`
`Filed on behalf of Samsung Bioepis Co., Ltd.
`By: Dimitrios T. Drivas
`
`Scott T. Weingaertner
`
`White & Case LLP
`
`1221 Avenue of the Americas
`
`New York, New York 10020
`
`
`Filed: September 29, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`
`SAMSUNG BIOEPIS CO., LTD., Petitioner,
`
`v.
`
`GENENTECH, INC., Patent Owner.
`
`________________
`
`United States Patent No. 6,407,213
`Title: Method for making humanized antibodies
`
`
`Case No.: IPR2017-02139
`
`________________
`
`MOTION FOR JOINDER WITH IPR2017-01488
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`I.
`
`TABLE OF CONTENTS
`
`Statement of the Precise Relief Requested .................................................. 1
`
`II. Argument ..................................................................................................... 2
`
`A. Bioepis’s Motion for Joinder is Timely ............................................ 2
`
`B.
`
`The Factors Weigh in Favor of Joinder ............................................. 3
`
`1.
`
`2.
`
`3.
`
`4.
`
`Joinder of Bioepis is appropriate ............................................ 3
`
`Bioepis’s petition does not raise any new grounds of
`unpatentability ......................................................................... 4
`
`Joinder of Bioepis will have no impact on the trial schedule . 5
`
`Joinder of Bioepis will simplify briefing and discovery ........ 6
`
`III. Conclusion ................................................................................................... 7
`
`
`
`
`
`
`
`
`
`
`i
`
`
`
`
`
`
`
`
`
`
`I.
`
`Statement of the Precise Relief Requested
`
`
`
`Samsung Bioepis Co., Ltd. (“Bioepis” or “Petitioner”) submits, concurrently
`
`with this motion, a petition for inter partes review (“Petition”) of claims 1, 2, 4,
`
`12, 25, 29-31, 33, 42, 60, 62-67, 69, and 71-81 of U.S. Patent No. 6,407,213 (the
`
`“’213 patent”), which is assigned to Genentech, Inc. (“Genentech” or “Patent
`
`Owner”). Pursuant to 35 U.S.C. § 315(c) and 37 C.F.R. § 42.122(b), Bioepis
`
`respectfully requests joinder of the Petition with pending IPR2017-01488.
`
`
`
`Bioepis’s request for joinder is timely. On May 24, 2017, Pfizer Inc.
`
`(“Pfizer”) filed an inter partes review petition (the “Pfizer Petition”) concerning
`
`the ’213 patent. The Patent Trial and Appeal Board (the “Board”) is still
`
`considering whether to institute review of the Pfizer Petition. As the Board has not
`
`yet made an institution decision, Bioepis’s request for joinder is therefore timely.
`
`See 37 C.F.R. § 42.122(b).
`
`
`
`The Petition closely follows the references cited and the grounds raised in
`
`the Pfizer Petition. The Petition is, in fact, essentially a copy of the Pfizer Petition,
`
`which is currently being considered by the Board. As such, institution and joinder
`
`create no additional burden for the Board, Genentech, or Pfizer. Institution and
`
`joinder will therefore lead to the efficient resolution of the validity of claims 1, 2,
`
`4, 12, 25, 29-31, 33, 42, 60, 62-67, 69, and 71-81 of the ’213 patent.
`
`
`
`1
`
`
`
`
`
`
`
`
`
`
`
`
`Absent termination of Pfizer as a party to the proceeding, Bioepis anticipates
`
`participating in the proceeding in a limited “understudy” capacity. Joinder will
`
`therefore have no impact on the trial schedule of IPR2017-01488 because that IPR
`
`is still in its early stages and Bioepis, in its limited role, is agreeable to whatever
`
`schedule is implemented in that proceeding.
`
`II. Argument
`
`
`
`The Board may join any person that properly files a petition for inter partes
`
`review to a separate, ongoing inter partes review. 35 U.S.C. § 315(c). A petition
`
`which seeks joinder must be filed “no later than one month after the institution date
`
`of any inter partes review for which joinder is requested.” 37 C.F.R. § 42.122(b).
`
`
`
`A motion for joinder should also “(1) set forth the reasons why joinder is
`
`appropriate; (2) identify any new grounds of unpatentability asserted in the
`
`petition; (3) explain what impact (if any) joinder would have on the trial schedule
`
`for the existing review; and (4) address specifically how briefing and discovery
`
`may be simplified.” Macronix Int’l Co., Ltd. v. Spansion LLC, Paper 15 at 4
`
`(PTAB Aug. 13, 2014) (citing Kyocera Corp. v. SoftView LLC, IPR2013-00004,
`
`Paper 15 at 4 (PTAB Apr. 24, 2013).
`
`A.
