DCT

1:24-cv-00696

Amicus Therap US, LLC v. Teva Pharma USA, Inc.

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-00696, D. Del., 06/13/2024
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant entities Teva USA and Teva Pharmaceuticals are incorporated in Delaware. For Defendant Teva Industries, an Israeli corporation, Plaintiff alleges venue is proper because it may be sued in any U.S. judicial district and because it is a submitter of the ANDA at issue. The complaint notes that in a related matter, Defendants did not contest venue in the district.
  • Core Dispute: Plaintiff alleges that Defendant's submission of an Abbreviated New Drug Application (ANDA) to the FDA, seeking to market a generic version of Plaintiff's GALAFOLD (migalastat) capsules, constitutes an act of infringement of a patent covering methods of treating Fabry disease in patients with specific genetic mutations.
  • Technical Context: The technology lies in the field of precision medicine for rare genetic disorders, specifically concerning the use of a pharmacological chaperone to treat Fabry disease, a lysosomal storage disorder, in patients identified as having specific, responsive mutations in the GLA gene.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant's submission of ANDA No. 217586 and its associated Paragraph IV certification, which asserts that U.S. Patent No. 11,833,164 is invalid, unenforceable, or will not be infringed by its proposed generic product. The complaint also references a prior, related case (1:22-cv-01461-CJB) involving the same ANDA but different patents.

Case Timeline

Date Event
2018-08-10 FDA approves NDA for Plaintiff's GALAFOLD
2019-08-07 '164 Patent Priority Date
2020-08-05 Defendant submits CREATES Act request to purchase GALAFOLD for testing
2022-02-28 Defendant Teva Industries submits Drug Master File for migalastat hydrochloride
2022-10-05 Defendant notifies Plaintiff of ANDA submission via first of several notice letters
2023-12-05 U.S. Patent No. 11,833,164 issues
2024-06-13 Complaint Filed

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

  • Patent Identification: U.S. Patent No. 11,833,164, issued December 5, 2023. (Compl. ¶43)

The Invention Explained

  • Problem Addressed: Fabry disease is a genetic disorder caused by mutations in the gene encoding the enzyme α-galactosidase A (α-Gal A), leading to a harmful buildup of a substrate known as GL-3. ('164 Patent, col. 1:49-54). One therapeutic approach involves using small molecules called pharmacological chaperones (PCs) to stabilize the faulty enzyme. However, a significant technical challenge is that it is very difficult to predict whether a patient with a particular genetic mutation will respond to treatment with a PC. ('164 Patent, col. 2:35-41).
  • The Patented Solution: The invention provides methods for treating Fabry disease by identifying a large number of specific missense mutations in the GLA gene that are "amenable" to treatment with a PC, such as migalastat. By administering the PC to patients confirmed to have one of these specific mutations, the treatment can be targeted to a population known to be responsive, solving the unpredictability problem. ('164 Patent, col. 2:44-51, Abstract).
  • Technical Importance: This technology provides a basis for a personalized medicine approach to treating Fabry disease, enabling clinicians to select patients for therapy based on their specific genetic profile. (Compl. ¶4).

Key Claims at a Glance

  • The complaint asserts infringement of "at least one claim" of the '164 Patent without specifying which claims. (Compl. ¶71). Independent claim 1 is representative of the patented method.
  • Claim 1 Essential Elements:
    • A method of treating a patient diagnosed with Fabry disease.
    • The method comprises administering to the patient a therapeutically effective dose of a pharmacological chaperone for α-galactosidase A.
    • The patient has a missense mutation in the nucleic acid sequence encoding α-galactosidase A.
    • The mutation is selected from a large, explicitly enumerated "first group" of specific mutations.

III. The Accused Instrumentality

Product Identification

Defendant's proposed generic version of GALAFOLD migalastat 123 mg free base capsules, identified as "Teva's ANDA Product" associated with ANDA No. 217586. (Compl. ¶¶1, 48).

