`Trials@uspto.gov
`571-272-7822
`
` Entered: April 25, 2024
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`DR. REDDY’S LABORATORIES, INC. and
`DR. REDDY’S LABORATORIES, LTD.,
`Petitioner,
`v.
`NOVO NORDISK A/S,
`Patent Owner.
`____________
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`IPR2024-00009
`Patent 10,335,462 B2
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`Before JOHN G. NEW, SUSAN L. C. MITCHELL, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`MITCHELL, 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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`IPR2024-00009
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`I. INTRODUCTION
`
`A. Background
`
`Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd.
`(“Petitioner”) filed a Petition requesting an inter partes review of claims 1–
`10 of U.S. Patent No. 10,335,462 B2 (Ex. 1001, “the ’462 patent”). Paper 2
`(“Pet.”). Petitioner also filed a Motion for Joinder with the Petition seeking
`joinder with Mylan Pharmaceuticals Inc. v. Novo Nordisk A/S, IPR2023-
`00724 (“Mylan IPR”), which we have previously instituted on the same
`challenged claims of the ’462 patent. Paper 3 (“Mot.”); see IPR2023-00724,
`Paper 10 (PTAB Oct. 4, 2024) (“Mylan Dec.”).
`Patent Owner Novo Nordisk A/S (“Patent Owner”) did not file an
`opposition to Petitioner’s Motion for Joinder. See Paper 12 (Joint
`Stipulation Regarding Petitioners’ Motion for Joinder submitted “in lieu of
`[Patent Owner] filing an opposition to that motion”). Patent Owner,
`however, filed a Preliminary Response requesting that we exercise our
`discretion to deny the Petition under 35 U.S.C. §§ 314(a) and 315(c)1 in light
`
`
`1 Patent Owner asserts that the Petition was not “properly filed” because it
`was filed more than one year after Petitioner was served with a complaint
`alleging infringement of the ’462 patent. See Prelim. Resp.
`24–25. Although acknowledging that the United States Court of Appeals for
`the Federal Circuit has taken an opposing view, Patent Owner raised this
`issue to preserve it in light of a petition for a writ of certiorari at the
`Supreme Court in which it was argued that such petitions are not properly
`filed. Id. (citing VirnetX Inc. v. Mangrove Partners Master Fund, Ltd., No.
`23-315, Dkt. 1, at 11 (U.S. Sept. 20, 2024)). The petition for writ of
`certiorari in VirnetX has since been denied. See id., cert. denied Feb. 20,
`2024.
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`of the parallel district court proceeding and Petitioner’s delay in filing this
`Petition requesting inter partes review. Paper 13, 1.
`Petitioner filed an authorized Reply addressing whether discretionary
`denial is appropriate. Paper 14. Patent Owner filed an authorized Sur-Reply
`in response. Paper 15.
`After a conference call with the parties, we further authorized
`Petitioner to file a Sotera2 stipulation in which it agrees that it is estopped to
`the same extent as the petitioner in the original case to which it seeks
`joinder, and the District Court Order changing the trial date in the parallel
`proceeding. See Exhibits 1098 (District Court’s Order) and 1099 (Sotera
`Stipulation). We also authorized Patent Owner an additional brief to address
`discretionary denial in view of Petitioner’s Sotera stipulation. See Paper 18.
`We have authority to determine whether to institute an inter partes
`review under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a). To institute an inter
`partes review, we must determine that the information presented in the
`Petition shows “a reasonable likelihood that the petitioner would prevail
`with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C.
`§ 314(a).
`For the reasons set forth below, we decline to exercise our discretion
`to deny the Petition under 35 U.S.C. §§ 314(a) or 315(c) because of
`Petitioner’s Sotera stipulation and the postponement of the district court’s
`trial date, and conclude that Petitioner has established a reasonable
`likelihood that it would prevail in showing the unpatentability of at least one
`
`2 See Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12
`(PTAB Dec. 1, 2020) (precedential as to § II.A) (discussing the petitioner’s
`broad stipulation to limit invalidity grounds in district court).
