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`Filed on behalf of Samsung Bioepis Co., Ltd.
`By: Dimitrios T. Drivas
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`Scott T. Weingaertner
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`White & Case LLP
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`1221 Avenue of the Americas
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`New York, New York 10020
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`Filed: September 29, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________
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`SAMSUNG BIOEPIS CO., LTD., Petitioner,
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`v.
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`GENENTECH, INC., Patent Owner.
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`________________
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`United States Patent No. 6,407,213
`Title: Method for making humanized antibodies
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`Case No.: IPR2017-02140
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`________________
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`MOTION FOR JOINDER WITH IPR2017-01489
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`I.
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`TABLE OF CONTENTS
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`Statement of the Precise Relief Requested .................................................. 1
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`II. Argument ..................................................................................................... 2
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`A. Bioepis’s Motion for Joinder is Timely ............................................ 2
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`B.
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`The Factors Weigh in Favor of Joinder ............................................. 3
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`1.
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`2.
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`3.
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`4.
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`Joinder of Bioepis is appropriate ............................................ 3
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`Bioepis’s petition does not raise any new grounds of
`unpatentability ......................................................................... 4
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`Joinder of Bioepis will have no impact on the trial schedule . 5
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`Joinder of Bioepis will simplify briefing and discovery ........ 6
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`III. Conclusion ................................................................................................... 7
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`I.
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`Statement of the Precise Relief Requested
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`Samsung Bioepis Co., Ltd. (“Bioepis” or “Petitioner”) submits, concurrently
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`with this motion, a petition for inter partes review (“Petition”) of claims 1, 2, 4,
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`12, 25, 29-31, 33, 42, 60, 62-67, 69, and 71-81 of U.S. Patent No. 6,407,213 (the
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`“’213 patent”), which is assigned to Genentech, Inc. (“Genentech” or “Patent
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`Owner”). Pursuant to 35 U.S.C. § 315(c) and 37 C.F.R. § 42.122(b), Bioepis
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`respectfully requests joinder of the Petition with pending IPR2017-01489.
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`Although the Board has not yet instituted IPR2017-01489, the Board has
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`discretion to receive briefing on joinder prior to institution of the related
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`proceeding. See Apple Inc. v. Virnetx, Inc., IPR2013-00348, Paper 6 at 3 (PTAB
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`Aug. 14, 2013) (“[I]t is within the Board’s discretion to obtain briefing from the
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`parties regarding joinder prior to determining whether it will institute any” IPR.)
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`Bioepis respectfully requests that the Board exercise its discretion here.
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`The Petition closely follows the references cited and the grounds raised in
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`the Pfizer Petition. The Petition is, in fact, essentially a copy of the Pfizer Petition,
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`which is currently being considered by the Board. As such, institution and joinder
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`create no additional burden for the Board, Genentech, or Pfizer. Institution and
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`joinder will therefore lead to the efficient resolution of the validity of claims 1, 2,
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`4, 12, 25, 29-31, 33, 42, 60, 62-67, 69, and 71-81 of the ’213 patent.
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`1
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`Absent termination of Pfizer as a party to the proceeding, Bioepis anticipates
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`participating in the proceeding in a limited “understudy” capacity. Joinder will
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`therefore have no impact on the trial schedule of IPR2017-01489 because that IPR
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`is still in its early stages and Bioepis, in its limited role, is agreeable to whatever
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`schedule is implemented in that proceeding.
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`II. Argument
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`The Board may join any person that properly files a petition for inter partes
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`review to a separate, ongoing inter partes review. 35 U.S.C. § 315(c). A petition
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`which seeks joinder must be filed “no later than one month after the institution date
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`of any inter partes review for which joinder is requested.” 37 C.F.R. § 42.122(b).
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`A motion for joinder should also “(1) set forth the reasons why joinder is
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`appropriate; (2) identify any new grounds of unpatentability asserted in the
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`petition; (3) explain what impact (if any) joinder would have on the trial schedule
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`for the existing review; and (4) address specifically how briefing and discovery
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`may be simplified.” Macronix Int’l Co., Ltd. v. Spansion LLC, Paper 15 at 4
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`(PTAB Aug. 13, 2014) (citing Kyocera Corp. v. SoftView LLC, IPR2013-00004,
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`Paper 15 at 4 (PTAB Apr. 24, 2013).
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`A.
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`Bioepis’s Motion for Joinder is Timely
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`Joinder may be requested no later than one month after the Board’s
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`institution of an inter partes review for which joinder is requested. 37 C.F.R. §
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`2
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`42.122. Here, the Board has not yet issued an institution decision in IPR2017-
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`01489. This motion for joinder is therefore timely. See id.; Oracle Am., Inc. v.
