`Filed on behalf of: Otsuka Pharmaceutical Co., Ltd.
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
`
`ALKERMES PHARMA IRELAND LTD.
`and ALKERMES, INC.,
`Petitioner,
`
`
`v.
`
`
`OTSUKA PHARMACEUTICAL CO., LTD.,
`Patent Owner.
`____________________________________________
`
`Case IPR2017-00287
`Patent 9,125,939 B2
`____________________________________________
`
`
`
`
`Filed: February 28, 2017
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`
`
`

`

`TABLE OF CONTENTS
`
`U.S. Patent No. 9,125,939
`IPR2017-00287
`
`Page(s)
`
`I.
`
`II.
`
`Introduction ...................................................................................................... 1
`
`Petitioner Has Not Established That Keck, Citrome & BMS/Otsuka
`Press Release Are Printed Publications As Required by § 311(b) .................. 3
`
`A. An IPR Challenge Can Only Rely on Printed Publications .................. 4
`
`B.
`
`Petitioner Provides No Evidence of the Publication,
`Dissemination, or Public Availability of Keck and Citrome ................ 6
`
`1.
`
`2.
`
`Dr. Frances’s Testimony Fails to Establish that Keck and
`Citrome Were Published ............................................................. 6
`
`Petitioner Did Not Provide the Source of Keck and
`Citrome ......................................................................................10
`
`C.
`
`Petitioner Provides No Evidence of the Publication,
`Dissemination, or Public Availability of BMS/Otsuka Press
`Release .................................................................................................10
`
`1.
`
`2.
`
`3.
`
`Petitioner Provides No Evidence Supporting the
`Publication of BMS/Otsuka Press Release Before the
`Critical Date ..............................................................................11
`
`Petitioner Fails to Establish That Persons Interested in
`the Art Would Have Been Able to Access BMS/Otsuka
`Press Release .............................................................................14
`
`Petitioner Does Not Provide the Source of BMS/Otsuka
`Press Release .............................................................................15
`
`III. Even If Certain Documents Constitute Printed Publications, Which
`Petitioner Has Not Shown, Petitioner Fails to Establish a Reasonable
`Likelihood that Any Claim is Unpatentable ..................................................16
`
`A.
`
`Petitioner Fails to Establish the Requisite Motivation to Support
`Its Proposed Grounds of Unpatentability ............................................17
`
`i
`
`

`

`U.S. Patent No. 9,125,939
`IPR2017-00287
`
`1.
`
`2.
`
`3.
`
`Petitioner Has Not Demonstrated That Atypical
`Antipsychotics Would Be Added to Mood Stabilizers
`“Whenever the Mood Stabilizer Was Insufficiently
`Effective” ..................................................................................17
`
`Petitioner Does Not Argue and Provides No Evidence
`that Aripiprazole Was Viewed as Interchangeable With
`Other Atypical Antipsychotics for Bipolar Disorder ................21
`
`Petitioner’s Remaining Documents Do Not Cure These
`Deficiencies ...............................................................................23
`
`B.
`
`Petitioner Provides No Basis to Support a Reasonable
`Expectation of Success ........................................................................25
`
`1.
`
`2.
`
`3.
`
`Petitioner Does Not Account for Aripiprazole’s
`Distinctiveness ..........................................................................26
`
`Petitioner Does Not Account for the Claimed Patient
`Population .................................................................................28
`
`Petitioner’s Allegation of Reasonable Expectation of
`Success Impermissibly Relies on the ’939 Patent
`Specification ..............................................................................32
`
`IV. Petitioner’s Grounds Should Be Denied as Redundant to the Art and
`Arguments Previously Considered and Overcome During Prosecution .......33
`
`A.
`
`B.
`
`C.
`
`The Board Should Deny Institution Where the Same or
`Substantially the Same Prior Art or Arguments Were
`Previously Presented ...........................................................................33
`
`Summary of the Prosecution of the ’939 Patent .................................34
`
`Petitioner Relies on the Same or Cumulative Documents and
`Uses Them in the Same Way the Examiner Did .................................39
`
`1.
`
`2.
`
`Keck and BMS/Otsuka Press Release are Cumulative of
`Clinical Trial Report .................................................................39
`
`Tohen is Tohen ..........................................................................40
`
`ii
`
`

