`571-272-7822
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` Paper No. 11
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`Entered: December 1, 2017
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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 IPR2017-01960
`Patent US 7,892,549 B2
`_______________
`
`Before ZHENYU YANG, CHRISTOPHER G. PAULRAJ, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`DECISION
`Instituting Inter Partes Review and Granting Motion for Joinder
`37 C.F.R. § 42.108; 37 C.F.R. § 42.122(b)
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`
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`IPR2017-001960
`Patent US 7,892,549 B2
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`
`INTRODUCTION
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`I.
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`Samsung Bioepis Co., LTD (“Bioepis”) filed a Petition requesting an
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`inter partes review of claims 1–17 of U.S. Patent No. 7,892,549 B2 (“the
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`’549 patent”). Paper 2 (“Pet.”). By email dated November 9, 2017, Patent
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`Owner Genentech, Inc. (“Genentech”) has waived its right to file a
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`Preliminary response to the Petition. Ex. 3001.
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`Along with its Petition, Bioepis filed a Motion for Joinder to join this
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`proceeding with IPR2017-00737. Paper 1 (“Mot.”). Bioepis filed the
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`Petition and Motion for Joinder in the present proceeding on August 25,
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`2017, within one month after we instituted trial in IPR2017-00737.
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`Genentech opposes the Motion. Paper 7.
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`As explained further below, we institute trial on the same grounds as
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`instituted in IPR2017-00737 and grant Bioepis’s Motion for Joinder.
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`2
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`IPR2017-001960
`Patent US 7,892,549 B2
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`DISCUSSION
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`II.
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`In IPR2017-00737, Hospira, Inc., (“Hospira”) challenged claims 1–17
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`of the ’549 Patent on the following grounds:
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`Ground Claim(s)
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`References
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`1–11 and 14–17 Baselga ’971 and Gelmon2
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`Basis
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`§ 103
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`§ 103
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`§ 103
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`§ 103
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`§ 103
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`§ 103
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`1
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`2
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`3
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`4
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`5
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`6
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`12
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`13
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`Baselga ’97, Gelmon, and
`Drebin3
`Baselga ’97, Gelmon, and
`Presta4
`1–11 and 14–17 Baselga ’96,5 Baselga ’94,6 and
`Gelmon
`Baselga ’96, Baselga ’94,
`Gelmon, and Drebin
`Baselga ’96, Baselga ’94,
`Gelmon, and Presta
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`12
`
`13
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`After considering the Petition and Patent Owner’s Preliminary
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`Response, we instituted trial in IPR2017-00737 on each of the six asserted
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`grounds. IPR2017-00737, Paper 19, 25–26.
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` Bioepis’s Petition is substantively identical to Hospira’s Petition,
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`challenging the same claims based on the same art and the same grounds.
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`Compare IPR2017-01960, Paper 2, with IPR2017-00737, Paper 1. For the
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`same reasons stated in our Decision on Institution in IPR2017-00737, we
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`institute trial in this proceeding on the same six grounds.
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`1 Baselga et al., 11(3) (Suppl. 2) ONCOLOGY 43–48 (1997). Ex. 1007.
`2 Gelmon et al., 14(4) J. CLIN. ONCOL. 1185–91 (1996). Ex. 1025.
`3 Drebin et al., 2(3) ONCOGENE 273–77 (1988). Ex. 1010.
`4 Presta et al., 57(20) CANCER RES. 4593–99 (1997). Ex. 1012.
`5 Baselga et al., 14(3) J. CLIN. ONCOL. 737–44 (1996). Ex. 1005.
`6 Baselga et al., 13 Proc. AM. SOC. CLIN. ONCOL. 63 (Abstract 53)
`(1994). Ex. 1006.
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`3
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`IPR2017-001960
`Patent US 7,892,549 B2
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`Having determined that institution is appropriate, we now turn to
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`Bioepis’s Motion for Joinder. 35 U.S.C. § 315(c). Section 315(c) provides,
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`in relevant part, that “[i]f the Director institutes an inter partes review, the
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`Director, in his or her discretion, may join as a party to that inter partes
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`review any person who properly files a petition under section 311.” Id.
