DCT

1:25-cv-00010

Acacia Pharma Ltd v. Galenicum Health Slu

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Amended Complaint
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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00010, D. Del., 04/29/2026
  • Venue Allegations: Venue is alleged to be proper because the Defendant is a foreign corporation that may be sued in any U.S. judicial district. Personal jurisdiction is asserted based on the Defendant's business activities in Delaware and, more specifically, its filing of an Abbreviated New Drug Application (ANDA) seeking approval to market a product for sale throughout the U.S., including in Delaware.
  • Core Dispute: Plaintiffs allege that Defendant's submission of an ANDA to the FDA for a generic version of Plaintiffs' procedural sedation drug, BYFAVO® (remimazolam), constitutes an act of infringement of seven U.S. patents covering specific dosing regimens for the drug.
  • Technical Context: The technology relates to dosing methods for remimazolam, an ultra-short-acting benzodiazepine used for procedural sedation in adults for procedures lasting 30 minutes or less.
  • Key Procedural History: This action arises under the Hatch-Waxman Act following Defendant Galenicum Health's submission of ANDA No. 219794 with a Paragraph IV certification. Galenicum seeks to market a generic version of Plaintiffs' Orange Book-listed drug, BYFAVO®, before the expiration of the seven Asserted Patents. Plaintiffs received notice letters from Galenicum regarding the ANDA filing on November 21, 2024, and September 10, 2025.

Case Timeline

Date Event
2010-11-08 Earliest Priority Date for Asserted Patents ('236, '547, '251, '334, '210, '800, '522 Patents)
2017-02-07 U.S. Patent No. 9,561,236 Issues
2017-08-22 U.S. Patent No. 9,737,547 Issues
2017-11-28 U.S. Patent No. 9,827,251 Issues
2018-08-21 U.S. Patent No. 10,052,334 Issues
2019-02-05 U.S. Patent No. 10,195,210 Issues
2019-07-09 U.S. Patent No. 10,342,800 Issues
2020-07-02 FDA Approves BYFAVO® NDA No. 212295
2020-07-28 U.S. Patent No. 10,722,522 Issues
2024-11-21 Plaintiffs Receive First Notice Letter regarding ANDA No. 219794
2025-09-10 Plaintiffs Receive Second Notice Letter regarding ANDA No. 219794
2026-04-29 First Amended Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 9,561,236 - "Dosing Regimen for Sedation with CNS 7056 (Remimazolam)"

  • Patent Identification: U.S. Patent No. 9,561,236 ("Dosing Regimen for Sedation with CNS 7056 (Remimazolam)"), issued February 7, 2017.

The Invention Explained

  • Problem Addressed: The patent documentation describes the challenge of safely and effectively dosing sedatives, particularly when co-administered with opioids Compl. ¶48 '334 Patent, col. 1:35-42 Patient response to sedatives can be highly variable, and combination therapy increases risks of side effects like hypotension and respiratory depression, making traditional dose-titration complex '334 Patent, col. 1:55-65
  • The Patented Solution: The invention provides a dosing regimen for the benzodiazepine remimazolam (CNS 7056) that is based on a fixed dose, irrespective of the patient's body weight '334 Patent, col. 2:46-54 This approach, based on pharmacokinetic and pharmacodynamic (PK/PD) analysis showing that body weight is not a significant predictor of drug clearance, simplifies administration and is intended to provide a convenient and safe sedation profile '334 Patent, abstract '334 Patent, col. 13:21-34
  • Technical Importance: The move from weight-based dosing to a fixed-dose regimen represented a simplification in administering procedural sedation, potentially reducing calculation errors and improving safety profiles for this class of drugs.

