Trials@uspto.gov
`571-272-7822
`
`
` Paper No. 37
`
`Entered: October 13, 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 IPR2017-001960
`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)
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`
` Paper No. 37
`
`Entered: October 13, 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 IPR2017-001960
`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)
`
`
`
`
`
`
`
`
`
`
`IPR2017-001960
`Patent US 7,892,549 B2
`
`
`INTRODUCTION
`I.
`Samsung Bioepis Co., LTD (“Bioepis”) filed a Petition requesting an
`inter partes review of claims 1–17 of U.S. Patent No. 7,892,549 B2 (“the
`’549 patent”). Paper 2 (“Pet.”). Genentech, Inc. (“Genentech”) has not filed
`a Preliminary Response to the Petition, and any such response is due
`November 27, 2017.
`Along with its Petition, Bioepis filed a Motion for Joinder to join this
`proceeding with IPR2017-00737. Paper 1 (“Mot.”). Bioepis filed the
`Petition and Motion for Joinder in the present proceeding on August 25,
`2017, within one month after we instituted trial in IPR2017-00737.
`Genentech opposes the Motion. Paper 7.
`As explained further below, we institute trial on the same grounds as
`instituted in IPR2017-00737 and grant Bioepis’s Motion for Joinder.
`
`
`
`2
`
`
`
`IPR2017-001960
`Patent US 7,892,549 B2
`
`
`DISCUSSION
`II.
`In IPR2017-00737, Hospira, Inc., (“Hospira”) challenged claims 1–17
`of the ’549 Patent on the following grounds:
`
`References
`Ground Claim(s)
`1
`1–11 and 14–17 Baselga ’971 and Gelmon2
`2
`12
`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
`
`3
`
`4
`
`5
`
`6
`
`13
`
`12
`
`13
`
`Basis
`§ 103
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
`
`After considering the Petition and Patent Owner’s Preliminary
`Response, we instituted trial in IPR2017-00737 on each of the six asserted
`grounds. IPR2017-00737, Paper 19, 25–26.
` Bioepis’s Petition is substantively identical to Hospira’s Petition,
`challenging the same claims based on the same art and the same grounds.
`Compare IPR2017-001960, Paper 2, with IPR2017-00737, Paper 1. For the
`same reasons stated in our Decision on Institution in IPR2017-00737, we
`institute trial in this proceeding on the same six grounds.
`
`
`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.
`
`3
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`IPR2017-001960
`Patent US 7,892,549 B2
`
`
`Having determined that institution is appropriate, we now turn to
`Bioepis’s Motion for Joinder. 35 U.S.C. § 315(c). Section 315(c) provides,
`in relevant part, that “[i]f the Director institutes an inter partes review, the
`Director, in his or her discretion, may join as a party to that inter partes
`review any person who properly files a petition under section 311.” Id.
`When determining whether to grant a motion for joinder we consider factors
`such as timing and impact of joinder on the trial schedule, cost, discovery,
`and potential simplification of briefing. Kyocera Corp. v. SoftView, LLC,
`Case IPR2013-00004, slip op. at 4 (PTAB Apr. 24, 2013) (Paper 15). Under
`the circumstances of this case, we determine that joinder is appropriate.
`Bioepis avers that joinder will “create no additional burden for the
`Board, Genentech, or Hospira,” “have no impact on the trial schedule of
`IPR2017-00737,” and result in no prejudice to either Genentech or Hospira.”
`Mot. 1–3. In particular, Bioepis asserts that its Petition raises no new
`grounds of unpatentability from IPR2017-00737, and is “essentially a copy
`of the Hospira Petition,” relying “on the same prior art analysis, the same
`expert testimony, and the same arguments that Hospira presented.” See id.
`at 1, 3, 4. Bioepis further asserts that “anticipates participating in the
`proceeding in a limited ‘understudy’ capacity,” unless Hospira is terminated
`as a party. Id. at 2; see also id. at 6 (agreeing that, “as long as Hospira
`remains a party . . . the Board may order petitioners to consolidate filings,
`and limit Bioepis to an understudy role”); id. at 3, n1, 5 (stating that it may
`rely on the testimony of its own expert if Hospira’s expert becomes
`unavailable).
`
`In response, Genentech argues that “Bioepis offers no real assurances
`that its role will be so limited as to prevent prejudice to Patent Owner.”
`
`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
`a party to IPR2017-000737, Bioepis should be precluded from any “right to
`its own briefing or oral argument,” “proceed solely on the arguments and
`evidence presented and maintained by Hospira,” undertake no additional
`discovery or ask any questions during deposition, “not attempt to alter the
`Hospira IRP trial schedule,” and “acknowledge[] that the estoppel provisions
`of 35 U.S.C. § 315(e) will be applicable to it even if remains in a
`circumscribed secondary role.” Id. at 2–3. We do not find Genentech’s
`arguments persuasive.
