Trials@uspto.gov
`571-272-7822
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`
`
`Paper 22
`Date: September 17, 2018
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`BRISTOL-MYERS SQUIBB COMPANY and PFIZER INC.,
`Patent Owners.
`
`
`
`Case IPR2018-00892
`Patent 9,326,945 B2
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN and ZHENYU YANG,
`Administrative Patent Judges.
`
`
`SNEDDEN, Administrative Patent Judge.
`
`
`ORDER
`Conduct of the Proceeding
`37 C.F.R. § 42.5
`
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`
`Paper 22
`Date: September 17, 2018
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`BRISTOL-MYERS SQUIBB COMPANY and PFIZER INC.,
`Patent Owners.
`
`
`
`Case IPR2018-00892
`Patent 9,326,945 B2
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN and ZHENYU YANG,
`Administrative Patent Judges.
`
`
`SNEDDEN, Administrative Patent Judge.
`
`
`ORDER
`Conduct of the Proceeding
`37 C.F.R. § 42.5
`
`
`
`
`
`
`
`
`
`I.
`
`IPR2018-00892
`Patent 9,326,945 B2
`
`INTRODUCTION
`In an email sent to the Board on August 9, 2018, counsel for
`Petitioner requested a conference call seeking authorization to file a reply to
`Patent Owner’s Preliminary Response (Paper 18, “Prelim. Resp.”) to address
`arguments made by Patent Owners that: (a) the Board should exercise its
`discretion to deny the Petition pursuant to 35 U.S.C. § 325(d) (id. at 15–44);
`and (b) the Petition does not include any evidence to show that the
`references Carreiro,1 FDA Dissolution Guidance, 2 and Rudnic3 qualify as
`printed publications (id. at 42–45). Patent Owners oppose Petitioner’s
`request.
`A conference call was held between counsel for the parties and the
`Board on August 30, 2018, to discuss Petitioner’s request. A transcript of
`the conference call has been entered by Petitioner as Ex. 1036.
`Petitioner may seek authorization to file a reply to the preliminary
`response, but “must make a showing of good cause.” 37 C.F.R. § 42.108(c)
`(revised April 1, 2016). For the reasons that follow, Petitioner’s request for
`authorization is denied for lack of good cause.
`
`
`1 Ex. 1004, Carreiro et al., Apixaban, an oral direct Factor Xa inhibitor:
`awaiting the verdict, 17(12) EXPERT OPIN. INVESTIG. DRUGS 1937–45
`(2008).
`2 Ex. 1015, Guidance for Industry: Dissolution Testing of Immediate Release
`Solid Oral Dosage Forms, U.S. Department of Health and Human Services,
`Food and Drug Administration, Center for Drug Evaluation and Research
`(CDER) (Aug. 1997).
`3 Ex. 1010, Rudnic et al., “Tablet Dosage Forms,” in Modern
`Pharmaceutics, 4th ed., G.S. Banker and C.T. Rhodes, eds., Taylor &
`Francis Group, Boca Raton, FL, pp. 333–59 (2002).
`2
`
`
`
`
`
`IPR2018-00892
`Patent 9,326,945 B2
`
`II. ANALYSIS
`A. Discretionary denial
`In its preliminary response, Patent Owners argue that Petitioner relies
`on the same or substantially the same references applied by the Examiner
`during prosecution. Prelim. Resp., 15. In particular, Patent Owners argued
`that “the portions of Wei relied upon by Petitioner are identical to the
`portions of Wei that were cited by the Examiner” and that “the portions of
`the Carreiro reference and the ’208 Patent asserted in the Grounds are
`cumulative to the Nause reference cited by the Examiner for substantially
`the same information.” Id. at 16.
`On the call, Petitioner argued that the Patent Owner Preliminary
`Response omits material facts contained in the record, in particular, that
`there is no mention of the testimonial evidence from Dr. Park submitted in
`support of the Petition. Patent Owners argued that the Board is typically
`capable of evaluating whether there are factual inaccuracies in Patent
`Owner’s Preliminary Response concerning the prosecution history without
`further briefing from Petitioner. Patent Owners further argued that
`Petitioner had the opportunity to address the issue in the Petition and that
`Petitioner was on notice that, by statute, consideration may be given to
`whether the prior art or arguments presented in the Petition are the same, or
`substantially the same, as those previously raised during prosecution.
