IPR2024-00009
`U.S. Patent 10,335,462
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`DR. REDDY’S LABORATORIES, INC.
`and
`DR. REDDY’S LABORATORIES, LTD.,
`
`Petitioners
`
`v.
`
`NOVO NORDISK A/S,
`Patent Owner
`______________________
`Case IPR2024-00009
`Patent 10,335,462
`______________________
`
`PRELIMINARY RESPONSE
`UNDER 37 C.F.R. §42.107
`
`
`
`

`

`Exhibit
`EX2001
`
`EX2002
`
`EX2003
`EX2004
`
`EX2005
`
`EX2006
`
`EX2007
`
`EX2008
`
`EX2009
`
`EX2010
`
`EX2011
`EX2012
`
`EX2013
`
`IPR2024-00009
`U.S. Patent 10,335,462
`
`LIST OF EXHIBITS
`
`
`Description
`Excerpt of Defendants’ Initial Invalidity Contentions
`Regarding U.S. Patent Nos. 8,129,343; 8,536,122; 8,114,833;
`8,920,383; 9,775,953; 9,457,154; and 10,335,462, In re:
`Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-
`CFC (D. Del. Oct. 20, 2022)
`Petition for Inter Partes Review, Mylan Pharms. Inc. v. Novo
`Nordisk A/S, IPR2023-00724, Pap.1 (Mar. 16, 2023)
`Declaration of Sayem Osman
`Stipulation and Order Regarding Trial of the MPI Ozempic
`Litigation, In re: Ozempic (Semaglutide) Patent Litigation,
`No. 22-MD-03038-CFC, Dkt. 245 (D. Del. Oct. 31, 2023)
`Nov. 29, 2023 Email from E. Goldschlager to Counsel, re:
`IPR2023-00724 – Request for Conference Call
`Scheduling Order, Novo Nordisk Inc. v. Rio Biopharms., Inc.,
`No. 1:22-cv-00294-CFC, Dkt. 22 (D. Del.)
`Excerpt of Transcript of Dec. 13, 2023 Claim Construction
`Hearing, Novo Nordisk Inc. v. Mylan Pharmaceuticals Inc.,
`No. 23-101-CFC (D. Del. Dec. 13, 2023)
`Claim Construction Order, In re: Ozempic (Semaglutide)
`Patent Litigation, No. 22-MD-03038-CFC, Dkt. 148 (D. Del.
`July 25, 2023)
`Joint Stipulation and Order Amending Scheduling Order, In
`re: Ozempic (Semaglutide) Patent Litigation, MDL No. 22-
`MD-03038-CFC, Dkt. 268 (D. Del. Dec. 1, 2023)
`Excerpt of Novo Nordisk’s Second Amended Disclosures to
`Dr. Reddy’s Laboratories Ltd. and Dr. Reddy’s Laboratories,
`Inc., In re: Ozempic (Semaglutide) Patent Litigation, No. 22-
`MD-03038-CFC (D. Del. July 28, 2023)
`U.S. Patent No. 8,114,833
`Waiver of Service of Summons for Dr. Reddy’s Laboratories,
`Inc., Novo Nordisk Inc. v. Dr. Reddy’s Lab’ys Ltd., No. 1:22-
`cv-00298-CFC, Dkt. 6 (D. Del., Mar. 4, 2022)
`Waiver of Service of Summons for Dr. Reddy’s Laboratories
`Ltd., Novo Nordisk Inc. v. Dr. Reddy’s Lab’ys Ltd., No. 1:22-
`cv-00298-CFC, Dkt. 7 (D. Del. Mar. 4, 2022)
`
`i
`
`

