Trials@uspto.gov
`Tel: 571-272-7822
`
`
`Paper 11
`Entered: February 22, 2018
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`
`
`
`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-02139
`Patent 6,407,213 B1
`____________
`
`
`
`
`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)
`
`
`
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`
`Tel: 571-272-7822
`
`
`Paper 11
`Entered: February 22, 2018
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`
`
`
`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-02139
`Patent 6,407,213 B1
`____________
`
`
`
`
`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)
`
`
`
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`
`
`IPR2017-02139
`Patent 6,407,213 B1
`
`
`I.
`INTRODUCTION
`Samsung Bioepis Co., LTD (“Bioepis”) filed a Petition, seeking
`an inter partes review of claims 1, 2, 4, 12, 25, 29–31, 33, 42, 60, 62–
`67, 69, 71–81 of U.S. Patent No. 6,407,213 B1 (Ex. 1001, “the ’213
`patent”). Paper 1 (“Pet.”). Genentech, Inc. (“Patent Owner”) did not
`file a Preliminary response to the Petition. Along with the Petition,
`Bioepis filed a Motion for Joinder to join this proceeding with
`IPR2017-01488. Paper 3 (“Mot.”). Patent Owner opposes the
`Motion. Paper 7 (“Opp.”).
`As explained further below, we institute an inter partes review
`on the same grounds as instituted in IPR2017-01488 and grant
`Petitioner’s Motion for Joinder.
`
`Basis
`§ 102 Kurrle1
`
`Reference(s)
`
`II. DISCUSSION
`In IPR2017-01488, Pfizer, Inc. challenged claims 1, 2, 4, 12,
`25, 29–31, 33, 42, 60, 62–67, 69, and 71–81 of the ’213 patent on the
`following grounds:
`Ground
`Claim(s)
`1
`1, 2, 25, 29, 63, 66,
`67, 71, 72, 75, 76, 80,
`and 81
`1, 2, 4, 29, 62–64, 80,
`and 81
`1, 2, 4, 25, 29, 62–64,
`66, 67, 69, 71, 72, 75,
`76, 78, 80, and 81
`
`2
`
`3
`
`§ 102 Queen 19902
`
`§ 103 Kurrle and Queen 1990
`
`
`1 Kurrle, et al., European Patent Application Publication No. 0 403
`156, published December 19, 1990. Ex. 1071.8
`2 Queen, et al., International Publication No. WO 1990/07861,
`published July 26, 1990. Ex. 1050.
`
`
`
`2
`
`
`
`IPR2017-02139
`Patent 6,407,213 B1
`
`
`Ground
`4
`
`12
`
`Claim(s)
`
`Reference(s)
`Basis
`§ 103 Kurrle, Queen 1990, and
`Furey 3
`§ 103 Kurrle, Queen 1990, and
`Chothia & Lesk4
`§ 103 Kurrle, Queen 1990, and
`Chothia 19855
`§ 103 Kurrle, Queen 1990, Chothia
`& Lesk, and Chothia 1985
`§ 103 Queen 1990 and Hudziak6
`§ 103 Queen 1990, Hudziak and
`Furey
`§ 103 Queen 1990, Hudziak, and
`Chothia & Lesk
`On December 1, 2017, we instituted an inter partes review to
`review the patentability of those claims. Pfizer, Inc. v. Genentech,
`Inc., IPR2017-01488, Paper 27.
`The Petition in this case is substantively identical to the one in
`IPR2017-01488. Compare IPR2017-01488, Paper 1 with IPR2017-
`02139, Paper 1; see Mot. 3–4 (admitting that “the Petition and
`evidence offered by Bioepis is nearly identical to that in IPR2017—
`01488”). For the reasons stated in our Decision on Institution in
`
`5
`
`6
`
`7
`
`73 and 77
`
`74
`
`79 and 65
`
`8
`9
`
`30, 31, 33, and 42
`42
`
`10
`
`60
`
`
`3 Furey et al., Structure of a Novel Bence-Jones Protein (Rhe)
`Fragment at 1.6 Å Resolution, 167 J. MOL. BIOL. 661–92 (1983). Ex. 1125.