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 Compl. ¶49
  • Independent Claim 1 includes these essential elements:
    • A method of sedating a subject.
    • Administering to the subject an initial dose of the besylate salt of 3-[(4S)-8-bromo-1-methyl-6-(2-pyridinyl)-4H-imidazo[1,2-a][1,4]benzodiazepin-4-yl]-propionic methyl ester (CNS 7056).
    • The initial dose is a fixed dose of between about 2 mg and about 10 mg.
    • The initial dose is irrespective of the body weight of the subject.
    • The administration is in combination with one or more doses of an opioid.
      Compl. ¶48

U.S. Patent No. 9,827,251 - "Dosing Regimen for Sedation with CNS 7056 (Remimazolam)"

  • Patent Identification: U.S. Patent No. 9,827,251 ("Dosing Regimen for Sedation with CNS 7056 (Remimazolam)"), issued November 28, 2017.

The Invention Explained

The technology disclosed in the '251 Patent is substantively identical to that of the '236 Patent, as they are part of the same patent family and share a common specification Compl. ¶¶23, 29 '334 Patent, Related U.S. Application Data The patent addresses the problem of variable patient response to sedatives by providing a fixed-dose, weight-independent regimen for remimazolam '334 Patent, col. 1:35-42 '334 Patent, col. 2:46-54

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 Compl. ¶64
  • Independent Claim 1 includes these essential elements:
    • A method of sedating a subject undergoing a procedure.
    • Administering intravenously to the subject one or more fixed doses of a composition comprising the besylate salt of CNS 7056.
    • The amount of the besylate salt administered does not depend on the body weight of the subject.
      Compl. ¶63

Multi-Patent Capsules

  • U.S. Patent No. 9,737,547: ("Dosing Regimen for Sedation with CNS 7056 (Remimazolam)"), issued August 22, 2017 Compl. ¶26

    • Technology Synopsis: This patent, part of the same family, covers a method for sedating a subject using a fixed initial dose of remimazolam besylate that is administered irrespective of the subject's body weight Compl. ¶78 The technology is substantially the same as described for the '236 and '251 Patents.
    • Asserted Claims: At least independent claim 1 Compl. ¶79
    • Accused Features: The use of Galenicum's product as directed by its proposed labeling is alleged to involve administering an initial fixed dose of remimazolam between 2 mg and 10 mg, irrespective of body weight Compl. ¶79

  • U.S. Patent No. 10,052,334: ("Dosing Regimen for Sedation with CNS 7056 (Remimazolam)"), issued August 21, 2018 Compl. ¶29

    • Technology Synopsis: This patent covers a method for both inducing and maintaining sedation by administering an initial dose and one or more supplemental doses of remimazolam (or a salt thereof) '334 Patent, abstract The administered amounts do not depend on the subject's body weight Compl. ¶93
    • Asserted Claims: At least independent claim 1 Compl. ¶94
    • Accused Features: The proposed labeling for Galenicum's product is alleged to instruct inducing and maintaining sedation by administering an initial dose and supplemental doses in amounts that do not depend on body weight Compl. ¶94

  • U.S. Patent No. 10,195,210: ("Dosing Regimen for Sedation with CNS 7056 (Remimazolam)"), issued February 5, 2019 Compl. ¶32

    • Technology Synopsis: This patent covers a method for conducting a procedure involving sedation, which includes administering one or more fixed doses of a remimazolam composition and passing an endoscope into the subject '210 Patent, abstract Compl. ¶108
    • Asserted Claims: At least independent claim 1 Compl. ¶109
    • Accused Features: The use of Galenicum's product according to its proposed labeling is alleged to involve administering fixed doses of remimazolam to sedate a subject and passing an endoscope into the subject Compl. ¶109

  • U.S. Patent No. 10,342,800: ("Dosing Regimen for Sedation with CNS 7056 (Remimazolam)"), issued July 9, 2019 Compl. ¶35

    • Technology Synopsis: This patent covers a method for inducing general anesthesia by co-administering remimazolam (or a salt thereof) with an analgesic drug '800 Patent, abstract The administered amount of remimazolam does not depend on the subject's body weight Compl. ¶123
    • Asserted Claims: At least independent claim 1 Compl. ¶124
    • Accused Features: The proposed labeling for Galenicum's product is alleged to instruct inducing general anesthesia by administering remimazolam in combination with an analgesic drug, in an amount that does not depend on body weight Compl. ¶124

