DCT

2:24-cv-00309

Axsome Malta Ltd v. Aurobindo Pharma USA Inc

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-00309, D.N.J., 01/18/2024
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant Aurobindo Pharma USA, Inc. maintains a regular and established place of business in the district, and because Defendant Aurobindo Pharma Limited is a foreign corporation with sufficient contacts with the United States.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market a generic version of Plaintiff's Sunosi® (solriamfetol) drug product constitutes an act of patent infringement.
  • Technical Context: The technology relates to methods for administering solriamfetol, a treatment for excessive daytime sleepiness, to lactating women in a manner designed to reduce the drug's exposure to a breastfed infant.
  • Key Procedural History: The litigation was triggered by Defendant's submission of ANDA No. 218725 to the FDA. In connection with this ANDA, Defendant sent Plaintiff Paragraph IV Certification notice letters alleging that the patents-in-suit are invalid and/or will not be infringed by its proposed generic product.

Case Timeline

Date Event
2022-12-30 Earliest Priority Date for all Patents-in-Suit
2023-08-10 Aurobindo sends First Paragraph IV Notice Letter
2023-10-03 U.S. Patent No. 11,771,666 Issues
2023-10-03 U.S. Patent No. 11,771,667 Issues
2023-10-10 U.S. Patent No. 11,779,554 Issues
2023-10-24 U.S. Patent No. 11,793,776 Issues
2023-12-08 Aurobindo sends Second Paragraph IV Notice Letter
2024-01-18 Complaint Filed

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

U.S. Patent No. 11,771,666 - Methods of Administering Solriamfetol to Lactating Women

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of treating a lactating person with solriamfetol while minimizing potential adverse events in the breastfed infant, as pharmacokinetic studies show the drug is excreted into breast milk (Compl. ¶ 1; ’666 Patent, col. 1:5-11, col. 6:15-20).
  • The Patented Solution: The invention provides a specific dosing regimen based on pharmacokinetic data. It claims a method that involves orally administering a daily dose of solriamfetol (e.g., about 150 mg) to the lactating subject, and then waiting at least five hours before feeding the infant breast milk from that subject. This waiting period is timed to coincide with the period after the drug's concentration has peaked and begun to decline in breast milk, thereby reducing the total dose transferred to the infant (’666 Patent, Abstract; col. 2:36-48). The relationship between solriamfetol concentration in plasma and breast milk over time is illustrated in Figure 1 of the patent (’666 Patent, FIG. 1).
  • Technical Importance: The claimed method provides a data-driven protocol intended to allow lactating individuals who require treatment for conditions like narcolepsy to continue both their medication and breastfeeding with a reduced risk of infant exposure (’666 Patent, col. 6:7-15).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶ 32).
  • Essential elements of independent claim 1 include:
    • A method of reducing exposure to solriamfetol in an infant fed breast milk from a human subject treated with solriamfetol.
    • Orally administering solriamfetol to the subject at a once-daily dose of about 150 mg.
    • Feeding the infant breast milk from the subject at least about 5 hours after the administration.
    • Wherein the daily infant dose of solriamfetol is reduced to about 0.3 mg or lower.
  • The complaint does not explicitly reserve the right to assert dependent claims, but infringement is alleged for "one or more claims" of the patent (Compl. ¶ 34).

U.S. Patent No. 11,771,667 - Methods of Administering Solriamfetol to Lactating Women

The Invention Explained

  • Problem Addressed: As with the ’666 Patent, this patent addresses the need to manage infant exposure to solriamfetol when the drug is administered to a lactating person (’667 Patent, col. 1:12-19).
  • The Patented Solution: The invention is a method of treating certain disorders (e.g., excessive daytime sleepiness) in a lactating mother. The claimed method specifies an oral administration of a daily dose (e.g., about 150 mg) and feeding the infant breast milk at least five hours later, with the stated goals of reducing the infant's drug dose and decreasing the potential for adverse events (’667 Patent, Abstract; col. 2:3-13). This solution is based on the same pharmacokinetic principles and data as the ’666 Patent (’667 Patent, FIG. 1).
  • Technical Importance: This patent claims the therapeutic application of the dosing regimen, providing a method for actively treating the mother's underlying condition while implementing the safety protocol for the infant (’667 Patent, col. 2:1-13).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶ 41).
  • Essential elements of independent claim 1 include:
    • A method of treating specified conditions (e.g., excessive daytime sleepiness) in a lactating human mother feeding an infant.
    • Orally administering solriamfetol to the mother at a once-daily dose of about 150 mg.
    • Feeding the infant the breast milk obtained from the mother at least about 5 hours after administration.
    • Wherein the daily infant dose is reduced to about 0.3 mg or lower, and the potential for adverse events is decreased.
  • The complaint alleges infringement of "one or more of the claims" (Compl. ¶ 41).

Multi-Patent Capsule: U.S. Patent No. 11,779,554 - Methods of Administering Solriamfetol to Lactating Women

  • Technology Synopsis: This patent, part of the same family, is also directed to methods of administering solriamfetol to lactating women. It claims a method for reducing the risk of agitation in a breastfed infant by administering a specific dose of solriamfetol (e.g., 150 mg) and waiting at least five hours before feeding, thereby limiting the infant's total exposure to the drug (’554 Patent, Abstract; col. 1:5-11).
  • Asserted Claims: At least independent claim 1 (Compl. ¶ 50).
  • Accused Features: The accused act of infringement is Defendant's submission of ANDA No. 218725 seeking FDA approval for its generic solriamfetol product (Compl. ¶ 50).

