DCT
2:25-cv-00643
Axsome Malta Ltd v. Aurobindo Pharma USA Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Axsome Malta Ltd. (Malta) and Axsome Therapeutics, Inc. (Delaware)
- Defendant: Aurobindo Pharma USA, Inc. (Delaware) and Aurobindo Pharma Limited (India)
- Plaintiff’s Counsel: Saul Ewing LLP
- Case Identification: 2:25-cv-00643, D.N.J., 01/21/2025
- Venue Allegations: Venue is based on Defendant Aurobindo Pharma USA, Inc.’s principal place of business in New Jersey and the alleged systematic contacts of its foreign parent, Aurobindo Pharma Limited, with the state.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of the drug Sunosi® (solriamfetol) constitutes an act of infringement of a patent covering methods of its administration.
- Technical Context: The technology relates to pharmaceutical methods for safely administering solriamfetol, a treatment for excessive daytime sleepiness, to lactating women by timing the drug intake and breastfeeding to minimize infant exposure.
- Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following Defendant’s Paragraph IV certification notice, sent to Plaintiff on or after December 10, 2024, which asserted that the patent-in-suit is invalid and/or would not be infringed by the proposed generic product. The patent is listed in the FDA’s “Orange Book” in connection with Plaintiff’s Sunosi® drug product.
Case Timeline
| Date | Event |
|---|---|
| 2022-12-30 | U.S. Patent No. 12,102,609 Priority Date |
| 2024-10-01 | U.S. Patent No. 12,102,609 Issues |
| 2024-12-10 | Aurobindo sends Paragraph IV Notice Letter for '609 Patent (at earliest) |
| 2025-01-21 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
- Patent Identification: U.S. Patent No. 12,102,609, Methods of Administering Solriamfetol to Lactating Women, issued October 1, 2024.
The Invention Explained
- Problem Addressed: The patent addresses the challenge that solriamfetol, a drug used to treat conditions like narcolepsy, is excreted into breast milk, which may pose a risk of adverse events to a nursing infant (ʼ609 Patent, col. 7:21-30).
- The Patented Solution: The invention provides a method to reduce an infant's exposure to the drug by creating a specific time delay between when the mother takes a dose and when she breastfeeds. By waiting a defined period, the peak concentration of the drug in the breast milk has passed, thereby lowering the dose transferred to the infant ('609 Patent, col. 2:50-60). The patent supports this method with pharmacokinetic data, including a figure that illustrates the time course of solriamfetol concentration in both plasma and breast milk after administration ('609 Patent, FIG. 1; col. 4:26-34).
- Technical Importance: The method provides a protocol that may allow lactating women who require treatment for excessive daytime sleepiness to continue their therapy while mitigating potential risks to their breastfed infants (ʼ609 Patent, col. 2:37-43).
Key Claims at a Glance
- The complaint asserts infringement of at least independent claim 1 (Compl. ¶36).
- The essential elements of independent claim 1 are:
- A method for decreasing the potential for adverse events from solriamfetol in an infant fed breast milk from a human subject treated with solriamfetol.
- Orally administering solriamfetol at a once-daily dose of about 150 mg to the subject.
- Feeding the infant breast milk from the subject at least about 5 hours after administration.
- Wherein the cumulative amount of solriamfetol excreted in breast milk over 8 hours is about 0.26 mg or lower.
- The complaint does not explicitly reserve the right to assert dependent claims but seeks judgment on "one or more claims" (Compl. ¶38).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Aurobindo’s proposed generic solriamfetol oral tablets, for which it seeks FDA approval via ANDA No. 218725 (Compl. ¶1, ¶15).
Functionality and Market Context
- The proposed product is a generic version of Axsome's Sunosi®, which is a dopamine and norepinephrine reuptake inhibitor (DNRI) indicated for improving wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (Compl. ¶2, ¶9). The complaint alleges that Aurobindo seeks to manufacture and sell this generic product for the same indications prior to the expiration of the ’609 Patent (Compl. ¶1, ¶15). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not include a claim chart. The infringement theory is that the instructions for use on the label of Aurobindo’s proposed product will induce medical professionals and patients to perform the patented method.