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`When determining whether to grant a motion for joinder we consider factors
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`such as timing and impact of joinder on the trial schedule, cost, discovery,
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`and potential simplification of briefing. Kyocera Corp. v. SoftView, LLC,
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`Case IPR2013-00004, slip op. at 4 (PTAB Apr. 24, 2013) (Paper 15). Under
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`the circumstances of this case, we determine that joinder is appropriate.
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`Bioepis avers that joinder will “create no additional burden for the
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`Board, Genentech, or Hospira,” “have no impact on the trial schedule of
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`IPR2017-00737,” and result in no prejudice to either Genentech or Hospira.
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`Mot. 1–3. In particular, Bioepis asserts that its Petition raises no new
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`grounds of unpatentability from IPR2017-00737, and is “essentially a copy
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`of the Hospira Petition,” relying “on the same prior art analysis, the same
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`expert testimony, and the same arguments that Hospira presented.” See id.
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`at 1, 3, 4. Bioepis further asserts that it “anticipates participating in the
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`proceeding in a limited ‘understudy’ capacity,” unless Hospira is terminated
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`as a party. Id. at 2; see also id. at 6 (agreeing that, “as long as Hospira
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`remains a party . . . the Board may order petitioners to consolidate filings,
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`and limit Bioepis to . . . [an] understudy role”); id. at 3, n1, 5 (stating that it
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`may rely on the testimony of its own expert if Hospira’s expert becomes
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`unavailable).
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`
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`In response, Genentech argues that “Bioepis offers no real assurances
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`that its role will be so limited as to prevent prejudice to Patent Owner.”
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`4
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`IPR2017-001960
`Patent US 7,892,549 B2
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`Paper 7, 1. Genentech asserts, for example, that as long as Hospira remains
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`a party to IPR2017-00737, Bioepis should be precluded from any “right to
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`its own briefing or oral argument,” “proceed based solely on the arguments
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`and evidence presented and maintained by Hospira,” undertake no additional
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`discovery or ask any questions during deposition, “not attempt to alter the
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`Hospira IRP trial schedule,” and “acknowledge[] that the estoppel provisions
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`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. We do not find Genentech’s
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`arguments persuasive.
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`
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`Where, as in the present case, a party seeks to take a secondary role in
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`an on-going IPR, joinder promotes economy and efficiency, thereby
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`reducing the burden on the Patent Owner and on the limited resources of the
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`Board, as compared to distinct, parallel proceedings. Counterintuitively,
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`Genentech’s proposed conditions seem designed to discourage petitioners
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`from seeking joinder under these circumstances and, thus, incompatible with
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`“the just, speedy, and inexpensive resolution of every proceeding.” See 37
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`C.F.R. § 42.1(b).
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`For example, although Bioepis “anticipates” taking an understudy role
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`in this proceeding, we can envision circumstances in which it “strongly
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`disagrees” with a position that Hospira adopts (or repudiates) subsequent to
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`the filing of Hospira Petition. See Mot. 6. Under these circumstances, this
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`panel may wish to entertain requests for additional briefing, additional
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`discovery, or an opportunity for Bioepis to ask questions at a deposition.7
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`7 Parties are reminded that communications regarding these and all other
`matters are conducted with courtesy, candor, good faith. 37 C.F.R. §
`42.1(c), 42.11(a).
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`5
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`IPR2017-001960
`Patent US 7,892,549 B2
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`Strict adherence to Genentech’s proposed conditions, however, would be at
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`odds with our discretion to managing this case. See generally, 37 C.F.R. §
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`42.71(a).
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`We also address Genentech’s proposed condition that “Bioepis
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`acknowledges that the estoppel provisions of 35 U.S.C. § 315(e) will be
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`applicable to it even if remains in a circumscribed secondary role.” Paper 7,
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`3. To the extent we grant its Motion for Joinder, Bioepis becomes a
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`“petitioner” in the IPR2017-00737 inter partes review pursuant to 35 U.S.C.
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`§ 315(e). Patent Owner does not cite to (nor are we aware of) any authority
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`suggesting that a passive role in an IPR proceeding insulates a petitioner
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`from the estoppel provision of this section. Rather, the provision vests as a
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`matter of law such that Bioepis’s formal acknowledgement of § 315(e) is
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`irrelevant.