Multi-Patent Capsule: U.S. Patent No. 11,793,776 - Methods of Administering Solriamfetol to Lactating Women

  • Technology Synopsis: This patent is also directed to methods of treating a postpartum human subject with solriamfetol while managing infant exposure. The claims specify a method of treatment that involves administering a dose of solriamfetol (e.g., 150 mg) and feeding the infant breast milk at least five hours later, resulting in a decreased total drug exposure for the infant and a reduced potential for adverse events (’776 Patent, Abstract; col. 1:12-19).
  • Asserted Claims: At least independent claim 1 (Compl. ¶ 59).
  • Accused Features: The accused act of infringement is Defendant's submission of ANDA No. 218725 seeking FDA approval for its generic solriamfetol product (Compl. ¶ 59).

III. The Accused Instrumentality

Product Identification

  • Defendant’s proposed generic solriamfetol oral tablets, for which Defendant seeks FDA approval via ANDA No. 218725 (“Aurobindo’s Proposed Product”) (Compl. ¶¶ 1, 18).

Functionality and Market Context

  • The proposed product is a generic version of Plaintiff’s Sunosi® oral tablets (Compl. ¶ 1). Sunosi® is 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). The complaint alleges that upon approval, Defendant will manufacture, market, and sell this product for distribution in the United States (Compl. ¶¶ 18, 27). The core of the infringement allegation is that the proposed product, when used as directed by its label for these indications, will be administered in accordance with the patented methods.

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a full claim-chart analysis, as it does not include Defendant's proposed product labeling, which is the central instrument of infringement in a Hatch-Waxman case involving method-of-use patents. The infringement theory is statutory, based on the submission of the ANDA under 35 U.S.C. § 271(e)(2)(A) (Compl. ¶ 32). Plaintiff alleges that Defendant is seeking approval for a generic drug for the same approved indications as Sunosi®, and that the instructions for use in Defendant's proposed label will necessarily instruct or encourage physicians and patients to perform the steps of the patented methods, leading to direct and indirect infringement upon commercial launch (Compl. ¶¶ 34-36).

  • Identified Points of Contention:
    • Scope Questions: A central question for the court will be whether the language of Defendant's proposed product label directs or suggests a dosing regimen that meets every limitation of the asserted claims. For example, does the label instruct waiting "at least about 5 hours" after administration before breastfeeding?
    • Technical Questions: A key evidentiary question will be whether use of the proposed generic product as directed by its label will inherently result in an infant dose of "about 0.3 mg or lower," as required by claim 1 of the ’666 and ’667 Patents.

V. Key Claim Terms for Construction

  • The Term: "at least about 5 hours"

    • Context and Importance: This term defines the minimum waiting period between drug administration and breastfeeding and is the core functional step of the claimed methods. The scope of "about" will be critical; a narrow construction could allow a generic label with slightly different timing instructions to avoid infringement, while a broader one could capture more variations. Practitioners may focus on this term because its interpretation will directly impact the infringement analysis of Defendant’s proposed label instructions.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The term "about" itself suggests some degree of numerical flexibility is intended. The specification does not explicitly define the term, which may support an argument for its plain and ordinary meaning as understood by a person of ordinary skill in the art.
      • Evidence for a Narrower Interpretation: The specification discloses that the mean elimination half-life in breast milk was "approximately 5.0 hours" (’666 Patent, col. 10:58-59). A party might argue that "about 5 hours" should be construed in light of this specific data point, limiting its scope to values scientifically proximate to 5.0 hours based on the study results.

  • The Term: "decreasing the potential for adverse events"

    • Context and Importance: This is a result-oriented limitation present in several asserted claims (e.g., ’667 Patent, claim 1). Its construction will determine what Plaintiff must prove to show infringement and whether the claim is sufficiently definite. The dispute will likely center on whether this phrase requires a proven clinical reduction in adverse events or is simply met by showing a reduction in infant drug exposure that is known to correlate with such events.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification links the method to reducing exposure to solriamfetol, which in turn decreases the potential for adverse events, suggesting that proving reduced exposure may be sufficient (’666 Patent, col. 2:36-48).
      • Evidence for a Narrower Interpretation: The specification explicitly names potential adverse events such as "agitation, insomnia, anorexia, or reduced weight gain" (’666 Patent, col. 2:27-28). A party could argue that the "potential" must relate to these specific, identified events and that the term requires more than a mere reduction in drug concentration.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all four patents-in-suit. The inducement allegation is based on the assertion that Defendant, with knowledge of the patents, will encourage infringement through its product labeling, marketing, and instructions (e.g., Compl. ¶ 44). The contributory infringement allegation is based on the assertion that Defendant's product is specifically designed for an infringing use and lacks a substantial non-infringing use (e.g., Compl. ¶ 45).
  • Willful Infringement: The complaint does not use the term "willful," but it alleges that Defendant had knowledge of the patents-in-suit at least as of the dates of its Paragraph IV notice letters (Compl. ¶¶ 29-30). It further alleges the case is "exceptional" and requests attorneys' fees under 35 U.S.C. § 285, which is the statutory basis for such an award in cases of egregious infringement or litigation misconduct (e.g., Compl. ¶ 39).

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

  • A core issue will be one of infringement via labeling: will the specific text of Aurobindo’s proposed product label contain instructions or recommendations that satisfy every element of at least one asserted claim, particularly the "at least about 5 hours" waiting period?
  • A key question for validity will be obviousness: was it obvious for a person of ordinary skill in the art to conduct a pharmacokinetic study of solriamfetol in lactating women and, based on the predictable results, define a specific waiting period post-administration to minimize infant exposure?
  • A central claim construction dispute will be one of definitional scope: what is the permissible range of the term "about" as used in "about 5 hours" and "about 0.3 mg," and how does the clinical data disclosed in the specification inform that range?