Trials@uspto.gov
`571-272-7822
`
`Paper 15
`Entered: December 14, 2022
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MSN LABORATORIES PRIVATE LTD. and
`MSN PHARMACEUTICALS INC.,
`Petitioners,
`v.
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`
`IPR2023-00016
`Patent 7,041,786 B2
`
`
`Before TINA E. HULSE, CYNTHIA M. HARDMAN, and
`MICHAEL A. VALEK, Administrative Patent Judges.
`
`VALEK, Administrative Patent Judge.
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`Granting Motion for Joinder
`35 U.S.C. § 315(c); 37 C.F.R. § 42.122
`
`
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`571-272-7822
`
`Paper 15
`Entered: December 14, 2022
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MSN LABORATORIES PRIVATE LTD. and
`MSN PHARMACEUTICALS INC.,
`Petitioners,
`v.
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`
`IPR2023-00016
`Patent 7,041,786 B2
`
`
`Before TINA E. HULSE, CYNTHIA M. HARDMAN, and
`MICHAEL A. VALEK, Administrative Patent Judges.
`
`VALEK, Administrative Patent Judge.
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`Granting Motion for Joinder
`35 U.S.C. § 315(c); 37 C.F.R. § 42.122
`
`
`
`
`
`
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`
`
`
`IPR2023-00016
`Patent 7,041,786 B2
`
`I.
`INTRODUCTION
`On September 14, 2022 in IPR2022-00722, we instituted inter partes
`review of claims 1–6 of U.S. Patent No. 7,041,786 B2 (“the ’786 patent”) on
`a petition filed by Mylan Pharmaceuticals Inc. (“Mylan”). IPR2022-00722,
`Paper 16 (“’722 Institution Decision”). Within one month of the ’722
`Institution Decision, MSN Laboratories Private Ltd. and MSN
`Pharmaceuticals Inc. (collectively “MSN”) filed the present Petition
`(Paper 1, “Petition”), seeking inter partes review of the same patent claims
`on the same grounds as those in IPR2022-00722.
`Along with its Petition, MSN filed a Motion for Joinder with the
`proceeding in IPR2022-00722. Paper 4 (“Joinder Motion”). Bausch Health
`Ireland Limited (“Patent Owner”) filed an Opposition to the Joinder Motion,
`objecting to the proposed “understudy role” MSN outlined in the Joinder
`Motion. Paper 10, 1. We issued an order asking MSN to clarify the scope of
`the “understudy role” it would accept in the event joinder were granted.
`Paper 12, 3. In response, MSN filed an authorized Reply providing the
`requested clarification and indicating that it had “reached an agreement”
`with Patent Owner regarding its role as an understudy. Paper 14, 3. Patent
`Owner has since confirmed this agreement and waived the filing of a
`Preliminary Response to the Petition in this proceeding. Ex. 3001 (Email to
`the Board dated Dec. 7, 2022).
`As explained below, we institute trial on the same grounds and claims
`previously instituted in IPR2022-00722 and grant the Joinder Motion.
`
`2
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`IPR2023-00016
`Patent 7,041,786 B2
`
`II. DISCUSSION
`In IPR2022-00722, after considering the arguments and evidence in
`
`Mylan’s petition and the preliminary response filed by Patent Owner in that
`proceeding, we instituted review on the following grounds:
`Claim(s) Challenged
`35 U.S.C. §1
`Reference(s)/Basis
`1
`103
`Currie2, Li3
`2, 4, 5
`103
`Currie, Li, Narayani4
`3–5
`103
`Currie, Li, Narayani, Campieri5
`6
`103
`Currie, Li, Ekwuribe6
`
`MSN’s Petition is identical in substance to the petition in
`
`IPR2022-00722, challenging the same claims based on the same grounds
`and relying on the same declarant testimony and other evidence for support.
`See Pet. 4–5 (stating its grounds are “substantially identical,” “challenge the
`same claims over the same prior art,” and “rely on the same exhibits,
`arguments and expert testimony presented with the Mylan Petition”). Patent
`Owner does not dispute that MSN’s Petition is substantially identical to
`Mylan’s, nor identify any material distinction between the arguments
`
`
`1 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011) (“AIA”), included revisions to 35 U.S.C. § 103 that became effective
`after the filing of the application that led to the ’786 patent. Therefore, we
`apply the pre-AIA version of 35 U.S.C. § 103.