`

`IPR2024-00009
`U.S. Patent 10,335,462
`
`Description
`Excerpt of Redacted Patent Owner’s Response, Mylan
`Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724, Pap.30
`(Jan. 17, 2023)
`Excerpt of Novo Nordisk’s Initial Responses to Defendants’
`Initial Invalidity Contentions Regarding U.S. Patent Nos.
`8,129,343; 8,536,122; 8,114,833; 8,920,383; 9,775,953;
`9,457,154; and 10,335,462, In re: Ozempic (Semaglutide)
`Patent Litigation, No. 22-MD-03038-CFC (D. Del. Dec. 21,
`2022)
`Transfer Order, In re: Ozempic (Semaglutide) Patent
`Litigation, No. 22-MD-03038-CFC, Dkt. 1 (D. Del. Aug. 5,
`2022)
`INTENTIONALLY OMITTED
`Excerpt of Defendants’ Supplemental Invalidity Contentions
`Regarding U.S. Patent Nos. 8,129,343; 8,536,122; 8,114,833;
`8,920,383; 9,775,953; 9,457,154; and 10,335,462, In re:
`Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-
`CFC (D. Del. Nov. 2, 2023)
`Novo Nordisk Production Letter, In re: Ozempic
`(Semaglutide) Patent Litigation, No. 22-MD-03038-CFC (D.
`Del. Oct. 17, 2023) [REDACTED]
`Compilation of Defendants’ Production Letters, In re:
`Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-
`CFC (D. Del.) [REDACTED]
`Compilation of Rule 30(b)(1) Deposition Notices, In re:
`Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-
`CFC (D. Del.)
`Notice of Service for Defendants’ Initial Invalidity
`Contentions, In re: Ozempic (Semaglutide) Patent Litigation,
`No. 22-MD-03038-CFC (D. Del. Oct. 20, 2022).
`Notice of Service for Defendants’ Supplemental Invalidity
`Contentions, In re: Ozempic (Semaglutide) Patent Litigation,
`No. 22-MD-03038-CFC (D. Del. Nov. 6, 2023).
`
`Exhibit
`EX2014
`
`EX2015
`
`EX2016
`
`EX2017
`EX2018
`
`EX2019
`
`EX2020
`
`EX2021
`
`EX2022
`
`EX2023
`
`
`
`ii
`
`

`

`IPR2024-00009
`U.S. Patent 10,335,462
`
`IV.
`
`TABLE OF CONTENTS
`
`I.
`Introduction ...................................................................................................... 1
`Fintiv Is Appropriate and Necessary to Consider Before Institution .............. 4
`II.
`III. This is PO’s First Genuine Opportunity to Brief Fintiv in Connection with
`Petitioner’s Delaware Litigation ...................................................................... 5
`Institution Should Be Denied Under 35 U.S.C. §314(a) ................................. 7
`A. The Parallel Litigation Will Not Be Stayed (Factor 1) ............................ 7
`B. Even if Mylan’s Final Written Decision Date Were Considered, the
`Parallel Litigation Trial Date Precedes It; and No Final Written
`Decision Date Will Apply if This Petition is Instituted and Joinder is
`Granted (Factor 2) .................................................................................... 9
`C. The Court and Parties Have Already Invested Significantly in the
`Parallel Litigation (Factor 3) ..................................................................13
`D. There Is Overlap Between Issues Raised in the Petition and in the
`Parallel Litigation (Factor 4) ..................................................................17
`E. Petitioner Is a Defendant in the Parallel Litigation (Factor 5) ..............23
`F. Other Circumstances that Impact the Board’s Exercise of Discretion,
`Including the Merits (Factor 6) ..............................................................23
`Institution Should Additionally Be Denied Because This Petition Was Filed
`After the One-Year Bar Date .........................................................................24
`VI. Conclusion .....................................................................................................25
`
`
`
`V.
`
`
`
`iii
`
`

`

`
`
`TABLE OF AUTHORITIES
`
`IPR2024-00009
`U.S. Patent 10,335,462
`
` Page(s)
`
`Cases
`Amerigen Pharms., Ltd. v. Janssen Oncology, Inc.,
`IPR2016-00286, Pap.14 (May 31, 2016) ............................................................ 11
`Amerigen Pharms., Ltd. v. Janssen Oncology, Inc.,
`IPR2016-00286, Pap.30 (Sept. 19, 2016) ........................................................... 11
`Amerigen Pharms., Ltd. v. Janssen Oncology, Inc.,
`IPR2016-00286, Pap.86 (Jan. 17, 2018) ............................................................. 11
`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Pap.11 (Mar. 20, 2020) ....................................................passim
`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Pap.15 (May 13, 2020) ...................................................... 17, 19
`Apple Inc. v. Maxell, Ltd.,
`IPR2020-00408, Pap.13 (Aug. 11, 2020) ..................................................... 18, 20
`Apple Inc. v. Memory Integrity, LLC,
`IPR2015-00163, Pap.18 (May 8, 2015) .............................................................. 12
`Apple Inc. v. Traxcell Techs., LLC,
`IPR2021-01552, Pap.18 (May 25, 2022) ............................................................ 11
`Apple Inc. v. Uniloc 2017
`LLC, IPR2020-00854, Pap.9 (Oct. 28, 2020) (precedential) ........................... 5, 9
`Astellas US LLC v. Apotex Inc.,
`No. 1:18-cv-1675-CFC-CJB, 2021 WL 9031821 (D. Del. Feb. 19,
`2021) ..................................................................................................................... 8
`In re Brimonidine Pat. Litig.,
`No. 07-MD-1866 GMS, 2008 WL 4809037 (D. Del. Nov. 3, 2008) ............. 8, 13
`Commscope Techs. LLC v. Dali Wireless, Inc.,
`IPR2022-01242, Pap.23 (Feb. 27, 2023) ............................................................ 23
`
`iv
`
`

