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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`NEURELIS, INC.,
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`Plaintiff,
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`v.
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`PADAGIS LLC, PADAGIS US LLC, AND
`PADAGIS ISRAEL PHARMACEUTICALS LTD.,
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`Defendants.
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`C.A. No. 24-562 (MN)
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`(LEAD CASE)
`NEURELIS, INC.,
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`Plaintiff,
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`v.
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`PADAGIS LLC, PADAGIS US LLC, AND
`PADAGIS ISRAEL PHARMACEUTICALS LTD.,
`LUPIN INC., LUPIN LTD., AND LUPIN
`PHARMACEUTICALS, INC.,
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`Defendants.
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`C.A. No. 25-821 (MN)
`NEURELIS, INC.,
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`Plaintiff,
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`v.
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`PADAGIS LLC, PADAGIS US LLC, AND
`PADAGIS ISRAEL PHARMACEUTICALS LTD.,
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`Defendants.
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`C.A. No. 25-1228 (MN)
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`DEFENDANTS’ PADAGIS LLC, PADAGIS US LLC, AND PADAGIS ISRAEL
`PHARMACEUTICALS LTD. STIPULATION REGARDING CLAIM CONSTRUCTION
`Case 1:24-cv-00562-MN Document 124 Filed 03/30/26 Page 1 of 5 PageID #: 3153
`Padagis US LLC, EX1083
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` Defendants Padagis LLC, Padagis US LLC, and Padagis Israel Pharmaceuticals Ltd.
`(collectively, “Padagis”) submit the following stipulation to remove certain claim construction
`positions related to U.S. Patent Nos. 8,895,546 (“the ’546 patent”), 11,241,414 (“the ’414 patent”),
`and 11,793,786 (“the ’786 patent”) (collectively, “the Asserted Patents”).1
` WHEREAS, on May 8, 2024, Plaintiff Neurelis, Inc. (“Neurelis”) filed a complaint
`alleging that Padagis’s Abbreviated New Drug Application for diazepam nasal spray (10
`mg/spray) infringes the Asserted Patents. See C.A. No. 24-562 at D.I. 1.
` WHEREAS, on January 17, 2025, Padagis filed petitions requesting inter partes review of
`the Asserted Patents with the Patent Trial and Appeal Board. See IPR2025-00464 at Paper 2;
`IPR2025-00465 at Paper 2; IPR2025-00466 at Paper 2.
` WHEREAS, on August 15, 2025, the parties filed a joint claim construction brief in this
`Court disputing the meaning of the following claim term from all Asserted Patents:
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`See C.A. No. 24-562, D.I. 83 at 20.
` WHEREAS, on September 8, 2025, the Court issued an order staying the case and
`canceling the claim construction hearing so that the parties could negotiate and submit an amended
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`1 Padagis submits this stipulation on its own behalf only and not on the behalf of any other parties
`in these or any related proceedings.
`Case 1:24-cv-00562-MN Document 124 Filed 03/30/26 Page 2 of 5 PageID #: 3154
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`scheduling order to consolidate and coordinate additional related cases filed by Neurelis. See C.A.
`No. 24-562 at D.I. 85.
` WHEREAS, on September 17, 2025, the PTAB granted institution of Padagis’s petitions
`for inter partes review of the Asserted Patents. See IPR2025-00464 at Paper 13; IPR2025-00465
`at Paper 13; IPR2025-00466 at Paper 13. In its institution decisions, the PTAB noted that Padagis
`“suggests the transitional phrase ‘consisting of’ means the claimed pharmaceutical solutions
`include only those components recited in the claims . . . [s]uch interpretation tracks the
`conventional meaning of the ‘consisting of’ transitional phrase in claim drafting.” See IPR2025-
`00464 at Paper 13 at 7, n. 5; IPR2025-00465 at Paper 13 at 9, n. 7; IPR2025-00466 at Paper 13 at
`10, n. 9.
` WHEREAS, after Padagis’s petitions for inter partes review were instituted, the Director
`of the United States Patent and Trademark Office issued several precedential and informative
`decisions explaining that Petitioners in inter partes review proceedings should generally propose
`the same constructions of claim terms in both the IPR petitions and any parallel district court
`proceedings, or otherwise explain why it has proposed different claim constructions in the parallel
`proceedings.