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`In view of the foregoing, we find that joinder based upon the
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`conditions stated in Bioepis’s Motion for Joinder will have little or no
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`impact on the timing, cost, or presentation of the trial on the instituted
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`grounds and promote the just, speedy, and inexpensive resolution of the
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`involved proceedings. Moreover, discovery and briefing will be simplified
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`if the 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.
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`ORDER
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`Accordingly, it is
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`ORDERED that, pursuant to 35 U.S.C. § 314(a), an inter partes
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`review is instituted as to claims 1–17 of U.S. Patent No. 7,892,549 B2 based
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`on the following grounds of unpatentability:
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`6
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`IPR2017-001960
`Patent US 7,892,549 B2
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`1) Claims 1–11 and 14–17 under 35 U.S.C. § 103 as obvious over the
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`combination of Baselga ’97 and Gelmon;
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`2) Claim 12 under 35 U.S.C. § 103 as obvious over the combination
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`of Baselga ’97, Gelmon and Drebin;
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`3) Claim 13 under 35 U.S.C. § 103 as obvious over the combination
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`of Baselga ’97, Gelmon and Presta;
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`4) Claims 1–11 and 14–17 under 35 U.S.C. § 103 as obvious over the
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`combination of Baselga ’96, Baselga ’94, and Gelmon;
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`5) Claim 12 under 35 U.S.C. § 103 as obvious over the combination
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`of Baselga ’96, Baselga ’94, Gelmon, and Drebin;
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`6) Claim 13 under 35 U.S.C. § 103 as obvious over the combination
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`of Baselga ’96, Baselga ’94, Gelmon, and Presta.
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`FURTHER ORDERED that Bioepis’s Motion for Joinder with
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`IPR2017-00737 is granted;
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`FURTHER ORDERED that IPR2017-01960 is terminated and joined
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`to IPR2015-00737, pursuant to 37 C.F.R. §§ 42.72, 42.122, based on the
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`conditions discussed above;
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`FURTHER ORDERED that absent leave of the Board, Bioepis shall
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`maintain an understudy role with respect Hospira, coordinate filings with
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`Hospira, not submit separate substantive filings, not participate substantively
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`in oral argument, and not actively participate in deposition questioning
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`except with the assent of all parties;
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`7
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`IPR2017-001960
`Patent US 7,892,549 B2
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`FURTHER ORDERED that the Scheduling Order in place for
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`IPR2017-00737 (Paper 18, as amended in Paper 36) shall govern the joined
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`proceedings;
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`FURTHER ORDERED that all future filings in the joined proceeding
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`shall be made only in IPR2017-00737;
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`FURTHER ORDERED that the case caption in IPR2017-00737 for all
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`further submissions shall be changed to add Bioepis as a named Petitioner
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`after Apotex, and to indicate by footnote the joinder of IPR2017-01960 to
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`that proceeding, as indicated in the attached sample case caption;
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`FURTHER ORDERED that a copy of this Decision shall be entered into the
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`record of IPR2017-00737.
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`8
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`IPR2017-001960
`Patent US 7,892,549 B2
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`FOR PETITIONER BIOEPIS:
`
`
`
`Dimitrios Drivas
`ddrivas@whitecase.com
`
`Scott Weingaertner
`sweingaertner@whitecase.com
`
`
`FOR PATENT OWNER GENENTECH:
`
`David Cavanaugh
`david.cavanaugh@wilmerhale.com
`
`Owen Allen
`owen.allen@wilmerhale.com
`
`Adam Brausa
`abrausa@durietangri.com
`
`
`FOR PETITIONER HOSPIRA (IPR2017-00737):
`
`Amanda Hollis
`Stefan Miller
`Karen Younkins
`Mark McLennan
`Benjamin Lasky
`Sarah K. Tsou
`Christopher J. Citro
`KIRKLAND & ELLIS LLP
`Amanda.hollis@kirkland.com
`Stefan.miller@kirkland.com
`Karen.younkins@kirkland.com
`Mark.mclennan@kirkland.com
`Blasky@kirkland.com
`Sarah.tsou@kirkland.com
`Christopher.citro@kirkland.com
`
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`9
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`IPR2017-001960
`Patent US 7,892,549 B2
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`Sample Case Caption
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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 IPR2017-00737
`Patent US 7,892,549 B2
`____________
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