`
`Bioepis’s Motion for Joinder is Timely
`
`
`
`Joinder may be requested no later than one month after the Board’s
`
`institution of an inter partes review for which joinder is requested. 37 C.F.R. §
`
`
`
`
`2
`
`
`
`
`
`
`
`
`
`42.122. Here, the Board has not yet issued an institution decision in IPR2017-
`
`01488. This motion for joinder is therefore timely.
`
`
`
`Bioepis’s motion is also not premature. See, e.g., Apple, IPR2013-00348,
`
`Paper 6 at 3 (PTAB Aug. 14, 2013); see also Oracle Am., IPR2016-01672, Paper
`
`13, at 4 (PTAB Mar. 7, 2017).
`
`B.
`
`The Four Factors Weigh in Favor of Joinder
`
`
`
`Each of the four factors considered by the Board for joinder motions favors
`
`joinder of Bioepis to the IPR2017-01488 proceeding. As shown in Sections II.B.1-
`
`4 below, joinder will not negatively affect the timing of discovery or trial in
`
`IPR2017-01488, and so neither Genentech nor Pfizer will face any prejudice due to
`
`the joinder. Joinder will, however, significantly simplify the briefing, discovery,
`
`and trial associated with the Petition.
`
`1.
`
`Joinder of Bioepis is appropriate
`
`
`
`Joinder with IPR2017-01488 is appropriate because the Petition is limited to
`
`the same grounds and claims on which the Board is considering institution in
`
`IPR2017-01488. The Petition further relies solely on the same prior art analysis
`
`and expert testimony submitted by Pfizer.1 Other than the mandatory notice and
`
`
`1 Beyond the expert testimony offered by Pfizer in IPR2017-01488, Bioepis
`submitted expert declarations from Drs. Diljeet Athwal and Mark Gerstein. Dr.
`Athwal’s declaration is substantively identical to the declaration of Dr.
`Jefferson Foote submitted by Pfizer. Dr. Gerstein’s declaration is substantively
`identical to the declaration of Mr. Timothy Buss submitted by Pfizer. Bioepis,
`
`3
`
`
`
`
`
`
`
`
`
`
`
`background sections, the Petition and evidence offered by Bioepis is nearly
`
`identical to that in IPR2017-01488. There are no substantive differences.
`
`
`
`Furthermore, joinder is appropriate because it will promote the just, speedy,
`
`efficient, and inexpensive resolution of patentability issues, including the validity
`
`of the challenged claims of the ’213 patent. For example, a final written decision
`
`in IPR2017-01488 will minimize issues and potentially prevent the need to fully
`
`investigate similar issues separately in association with this Petition.
`
`
`
`Finally, joinder is appropriate because it will not prejudice Genentech or
`
`Pfizer. The Petition does not raise any new grounds but is limited to the grounds
`
`raised in IPR2017-01488. Bioepis and the public may be prejudiced if joinder is
`
`denied. Absent joinder, for example, Genentech and Pfizer may settle IPR2017-
`
`01488 and request to terminate the proceeding, leaving intact claims in a patent
`
`that may be unpatentable.
`
`
`
`
`
`This factor favors joinder.
`
`2.
`
`Bioepis’s petition does not raise any new grounds of
`unpatentability
`
`The Petition does not present any grounds for unpatentability that are not
`
`presented – and instituted – in IPR2017-01488. As noted above, the Petition is
`
`based on the same prior art analysis, the same expert testimony, and the same
`
`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.
`
`4
`
`
`
`
`
`
`
`
`
`
`
`arguments that Pfizer presented. The Petition and Pfizer’s Petition do not different
`
`in any substantive way. In similar situations, the Board has granted joinder. See,
`
`e.g., Hyundai Motor Co. v. Am Vehicular Scis. LLC, IPR2014-01543, Paper 11 at
`
`2-4 (PTAB Oct. 24, 2014); Sony Corp. of Am. v. Network-1 Sec. Solutions, Inc.,
`
`IPR2013-00495, Paper 13 at 5-9 (PTAB Sept. 16, 2013); Dell Inc. v. Network-1
`
`Solutions, Inc., IPR2013-00385, Paper 17 at 6-10 (PTAB July 29, 2013); Motorola
`
`Mobility, IPR2013-00256, Paper 10 at 4-10.
`
`
`
`
`
`This factor favors joinder.
`
`3.
`
`Joinder of Bioepis will have no impact on the trial schedule
`
`The Petition, including the arguments, prior art analysis, and expert
`
`testimony, is in all substantive respects a copy of the Pfizer Petition. As such, the
`
`joinder of Bioepis will have no substantial effect on the parties or prevent the
`
`Board from issuing a final written decision in a timely manner.