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`of the challenged claims of the ’462 patent. Therefore, we institute an inter
`partes review for claims 1–10 of the ’462 patent on the same grounds
`instituted in the Mylan IPR, and we grant Petitioner’s Motion for Joinder.
`
`B. Related Proceedings
`
`The parties identify the following consolidated litigation involving the
`
`’462 patent to which Petitioner is a defendant: (1) Novo Nordisk Inc. v.
`Mylan Pharms. Inc., No. 22-cv-01040-CFC (D. Del.); (2) In re Ozempic
`(Semaglutide) Patent Litigation, No. 22-md-3038-CFC (D. Del.)
`(“Delaware Litigation”); and (3) Novo Nordisk Inc. v. Mylan Pharms.
`Inc., No. 22-cv-00023 (N.D. W. Va.). Pet 1–2; Paper 6, 1 (noting
`Northern District of West Virginia case transferred to the District of
`Delaware); Paper 8, 1; Paper 10, 1. The parties also list the following
`litigations that involve the ’462 patent: (1) Novo Nordisk Inc. v.
`Aurobindo Pharma USA, Inc., No. 1:22-cv-00295 (D. Del.) (dismissed on
`March 28, 2022); (2) Novo Nordisk Inc. v. Rio Biopharmaceuticals, Inc.,
`No. 1:22-cv-00294 (D. Del.); (3) Novo Nordisk A/S v. Sun Pharm. Indus.
`Ltd., No. 1:22-cv-00296 (D. Del.); (4) Novo Nordisk Inc. v. Zydus
`Worldwide DMCC, No. 1:22-cv-00297 (D. Del.); (5) Novo Nordisk Inc. v.
`Dr. Reddy’s Laby’s Ltd., No. 1:22-cv-00298 (D. Del.); and (6) Novo
`Nordisk Inc. v. Alvogen, Inc., No. 1:22-cv-00299 (D. Del.). Pet. 2; Paper
`6, 2; Paper 8, 2; Paper 10, 1.
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`Patent Owner further identifies the following inter partes review
`proceeding as a related matter involving the ’462 patent: Mylan
`Pharmaceuticals Inc. v. Novo Nordisk A/S, IPR2023-00724 (PTAB).
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`Paper 6, 1; Paper 8, 1; Paper 10, 1. There are also two additional petitions
`filed along with motions for joinder to IPR2023-00724 that are pending
`decisions on whether to institute trial: (1) Sun Pharmaceutical Industries
`Ltd. v. Novo Nordisk A/S, IPR2024-00107 (PTAB); and (2) Apotex Inc. v.
`Novo Nordisk A/S, IPR2024-00631 (PTAB).
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`C. Asserted Grounds of Unpatentability
`
`Petitioner asserts the following grounds of unpatentability, which are
`identical to the grounds on which we instituted trial in IPR2023-00724:
`
`Claim(s) Challenged 35 U.S.C. §3
`1–3
`102(a), (e)
`1–3
`102(b)
`1–10
`103(a)
`1–10
`103(a)
`
`Reference(s)/Basis
`WO4214
`Lovshin5
`WO421, ’424 publication6
`WO537,7 Lovshin
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`3 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011) (“AIA”), included revisions to 35 U.S.C. §§ 102 and 103 that became
`effective on March 16, 2013, after the filing of the applications to which the
`’462 patent claims priority. Therefore, we apply the pre-AIA versions of
`Sections 102 and 103.
`4 Thomas Klein et al., WO 2011/138421 A1, published November 10, 2011
`(Ex. 1011, “WO421”).
`5 Julie A. Lovshin and Daniel J. Drucker, Incretin-based therapies for type 2
`diabetes mellitus, 5 NATURE REVIEWS/ENDOCRINOLOGY 262–269 (2009)
`(Ex. 1012, “Lovshin”).
`6 Tina B. Pedersen et al., US 2007/0010424 A1, published Jan. 11, 2007
`(Ex. 1016, “’424 publication”).