`

`U.S. Patent No. 9,125,939
`IPR2017-00287
`
`3.
`
`4.
`
`5.
`
`6.
`
`Citrome is Almost Citrome S187 ..............................................41
`
`APA Guidelines are Cumulative of Kowatch ...........................43
`
`Expert Consensus Adds Nothing to the Art the Examiner
`Considered ................................................................................46
`
`Conclusion ................................................................................48
`
`D.
`
`E.
`
`Petitioner’s “Side Effects” Arguments Are Irrelevant ........................49
`
`Petitioner’s Arguments Regarding Dr. Hirose’s Declaration Are
`Irrelevant and Do Not Undermine the Examiner’s Conclusions
`Regarding Patentability .......................................................................50
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`The Hirose Data ........................................................................50
`
`The Results Do Not Change by Expressing Them as %
`Suppression or by Normalizing Them ......................................53
`
`The Data was Sufficiently Explained .......................................54
`
`Dr. Au’s Synergy Model Would Not Have Been
`Appropriate ...............................................................................57
`
`Dr. Au’s Arguments Strongly Suggest that a Person of
`Ordinary Skill in the Art Would Not Have Had a
`Reasonable Expectation of Success ..........................................57
`
`V.
`
`Petitioner’s Six Grounds of Unpatentability Are Redundant of One
`Another ..........................................................................................................59
`
`A. All Grounds Are Horizontally Redundant ..........................................59
`
`B. Grounds 1 and 4, Grounds 2 and 4, and Grounds 2 and 6 Are
`Vertically Redundant ...........................................................................61
`
`VI. Conclusion .....................................................................................................63
`
`
`
`
`
`
`
`iii
`
`

`

`U.S. Patent No. 9,125,939
`IPR2017-00287
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Air Liquide Large Indus. U.S., LP v. Praxair Tech. Inc.,
`IPR2015-01074, Paper 11 (P.T.A.B. Oct. 26, 2015) .......................................... 13
`
`Amgen Inc. v. F. Hoffman-La Roche Ltd.,
`580 F.3d 1340 (Fed. Cir. 2009) .......................................................................... 25
`
`Apotex Inc. v. OSI Pharms., Inc.,
`IPR2016-01284, Paper 8 (P.T.A.B. Jan. 9, 2017) .............................................. 33
`
`Ashland Oil, Inc. v. Delta Resins & Refractories, Inc.,
`776 F.2d 281 (Fed. Cir. 1985) ............................................................................ 18
`
`Boehringer Ingelheim Int’l GmbH v. Biogen Inc.,
`IPR2015-00418, Paper 14 (P.T.A.B. July 13, 2015) ...................................passim
`
`Broadcom Corp. v. Emulex Corp.,
`732 F.3d 1325 (Fed. Cir. 2013) .......................................................................... 25
`
`Cisco Sys., Inc. v. Constellation Techs. L.L.C.,
`IPR2014-01085, Paper 11 (P.T.A.B. Jan. 9, 2015) ............................................ 15
`
`Coal. for Affordable Drugs IV LLC (“ADROCA”) v. Pharmacyclics,
`Inc.,
`IPR2015-01076, Paper 33 (P.T.A.B. Oct. 19, 2015) ...................................passim
`
`Daiichi Sankyo Co. v. Matrix Labs., Ltd.,
`619 F.3d 1346 (Fed. Cir. 2010) .......................................................................... 49
`
`DePuy Spine, Inc v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) .......................................................................... 28
`
`DIRECTV, LLC v. Qurio Holdings, Inc.,
`IPR2015-02006, Paper 6 (P.T.A.B. Apr. 4, 2016) ....................................... 18, 19
`
`EMC Corp. v. PersonalWeb Techs., LLC,
`IPR2013-00082, Paper 33 (P.T.A.B. June 5, 2013) ........................................... 60
`
`iv
`
`

