throbber
Trials@uspto.gov
`571-272-7822
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`
`
`
`
`Paper No. 9
`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 IPR2017-01959
`Patent 7,371,379 B1
`____________
`
`
`Before ZHENYU YANG, CHRISTOPHER G. PAULRAJ, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`PAULRAJ, 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)
`
`
`
`
`
`
`
`
`
`

`

`IPR2017-01959
`Patent 7,371,379 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, 16–28, and
`
`30–40 of U.S. Patent No. 7,371,379 B1 (Ex. 1001, “the ’379 patent”). Paper
`
`2 (“Pet.”). Genentech, Inc. (“Patent Owner”) has 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
`
`IPR2017-00805. Paper 1 (“Mot.”). Patent Owner opposes the Motion.
`
`Paper 7.
`
`As explained further below, we institute trial on the same grounds as
`
`instituted in IPR2017-00805 and grant Petitioner’s Motion for Joinder.
`
`II. DISCUSSION
`
`In IPR2017-00805, Hospira, Inc. (“Hospira”) challenged claims 1–3,
`
`5, 7, 9–11, 16–28, and 30–40 of the ’379 patent as obvious under 35 U.S.C.
`
`§ 103(a) over the combination of the Herceptin Label,1 Baselga ’96,2 Pegram
`
`’98,3 and the Knowledge of a Person of Ordinary Skill in the Art. On July
`
`27, 2017, we instituted trial to review the patentability of those claims.
`
`Hospira, Inc. v. Genentech, Inc., IPR2017-00805, Paper 13.
`
`
`1 Genentech, Inc, Herceptin® Trastuzumab, Sept. 1998 (hereinafter “Herceptin
`Label” (Ex. 1008).
`2 Jose Baselga, Phase ll Study of Weekly Intravenous Recombinant Humanized
`Anti-p185HER2 Monoclonal Antibody in Patients With HER2/neu-Overexpressing
`Metastatic Breast Cancer, 14 JOURNAL OF CLINICAL ONCOLOGY 737–744 (1996)
`(hereinafter “Baselga ’96”) (Ex. 1013).
`3 Mark D. Pegram, Phase ll Study of Receptor-Enhanced Chemosensitivity Using
`Recombinant Humanized Anti-p185HER21neu Monoclonal Antibody Plus Cisplatin in
`Patients With HER2/neu-Overexpressing Metastatic Breast Cancer Refractory to
`Chemotherapy Treatment, 16 JOURNAL OF CLINICAL ONCOLOGY 2659–71 (1998)
`(hereinafter “Pegram ’98”) (Ex. 1014).
`
`
`
`
`
`

`

`IPR2017-01959
`Patent 7,371,379 B1
`
`
`The Petition in this case is substantively identical to the one in
`
`IPR2017-00805. Compare IPR2017-00805, Paper 1 with IPR2017-01959,
`
`Paper 2. For the same reasons stated in our Decision on Institution in
`
`IPR2017-00805, we institute trial in this proceeding on the same ground.
`
`See IPR2017-00805, Paper 13.
`
`Having determined that institution is appropriate, we now turn to
`
`Bioepis’s Motion for Joinder. Under the statute, “[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.” 35 U.S.C. § 315(c). 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 filed the Petition and Motion for Joinder in the present
`
`proceeding within one month after we instituted trial in IPR2017-00805.
`
`See 37 C.F.R. § 42.122(b). Bioepis represents that the Petition in this case is
`
`“essentially a copy of the Hospira Petition, including a ground that is
`
`substantially identical to that presented in the Hospira Petition in IPR2017-
`
`00805.” Mot. 1. According to Bioepis, the Petition “relies solely on the
`
`same prior art analysis and expert testimony submitted by Hospira.” Id. at 3.
`
`Bioepis asserts that it “anticipates participating in the proceeding in a limited
`
`‘understudy’ capacity,” unless Hospira is terminated as a party. Id. at 2, 5;
`
`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 . . .
`
`
`
`
`
`

