Case 1:22-cv-01233-GBW Document 284 Filed 07/07/25 Page 1 of 6 PagelD #: 8922
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`NEXUS PHARMACEUTICALS, INC.,
`Plaintiff,
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`V. Civil Action No. 22-1233-GBW
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`EXELA PHARMA SCIENCES, LLC,
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`Defendant.
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`Kelly E. Farnan, Christine D. Haynes, RICHARDS, LAYTON & FINGER, P.A., Wilmington,
`DE; Imron T. Aly, Kevin Nelson, Matthew T. Wilkerson, Julie A. Vernon, ARENTFOX SCHIFF
`LLP, Chicago, II.; Ahmed M.T. Riaz, Max Heckendorn, ARENTFOX SCHIFF LLP, New York,
`NY.
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`Counsel for Plaintiff
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`Robert M. Oakes, Douglas E. McCann, Gregory R. Booker, FISH & RICHARDSON P.C.,
`Wilmington, DE; Deanna J. Reichel, Sarah E. Jack, Madison Murhammer Colon, FISH &
`RICHARDSON P.C., Minneapolis, MN; Corrin N. Drakulich, Christina D. Brown-Marshall,
`Dexter S. Whitley, Charles N. Reese, FISH & RICHARDSON P.C., Atlanta, GA; Caroline G.
`Koonce, FISH & RICHARDSON P.C., Washington, DC; Satish Chintapalli, CHINTAPALLI
`LAW FIRM PLLC, Cary, NC.
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`Counsel for Defendant
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`MEMORANDUM OPINION
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`July 7, 2025
`Wilmington, Delaware
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`[ P e
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`GREGORY B. WILLIAMS
`UNITED STATES DISTRICT JUDGE
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`Case 1:22-cv-01233-GBW Document 284 Filed 07/07/25 P/a’@}? 2 of 6 PiageID #: 8923
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`The following motions and requests from the parties! are pending before the Court and are
`the subject of this Memorandum Opinion:
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`1. Exela’s Motion for Summary Judgment #1: The Asserted Claims Are Invalid for Lacking
`Written Description Support (“Exela’s First Motion for Summary Judgment”) (D.I. 196),
`which has been fully briefed (D.I. 201; D.1. 237; D.1. 252);
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`2. Exela’s Motion for Summary Judgment #2: Non-Infringement of the Asserted Claims of
`the *369 Patent (“Exela’s Second Motion for Summary Judgment”) (D.1. 197), which has
`been fully briefed (D.1. 201; D.1. 237; D.I. 252);
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`3. Exela’s Motion for Summary Judgment #3: No Lost Profits and No Price Erosion Damages
`(“Exela’s Third Motion for Summary Judgment”) (D.I. 198) (together with the Exela’s
`First and Second Motions for Summary Judgment, “Exela’s Motions for Summary
`Judgment”), which has been fully briefed (D.I. 201; D.I. 237; D.1. 252),;
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`4. Exela’s Request for Oral Argument (D.I. 262), which includes, but is not limited to,
`requests for oral argument on Exela’s Motions for Summary Judgment; and
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`5. Exela’s request, in letter format, for the Court to set a case narrowing schedule (D.I. 277)
`(“Exela’s Request for Case Narrowing”), to which Nexus has responded (D.1. 278).
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`For the following reasons, the Court denies Exela’s Motions for Summary Judgment (D.1.
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`196, D.1. 197, and D.I. 198), denies-as-moot Exela’s Request for Oral Argument as it pertains to
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`! The Plaintiff is Nexus Pharmaceuticals, Inc, (“Nexus” or “Plaintiff*), The Defendant is Exela
`Pharma Sciences, LLC (“Exela” or “Defendant”).
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`Case 1:22-cv-01233-GBW Document 284 Filed 07/07/25 Page 3 of 6 PagelD #: 8924
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`Exela’s Motions for Summary Judgment (D.I. 262), and denies Exela’s Request for Case
`Narrowing (D.I. 277).
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`L LEGAL STANDARD
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`“The court shall grant summary judgment if the movant shows that there is no genuine
`dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R.
`Civ. P. 56(a). “A genuine issue of material fact is one that could lead a reasonable jury to find in
`favor of the nonmoving party.” Bletz v. Corrie, 974 F.3d 306, 308 (3d Cir. 2020). “The court
`must review the record as a whole, draw all reasonable inferences in favor of the nonmoving party,
`and must not ‘weigh the evidence or make credibility determinations.” Id. at 308 (quoting Parkell
`v. Danberg, 833 F.3d 313, 323 (3d Cir. 2016)).
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`1I. DISCUSSION
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`The Court divides its Discussion into the following Sections: (A) The Court Denies Exela’s
`First Motion for Summary Judgment; (B) The Court Denies Exela’s Second and Third Motions
`for Summary Judgment; and (C) The Court Denies Exela’s Request for Case Narrowing.
