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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.,
`Petitioners
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`v.
`
`NOVO NORDISK A/S,
`Patent Owner
`______________________
`Case IPR2024-00631
`Patent 10,335,462
`______________________
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`PATENT OWNER’S OPPOSITION TO PETITIONER’S
`MOTION FOR JOINDER
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`PROTECTIVE ORDER INFORMAITON
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`I.
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`II.
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`TABLE OF CONTENTS
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`Petitioner Does Not Establish Good Cause For Its Untimely Joinder
`Motion ...............................................................................................................................1
`Petitioner’s Request For Consolidation of IPRs On Different Timelines Is
`Nonsensical ......................................................................................................................9
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`i
`PROTECTIVE ORDER INFORMAITON
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`TABLE OF AUTHORITIES
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` Page(s)
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`Cases
`Apple Inc. v. Evolved Wireless, LLC,
`IPR2016-01209, Paps. 7 & 8 (Dec. 21, 2016) .................................................... 10
`Dr. Reddy’s Labs., Inc. v. Novo Nordisk A/S,
`IPR2024-00009, Pap.12 (Nov. 20, 2023) ......................................................... 3, 9
`GlobalFoundries U.S. Inc. v. Godo Kaisha IP Bridge 1,
`IPR2017-00925, Pap.13 (June 9, 2017) ................................................................ 7
`Google Inc. v. Personalweb Techs., LLC,
`IPR2014-00978, Pap.11 (Oct. 30, 2014) .......................................................... 2, 4
`LG Elecs. Inc. v. Jawbone Innovations, LLC,
`IPR2023-01110, Pap.3 (June 23, 2023) .............................................................. 10
`Mylan Pharms. Inc. v. Novo Nordisk A/S,
`IPR2023-00724, Pap.14 (Nov. 9, 2023) ............................................................... 9
`Roche Molecular Systems Inc. v. Illumina, Inc.,
`IPR2015-01091, Pap.18 (Oct. 30, 2015) .............................................................. 6
`Shaw Indus. Grp., Inc. v. Automated Creel Sys., Inc.,
`IPR2013-00584, Pap.20 (Dec. 31, 2013) ...................................................... 2, 4, 5
`Sony Corp. of Am. v. Network-1 Security Sols.,
`IPR2013-00495, Pap.13 (Sept. 16, 2013) ............................................................. 7
`Sony Elecs. Inc. v. Jawbone Innovations, LLC,
`IPR2023-01110, Pap.12 (Feb. 9, 2024) .............................................................. 10
`Sony Elecs. Inc. v. Jawbone Innovations, LLC,
`IPR2023-01119, Pap.14 (Feb. 9, 2024) .............................................................. 10
`Sony Elecs. Inc. v. Jawbone Innovations, LLC,
`IPR2023-01119, Pap.3 (June 23, 2023) .............................................................. 10
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`ii
`PROTECTIVE ORDER INFORMAITON
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`Sun Pharm. Ltd. v. Novo Nordisk A/S,
`IPR2024-00009, Pap.8 (Nov. 28, 2023) ........................................................... 3, 9
`TrickleStar LLC v. Embertec Pty Ltd.,
`IPR2017-00839, Pap.11 (June 10, 2017) .............................................................. 4
`ZTE (USA) Inc. v. Evolved Wireless LLC,
`IPR2016-01277, Pap.8 (Dec. 21, 2016) .............................................................. 10
`Other Authorities
`37 C.F.R. §41.122 ...................................................................................................... 1
`37 C.F.R. §42.5(b) ..................................................................................................... 1
`37 C.F.R. §42.20(c) .................................................................................................... 2
`37 C.F.R. §42.53 ........................................................................................................ 9
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`iii
`PROTECTIVE ORDER INFORMAITON
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`Patent Owner Novo Nordisk A/S (“PO”) submits this Opposition to
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`Petitioner’s four-month-late Motion for Joinder (“Motion”/Pap.5) and its
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`alternative request to “consolidate” its late proceeding with IPR2023-00724 (the
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`“Mylan IPR”)—an IPR in which a POR has already been filed, and in which a
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`Reply and Sur-Reply would be filed, and oral argument presented, long before any
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`institution decision would even be due in this case.
