Trials@uspto.gov Paper 33
`571-272-7822 Date: July 18, 2017
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PFIZER, INC.
`Petitioner,
`
`v.
`
`BIOGEN, INC. and GENENTECH, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01115
`Patent 7,820,161 B1
`____________
`
`
`Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review, Grant of Motion for Joinder, and Grant of
`Joint Motion to Dismiss Certain Challenges in the Petition
`37 C.F.R. §§ 42.71 (a), 42.108, 42.122(b)
`
`
`
`
`

`

`IPR2017-01115
`Patent 7,820,161 B1
`
`
`INTRODUCTION
`I.
`Pfizer, Inc. (“Petitioner”) timely filed a Petition (“Pfizer Petition”)
`requesting an inter partes review of claims 1–12 of U.S. Patent No.
`7,820,161 B1 (Ex. 1001, “the ’161 patent”). Paper 2 (“Pet.”). Petitioner
`also timely filed a Motion for Joinder to join this proceeding with Celltrion
`Inc. v. Biogen, Inc. and Genentech, Inc., Case IPR2016-01614 (the
`“Celltrion IPR”) which was instituted on February 24, 2017. Paper 3
`(“Joinder Mot.”). Biogen, Inc. and Genentech, Inc.1 (collectively, “Patent
`Owner”) did not file a Preliminary Response to the Petition. With our
`authorization, Petitioner and Patent Owner filed a Joint Motion to Dismiss
`the claim challenges not instituted in the Celltrion IPR. Paper 11.
`For the reasons set forth below, we (1) grant the Joint Motion to
`Dismiss certain challenges raised in the Petition; (2) institute an inter partes
`review based on the same grounds as instituted in the Celltrion IPR, and (3)
`grant Petitioner’s Motion for Joinder, subject to the conditions detailed
`herein.
`
`JOINT MOTION TO DISMISS
`II.
`In the Pfizer Petition, Petitioner raises the identical grounds raised in
`the Celltrion IPR. Those grounds include challenges to claims that were not
`instituted in the Celltrion IPR. In the Joint Motion to Dismiss, Petitioner
`and Patent Owner jointly move to dismiss the challenges of those claims not
`instituted in the Celltrion IPR. Specifically, the motion seeks to dismiss “the
`challenge of claims 1–12 as set forth in Ground 1 and the challenge of
`
`
`1 In its Mandatory Notices, Patent Owner explains that the real party-in-
`interest are Genentech, Inc. and Biogen, Inc. Paper 7, 2.
`2
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`IPR2017-01115
`Patent 7,820,161 B1
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`claims 4, 8, and 12 as set forth in Grounds 2 and 3.” Paper 11, 1. In other
`words, the Petitioner seeks to modify the challenges in the Petition from:
`Claims Basis
`References
`1–12
`§ 103(a) Edwards,2 FDA Conversation,3 and the Rituxan® Label4
`1–12
`§ 103(a) Edwards, O’Dell,5 and the Rituxan® Label
`1–12
`§ 103(a) Edwards, Kalden,6 and the Rituxan® Label
`
`
`
`to:
`Claims
`1–3, 5–7, and 9–11
`1–3, 5–7, and 9–11
`
`References
`Basis
`§ 103(a) Edwards, O’Dell, and the Rituxan® Label
`§ 103(a) Edwards, Kalden, and the Rituxan® Label
`
`The parties explain that the motion seeks to “clarify that Pfizer seeks
`institution of the same claims and ground for which the Board instituted in
`the Celltrion IPR.” Paper 11, 1.
`Upon consideration of the agreement of the parties and the
`circumstances involved, including an unopposed joinder motion, Paper 3,
`
`
`2 Edwards et al., Rheumatoid Arthritis: The Predictable Effect of Small
`Immune Complexes in Which Antibody is Also Antigen, 37 BRITISH J.
`RHEUMATOLOGY 126–130 (1998) (Ex. 1030).
`3 Schwieterman, Immunosuppression in Combination with Monoclonal
`Antibodies, BIOLOGIC AGENTS IN AUTOIMMUNE DISEASE 291–298 (1995)
`(Ex. 1030).
`4 IDEC Pharmaceuticals Corporation and Genentech, Inc., Product label for
`Rituxan® (1997) (Ex. 1037).
`5 O’Dell, Methotrexate Use In Rheumatoid Arthritis, 23 RHEUMATIC
`DISEASE CLINICS OF NORTH AMERICA 779–796 (1997) (Ex. 1015).
`6 Kalden et al., Rescue of DMARD failures by means of monoclonal
`antibodies or biological agents, 15 J. CLINICAL AND EXPERIMENTAL
`RHEUMATOLOGY S91–S98 (1997) (Ex. 1051).
`
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`IPR2017-01115
`Patent 7,820,161 B1
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`the joint motion to dismiss certain claim challenges is granted. See 37
`C.F.R. § 42.71 (a) (“The Board may . . . enter any appropriate order.”).
`INSTITUTION OF INTER PARTES REVIEW
`III.
`In the Celltrion IPR, we instituted trial on the following ground:
`Claims 1–3, 5–7, and 9–11 of the ’161 patent under 35 U.S.C. § 103(a) as
`obvious over Edwards, the Rituxan® Label, O’Dell, and Kalden. Celltrion
`IPR, Paper 12, 12. Pfizer’s Petition is substantially identical to Celltrion’s
`Petition, challenging the same claims based on the same art and the same
`grounds. Pfizer’s Petition relies on its own declarant, Elena Massarotti,
`M.D. (Ex. 1002). Her declaration testimony, however, supports the Pfizer
`Petition in a similar manner as the declarants relied upon by Celltrion in the
`Celltrion IPR. Indeed, Petitioner confirms in the Motion for Joinder that
`“[t]he opinions set forth in Dr. Massaratti’s declaration are nearly identical
`to the opinions set forth in the declaration of Dr. Maarten Boers filed in the
`Celltrion IPR.” Paper 3, 3. As discussed in our Decision granting the Joint
`Motion to Dismiss, Section II above, Petitioner seeks only institution of the
`same claims and ground for which the Board instituted in the Celltrion IPR.