  • U.S. Patent No. 10,722,522: ("Dosing Regimen for Sedation with CNS 7056 (Remimazolam)"), issued July 28, 2020 Compl. ¶38

    • Technology Synopsis: This patent covers a method of sedating an adult subject by administering a 5 mg initial dose of remimazolam (or a salt thereof) intravenously over a period of 1 minute '522 Patent, abstract Compl. ¶138
    • Asserted Claims: At least independent claim 1 Compl. ¶139
    • Accused Features: The use of Galenicum's product as directed by its proposed labeling is alleged to involve administering a 5 mg initial dose over a 1-minute period Compl. ¶139

III. The Accused Instrumentality

Product Identification

The accused instrumentality is "Galenicum's Proposed ANDA Product," which is a generic version of BYFAVO® (remimazolam) for which Galenicum has filed ANDA No. 219794 seeking FDA approval Compl. ¶1

Functionality and Market Context

The complaint alleges the accused product is remimazolam for injection, supplied as a 20 mg per vial lyophilized powder that is reconstituted for intravenous use to a concentration of 2.5 mg/mL Compl. ¶44 It is intended for the induction and maintenance of procedural sedation in adults for procedures lasting 30 minutes or less Compl. ¶2 The complaint asserts that Galenicum's product is bioequivalent to BYFAVO® Compl. ¶45 and that its proposed product label will instruct healthcare providers to prescribe and administer it in a manner that will infringe the Asserted Patents Compl. ¶46

IV. Analysis of Infringement Allegations

'236 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
[a] method of sedating a subject comprising administering to the subject an initial dose of the besylate salt of 3-[(4S)-8-bromo-1-methyl-6-(2-pyridinyl)-4H-imidazo[1,2-a][1,4]benzodiazepin-4-yl]-propionic methyl ester (CNS 7056) of formula (I) The complaint alleges that the proposed label for Galenicum's product, which contains remimazolam, will instruct healthcare providers to sedate a subject by administering the product. The complaint provides a chemical diagram of formula (I) for remimazolam (Compl. p. 9). ¶49; ¶50 col. 2:49-54
wherein the initial dose is a fixed dose of between about 2 mg and about 10 mg Galenicum's proposed labeling allegedly directs administering an initial fixed dose within the 2 mg to 10 mg range. ¶49 col. 6:28-30
and is irrespective of the body weight of the subject, The proposed labeling allegedly directs administering an initial dose that is a fixed amount and is not adjusted based on the subject's body weight. ¶49 col. 7:50-54
in combination with one or more doses of an opioid. The proposed labeling allegedly directs administering the product in combination with an opioid, specifically fentanyl. ¶49 col. 2:25-27

'251 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
[a] method of sedating a subject undergoing a procedure, comprising administering intravenously to the subject one or more fixed doses of a composition comprising the besylate salt of 3-[(4S)-8-bromo-1-methyl-6-(2-pyridinyl)-4H-imidazo[1,2-a][1,4]benzodiazepin-4-yl]-propionic methyl ester (CNS 7056) of formula (I) The proposed labeling for Galenicum's product allegedly directs sedating a subject by administering one or more fixed doses of the remimazolam composition intravenously. ¶64 col. 2:49-54
wherein the amount of the besylate salt of the compound of formula (I) administered to the subject does not depend on the body weight of the subject. The proposed labeling allegedly directs administering an amount of the drug that is not dependent on the subject's body weight. ¶64 col. 2:52-54
  • Identified Points of Contention:
    • Scope Questions: The core of the infringement allegation for the '236 and '251 patents rests on the claim term "irrespective of the body weight of the subject" or its equivalent "does not depend on the body weight of the subject." A central question will be whether Galenicum's proposed product label, which is not included in the complaint, contains any instructions, contraindications, or warnings related to patient size, obesity, or other weight-related factors that could be argued to fall outside the scope of this negative limitation.
    • Technical Questions: The infringement theory is based entirely on the future, intended use of the product as directed by a proposed label Compl. ¶¶50, 65 A key question for the court will be whether the final, FDA-approved label for Galenicum's product will, in fact, contain the specific instructions that Plaintiffs allege will directly infringe the asserted claims.