`

`U.S. Patent No. 9,125,939
`IPR2017-00287
`
`Ford Motor Co. v. Versata Dev. Grp., Inc.,
`IPR2016-01012, Paper 12 (P.T.A.B. Nov. 4, 2016) ....................................passim
`
`Gen. Elec. Co. v. TAS Energy Inc.,
`IPR2014-00163, Paper 11 (P.T.A.B. May 13, 2014) ................................... 18, 23
`
`Google Inc. v. ART+COM Innovationpool GmbH,
`IPR2015-00789, Paper 8 (P.T.A.B. Sept. 2, 2015)........................................ 4, 13
`
`Groupon, Inc. v. Blue Calypso, LLC,
`CBM2013-00035, Paper 45 (P.T.A.B. Dec. 17, 2014) ........................................ 5
`
`In re Bayer,
`568 F.2d 1357 (Fed. Cir. 1978) .......................................................................... 14
`
`In re Cronyn,
`890 F.2d 1158 (Fed. Cir. 1989) ............................................................................ 4
`
`In re Klopfenstein,
`380 F.3d 1345 (Fed. Cir. 2004) ............................................................................ 7
`
`In re Lister,
`583 F.3d 1307 (Fed. Cir. 2009) ............................................................................ 5
`
`In re Magnum Oil Tools Int’l., Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) .......................................................................... 23
`
`Intelgenx Corp v. ICOS Corp.,
`IPR2016-00678, Paper 13 (P.T.A.B. Sept. 1, 2016)........................................... 31
`
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) .................................................................... 26, 29
`
`Jiawei Tech. (HK) Ltd. v. Richmond,
`IPR2014-00937, Paper 22 (P.T.A.B. Dec. 16, 2014) ......................................... 31
`
`Kayak Software Corp. v. Int’l Bus. Machs. Corp.,
`CBM2016-00075, Paper 16 (P.T.A.B. Dec. 15, 2016)...................................... 34
`
`KSR Int’l v. Teleflex Inc.,
`550 U.S. 398 (2007) ...................................................................................... 28, 32
`
`v
`
`

`

`U.S. Patent No. 9,125,939
`IPR2017-00287
`
`LG Elecs., Inc. v. Advanced Micro Devices, Inc.,
`IPR2015-00329, Paper 13 (P.T.A.B. July 10, 2015) .......................................... 11
`
`Liberty Mutual Ins. Co. v. Progressive Casualty Ins. Co.,
`CBM2012-00003, Paper 7 (P.T.A.B. Oct. 25, 2012) ................................... 59, 61
`
`Life Techs. v. Clontech Labs., Inc.,
`224 F.3d 1320 (Fed. Cir. 2000) .......................................................................... 32
`
`Logic Tech. Dev., LLC v. Fontem Holdings 1 B.V.,
`IPR2015-00098, Paper 8 (P.T.A.B. May 11, 2015) ........................................... 23
`
`Lower Drug Prices for Consumers, LLC v. Forest Labs. Holdings
`Ltd.,
`IPR2016-00379, Paper 14 (P.T.A.B. July 1, 2016) ............................................ 33
`
`Microsoft Corp. v. Corel Software, LLC,
`IPR2016-01300, Paper 13 (P.T.A.B. Jan. 4, 2017) ............................................ 14
`
`Mylan Pharms. Inc. v. Yeda Research & Dev. Co.,
`PGR2016-00010, Paper 9 (P.T.A.B. Aug. 15, 2016) ......................................... 33
`
`Neil Ziegmann, N.P.Z., Inc. v. Stephens,
`IPR2015-01860, Paper 11 (P.T.A.B. Feb. 24, 2016) .......................................... 33
`
`Norian Corp. v. Stryker Corp.
`363 F.3d 1321 (Fed. Cir. 2004) ............................................................................ 8
`
`Otsuka Pharm. Co., Ltd. v. Sandoz, Inc.,
`3:07-cv-01000, 2010 WL 4596324 (D.N.J. Nov. 15, 2010) .............................. 22
`
`Otsuka Pharm. Co., Ltd. v. Sandoz, Inc.,
`678 F.3d 1280 (Fed. Cir. 2012) .......................................................................... 22
`
`Par Pharm. Inc. v. Jazz Pharm. Ireland Ltd.,
`IPR2016-00002, Paper 12 (P.T.A.B. Apr. 12, 2016) ......................................... 27
`
`Personal Web Techs., LLC v. Apple, Inc.,
`--- F.3d ----, 2017 WL 587132 (Fed. Cir. Feb. 14, 2017) ................................... 20
`
`Phigenix, Inc. v. Genentech, Inc.,
`IPR2014-00842, Paper 10 (P.T.A.B. Dec. 9, 2014) ........................................... 30
`
`vi
`
`