`
`
`
`The absence of any impact that joinder of Bioepis will have on the schedule
`
`is further demonstrated by Bioepis’s proposed role in this proceeding. As
`
`mentioned above, unless Pfizer is terminated as a party, Bioepis anticipates
`
`participating in the proceeding in a limited capacity. For example, if the
`
`proceedings are joined and Pfizer is not terminated as a party, there is no need for
`
`expert witnesses beyond those presented by Pfizer and Genentech.
`
`
`
`
`5
`
`
`
`
`
`
`
`
`
`
`
`Bioepis does not believe that any extension of the schedule will be necessary
`
`due to the joinder of Bioepis as a petitioner to this proceeding. This factor therefor
`
`favors joinder.
`
`4.
`
`Joinder of Bioepis will simplify briefing and discovery
`
`
`
`Given that the arguments, prior art, and expert testimony raised in the
`
`Petition are identical to those in the Pfizer Petition in IPR2017-01488, the Board
`
`may simplify discovery and briefing via procedures it has used in the past. See,
`
`e.g. Hyundai, IPR2017-01543, Paper No. 11 at 5; Dell, IPR2013-00385, Paper 17
`
`at 8-10; Motorola, IPR2013-00256, Paper 10 at 8-10.
`
`For briefing and document submissions, as long as Pfizer remains a party to
`
`the inter partes review, the Board may order petitioners to consolidate filings, and
`
`limit Bioepis to no additional filings in its understudy role. That is, if Pfizer
`
`remains a party to the inter partes review, then Bioepis will not submit any
`
`separate filings unless it strongly disagrees with a position adopted by Pfizer
`
`(which is not anticipated). And, under such circumstances, Bioepis will not file
`
`any papers without first seeking leave from the Board. In the unlikely event of
`
`separate filings, the Board may then grant Genentech an equal – and likely a very
`
`limited – number of pages to respond to Bioepis’s arguments.
`
`For depositions, no adjustments to the scheduling of IPR2017-01488 are
`
`required. No additional depositions will be necessary. Bioepis will not rely on
`
`
`
`
`6
`
`
`
`
`
`
`
`
`
`expert testimony beyond that submitted by Pfizer, unless Pfizer is terminated from
`
`the case prior to any necessary expert depositions. That is, although Bioepis is
`
`submitting declarations from Drs. Athwal and Gerstein, Bioepis will not rely on
`
`those declarations if Pfizer’s experts, Dr. Foote and Mr. Buss, remain available in
`
`the inter partes review.
`
`To the extent Bioepis participates in the proceedings, Bioepis will try to
`
`coordinate with Pfizer, to the fullest extent possible, to consolidate and minimize
`
`authorized additional filings, manage questions at depositions, and avoid
`
`redundancies. To be clear, however, Bioepis anticipates participating only in a
`
`secondary role, absent a settlement between Pfizer and Genentech that would
`
`otherwise terminate the proceeding.
`
`The above considerations will avoid any complication or delay that might
`
`otherwise allegedly be caused by the joinder of Bioepis. This factor therefore
`
`favors joinder.
`
`III. Conclusion
`
`
`
`For the foregoing reasons, Bioepis respectfully requests that the Board grant
`
`its motion that an inter partes review of claims 1, 2, 4, 12, 25, 29-31, 33, 42, 60,
`
`62-67, 69, and 71-81 of the ’213 patent be instituted on the same grounds raised in
`
`IPR2017-01488, and that this proceeding be joined with IPR2017-01488.
`
`
`Dated: September 29, 2017
`
`
`
`
`
`Respectfully submitted,
`
`
`
`
`7
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/s/ Dimitrios T. Drivas .
`Dimitrios T. Drivas
`Reg. No. 32,218
`Scott T. Weingaertner
`Reg. No. 37,756
`
`Counsel to
`Samsung Bioepis Co., Ltd.
`
`
`8
`
`
`
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6 and 42.105, I hereby certify that on this 29th
`
`day of September, 2017, the foregoing Motion for Joinder with IPR2017-01488
`
`and accompanying exhibits referenced therein were served via PRIORITY MAIL
`
`EXPRESS® for single-day overnight delivery on the Patent Owner at the following
`
`addresses:
`
`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 IPR2017-01488, as follows:
`Amanda Hollis
`Kirkland & Ellis LLP
`300 North LaSalle Street
`Chicago, IL 60654
`
` -
`
`
`
`
`
`
`
`
`
`
`Date: September 29, 2017
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Signed,
`
`/s/ Dimitrios T. Drivas .
`Dimitrios T. Drivas
`USPTO Reg. No. 32,218
`Scott T. Weingaertner
`Reg. No. 37,756
`
`Counsel for
`Samsung Bioepis Co., Ltd.
`
`
`
`
`
`
`
`
`
`
`