`In consideration of the arguments advanced during the teleconference
`by both parties, we determine that good cause for authorization to file the
`requested reply has not been shown for the reasons articulated by Patent
`Owners, summarized above. Furthermore, we are aware of Dr. Park’s
`declaration and there is no indication that the record lacks sufficient
`
`
`
`3
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`IPR2018-00892
`Patent 9,326,945 B2
`
`information hindering our ability to scrutinize Patent Owner’s contentions
`regarding the prosecution history.
`B. Printed publication
`In its preliminary response, Patent Owners argued that “Petitioner has
`not met its burden of production to establish that Rudnic, FDA Guidance
`Document, and Carreiro are ‘printed publications’ under 35 U.S.C.
`§102(b).” Prelim. Resp. 42. In particular, Patent Owner argued that
`“Petitioner has not established that [Rudnic] is a ‘printed publication,’ or, if
`it is, that the version of Rudnic in Exhibit 1010 is authentic.” Id. Patent
`Owner argued also that the Petition does not include any evidence
`supporting the public accessibility of FDA Guidance Document and that the
`copyright date of 2008 for Carreiro is not enough to establish that the
`document is a printed publication. Id. at 43–44.
`On the call, Petitioner requested that it be given the opportunity to
`address factual and legal errors on the current record and to recite recent
`Federal Circuit case law related to the issue of public accessibility, namely
`Jazz Pharm., Inc. v. Amneal Pharm., LLC, 895 F.3d 1347 (Fed. Cir. 2018)
`and Gopro, Inc. v. Contour IP Holding LLC, 898 F.3d 1170, 1176 (Fed. Cir.
`2018). Patent Owners argued that the cases cited by Petitioner do not
`announce new law or modify existing law and, as such, Petitioner cannot
`rely on these cases to show good cause.
`In consideration of the arguments advanced during the teleconference
`by both parties, we determine that good cause for authorization to file the
`requested reply has not been shown for the reasons articulated by Patent
`Owners, summarized above. Furthermore, we note that, if trial is instituted,
`Petitioner will have the opportunity at trial to respond to Patent Owner’s
`
`
`
`4
`
`
`
`IPR2018-00892
`Patent 9,326,945 B2
`
`contentions with regard to sufficiency of evidence with supplemental
`information under § 42.123(a) and/or evidentiary objections with
`supplemental evidence under 37 C.F.R. § 42.64(b)(2). See generally
`Groupon Inc. v. Blue Calypso, LLC, Case CBM2013-00033, slip op. at 2-5
`(PTAB May 12, 2013) (Paper 29) (distinguishing admissibility of evidence
`from sufficiency of evidence); see also BioMarin Pharmaceutical Inc. v.
`Genzyme Therapeutic Products Limited Partnership, IPR2013-00534, Paper
`80, 5–6 (granting motion to submit supplemental information allegedly
`confirming the public accessibility of a prior art document); cf. Illumina, Inc.
`v. The Trustees of Columbia Univ. in the City of New York, IPR2012-00006,
`Paper 125, 3 (denying motion to submit supplemental information based on
`nineteen day delay in seeking relief and proximity to end of proceedings).
`
`III. ORDER
`For the reasons given, it is hereby:
`ORDERED that Petitioner’s request to file a reply to Patent Owner’s
`Preliminary Response is denied.
`
`
`
`
`
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`
`
`
`
`5
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`
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`IPR2018-00892
`Patent 9,326,945 B2
`
`PETITIONER:
`
`Robert L. Florence
`Karen L. Carroll
`Michael L. Binns
`Sharad K. Bijanki
`Parker Poe Adams & Bernstein LLP
`robertflorence@parkerpoe.com
`karencarroll@parkerpoe.com
`michealbinns@parkerpoe.com
`sharadbijanki@parkerpoe.com
`
`PATENT OWNER:
`
`Heather M. Petruzzi
`Timothy A. Cook
`Kevin M. Yurkerwich
`Michael E. Nelson
`Wilmer Cutler Pickering Hale and Dorr LLP
`heather.petruzzi@wilmerhale.com
`tim.cook@wilmerhale.com
`kevin.yurkerwich@wilmerhale.com
`michael.nelson@wilmerhale.com
`
`Jason M. Okun
`Fitzpatrick, Cella, Harper & Scinto
`jokun@fchs.com
`
`
`
`6
`
`
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