- ’609 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| administering solriamfetol orally at a once-daily dose of about 150 mg to the subject; and | The complaint alleges that Aurobindo's proposed product is a generic equivalent of Sunosi®, which is approved and prescribed at a 150 mg dosage, and that Aurobindo's product label will instruct or encourage this administration for the same indications. | ¶9, ¶39, ¶40 | col. 2:2-3 |
| feeding the infant breast milk from the subject at least about 5 hours after administering the solriamfetol to the subject, | The complaint’s allegation of inducement suggests that Aurobindo’s proposed product label will instruct, or at minimum encourage, a lactating patient to wait for a period of time consistent with the claim limitation before breastfeeding to mitigate risk to the infant. | ¶39 | col. 2:56-60 |
| wherein the cumulative amount of solriamfetol excreted in breast milk over 8 hours is about 0.26 mg or lower. | This limitation describes a result of performing the preceding method steps. The complaint alleges that use of Aurobindo's product as instructed by its label will result in infringement of the claim, which implies this condition will be met. | ¶36 | col. 11:15-18 |
- Identified Points of Contention:
- Scope Questions: A central dispute may be whether the language of Aurobindo's proposed product label will be found to actively instruct or encourage the specific timing ("at least about 5 hours") and dosage ("about 150 mg") required by claim 1. The outcome could depend on whether the label contains explicit instructions, warnings, or pharmacokinetic data that would lead a user to perform the claimed method.
- Technical Questions: What evidence will be presented to establish that following the instructions on Aurobindo's label will necessarily result in the claimed outcome, i.e., that the cumulative amount of solriamfetol excreted in breast milk over 8 hours will be "about 0.26 mg or lower"?
V. Key Claim Terms for Construction
The Term: "at least about 5 hours"
- Context and Importance: This term defines the core manipulative step of the invention—the waiting period. The interpretation of "about" will be critical to determining the scope of literal infringement, as it controls how much deviation from the "5 hours" mark is permissible while still falling within the claim.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification introduces the time-delay concept with the phrase "at least about 2 hours (e.g., at least about 3, 4, or 5 hours)" ('609 Patent, col. 2:56-58). A party could argue that this language, along with the general use of "about," indicates the patentee did not intend a precise numerical cutoff.
- Evidence for a Narrower Interpretation: Claim 1 specifically recites "5 hours," which is the endpoint of the exemplary range provided in the specification. A party could argue that this choice signifies a particular importance for this duration and that "about" should be narrowly construed to prevent encompassing embodiments that are functionally different.
The Term: "adverse events"
- Context and Importance: The claim is a method for "decreasing the potential for adverse events." Practitioners may focus on this term because its definition frames the purpose and utility of the claimed method. Whether the term is limited to specific events mentioned in the patent could impact infringement and validity arguments.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term itself is general, and a party could argue it should be given its plain and ordinary meaning, covering any negative medical outcome for the infant resulting from solriamfetol exposure.
- Evidence for a Narrower Interpretation: The specification repeatedly provides a specific list of potential adverse events: "agitation, insomnia, anorexia, or reduced weight gain" ('609 Patent, col. 3:17-19, col. 8:40-43). A party could argue that these examples define and limit the scope of the term within the context of the patent.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that upon FDA approval, Aurobindo will induce infringement by "intentionally encourag[ing] acts of direct infringement," which in the ANDA context refers to the instructions and recommendations on the proposed product's label (Compl. ¶39). It also alleges contributory infringement, stating that the proposed product is designed for an infringing use and "lacks a substantial non-infringing use" (Compl. ¶40).
- Willful Infringement: The complaint does not use the word "willful" but alleges the case is "exceptional" and requests attorneys' fees under 35 U.S.C. § 285 (Compl. ¶43; Prayer for Relief ¶(J)). The basis for this appears to be Aurobindo's alleged knowledge of the '609 patent, evidenced by its submission of the Paragraph IV certification notice (Compl. ¶34).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of induced infringement: will the final FDA-approved label for Aurobindo's generic product contain language that instructs, encourages, or otherwise leads a lactating patient to perform the specific, timed method of administration and feeding recited in claim 1?
- A key question for claim construction will be the definitional scope of numerical terms: how broadly will the court interpret "about 150 mg" and "at least about 5 hours," and will the instructions anticipated for Aurobindo's product fall within that scope?
- A central evidentiary question will be one of inevitable result: assuming a patient follows the instructions on Aurobindo's label, does that action necessarily and inherently result in meeting the final limitation of claim 1 concerning the cumulative amount of drug excreted in breast milk?