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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`APOTEX INC.,
`Petitioner
`v.
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner
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`Inter Partes Review No.: IPR2022-00301
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`U.S. Patent No. 9,669,069 B2
`Filed: December 17, 2015
`Issued: June 6, 2017
`Inventor: George D. Yancopoulos
`
`Title: USE OF A VEGF ANTAGONIST TO TREAT
`ANGIOGENIC EYE DISORDERS
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`MOTION FOR JOINDER UNDER 35 U.S.C § 315(c),
`37 C.F.R. §§ 42.22, AND 42.122(b)
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`
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`Apotex’s Motion for Joinder
`IPR of U.S. Patent 9,669,069
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`TABLE OF CONTENTS
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`Page
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`STATEMENT OF THE PRECISE RELIEF REQUESTED .......................... 1
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`I.
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`II.
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`STATEMENT OF MATERIAL FACTS ........................................................ 1
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`III.
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`STATEMENT OF REASONS FOR RELIEF REQUESTED ........................ 2
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`A.
`B.
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`Legal Standard ....................................................................................... 2
`Each Factor Weighs in Favor of Granting the Motion for
`Joinder ................................................................................................... 3
`1.
`Joinder with the Mylan IPR is Appropriate ................................ 3
`2.
`Apotex Raises No New Grounds of Unpatentability .................. 4
`3.
`Joinder Would Not Affect the Schedule in the Mylan IPR ........ 5
`4.
`Briefing and Discovery Will Be Simplified ............................... 6
`IV. THE GENERAL PLASTIC FACTORS PROVIDE NO REASON TO
`DENY INSTITUTION .................................................................................... 7
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`V.
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`CONCLUSION ................................................................................................ 8
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`ii
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`I.
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`Apotex’s Motion for Joinder
`IPR of U.S. Patent 9,669,069
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`STATEMENT OF THE PRECISE RELIEF REQUESTED
`Apotex Inc. (“Apotex” or “Petitioner”) respectfully submits this Motion for
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`Joinder, concurrently with a Petition for inter partes review of U.S. Patent No.
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`9,669,069 (“the ’069 Patent”). Apotex requests its Petition for inter partes review
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`of the ‘069 Patent be instituted and joined pursuant to 35 U.S.C. § 315(c) and 37
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`C.F.R. §§ 42.22 and 42.122(b) with the inter partes review proceeding initiated by
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`Mylan Pharmaceuticals Inc. (“Mylan”) concerning the ‘069 Patent, Mylan Pharms.
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`Inc. v. Regeneron Pharms., Inc., IPR2021-00880 (“the Mylan IPR”), which was
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`instituted on November 10, 2021.
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`Apotex’s Petition is essentially a copy of the Mylan IPR Petition. It includes
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`the identical grounds and relies on the same evidence presented in the Mylan IPR.
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`Apotex also stipulates that if joinder is granted, it agrees to an “understudy” role
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`and will not raise any additional issues in the joined proceeding so long as Mylan
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`remains an active party. Joinder would thus create no additional burden for the
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`Board, the Mylan IPR Petitioner, or Patent Owner. Nor should it impact the Mylan
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`IPR schedule. As such, joinder will promote judicial efficiency in determining
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`patentability of the ‘069 Patent without prejudice to Patent Owner.
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`II.
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`STATEMENT OF MATERIAL FACTS
`On May 5, 2021, Mylan filed the Mylan IPR. On November 10, 2021, the
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`Board instituted the proceeding.
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`1
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`
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`Mylan has represented to Apotex that it will not oppose Apotex’s Motion for
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`Apotex’s Motion for Joinder
`IPR of U.S. Patent 9,669,069
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`
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`Joinder.
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`This motion is timely. Under 37 C.F.R. § 42.122(b), joinder can be
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`requested without prior authorization no later than one month after the institution
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`date of the proceeding to which joinder is requested. This motion is being filed
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`within one month of the Board’s decision instituting trial in the Mylan IPR, thus
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`meeting the requirements of § 42.122(b).
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`The present Petition is the first IPR petition filed by Apotex against the ‘069
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`Patent. The Mylan IPR Petition and the present Petition are substantively
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`identical; they contain the same grounds, based on the same prior art combinations,
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`against the same claims and rely on the same evidence, including identical expert
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`declarations.1
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`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
`A. Legal Standard
`Pursuant to 35 U.S.C. § 315(c), the Board may grant a motion for joining an
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`inter partes review petition with another inter partes review proceeding. See 35
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`U.S.C. § 315(c). The Board, in determining whether to exercise its discretion to
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`grant joinder, considers whether the joinder motion: (1) sets forth the reasons why
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`1 The only differences between the Petition in this proceeding and in the
`Mylan IPR relate to the identification of petitioner-specific information.