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`A. The Court Denies Exela’s First Motion for Summary Judgment
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`The asserted claims recite a chemical formulation, with certain stability characteristics, in
`glass and plastic containers. See D.I. 201 at 1. The asserted patents have a shared specification,
`which discloses testing results that corroborate the recited stability characteristics in glass, but not
`plastic, containers. See D.I. 201 at 5-8. Nexus’ expert opines, in a context other than written
`description, that the only way to confirm whether the formulation’s stability is affected by the
`container is to perform a stability study in that container. See D.I, 201 at 2. Since the shared
`specification does not disclose any stability studies in plastic containers, Exela challenges whether
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`a person of ordinary skill in the art would understand that the inventor had possession of the full
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`Case 1:22-cv-01233-GBW Document 284 Filed 07/07/25 Page 4 of 6 PagelD #: 8925
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`scope of the asserted claims. See D.I. 201 at 1. In other words, Exela contends that the shared
`specification of the asserted patents lacks written description, See D.I. 201 at 1.
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`Conversely, Nexus flags that Exela’s experts opine that “the claimed stability features are
`the inherent result of the formulation alone.” See D.I. 237 at 20. While Nexus disputes this point,
`Nexus nonetheless contends that it constitutes a “disputed question of fact” that precludes
`summary judgment. D.I. 237 at 20.
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`Here, if the claimed stability features are an inherent result of the formulation alone,
`Nexus’s testing of the formulation in glass containers would appear to reasonably extend to the
`same formulation in plastic containers, tending to support adequate written description. Since the
`parties genuinely dispute whether the claimed stability features are an inherent result of the
`formulation alone and, since that factual dispute is material to the written description question
`before the Court, the Court denies Exela’s First Motion for Summary Judgment.? See Fed. R. Civ.
`P. 56(a) (“The court shall grant summary judgment if the movant shows that there is no genuine
`dispute as to any material fact and the movant is entitled to judgment as a matter of law.”).
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`B. The Court Denies Exela’s Second and Third Motions for Summary Judgment
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`Since the Court denies Exela’s First Motion for Summary Judgment, the Court denies
`Exela’s Second and Third Motions for Summary Judgment pursuant to the Court’s summary
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`judgment ranking procedures.® Since the Court denies each of Exela’s Motions for Summary
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`2 The Court does not consider the remaining arguments advanced by the parties.
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`3 Exela’s First Motion for Summary Judgment is actually two motions for summary judgment and,
`thus, the Court only considers the first issue presented in Exela’s First Motion for Summary
`Judgment and denies the second issue pursuant to the Court’s summary judgment ranking
`procedures.
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`Judgment, the Court denies-as-moot Exela’s request for oral argument (D.]. 262) on each of these
`motions.
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`C. The Court Denies Exela’s Request for Case Narrowing Without Prejudice
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`Exela complains that Nexus “has not made any meaningful attempts to narrow its number
`of asserted claims” and “requests that the Court set a case narrowing schedule in advance of trial.”
`D.I. 277 at 1. “Nexus is not opposed to claim narrowing but opposes the timing of claim narrowing
`before a summary judgment ruling” since, according to Nexus, “Exela’s pending summary
`judgment motions could affect none, some, or all of Nexus’s claims in ways that Nexus cannot
`predict, so it would not be fair or prudent to narrow them” before a summary judgment ruling, D.I.
`278 at 1. Nexus further contends that “Exela is not prejudiced by narrowing its obviousness
`defenses at this stage because they are not the subject of any summary judgment motion.” D.L
`278 at 2.
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`Since the Court, with this Memorandum Opinion, is ruling on Exela’s Motions for
`Summary Judgment, Nexus® concern (about the potential of the Court ordering claim narrowing
`before ruling on Exela’s motions for summary judgment) is moot. Since this concern appears to
`be the primary obstacle in the parties’ attempt to reach agreement on how to narrow the claims and
`defenses in this action, the Court denies Exela’s Request for Case Narrowing without prejudice.
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`In thé Order that accompanies this Memorandum Opinion, the Court will instruct the
`parties to me>et and confer by no later than July 14, 2025, and attempt to reach an agreement on
`how and when to narrow the claims and defenses in this action. The Court reminds the parties that
`the five (5) day jury trial will be timed and each party will have an allocated amount of time to
`present their respective cases. As such, the Court strongly encourages the parties to reach
`agreement on narrowing the claims and defenses in this action given that the Court has now ruled
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`on Exela’s motions for summary judgment.
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`III. CONCLUSION
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`For the foregoing reasons, the Court denies the following: Exela’s Motion for Summary
`Judgment #1: The Asserted Claims Are Invalid for Lacking Written Description Support (D.L
`196); Exela’s Motion for Summary Judgment #2: Non-Infringement of the Asserted Claims of the
`’369 Patent (D.I. 197); and Exela’s Motion for Summary Judgment #3: No Lost Profits and No
`Price Erosion Damages (D.I. 198). The Court also denies-as-moot Exela’s Request for Oral
`Argument (D.I. 262) as it pertains to Exela’s Motions for Summary Judgment. In addition, the
`Court denies Exela’s request for the Court to set a case narrowing schedule (D.I. 277) without
`prejudice.
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`In the accompanying Order, the Court is instructing the parties to meet and confer by no
`later than July 14, 2025, and attempt to reach agreement on how and when to narrow the claims
`and defenses in this action. The Court strongly encourages the parties to reach agreement on
`narrowing the claims and defenses in this action and to actually complete the narrowing of the
`claims and defenses in this action by no later than thirty (30) days prior to the pretrial conference.
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`The Court intends to rule on the remaining motions pending before the Court before the
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`pretrial conference, which is scheduled for August 20, 2025, at 3:00 pm.
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