`

`IPR2024-00009
`U.S. Patent 10,335,462
`
`Duplo U.S.A. Corp. v. MGI Digital Tech. S.A.,
`IPR2023-00936, Pap.8 (Dec. 5, 2023) ................................................................ 16
`Facebook, Inc. v. Windy City Innov., LLC,
`973 F.3d 1321 (Fed. Cir. 2020) ...................................................................... 5, 20
`Google LLC v. Uniloc 2017 LLC,
`IPR2020-00115, Pap.8 (Mar. 27, 2020) ..................................................... 8-9, 16
`KeyMe, LLC v. The Hillman Grp. Inc.,
`IPR2020-01028, Pap.12 (Jan. 13, 2021) ................................................. 17, 19, 20
`LG Elecs., Inc. v. Ancora Techs., Inc.,
`IPR2021-00581, Pap.16 (June 10, 2021) .................................................. 5, 20, 24
`LG Elecs., Inc. v. Memory Integrity, LLC,
`IPR2015-01353, Pap.11 (Oct. 15, 2015) ............................................................ 11
`Mylan Lab’ys Ltd. v. Janssen Pharmaceutica, N.V.,
`989 F.3d 1375 (Fed. Cir. 2021) .......................................................................... 25
`Mylan Lab’ys Ltd v. Janssen Pharms.,
`IPR2020-00440, Pap.17 (Sept. 16, 2020) ....................................................... 8, 17
`Mylan Pharms. Inc. v. St. Regis Mohawk Tribe,
`IPR2016-01127, Pap.144 (2018) .................................................................. 10-11
`Network-1 Technologies, Inc. v. Hewlett-Packard Co.,
`981 F.3d 1015 (Fed. Cir. 2020) .................................................................... 21, 24
`ResMed Corp. v. Cleveland Med. Devices Inc.,
`IPR2023-00565, Pap.13 (Sept. 25, 2023) ........................................................... 10
`Samsung Elecs. Co. v. Ancora Techs., Inc.,
`IPR2020-01184, Pap.11 (Jan 5, 2021) .........................................................passim
`Samsung Elecs. Co. v. Clear Imaging Rsch., LLC,
`IPR2020-01402, Pap.12 (Mar. 4, 2021) ................................................. 17, 19, 20
`Samsung Elecs. Co. v. Mojo Mobility Inc.,
`IPR2023-01091, Pap.11 (Jan. 8, 2024) ......................................................... 16, 22
`
`v
`
`

`

`IPR2024-00009
`U.S. Patent 10,335,462
`
`TCO AS v. NCS Multistage Inc.,
`PGR2020-00077, Pap.16 (Feb. 18, 2021) .......................................................... 22
`VirnetX Inc. v. Mangrove Partners Master Fund, Ltd.,
`No.23-315, Dkt.1 (U.S. Sept 20, 2023) ........................................................ 24, 25
`Statutes
`21 U.S.C. §355(c)(3)(C) .......................................................................................... 10
`35 U.S.C. §314(a) .............................................................................................passim
`35 U.S.C. §315(b) .................................................................................................... 24
`35 U.S.C. §315(c) .................................................................................... 1, 11, 24, 25
`35 U.S.C. §315(e)(2) ................................................................................................ 21
`35 U.S.C. §316(a)(11) ................................................................................ 7, 9, 10, 11
`Other Authorities
`37 C.F.R. §42.100(c) ............................................................................................ 9-11
`37 C.F.R. §42.107 ...................................................................................................... 1
`USPTO, Interim Procedure for Discretionary Denials in AIA Post-
`Grant Proceedings with Parallel District Court Litigation (June
`21, 2022) ......................................................................................................... 3, 23
`
`
`
`
`
`vi
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`

