Nexus Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC

District Court, D. Delaware·Decided July 11, 2025·No. 1:22-cv-01233·Unknown

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE NEXUS PHARMACEUTICALS, INC., Plaintiff, Vv. Civil Action No. 22-1233-GBW EXELA PHARMA SCIENCES, LLC, Defendant.

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, IL; Ahmed M.T. Riaz, Max Heckendorn, ARENTFOX SCHIFF LLP, New York, NY. Counsel for Plaintiff 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. Counsel for Defendant

MEMORANDUM OPINION July 11, 2025 Wilmington, Delaware

1) A h jn GREGORY B. WILLIAMS UNITED STATES DISTRICT JUDGE

The following motions and requests from Plaintiff! are pending before the Court and are the subject of this Memorandum Opinion: 1. Nexus’ Motion for Partial Summary Judgment (MSJ No. 1) (“Nexus’ First Motion for Summary Judgment”) (D.I. 207), which has been fully briefed (DI. 210; DI. 228; DI. 257); 2. Nexus’ Motion for Partial Summary Judgment (No. 2) of Infringement for the °369 Patent (“Nexus’ Second Motion for Summary Judgment”) (D.I. 211)? (together with Nexus’ First Motion for Summary Judgment, “Nexus’ Motions for Summary Judgment”), which has been fully briefed (D.I. 213; D.I. 230; D.I. 259); 3. Nexus’ Request for Oral Argument (D.I. 263), which pertains to Nexus’ Motions for Summary Judgment; 4. Nexus’ Motion to Strike Anticipation Opinions of the Opening Expert Report of Dr. Robert Myers (“Nexus’ Motion to Strike”) (D.I. 174), which has been fully briefed (D.I. 175; D.L. 176); and 5. Nexus’s request for a teleconference on Nexus’ Motion to Strike (D.I. 179).

' The Plaintiff is Nexus Pharmaceuticals, Inc. (“Nexus” or “Plaintiff’). The Defendant is Exela Pharma Sciences, LLC (“Exela” or “Defendant”). ? Nexus’ Second Motion for Summary Judgment (D.I. 211) inadvertently mirrors, verbatim, the Nexus’ First Motion for Summary Judgment (D.I. 207). The Court uses as a title for Nexus’ Second Motion for Summary Judgment the title that Nexus uses in its opening brief in support of its Second Motion for Summary Judgment (D.I. 213).

For the following reasons, the Court grants-in-part and denies-in-part Nexus’ First Motion for Summary Judgment (D.I. 207), denies Nexus’ Second Motion for Summary Judgment (D.I. 211), denies-as-moot Nexus’ Request for Oral Argument which pertains to Nexus’ Motions for Summary Judgment (D.I. 263), denies-as-moot Nexus’ Motion to Strike (D.I. 174), and denies-as- moot Nexus’ request for a teleconference on Nexus’ Motion to Strike (D.I. 179). I. LEGAL STANDARD “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.’” /d. at 308 (quoting Parkell v. Danberg, 833 F.3d 313, 323 (d Cir. 2016)). il. DISCUSSION The Court divides its Discussion into the following Sections: (A) The Court Grants-in-Part and Dénies-in-Part Nexus’ First Motion for Summary Judgment; (B) The Court Denies Nexus’ Second Motion for Summary Judgment; and (C) The Court Denies-as-Moot Nexus’ Motion to Strike. A. The Court Grants-in-Part and Denies-in-Part Nexus’ First Motion for Summary Judgment The Court divides this Section into the following Subsections: (1) Background, (2) Anticipation Law, and (3) Legal Analysis.

1. Background? This action concerns U.S. Patent Nos. 11,464,752 (“the ’752 patent”), 11,426,369 (“the patent”), and 11,571,398 (“the ’398 patent’) (together, the “Asserted Patents”). See D.I. 210 at 1. The Asserted Patents “generally relate to 5 mg/mL ephedrine sulfate products” that are “stable and sterile” for certain “periods of time, at least six months under elevated temperature or twelve months under room temperature.” See D.J. 210 at 3. The prior art required higher concentrations of ephedrine sulfate, i.e., levels of 50 mg/mL, which” others used “to manually prepare 5 mg/mL syringes.” See D.I. 210 at 3. “Entities who manually prepared syringes included ‘compounders.’” See D.I. 210 at 3. On November 13, 2024, Exela served the Opening Report of Dr. Myers (“the Myers Opening Report”). D.J. 210 at 4; D.I. 214-1, Ex. M. The Myers Opening Report opines that eight “Compounded Ephedrine Syringe Products” (“Ephedrine Syringe Products”) anticipate claims 1- 16 of the ’752 patent, claims 1-9 of the 369 patent, and claims 1-9 of the °398 patent. D.I. 210 at 1; 214-1, Ex. M at 11-12, 128. Dr. Myers characterizes the Compounded Ephedrine Syringe Products as “packaged syringes containing a sterilized, ready-to-use ephedrine sulfate composition.” D.J. 214-1, Ex. M at 11. The eight products include: (1) CAPS PFS (“CAPS”); (2) Ameridose PFS (“Ameridose”); (3) Pharmedium PFS (“Pharmedium”); (4) Advanced Pharma PFS (“Advanced Pharma”); (5) SCA Pharma PFS (“SCA Pharma”); (6) IntegraDose PFS (“IntegraDose”); (7) Products from the 503B Product Reports-July-to-December 2018 (“2018 503B Report Products”); and (8) Products from the January 2019 FDA Outsourcing Facility Product Report (“2019 Outsourcing Product Report

3 The Court briefly sets forth relevant background and otherwise assumes the parties’ familiarity with this action.

Products”). D.I. 214-1, Ex. M951. The 2018 503B Report Products and the 2019 Outsourcing Product Report Products are, as their names imply, a collection of products. On February 28, 2025, Nexus moved for summary judgment that claims 1-16 of the ’752 patent, claims 1-9 of the °369 patent, and claims 1-9 of the °398 patent “are not invalid as anticipated by the” Ephedrine Syringe Products. D.J. 210 at 1. Briefing is complete. 2. Anticipation Law “Under patent law, a single prior art reference anticipates a patent claim if it expressly or inherently describes each and every limitation set forth in the patent claim.” Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1295 (Fed. Cir. 2002). “While a single reference may expressly anticipate a claim where the reference explicitly discloses each and every claim limitation, the prior art need not be ipsissimis verbis (i.e., use identical words as those recited in the claims) to be expressly anticipating.” Bd. of Regents v. Bos. Sci. Corp., No. 18-392, 2024 U.S. Dist. LEXIS 99773, at *7-8 (D. Del. June 5, 2024) (citing Structural Rubber Prods. Co. v. Park Rubber Co., 749 F.2d 707, 716 (Fed.Cir.1984)). “Instead, a reference may still anticipate if that reference teaches that the disclosed components or functionalities may be combined and one of skill in the art would be able to implement the combination.” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331

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Nexus Pharmaceuticals, Inc. v. Exela Pharma Sciences, LLC, (D. Del. 2025).

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