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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.
`Petitioner,
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`v.
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`BRISTOL-MYERS SQUIBB COMPANY and PFIZER INC.,
`Patent Owners.
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`U.S. Patent No. 9,326,945 to Patel et al.
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`Inter Partes Review IPR2018-00892
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`Before SHERIDAN K SNEDDEN, ZHENYU YANG, and
`KRISTI L. R. SAWERT, Administrative Patent Judges
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`PETITIONER’S MOTION TO FILE SUPPLEMENTAL INFORMATION
`PURSUANT TO 37 C.F.R § 42.123(a)
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`I.
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`INTRODUCTION AND RELIEF REQUESTED
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`Pursuant to the Board’s Order of November 20, 2018 (Paper No. 30),
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`Petitioner moves to submit supplemental information pursuant to 37 C.F.R.
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`§ 42.123(a). In this proceeding, trial has been instituted for claims 1-38 of U.S.
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`Patent No. 9,326,945 B2, based on, in part, Rudnic (Ex. 1010). In a Preliminary
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`Response, Patent Owners challenged the admissibility and/or public availability of
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`Rudnic and have maintained that position in Objections to Evidence. (See Paper
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`No. 26). As detailed in Petitioner’s Motion to Correct a Typographical or Clerical
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`Mistake filed concurrently herewith, the Petition (Paper No. 2) and the Park
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`Declaration (Ex. 1002) incorrectly referred to Rudnic as Chapter 10 of the fourth
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`edition of the textbook Modern Pharmaceutics published in 2002, rather than
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`from the third edition published in 1996, due to a third-party prior art search
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`providing Petitioner with a copy of Chapter 10 of Modern Pharmaceutics from
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`the third edition, but misidentifying that chapter as coming from the fourth
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`edition. (See generally, Carroll Decl.). Petitioner seeks to replace Ex. 1010
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`submitted with the Petition with a clean copy of Rudnic (Ex. 1042), thereby
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`removing the incorrect header pages (i.e., cover and publishing information) from
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`the fourth edition with a new Ex. 1010 having the correct header pages.
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`II. DISCUSSION OF AUTHORITY AND MATERIAL FACTS
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`Petitioner first became aware of a possible error relating to Rudnic when
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`1
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`Patent Owners challenged the admissibility and prior art status of Rudnic in a
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`Preliminary Response (Paper No. 18, pp. 42-43) and submitted a table of contents
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`purporting to be from the fourth edition of Modern Pharmaceutics (Ex. 2019).
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`(See Carroll Decl., ¶ 7). Petitioner investigated further by obtaining a complete
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`copy of the fourth edition of Modern Pharmaceutics, comparing Chapter 10 from
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`both editions, and discovered the error necessitating this motion. (See Carroll
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`Decl., ¶ 8). Patent Owners have maintained their assertions regarding the
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`admissibility and prior art status of Rudnic, further necessitating this motion.
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`Within one month of the Board’s institution decision, Petitioner timely
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`requested authorization from the Board to file this motion1 and the supplemental
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`information is relevant to a claim for which the trial has been instituted as Rudnic
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`was cited by Petitioner in support of Grounds 2 and 4 instituted by the Board. See
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`37 C.F.R. § 42.123(a); Palo Alto Networks, Inc. v. Juniper Network, Inc.,
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`IPR2013–00369, Paper No. 37 at pp. 2-3; (Decision, Paper No. 24, pp. 2, 5-6, and
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`33); Redline Detection, LLC v. Star Envirotech, Inc., 811 F.3d 435 (Fed. Cir.
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`2015) (holding that supplemental information requests pursuant to 37 C.F.R.
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`1 Pursuant to the Scheduling Order (Paper No. 25), the parties requested an initial
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`conference call with the Board within one month of institution to discuss two
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`proposed motions requested by Petitioner, including the present motion to file
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`supplemental information pursuant to 37 C.F.R. § 42.123.
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`2
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`§ 42.123(a) are not automatically granted and the Board may discretionally
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`consider additional information beyond timeliness and relevancy).2 Here,
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`Petitioner could not have anticipated that the citation to Rudnic contained a
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`typographical error when the Petition was initially filed, nor that the copy of
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`Rudnic originally filed contained incorrect header information, until Patent
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`Owners questioned the same and submitted a copy of the table of contents from
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`the fourth edition (Ex. 2019) along with Patent Owners’ Preliminary Response.
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`The present situation is analogous to Palo Alto Networks, Inc. v. Juniper
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`Network, Inc., where the petitioner sought to submit supplemental information in
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`the form of new exhibits that would establish that cited prior art within the
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`Petition did in fact qualify as a prior art printed publication. IPR2013-00369,
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`Paper No. 37, at p. 2-3 (Feb. 5, 2014) (finding that “Petitioner has met its burden
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`because the supplemental information Petitioner seeks to submit does not change
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`the grounds of unpatentability authorized in this proceeding, nor does it change
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`the evidence initially presented in the Petition to support those grounds of
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`2 See also 37 C.F.R. § 42.123(b) (requiring a showing “why the supplemental
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`information reasonably could not have been obtained earlier, and that consideration
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`of the supplemental information would be in the interests-of-justice” for requests
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`made more than a month after institution). Petitioner has satisfied this additional
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`burden despite the inapplicability of § 42.123(b).