`2 U.S. Pat. 5,489,670, issued Feb. 6, 1996 (Ex. 1005) (“Currie”).
`3 Zhiping Li et al., Purification, cDNA Sequence, and Tissue Distribution of
`Rat Uroguanylin, 68 Regulatory Peptides 45–56 (1997) (Ex. 1006) (“Li”).
`4 R. Narayani et al., Polymer-coated Gelatin Capsules as Oral Delivery
`Devices and their Gastrointestinal Tract Behavior in Humans, 7 J.
`Biomater. Sci. Polymer Edn. 39–48 (1995) (Ex. 1007) (“Narayani”).
`5 M. Campieri et al., Oral Budesonide is as Effective as Oral Prednisolone
`in Active Crohn’s Disease, 41 Gut 209–214 (1997) (Ex. 1008) (“Campieri”).
`6 U.S. Pat. 5,359,030, issued Oct. 25, 1994 (Ex. 1009) (“Ekwruibe”).
`
`3
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`IPR2023-00016
`Patent 7,041,786 B2
`presented in the two proceedings. See generally Paper 10. Accordingly, for
`the same reasons stated in the ’722 Institution Decision, we institute inter
`partes review on the same grounds here.
`
`Having determined that institution is warranted, we now turn to the
`Joinder Motion. MSN timely filed the Joinder Motion within one month of
`the ’722 Institution Decision. See 37 C.F.R. § 42.122(b) (requiring any
`joinder motion be filed “no later than one month after the institution date of
`any inter partes review for which joinder is requested”). Our decision
`whether to grant joinder is subject to discretion. See 35 U.S.C. § 315(c).
`When exercising the discretion delegated to us we are mindful that patent
`trial regulations, including the rules for joinder, should be construed to
`secure the just, speedy, and inexpensive resolution of every proceeding. See
`35 U.S.C. § 316(b); 37 C.F.R. § 42.1(b). Furthermore, a motion for joinder
`should (1) set forth reasons why joinder is appropriate; (2) identify any new
`grounds of unpatentability asserted in the petition; (3) explain what impact
`(if any) joinder would have on the trial schedule for the existing review; and
`(4) address specifically how briefing and discovery may be simplified. See
`Kyocera Corp. v. SoftView, LLC, IPR2013-00004, Paper 15, 4 (PTAB Apr.
`24, 2013).
`
`MSN’s Joinder Motion addresses these concerns and we generally
`agree with the arguments MSN makes for joinder. See Paper 4, 8–12. As
`discussed above, the Petition raises the same unpatentability grounds as
`IPR2022-00722, and no others. Thus, this review does not present any
`ground not already at issue in IPR2022-00722. Efficiency favors addressing
`these challenges in a joined proceeding.
`
`4
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`IPR2023-00016
`Patent 7,041,786 B2
`
`This is particularly so given the silent understudy role MSN has
`agreed to accept in the joined proceeding. MSN agrees that it will be a silent
`understudy to Mylan––accepting limitations on its participation similar to
`those in other Board cases involving an understudy petitioner. See Paper 12,
`3 (articulating our understanding of a silent understudy role); Paper 14, 2
`(“Petitioner hereby adopts the Board’s understanding of an understudy”). In
`particular, MSN has agreed that “so long as Mylan remains a party to the
`proceeding” it will be bound by Mylan’s filings and presentation at oral
`hearing and not make any substantive filings or presentation of its own; will
`not take cross-examination testimony of any witness or have a role in
`defending the cross-examination of a witness; and will not seek any other
`discovery during the joined proceeding. Id. These limits on the scope of
`MSN’s participation greatly streamline matters and mitigate inefficiencies
`allowing our focus to remain on reaching a timely final written decision
`addressing the merits of the patentability challenges first raised in IPR2022-
`00722, and now again in the present Petition.