`

`U.S. Patent No. 9,125,939
`IPR2017-00287
`
`Praxair Distribution, Inc. v. INO Therapeutics, Inc.,
`IPR2015-00522, Paper 12 (P.T.A.B. July 29, 2015) .............................. 13, 18, 23
`
`PRISM Pharma Co. v. Choongwae Pharma Corp.,
`IPR2014-00315, Paper 14 (P.T.A.B. July 8, 2014) ............................................ 34
`
`ResQNet.com, Inc. v. Lansa, Inc.,
`594 F.3d 860 (Fed. Cir. 2010) ...................................................................... 15, 42
`
`SAS Institute, Inc. v. ComplementSoft, LLC,
`IPR2013-00581, Paper 17 (P.T.A.B. Feb. 25, 2014) .......................................... 23
`
`Square, Inc. v. Unwired Planet, LLC,
`CBM2014-00156, Paper 11 (P.T.A.B. Dec. 24, 2014) ...................................... 11
`
`SRI Intern., Inc. v. Internet Sec. Sys., Inc.,
`511 F.3d 1186 (Fed. Cir. 2008) ...................................................................... 5, 15
`
`Star Sci., Inc. v. R.J. Reynolds Tobacco Co.,
`655 F.3d 1364 (Fed. Cir. 2011) .......................................................................... 20
`
`Temporal Power, Ltd. v. Beacon Power, LLC,
`IPR2015-00146, Paper 10 (P.T.A.B. Apr. 27, 2015) ......................................... 10
`
`Whole Space Indus. Ltd. v. Zipshade Indus. (B.V.I.) Corp.,
`IPR2015-00488, Paper 14 (P.T.A.B. July 24, 2015) .......................................... 18
`
`Federal Statutes
`
`35 U.S.C. § 102(b) ......................................................................................... 7, 11, 14
`
`35 U.S.C. § 103(a) ................................................................................................... 32
`
`35 U.S.C. § 311(b) ............................................................................................passim
`
`35 U.S.C. § 325(d) ............................................................................................passim
`
`35 U.S.C. § 371 ........................................................................................................ 34
`
`Regulations
`
`37 C.F.R. § 42.107 ..................................................................................................... 1
`
`vii
`
`

`

`U.S. Patent No. 9,125,939
`IPR2017-00287
`
`Other Authorities
`
`H.R. REP. No. 112-98, pt.1 (2011) ........................................................................... 33
`
`
`
`
`
`viii
`
`

`

`U.S. Patent No. 9,125,939
`IPR2017-00287
`
`PATENT OWNER’S EXHIBIT LIST
`
`
`
`EXHIBIT
`
`2001
`
`2002
`
`2003
`2004
`
`2005
`
`2006
`2007
`2008
`
`DESCRIPTION
`Image of webpage accessed via hyperlink,
`http://www.prnewswire.com/news-releases/data-demonstrate-
`aripiprazole-significantly-improved-symptoms-of-acute-mania-
`in-patients-with-bipolar-disorder-77570072.html, provided by Dr.
`Frances in Ex. 1002, ¶ 35
`Burris et al., Aripiprazole, a Novel Antipsychotic, Is a High-
`Affinity Partial Agonist at Human Dopamine D2 Receptors, 302
`J. PHARMACOLOGY & EXPERIMENTAL THERAPEUTICS 381 (2002)
`Jordan et al., U.S. Patent Application Publication No.
`2002/0173513
`Clinical Trial Report, CN138-00ST (“Clinical Trial Report”)
`Citrome et al., Pharmacokinetics and Safety of Aripiprazole and
`Concomitant Mood Stabilizers, 5 INT’L J.
`NEUROPSYCHOPHARMACOLOGY, S187, P.4.E. 035
`November 15, 2002, Prescription Information of Abilify®
`November 15, 2002, Letter from the FDA regarding Approval of
`Abilify®
`Excerpt from Hirose Declaration, Ex. 1076 at 1162
`
`
`
`
`
`
`ix
`
`