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`3
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`unpatentability”). In particular, the Board found that Patent Owner would not be
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`prejudiced because the “Patent Owner already [had] possession of the [identical]
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`supplemental information” when it was served “in response to Patent Owner’s
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`objections” and allowing submission of the same into the record did not limit the
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`Board’s ability to timely complete the proceeding. (Id. at 4-5). The same is true
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`here where Petitioner is only supplementing non-substantive information already
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`in possession of, and considered by, Patent Owners.
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`The correct Chapter 10 from the third edition of Modern Pharmaceutics was
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`filed along with the Petition as Ex. 1010 – only the header information from the
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`fourth edition was incorrect. Moreover, the corrected version of Rudnic (with
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`correct header information from the third edition), that Petitioner seeks to submit
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`as a replacement for Ex 1010 was timely served on Patent Owners in response to
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`their objections. Finally, as stated in Petitioner’s Motion to Correct, Patent
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`Owners already addressed the identical substance of Rudnic in their Preliminary
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`Response (see Paper No. 18, p. 16 and 23; Paper No. 24, p. 8) and will also have
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`an opportunity to further address it in their Response due on January 15, 2019 (see
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`Paper No. 24, p. 34; Paper No. 25, p. 8). Patent Owners cannot credibly argue
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`they will be prejudiced if Petitioner’s motion is granted, and granting the motion
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`will not interfere with the Board’s ability to timely complete this proceeding.
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`The current situation is vastly distinguishable from cases where the Board
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`4
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`has denied motions to file supplemental information. See, e.g., Redline Detection,
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`LLC, 811 F.3d at 443 (affirming Board’s denial of motion where Petitioner failed
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`to make “any attempt to justify the submission of an expert declaration after filing
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`its petition and after a decision to institute ha[d] been made except to note that the
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`move was cost effective” and admitted that it “intentionally delayed filing [the]
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`information”); Laboratoire Francais du Fractionnement et des Biotechnologies
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`S.A. v. Novo Nordisk Healthcare AG, IPR2017-00028, Paper No. 22, pp. 2 and 4-
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`5 (Jun. 13, 2017) (denying motion to file supplemental information where the
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`information was an entirely new reference and an expert declaration regarding the
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`substance of the new reference). Finally, granting Petitioner’s motion is also in
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`the interest of justice as Rudnic implicates each of the claims on which the Board
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`instituted trial for Grounds 2 and 4 and the supplemental information does not
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`change the substantive evidence provided in the original version of Rudnic; rather,
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`it merely clarifies the edition of Modern Pharmaceutics from which the substance
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`was obtained. See Quanergy Sys., Inc. v. Velodyne Lidar, Inc., IPR2018-00255, -
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`00256, Paper No. 23, p. 3 (Aug. 8, 2018) (granting motion to file new English
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`translation of original exhibit); Changer & Dresser, Inc. v. 002152706 Ontario
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`Ltd., IPR2017-00341, 2017 WL 3530842 *1-3 (PTAB Aug. 16, 2017) (granting
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`motion to file declaration of substitution expert). Accordingly, Petitioner
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`respectfully requests the Board grant the relief requested.
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`5
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`Dated: November 26, 2018
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`Respectfully submitted,
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`/ Robert L. Florence /
`Robert L. Florence (Reg. No. 54,933)
`Karen L. Carroll (Reg. No. 50,748)
`Sharad K. Bijanki (Reg. No. 73,400)
`Michael L. Binns (Reg. No. 65,836)
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`6
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`CERTIFICATE OF SERVICE
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`This is to certify that I caused to be served a true and correct copy of the
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`foregoing Petitioner’s Motion to File Supplemental Information Pursuant to 37
`C.F.R § 42.123(a) by email on this 26th day of November, 2018 on the following
`attorneys of record:
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`Heather M. Petruzzi
`Michael E. Nelson
`Amy K. Wigmore
`Wilmer Cutler Pickering Hale and Dorr LLP
`1875 Pennsylvania Ave, NW
`Washington, DC 20006
`E-mail: Heather.Petruzzi@wilmerhale.com
`E-mail: Michael.Nelson@wilmerhale.com
`E-mail: Amy.Wigmore@wilmerhale.com
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`Timothy A. Cook
`Kevin M. Yurkerwich
`Kevin S. Prussia
`Wilmer Cutler Pickering Hale and Dorr LLP
`60 State Street
`Boston, MA 02109
`E-mail: Tim.Cook@wilmerhale.com
`E-mail: Kevin.Yurkerwich@wilmerhale.com
`E-mail: Kevin.Prussia@wilmerhale.com
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`Jason M. Okun
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`E-mail: JOkun@fchs.com
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`Respectfully submitted,
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`Dated: November 26, 2018
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`/ Robert L. Florence /
`Robert L. Florence, Lead Counsel
`Registration No. 54,933
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`7
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