`4 Chothia and Lesk, Canonical Structures for the Hypervariable
`Regions of Immunoglobulins, 196 J. MOL. BIOL. 901–17 (1987). Ex. 1062.
`5 Chothia et al., Domain Association in Immunoglobulin Molecules:
`The Packing of Variable Domains, 186 J. MOL. BIOL. 651–63 (1985).
`Ex. 1063.
`6 Hudziak et al., p185HER2 Monoclonal Antibody Has Antiproliferative
`Effects In Vitro and Sensitizes Human Breast Tumor Cells to Tumor
`Necrosis Factor, 9 MOL. CELL BIOL. 1165–72 (1989). Ex. 1021.
`3
`
`
`
`
`
`IPR2017-02139
`Patent 6,407,213 B1
`
`IPR2017-01488, we institute an inter partes review in this proceeding
`on the same grounds. See IPR2017-01488, Paper 27.
`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 before we instituted an inter partes review in
`IPR2017-01488, and thus, satisfies the requirement of 37 C.F.R.
`§ 42.122(b). Bioepis represents that the Petition in this case is
`“essentially a copy of the Pfizer Petition.” Mot. 1. According to
`Bioepis, the Petition “relies solely on the same prior art analysis and
`expert testimony submitted by Pfizer.” Id. at 3. Bioepis asserts that it
`“anticipates participating in the proceeding in a limited ‘understudy’
`capacity,” unless Pfizer is terminated as a party. Id. at 2, 5; see also
`id. at 6 (agreeing that, “as long as Pfizer remains a party . . . the Board
`may order petitioners to consolidate filings, and limit Bioepis to . . .
`[an] understudy role”). As a result, Bioepis avers that joinder will
`“create no additional burden for the Board, Genentech, or Pfizer,”
`
`
`
`4
`
`
`
`IPR2017-02139
`Patent 6,407,213 B1
`
`“have no impact on the trial schedule of IPR2017-01488,” and result
`in no prejudice to either Genentech or Pfizer. Id. at 1–3.
`In its Opposition, Genentech does not challenge Bioepis’s
`arguments. Instead, Genentech urges that we impose certain
`conditions on Bioepis. Opp. 4–5. According to Genentech,
`previously, when Bioepis filed petitions to challenge three patents
`other than the ’213 patent and sought to join three other IPRs, we
`instituted inter partes reviews and “granted joinder without any
`conditions.” Id. at 2. This representation is inaccurate.
`In IPR2017-01958, -01959, and -01960, Bioepis sought to join
`IPR2017-00804, -00805, and -00737 (all filed by Hospira, Inc.),
`respectively. IPR2017-01958, Paper 1; IPR2017-01959, Paper 1;
`IPR2017-01960, Paper 1. We instituted an inter partes review and
`granted joinder in each case. IPR2017-01958, Paper 9; IPR2017-
`01959, Paper 9; IPR2017-01960, Paper 11. When doing so, we
`specifically ordered that “absent leave of the Board, Bioepis shall
`maintain an understudy role with respect to 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.” See, e.g.,
`IPR2017-01960, Paper 11, 7. Those requirements, although not
`verbatim, appear to be substantially the same as Genentech requests
`here. See Opp. 4–5.
`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
`
`
`
`5
`
`
`
`IPR2017-02139
`Patent 6,407,213 B1
`
`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 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 Opposition, the Motion is granted.
