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
`______________________
`
`PATENT OWNER’S FURTHER AUTHORIZED REPLY*
`
`
`
`
`
`*Authorized by Pap.16 (Mar. 29, 2024). Emphases herein are added, and abbrevia-
`
`tions/references are as in Paps.13 and 15.
`
`
`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
`______________________
`
`PATENT OWNER’S FURTHER AUTHORIZED REPLY*
`
`
`
`
`
`*Authorized by Pap.16 (Mar. 29, 2024). Emphases herein are added, and abbrevia-
`
`tions/references are as in Paps.13 and 15.
`
`
`
`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 Regard-
`ing 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) Pa-
`tent 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
`
`
`
`Exhibit
`EX2014
`
`EX2015
`
`EX2016
`
`EX2017
`EX2018
`
`EX2019
`
`EX2020
`
`EX2021
`
`EX2022
`
`EX2023
`
`EX2024
`
`EX2025
`
`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) Pa-
`tent Litigation, No. 22-MD-03038-CFC (D. Del. Dec. 21,
`2022)
`Transfer Order, In re: Ozempic (Semaglutide) Patent Litiga-
`tion, 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 (Semag-
`lutide) 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 Conten-
`tions, 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).
`Excerpt of Opening Expert Report of Dr. John Bantle Regard-
`ing Invalidity of U.S. Patent No. 10,335,462, In re: Ozempic
`(Semaglutide) Patent Litigation, No. 22-MD-03038-CFC (D.
`Del.)
`Excerpt of Opening Expert Report of William J. Jusko, Ph.D.
`Regarding Invalidity of U.S. Patent No. 10,335,462, In re:
`
`ii
`
`
`
`Exhibit
`
`EX2026
`
`
`
`
`IPR2024-00009
`U.S. Patent 10,335,462
`
`Description
`Ozempic (Semaglutide) Patent Litigation, No. 22-MD-03038-
`CFC (D. Del.)
`Excerpt of Opening Expert Report of Dr. Paul Dalby Regard-
`ing Invalidity of U.S. Patent No. 10,335,462, In re: Ozempic
`(Semaglutide) Patent Litigation, No. 22-MD-03038-CFC (D.
`Del.)
`
`
`
`iii
`
`
`
`IPR2024-00009
`U.S. Patent 10,335,462
`Petitioner, effectively conceding its two prior stipulations failed to counter
`
`PO’s Fintiv showing, proffers yet another “do-over”—its third incremental bite at
`
`the apple, attempting to find the least estoppel it might get away with. Petitioner has
`
`now experimented with three different, serial stipulations at PO’s and the Board’s
`
`expense, using PO’s arguments as a roadmap to determine the scope of incremental
`
`replacement stipulations, and wasting time and resources on briefing stipulations
`
`that were twice replaced. See Pap.2, 64; Pap.13, 17-23. Only after all extra briefing
`
`was finished and PO’s Sur-Reply confirmed this “‘do-over’ stipulation… ha[d] the
`
`same inadequate impact as [the] original” (Pap.15, 2-3) did Petitioner propose its
`
`third stipulation with what the Board’s recent Order notes was new wording: “addi-
`
`tional language… agreeing [Petitioner] is estopped to the same extent as the Peti-
`
`tioner in the original case [(Mylan)] to which it seeks joinder…” Pap.16, 2.
`
`Petitioner’s ever-changing positions significantly prejudice PO, and the Peti-
`
`tion should be denied under §314(a). First, PO determined what substance to in-
`
`clude in its POPR and to oppose only institution (rather than institution and joinder)
`
`in light of Petitioner’s stated reliance on only Sand Revolution—allocating resources
`
`to Fintiv rather than, e.g., additional substantive arguments based on Mylan’s ex-
`
`perts’ deposition concessions, or seeking discovery of Petitioner’s relationship with
`
`Mylan and the remaining litigation defendants. The full scope of that undisclosed
`
`relationship and resulting prejudice is only now becoming clearer: Petitioner used
`
`1
`
`
`
`IPR2024-00009
`U.S. Patent 10,335,462
`three IPR experts different from Mylan’s, suggesting it had no choice (e.g., Pap.3,
`
`2, 5 (“in the event that Mylan does not agree to allow DRL to retain [them]”)), but
`
`Petitioner actually shares those same experts (and their declarations and presum-
`
`ably their cost) in litigation with both Mylan (in violation of the stipulation Mylan
`
`promised in its Petition, but never provided in litigation) and other parties who
`
`have not agreed to any estoppel. See EX2024, 10; EX2025, 9; EX2026, 6. Cf.