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`I.
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`Petitioner Does Not Establish Good Cause For Its Untimely Joinder
`Motion
`No special circumstances exist that would justify waiver of the one-month
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`time period for requesting joinder. See 37 C.F.R. §42.5(b). Petitioner filed its
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`copycat petition and motion for joinder on March 1, 2024, almost four months after
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`the deadline to move to join IPR2023-00724, and about a month and a half after
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`the Patent Owner Response was filed in IPR2023-00724. 37 C.F.R. §41.122.0F
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`1
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`1 Petitioner’s motion for joinder was, itself, also unauthorized as it was not filed
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`within the Rule 41.122(b) deadline, and Petitioner has not sought (nor shown the
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`required basis for) permission to file its motion out of time.
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`1
`PROTECTIVE ORDER INFORMAITON
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`As movant, Petitioner has the burden to show entitlement to the requested
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`relief, and has not shown “special” or “extraordinary circumstance[s]” to justify
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`waiver of the joinder deadline. Google Inc. v. Personalweb Techs., LLC, IPR2014-
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`00978, Pap.11, 4-5 (Oct. 30, 2014) (“Simply because the parties in IPR2014-00062
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`stipulated to new dates for DUE DATES 1 and 2—a common practice in
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`proceedings before us—does not constitute an extraordinary circumstance that
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`would persuade us to waive the one-month time limit for Google to file its Motion
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`for Joinder” even where the request occurred before the POR); Shaw Indus. Grp.,
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`Inc. v. Automated Creel Sys., Inc., IPR2013-00584, Pap.20, 4-5 (Dec. 31, 2013)
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`(“We are not persuaded that special circumstances exist that would justify waiver
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`of the one-month time period for requesting joinder… Petitioner does not contend
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`that it was unable to file its Petition in the instant proceeding within one month
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`of July 25, 2013. Rather, it simply preferred to wait and see if the Board granted
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`its request for rehearing.”)1F
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`2; 37 C.F.R. §42.20(c) (“The moving party has the
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`burden of proof to establish that it is entitled to the requested relief”). Here,
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`Petitioner provides no showing of any “special” or “extraordinary circumstance.”
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`2 Unless stated, all statutory and regulatory citations are to 35 U.S.C. or 37 C.F.R.,
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`as context indicates, all internal citations omitted, and all emphases/annotations are
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`added.
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`2
`PROTECTIVE ORDER INFORMAITON
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`Indeed, Petitioner’s brief does not even acknowledge this standard. Petitioner’s
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`preference to wait to file an IPR, despite knowing of the patent and the IPR it seeks
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`to join (confirmed in the March 11, 2024 call with the Board), is the opposite of a
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`3
`special or extraordinary circumstance.2F
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`Petitioner’s own admissions about the circumstances of its filing shows that
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`it merely made a business decision to wait to file (waiting for “heightened
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`3 Apotex asserts, without explaining, that the fact that the Board has not issued a
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`joinder decision in the Dr. Reddy’s Laboratories, Inc. (“DRL”) or Sun
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`Pharmaceutical Ltd. (“Sun”) IPRs means the joinder deadline here should be
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`waived. Pap.5, 1-2. But these assertions are irrelevant to whether the untimely
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`and opposed Apotex joinder motion should be granted, particularly where the
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`timely DRL and Sun joinder motions were not opposed. Dr. Reddy’s Labs., Inc. v.
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`Novo Nordisk A/S, IPR2024-00009, Pap.12, 1 (Nov. 20, 2023); Sun Pharm. Ltd. v.
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`Novo Nordisk A/S, IPR2024-00009, Pap.8, 1 (Nov. 28, 2023). Further, Apotex is
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`differently situated than DRL and Sun, who have submitted ANDAs and are
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`parties to parallel litigation, and for whom motivations relating to, e.g., settlement,
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`may be different. Dr. Reddy’s Labs., Inc. v. Novo Nordisk A/S, IPR2024-00009,
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`EX2010, 2 (Jan. 26, 2024); Sun Pharm. Ltd. v. Novo Nordisk A/S, IPR2024-00009,
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`EX2010, 2 (Feb. 29, 2024).