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`2
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`joinder is appropriate; (2) identifies any new grounds of unpatentability asserted in
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`Apotex’s Motion for Joinder
`IPR of U.S. Patent 9,669,069
`
`the petition; (3) explains what impact (if any) joinder would have on the trial
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`schedule for the existing review; and (4) addresses specifically how briefing and
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`discovery may be simplified. Dell, Inc. v. Network-1 Security Solutions, Inc.,
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`IPR2013-00385, Paper No. 17 at 4 (PTAB July 29, 2013); see also Kyocera Corp.
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`v. Softview LLC, IPR2013-00004, Paper 15, at 4 (PTAB April 24, 2013).
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`B.
`Each Factor Weighs in Favor of Granting the Motion for Joinder
`The Board “routinely grants motions for joinder where [like here] the party
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`seeking joinder introduces identical arguments and the same grounds raised in the
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`existing proceeding.” Samsung Elecs. Co., Ltd. v. Raytheon Co., IPR2016-00962,
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`Paper No. 12 at 9 (PTAB Aug. 24, 2016) (internal quotations and citations
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`omitted); see also Sony Mobile Communications v. Ancora Tech., IPR2021-00663,
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`Paper 17 at 29-33 (PTAB June 10, 2021) (granting motion for joinder of “copycat”
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`petition, that challenged the same claims of the same patent based on the same
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`grounds of unpatentability and that was supported by essentially the same expert
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`declaration as the first Petition).
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`1.
`Joinder with the Mylan IPR is Appropriate
`Joinder of Apotex’s IPR with the Mylan IPR is appropriate because it will
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`resolve patentability issues between Patent Owner and Petitioners without
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`significant impact on the Mylan IPR.
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`3
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`
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`The instant Petition copies verbatim the challenges set forth in the Mylan
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`Apotex’s Motion for Joinder
`IPR of U.S. Patent 9,669,069
`
`
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`IPR Petition and relies on identical expert declarations. The only differences
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`between the instant Petition and the Mylan Petition relate to formalities of a
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`different party and counsel filing the petition and updating the petition regarding
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`the related actions; there are no other changes to the facts, citations, evidence, or
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`patentability arguments introduced in the Mylan IPR Petition.
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`Granting joinder will not prejudice Patent Owner or Mylan. As discussed
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`above, the instant Petition does not raise any new ground that is not raised in the
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`Mylan IPR Petition. Therefore, there should be no additional burden to Patent
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`Owner or Mylan due to Apotex’s joinder.
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`Because these IPR proceedings are virtually identical, joining this
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`proceeding with the Mylan IPR would permit the Board to “secure the just, speedy,
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`and inexpensive resolution” of the instant Petition and the Mylan IPR Petition in a
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`single proceeding. See 37 C.F.R. § 42.1(b).
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`2.
`Apotex Raises No New Grounds of Unpatentability
`The instant IPR does not assert any new grounds of unpatentability beyond
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`those in the Mylan IPR Petition. As stated above, the instant Petition challenges
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`the same claims of the ‘069 Patent based on the same prior art, the same
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`arguments, and the same evidence as the Mylan IPR. In addition, Apotex relies on
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`the expert declarations filed in the Mylan IPR. Therefore, joinder of this
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`4
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`
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`proceeding with the Mylan IPR will not raise any new issues of unpatentability and
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`Apotex’s Motion for Joinder
`IPR of U.S. Patent 9,669,069
`
`will not impose any additional burden on the Board or add additional complexity to
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`the proceeding.
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`3.
`Joinder Would Not Affect the Schedule in the Mylan IPR
`Joinder should have no impact on the Mylan IPR trial schedule because the
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`instant Petition presents no new issues or grounds of unpatentability. There are no
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`new issues for the Board to address, and Patent Owner will not be required to
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`present any additional responses or arguments, or conduct any additional
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`discovery. Moreover, Apotex will adhere to all deadlines set by the Board’s
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`Scheduling Order for the Mylan IPR. The Patent Owner’s Response will not be
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`impacted because the issues presented in the instant Petition are identical to the
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`issues presented in the Mylan IPR Petition. Patent Owner will not be required to
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`provide any additional analysis or arguments beyond what it will already provide
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`in responding to the Mylan IPR Petition, and the instant Petition will not impact
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`the due date for the Patent Owner Response.
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`Further, no additional expert discovery will be needed. Apotex is relying on
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`the same experts as Mylan and has filed identical expert declarations of each
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`declarant. Thus, there will be no need for any separate deposition of Apotex’s
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`expert, and there will be no impact to the trial schedule.
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`Accordingly, joinder of Apotex to the Mylan IPR will not impact any due
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`5
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`
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`dates in the Mylan IPR or affect the Board’s ability to complete its review and final
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`Apotex’s Motion for Joinder
`IPR of U.S. Patent 9,669,069
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`decision within the statutory time limits under 35 U.S.C. § 316(a)(11) and 37
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`C.F.R. § 42.100(c).
