DCT
2:25-cv-02860
Aragon Pharma Inc v. Lupin Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Aragon Pharmaceuticals, Inc. (Delaware) and Janssen Biotech, Inc. (Pennsylvania)
- Defendant: Lupin Limited (India) and Lupin Pharmaceuticals, Inc. (Delaware)
- Plaintiff’s Counsel: Robinson Miller LLC; Akin Gump Strauss Hauer & Feld LLP
- Case Identification: 2:25-cv-02860, D.N.J., 04/18/2025
- Venue Allegations: Plaintiffs allege venue is proper in the District of New Jersey because Defendant Lupin Pharmaceuticals, Inc. maintains a regular and established place of business in Somerset, New Jersey, and Defendant Lupin Ltd. is a foreign corporation that has previously consented to jurisdiction in the district.
- Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA to market a generic version of the prostate cancer drug Erleada® constitutes an act of infringement of a patent covering a specific method of treatment using the drug.
- Technical Context: The technology involves a second-generation anti-androgen compound, apalutamide, used in a method to treat metastatic castration-sensitive prostate cancer (mCSPC), a lethal stage of the disease.
- Key Procedural History: This is a Hatch-Waxman action filed under 35 U.S.C. § 271(e)(2) in response to a notice letter dated March 4, 2025, in which Defendants provided a Paragraph IV Certification asserting that U.S. Patent No. 11,963,952 is invalid, unenforceable, or will not be infringed by their proposed generic product.
Case Timeline
| Date | Event |
|---|---|
| 2019-01-30 | U.S. Patent No. 11,963,952 Earliest Priority Date |
| 2024-04-23 | U.S. Patent No. 11,963,952 Issued |
| 2025-03-04 | Defendants' ANDA Paragraph IV Certification Notice Letter |
| 2025-04-18 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,963,952 - “Anti-Androgens for the Treatment of Metastatic Castration-Sensitive Prostate Cancer”
- Patent Identification: U.S. Patent No. 11,963,952 (“Anti-Androgens for the Treatment of Metastatic Castration-Sensitive Prostate Cancer”), issued April 23, 2024. (Compl. ¶41).
The Invention Explained
- Problem Addressed: The patent addresses the progression of prostate cancer to metastatic castration-sensitive prostate cancer (mCSPC), for which there is an "unmet medical need for alternative treatment options" that can delay disease progression and improve survival beyond standard androgen deprivation therapy (ADT). (’952 Patent, col. 1:31-57).
- The Patented Solution: The invention is a method of treatment that involves administering the specific anti-androgen compound apalutamide. Crucially, the claimed method also includes a specific dosing regimen where the daily dose is reduced from a standard amount to 180 mg or 120 mg if the patient experiences "Grade 3 toxicity." (’952 Patent, Abstract; col. 3:1-5). This dose modification step is presented as an integral part of the method.
- Technical Importance: This therapeutic method is asserted to provide a significant clinical benefit by increasing both overall survival and progression-free survival in mCSPC patients compared to the existing standard of care. (’952 Patent, col. 2:9-23).
Key Claims at a Glance
- The complaint asserts independent claim 6 and dependent claims 7 and 8. (Compl. ¶51).
- Independent Claim 6 recites:
- A method of treating metastatic castration-sensitive prostate cancer in a male human,
- consisting essentially of administering a therapeutically effective amount of an anti-androgen to a male human with metastatic castration-sensitive prostate cancer,
- wherein the anti-androgen is 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide (apalutamide),
- and wherein the dose of the anti-androgen is decreased to 180 mg per day or 120 mg per day if the male human experiences a greater than or equal to Grade 3 toxicity.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendants' "Proposed ANDA Product," identified as "Apalutamide Tablets, 60 mg," which is a generic version of Plaintiffs' branded drug, Erleada®. (Compl. ¶¶2, 44).