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`PROTECTIVE ORDER INFORMAITON
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`confidence”), which is the opposite of a “special” or “extraordinary circumstance.”
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`Google, IPR2014-00978, Pap.11, 4-5; Shaw Indus. Grp., IPR2013-00584, Pap.20,
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`4-5. Here, just as in Shaw, “Petitioner does not contend that it was unable to file
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`its Petition in the instant proceeding within one month [of institution of the petition
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`it seeks to join]. Rather, it simply preferred to wait and see if the Board granted its
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`request for rehearing.” Shaw Indus. Grp., IPR2013-00584, Pap.20, 4-5. Petitioner
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`has not provided a sufficient excuse for any delay, let alone a four-month one. See
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`TrickleStar LLC v. Embertec Pty Ltd., IPR2017-00839, Pap.11, 32-33 (June 10,
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`2017) (denying joinder motion filed five days after deadline).
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` Petitioner’s own admissions show that it could have timely filed an
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`IPR with a motion for joinder. Petitioner’s preference to wait to file long after the
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`4
`PROTECTIVE ORDER INFORMAITON
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`deadline does not and cannot constitute special circumstances. Shaw Indus. Grp.,
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`IPR2013-00584, Pap.20, 4-5.
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`4 Petitioner provides no documentary evidence supporting the unsubstantiated
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`assertions of its employee. EX1507.
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`5
`PROTECTIVE ORDER INFORMAITON
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`At each step of the way, Petitioner made the business decision not to prepare
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`the IPR, and to continue to delay filing its Petition. Petitioner’s business decision
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`is similar to the rejected excuse offered by the petitioner, Roche, in Roche
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`Molecular Systems Inc. v. Illumina, Inc., IPR2015-01091, Pap.18 (Oct. 30, 2015).
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`There, Roche waited to file its motion for joinder “nearly four months after trial
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`was instituted” despite being aware of the proceeding to which it sought joinder,
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`and despite the acquisition being completed just four days after trial was instituted.
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`Id. at 9-10. There, like here, “Petitioner has not provided a reason as to why it
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`waited [months] to file the instant Petition,” let alone “special circumstances that
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`would justify waiving the one-month time limit for the filing of the Motion for
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`Joinder.” Id. at 11, 9. The Board in Roche denied joinder noting “Petitioner could
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`have also filed its own petition at any time, as there is no standing requirement to
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`file a petition for inter partes review.” Id. at 11. The same is true here.
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`: Petitioner chose to file
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`past the joinder deadline.
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`Petitioner cites no case waiving the deadline for joinder under similar
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`circumstances. Indeed, the only cases Petitioner cites in arguing the Board should
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`6
`PROTECTIVE ORDER INFORMAITON
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`waive the requirements are GlobalFoundries U.S. Inc. v. Godo Kaisha IP Bridge 1,
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`IPR2017-00925, Pap.13, 8 (June 9, 2017) and Sony Corp. of Am. v. Network-1
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`Security Sols., IPR2013-00495, Pap.13, 9 (Sept. 16, 2013). Yet those two cases are
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`easily distinguished. In both of those cases, the copycat petitioner or its parent
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`attempted to join the original proceeding within the one-month period.
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`GlobalFoundries, IPR2017-00925, Pap.13, 7-8 (“here Petitioner’s parent company
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`filed its petitions… within one month of institution in the -1246 Case, then
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`Petitioner re-filed shortly thereafter to include both entities as real parties-in-
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`interest.”); Sony Corp., IPR2013-00495, Pap.13, 7-9 (“Petitioners attempted
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`previously within the one-month time period to be joined”). The later-filed
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`petitions, for which joinder was ultimately granted, were submitted only because
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`the timely petitions were denied or to add a real party-in-interest.