`

`IPR2024-00009
`U.S. Patent 10,335,462
`
`
`I.
`
`Introduction
`
`
`As detailed in this §42.1070F1 Preliminary Response by Patent Owner Novo
`
`Nordisk A/S (“PO”), the extensively- and consciously-delayed Petition in this
`
`matter (“Petition”/“Pet.”) should be denied under the Board’s §314(a) discretion,
`
`and because it was not “properly filed” under §315(c).
`
`Petitioners Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories,
`
`Ltd. (collectively, “Petitioner”) filed the present IPR challenging the validity of
`
`U.S. Patent No. 10,335,462 (“’462”) eighteen months after they were sued for
`
`infringing the ’462, seeking to join the pending inter partes review proceedings in
`
`Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S, IPR2023-00724 (the “Mylan
`
`IPR”)—proceedings Petitioner had, until then, been watching from the sidelines.
`
`Petitioner’s Motion for Joinder confirmed that Petitioner’s request to participate
`
`would only affect these proceedings if (timely) petitioner Mylan settled and were
`
`terminated from the Mylan IPR: “DRL will assume a ‘silent understudy’ role and
`
`will not take an active role in the inter partes review proceeding unless, the Mylan
`
`Petitioner ceases to participate in the instituted IPR.” Pap.3, 2.
`
`
`1 Unless stated, statutory and regulatory citations are to 35 U.S.C. or 37 C.F.R., as
`
`context indicates, internal citations omitted, and emphases/annotations are added.
`
`1
`
`

`

`IPR2024-00009
`U.S. Patent 10,335,462
`Petitioner, along with Mylan, Sun Pharmaceutical Industries Ltd. and Sun
`
`Pharmaceuticals Industries, Inc. (which filed a subsequent copycat petition,
`
`IPR2024-00107), and several other defendants who have not filed IPRs (e.g.,
`
`Zydus Worldwide DMCC, Zydus Pharmaceuticals (USA) Inc., Zydus Lifesciences
`
`Limited, and Rio Biopharmaceuticals, Inc.), have also challenged the validity of
`
`’462 in parallel Hatch-Waxman litigation that is currently pending in the District of
`
`Delaware as In re: Ozempic (Semaglutide) Patent Litigation, No. 22-MD-3038 (D.
`
`Del.) (consolidated case) (the “Delaware Litigation” or “parallel litigation”).1F
`
`2
`
`EX2001, 33-34. While Petitioner has watched the Mylan IPR move forward,
`
`Delaware Litigation claim construction has been completed, fact discovery has
`
`closed, and the district court has continued to move toward trial eight months from
`
`now.
`
`The circumstances here support denial under §314(a) based on the factors
`
`laid out in Apple Inc. v. Fintiv, Inc., IPR2020-00019, Pap.11 (Mar. 20, 2020)
`
`(“Fintiv”) (precedential). In evaluating the Fintiv factors, “the Board takes a
`
`
`2 The Delaware Litigation is a consolidated case involving several defendant
`
`groups. The case against Petitioner is individually captioned as Novo Nordisk Inc.
`
`and Novo Nordisk A/S v. Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
`
`Laboratories, Inc., C.A. No. 22-298-CFC.
`
`2
`
`

`

`IPR2024-00009
`U.S. Patent 10,335,462
`holistic view of whether efficiency and integrity of the system are best served by
`
`denying or instituting review.” Id. at 6. The Office, based on its experience
`
`administering the AIA, “has recognized the potential for inefficiency and
`
`gamesmanship in AIA proceedings, given the existence of parallel proceedings
`
`between the Office and district courts.” USPTO, Interim Procedure for
`
`Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court
`
`Litigation, at 1 (June 21, 2022) (hereinafter USPTO Interim Procedure for
`
`Discretionary Denials). The Office designated Fintiv as precedential to “minimize
`
`potential conflict between the [PTAB] and district court proceedings,” and thereby
`
`“mitigate[] concerns of potentially conflicting decisions and duplicative efforts
`
`between the district court and the PTAB.” Id. at 1, 7. And in refining its approach
`
`to the Fintiv analysis in June 2022, the Office reiterated the importance of
`
`efficiency and limiting unnecessary and counterproductive litigation costs while
`
`improving patent quality—including by “avoid[ing] inconsistent outcomes
`
`between the PTAB and the district court….” Id. at 1, 7-8.
`
`In the parallel litigation here, which is far-advanced, Petitioner is already
`
`actively litigating almost all of the IPR art (compare Pet.22, 27-29, 36-37, 54-55
`
`with EX2018, 6-38) including two of the three weak obviousness combinations
`
`that Petitioner advances here. The parallel litigation is scheduled to start trial on
`
`September 30, 2024—before even the current final written decision date of the
`
`3
`
`