`

`U.S. Patent No. 9,125,939
`IPR2017-00287
`
`I.
`
`Introduction
`
`Patent Owner Otsuka Pharmaceutical Co., Ltd. respectfully submits this
`
`preliminary response under 37 C.F.R. § 42.107 to the Petition for Inter Partes
`
`Review of U.S. Patent No. 9,125,939 (“the ’939 patent”).
`
`The claims relate to a method of treating bipolar disorder in a patient
`
`partially nonresponsive to lithium or valproic acid, divalproex sodium or a salt
`
`thereof monotherapy by administering aripiprazole and lithium in a ratio of about 1
`
`part by weight aripiprazole to about 0.01 to 500 parts by weight lithium. Petitioner
`
`contends that claims 2, 6, 7, and 9 would have been obvious according to six
`
`proposed grounds of unpatentability. The requested grounds, however, fail to
`
`demonstrate that trial should be instituted for three independent reasons.
`
`First, negating all six grounds, Petitioner fails to establish that at least three
`
`of the documents that it relies on are printed publications as required by § 311(b).
`
`Specifically, Petitioner does not establish that the abstracts of Keck (Ex. 1007) and
`
`Citrome (Ex. 1008) were publicly available at any date before the ’939 patent was
`
`filed, let alone as of the critical date. Petitioner also fails to provide sufficient
`
`evidence to establish that Otsuka/BMS Press Release (Ex. 1028) was publicly
`
`available before the critical date or that it would have been accessible to the
`
`interested public.
`
`1
`
`

`

`U.S. Patent No. 9,125,939
`IPR2017-00287
`
`Second, even if Petitioner’s documents constitute printed publications,
`
`which Petitioner has not shown, none of its requested grounds establishes a
`
`reasonable likelihood that any challenged claim is unpatentable. Every ground
`
`relies on the same conclusions that preliminary findings for specific atypical
`
`antipsychotics would have been extrapolated to all atypical antipsychotics,
`
`including aripiprazole, and that aripiprazole would have been expected to have the
`
`same usefulness in combination with mood stabilizing drugs as other antipsychotic
`
`medication. The record, however, does not support these conclusions. Instead,
`
`Petitioner’s own exhibits repeatedly recognize aripiprazole as a novel antipsychotic
`
`having a chemical structure and mechanism of action that differed from the
`
`marketed typical and atypical antipsychotics at the time.
`
`Moreover, Petitioner and its declarant present no evidence to support why a
`
`combination of aripiprazole and lithium would have been reasonably expected to
`
`treat bipolar disorder in the specific claimed population of bipolar disorder
`
`patients, i.e., “in a patient partially nonresponsive to lithium or valproic acid,
`
`divalproex sodium or salt thereof monotherapy.” Petitioner instead simply
`
`references certain examples in the ’939 patent specification and alleges that the
`
`inventors had a reasonable expectation of success based on the prior art.
`
`Petitioner’s reasoning is prohibited by law. It cannot rely on the examples in the
`
`2
`
`

`

`U.S. Patent No. 9,125,939
`IPR2017-00287
`
`’939 patent or the inventors’ alleged mindset to evidence what a person of ordinary
`
`skill in the art would have known or expected.
`
`Third, Petitioner’s grounds simply rehash the arguments that the Office fully
`
`vetted and ultimately withdrew during the prosecution of the ’939 patent.
`
`Although Petitioner relies on facially different documents, the disclosures and
`
`arguments based on them mirror the Examiner’s efforts. And none of Petitioner’s
`
`challenges to Patent Owner’s showing of unexpected results should undo the
`
`careful analysis that this Office already did. As a result, the Board should use its
`
`discretion under § 325(d) to deny institution.
`
`Thus, for these and other reasons presented below, Petitioner fails to show a
`
`reasonable likelihood of prevailing on any challenged claim. The Board should
`
`therefore deny institution of inter partes review.
`
`II.
`
`Petitioner Has Not Established That Keck, Citrome & BMS/Otsuka
`Press Release Are Printed Publications As Required by § 311(b)
`
`Petitioner asserts
`
`that Keck (Ex. 1007), Citrome (Ex. 1008) and
`
`BMS/Otsuka Press Release (Ex. 1028) are prior art (Pet. at 15 n.1, 16, 22 n.2), but
`
`fails to establish that any of those exhibits are printed publications as required by
`
`35 U.S.C. § 311(b). The critical date of the ’939 patent is May 23, 2002, which
`
`Petitioner does not challenge. Petitioner alleges that Keck and Citrome are
`
`abstracts from a 2002 Annual Meeting of the American Psychiatric Association
`
`3
`
`