`
`Where, as in the present case, a party seeks to take a secondary role in
`an on-going IPR, joinder promotes economy and efficiency, thereby
`reducing the burden on the Patent Owner and on the limited resources of the
`Board, as compared to distinct, parallel proceedings. Counterintuitively,
`Genentech’s proposed conditions seem designed to discourage petitioners
`from seeking joinder under these circumstances and, thus, incompatible with
`“the just, speedy, and inexpensive resolution of every proceeding.” See 37
`C.F.R. § 42.1(b).
`For example, although Bioepis “anticipates” taking an understudy role
`in this proceeding, we can envision circumstances in which it “strongly
`disagrees” with a position that Hospira adopts (or repudiates) subsequent to
`the filing of Hospira Petition. See Mot. 6. Under these circumstances, this
`panel may wish to entertain requests for additional briefing, additional
`discovery, or an opportunity for Bioepis to ask questions at a deposition.7
`
`
`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).
`
`5
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`IPR2017-001960
`Patent US 7,892,549 B2
`
`
`Strict adherence to Genentech’s proposed conditions, however, would be at
`odds with our discretion to managing this case. See generally, 37 C.F.R. §
`42.71(a).
`We also address Genentech’s proposed condition that “Bioepis
`acknowledges that the estoppel provisions of 35 U.S.C. § 315(e) will be
`applicable to it even if remains in a circumscribed secondary role.” Paper 7,
`3. To the extent we grant its Motion for Joinder, Bioepis becomes a
`“petitioner” in the IPR2017-00737 inter partes review pursuant to 35 U.S.C.
`§ 315(e). Patent Owner cites (nor are we aware of) any authority suggesting
`that a passive role in an IPR proceeding insulates a petitioner from the
`estoppel provision of this section. Rather, the provision vests as a matter of
`law such that Bioepis’s formal acknowledgement of § 315(e) is irrelevant.
` In view of the foregoing, we find that joinder based upon the
`conditions stated in Bioepis’s Motion for Joinder will have little or no
`impact on the timing, cost, or presentation of the trial on the instituted
`grounds and promote the just, speedy, and inexpensive resolution of the
`involved proceedings. Moreover, discovery and briefing will be simplified
`if the proceedings are joined. Having considered Bioepis’s Motion in light
`of Genetech’s response, the Motion is granted.
`
`III.
`
`ORDER
`
`Accordingly, it is
`ORDERED that, pursuant to 35 U.S.C. § 314(a), an inter partes review is
`instituted as to claims 1–17 of U.S. Patent No. 7,892,549 B2 based on the
`following grounds of unpatentability:
`
`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
`combination of Baselga ’97 and Gelmon;
`
`2) Claim 12 under 35 U.S.C. § 103 as obvious over the combination
`of Baselga ’97, Gelmon and Drebin;
`
`3) Claim 13 under 35 U.S.C. § 103 as obvious over the combination
`of Baselga ’97, Gelmon and Presta;
`
`4) Claims 1–11 and 14–17 under 35 U.S.C. § 103 as obvious over the
`combination of Baselga ’96, Baselga ’94, and Gelmon;
`
`5) Claim 12 under 35 U.S.C. § 103 as obvious over the combination
`of Baselga ’96, Baselga ’94, Gelmon, and Drebin;
`
`6) Claim 13 under 35 U.S.C. § 103 as obvious over the combination
`of Baselga ’96, Baselga ’94, Gelmon, and Presta.
`
`FURTHER ORDERED that Bioepis’s Motion for Joinder with
`IPR2017-00737 is granted;
`
`FURTHER ORDERED that IPR2017-01960 is terminated and joined to
`IPR2015-00737, pursuant to 37 C.F.R. §§ 42.72, 42.122, based on the
`conditions discussed above;
`
`FURTHER ORDERED that absent leave of the Board, Bioepis shall
`maintain an understudy role with respect Hospira, coordinate filings with
`Hospira, not submit separate substantive filings, not participate substantively
`in oral argument, and not actively participate in deposition questioning
`except with the assent of all parties;
`
`7
`
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`IPR2017-001960
`Patent US 7,892,549 B2
`
`
`FURTHER ORDERED that the Scheduling Order in place for
`IPR2017-00737 (Paper 18, as amended in Paper 36) shall govern the joined
`proceedings;
`
`FURTHER ORDERED that all future filings in the joined proceeding shall
`be made only in IPR2017-00737;
`
`FURTHER ORDERED that the case caption in IPR2017-00737 for all
`further submissions shall be changed to add Bioepis as a named Petitioner
`after Apotex, and to indicate by footnote the joinder of IPR2017-01960 to
`that proceeding, as indicated in the attached sample case caption;
`
`FURTHER ORDERED that a copy of this Decision shall be entered into the
`record of IPR2017-00737.
`
`8
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`IPR2017-001960
`Patent US 7,892,549 B2
`
`
`
`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
`
`
`
`
`
`
`9
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`IPR2017-001960IPR2017-001960
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`IPR2017-001960
`Patent US 7,892,549 B2
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`Patent US 7,892,549 B2Patent US 7,892,549 B2
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`10
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`1010
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`IPR2017-001960
`Patent US 7,892,549 B2
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`Sample Case Caption
`
`
`
`
`
`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 IPR2017-001960
`Patent US 7,892,549 B2
`____________
`
`
`
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