`

`IPR2024-00009
`U.S. Patent 10,335,462
`Mylan IPR and certainly before any resulting extension of that final written
`
`decision date if this Petition is instituted and joined to the Mylan IPR (a step that
`
`would remove any statutory final-written-decision deadline). Had Petitioner
`
`wished to make arguments about ’462’s validity before the Board, it could have
`
`filed an IPR long ago. Having chosen not to do so, and to proceed, instead,
`
`through litigation in the district court, Petitioner should not now be permitted to
`
`foist onto the parties, the Board, and the district court the burdens and inevitable
`
`waste of resources its much-delayed duplicative Petition would entail upon any
`
`departure of Mylan from its own IPR. The only impact of this Petition and
`
`Petitioner’s presence in a joined IPR would be to continue proceedings if Mylan
`
`(the only timely petitioner under §315) were dismissed. E.g., Pap.3, 2 (Petitioner
`
`“will not take an active role… unless the Mylan Petitioner ceases to participate”).
`
`And Petitioner’s choice to delay its own challenge before the Office—and its
`
`attendant request for joinder, eliminating any final-written-decision deadline—
`
`significantly increases the risk of inconsistent outcomes in close proximity in two
`
`different jurisdictions. Cf., e.g., USPTO Interim Procedure for Discretionary
`
`Denials, 7-8. PO respectfully requests that institution be denied.
`
`II. Fintiv Is Appropriate and Necessary to Consider Before Institution
`Although this is a copycat Petition, the Board nevertheless must first
`
`consider whether institution of this Petition is warranted, including with respect to
`
`4
`
`

`

`IPR2024-00009
`U.S. Patent 10,335,462
`discretionary denial, before addressing joinder. LG Elecs., Inc. v. Ancora Techs.,
`
`Inc., IPR2021-00581, Pap.16, 6, 11-12 (June 10, 2021) (denying institution of
`
`copycat petition based on Fintiv pursuant to §314(a), noting “before determining
`
`whether to join [copycat petitioner] as a party to the [] IPR, we first determine
`
`whether the petition warrants institution under § 314(a)”); see also Facebook, Inc.
`
`v. Windy City Innov., LLC, 973 F.3d 1321, 1332 (Fed. Cir. 2020) (“[T]he joinder
`
`decision is a separate and subsequent decision to the institution decision.”); Apple
`
`Inc. v. Uniloc 2017 LLC, IPR2020-00854, Pap.9, 4-5 (Oct. 28, 2020) (precedential)
`
`(denying copycat petition based on Director’s discretionary authority and General
`
`Plastic, noting “the discretion of the Director to join a party to an ongoing IPR is
`
`premised on the Director’s determination that the petition warrants institution….
`
`before determining whether to join Apple as a party… we first determine whether
`
`the application of the General Plastic factors warrants the exercise of discretion to
`
`deny the Petition under 314(a).”).
`
`III. This is PO’s First Genuine Opportunity to Brief Fintiv in Connection
`with Petitioner’s Delaware Litigation
`Although Mylan is also party to the Delaware trial, the fact that the Mylan
`
`IPR was instituted without any Fintiv dispute is irrelevant here. At the time of the
`
`October 4, 2023 institution decision date for the Mylan IPR (and the October 6,
`
`2023 expected institution date based on the date PO filed its POPR in the Mylan
`
`IPR), Mylan did not yet have a trial date. Mylan IPR, Paper 5, 1; id., Paper 1, 65-
`
`5
`
`

