DCT

2:26-cv-00168

Aragon Pharma Inc v. Hetero Labs Ltd Unit V

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:

  • Case Identification: 2:26-cv-00168, D.N.J., 01/09/2026

  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Hetero USA, Inc. maintains a regular and established place of business in Piscataway, New Jersey, and has committed acts of infringement in the district, including the submission of the Abbreviated New Drug Application (ANDA) that is the subject of this action.

  • Core Dispute: Plaintiffs allege that Defendants’ submission of an ANDA to the FDA seeking approval to market a generic version of the prostate cancer drug Erleada® (apalutamide) infringes two U.S. patents covering specific pharmaceutical compositions and methods of use for apalutamide.

  • Technical Context: The technology relates to pharmaceutical treatments for prostate cancer, specifically involving formulations of the anti-androgen compound apalutamide and methods for its use in treating metastatic castration-sensitive prostate cancer.

  • Key Procedural History: This action follows Defendants’ submission of ANDA No. 220525 and subsequent Paragraph IV certification letters in May and November 2025, asserting that the patents-in-suit are invalid, unenforceable, or will not be infringed. The complaint also references a prior, related litigation between the parties involving other patents covering Erleada®, filed in 2025.

Case Timeline

Date Event
2014-12-05 ’493 Patent Priority Date
2019-01-30 ’497 Patent Priority Date
2025-03-20 Defendants submit ANDA No. 220525 to the FDA
2025-05-08 Defendants send May 2025 Notice Letter to Plaintiffs
2025-05-20 ’493 Patent Issued
2025-05-20 ’497 Patent Issued
2025-06-06 Defendants produce ANDA documents to Plaintiffs
2025-11-26 Defendants amend ANDA and send November 2025 Notice Letter
2026-01-09 Complaint Filed

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

U.S. Patent No. 12,303,493 - *"Anticancer Compositions"*

The Invention Explained

  • Problem Addressed: The patent describes that an earlier formulation of the active ingredient ARN-509 (apalutamide) was a lipid-based solution in softgel capsules that suffered from poor stability, requiring cold chain storage and having only a six-month shelf life. This also resulted in a high "pill burden" for cancer patients, who needed to take eight capsules per day (’493 Patent, col. 2:36-53).
  • The Patented Solution: The invention is a "solid dispersion" that combines the active drug, ARN-509, with a polymer, hydroxypropyl methylcellulose acetate succinate (HPMCAS) (’493 Patent, Abstract). This mixture can be created through processes like melt-extrusion or spray drying and allows the drug to be formulated into a more stable solid dosage form, such as a tablet, thereby improving shelf life, removing the need for cold storage, and reducing the number of pills a patient must take (’493 Patent, col. 1:28-53).
  • Technical Importance: The formulation provides a solution to significant logistical, stability, and patient adherence challenges associated with the prior softgel formulation of apalutamide (’493 Patent, col. 2:48-53).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 20, and dependent claim 16 (Compl. ¶55).
  • Independent Claim 1:
    • A solid dispersion comprising
    • (ARN-509) and
    • hydroxypropyl methylcellulose acetate succinate (HPMCAS).
  • Independent Claim 20:
    • A pharmaceutical formulation according to claim 16 [which requires a pharmaceutically acceptable carrier and the solid dispersion of claim 1]
    • wherein the formulation comprises 240 mg of ARN-509.

U.S. Patent No. 12,303,497 B2 - *"Anti-Androgens for the Treatment of Metastatic Castration-Sensitive Prostate Cancer"*

