DCT

2:25-cv-17395

Axsome Malta Ltd v. Alkem Laboratories Ltd

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-17395, D.N.J., 11/12/2025
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant is a foreign corporation and conducts business within the District of New Jersey, has previously consented to personal jurisdiction in the district, and the district will be a destination for the accused generic drug products.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA, seeking to market generic versions of Plaintiff's Sunosi® (solriamfetol) oral tablets, constitutes an act of patent infringement.
  • Technical Context: The technology concerns pharmaceutical compositions of solriamfetol, a dopamine and norepinephrine reuptake inhibitor used to treat excessive daytime sleepiness, focusing on a specific crystalline form and high-drug-load, immediate-release tablet formulations.
  • Key Procedural History: The action arises from Defendant's submission of ANDA No. 218722 and a series of associated Paragraph IV certifications, beginning on or after August 11, 2023, notifying Plaintiff of Defendant's intent to market a generic product prior to the expiration of the patents-in-suit. The complaint also references prior related litigation between the parties in the same district.

Case Timeline

Date Event
2016-09-06 Earliest Priority Date for '743' and '419' Patents
2023-08-11 Alkem sent first Paragraph IV Certification Notice Letter
2024-03-29 Alkem sent second Paragraph IV Certification Notice Letter
2024-06-26 Alkem sent third Paragraph IV Certification Notice Letter
2024-10-15 Alkem sent fourth Paragraph IV Certification Notice Letter
2025-07-03 Alkem sent fifth Paragraph IV Certification Notice Letter
2025-08-12 U.S. Patent No. 12,384,743 Issued
2025-08-19 U.S. Patent No. 12,390,419 Issued
2025-10-01 Alkem sent sixth Paragraph IV Certification Notice Letter
2025-11-12 Complaint Filed

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

U.S. Patent No. 12,384,743 - "Compositions Comprising (R)-2-Amino-3-Phenylpropyl Carbamate and Uses Thereof," issued August 12, 2025

The Invention Explained

  • Problem Addressed: The patent's background describes the general utility of (R)-2-amino-3-phenylpropyl carbamate (APC), also known as solriamfetol, in treating various disorders and notes the need for methods of preparing the compound with minimal contaminants ('743 Patent, col. 1:31-47). The specification highlights that during manufacturing development, unacceptable levels of the impurity 2-chloropropane could appear during crystallization ('743 Patent, col. 6:38-42).
  • The Patented Solution: The specification describes the identification of a new solvate form of APC hydrochloride, designated "Form B," which is a hemihydrate ('743 Patent, col. 1:51-52). This Form B is characterized as being more stable at higher humidity levels compared to the anhydrous "Form A" ('743 Patent, col. 4:38-42). However, the asserted claim is directed to the anhydrous Form A.
  • Technical Importance: Identifying and controlling the specific crystalline form of an active pharmaceutical ingredient is critical for ensuring product stability, consistent manufacturing, and predictable bioavailability, which are key requirements for regulatory approval and commercial success ('743 Patent, col. 1:44-47).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶31).
  • Claim 1 requires:
    • Crystalline (R)-2-amino-3-phenylpropyl carbamate hydrochloride
    • having an X-ray powder diffraction pattern as shown in FIG. 1 Form A.
  • The complaint states that Alkem's actions infringe "one or more of the claims" of the patent, reserving the right to assert additional claims (Compl. ¶31).

U.S. Patent No. 12,390,419 - "Formulations of (R)-2-Amino-3-Phenylpropyl Carbamate," issued August 19, 2025

The Invention Explained

  • Problem Addressed: The patent addresses challenges associated with administering APC in a solid oral dosage form, particularly for patients who may have difficulty swallowing pills ('419 Patent, col. 4:54-57). A primary technical challenge is to create a small, easy-to-swallow tablet that contains a large amount of the active ingredient while still dissolving quickly to ensure rapid therapeutic effect ('419 Patent, col. 4:57-60).
  • The Patented Solution: The invention provides an immediate-release compressed tablet with a very high drug load (about 90-98% APC by weight), combined with small amounts of a binder (1-5%) and a lubricant (0.1-2%) ('419 Patent, Abstract; col. 2:54-64). This specific composition allows the tablet to release over 85% of its active ingredient in less than 15 minutes, achieving rapid dissolution without the need for a disintegrant ('419 Patent, col. 7:12-17).
  • Technical Importance: Developing a high-drug-load, immediate-release formulation that dissolves rapidly is a significant achievement in pharmaceutical science, as it can enhance patient compliance by reducing pill burden and providing a faster onset of action ('419 Patent, col. 4:54-62).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 (Compl. ¶40).
  • Claim 1 requires:
    • An immediate release compressed tablet for oral delivery of (R)-2-amino-3-phenylpropyl carbamate.
    • The tablet comprises a salt of the active ingredient in an amount of about 90-98% by weight.
    • It further comprises at least one binder (1-5% by weight) and at least one lubricant (0.1-2% by weight).
    • The tablet must release at least 85% of the active ingredient in less than 15 minutes.
    • It must also exhibit "substantially identical dissolution rates" at pH 1.2, 4.5, and 6.8.
    • The tablet comprises a specific dosage strength (e.g., about 300 mg, 150 mg, 75 mg, or 37.5 mg).
  • The complaint reserves the right to assert additional claims (Compl. ¶40).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is "Alkem's Proposed Product," which is a generic version of Axsome's solriamfetol oral tablets for which Alkem seeks FDA approval via ANDA No. 218722 (Compl. ¶¶1, 15, 21).