`

`IPR2024-00009
`U.S. Patent 10,335,462
`66. PO’s parallel litigation with Mylan was a separate case, venued in the
`
`Northern District of West Virginia, and had been consolidated with the Delaware
`
`Litigation as a multidistrict litigation case for pre-trial proceedings only. The
`
`Mylan litigation was then to be remanded to West Virginia for trial, with trial
`
`expected after the Delaware trial, but with no indication of exactly when that later
`
`trial would be scheduled. EX2016, 4 (transferring and consolidating in the District
`
`of Delaware all pretrial proceedings before jurisdiction is returned to the Northern
`
`District of West Virginia); EX2006, 38 (Delaware Litigation “Pretrial Conference”
`
`scheduled for September 19, 2024); EX2009, 4 (“No other deadlines set forth in
`
`the Scheduling Order are altered by way of this stipulation.”). Indeed, Mylan
`
`affirmatively argued as much to avoid discretionary denial of its own petition.
`
`EX2002, 65-66 (arguing “Petitioner [Mylan]’s trial is likely to be even later” than
`
`September 30, 2024). Accordingly, given the particular circumstances in the
`
`Mylan IPR (including that there was no joinder pending), PO did not argue for
`
`discretionary denial of that IPR under Fintiv.2F
`
`3 The circumstances here are
`
`
`3 Mylan is only a party to the Delaware Litigation trial now because, on October
`
`31, 2023, after the institution decision in the Mylan IPR, Mylan stipulated to
`
`proceeding with trial together with Petitioner in the September 30, 2024 Delaware
`
`trial. EX2004, 3. Had Mylan stipulated to join the Delaware Litigation trial one
`
`
`
`6
`
`

`

`IPR2024-00009
`U.S. Patent 10,335,462
`different including because, at the time of this POPR, there is a trial date on ’462
`
`validity scheduled before the expected final written decision date, even on the
`
`Mylan petition, and Petitioner’s request for institution and joinder (whose sole
`
`impact would be to allow Petitioner to continue active proceedings if Mylan is
`
`dismissed) would mean there is no deadline for a final written decision.
`
`§316(a)(11). As detailed in the next section, here, the Fintiv factors weigh heavily
`
`against institution.
`
`IV.
`
`Institution Should Be Denied Under 35 U.S.C. §314(a)
`A. The Parallel Litigation Will Not Be Stayed (Factor 1)
`It is highly unlikely the Delaware Litigation will be stayed. No stay of the
`
`Delaware Litigation has been sought or granted. Patent Owner does not intend to
`
`ask for a stay. Nor has Petitioner indicated any plans to seek a stay (which would
`
`be a highly unusual request by a defendant in an ANDA case) or suggested the
`
`Court would grant one. Further, as discussed below, the trial is set only five
`
`months after the institution decision here is due, and the case is in its late stages,
`
`with fact discovery complete and expert discovery expected to be almost complete
`
`
`month earlier, PO would have been able to timely argue that institution should be
`
`denied based on Fintiv. PO’s request to brief this issue after institution in the
`
`Mylan IPR was denied. EX2005.
`
`7
`
`