`
`III. ORDER
`
`Accordingly, it is
`ORDERED that trial is instituted in IPR2017-02139 on the following
`grounds:
`1. claims 1, 2, 25, 29, 63, 66, 67, 71, 72, 75, 76, 80, and 81, as
`anticipated by Kurrle;
`2. claims 1, 2, 4, 29, 62–64, 80, and 81 as anticipated by Queen
`1990;
`3. claims 1, 2, 4, 25, 29, 62–64, 66, 67, 69, 71, 72, 75, 76, 78,
`80, and 81, as obvious over the combination of Kurrle and
`Queen 1990;
`4. claim 12 as obvious over the combination of Kurrle, Queen
`1990, and Furey;
`5. claims 73 and 77 as obvious over the combination of Kurrle,
`Queen 1990, and Chothia & Lesk;
`6. claim 74 as obvious over the combination of Kurrle, Queen
`1990 and Chothia 1985;
`7. claims 79 and 65 as obvious over the combination of Kurrle,
`Queen 1990, Chothia & Lesk, and Chothia 1985;
`8. claims 30, 31, 33, and 42 as obvious over the combination of
`Queen 1990, and Hudziak;
`
`
`
`6
`
`
`
`IPR2017-02139
`Patent 6,407,213 B1
`
`
`9. claim 42 as obvious over the combination of Queen 1990,
`Hudziak, and Furey; and
`10. claim 60 as obvious over the combination of Queen 1990,
`Chothia & Lesk, and Hudziak.
`FURTHER ORDERED that Bioepis’s Motion for Joinder with
`IPR2017-01488 is granted.
`FURTHER ORDERED that IPR2017-02139 is terminated and
`joined to IPR2017-01489, pursuant to 37 C.F.R. §§ 42.72, 42.122,
`based on the conditions discussed above, specifically, absent leave of
`the Board, Bioepis shall maintain an understudy role with respect
`Pfizer, coordinate filings with Pfizer, 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
`IPR2017-01489 shall govern the joined proceedings.
`FURTHER ORDERED that all future filings in the joined
`proceeding are to be made only in IPR2017-01488.
`FURTHER ORDERED that the case caption in IPR2017-01488
`for all further submissions shall be changed to add Bioepis as a named
`Petitioner after Pfizer, and to indicate by footnote the joinder of
`IPR2017-02140 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 IPR2017-01488.
`
`
`
`
`7
`
`
`
`IPR2017-02139
`Patent 6,407,213 B1
`
`FOR PETITIONER BIOEPIS:
`Dimitrios Drivas
`Scott T. Weingaertner
`WHITE & CASE LLP
`sweingaertner@whitecase.com
`ddrivas@whitecase.com
`
`FOR PETITIONER PFIZER (IPR2017-01488):
`
`Amanda Hollis
`Stefan M. Miller
`Karen Younkins
`Mark McLennan
`Christopher Citro
`Benjamin Lasky
`KIRKLAND & ELLIS LLP
`amanda.hollis@kirkland.com
`stefan.miller@kirkland.com
`karen.younkins@kirkland.com
`mark.mclennan@kirkland.com
`christopher.citro@kirkland.com
`blasky@kirkland.com
`
`
`
`
`8
`
`
`
`IPR2017-02139
`Patent 6,407,213 B1
`
`FOR PATENT OWNER:
`
`David L. Cavanaugh
`Owen Allen
`Robert J. Gunther, Jr.
`Daralyn J. Durie
`Lisa J. Pirozzolo
`Andrew J. Danford
`Rebecca Whitfield
`Kevin S. Prussia
`WILMER CUTLER PICKERING HALE AND DORR LLP
`David.Cavanaugh@wilmerhale.com
`owen.allen@wilmerhale.com
`Robert.Gunther@wilmerhale.com
`ddurie@durietangri.com
`Lisa.Pirozzolo@wilmerhale.com
`Andrew.Danford@wilmerhale.com
`rebecca.whitfield@wilmerhale.com
`Kevin.Prussia@wilmerhale.com
`
`Adam R. Brausa
`DURIE TANGRI LLP
`abrausa@durietangri.com
`
`
`
`9
`
`
`
`
`
`
`
`
`
`Sample Case Caption
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PFIZER, INC., and
`SAMSUNG BIOEPIS CO., LTD.,
`Petitioners,
`
`v.
`
`GENENTECH, INC,
`Patent Owner.
`____________
`
`Case IPR2017-014881
`Patent 6,407,213 B1
`
`____________
`
`
`
`
`
`
`1 Case IPR2017-02139 has been joined with this proceeding.
`10
`
`
`
`
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