The Invention Explained

  • Problem Addressed: The patent addresses the unmet medical need for more effective treatment options for patients with metastatic castration-sensitive prostate cancer (mCSPC), a lethal stage of the disease for which androgen deprivation therapy (ADT) was a standard but limited treatment (’497 Patent, col. 1:47-59).
  • The Patented Solution: The invention provides a method of treating mCSPC by administering apalutamide in combination with standard ADT. Clinical trial data described in the patent, including Kaplan-Meier curves, demonstrates that this combination therapy significantly increases both overall survival and radiographic progression-free survival when compared to patients receiving ADT and a placebo (’497 Patent, col. 2:10-27; Fig. 2A, Fig. 3A).
  • Technical Importance: This method establishes a new, more effective standard of care for mCSPC patients that leads to clinically meaningful improvements in survival outcomes (’497 Patent, col. 2:10-14).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 12 (Compl. ¶72).
  • Independent Claim 1:
    • A method for increasing overall survival and progression-free survival in a patient having metastatic castration-sensitive prostate cancer,
    • said method comprising administering apalutamide in a therapeutically effective amount in combination with androgen deprivation therapy to the patient,
    • wherein administration of the apalutamide...provides an increase in the overall survival rate relative to the overall survival rate of a population of patients...having been administered a placebo in combination with an androgen deprivation therapy, and
    • wherein administration of the apalutamide...provides an increase in the progression-free survival rate of the patient relative to progression-free survival rate of a population of patients...having been administered a placebo in combination with an androgen deprivation therapy.
  • Independent Claim 12:
    • A method according to claim 1, wherein administration of apalutamide in combination with androgen deprivation therapy provides
    • (i) an increase in overall survival and a 33% reduction in risk of death or
    • (ii) an increase in progression free survival and a 52% reduction in risk of radiographic progression or death.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendants' "Proposed ANDA Product," a generic version of Erleada® 240 mg tablets, for which Defendants seek FDA approval via ANDA No. 220525 (Compl. ¶2, ¶47).

Functionality and Market Context

  • The Proposed ANDA Product contains the active pharmaceutical ingredient apalutamide and is intended for oral administration for the treatment of prostate cancer (Compl. ¶36, ¶47). As an ANDA product, it is a generic drug designed to be therapeutically equivalent to the branded drug Erleada®. The filing of the ANDA represents a commercial effort to market this generic version prior to the expiration of Plaintiffs' patents (Compl. ¶2).

IV. Analysis of Infringement Allegations

12,303,493 Infringement Allegations

The complaint alleges infringement of the ’493 Patent under the doctrine of equivalents, asserting that the Proposed ANDA Product contains a material that is "equivalent to" the claimed HPMCAS (Compl. ¶56). The complaint illustrates the chemical structure of apalutamide, the claimed ARN-509 compound (Compl. ¶57).

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A solid dispersion comprising (ARN-509) The Proposed ANDA Product allegedly contains a solid dispersion comprising apalutamide. ¶56-57 col. 1:54-55
and hydroxypropyl methylcellulose acetate succinate (HPMCAS). The Proposed ANDA Product allegedly contains a material that is the "equivalent to" HPMCAS. ¶56 col. 1:55-56
  • Identified Points of Contention:
    • Equivalence Questions: The complaint's exclusive reliance on the doctrine of equivalents raises the primary question of the case: what material is used in the Proposed ANDA Product in place of HPMCAS, and is it in fact equivalent? The analysis will focus on whether this unidentified material performs substantially the same function (forming a stable solid dispersion with apalutamide), in substantially the same way, to achieve substantially the same result (improved stability and bioavailability).
    • Scope Questions: The complaint does not provide sufficient detail for analysis of whether the accused product literally contains a "solid dispersion." The scope of this term, and whether the accused formulation meets it, may become a point of contention.

12,303,497 Infringement Allegations

The complaint alleges that Defendants will induce infringement of the ’497 Patent’s method claims by marketing their generic apalutamide product with a label that instructs or encourages physicians and patients to use it for treating mCSPC in combination with ADT (Compl. ¶73-74).