Functionality and Market Context
- The product is an oral tablet containing the active pharmaceutical ingredient apalutamide. (Compl. ¶¶39-40). The alleged act of infringement is the submission of ANDA No. 217084, which seeks FDA approval to market this generic drug for the treatment of prostate cancer prior to the expiration of the ’952 Patent. (Compl. ¶2). The complaint alleges that the Proposed ANDA Product will be "specifically labeled for use in practicing the claims of the 952 Patent." (Compl. ¶54).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
11,963,952 Patent Infringement Allegations
| Claim Element (from Independent Claim 6) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating metastatic castration-sensitive prostate cancer in a male human... | The Proposed ANDA Product is intended for the treatment of metastatic castration-sensitive prostate cancer, and its proposed label will allegedly instruct physicians and patients to use it for this purpose. | ¶52, ¶54 | col. 25:1-3 |
| consisting essentially of administering a therapeutically effective amount of an anti-androgen... | The Proposed ANDA Product contains the anti-androgen apalutamide, and its proposed label will allegedly instruct administration of a therapeutically effective amount. | ¶52 | col. 25:3-5 |
| wherein the anti-androgen is 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide... | The active pharmaceutical ingredient in the Proposed ANDA Product is apalutamide, the compound recited in the claim. | ¶40, ¶44 | col. 25:6-10 |
| and wherein the dose of [the anti-androgen] is decreased to 180 mg per day or 120 mg per day if the male human experiences a greater than or equal to Grade 3 toxicity. | The complaint alleges that upon approval, physicians and patients will practice this specific dose-reduction step, implying that Defendants' proposed product label will instruct or encourage this precise course of action in response to patient toxicity. | ¶52, ¶53 | col. 3:1-5 |
- Identified Points of Contention:
- Scope Questions: A potential dispute may arise over the transitional phrase "consisting essentially of." A court will need to determine the "basic and novel characteristics" of the invention and whether any other therapies or excipients used with the generic product would "materially affect" those characteristics. The patent itself defines this characteristic as improving patient survivability, which may provide a basis for argument. (’952 Patent, col. 6:8-14).
- Technical Questions: A key evidentiary question is whether the Defendants' proposed product label for their generic drug will instruct physicians to perform the specific dosage decrease recited in the claim ("decreased to 180 mg per day or 120 mg per day") in response to the specific condition recited in the claim ("greater than or equal to Grade 3 toxicity"). If the proposed label omits this instruction, or phrases it differently, Defendants may argue that they do not induce infringement of the full method claim.
V. Key Claim Terms for Construction
The Term: "consisting essentially of"
- Context and Importance: This transitional phrase defines the scope of the claimed method. It is narrower than "comprising" but broader than "consisting of," permitting the presence of unrecited method steps so long as they do not materially affect the invention's fundamental character. The infringement analysis will depend on how the administration of Defendants' generic product in a real-world clinical setting aligns with this scope.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The phrase itself is a term of art that explicitly allows for the presence of some unrecited steps, distinguishing it from the more restrictive "consisting of."
- Evidence for a Narrower Interpretation: The patent specification provides a potential definition for the "basic and novel characteristic(s)" of the invention, stating it "relates to the ability of the method to provide at least one of the benefits described herein, including but not to the ability to improve the survivability of the male human population." (’952 Patent, col. 6:8-14). A party could argue this specific definition narrows the scope of what additional steps are permissible without being "material."
The Term: "Grade 3 toxicity"
- Context and Importance: This clinical term is the trigger for the claimed dose-reduction step, a central element of the asserted independent claim. The definition of this term is critical for determining whether the instructions on a generic drug's label would lead a physician to infringe the method.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not provide an explicit definition of the term in the claims or summary, which could support using the plain and ordinary meaning as understood by a person of ordinary skill in the art at the time.
- Evidence for a Narrower Interpretation: The specification's description of the underlying clinical trial states that adverse events were "graded according to NCI-CTCAE Version 4.03." (’952 Patent, col. 39:62-64). A party may argue that this reference incorporates the specific, well-defined NCI-CTCAE standard as the proper construction for "Grade 3 toxicity."
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b), asserting that Defendants will actively induce infringement by physicians and patients. (Compl. ¶53). The factual basis for this claim is the allegation that Defendants' proposed product will be "specifically labeled for use in practicing the claims" and that Defendants know users will follow these instructions. (Compl. ¶54).
- Willful Infringement: The complaint does not contain a formal count for willful infringement. However, it alleges that Defendants have "actual knowledge of the 952 Patent" based on the patent's listing in the FDA's Orange Book and its discussion in Defendants' notice letter. (Compl. ¶¶47, 55). These allegations of pre-suit knowledge could form the basis for a later claim for enhanced damages should infringement be found after commercial launch.
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of induced infringement: does the precise language of the proposed label for Lupin’s generic product instruct, encourage, or otherwise lead physicians and patients to perform every step of the patented method, including the specific dose reduction in response to "Grade 3 toxicity"? The case may turn on whether the label carves out or modifies this instruction.
- Another key question will be one of claim scope: can the phrase "consisting essentially of" be interpreted to exclude the real-world use of Lupin's product? This will depend on whether co-administered therapies or other aspects of the generic's formulation are found to "materially affect" the invention's stated characteristic of improving patient survivability.