`

`IPR2024-00009
`U.S. Patent 10,335,462
`by the time the institution decision here is due. Infra, §VI.C. Further, stays are
`
`particularly discouraged in ANDA cases due to prejudice. See, e.g., In re
`
`Brimonidine Pat. Litig., No. 07-MD-1866 GMS, 2008 WL 4809037, at *2 (D. Del.
`
`Nov. 3, 2008) (denying motion for stay, finding defendant would “be unduly
`
`prejudiced if this action were stayed” because, in part, “staying this action against
`
`[defendant] will delay market entry of any [defendant] generic product covered by
`
`the ANDA at issue in this litigation,” a consequence that is “not insignificant”).
`
`And it is further unlikely that the Court would stay the Delaware Litigation given
`
`the advanced status of the case. See Astellas US LLC v. Apotex Inc., No. 1:18-cv-
`
`1675-CFC-CJB, 2021 WL 9031821, at *2 (D. Del. Feb. 19, 2021) (denying motion
`
`to stay in ANDA case and stating, “the status of this case is undoubtedly well
`
`advanced, which weighs against a stay.... [E]xpert discovery is set to close in April
`
`of this year. And trial is set to happen soon, in June 2021. Absent a really good
`
`reason to do otherwise, when a case gets this close to trial and the Court and the
`
`parties have put this much effort into the litigation, the case is not normally
`
`stayed.”); see also Fintiv, Pap.11, 5-6; infra, §IV.C (Fintiv Factor 3). Therefore,
`
`this factor favors denial of institution. Mylan Lab’ys Ltd v. Janssen Pharms.,
`
`IPR2020-00440, Pap.17, 13-14 (Sept. 16, 2020) (finding stay of parallel litigations
`
`unlikely in view of, e.g., 30-month 355(j)(5)(B)(iii) limit and advanced stage of
`
`litigation); Google LLC v. Uniloc 2017 LLC, IPR2020-00115, Pap.8, 4 (Mar. 27,
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`8
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`IPR2024-00009
`U.S. Patent 10,335,462
`2020) (finding factor 1 “weigh[s] in favor of denying institution,” noting “[t]here is
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`no evidence that the district court has granted (or would grant) a stay pending inter
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`partes review”).
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`B.
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`Even if Mylan’s Final Written Decision Date Were Considered,
`the Parallel Litigation Trial Date Precedes It; and No Final
`Written Decision Date Will Apply if This Petition is Instituted and
`Joinder is Granted (Factor 2)
`If this Petition is instituted and joinder is granted, the Board will have no
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`deadline to issue its final written decision. §316(a)(11); §42.100(c). Moreover,
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`Petitioner itself has made clear that its Petition and joinder request have an impact
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`here only if trial on Mylan’s petition is terminated and Mylan is no longer a party
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`(DRL IPR, Pap.3, 2)—further underscoring the meaninglessness of looking to
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`Mylan’s final written decision date as a point of comparison. Cf. Apple v. Uniloc,
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`IPR2020-00854, Pap.9, 4, 8, 11-12 (considering impact on IPR if copycat
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`petitioner is joined and original petitioner settles in the context of General Plastic
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`§314(a) analysis, noting institution and joinder would allow copycat petitioner to
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`continue an otherwise terminated proceeding and use Board resources).
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`Nonetheless, even if it is considered, the Delaware trial precedes Mylan’s current
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`final written decision deadline.
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`The Delaware trial is currently scheduled on September 30, 2024. EX2006,
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`38; EX2009, 4; Samsung Elecs. Co. v. Ancora Techs., Inc., IPR2020-01184,
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`Pap.11, 11-12 (Jan 5, 2021) (noting Board focuses on trial date and “do[es] not
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`9
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`IPR2024-00009
`U.S. Patent 10,335,462
`speculate as to the schedule for post-trial motions”). The final written decision in
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`the Mylan IPR (before joinder) is due October 4, 2024. IPR2023-00724, Pap.11
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`(Oct. 4, 2023). Thus, even if Mylan IPR’s final written decision date were
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`considered, the Delaware Litigation will start trial before a final written decision
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`regarding ’462 validity is expected to issue. E.g., ResMed Corp. v. Cleveland Med.
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`Devices Inc., IPR2023-00565, Pap.13, 11 (Sept. 25, 2023) (finding Fintiv factor 2
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`“weighs in favor of exercising discretion to deny institution” where the “trial date
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`in the [] district court is set for one month before a final decision is due in this
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`case”). Petitioner has presented no other evidence regarding trial dates, and the
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`Board “generally take[s] courts’ trial schedules at face value absent some strong
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`evidence to the contrary.” See Samsung v. Ancora, IPR2020-01184, Pap.11, 21;
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`ResMed Corp., IPR2023-00565, Pap.13 at 12. Moreover, the Delaware Litigation
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`is a Hatch-Waxman (ANDA) case and, as such, is time-pressured to be completed
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`before the expiration of the stay of regulatory approval under 21 U.S.C.
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`§355(c)(3)(C) (there, June 5, 2025).
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`And again, if this IPR is instituted, it will be joined to the Mylan petition, so
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`there will be no one-year statutory deadline for the final written decision: under
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`§42.100(c) and §316(a)(11), the Board “may adjust th[is one-year] time period[]”
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`and ignore the prior October 4, 2024 date without making any showing or meeting
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`any other requirements. E.g., Mylan Pharms. Inc. v. St. Regis Mohawk Tribe,
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`10
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`IPR2024-00009
`U.S. Patent 10,335,462
`IPR2016-01127, Pap.144, 5 n.4 (2018) (“[W]e are not under any statutory
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`deadlines given the joinder of these proceedings under 35 U.S.C. § 315(c) (see
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`§ 42.100(c))....”); Amerigen Pharms., Ltd. v. Janssen Oncology, Inc., IPR2016-
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`00286, Paps. 14, 30, 86 (following joinder of a single party raising the same
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`grounds and prior art and diverging only in an expert’s declaration, final written
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`decision issued 19 months and 17 days after institution of the original petition and
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`15 months and 29 days after joinder). Indeed, the Board regularly issues its final
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`written decisions for joined proceedings more than a year after instituting the first
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`of the joined petitions. E.g., Amerigen Pharms., Paps. 14, 30, 86; see also, e.g.,
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`Apple Inc. v. Traxcell Techs., LLC, IPR2021-01552, Pap.18, 2 (May 25, 2022)
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`(granting 3-and-a-half-month extension under §42.100(c) to one-year deadline to
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`issue a final determination following institution and joinder of copycat petition,
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`resulting in final written decision being due approximately a year after institution
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`of copycat petition).
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`In support of its Motion for Joinder, Petitioner cites LG Elecs., Inc. v.
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`Memory Integrity, LLC to argue that “joinder should have no impact on the
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`schedule of the Mylan IPR.” Mot. for Joinder at 6 (citing IPR2015-01353, Pap.11,
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`6 (Oct. 15, 2015)). But Petitioner neglects to mention, including in its Fintiv
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`arguments, that the Memory Integrity joinder resulted in a final written decision
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`issuing more than 13 months after its institution date, exceeding the 1-year
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`11
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`

