Trials@uspto.gov
`571-272-7822
`
`
`
`
`Paper No. 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 IPR2017-02140
`Patent 6,407,213 B1
`____________
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, 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)
`
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`Paper No. 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 IPR2017-02140
`Patent 6,407,213 B1
`____________
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, 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)
`
`
`
`
`
`
`
`
`
`
`
`IPR2017-02140
`Patent 6,407,213 B1
`
`
`I.
`
`INTRODUCTION
`
`On September 29, 2017, 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 also filed a Motion
`
`for Joinder to join this proceeding with IPR2017-01489. 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 IPR2017-01489 and grant
`
`Petitioner’s Motion for Joinder.
`
`II. DISCUSSION
`
`In IPR2017-01489, Pfizer, Inc. challenged claims 1, 2, 4, 12,
`
`25, 29–31, 33, 42, 60, 62–67, 69, and 71–81 of the ’213 patent based
`
`on the following grounds:
`
`Claim(s)
`1, 2, 12, 25, 29, 63,
`64, 66, 67, and 71–81
`1, 2, 4, 12, 25, 29,
`62–64, 66, 67, 69,
`and 71–81
`65, 75–77, and 79
`
`Basis
`§ 103
`
`§ 103
`
`§ 103
`
`Reference(s)
`Queen 19891 and Protein Data Bank
`(PDB database)
`Queen 19902 and PDB database
`
`Queen 1989, PDB database, and
`Tramontano3
`
`
`1 Queen et al., A Humanized Antibody that Binds to the Interleukin 2
`Receptor, 86 PRO. NAT’L ACAD. SCI. 10029–33 (1989) (Ex. 1534).
`2 Queen, et al., International Publication No. WO 1990/07861 A1, published
`July 26, 1990 (Ex. 1550).
`3 Tramontano, A. et al., Framework Residue 71 is a Major Determinant of
`the Position and Conformation of the Second Hypervariable Region in the
`
`
`
`2
`
`
`
`IPR2017-02140
`Patent 6,407,213 B1
`
`
`Claim(s)
`65, 75–77, and 79
`
`Basis
`§ 103
`
`4, 62, 64, and 69
`
`§ 103
`
`30, 31, 42, and 60
`
`§ 103
`
`30, 31, 33, 42, and 60 § 103
`
`Reference(s)
`Queen 1990, PDB database, and
`Tramontano
`Queen 1989, PDB database, and
`Kabat 19874
`Queen 1989, PDB database, and
`Hudziak5
`Queen 1990, PDB database, and
`Hudziak
`
`On December 1, 2017, we instituted an inter partes review to
`
`review the patentability of those claims. Pfizer, Inc. v. Genentech,
`
`Inc., IPR2017-01489, Paper 27.
`
`The Petition in this case is substantively identical to the one in
`
`IPR2017-01489. Compare IPR2017-01489, Paper 1 with IPR2017-
`
`02140, Paper 1. For the same reasons stated in our Decision on
`
`Institution in IPR2017-01489, we institute an inter partes review in
`
`this proceeding on the same grounds. See IPR2017-01489, 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
`
`
`VH Domains of Immunoglobulins, 215 J. MOL. BIOL. 175–82 (1990) (Ex.
`1551).
`4 Kabat, et al., Sequences of Proteins of Immunological Interest 4th Ed.,
`Tabulation and Analysis of Amino Acid and Nucleic Acid Sequences of
`Precursors, V-Regions, C-Regions, J-Chain, T-Cell Receptor for Antigen, T-
`Cell Surface Antigens (National Institutes of Health, Bethesda, Md.) (1987)
`(Ex. 1552).
`5 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. 1521).
`
`
`
`3
`
`
`
`IPR2017-02140
`Patent 6,407,213 B1
`
`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
`
`IPR2017-01489, 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,”
`
`“have no impact on the trial schedule of IPR2017-01489,” 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
`
`
`
`4
`
`
`
`IPR2017-02140
`Patent 6,407,213 B1
`
`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.,
`
`IPR2017-01958, Paper 9, 6. Those requirements, although not
`
`verbatim, appear to be substantially the same as Genentech requests.
`
`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
`
`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
`
`
`
`5
`
`
`
`IPR2017-02140
`Patent 6,407,213 B1
`
`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 IPR2017-02140 on the following
`
`grounds:
`
`1. claims 1, 2, 12, 25, 29, 63, 66, 67, and 71–81 as obvious over the
`
`combination of Queen 1989 and PDB database;
`
`2. claims 1, 2, 4, 12, 25, 29, 62–64, 66, 67, 69, and 71–81 as obvious
`
`over the combination of Queen 1990 and PDB database;
`
`3. claims 65, 75–77, and 79 as obvious over the combination of
`
`Queen 1989, PDB database, and Tramontano;
`
`4. claims 65, 75–77, and 79 as obvious over the combination of
`
`Queen 1990, PDB database, and Tramontano;
`
`5. claims 4, 62, 64, and 69 as obvious over the combination of Queen
`
`1989, PDB database, and Kabat 1987;
`
`6. claims 30, 31, 42, and 60 as obvious over the combination of
`
`Queen 1989, PDB database, and Hudziak; and
`
`7. claims 30, 31, 33, 42, and 60 as obvious over the
`
`combination of Queen 1990, PDB database, and Hudziak;
`
`FURTHER ORDERED that Bioepis’s Motion for Joinder with
`
`IPR2017-01489 is granted;
`
`FURTHER ORDERED that IPR2017-02140 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
`
`
`
`6
`
`
`
`IPR2017-02140
`Patent 6,407,213 B1
`
`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 IPR2017-01489;
`
`FURTHER ORDERED that the case caption in IPR2017-01489
`
`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 IPR2017-01489.
`
`
`
`
`
`7
`
`
`
`IPR2017-02140
`Patent 6,407,213 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 PFIZER (IPR2017-01489):
`
`Amanda Hollis
`amanda.hollis@kirkland.com
`
`Stefan Miller
`Stefan.Miller@kirkland.com
`
`Karen Younkins
`karen.younkins@kirkland.com
`
`Mark McLennan
`mark.mclennan@kirkland.com
`
`Christopher Citro
`christopher.citro@kirkland.com
`
`Benjamin A. Lasky
`blasky@kirkland.com
`
`
`
`8
`
`
`
`IPR2017-02140
`Patent 6,407,213 B1
`
`
`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 IPR2017-014896
`Patent 6,407,213 B1
`
`____________
`
`
`
`
`
`
`6 Case IPR2017-02140 has been joined with this proceeding.
`9
`
`
`
`
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