`

`U.S. Patent No. 9,125,939
`IPR2017-00287
`
`(“APA”) held during May 18-23, 2002. Id. at 15 n.1, 22 n.2. Petitioner also
`
`asserts that they were published on or before the first day of the conference, i.e.,
`
`before the May 23, 2002, critical date. Id. Petitioner also argues that BMS/Otsuka
`
`Press Release was published on May 22, 2002, one day before the critical date. Id.
`
`at 16. Despite Petitioner’s assertions, however, it has not presented evidence
`
`sufficient to establish that Keck, BMS/Otsuka Press Release, and Citrome are
`
`printed publications at any date relevant for prior art purposes, let alone as of the
`
`critical date. Thus, because all of Petitioner’s grounds of unpatentability rely on
`
`either Keck or BMS/Otsuka Press Release or Citrome, the Petition must be denied
`
`as to all grounds.
`
`A. An IPR Challenge Can Only Rely on Printed Publications
`An IPR may only be initiated “on the basis of prior art consisting of patents
`
`or printed publications.” 35 U.S.C. § 311(b). Whether a document qualifies as a
`
`printed publication
`
`involves a case-by-case
`
`inquiry
`
`into
`
`the facts and
`
`circumstances surrounding the document’s disclosure to members of the public. In
`
`re Cronyn, 890 F.2d 1158, 1161 (Fed. Cir. 1989); Google Inc. v. ART+COM
`
`Innovationpool GmbH, IPR2015-00789, Paper 8 at 4, 6-10 (P.T.A.B. Sept. 2,
`
`2015). The key inquiry is whether the document was made “sufficiently accessible
`
`to the public interested in the art” before the critical date. Cronyn, 890 F.2d at
`
`1160.
`
`4
`
`

`

`U.S. Patent No. 9,125,939
`IPR2017-00287
`
`Petitioner has the burden of proving that a document was published or
`
`otherwise sufficiently disseminated to the public. See, e.g., In re Lister, 583 F.3d
`
`1307, 1317 (Fed. Cir. 2009) (burden is on the proponent to show document was
`
`publicly available); Coal. for Affordable Drugs IV LLC (“ADROCA”) v.
`
`Pharmacyclics, Inc., IPR2015-01076, Paper 33 at 6 (P.T.A.B. Oct. 19, 2015)
`
`(“Petitioner must make a threshold showing that the reference is a prior art ‘printed
`
`publication[].’”); Ford Motor Co. v. Versata Dev. Grp., Inc., IPR2016-01012,
`
`Paper 12 at 6 (P.T.A.B. Nov. 4, 2016). A document is publicly accessible “upon a
`
`satisfactory showing that such document has been disseminated or otherwise made
`
`available to the extent that persons interested and ordinarily skilled in the subject
`
`matter or art exercising reasonable diligence, can locate it.” SRI Intern., Inc. v.
`
`Internet Sec. Sys., Inc., 511 F.3d 1186, 1195 (Fed. Cir. 2008). A conclusory
`
`assertion without evidence of distribution or dissemination is insufficient to
`
`establish that a document is a “printed publication.” ADROCA, IPR2015-01076,
`
`Paper 33 at 7 (“Given his unsupported assertions, we give little to no weight to Dr.
`
`Atanackovic’s conclusory testimony that NCT00849654 constitutes prior art.’”);
`
`Groupon, Inc. v. Blue Calypso, LLC, CBM2013-00035, Paper 45 at 18-23
`
`(P.T.A.B. Dec. 17, 2014).
`
`5
`
`