`
`Pap.16, 2 (“Petitioner also stated that it would not present any invalidity arguments
`
`in [litigation] based on…§§102 or 103”); Guidance, 7-8 (Sotera policy enables
`
`Board “to review grounds that… district court litigation will not resolve” and
`
`“avoid[] inconsistent outcomes”). Second, far from sparing PO “any additional bur-
`
`den” (Pap.3, 8), Petitioner has already compelled extended, wasted briefing: first of
`
`its inadequate Sand Revolution stipulation (Pap.13, 17-23); next, of its inadequate
`
`“joiner” stipulation (Pap.15, 1-3); and now of its newest change in position. Peti-
`
`tioner’s serial gambit to try out lesser levels of estoppel constitutes harassing, bur-
`
`densome, prejudicial gamesmanship meriting §314(a) denial (see, e.g. Consolidated
`
`Trial Practice Guide, 2 (aiming to “streamlin[e] and converg[e]… issues for deci-
`
`sion [and] conduct proceedings in a timely, fair, and efficient manner”), 55-58),
`
`which should be granted for the reasons briefed here and earlier. Cf. General Plastic
`
`Indus. Co., Ltd. v. Canon Kabushiki Kaisha, IPR2016-01357, Pap. 19 (Sept. 6, 2017)
`
`(§II.B.4.i precedential) (considering, inter alia, harassment, “potential for abuse,”
`
`2
`
`
`
`IPR2024-00009
`U.S. Patent 10,335,462
`“roadmap[ping],” “fundamental fairness,” “efficiency,” and “prejudice” in analyz-
`
`ing discretionary denial). And, while Petitioner’s first stipulation tracked Mylan’s
`
`in the IPR it seeks to join, Petitioner’s two subsequent stipulations have not. Thus,
`
`Petitioner has also disregarded its promise that, for joinder, “no additional briefing
`
`or discovery would be required, and no additional burdens would be placed on any
`
`party or the PTAB….” Pap.3, 5, 8, 3 (“will promote judicial efficiency… without
`
`prejudice to [PO]”).
`
`Further, the Fintiv guidance does not require that a Sotera stipulation be con-
`
`sidered regardless of when it is filed. Indeed, including for the reasons above, the
`
`new, prejudicial, stipulation should not be considered. Petitioner has identified no
`
`case in which a third stipulation filed after the sur-reply to the POPR was relied on
`
`to skirt Fintiv. And doing so here would encourage gamesmanship and ever-chang-
`
`ing positions until institution from petitioners seeking advantage (and more unnec-
`
`essary briefing). Institution should be denied based on Fintiv—including because of
`
`Petitioner’s chosen relationship with other litigation defendants (and despite the De-
`
`cember 2024 trial date; see Pap.15, 1; Amerigen Pharms. Ltd. v. Janssen Oncology,
`
`Inc., IPR2016-00286, Pap.86 (Jan. 17, 2018) (FWD 19 months after institution
`
`(Pap.14)); West-Ward Pharms. Int’l Ltd. v. Novartis Pharms. Corp., IPR2017-
`
`01592, Pap.78, 2-3 (Dec. 31, 2018) (extending FWD by 6 months due to joinder)).
`
`Respectfully submitted: /Megan Raymond/
`
`
`
`
`
`April 3, 2024
`
`3
`
`
`
`IPR2024-00009
`U.S. Patent 10,335,462
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of NOVO NORDISK’S FUR-
`THER AUTHORIZED REPLY AND EXHIBITS 2024-2026 have been served in
`their entirety on April 3, 2024, by causing the aforementioned documents to be
`electronically mailed to the following attorneys of record for the Petitioner listed
`below.
`Petitioner’s Counsel of Record:
`
`Lead Counsel:
`
`Jovial Wong
`Reg. No. 60,115
`Winston & Strawn LLP
`1901 L Street NW
`Washington, DC 20036
`Telephone: (202) 282-5867
`jwong@winston.com
`
`By Electronic Mail
`Backup Counsel: Scott Border
`Reg. No. 77,744
`Winston & Strawn LLP
`1901 L Street NW
`Washington, DC 20036
`Telephone: (202) 285-5054
`sborder@winston.com
`
`Sharon Lin McIntosh
`(pro hac vice to be submitted)
`Winston & Strawn LLP
`1901 L Street NW
`Washington, DC 20036
`Telephone: (202) 285-5756
`slin@winston.com
`
`By Electronic Mail
`
`4
`
`
`
`IPR2024-00009
`U.S. Patent 10,335,462
`
`
`
`
`
`Dated: April 3, 2024
`
`
`
`
`
` Respectfully submitted,
`
`By: /Sayem Osman/
`Sayem Osman
`
`5
`
`
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