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for increasing overall survival and progression-free survival in a patient having metastatic castration-sensitive prostate cancer, Defendants will allegedly sell and label their Proposed ANDA Product for use in practicing a method for treating mCSPC that increases survival outcomes. ¶73-74 col. 2:10-14
said method comprising administering apalutamide in a therapeutically effective amount The Proposed ANDA Product contains apalutamide, and its proposed label will instruct administration in a therapeutically effective amount for treating mCSPC. ¶73 col. 1:61-65
in combination with androgen deprivation therapy to the patient, The proposed label will instruct co-administration with androgen deprivation therapy. ¶73 col. 2:10-14
wherein administration...provides an increase in the overall survival rate...[and] progression-free survival rate...relative to...a placebo... The proposed label will allegedly contain data demonstrating the claimed increases in survival rates, thereby encouraging physicians to perform the infringing method. ¶73 col. 2:10-27
  • Identified Points of Contention:
    • Label Scope Questions: A central question will be whether the content of the Defendants’ proposed product label specifically encourages, recommends, or instructs the performance of the patented method. The dispute may turn on whether the label language merely describes clinical trial results or actively promotes a method of use that meets all limitations of the asserted claims.
    • Intent Questions: To prove inducement, Plaintiffs must show that Defendants acted with the specific intent to encourage infringement. This analysis will focus on evidence that Defendants knew of the patent and, through their product labeling and marketing, intended for physicians and patients to perform the claimed method.

V. Key Claim Terms for Construction

  • The Term: "a solid dispersion" (’493 Patent, Claim 1)

  • Context and Importance: This term defines the fundamental structure of the claimed composition. The complaint's reliance on the doctrine of equivalents suggests that the precise definition of "solid dispersion" and what constitutes the HPMCAS component will be central. Practitioners may focus on this term because if Defendants' formulation does not meet this limitation, either literally or equivalently, there can be no infringement.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification suggests "a solid dispersion" can encompass systems that are not perfectly uniform, relating to systems with "domains or small regions wherein amorphous, microcrystalline or crystalline" components are "dispersed more or less evenly in another phase" (’493 Patent, col. 8:41-54).
    • Evidence for a Narrower Interpretation: The patent identifies "solid solutions" as a preferred type of solid dispersion, which are described as being "chemically and physically uniform or homogenous throughout" (’493 Patent, col. 8:23-34). A party could argue that the invention is properly limited to these preferred homogenous systems.

  • The Term: "increasing overall survival and progression-free survival" (’497 Patent, Claim 1)

  • Context and Importance: This is a functional, results-oriented limitation that defines the purpose and outcome of the claimed method. Infringement of this method claim by inducement depends on the defendant’s label instructing a use that achieves this result. The construction of this term will determine the benchmark against which the instructions on the accused product's label are measured.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The term could be interpreted to cover any statistically significant increase in the specified survival metrics when apalutamide is added to ADT, as compared to ADT alone.
    • Evidence for a Narrower Interpretation: The specification and dependent claims provide highly specific quantitative definitions of this "increase," such as a "33% reduction in risk of death" or a "52% reduction in risk of radiographic progression or death" (’497 Patent, Claim 12). A party may argue that the term should be construed in light of these specific clinical outcomes disclosed and claimed in the patent.

VI. Other Allegations

  • Indirect Infringement:
    • For the ’493 Patent, the complaint alleges both induced and contributory infringement, asserting Defendants intend for their product to be used in an infringing manner and that the product is specifically designed for such use (Compl. ¶66-68).
    • For the ’497 Patent, the infringement theory is entirely based on induced infringement. The complaint alleges Defendants will induce infringement by physicians and patients through the instructions and indications on the Proposed ANDA Product's label (Compl. ¶74, ¶82).
  • Willful Infringement: The complaint does not contain a specific count for willful infringement. However, it alleges that Defendants have "actual knowledge" of both patents-in-suit, citing their listing in the FDA's Orange Book and their identification in Defendants' November 2025 Notice Letter (Compl. ¶51, ¶61, ¶77). These allegations may form the basis for a later claim of willfulness.

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

  • A core issue will be one of compositional equivalence: As infringement of the ’493 Patent is alleged solely under the doctrine of equivalents, the case will likely turn on an evidentiary question: does the unidentified excipient in the accused generic product perform substantially the same function, in substantially the same way, to achieve substantially the same result as the claimed HPMCAS in creating a stable apalutamide formulation?
  • A central question for the ’497 Patent will be one of inducement via labeling: Does the proposed label for the generic apalutamide product actively instruct or encourage medical professionals to administer the drug for the specific, claimed purpose of "increasing overall survival and progression-free survival" in mCSPC patients, thereby establishing the requisite intent for induced infringement?