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`IPR2024-00009
`U.S. Patent 10,335,462
`statutory deadline. Compare Apple Inc. v. Memory Integrity, LLC, IPR2015-
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`00163, Pap.18 (May 8, 2015) (Institution Decision), with id., Pap.52 (June 21,
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`2016) (Final Decision). This only further supports PO’s point that institution and
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`joinder of this Petition could lead to delays in PO receiving a final written decision
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`in the Mylan IPR.
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`Because, if this Petition is instituted and joinder is granted, there are no
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`constraints on the timing of the final written decision—and because, even if the
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`Mylan IPR due date were considered, a final written decision would be due after
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`4
`the scheduled start of trial—this factor favors discretionary denial.3F
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`
`4 While Petitioner may argue that the September 2024 trial date could be delayed,
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`any such argument is speculative to begin with, and should in any event be
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`disregarded because instituting and joining this Petition would mean there is no
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`deadline for the final written decision. As to a possible trial delay, the Delaware
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`district court stated at the end of a claim construction hearing in a different,
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`separately filed lawsuit that it might “move that [Delaware Litigation] trial date a
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`little bit” due to scheduling conflicts in September and October generally.
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`EX2007, 3-4 (104:16-105:18). But the Court has yet to do so, or even to raise the
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`issue in the Delaware Litigation. The Court also did not indicate whether trial
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`would be rescheduled earlier or later (if at all). Indeed, as the Delaware Litigation
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`
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`12
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`IPR2024-00009
`U.S. Patent 10,335,462
`C. The Court and Parties Have Already Invested Significantly in the
`Parallel Litigation (Factor 3)
`The Delaware Litigation has been pending since March 2022 and is now in
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`its late stages. Much substantive work has already been done by both the parties
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`and the Court:
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`Claim construction has issued. The parties have negotiated agreement on
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`three ’462 claim terms, and the Court heard oral argument and subsequently issued
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`its claim construction order on the disputed term six months ago. EX2008, 2-3; see
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`Fintiv, Pap.11, 9-10 (“district court claim construction orders may indicate that the
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`court and parties have invested sufficient time in the parallel proceeding to favor
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`denial”).
`
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`is a time-pressured Hatch-Waxman (ANDA) case, postponing trial in any
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`significant way would be unlikely. In re Brimonidine Pat. Litig., 2008 WL
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`4809037, at *2. There is thus no basis to treat the trial date as anything but
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`September 2024. Even if the trial were later, the other factors still weigh in favor
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`of discretionary denial. Fintiv, Pap.11, 9 (“If the court's trial date is at or around
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`the same time as the projected statutory deadline or even significantly after the
`
`projected statutory deadline, the decision whether to institute will likely implicate
`
`other factors discussed herein.”).
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`13
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`IPR2024-00009
`U.S. Patent 10,335,462
`Fact discovery is complete. Fact discovery in the district court litigation
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`has been closed since December 15, 2023 (with the exception of a single discrete
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`dispute regarding additional discovery relating to marketing and sales). EX2009,
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`2. During the fact discovery period, PO produced over 4.8 million pages of
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`documents and the defendants collectively produced approximately 500,000 pages
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`(with Petitioner alone producing approximately 158,000 pages, Mylan alone