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`Realtime Data LLC, IPR2016-01672, Paper 13, at 4 (PTAB Mar. 7, 2017).
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`Bioepis’s motion is also not premature. See, e.g., Apple, IPR2013-00348,
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`Paper 6 at 3 (PTAB Aug. 14, 2013); see also Oracle Am., IPR2016-01672, Paper
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`13, at 4 (PTAB Mar. 7, 2017).
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`B.
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`The Four Factors Weigh in Favor of Joinder
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`Each of the four factors considered by the Board for joinder motions favors
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`joinder of Bioepis to the IPR2017-01489 proceeding. As shown in Sections II.B.1-
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`4 below, joinder will not negatively affect the timing of discovery or trial in
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`IPR2017-01489, and so neither Genentech nor Pfizer will face any prejudice due to
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`the joinder. Joinder will, however, significantly simplify the briefing, discovery,
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`and trial associated with the Petition.
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`1.
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`Joinder of Bioepis is appropriate
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`Joinder with IPR2017-01489 is appropriate because the Petition is limited to
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`the same grounds and claims on which the Board is considering institution in
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`IPR2017-01489. The Petition further relies solely on the same prior art analysis
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`and expert testimony submitted by Pfizer.1 Other than the mandatory notice and
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`1 Beyond the expert testimony offered by Pfizer in IPR2017-01489, Bioepis
`submitted expert declarations from Drs. Diljeet Athwal and Mark Gerstein. Dr.
`Athwal’s declaration is substantively identical to the declaration of Dr.
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`3
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`background sections, the Petition and evidence offered by Bioepis is nearly
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`identical to that in IPR2017-01489. There are no substantive differences.
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`Furthermore, joinder is appropriate because it will promote the just, speedy,
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`efficient, and inexpensive resolution of patentability issues, including the validity
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`of the challenged claims of the ’213 patent. For example, a final written decision
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`in IPR2017-01489 will minimize issues and potentially prevent the need to fully
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`investigate similar issues separately in association with this Petition.
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`Finally, joinder is appropriate because it will not prejudice Genentech or
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`Pfizer. The Petition does not raise any new grounds but is limited to the grounds
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`raised in IPR2017-01489. Bioepis and the public may be prejudiced if joinder is
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`denied. Absent joinder, for example, Genentech and Pfizer may settle IPR2017-
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`01489 and request to terminate the proceeding, leaving intact claims in a patent
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`that may be unpatentable.
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`This factor favors joinder.
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`2.
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`Bioepis’s petition does not raise any new grounds of
`unpatentability
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`The Petition does not present any grounds for unpatentability that are not
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`presented in IPR2017-01489. As noted above, the Petition is based on the same
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`Jefferson Foote submitted by Pfizer. Dr. Gerstein’s declaration is substantively
`identical to the declaration of Mr. Timothy Buss submitted by Pfizer. Bioepis,
`however, does not intend to rely on Drs. Athwal’s or Gerstein’s declaration or
`testimony unless Pfizer’s experts become unavailable, such as, for example, if
`Genentech and Pfizer reach a settlement.
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`4
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`prior art analysis, the same expert testimony, and the same arguments that Pfizer
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`presented. The Petition and Pfizer’s Petition do not differ in any substantive way.
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`In similar situations, the Board has granted joinder. See, e.g., Hyundai Motor Co.
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`v. Am Vehicular Scis. LLC, IPR2014-01543, Paper 11 at 2-4 (PTAB Oct. 24,
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`2014); Sony Corp. of Am. v. Network-1 Sec. Solutions, Inc., IPR2013-00495, Paper
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`13 at 5-9 (PTAB Sept. 16, 2013); Dell Inc. v. Network-1 Solutions, Inc., IPR2013-
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`00385, Paper 17 at 6-10 (PTAB July 29, 2013); Motorola Mobility, IPR2013-
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`00256, Paper 10 at 4-10.
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`This factor favors joinder.
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`3.
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`Joinder of Bioepis will have no impact on the trial schedule
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`The Petition, including the arguments, prior art analysis, and expert
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`testimony, is in all substantive respects a copy of the Pfizer Petition. As such, the
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`joinder of Bioepis will have no substantial effect on the parties or prevent the
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`Board from issuing a final written decision in a timely manner.