`

`IPR2017-01959
`Patent 7,371,379 B1
`
`[an] understudy role”). As a result, Bioepis avers that joinder will “create no
`
`additional burden for the Board, Genentech, or Hospira,” “have no impact
`
`on the trial schedule of IPR2017-00805,” and result in no prejudice to either
`
`Genentech or Hospira. Id. at 1–3.
`
`Genentech argues that “Bioepis offers no real assurances that its role
`
`will be so limited as to prevent prejudice to Patent Owner.” Paper 7, 1.
`
`Genentech asks us to impose certain conditions on Bioepis, including: (1) as
`
`long as Hospira remains a party to IPR2017-00805, 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
`
`circumscribed secondary role.” Id. at 2–3.
`
`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 filing of Hospira Petition. See
`
`Mot. 6. Under those circumstances, this panel may wish to entertain
`
`requests for additional briefing, additional discovery, or an opportunity for
`
`Bioepis to ask questions at a deposition. See 37 C.F.R. § 42.5 (authorizing
`
`the panel “may determine a proper course of conduct in a proceeding”). In
`
`addition, to the extent we grant its Motion for Joinder, Bioepis becomes a
`
`“petitioner” in the IPR2017-00805 proceeding. Patent Owner does not cite
`
`to, nor are we aware of, any authority suggesting that a passive role in an
`
`
`
`
`
`

`

`IPR2017-01959
`Patent 7,371,379 B1
`
`IPR proceeding insulates a petitioner from the estoppel provision of
`
`§ 315(e). Rather, the provision vests as a matter of law such that Bioepis’s
`
`formal acknowledgement of § 315(e) is irrelevant.
`
`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. See 37 C.F.R.
`
`§ 42.1(b) (instructing that an inter partes review must be conducted to
`
`“secure the just, speedy, and inexpensive resolution”).
`
`In view of the foregoing, we find that joinder based upon the
`
`conditions stated by Bioepis’s in its Motion for Joinder will have little or no
`
`impact on the timing, cost, or presentation of the trial on the instituted
`
`ground. Discovery and briefing will be simplified if the proceedings are
`
`joined. Having considered Bioepis’s Motion in light of Genentech’s
`
`response, the Motion is granted.
`
`III. ORDER
`
`Accordingly, it is
`
`ORDERED that trial is instituted in IPR2017-01959 to determine
`
`whether claims 1–3, 5, 7, 9–11, 16–28, and 30–40 of the ’379 patent would
`
`have been obvious over the combination of the Herceptin Label, Baselga
`
`’96, Pegram ’98, and the Knowledge of a Person of Ordinary Skill in the
`
`Art;
`
`FURTHER ORDERED that Bioepis’s Motion for Joinder with is
`
`granted;
`
`FURTHER ORDERED that IPR2017-01959 is terminated and joined
`
`to IPR2017-00805, pursuant to 37 C.F.R. §§ 42.72, 42.122, based on the
`
`
`
`
`
`

`

`IPR2017-01959
`Patent 7,371,379 B1
`
`conditions discussed above, specifically, 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;
`
`FURTHER ORDERED that the Scheduling Order in place for
`
`IPR2017-00805 shall govern the joined proceedings;
`
`FURTHER ORDERED that all future filings in the joined proceeding
`
`are to be made only in IPR2017-00805;
`
`FURTHER ORDERED that the case caption in IPR2017-00805 for all
`
`further submissions shall be changed to add Bioepis as a named Petitioner
`
`after Hospira, and to indicate by footnote the joinder of IPR2017-01959 to
`
`that proceeding, as indicated in the attached form of caption;
`
`FURTHER ORDERED that a copy of this Decision shall be entered
`
`into the record of IPR2017-00805.
`
`
`
`
`
`
`
`
`
`

`

`IPR2017-01959
`Patent 7,371,379 B1
`
`
`
`
`
`
`
`
`
`
`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 IPR2017-008051
`Patent 6,627,196 B1
`
`____________
`
`
`
`
`
`1 Case IPR2017-01959 has been joined with this proceeding.
`
`
`
`
`
`

`

`IPR2017-01959
`Patent 7,371,379 B1
`
`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 (IPR2017-00805):
`
`Amanda Hollis
`amanda.hollis@kirkland.com
`
`Stefan Miller
`Stefan.Miller@kirkland.com
`
`Karen Younkins
`karen.younkins@kirkland.com
`
`
`
`
`
`
`
`
`
`

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