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`4.
` Briefing and Discovery Will Be Simplified
`Apotex agrees to an “understudy” role and will not raise any additional
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`issues. Specifically, Apotex agrees that, if joined, the following conditions shall
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`apply so long as Mylan remains an active party:
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`a) All substantive filings will be consolidated, for which Mylan will
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`maintain responsibility (i.e., Apotex will rely on the filings of Mylan), unless a
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`filing solely concerns issues that do not involve Mylan (e.g., Mandatory Notices);
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`b) Apotex shall rely on the grounds instituted by the Board in the Mylan
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`IPR, and the arguments and discovery introduced by Mylan; Apotex shall not raise
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`grounds not already instituted by the Board in the Mylan IPR, or introduce
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`argument or discovery not introduced by Mylan;
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`c) Apotex agrees not to seek discovery or depositions in this proceeding
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`beyond any agreement reached between Patent Owner and Mylan concerning
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`discovery and depositions for the Mylan IPR;
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`d) Apotex at deposition shall not request any direct, cross examination or
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`redirect time beyond that permitted for Mylan alone; and
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`e) Apotex agrees to be bound by the depositions and declarations of Mylan’s
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`6
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`experts, unless Mylan ceases to be an active participant in its IPR prior to its
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`Apotex’s Motion for Joinder
`IPR of U.S. Patent 9,669,069
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`experts’ depositions.
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`IV. THE GENERAL PLASTIC FACTORS PROVIDE NO REASON TO
`DENY INSTITUTION
`The Petition accompanying this motion is Apotex’s first Petition with regard
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`to the ‘069 Patent and not a coordinated serial attack that presents the “undue
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`inequities and prejudices” addressed by the Board’s precedent. See General Plastic
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`Indus. Co. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19 at 17–18 (PTAB
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`Sept. 6, 2017) (Paper 19). The General Plastic factors do not favor denial.
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`Factor 1 considers “whether the same petitioner previously filed a petition
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`directed to the same claims of the same patent.” Id., at 16. Here, Apotex has not
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`previously filed any petition against the ‘069 patent. Apotex and Mylan are
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`separate, unrelated petitioners, and are not similarly situated for purposes of Factor
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`1. Apotex and Mylan are not codefendants in a litigation involving the ‘069 patent.
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`This factor thus weighs in favor of institution and against discretionary denial.
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`As to the timing examined in factors 2-5, Apotex did not previously file an
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`earlier petition prior to this Petition. See Sony Mobile Communications v. Ancora
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`Tech., IPR2021-00663, Paper 17 at 11-15 (PTAB June 10, 2021) (finding that
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`factors 2-5 weighed “strongly” in favor of institution for joinder motion of
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`“copycat” Petition where it was the joining petitioner’s first petition challenging
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`7
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`
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`the patent); Netflix, Inc. v. Broadcom Corp., IPR2020-01423, Paper 7 at 5−6
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`Apotex’s Motion for Joinder
`IPR of U.S. Patent 9,669,069
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`(PTAB Mar. 11, 2021) (a prior petition filed by an unrelated petitioner is not a
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`basis for denial of institution). Furthermore, Apotex made no serial attack on the
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`‘069 Patent asserting different combinations of prior art, but rather chose to file a
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`substantively identical IPR to the Mylan IPR within the one-month time period
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`allowed under 37 C.F.R. § 42.122(b). In other words, Apotex did not seek to gain
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`any tactical advantage from Patent Owner’s earlier Preliminary Response, as it
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`filed the same Petition as in the Mylan IPR, without modification and based on the
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`same arguments. These factors thus weigh in favor of institution and against
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`discretionary denial.
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`Factors 6 and 7 also factors weigh in favor of institution, as there should be
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`no material impact on the Board’s finite resources or its ability to issue a final
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`determination on the Mylan IPR Petition within one year as explained in detail
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`above.
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`V. CONCLUSION
`For the foregoing reasons, Apotex respectfully requests that the Board grant
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`its Petition for inter partes review of the ‘069 Patent and that this proceeding be
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`joined with IPR2021-00880.
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`8
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`Dated: December 9, 2021
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`
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`Apotex’s Motion for Joinder
`IPR of U.S. Patent 9,669,069
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`Respectfully Submitted,
`
`/Teresa Stanek Rea/
`Teresa Stanek Rea
`Reg. No. 30,427
`Deborah H. Yellin
`Reg. No. 45,904
`Shannon M. Lentz
`Reg. No. 65,382
`CROWELL & MORING LLP
`Intellectual Property Group
`P.O. Box 14300
`Washington, DC 20044-4300
`
`Counsel for Apotex
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`9
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`
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