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`GlobalFoundries, IPR2017-00925, Pap.13, 7-8; Sony Corp., IPR2013-00495,
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`Pap.13, 7-9. Here, Petitioner never attempted to file any IPR or motion for joinder
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`within a month of institution of the Mylan IPR. Instead, it made the business
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`5
`decision to wait.4F
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`5 In the event Apotex’s motion for joinder is granted, Apotex consented to the
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`stipulations agreed to by DRL and Sun so long as the fourth and fifth stipulations
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`are revised as follows: (1) “In the event Apotex’s Petition is instituted, only
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`7
`PROTECTIVE ORDER INFORMAITON
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`Apotex will be joined to Mylan Pharmaceuticals, Inc. v. Novo Nordisk, A/S,
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`IPR2023-00724. Apotex’s Petition and related papers will not be joined or added
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`as part of institution”; (2) “In the event (1) Apotex’s Petition is instituted, (2)
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`Apotex is joined to the Mylan IPR, and (3) Mylan is terminated before Novo has
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`had the opportunity to depose an expert for which Mylan filed a corresponding
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`expert declaration (and within the time period for taking the corresponding
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`deposition), the parties will meet and confer as to (1) depositions, (2) whether any
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`substitute expert(s) will be needed and/or deposed on the already-filed expert
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`declaration(s) or whether the expert declaration(s) themselves will be expunged
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`and replaced by the declaration(s) filed with one (and only one) of the copycat
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`petitions, and (3) what sort of adjustment to the schedule, if any, is needed.
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`Having met and conferred, the parties will then request a call with the Board
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`regarding these issues”; (3) “Unless Mylan is terminated, Apotex will serve in the
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`silent understudy role. In the event that either or both (1) Sun’s Petition is
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`instituted and Sun is joined to the Mylan IPR and (2) DRL is instituted and DRL is
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`joined to the Mylan IPR, only one of the joined Petitioners should take the lead
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`role, and the other(s) should assume the understudy role”; (4) “In the event that
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`Apotex’s Petition is instituted and Apotex is joined to the Mylan IPR, Apotex shall
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`not be permitted to raise any new grounds not instituted by the Board in the Mylan
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`8
`PROTECTIVE ORDER INFORMAITON
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`II.
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`Petitioner’s Request For Consolidation of IPRs On Different Timelines
`Is Nonsensical
`Petitioner, without authorization, used its joinder motion to alternatively
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`request consolidation of this IPR with the Mylan IPR, asserting it is appropriate for
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`the same reasons as joinder. Pap.5, 11. First, this is an improper attempt to end-
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`run the joinder deadline without justification. Second, because of Petitioner’s
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`extensive delay in filing its IPR, the schedules in this IPR and the Mylan IPR
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`would be entirely incompatible. Indeed, in the Mylan IPR, the POR was already
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`filed on January 17, 2024, the Reply is due on May 1, 2024, and the Sur-Reply is
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`due on June 12, 2024. Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724,
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`Pap.14, 1 (Nov. 9, 2023). But even the institution decision in this IPR is not due
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`until September 12, 2024.
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`IPR, or introduce any argument not already introduced by Mylan”; (5) “With
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`regard to the taking of testimony, in the event that Apotex’s Petition is instituted
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`and Apotex is joined to the Mylan IPR, Apotex will abide by 37 C.F.R. §42.53 and
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`any agreement between the Patent Owner and Mylan.” Dr. Reddy’s Labs.,
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`IPR2024-00009, Pap.12, 1-3; Sun Pharm. Ltd., IPR2024-00009, Pap.8, 1-3.
