DCT

1:26-cv-00453

Harmony Biosciences Management Inc v. AET Pharma US Inc

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Amended Complaint
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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:26-cv-00453, D. Del., 07/07/2026
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because certain defendants are organized under Delaware law, and foreign defendants are subject to personal jurisdiction in the district and may be sued in any judicial district.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) for generic versions of the narcolepsy drug WAKIX® constitutes an act of infringement of a patent covering amorphous solid dispersions of pitolisant hydrochloride.
  • Technical Context: The technology relates to pharmaceutical formulations, specifically stable, amorphous solid-state forms of pitolisant hydrochloride, the active ingredient in a drug used to treat narcolepsy.
  • Key Procedural History: This is a Hatch-Waxman action triggered by Defendants' submission of ANDA No. 218892 with a Paragraph IV certification. The complaint notes that prior litigation was filed against the same defendants concerning the same ANDA but involving different patents, and that those cases were consolidated. The complaint also references representations made by Defendants' counsel and a corporate representative in a prior trial, stating that the accused generic product is "completely amorphous."

Case Timeline

Date Event
2019-08-14 WAKIX® first receives FDA approval
2021-06-07 '920 Patent Priority Date
2023-04-11 '920 Patent Issue Date
2023-10-14 AET sends first Notice of Paragraph IV Certification letter regarding other patents
2023-11-21 Initial litigation filed against AET regarding other patents
2024-08-07 AET sends second Notice of Paragraph IV Certification letter
2026-01-11 Novitium grants Harmony an exclusive license to the '920 Patent
2026-07-07 Complaint Filing Date

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

U.S. Patent No. 11,623,920 - "Process for Preparing Pitolisant Hydrochloride and Solid-State Forms Thereof"

The Invention Explained

  • Problem Addressed: The patent's background describes prior art methods for manufacturing pitolisant that utilize sodium hydride (NaH), a reagent characterized as "hazardous and pyrophoric" and thus "not suitable for a commercial scale" '920 Patent, col. 2:61-65 These prior processes could also result in "deschloro" impurities that are difficult to remove from the final product '920 Patent, col. 3:1-11
  • The Patented Solution: The invention discloses improved processes for preparing pitolisant hydrochloride that avoid hazardous reagents '920 Patent, col. 3:39-45 A central aspect of the invention is the creation of novel "solid-state forms" of pitolisant hydrochloride, particularly "amorphous solid dispersions" where the active ingredient is combined with pharmaceutically acceptable excipients to form a stable, non-crystalline composition '920 Patent, abstract '920 Patent, col. 5:44-48 These solid dispersions are intended to provide stable and effective pharmaceutical formulations.
  • Technical Importance: Creating stable, commercially-scalable, and safe-to-manufacture formulations is a critical step in pharmaceutical development, enabling a drug to be produced reliably and delivered effectively to patients.

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claims 2, 6, 29, and 30 Compl. ¶88
  • Independent Claim 1:
    • An amorphous solid dispersion
    • comprising pitolisant hydrochloride
    • and one or more pharmaceutically acceptable excipients.
  • The complaint alleges infringement of these specific claims and seeks relief related to the '920 Patent generally Compl. ¶89 Compl., prayer b

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the generic pitolisant hydrochloride tablets, 4.45 mg and 17.8 mg, described in Defendants' Abbreviated New Drug Application (ANDA) No. 218892 (the "AET ANDA Products") Compl. ¶1 Compl. ¶47

Functionality and Market Context

  • The AET ANDA Products are alleged to be generic versions of WAKIX®, a first-in-class drug for treating excessive daytime sleepiness or cataplexy in patients with narcolepsy Compl. ¶1 Compl. ¶35
  • Technically, the complaint alleges the AET ANDA Products are formulated as a "solid dispersion of pitolisant hydrochloride and maltodextrin" Compl. ¶57 Citing representations from a prior trial, the complaint asserts this solid dispersion is "completely amorphous," containing "100 percent amorphous API in the finished AET ANDA product" Compl. ¶¶59-60 Maltodextrin is identified as a "pharmaceutically acceptable excipient and a water-soluble sugar excipient" Compl. ¶58
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