V. Key Claim Terms for Construction

"irrespective of the body weight of the subject" / "does not depend on the body weight of the subject"

  • The Term: "irrespective of the body weight of the subject" (from '236 Patent) and "does not depend on the body weight of the subject" (from '251 Patent).
  • Context and Importance: This negative limitation is the central inventive concept distinguished from prior art weight-based (e.g., mg/kg) dosing. Its construction is critical because infringement hinges on whether Galenicum's proposed label instructs a dosing method that falls within this definition. Practitioners may focus on this term because the Defendant's non-infringement position will likely center on arguing that its proposed use is not entirely "irrespective" of body weight, perhaps due to warnings or other guidance related to patient characteristics.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specifications repeatedly emphasize a "fixed dose per patient" regimen '334 Patent, col. 7:50-51 The analysis concluding that "body weight was not a statistically significant predictor of the systemic clearance" could support an interpretation that any regimen not calculated on a mg/kg basis is "irrespective" of weight '334 Patent, col. 7:51-54
    • Evidence for a Narrower Interpretation: The specification's discussion of prior art body-weight adjusted doses contrasts with the "optimised dosing regimen" of the invention '334 Patent, col. 2:18-20 '334 Patent, col. 2:45-46 A defendant may argue this contrast limits the term to only the specific fixed-dose ranges disclosed and found to be weight-independent in clinical trials, not any theoretical non-weight-based dose. The detailed PK/PD modeling results could be cited to argue the term is tied to the specific outcomes of that analysis '334 Patent, col. 13:21-41

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement for all asserted patents. The basis for this allegation is that Galenicum, upon information and belief, plans to sell its Proposed ANDA Product with a label that includes instructions for healthcare providers to administer the product in a manner that directly infringes the claims of the Asserted Patents Compl. ¶¶58, 73, 88, 103, 118, 133, 148 The complaint alleges Galenicum will act with specific intent to induce infringement Compl. ¶58
  • Willful Infringement: The complaint does not contain an explicit count for willful infringement. However, it alleges that Galenicum has knowledge of the Asserted Patents, at a minimum, because they are listed in the FDA's Orange Book for the reference drug BYFAVO® Compl. ¶¶57, 72, 87, 102, 117, 132, 147 The complaint further alleges that despite this knowledge, Galenicum intends to engage in the infringing activities upon FDA approval Compl. ¶57 Plaintiffs request an award of attorneys' fees pursuant to 35 U.S.C. § 285, alleging this is an "exceptional case" Compl. p.31, req. (e)

VII. Analyst's Conclusion: Key Questions for the Case

  • A primary issue for the court will be one of induced infringement: As this is an ANDA case preceding the launch of the generic product, the dispute will center on the specific language of Galenicum's proposed product label. The key question is whether the instructions on that label will direct clinicians to perform each and every limitation of the asserted method claims.
  • A central question of claim construction will be the scope of the negative limitation "irrespective of the body weight of the subject" (and its variants). The case may turn on whether this phrase simply means "not dosed on a mg/kg basis," or if it carries a stricter meaning that precludes any label guidance related to patient size, obesity, or other weight-correlated factors from influencing the dose.
  • Finally, an evidentiary question will focus on the extent of overlap between the patent families. Given that all seven asserted patents stem from the same priority application and cover closely related dosing regimens for the same compound, the court will likely face questions regarding claim differentiation, potential double patenting invalidity defenses, and the preclusive effect of any construction or finding on one patent as it applies to the others.
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