`7 Jesper Lau et al., WO 2006/097537 A2, published Sept. 21, 2006
`(Ex. 1015, “WO537”).
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`Claim(s) Challenged 35 U.S.C. §3
`1–10
`103(a)
`
`Reference(s)/Basis
`NCT657,8 NCT773,9 ’424
`publication
`
`See Mylan Dec. 6–7, 40.
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`II. DISCRETIONARY DENIAL UNDER 35 U.S.C. § 314(a)
`Under 35 U.S.C. § 314(a), institution of inter partes review is
`discretionary. See Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1367
`(Fed. Cir. 2016); see also 35 U.S.C. § 314(a). In Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential), the Board set
`forth six non-exclusive factors for determining “whether efficiency, fairness,
`and the merits support the exercise of authority to deny institution in view of
`an earlier trial date in the parallel proceeding.” Id. at 6. These factors are as
`follows:
`1. whether the court granted a stay or evidence exists that one
`may be granted if a proceeding is instituted;
`2. proximity of the court’s trial date to the Board’s projected
`statutory deadline for a final written decision;
`3. investment in the parallel proceeding by the court and the
`parties;
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`8 ClinicalTrials.gov, Clinical Trial No. NCT00696657, A Randomised
`Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to
`Placebo and Liraglutide, http://web.archive.org/web/20111020123620/https:
`//clinicaltrials.gov/ct2/show/NCT00696657 (Ex. 1013, “NCT657”).
`9 ClinicalTrials.gov, Clinical Trial No. NCT00851773, Safety, Tolerability,
`and Profile of Action of Drug in the Body of NN9536 in Healthy Male
`Japanese and Caucasian Subjects, https://web.archive.org/web/
`20090911011536/https://clinicaltrials.gov/ct2/show/NCT00851773
`(Ex. 1014, “NCT773”).
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`4. overlap between issues raised in the petition and in the
`parallel proceeding;
`5. whether the petitioner and the defendant in the parallel
`proceeding are the same party; and
`6. other circumstances that impact the Board’s exercise of
`discretion, including the merits.
`Id. at 5–6.
`In evaluating these factors, we take a holistic view of whether
`efficiency and integrity of the system are best served by denying or
`instituting review. Id. at 6. The Director has also issued interim guidance to
`the Board on applying the factors. See Katherine K. Vidal, Interim
`Procedure for Discretionary Denials in AIA Post-Grant Proceedings with
`Parallel District Court Litigation (June 21, 2022) 9, available at:
`https://www.uspto.gov/sites/default/files/documents/interim_proc_discretion
`ary_denials_aia_parallel_district_court_litigation_memo_20220621_.pdf
`(“Interim Procedure”).
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`Patent Owner raises several arguments in favor of our exercise of
`discretion to deny this Petition under 35 U.S.C. 314(a). See Prelim. Resp.
`7–24. Namely, Patent Owner asserts that Petitioner inappropriately delayed
`eighteen months to file this Petition after Petitioner was sued for infringing
`the ’462 patent, “watching from the sidelines” while “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.”
`Prelim. Resp. 1–2; see id. at 13–17 (further stating final invalidity
`contentions have been served and expert discovery is underway in the
`parallel district court proceeding). Patent Owner further states that
`“Petitioner’s choice to delay its own challenge before the Office—and its
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`attendant request for joinder, eliminating any final-written-decision
`deadline—significantly increases the risk of inconsistent outcomes in close
`proximity in two different jurisdictions.” Id. at 4 (emphases in original).
`
`In evaluating the Fintiv factors as set forth above, Patent Owner
`asserts that due to the advanced stage of the Delaware Litigation, it is
`unlikely to be stayed, the joined nature of this proceeding with the Mylan
`IPR renders the October 4, 2024 final written decision date a nullity, there is
`significant overlap between the issues raised in this Petition and those in the
`Delaware Litigation, and there are at least two defendants in the Delaware
`Litigation that are not subject to Petitioner’s Sotera stipulation here. Prelim.