`

`U.S. Patent No. 9,125,939
`IPR2017-00287
`
`B.
`
`the Publication,
`of
`Petitioner Provides No Evidence
`Dissemination, or Public Availability of Keck and Citrome
`
`Petitioner fails to show that Keck and Citrome qualify as prior art printed
`
`publications. Petitioner offers no evidence of the publication, dissemination, or
`
`public availability to support its assertion that Keck and Citrome were published
`
`and distributed before the critical date of the ’939 patent.
`
`1.
`
`Dr. Frances’s Testimony Fails to Establish that Keck and
`Citrome Were Published
`
`The exhibits themselves provide no support that they were published before
`
`the critical date. Both Keck and Citrome are two-page exhibits that include an
`
`identical first page stating “New Research Abstracts” for the 2002 Annual Meeting
`
`of the APA. Ex. 1007 at 1; Ex. 1008 at 1. The second page of Keck indicates that
`
`it is the eighty-sixth page of an unidentified document. Ex. 1007 at 2. Similarly,
`
`the second page of Citrome indicates that it is the eighty-seventh page of an
`
`unidentified document. Ex. 1008 at 2. The only dates found on either of these
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`documents relate to when the 2002 Annual Meeting and presentations supposedly
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`occurred. Ex. 1007; Ex. 1008. Accordingly, the exhibits themselves fail to
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`provide any indication of when they were published or disseminated to the
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`interested public.
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`Nevertheless, Petitioner asserts
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`that Keck and Citrome are printed
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`publications that were available at least as early as May 18, 2002, making them
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`prior art under § 102(b).1 Pet. at 15 n.1, 22 n.2. As support, Petitioner cites to Dr.
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`Frances’s declaration, which states that he has purportedly attended more than 20
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`Annual Meetings of the APA, and that Abstracts from those meetings are routinely
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`made available in print form to psychiatrists and to the public on or before the first
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`day of the conference. Id.; Ex. 1002 ¶ 34 n.3, ¶ 37 n.4. Dr. Frances did not testify
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`that he actually attended the 2002 Annual Meeting or that Keck and Citrome, in
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`particular, were actually distributed to the attendees on or before the first day of the
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`conference. As such, Dr. Frances fails to establish that these exhibits qualify as
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`prior art printed publications. To conclude otherwise would contravene Federal
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`Circuit and Board precedent.
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`Indeed, the Federal Circuit and Board both require evidence that a document
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`was actually published or distributed, rather than an unsupported assertion that it
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`1 To the extent Petitioner is arguing that the presentations themselves make Keck
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`and Citrome printed publications, Petitioner is wrong. An IPR may only be
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`initiated “on the basis of prior art consisting of patents or printed publications.” 35
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`U.S.C. § 311(b). Moreover, a presentation at a conference is not necessarily prior
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`art. In re Klopfenstein, 380 F.3d 1345, 1349 n.4 (Fed. Cir. 2004). Here, Petitioner
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`provides no evidence that the presentations underlying the abstracts actually
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`occurred.
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`was. For example, in Norian Corp. v. Stryker Corp., the Federal Circuit upheld the
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`district court’s finding that an abstract allegedly distributed at a conference was not
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`a printed publication because, among other things, the co-author of the abstract
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`testified that he had attended the meeting and had taken along a copy of the
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`abstract to be given to a meeting organizer, but could not recall whether he
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`attended the presentation and could not recall whether copies of the abstract were
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`actually available to hand out. 363 F.3d 1321, 1330 (Fed. Cir. 2004). The Court
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`upheld this finding despite record testimony that presenters at the conference
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`generally provided handouts to attendees. Id. By contrast, here Petitioner provides
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`no evidence 1) regarding the APA’s practice of distributing conference abstracts;
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`2) whether the APA even had standard distribution practices; and 3) whether those
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`practices (which have not been shown to exist) were actually followed for the 2002
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`Annual Meeting. Thus, Dr. Frances’s unsubstantiated testimony that the abstracts
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`for the annual meetings are “routinely made available” is insufficient to establish
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`Keck and Citrome as printed publications. Ex. 1002 ¶ 35.
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`The Board also requires firsthand knowledge of a document’s alleged
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`dissemination to the public. For example, the petitioner in Ford argued that an
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`article was published during a conference. IPR2016-01012, Paper 12 at 4-5. The
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`Board, however, found that “the only information on the face of Stahl to indicate