`
`Patent Owner initially opposed joinder, urging that Petitioner had not
`agreed to “a complete understudy role.” Paper 10, 1. However, the parties
`have since reached agreement on the conditions of MSN’s limited role in the
`joined proceeding. Paper 14, 3; Ex. 3001, 1. We appreciate the parties’
`efforts to reach this agreement and understand that, given this agreement,
`Patent Owner no longer opposes joinder. See Paper 10, 1 (stating that Patent
`Owner “opposes joinder unless and until MSN accepts a complete
`understudy role”).7
`
`
`7 MSN also represents that Mylan does not oppose joinder. See Paper 4, 13.
`
`5
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`IPR2023-00016
`Patent 7,041,786 B2
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`As for the potential impact on the existing schedule in IPR2022-
`00722, we do not presently perceive that joinder will have any significant
`impact on that schedule. MSN “is willing to adhere to the existing
`Scheduling Order in” IPR2022-00722. Paper 4, 12–13. And given its role as
`a silent understudy, MSN’s actions, if any, are unlikely to impact the
`existing schedule as it will not be making substantive filings, presenting at
`oral hearing, or pursuing discovery. Moreover, Patent Owner has not
`identified any reason why granting joinder on these conditions might impact
`the existing trial schedule. See generally Paper 10.
`
`For these reasons, given the present circumstances, joinder is
`appropriate because it will promote the just, speedy, and inexpensive
`resolution of both proceedings without prejudice to the parties. The Joinder
`Motion is therefore granted.
`
`III. ORDER
`
`Accordingly, it is:
`
`ORDERED that pursuant to 35 U.S.C. § 314, an inter partes review is
`
`hereby instituted as to claims 1–6 of the ’786 patent based on the
`unpatentability challenges presented in the Petition;
`
`FURTHER ORDERED that MSN’s Motion for Joinder with
`IPR2022-00722 is granted, and MSN is joined as a party to that proceeding
`subject to the conditions and limitations agreed to by MSN in its Motion for
`Joinder (Paper 4) and Reply to Patent Owner’s Opposition to Motion for
`Joinder (Paper 14);
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`6
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`IPR2023-00016
`Patent 7,041,786 B2
`
`FURTHER ORDERED that, subsequent to joinder, MSN is bound by
`every paper filed and every representation made by Mylan in IPR2022-
`00722, except for papers and representations regarding settlement between
`Mylan and Patent Owner;
`
`FURTHER ORDERED that the Scheduling Order in place for
`IPR2022-00722 (IPR2022-00722, Paper 17) remains unchanged, subject to
`any change already made by stipulation between Mylan and Patent Owner;
`
`FURTHER ORDERED that all further filings by the parties shall be
`made only in IPR2022-00722;
`
`FURTHER ORDERED that the case caption in IPR2022-00722 shall
`be changed to comport with the attached example case caption; and
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`FURTHER ORDERD that a copy of this Decision shall be entered
`into the record of IPR2022-00722.
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`7
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`IPR2023-00016
`Patent 7,041,786 B2
`For PETITIONER:
`
`Andrew Larsen
`Melissa Hayworth
`MERCHANT & GOULD P.C.
`alarsen@merchantgould.com
`mhayworth@merchantgould.com
`For PATENT OWNER:
`
`Justin Hasford
`Bryan Diner
`Joshua Goldberg
`Caitlin O’Connell
`Kyu Yun Kim
`Kassandra Officer
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
`justin.hasford@finnegan.com
`bryan.diner@finnegan.com
`joshua.goldberg@finnegan.com
`caitlin.oconnell@finnegan.com
`kyuyun.kim@finnegan.com
`Kassandra.officer@finnegan.com
`
`8
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`
`
`Trials@uspto.gov
`571-272-7822
`
`
`
`
`Paper 15
`Entered: December 14, 2022
`
`EXAMPLE CASE CAPTION
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC., MSN LABORATORIES
`PRIVATE LTD. and MSN PHARMACEUTICALS INC.,
`Petitioners,
`v.
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`
`
`
`IPR2022-007221
`Patent 7,041,786 B2
`
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`1 IPR2023-00016 has been joined with this proceeding.
`
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`
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