`Resp. 7–23. Patent Owner concludes that the Petition does not present
`“compelling merits” especially in light of Patent Owner’s intent to swear
`behind some of the asserted prior art and its reliance on objective indicia of
`non-obviousness. Id. at 23–24.
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`Petitioner responds that Fintiv Factors 1, 2, and 5 are neutral because
`neither party has asked for a stay, the expected trial date in the Delaware
`Litigation and the Mylan IPR are “around the same time,” and Factor 5 plays
`no role because Petitioner here is a defendant in the Delaware Litigation.
`Reply 1–3. Petitioner asserts that the remaining Fintiv factors favor
`institution because claims 2, 6, and 8–10 involved in this proceeding are not
`at issue in the Delaware Litigation, Petitioner stipulates that if the Petition
`here is instituted it “will not pursue in the parallel district court proceeding
`the same grounds as in the Petition or any grounds that could have
`reasonably been raised therein,” and the Petition offers compelling evidence
`of unpatentability. Reply 2–3.
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`Patent Owner responds that Petitioner’s stipulation set forth in the
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`paragraph above is a “do-over” stipulation that does not qualify as a Sotera
`stipulation “because it was filed by Petitioner as a joining party and thus
`does not ensure avoidance of overlap between the IPR and litigation here.”
`Sur-Reply 2 (emphasis in original).
`
`Petitioner sought our authorization to file a stipulation to clarify that
`the stipulation in its Reply was intended to estop Petitioner to the same
`extent as Mylan as a result of the Mylan IPR. See Paper 16, 2. We granted
`Petitioner such authorization. See id. at 3; Ex. 1099 (Proposed Stipulation).
`We also authorized Petitioner to file the District Court Order in the
`Delaware Litigation moving the trial date to December 9, 2024. See Paper
`16, 3; Ex. 1098.
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`Director Vidal set forth in the Interim Procedure that “the PTAB will
`not discretionarily deny institution of an IPR or PGR in view of parallel
`district court litigation where a petitioner stipulates not to pursue in a
`parallel district court proceeding the same grounds as in the petition or any
`grounds that could have reasonably been raised in the petition.” Interim
`Procedure, 7, 9. This guidance does not condition or otherwise qualify the
`effect of a Sotera stipulation on our exercise of discretion to deny the
`Petition based on any remaining defendants in the parallel litigation that are
`not subject to the stipulation. Petitioner has filed such a stipulation. Reply 2
`(“Petitioners stipulate that, if instituted, they will not pursue in the parallel
`district court proceeding the same grounds as in the Petition or any grounds
`that could have reasonably been raised therein”). Therefore, we will not
`exercise our discretion to deny the Petition.
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`We also find that with the change of the district court trial date to over
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`two months after the current statutory due date for the Mylan IPR, the Mylan
`IPR should be completed before a trial in the district court begins. See
`Ex. 1098. This change in trial date, in addition to the lack of complete
`overlap in the claims asserted here and in the Delaware Litigation, provide
`further reason for us to refrain from exercising our discretion to deny the
`Petition under 35 U.S.C. § 314(a) regardless of remaining defendants in the
`Delaware Litigation that are not bound by any estoppel arising from the
`Mylan IPR.10
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`For the reasons set forth above, we decline to exercise our discretion
`to deny the Petition under 35 U.S.C. § 314(a).
`III. INSTITUTION OF INTER PARTES REVIEW
`The Petition in this proceeding asserts the same grounds of
`unpatentability as the ones on which we instituted review in the Mylan IPR.