` WHEREAS, in view of the USPTO Director’s recent guidance, Padagis wishes to remove
`any doubt as to the consistency of its claim construction positions, and Padagis also wishes to
`streamline the disputed issues in this proceeding;
` WHEREAS, on November 13, 2025, the Court issued a Scheduling Order consolidating
`C.A. No. 24-562; C.A. No. 25-821; C.A. No. 25-1228; and C.A. No. 25-1443.2
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`2 The now consolidated cases involve three additional patents that Neurelis has asserted against
`Padagis (U.S. Patent Nos. 12,268,664; 12,324,852; and 12,337,061) and an additional defendant
`unrelated to Padagis: Lupin Inc., Lupin Pharmaceuticals, Inc., and Lupin Limited (collectively,
`“Lupin”).
`Case 1:24-cv-00562-MN Document 124 Filed 03/30/26 Page 3 of 5 PageID #: 3155
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` WHEREAS, the Court’s consolidated Scheduling Order preserves the prior claim
`construction briefing and dispute filed by Padagis and Neurelis. See C.A. No. 24-562, D.I. 111 at
`10 (“On July 22, 2026 at 10:00 a.m., the Court will hear argument on claim construction (including
`matters raised in briefing submitted in C.A. 1:24-cv-00562 (D.I. 83)”).
` WHEREAS, the parties have not yet begun the claim construction process in the
`consolidated cases.
` NOW THEREFORE, Padagis hereby stipulates and agrees as follows:
`1. Padagis withdraws the claim construction positions it raised in the parties’ joint
`claim construction brief with respect to the Asserted Patents, including both the proposed
`construction and indefiniteness position and the supporting Declaration of Maureen Donovan,
`Ph.D. See C.A. No. 24-562 at D.I. 83 and 84 (Exhibit 30).
`2. Padagis agrees to adopt Neurelis’s proposed construction with respect to the
`disputed claim term (i.e., “no construction necessary; the scope of ‘consisting of’ is established by
`law”), which is consistent with the construction proposed by Padagis in its petitions for inter partes
`review of the Asserted Patents. See C.A. No. 24-562, D.I. 83 at 20; see also IPR2025-00464 at
`Paper 13 at 7, n. 5; IPR2025-00465 at Paper 13 at 9, n. 7; IPR2025-00466 at Paper 13 at 10, n. 9.
`3. Nothing in this stipulation affects Padagis’s right to propose constructions of claim
`terms from U.S. Patent Nos. 12,268,664; 12,324,852; 12,337,061; or any other patent that Neurelis
`later asserts against Padagis.
` OF COUNSEL:
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`Mark T. Deming
`POLSINELLI PC
`150 N. Riverside Plaza, Suite 3000
`Chicago, IL 60606
`(312) 819-1900
`mdeming@polsinelli.com
`POLSINELLI PC
`/s/ Stephen J. Kraftschik
`Stephen J. Kraftschik (#5623)
`222 Delaware Avenue, Suite 1101
`Wilmington, DE 19801
`(302) 252-0920
`skraftschik@polsinelli.com
`Case 1:24-cv-00562-MN Document 124 Filed 03/30/26 Page 4 of 5 PageID #: 3156
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`Dominique E. Smith
`POLSINELLI LLP
`2049 Century Park East, Suite 2900
`Los Angeles, CA 90067
`(310) 229-1390
`dominique.smith@polsinelli.com
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`Chad A. Landmon
`Christopher D. Jones
`POLSINELLI LLP
`1401 Eye Street, N.W., Suite 800
`Washington, D.C. 20005
`clandmon@polsinelli.com
`chris.jones@polsinelli.com
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`Corey M. Casey
`POLSINELLI LLP
`900 W. 48th Place, Suite 900
`Kansas City, MO 64112
`ccasey@polsinelli.com
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`Dated: March 30, 2026
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`Attorneys for Defendants Padagis LLC,
`Padagis US LLC and Padagis Israel
`Pharmaceuticals Ltd.
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`Case 1:24-cv-00562-MN Document 124 Filed 03/30/26 Page 5 of 5 PageID #: 3157
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