Trials@uspto.gov
`571.272.7822
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`
`
`Paper 9
`Entered: December 9, 2017
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`
`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01958
`Patent 6,627,196 B1
`____________
`
`
`Before ZHENYU YANG, CHRISTOPHER G. PAULRAJ, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Institution of Inter Partes Review and Grant of Motion for Joinder
`37 C.F.R. § 42.108; 37 C.F.R. § 42.122(b)
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`
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`571.272.7822
`
`
`
`
`Paper 9
`Entered: December 9, 2017
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`
`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01958
`Patent 6,627,196 B1
`____________
`
`
`Before ZHENYU YANG, CHRISTOPHER G. PAULRAJ, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Institution of Inter Partes Review and Grant of Motion for Joinder
`37 C.F.R. § 42.108; 37 C.F.R. § 42.122(b)
`
`
`
`
`
`
`
`
`
`
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`IPR2017-01958
`Patent 6,627,196 B1
`
`
`I.
`
`INTRODUCTION
`
`On August 25, 2017, Samsung Bioepis Co., LTD (“Bioepis”)
`
`filed a Petition, seeking an inter partes review of claims 1–3, 5, 7, 9–
`
`11, and 17–33 of U.S. Patent No. 6,627,196 B1 (Ex. 1001, “the ’196
`
`patent”). Paper 2 (“Pet.”). Genentech, Inc. (“Patent Owner”) has
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`waived its right to file a Preliminary response to the Petition.
`
`Ex. 3001. Along with the Petition, Bioepis also filed a Motion for
`
`Joinder to join this proceeding with IPR2017-00804. Paper 1
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`(“Mot.”). Patent Owner opposes the Motion. Paper 7.
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`As explained further below, we institute trial on the same
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`grounds as instituted in IPR2017-00804 and grant Petitioner’s Motion
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`for Joinder.
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`II. DISCUSSION
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`In IPR2017-00804, Hospira, Inc. (“Hospira”) challenged claims
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`1–3, 5, 7, 9–11, and 17–33 of the ’196 patent as obvious under 35
`
`U.S.C. § 103(a) over the combination of the Herceptin Label,1
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`Baselga ’96,2 Pegram ’98,3 and the Knowledge of a Person of
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`Ordinary Skill in the Art. On July 27, 2017, we instituted trial to
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`1 1998 FDA Approved Label for Herceptin® (Ex. 1008).
`2 Baselga et al., Phase II Study of Weekly Intravenous Recombinant
`Humanized Anti-p185HER2 Monoclonal Antibody in Patients with HER2/neu-
`Overexpressing Metastatic Breast Cancer, 14 J. CLIN. ONCOL. 737–44
`(1996) (Ex. 1013).
`3 Pegram, et al., Phase II Study of Receptor-Enhanced Chemosensitivity
`Using Recombinant Humanized Anti-p185HER2/neu Monoclonal Antibody Plus
`Cisplatin in Patients with HER2/neu-Overexpressing Metastatic Breast
`Cancer Refractory to Chemotherapy Treatment, 16 J. CLIN. ONCOL. 2659–
`71 (1998) (Ex. 1014).
`
`
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`IPR2017-01958
`Patent 6,627,196 B1
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`review the patentability of those claims. Hospira, Inc. v. Genentech,
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`Inc., IPR2017-00804, Paper 13.
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`The Petition in this case is substantively identical to the one in
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`IPR2017-00804. Compare IPR2017-00804, Paper 1 with IPR2017-
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`01958, Paper 2. For the same reasons stated in our Decision on
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`Institution in IPR2017-00804, we institute trial in this proceeding on
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`the same ground. See IPR2017-00804, Paper 13.
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`Having determined that institution is appropriate, we now turn
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`to Bioepis’s Motion for Joinder. Under the statute, “[i]f the Director
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`institutes an inter partes review, the Director, in his or her discretion,
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`may join as a party to that inter partes review any person who
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`properly files a petition under section 311.” 35 U.S.C. § 315(c).
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`When determining whether to grant a motion for joinder we consider
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`factors such as timing and impact of joinder on the trial schedule, cost,
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`discovery, and potential simplification of briefing. Kyocera Corp. v.
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`SoftView, LLC, Case IPR2013-00004, slip op. at 4 (PTAB Apr. 24,
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`2013) (Paper 15).
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`Under the circumstances of this case, we determine that joinder
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`is appropriate. Bioepis filed the Petition and Motion for Joinder in the
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`present proceeding within one month after we instituted trial in
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`IPR2017-00804. See 37 C.F.R. § 42.122(b). Bioepis represents that
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`the Petition in this case is “essentially a copy of the Hospira Petition,
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`including a ground that is substantially identical to that presented in
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`the Hospira Petition in IPR2017-00804.” Mot. 1. According to
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`Bioepis, the Petition “relies solely on the same prior art analysis and
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`expert testimony submitted by Hospira.” Id. at 3. Bioepis asserts that
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`IPR2017-01958
`Patent 6,627,196 B1
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`it “anticipates participating in the proceeding in a limited ‘understudy’
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`capacity,” unless Hospira is terminated as a party. Id. at 2, 5; see also
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`id. at 6 (agreeing that, “as long as Hospira remains a party . . . the
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`Board may order petitioners to consolidate filings, and limit Bioepis
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`to . . . [an] understudy role”). As a result, Bioepis avers that joinder
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`will “create no additional burden for the Board, Genentech, or
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`Hospira,” “have no impact on the trial schedule of IPR2017-00804,”
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`and result in no prejudice to either Genentech or Hospira. Id. at 1–3.
