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 SUR-REPLY
`
`
`
`
`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 SUR-REPLY
`
`
`
`
`
`IPR2024-00009
`U.S. Patent 10,335,462
`Petitioner’s “Reply” is largely unresponsive to Patent Owner’s (“PO”) Fintiv
`
`analysis in its POPR, and fails to show Fintiv does not support denial—including
`
`because Petitioner’s stipulation is not a Sotera stipulation as addressed in the Di-
`
`rector’s Fintiv guidance. Fintiv denial is proper and should result here.
`
`Factor 1. Petitioner does not dispute that it is highly unlikely the Delaware
`
`Litigation will be stayed. Indeed, Petitioner does not even argue it will seek a stay,
`
`and does not dispute that the Court would disfavor staying the Delaware Litigation.
`
`This factor is not neutral: rather, it favors denial. POPR, 7-9.
`
`Factor 2. Petitioner does not dispute that the Delaware trial is scheduled to
`
`precede Mylan’s current FWD deadline. Instead, Petitioner speculates trial might
`
`move “a little bit” before chastising PO for speculating about “delay” in receiving
`
`a FWD. But even setting aside the Board’s obligation to “take courts’ trial sched-
`
`ules at face value absent some strong evidence to the contrary” (Samsung v. An-
`
`cora, IPR2020-01184, Pap.11, 21), Petitioner ignores that—even per Petitioner—
`
`the “delay[ed]” trial date and original FWD would be close in time, and that after
`
`joinder the FWD would have no statutory deadline. Fintiv, IPR2020-00019,
`
`Pap.11, 9; §316(a)(11); §42.100(c). Petitioner also does not address Petitioner’s
`
`cited Memory Integrity joinder decision, resulting in a FWD more than 13 months
`
`after institution. Compare IPR2015-00163, Pap.18 (May 8, 2015), with IPR2015-
`
`00163, Pap.52 (June 21, 2016). This, again, favors denial. See also POPR, 9-13.
`
`1
`
`
`
`IPR2024-00009
`U.S. Patent 10,335,462
`Factor 3. Petitioner does not dispute that the parties have already invested
`
`significantly in the Delaware Litigation, which weighs heavily in favor of denial.
`
`See POPR, 13-17. Petitioner instead asserts this favors institution because certain
`
`challenged claims are not asserted in the litigation. But Petitioner ignores PO’s
`
`stipulation about assertion of non-overlapping claims in litigation, and that, accord-
`
`ingly, there is no such issue here. POPR, 22 n.9. Further, Petitioner’s citation of
`
`Samsung Bioepis Co. v. Regeneron Pharmaceuticals, Inc., IPR2023-00739, Pap.9,
`
`57 (Oct. 20, 2023) is inapposite. Unlike here, that IPR involved little overlap in
`
`claims (only two of twelve challenged claims were asserted in the litigation), and a
`
`non-overlapping independent claim. Moreover, Petitioner’s assertion here that
`
`claims 2 and 6 are not at issue in the Delaware Litigation is simply incorrect under
`
`Samsung given that claims 3 and 7 (which depend from 2 and 6) are asserted.
`
`Factor 4. Petitioner’s February 21, 2024 “do-over” stipulation is not a So-
`
`tera stipulation as addressed in the Director’s Fintiv guidance because it was filed
`
`by Petitioner as a joining party and thus does not ensure avoidance of overlap be-
`
`tween the IPR and litigation here. See USPTO Interim Procedure for Discretion-
`
`ary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation
`
`at 7-8 (USPTO, June 21, 2022). Indeed, if instituted and joined, Petitioner can be
`
`expected to argue “could have reasonably been raised” in its new stipulation is a
`
`nullity based on Network-1 Technologies, Inc. v. Hewlett-Packard Co., 981 F.3d
`
`2
`
`
`
`IPR2024-00009
`U.S. Patent 10,335,462
`1015, 1026-28 (2020)—meaning (1) Petitioner is not estopped the way an original
`
`petitioner would be estopped by a Sotera stipulation because Petitioner (unlike an
`
`original petitioner) can raise any argument in litigation that was not actually raised
`
`in the original IPR, and (2) Petitioner’s new stipulation has the same inadequate
`
`impact as Petitioner’s original Sand Revolution stipulation (Pet.65). And the pres-
`
`ence of other litigation defendants who are not subject to any stipulation belies any
`
`promise that the grounds in the PTAB will differ from those in the litigation.
`
`Factor 5. Petitioner argues Factor 5 “should only play a role where a Peti-
`
`tioner is unrelated to a defendant in a district court proceeding” in asserting this
`
`factor should be neutral. Pet’r’s Rep., 2-3. But that is not what Fintiv says.
`
`IPR2020-00019, Pap.11, 14. Indeed, the Board’s Fintiv institution decision found
`
`that, “[b]ecause the petitioner and the defendant in the parallel proceeding are the
`
`same party, this factor weighs in favor of discretionary denial.” Fintiv, IPR2020-
`
`0019, Pap.15, 15 (May 13, 2020). Here, too, Factor 5 weighs in favor of denial.
`
`Factor 6. Finally, Petitioner cannot overcome the other Fintiv factors and
`
`show “compelling merits” simply by arguing Mylan’s petition met the basic
`
`threshold for institution. See POPR, 23-24. Moreover, Petitioner simply ignores
`
`PO’s stated intent to swear behind prior art and argue objective indicia, and fails to
`
`address Petitioner’s unexplained delay in filing an IPR. See POPR, 23-24.
`
`Respectfully submitted: /Mega Raymond/
`Megan Raymond
`
`
`
`
`
`March 6, 2024
`
`
`
`3
`
`
`
`IPR2024-00009
`U.S. Patent 10,335,462
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of NOVO NORDISK’S SUR-
`
`REPLY have been served in their entirety on March 6, 2024, by causing the afore-
`
`mentioned documents to be electronically mailed to the following attorneys of rec-
`
`ord for the Petitioner listed below.
`
`Petitioner’s Counsel of Record:
`
`Lead Counsel:
`
`Brian Sodikoff
`KATTEN MUNCHIN ROSENMAN LLP
`525 West Monroe Street
`Chicago, IL 60661
`P: (312) 902-5200
`brian.sodikoff@katten.com
`
`By Electronic Mail
`Backup Counsel: Christopher West
`KATTEN MUNCHIN ROSENMAN LLP
`550 South Tryon Street
`Suite 2900
`Charlotte, NC 28202
`P: (704) 444-2000
`christopher.west@katten.com
`
`Christopher B. Ferenc
`KATTEN MUNCHIN ROSENMAN LLP
`1919 Pennsylvania Ave., N.W.
`Suite 800
`Washington, DC 20006
`P: (202) 625-3500
`christopher.ferenc@katten.com
`
`By Electronic Mail
`
`
`
`4
`
`
`
`Dated: March 6, 2024
`
`
`
`
`
`IPR2024-00009
`U.S. Patent 10,335,462
` Respectfully submitted,
`
`By: /Sayem Osman/
`Sayem Osman
`
`5
`
`
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