
`
`Case IPR2016-01565
`Patent 8,853,156
`
`testimony. For instance, Huettner contains:
`
`
`
`
`
`The name, date, and location of the scientific conference (“ADA 22–26
`June 2007, Chicago”);
`A poster number (“Poster No. 0536P”);
`
`
`
`
`
`logo; and
`The Patent Owner’s own
`A prominent acknowledgment thanking the participants (“We would
`like to thank all those who participated in this study and were involved
`in the preparation, conduct, and analysis of this study.”)
`(Ex. 1004); These indicia, taken alone or with Dr. Davidson’s testimony, are more
`
`than sufficient
`
`to meet
`
`the threshold for showing that Huettner is a printed
`
`publication for purposes of institution. See, e.g., Informatica Corp., 2015 WL
`
`3523401, at *18; Oracle Am., Inc., Paper 7 at 17 (“threshold showing” of public
`
`accessibility because facial indicia, including the “format and appearance” of the
`
`document were “consistent” with publication); Toshiba Corp, 2015 WL 1090309, at
`
`*17–*18 (“logo of the manufacturer,” “product number,” and “date” were “sufficient
`
`evidence at this stage of the proceeding to establish” public availability).
`
`Also, like the document at issue in Under Armour, there “is no indication in
`
`[Huettner] that it was a draft document, that it was intended for internal, limited, or
`
`restricted distribution, or that it would have been printed, but not distributed.”
`
`IPR2015-00700, Paper 9, at 12; see also Veeam Sw. Corp, IPR2014–00089, Paper 9
`
`at 14 (“no indication in the [references] that they are merely drafts or internal
`
`documents”). And unlike in Frontier Theraputics, which the Board relies upon,
`
`14
`
`
`
`Case IPR2016-01565
`Patent 8,853,156
`Huettner is Patent Owner’s own document—not a third-party’s—and two of the
`
`Huettner authors are also named inventors on the ’156 patent. IPR2016-00649, Paper
`
`10 at 22. The fact that Patent Owner puts forward no evidence denying the
`
`publication of its own document, weighs in favor of finding that Huettner was
`
`publically accessible at this stage of the proceeding. See 37 C.F.R. § 42.108(c)
`
`(evidence to be “viewed in the light most favorable to the petitioner solely for
`
`purposes of deciding whether to institute an inter partes review”).
`
`Accordingly, the Board erred in finding that, for the purpose of institution,
`
`Petitioner required more evidence than that provided in Dr. Davidson’s Declaration
`
`and in Huettner. Given that Petitioner is only required to make a “threshold
`
`showing,” and in light of prior Board decisions interpreting this standard,
`
`Petitioner’s evidence sufficiently establishes that Huettner was publicly accessible
`
`in 2007 for institution purposes. See Toshiba Corp., 2015 WL1090309, at *17–18
`
`(PTAB Mar. 10, 2015). Thus, the Board should grant Petitioner’s motion for
`
`rehearing and institute inter partes review on Petitioner’s Ground 2.
`
`III. CONCLUSION
`
`For the foregoing reasons, Petitioner Mylan Pharmaceuticals Inc. respectfully
`
`requests that the Board institute inter partes review of claims 1, 2, 4–8, 10–18, and
`
`23–25 on the ground that the claims are obvious over the Januvia Label, Huettner,
`
`and Mikhail or the Knowledge of a POSA (Ground 2).
`
`15
`
`
`
`Dated: February 23, 2017
`
`Respectfully submitted,
`
`Case IPR2016-01565
`Patent 8,853,156
`
`/ Thomas J. Parker /
`Thomas J. Parker
`Reg. No. 42,062
`ALSTON & BIRD LLP
`90 Park Avenue, 15th Floor
`New York, NY 10016
`Telephone: 212.210.9400
`Fax: 212.210.9444
`thomas.parker@alston.com
`
`Counsel for Petitioner
`
`16
`
`
`
`Case IPR2016-01565
`Patent 8,853,156
`
`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. §42.6(e), the undersigned hereby certifies that, on the
`
`23rd day of February, 2017 a complete copy of the foregoing “MOTION FOR
`
`REHEARING UNDER 37 C.F.R. § 42.71” was served via e-mail on counsel for
`
`Patent Owner:
`
`Leora Ben-Ami (Reg. No. 32,455)
`Email: leora.benami@kirkland.com
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, New York 10022
`Tel: (212) 446-4800
`Fax: (212) 446-4900
`
`Jeanna Wacker (Pro Hac Vice)
`Email: jeanna.wacker@kirkland.com
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, New York 10022
`Tel: (212) 446-4800
`Fax: (212) 446-4900
`
`Eugene Goryunov (Reg. No. 61,579)
`Email: eugene.goryunov@kirkland.com
`KIRKLAND & ELLIS LLP
`300 North LaSalle
`Chicago, Illinois 60654
`Tel: (312) 862-2000
`Fax: (312) 862-2200
`
`Mira Mulvaney (Reg. No. 69,850)
`Email: mira.mulvaney@kirkland.com
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, New York 10022
`Tel: (212) 446-4800
`Fax: (212) 446-4900
`
`Dated: February 23, 2017
`
`/ Thomas J. Parker /
`Thomas J. Parker
`(Reg. No. 42,062)
`
`17
`
`
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