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`Genentech argues that “Bioepis offers no real assurances that its
`
`role will be so limited as to prevent prejudice to Patent Owner.”
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`Paper 7, 1. Genentech asks us to impose certain conditions on
`
`Bioepis, including: (1) as long as Hospira remains a party to IPR2017-
`
`00804, Bioepis “has no right to its own briefing or oral argument;”
`
`(2) Bioepis may “proceed based solely on the arguments and evidence
`
`presented and maintained by Hospira;” (3) no additional discovery is
`
`permitted by Bioepis, and Bioepis may not ask any questions during
`
`deposition; (4) Bioepis may not alter the Hospira IRP trial schedule,
`
`and (5) “Bioepis acknowledges that the estoppel provisions of 35
`
`U.S.C. § 315(e) will be applicable to it even if it remains in a
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`circumscribed secondary role.” Id. at 2–3.
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`We find certain conditions Genentech proposes overly
`
`restrictive. For example, although Bioepis anticipates taking an
`
`understudy role in this proceeding, it may unexpectedly “strongly
`
`disagrees” with a position adopted (or repudiated) by Hospira after the
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`filing of Hospira Petition. See Mot. 6. Under those circumstances,
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`this panel may wish to entertain requests for additional briefing,
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`IPR2017-01958
`Patent 6,627,196 B1
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`additional discovery, or an opportunity for Bioepis to ask questions at
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`a deposition. See 37 C.F.R. § 42.5 (authorizing the panel “may
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`determine a proper course of conduct in a proceeding”). In addition,
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`to the extent we grant its Motion for Joinder, Bioepis becomes a
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`“petitioner” in the IPR2017-00804 proceeding. Patent Owner does
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`not cite to, nor are we aware of, any authority suggesting that a
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`passive role in an IPR proceeding insulates a petitioner from the
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`estoppel provision of § 315(e). Rather, the provision vests as a matter
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`of law such that Bioepis’s formal acknowledgement of § 315(e) is
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`irrelevant.
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`Where, as in the present case, a party seeks to take a secondary
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`role in an on-going IPR, joinder promotes economy and efficiency,
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`thereby reducing the burden on the Patent Owner and on the limited
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`resources of the Board, as compared to distinct, parallel proceedings.
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`See 37 C.F.R. § 42.1(b) (instructing that an inter partes review must
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`be conducted to “secure the just, speedy, and inexpensive resolution”).
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`In view of the foregoing, we find that joinder based upon the
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`conditions stated by Bioepis’s in its Motion for Joinder will have little
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`or no impact on the timing, cost, or presentation of the trial on the
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`instituted ground. Discovery and briefing will be simplified if the
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`proceedings are joined. Having considered Bioepis’s Motion in light
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`of Genentech’s response, the Motion is granted.
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`III. ORDER
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`Accordingly, it is
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`ORDERED that trial is instituted in IPR2017-01958 to
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`determine whether claims 1–3, 5, 7, 9–11, and 17–33 of the ’196
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`IPR2017-01958
`Patent 6,627,196 B1
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`patent would have been obvious over the combination of the
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`Herceptin Label, Baselga ’96, Pegram ’98, and the knowledge of a
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`person of ordinary skill in the art;
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`FURTHER ORDERED that Bioepis’s Motion for Joinder with
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`is granted;
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`FURTHER ORDERED that IPR2017-01958 is terminated and
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`joined to IPR2017-00804, pursuant to 37 C.F.R. §§ 42.72, 42.122,
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`based on the conditions discussed above, specifically, absent leave of
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`the Board, Bioepis shall maintain an understudy role with respect
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`Hospira, coordinate filings with Hospira, not submit separate
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`substantive filings, not participate substantively in oral argument, and
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`not actively participate in deposition questioning except with the
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`assent of all parties;
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`FURTHER ORDERED that the Scheduling Order in place for
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`IPR2017-00804 shall govern the joined proceedings;
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`FURTHER ORDERED that all future filings in the joined
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`proceeding are to be made only in IPR2017-00804;
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`FURTHER ORDERED that the case caption in IPR2017-00804
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`for all further submissions shall be changed to add Bioepis as a named
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`Petitioner after Hospira, and to indicate by footnote the joinder of
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`IPR2017-01958 to that proceeding, as indicated in the attached form
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`of caption;
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`FURTHER ORDERED that a copy of this Decision shall be
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`entered into the record of IPR2017-00804.
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`IPR2017-01958
`Patent 6,627,196 B1
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`
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`FOR PETITIONER BIOEPIS:
`
`Dimitrios Drivas
`ddrivas@whitecase.com
`
`Scott Weingaertner
`sweingaertner@whitecase.com
`
`
`FOR PATENT OWNER:
`
`David Cavanaugh
`david.cavanaugh@wilmerhale.com
`
`Owen Allen
`owen.allen@wilmerhale.com
`
`Adam Brausa
`abrausa@durietangri.com
`
`
`FOR PETITIONER HOSPIRA (IPR2017-00804):
`
`Amanda Hollis
`amanda.hollis@kirkland.com
`
`Stefan Miller
`Stefan.Miller@kirkland.com
`
`Karen Younkins
`karen.younkins@kirkland.com
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`IPR2017-01958
`Patent 6,627,196 B1
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`Sample Case Caption
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`
`
`
`HOSPIRA, INC., and
`SAMSUNG BIOEPIS CO., LTD.,
`Petitioners,
`
`v.
`
`GENENTECH, INC,
`Patent Owner.
`____________
`
`Case IPR2017-008041
`Patent 6,627,196 B1
`
`____________
`
`
`
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`1 Case IPR2017-01958 has been joined with this proceeding.
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