`Compare Pet. 4, with Mylan Dec. 6–7, 40. Here, Petitioner states:
`This Petition is substantively identical to Mylan’s
`petition filed in IPR2023-00724, except for any
`Petitioners-specific information provided consistent with
`requirements related to mandatory notices. For example, this
`Petition asserts the same grounds of unpatentability of the ’462
`patent upon which the Patent Trial and Appeal Board already
`instituted review in the Mylan IPR. Accordingly, there exists a
`reasonable likelihood that Petitioner will prevail in
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`10 Patent Owner stipulates that if we deny institution here, “and to the extent
`any claims challenged here are not asserted in the Delaware Litigation, it
`will not seek to assert those claims in the Delaware Litigation against this
`Petitioner.” Prelim. Resp. 22 n.9. This stipulation leaves Patent Owner free
`to assert all these challenged claims against other defendants in the Delaware
`Litigation, which does not promote the public interest in resolving
`patentability issues for those claims.
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`demonstrating unpatentability of at least one of the Challenged
`Claims, and Petitioners respectfully seek to join the Mylan IPR.
`Pet. 1. Petitioner also states:
`
`In support of these grounds for unpatentability, Petitioners
`submit the Declarations of Drs. Bantle, Jusko, and Dalby and
`relies on the Exhibits identified in the concurrently filed Listing
`of Exhibits. Solely to preserve its right to rely on expert
`testimony in the event that . . . Mylan settles, Petitioner further
`relies on the accompanying Declarations of Dr. Randall M.
`Zusman (Ex. 1091), Dr. John P. Fruehauf (Ex. 1093), and Dr.
`Maureen D. Donovan (Ex. 1095), each of which adopts the
`opinions set forth by Drs. Bantle, Jusko, and Dalby,
`respectively, in connection with the Mylan IPR.
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`Pet. 4.
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`In Patent Owner’s Preliminary Response, Patent Owner addresses
`whether we should exercise our discretion under 35 U.S.C. 314(a) to deny
`the Petition and does not address the merits of the Petition at this stage of the
`proceeding. See generally Prelim. Resp.
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`For the same reasons set forth in our institution decision in the Mylan
`IPR, we determine that Petitioner has shown a reasonable likelihood that at
`least one claim is unpatentable. Mylan IPR, Paper 10, 17–29 (PTAB Oct. 4,
`2023). We therefore institute trial as to all challenged claims on all grounds
`stated in the Petition.
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`IV. MOTION FOR JOINDER
`Joinder for purposes of an inter partes review is governed by
`35 U.S.C. § 315(c), which states:
`If the Director institutes an inter partes review, the Director,
`in his or her discretion, may join as a party to that inter
`partes review any person who properly files a petition under
`section 311 that the Director, after receiving a preliminary
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`response under section 313 or the expiration of the time
`for filing such a response, determines warrants the institution
`of an inter parties review under section 314.
`As the moving party, Petitioner bears the burden of proving that it is
`entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder
`should: set forth the reasons joinder is appropriate; identify any new
`grounds of unpatentability asserted in the petition; and explain what impact
`(if any) joinder would have on the trial schedule for the existing review. See
`Kyocera Corp. v. Softview LLC, IPR2013-00004, Paper 15 at 4 (PTAB Apr.
`24, 2013).
`Petitioner timely filed the Motion no later than one month after
`institution of the Mylan IPR. See Mot. 2; 37 C.F.R. § 42.122(b). As noted,
`the Petition in this case asserts the same unpatentability grounds on which
`we instituted review in the Mylan IPR. See supra Section III; Mot. 3–4.
`Petitioner also relies on the same prior art analysis and substantially identical
`declarant testimony to that submitted by Mylan. See Mot. 3–4. Petitioner
`states:
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`While the instant Petition includes the declarations of
`Drs. Randall M. Zusman, John P. Fruehauf, and Maureen D.
`Donovan (“DRL Declarants”), these declarations present[]
`substantially identical expert testimony to that put forth by
`Drs. John Bantle, William J. Jusko, and Paul Dalby (“Myland
`Declarant(s)”) in the Mylan IPR. If Mylan allows [Petitioner]
`to use the Mylan Declarants, then [Petitioner] will withdraw the
`DRL Declarants, and rely only on the Mylan Declarants.
