DCT

1:24-cv-00698

Amicus Therap US LLC v. Aurobindo Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-00698, D. Del., 06/13/2024
  • Venue Allegations: Venue is alleged as proper in the District of Delaware because Defendant Aurobindo Pharma USA is incorporated in Delaware, and Defendant Aurobindo Pharma Ltd. is a foreign corporation subject to suit in any U.S. judicial district.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of GALAFOLD® (migalastat) constitutes an act of infringement of a patent covering methods of treating Fabry disease in patients with specific genetic mutations.
  • Technical Context: The dispute is in the field of precision medicine for rare genetic disorders, involving a small molecule "pharmacological chaperone" designed to restore function to a deficient enzyme in patients with particular mutations.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s February 2024 notice letter, which contained a Paragraph IV certification asserting that U.S. Patent No. 11,833,164 is invalid, unenforceable, and/or will not be infringed by its proposed generic product. Plaintiff’s drug, GALAFOLD, has Orphan Drug Exclusivity until August 10, 2025.

Case Timeline

Date Event
2018-08-10 FDA approves Amicus's New Drug Application for GALAFOLD
2019-08-07 U.S. Patent No. 11,833,164 Priority Date
2020-04-XX Aurobindo first requests to purchase GALAFOLD for testing
2022-02-25 Aurobindo submits Drug Master File for migalastat hydrochloride
2022-03-28 Aurobindo sends second request to purchase GALAFOLD
2023-12-05 U.S. Patent No. 11,833,164 Issues
2024-02-15 Aurobindo sends Notice Letter concerning the '164 Patent
2024-06-13 Complaint Filing Date

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

U.S. Patent No. 11,833,164 - “Methods Of Treating Fabry Disease In Patients Having A Mutation In The GLA GENE”

The Invention Explained

  • Problem Addressed: The patent addresses the difficulty of predicting whether a patient with Fabry disease will respond to treatment with a pharmacological chaperone (PC), a type of small molecule drug that can stabilize deficient enzymes (Compl. ¶ 4; ’164 Patent, col. 2:32-42). Existing therapies have significant drawbacks, and while PCs offer an alternative, their effectiveness is highly dependent on the patient's specific genetic mutation, which produces the deficient enzyme ('164 Patent, col. 1:49-2:9).
  • The Patented Solution: The invention provides a method for treating Fabry disease by administering a therapeutically effective dose of a PC for the enzyme α-galactosidase A (α-Gal A), specifically to patients who have one of a long list of identified missense mutations in the GLA gene ('164 Patent, Abstract). These specified mutations are described as "amenable," meaning they produce a mutant enzyme that, while unstable, can be stabilized by the chaperone, allowing it to be properly transported within the cell to the lysosome and perform its function ('164 Patent, col. 2:25-32).
  • Technical Importance: The invention claims to move beyond a trial-and-error approach by creating a defined patient population, identified by genotype, for whom the pharmacological chaperone therapy is asserted to be effective, embodying a precision medicine strategy for this rare disease ('164 Patent, col. 2:32-42).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims of the patent, without specifying which ones (Compl. ¶ 62). Independent claim 1 is representative of the method claims.
  • Independent Claim 1:
    • A method of treating a patient diagnosed with Fabry disease,
    • the method comprising administering to the patient a therapeutically effective dose of a pharmacological chaperone for α-galactosidase A (α-Gal A),
    • wherein the patient has a missense mutation in the nucleic acid sequence encoding α-Gal A, and
    • wherein the mutation is selected from a large group of specified mutations listed in the claim.
  • The complaint does not explicitly reserve the right to assert dependent claims, but infringement is alleged as to "one or more claims" (Compl. ¶ 75).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Aurobindo's ANDA Product," a generic version of GALAFOLD® capsules containing 123 mg free base migalastat, for which Defendant has filed ANDA No. 217786 seeking FDA approval (Compl. ¶¶ 1, 49).