'920 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
An amorphous solid dispersion The AET ANDA Products contain a solid dispersion that is alleged to be "completely amorphous," based on representations made by AET's counsel and a corporate representative in a prior trial. ¶59; ¶60 col. 5:44-48
comprising pitolisant hydrochloride The AET ANDA Products are generic versions of WAKIX® and comprise the active ingredient pitolisant hydrochloride. ¶57 col. 1:26-30
and one or more pharmaceutically acceptable excipients The solid dispersion in the AET ANDA Products comprises maltodextrin, which is described as a "pharmaceutically acceptable excipient." ¶57; ¶58 col. 7:27-30

Identified Points of Contention

  • Scope Questions: The central dispute may focus on the proper construction of the term "amorphous solid dispersion." Defendants may argue for a narrower definition that requires more than the mere combination of an amorphous API with an excipient, potentially arguing it requires a specific molecular arrangement (e.g., the API being molecularly dissolved in a polymer matrix) or that it is limited by the manufacturing processes described in the patent's examples '920 Patent, col. 19:1-20:65
  • Technical Questions: A key factual question will be whether the accused product's formulation of pitolisant hydrochloride and maltodextrin meets the legal definition of an "amorphous solid dispersion." While the complaint cites Defendants' prior admissions that the product is "amorphous" Compl. ¶¶59-60, the analysis will likely require expert testimony on whether the formulation constitutes a "dispersion" in the manner contemplated by the patent, as opposed to a simple amorphous mixture.

V. Key Claim Terms for Construction

  • The Term: "amorphous solid dispersion"
  • Context and Importance: This term is the cornerstone of independent claim 1. Its construction will determine the scope of the claim and is therefore central to the infringement analysis. Practitioners may focus on this term because whether the accused product-a formulation of an amorphous API with maltodextrin-falls within its scope is the core of the dispute.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent itself claims "An amorphous solid dispersion" without limiting the type of excipient or manufacturing method in claim 1 '920 Patent, col. 33:59-61 The specification provides an extensive list of potential excipients, suggesting broad applicability '920 Patent, col. 5:48 - col. 7:39 This could support an argument that any combination resulting in a stable, amorphous formulation with an excipient qualifies.
    • Evidence for a Narrower Interpretation: The patent's detailed description and examples frequently use specific manufacturing techniques like spray drying and solvent evaporation to create the dispersions '920 Patent, col. 19-21 A defendant could argue these examples implicitly limit the term to compositions created by such methods, where the API is molecularly dispersed in a carrier, and that their formulation is not such a product. The patent also describes the solid dispersion as exhibiting "physicochemical stability under thermal, humid and stress conditions" '920 Patent, col. 9:7-9, which might be argued as a required functional property of the claimed "dispersion."

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b) Compl. ¶93 The asserted basis is that Defendants' future FDA-approved product insert will instruct and encourage physicians and patients to administer the AET ANDA Products for the treatment of narcolepsy, thereby directing them to perform the infringing use Compl. ¶63
  • Willful Infringement: The complaint alleges that "Defendants had actual knowledge of the '920 Patent prior to submitting the AET ANDA" Compl. ¶90 This allegation of pre-suit knowledge forms the basis for a potential claim of willful infringement, suggesting Defendants proceeded despite an objectively high likelihood that their actions constituted infringement of a valid patent.

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

  • Definitional Scope: A core issue will be one of claim construction: how will the court define "amorphous solid dispersion"? Will the term be construed broadly to cover any stable, amorphous formulation containing the API and an excipient, or will it be narrowed to require specific manufacturing processes or a particular molecular-level interaction between the drug and the carrier, as suggested by the patent's examples?
  • Factual Characterization: The case will likely turn on an evidentiary question regarding the technical nature of the accused product. Assuming a claim construction is established, does the Defendants' formulation of pitolisant hydrochloride with maltodextrin factually meet all the limitations of that construction, or can Defendants successfully characterize their product as a simple amorphous mixture that falls outside the scope of a true "solid dispersion" as claimed by the patent?
  • Estoppel and Prior Statements: A significant question will be the legal effect of Defendants' alleged admissions in a prior trial that their product is "completely amorphous." Plaintiffs will likely argue this serves as strong evidence of infringement, while Defendants may attempt to distinguish or contextualize those statements as irrelevant to the specific claim limitations of the '920 Patent.
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