`Mot. 2, 4. If Mylan does not agree to allow Petitioner to retain the Mylan
`Declarants, Petitioner asserts it “would agree to withdraw the DRL
`Declarants if the Mylan Declarants have already been deposed based on their
`declarations in the Mylan IPR and the deposition transcripts have been made
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`of record,” and Petitioner would rely on those declarations and testimony of
`the Mylan Declarants. Mot. 5.
`The Petition is substantively identical to the petition filed by Mylan.
`See supra Section III; Mot. 2–4. Thus, this inter partes review does not
`present any ground or matter not already at issue in the Mylan IPR.
`If joinder is granted, Petitioner agrees to assume a “silent understudy”
`role in the Mylan IPR, and agrees that this role shall apply unless Mylan
`ceases to participate in the instituted IPR. Mot. 6. Petitioner also agrees that
`as a “silent understudy,” it will abide by the following conditions:
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`(a) all filings by [Petitioner] in the joined proceeding be
`consolidated with the filings of Mylan, unless a filing solely
`concerns issues that do not involve Mylan;
`(b) DRL shall not be permitted to raise any new grounds not
`instituted by the Board in the Mylan IPR, or introduce
`any argument not already introduced by Mylan; and
`(c) With regard to taking of testimony, DRL will abide by
`37 C.F.R. § 42.53 or any agreement between the Patent
`Owner and Mylan.
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`Mot. 7.
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`In lieu of filing an opposition to Petitioner’s Motion for Joinder,
`Patent Owner filed a Joint Stipulation Regarding Petitioners’ Motion for
`Joinder setting forth the parties’ agreement as to the conduct of the Mylan
`proceeding if Petitioner is joined as a party. See Paper 12.
`
`Based on our review of Petitioner’s Motion for Joinder and the
`parties’ stipulations as set forth in Paper 12, we determine that joinder with
`the Mylan IPR is appropriate under the circumstances. Accordingly, we
`grant Petitioner’s Motion for Joinder.
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`V. CONCLUSION
`For the foregoing reasons, we decline to exercise our discretion under
`35 U.S.C. § 314(a) to deny the Petition and determine that the information
`presented in the Petition shows that there is a reasonable likelihood that
`Petitioner would prevail in challenging at least one claim of the ’462 patent.
`At this stage in the proceeding, we have not made a final determination with
`respect to patentability of the challenged claims.
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`VI. ORDER
`For the foregoing reasons, it is:
`ORDERED that pursuant to 35 U.S.C. § 314(a), an inter partes
`review of claims 1–10 of the ’462 patent is hereby instituted on the grounds
`set forth in the Petition;
`FURTHER ORDERED that the Motion for Joinder with
`IPR2023-00724 is granted;
`FURTHER ORDERED that Petitioner is joined as a party in
`IPR2023-00724, pursuant to 37 C.F.R. § 42.122, wherein Petitioner will
`maintain a secondary role in the proceeding, unless and until the current
`IPR2023-00724 petitioners cease to participate as a petitioner in the inter
`partes review;
`FURTHER ORDERED that all future filings in the joined proceeding
`are to be made only in IPR2023-00724;
`FURTHER ORDERED that the case caption in IPR2023-00724 shall
`be changed to reflect the joinder in accordance with the below example; and
`FURTHER ORDERED that a copy of this Decision shall be entered
`into the record of IPR2023-00724.
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`For PETITIONER:
`Jovial Wong
`Scott Border
`WINSTON & STRAWN LLC
`jwong@winston.com
`sborder@winston.com
`
`PATENT OWNER:
`
`Jon Baughman
`Megan Raymond
`GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
`steve.baughman@groombridgewu.com
`megan.raymond@groombridgewu.com
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`MYLAN PHARMACEUTICALS INC., DR. REDDY’S
`LABORATORIES, INC., and DR. REDDY’S LABORATORIES, LTD.,
`Petitioner,
`v.
`NOVO NORDISK A/S,
`Patent Owner.
`____________
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`IPR2023-0072411
`Patent 10,335,462 B2
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`11 IPR2024-00009 (Dr. Reddy’s Laboratories) has been joined with this
`proceeding.
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