Functionality and Market Context

  • The ANDA product is alleged to have the same active ingredient, method of administration, dosage form, and dosage amount as Plaintiff's GALAFOLD Capsules and to be therapeutically equivalent (Compl. ¶ 70). The infringement theory is not based on the composition of the drug itself, but on its future marketing for the patented method. The complaint alleges that upon approval, Defendant will market the ANDA Product with a label that "is identical in all relevant respects to the labeling of GALAFOLD," thereby instructing physicians and patients to use the drug in an infringing manner (Compl. ¶ 53).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

U.S. Patent No. 11,833,164 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating a patient diagnosed with Fabry disease... Defendant's proposed product label will instruct physicians and patients on the use of the ANDA Product for the treatment of Fabry disease. ¶53 col. 5:45-52
...comprising administering to the patient a therapeutically effective dose of a pharmacological chaperone for α-galactosidase A (α-Gal A)... The ANDA Product contains migalastat, which the patent identifies as a pharmacological chaperone for α-Gal A, and the label will instruct its administration at a therapeutically effective dose. ¶¶ 70, 74 col. 4:59-62
...wherein the patient has a missense mutation in the nucleic acid sequence encoding α-Gal A, and wherein the mutation is selected from the group consisting of... [a specified list of mutations]. The complaint alleges that administration of GALAFOLD per its FDA-approved label practices the claims, and that Defendant's proposed label will be identical and therefore instruct administration to patients with the claimed amenable mutations. ¶¶ 48, 53, 56 col. 5:1-10:48

Identified Points of Contention

  • Scope Questions: A central question will be whether Defendant's proposed product label, even if substantially similar to the GALAFOLD label, specifically encourages, recommends, or promotes administration of the generic drug to the precise patient sub-population defined by the extensive list of mutations in Claim 1. The dispute may focus on whether the label's language is merely informational or rises to the level of active inducement for this patented method.
  • Technical Questions: What evidence does the complaint provide that the FDA-approved prescribing information for GALAFOLD, which the generic label will allegedly copy, directs treatment specifically to the claimed group of mutations? The complaint alleges this as a fact (Compl. ¶ 48), but the sufficiency of the label's language to meet the legal standard for inducement will be a primary point of contention.

V. Key Claim Terms for Construction

  • The Term: "a patient ... has a missense mutation ... selected from the group consisting of ..."
  • Context and Importance: This limitation defines the specific patient population to whom the patented method applies. The entire inducement analysis will depend on whether Defendant’s actions, principally through its product label, are found to target this exact group. Practitioners may focus on this term because it transforms a general treatment method into a specific, genotype-defined method.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent lists hundreds of mutations, covering a significant portion of the potential missense mutations in the GLA gene ('164 Patent, col. 5-10). A party could argue that any label generally directing use for Fabry disease in patients with amenable mutations would inevitably lead to infringement, given the breadth of the list.
    • Evidence for a Narrower Interpretation: A party could argue that for inducement to be found, a label must do more than just mention treatment for Fabry disease; it must specifically guide a physician to treat a patient precisely because they have one of the listed mutations. The patent itself distinguishes mutations based on their level of responsiveness ('164 Patent, Table 7), potentially creating an argument that the term requires a specific level of "amenability" that a general label might not address.

VI. Other Allegations

Indirect Infringement

  • The complaint's primary infringement theory is active inducement under 35 U.S.C. § 271(b) (Compl. ¶ 75). The specific facts alleged to support this claim are that Defendant will knowingly provide its ANDA Product with a label that includes instructions for use that substantially copy those of GALAFOLD, and that these instructions will inevitably cause physicians and patients to directly infringe the method claims of the '164 Patent (Compl. ¶¶ 53, 61-64, 77-78).

Willful Infringement

  • While not pleaded as a separate count, the complaint alleges facts that could support a future claim for willfulness. It asserts that Defendant has "actual knowledge" of the '164 Patent, evidenced by its February 2024 notice letter, and that it "specifically intends" for its label to "encourage, recommend, promote, and/or instruct others" to infringe (Compl. ¶¶ 71, 78).

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

  • A core issue will be one of inducement via label scope: will the language in Defendant’s proposed generic drug label be deemed to specifically instruct or encourage physicians to treat the precise, genetically-defined patient population recited in the '164 Patent's claims, thereby satisfying the specific intent requirement for induced infringement?
  • A key evidentiary question will be one of market reality and causation: what evidence will be presented to demonstrate that the intended market for the generic drug substantially overlaps with the patented patient population, and that the proposed label—as opposed to other sources of medical information—would be the direct cause of physicians performing the infringing method of treatment?