`Patent Owner has not filed a Preliminary Response in this proceeding.
`Thus, at this stage of the proceeding, Patent Owner has not raised any
`arguments in response to the substantive grounds of the Pfizer Petition. In
`view of that, and our dismissal of the claim challenges in the Petition that
`differ from those instituted in the Celltrion IPR, we determine that, under the
`current circumstances, it is appropriate to exercise our discretion to institute
`an inter partes review of the remaining challenged claims based upon the
`same ground authorized and for the same reasons discussed in our Institution
`Decision in the Celltrion IPR. See Celltrion IPR, Paper 12.
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`IPR2017-01115
`Patent 7,820,161 B1
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`JOINDER OF INTER PARTES REVIEWS
`IV.
`An inter partes review may be joined with another inter partes
`review, subject to the provisions 35 U.S.C. § 315(c), which governs joinder
`of inter partes review proceedings:
`(c) JOINDER. — If 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 that the Director, after receiving a
`preliminary response under section 313 or the expiration of the
`time for filing such a response, determines warrants the
`institution of an inter partes review under section 314.
`
`As the moving party, Petitioner bears the burden of proving that it is
`entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder
`should: set forth the reasons joinder is appropriate; identify any new grounds
`of unpatentability asserted in the petition; and explain what impact (if any)
`joinder would have on the trial schedule for the existing review. See
`Kyocera Corp. v. Softview, LLC, Case IPR2013-00004, slip op. at 4 (PTAB
`Apr. 24, 2013) (Paper 15); see also, “Frequently Asked Questions H5,”
`http://www.uspto.gov/ip/boards/bpai/prps.jsp.
`Petitioner timely filed its Joinder Motion within one month of the
`institution of the Celltrion IPR, as required by 37 C.F.R. § 42.122(b). In the
`motion, Petitioner explains that it will “maintain a secondary role in the
`proceeding, if joined [with the Celltrion IPR proceeding]. Petitioner will
`assume a primary role only if the Celltrion IPR petitioner ceases to
`participate in the IPR.” Paper 3, 3. As discussed in the Institution Decision,
`Section III above, the instituted ground in this proceeding is the same as that
`instituted in the Celltrion IPR.
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`IPR2017-01115
`Patent 7,820,161 B1
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`Having considered the unopposed motion for joinder, and our
`decisions to institute the same ground in the Celltrion IPR and the Pfizer
`IPR, we determine that Petitioner Pfizer has established persuasively that
`joinder is appropriate and will have little to no impact on the timing, cost, or
`presentation of the trial on the instituted ground. Thus, in consideration of
`the foregoing, and in the manner set forth in the following Order, the Motion
`for Joinder is granted.
`V. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that the Joint Motion to Dismiss the challenge of claims
`1–12 as set forth in Ground 1, and the challenge of claims 4, 8, and 12 as set
`forth in Grounds 2 and 3, of the Pfizer Petition, Paper 2, is granted;
`FURTHER ORDERED that trial is instituted in IPR2017-01115 on
`the following ground:
`Claims 1–3, 5–7, and 9–11 of the ’161 patent under 35 U.S.C. §
`103(a) as obvious over Edwards, the Rituxan® Label, O’Dell, and Kalden;
`FURTHER ORDERED that Petitioner’s Unopposed Motion for
`Joinder with IPR2016-01614 is granted;
`FURTHER ORDERED that IPR2017-01115 is terminated and joined
`with IPR2016-01614, pursuant to 37 C.F.R. §§ 42.72, 42.122, wherein
`Pfizer will maintain a secondary role in the proceeding, unless and until
`Celltrion ceases to participate as a petitioner in the inter partes review;
`FURTHER ORDERED that the Scheduling Order in place for
`IPR2016-01614, along with modifications appropriately stipulated to by the
`parties, shall govern the joined proceeding;
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`Patent 7,820,161 B1
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`FURTHER ORDERED that all future filings in the joined proceeding
`are to be made only in IPR2016-01614;
`FURTHER ORDERED that the case caption in IPR2016-01614 for all
`further submissions shall be changed to add Pfizer, Inc. as a named
`Petitioner after the Celltrion Petitioner, and a footnote shall be added to
`indicate the joinder of IPR2017-01115 to that proceeding, as shown in the
`attached sample case caption; and
`FURTHER ORDERED that a copy of this Decision shall be entered
`into the record of IPR2016-01614.
`
`
`
`PETITIONER:
`Jovial Wong
`Charles B. Klein
`WINSTON & STRAWN LLP
`jwong@winston.com
`cklein@winston.com
`
`PATENT OWNER:
`
`Gary N. Frischling
`Keith A. Orso
`Yite John Lu
`David Gindler
`IRELL & MANELLA LLP
`Genentech/RituxanIPR@irell.com
`gfrishchling@irell.com
`korso@irell.com
`yjlu@irell.com
`dgindler@irell.com
`
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`Joined Case Caption
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`CELLTRION, INC., and PFIZER, INC.
`Petitioners,
`
`v.
`
`BIOGEN, INC. and GENENTECH, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-016141
`Patent 7,820,161 B1
`____________
`
`
`
`
`1 Case IPR2017-01115 has been joined with this proceeding.
`
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