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`9
`PROTECTIVE ORDER INFORMAITON
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`Petitioner’s citation to Sony Elecs. Inc. v. Jawbone Innovations, LLC,
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`IPR2023-01110, Pap.12 (Feb. 9, 2024) is also distinguishable.5F
`6 Pap.5, 11. The
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`joined petitions there were instituted within two days of one another and
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`consolidated with each other only about a month after institution. Sony Elecs.,
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`IPR2023-01119, Pap.14, 2. Further, the Petitioners in the two IPRs that were
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`ultimately consolidated had both filed timely joinder motions to join an earlier IPR,
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`which was terminated before joinder. LG Elecs. Inc. v. Jawbone Innovations, LLC,
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`IPR2023-01110, Pap.3, 3 (June 23, 2023) (filed motion for joinder on June 23,
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`2023 where the proceeding petitioner sought to join was instituted May 24, 2023);
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`Sony Elecs. Inc. v. Jawbone Innovations, LLC, IPR2023-01119, Pap.3, 3 (June 23,
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`2023) (same). And in ZTE (USA) Inc. v. Evolved Wireless LLC, IPR2016-01277,
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`Pap.8 (Dec. 21, 2016), the petitions were instituted on the same day as each other,
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`and consolidated at the same time. See Apple Inc. v. Evolved Wireless, LLC,
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`IPR2016-01209, Paps. 7 & 8 (Dec. 21, 2016).
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`6 PO assumes Petitioner intended to cite Sony Elecs. Inc. v. Jawbone Innovations,
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`LLC, IPR2023-01119, Pap.14 (Feb. 9, 2024) or LG Elecs. Inc. v. Jawbone
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`Innovations, LLC, IPR2023-01110, Pap.12 (Feb. 9, 2024), which are the same
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`document.
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`10
`PROTECTIVE ORDER INFORMAITON
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`Petitioner’s request for consolidation should be denied for all the reasons
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`joinder should be denied, and because consolidation is not appropriate (or feasible)
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`for two IPRs instituted at such vastly different points in time.
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`Dated: April 1, 2024
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`Respectfully submitted,
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`By: /Megan Raymond/
`J. Steven Baughman (Reg. No. 47,414)
`GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
`801 17th Street, NW, Suite 1050
`Washington, DC, 20006
`P: (202)-505-5832
`steve.baughman@groombridgewu.com
`
`Megan Raymond (Reg. No. 72,997)
`GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
`801 17th Street, NW, Suite 1050
`Washington, DC, 20006
`P: (202)-505-5878
`megan.raymond@groombridgewu.com
`
`Michael Milea (Reg. No. 71,863)
`GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
`565 5th Avenue, Suite 2900
`New York, NY 10017
`P: (332)-269-0029
`Mike.milea@groombridgewu.com
`
`Joshua Reich (Reg. No. 75,338)
`GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
`565 5th Avenue, Suite 2900
`New York, NY 10017
`P: (332)-269-0024
`Joshua.reich@groombridgewu.com
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`Attorneys for Patent Owner Novo Nordisk A/S
`11
`PROTECTIVE ORDER INFORMAITON
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`PAGE COUNT CERTIFICATE
`The undersigned certifies that the foregoing PATENT OWNER’S
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`OPPOSITION TO PETITIONER’S MOTION FOR JOINDER complies with the
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`15-page limitation in 37 C.F.R. §42.24(a)(1)(v).
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`Dated: April 1, 2024
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`Respectfully Submitted,
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`/Megan Raymond/
`By:
`Megan Raymond (Reg. No. 72,997)
`GROOMBRIDGE, WU, BAUGHMAN &
`STONE LLP
`801 17th Street, NW, Suite 1050
`Washington, DC, 20006
`P: (202)-505-5878
`megan.raymond@groombridgewu.com
`
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`12
`PROTECTIVE ORDER INFORMAITON
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`CERTIFICATE OF SERVICE
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`It is certified that a copy of the following document has been served in its
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`entirety on the patent owner as provided in 37 CFR §42.205:
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`The copy has been served on April 1, 2024 by causing the aforementioned
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`document to be electronically mailed to the following attorneys of record for
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`Petitioner listed below:
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`John J. Molenda
`Lawrence Kass
`Kyler Doh
`Michael I. Green
`Semaglutide@Steptoe.com
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`Dated: April 1, 2024
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` Respectfully submitted,
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`By: /Sayem Osman/
`Sayem Osman
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`13
`PROTECTIVE ORDER INFORMAITON
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