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`The absence of any impact that joinder of Bioepis will have on the schedule
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`is further demonstrated by Bioepis’s proposed role in this proceeding. As
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`mentioned above, unless Pfizer is terminated as a party, Bioepis anticipates
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`participating in the proceeding in a limited capacity. For example, if the
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`proceedings are joined and Pfizer is not terminated as a party, there is no need for
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`expert witnesses beyond those presented by Pfizer and Genentech.
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`5
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`Bioepis does not believe that any extension of the schedule will be necessary
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`due to the joinder of Bioepis as a petitioner to this proceeding. This factor therefor
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`favors joinder.
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`4.
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`Joinder of Bioepis will simplify briefing and discovery
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`Given that the arguments, prior art, and expert testimony raised in the
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`Petition are identical to those in the Pfizer Petition in IPR2017-01489, the Board
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`may simplify discovery and briefing via procedures it has used in the past. See,
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`e.g. Hyundai, IPR2017-01543, Paper No. 11 at 5; Dell, IPR2013-00385, Paper 17
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`at 8-10; Motorola, IPR2013-00256, Paper 10 at 8-10.
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`For briefing and document submissions, as long as Pfizer remains a party to
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`the inter partes review, the Board may order petitioners to consolidate filings, and
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`limit Bioepis to no additional filings in its understudy role. That is, if Pfizer
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`remains a party to the inter partes review, then Bioepis will not submit any
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`separate filings unless it strongly disagrees with a position adopted by Pfizer
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`(which is not anticipated). And, under such circumstances, Bioepis will not file
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`any papers without first seeking leave from the Board. In the unlikely event of
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`separate filings, the Board may then grant Genentech an equal – and likely a very
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`limited – number of pages to respond to Bioepis’s arguments.
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`For depositions, no adjustments to the scheduling of IPR2017-01489 are
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`required. No additional depositions will be necessary. Bioepis will not rely on
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`expert testimony beyond that submitted by Pfizer, unless Pfizer is terminated from
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`the case prior to any necessary expert depositions. That is, although Bioepis is
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`submitting declarations from Drs. Athwal and Gerstein, Bioepis will not rely on
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`those declarations if Pfizer’s experts, Dr. Foote and Mr. Buss, remain available in
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`the inter partes review.
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`To the extent Bioepis participates in the proceedings, Bioepis will try to
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`coordinate with Pfizer, to the fullest extent possible, to consolidate and minimize
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`authorized additional filings, manage questions at depositions, and avoid
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`redundancies. To be clear, however, Bioepis anticipates participating only in a
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`secondary role, absent a settlement between Pfizer and Genentech that would
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`otherwise terminate the proceeding.
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`The above considerations will avoid any complication or delay that might
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`otherwise allegedly be caused by the joinder of Bioepis. This factor therefore
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`favors joinder.
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`III. Conclusion
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`For the foregoing reasons, Bioepis respectfully requests that the Board grant
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`its motion that an inter partes review of claims 1, 2, 4, 12, 25, 29-31, 33, 42, 60,
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`62-67, 69, and 71-81 of the ’213 patent be instituted on the same grounds raised in
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`IPR2017-01489, and that this proceeding be joined with IPR2017-01489.
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`Dated: September 29, 2017
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`Respectfully submitted,
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`/s/ Dimitrios T. Drivas .
`Dimitrios T. Drivas
`Reg. No. 32,218
`Scott T. Weingaertner
`Reg. No. 37,756
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`Counsel to
`Samsung Bioepis Co., Ltd.
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`8
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6 and 42.105, I hereby certify that on this 29th
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`day of September, 2017, the foregoing Motion for Joinder with IPR2017-01489
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`and accompanying exhibits referenced therein were served via PRIORITY MAIL
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`EXPRESS® for single-day overnight delivery on the Patent Owner at the following
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`addresses:
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`David L. Cavanaugh
`Wilmer Cutler Pickering Hale and Dorr LLP
`1875 Pennsylvania Ave., NW
`Washington DC 200061
` and -
`Genentech, Inc.
`Wendy M. Lee
`1 DNA Way
`South San Francisco, CA 94080-4990
`And to counsel for Petitioner Pfizer Inc. in IPR2017-01489, as follows:
`Amanda Hollis
`Kirkland & Ellis LLP
`300 North LaSalle Street
`Chicago, IL 60654
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`Date: September 29, 2017
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`Signed,
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`/s/ Dimitrios T. Drivas .
`Dimitrios T. Drivas
`USPTO Reg. No. 32,218
`Scott T. Weingaertner
`Reg. No. 37,756
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`Counsel for
`Samsung Bioepis Co., Ltd.
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