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`that it was publicly accessible before the critical date is the header,” and that “the
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`exhibit contains no copyright date, and there is no further indication in Stahl itself
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`as to when and under what circumstances or conditions it may have been
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`disseminated to members of the public.” Id. at 7. The Board was also
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`unpersuaded by the expert’s testimony that the article was allegedly published
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`during the conference because the expert made no showing that he attended or had
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`personal knowledge of the conference. Id. at 8-9.
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`The Board has similarly held that a petitioner failed to establish that clinical
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`trial protocols were printed publications when petitioner’s expert testified only that
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`clinical trial protocols were “typically” widely disseminated, without any firsthand
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`knowledge about the distribution of the protocols at issue. Boehringer Ingelheim
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`Int’l GmbH v. Biogen Inc., IPR2015-00418, Paper 14 at 10-12 (P.T.A.B. July 13,
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`2015); see also, ADROCA, IPR2015-01076, Paper 33 at 7 (“Dr. Atanackovic has
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`not attested to any personal knowledge of the public accessibility or dissemination
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`of NCT00849654 in February 2009.”).
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`The situation is no different here. Dr. Frances claims no firsthand
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`knowledge of the 2002 Annual Meeting, or of the Keck and Citrome abstracts
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`themselves. Nor does he provide any support for the APA’s allegedly standard
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`distribution practice beyond a generalization from allegedly attending more than
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`20 annual meetings. Dr. Frances could have attempted to provide specifics,
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`including entries from his calendar, registration packets, and abstracts from other
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`meetings he attended to support his contention. He did not. Thus, just like the
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`petitioners in Ford and Boehringer, Petitioner here has failed to provide evidence
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`that Keck and Citrome were actually published or disseminated prior to the critical
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`date (or by any relevant prior art date).
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`Petitioner Did Not Provide the Source of Keck and Citrome
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`2.
`Moreover, Petitioner does not provide any information about where it
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`obtained Keck and Citrome or how Petitioner assembled those exhibits. Dr.
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`Frances did not testify that the exhibits were true and accurate copies of the
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`abstracts obtained from attending the 2002 Annual Meeting. See Ex. 1002 ¶ 34
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`n.3, ¶ 37 n.4. In a similar situation, where the petitioner failed to explain whether
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`the document at issue was an actual copy obtained at a conference, the Board
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`found that the petitioner failed to establish that the document qualified as a prior
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`art printed publication. Temporal Power, Ltd. v. Beacon Power, LLC, IPR2015-
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`00146, Paper 10 at 11 (P.T.A.B. Apr. 27, 2015).
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`Thus, for at least these reasons, Petitioner has not established that Keck and
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`Citrome are prior art printed publications.
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`C.
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`the Publication,
`of
`Petitioner Provides No Evidence
`Dissemination, or Public Availability of BMS/Otsuka Press
`Release
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`Petitioner argues—without any citations to record evidence, including Dr.
`
`Frances’s declaration—that BMS/Otsuka Press Release from PR Newswire (Ex.
`
`10
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`1028) is a press release that was “available to the public at least as early as May
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`22, 2002,” making it § 102(b) prior art. Pet. at 16. Such an unsupported statement,
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`here again, cannot support a finding that BMS/Otsuka Press Release is a prior art
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`printed publication.
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`1.
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`Petitioner Provides No Evidence Supporting the Publication
`of BMS/Otsuka Press Release Before the Critical Date
`
`The Board requires petitioners to explain the nature of any alleged
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`publication date, and has held against them when they failed to do so. See, e.g.,
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`ADROCA, IPR2015-01076, Paper 33 at 7; LG Elecs., Inc. v. Advanced Micro
`
`Devices, Inc., IPR2015-00329, Paper 13 at 13 (P.T.A.B. July 10, 2015) (“Petitioner
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`offers no evidence of the nature of this date.”); Square, Inc. v. Unwired Planet,
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`LLC, CBM2014-00156, Paper 11 at 18 (P.T.A.B. Dec. 24, 2014) (“Petitioner has
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`failed to provide any evidence that would allow us to determine the significance of
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`the ISBN number[,]” which included the alleged publication d