Functionality and Market Context

The complaint alleges that Alkem's product is a generic version of Sunosi®, a dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (Compl. ¶¶2, 9). The lawsuit is a direct result of Alkem's filing of an ANDA, which is the statutory pathway for seeking approval to market a generic drug product demonstrated to be bioequivalent to a branded reference product (Compl. ¶1).

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or sufficient technical detail to construct one. The infringement allegations are based on the statutory act of filing an ANDA under the Hatch-Waxman Act.

The infringement theory is that Alkem's submission of ANDA No. 218722 seeking approval to market its generic solriamfetol product constitutes an act of infringement of the '743 and '419 patents under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶¶31, 40). The complaint further alleges that upon FDA approval, Alkem's commercial manufacture, use, offer for sale, or sale of the generic product in the United States will constitute direct infringement (§ 271(a)), induced infringement (§ 271(b)), and contributory infringement (§ 271(c)) of both patents-in-suit (Compl. ¶¶33-35, 42-44). The core of the dispute will be whether Alkem's proposed generic product, as described in its confidential ANDA submission, meets all limitations of the asserted patent claims.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

’743 Patent

  • The Term: "Crystalline... hydrochloride having an X-ray powder diffraction pattern as shown in FIG. 1 Form A" (from Claim 1).
  • Context and Importance: This term defines the specific physical form of the drug substance covered by the claim. Infringement hinges on whether Alkem's proposed generic product contains this exact crystalline structure. The construction of this term will determine whether minor variations in an XRPD pattern fall within the scope of the claim.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes Form A simply as an "anhydrous, crystalline material" ('743 Patent, col. 8:46-48). A party could argue that this description supports a construction covering any anhydrous crystalline form that is substantially similar to the figure.
    • Evidence for a Narrower Interpretation: The claim's explicit recitation of "as shown in FIG. 1 Form A" ties the claim scope directly to that specific graphical representation. The patent's detailed description of a distinct "Form B" hemihydrate, with its own unique properties and XRPD pattern, reinforces the interpretation that "Form A" is a precise and distinct structure, not a general class of anhydrous forms ('743 Patent, col. 4:38-42).

’419 Patent

  • The Term: "immediate release" (from Claim 1).
  • Context and Importance: The patent is directed to "immediate release formulations," making this term's definition central to the scope of all claims. While the claim provides a functional definition (releasing ≥85% of drug in <15 minutes), its interpretation in light of the specification's teachings could be a point of contention.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: Claim 1 itself defines the term functionally: a tablet that "releases at least 85% of the... salt... contained therein within a period of less than 15 minutes." A party may argue that any formulation meeting this performance metric infringes, irrespective of its mechanism of release.
    • Evidence for a Narrower Interpretation: The specification emphasizes that the invention achieves rapid dissolution using a high-drug-load formulation without a disintegrant, stating the tablets "dissolve rather than disintegrate" ('419 Patent, col. 7:15-17). A defendant could argue that "immediate release" should be construed in this specific context, potentially limiting the claim to formulations that achieve release primarily through dissolution. However, the presence of dependent claim 3, which explicitly adds the limitation "wherein the tablet does not comprise a disintegrant," suggests that independent claim 1 is broader and does not inherently exclude disintegrants.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon FDA approval, Alkem will induce infringement by "intentionally encourag[ing] acts of direct infringement with knowledge of the" patents, which is typically based on the product's labeling and instructions for use (Compl. ¶¶34, 43). Contributory infringement is alleged on the basis that Alkem's product is designed for an infringing use and "lacks a substantial non-infringing use" (Compl. ¶¶35, 44).
  • Willful Infringement: The complaint does not use the term "willful," but it alleges the case is "exceptional" and seeks attorneys' fees under 35 U.S.C. § 285 (Compl. ¶¶38, 47). The factual basis for this allegation is Alkem's pre-suit knowledge of the patents, evidenced by the series of Paragraph IV certification notice letters sent to Axsome between August 2023 and October 2025 (Compl. ¶¶24-29).

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

  • A core issue will be one of structural identity: does the active pharmaceutical ingredient in Alkem's proposed generic product exist in the specific anhydrous crystalline structure ("Form A") claimed in the ’743 patent, or can Alkem demonstrate that its product utilizes a different, non-infringing polymorphic or solvated form?
  • A second key question will be one of compositional and functional scope: does Alkem's tablet formulation meet the specific high-drug-load percentages and achieve the claimed pH-independent dissolution profile required by the ’419 patent's claims, or is there a mismatch in either its composition or its release performance?