Functionality and Market Context

The accused product contains 123 mg of migalastat free base, the same active ingredient and dosage as Plaintiff's GALAFOLD Capsules. (Compl. ¶¶48, 73). Defendant has represented to the FDA that its product will be bioequivalent to GALAFOLD Capsules. (Compl. ¶73). The complaint alleges that Defendant will market its product with a label that will "substantially copy the instructions" of the GALAFOLD label, which will instruct administration to patients for the treatment of Fabry disease. (Compl. ¶52).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint alleges that Defendant's submission of its ANDA constitutes a statutory act of infringement under 35 U.S.C. § 271(e)(2) and that commercialization of the product upon approval would constitute direct and induced infringement under §§ 271(a) and (b). (Compl. ¶¶71, 74). The core of the infringement allegation is that physicians and patients who follow the instructions on the proposed label for Teva's ANDA Product will directly infringe the method claims of the '164 Patent.

'164 Patent 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 ANDA seeks approval to market its product for the treatment of Fabry disease, and its proposed label will instruct this use. ¶¶1, 52-53 col. 1:49-51
...the method comprising administering to the patient a therapeutically effective dose of a pharmacological chaperone for α-galactosidase A... Defendant's product contains a 123 mg dose of migalastat, a pharmacological chaperone for α-galactosidase A, and the proposed label will instruct its administration to patients. ¶¶1, 37, 48, 52 col. 2:25-27
...wherein the patient has a missense mutation in the nucleic acid sequence encoding α-galactosidase A, wherein the mutation is selected from a first group consisting of [list of mutations]. The complaint alleges that administration of GALAFOLD according to its FDA-approved label practices the claimed methods and that Defendant's label will be "identical in all relevant respects," thereby instructing use in patients with the claimed amenable mutations. ¶¶47, 52, 55 col. 2:48-51
  • Identified Points of Contention:
    • Scope Questions: A central issue may be whether the instructions for use on Defendant's proposed product label will require, or otherwise specifically encourage, administration of the drug only to the subset of Fabry patients having one of the specific mutations enumerated in the asserted claim(s). If the label's indication is broader than the claim's closed list of mutations, Defendant may assert that it does not induce infringement of that specific claim.
    • Technical Questions: The key evidentiary question will concern the precise language of the GALAFOLD label and Defendant's proposed generic label. The infringement analysis will depend on whether following the label's instructions would necessarily lead a physician or patient to practice all steps of the claimed method, including the patient-selection step based on the specific mutations listed in the patent.

V. Key Claim Terms for Construction

  • The Term: "wherein the patient has a missense mutation... selected from a first group consisting of [list of mutations]"
  • Context and Importance: This limitation defines the specific patient population to which the claimed method applies. The infringement analysis will depend entirely on whether the use induced by Defendant's product label is limited to this exact population. Practitioners may focus on this term because the phrase "consisting of" creates a closed-ended group, which is a significant restriction on claim scope.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: While the claim language is restrictive, parties seeking a broader context might point to the specification's more general discussion of "amenable" mutations, which suggests the invention's contribution was identifying a general principle of matching PCs to responsive mutations. ('164 Patent, col. 2:27-31).
    • Evidence for a Narrower Interpretation: The claim language "selected from a first group consisting of" is exceptionally strong evidence for a narrow interpretation, limiting the claim's scope exclusively to the mutations explicitly listed. The patent's summary and detailed description repeatedly emphasize the importance of identifying these specific mutations as being responsive to treatment. ('164 Patent, col. 2:44-51).

VI. Other Allegations

  • Indirect Infringement: The complaint's primary theory is induced infringement under 35 U.S.C. § 271(b). It alleges that Defendant knows and intends that its product label will instruct and encourage physicians and patients to administer the generic drug in a manner that directly infringes the patented method. (Compl. ¶¶60, 62-63, 77).
  • Willful Infringement: The complaint does not explicitly plead willfulness. However, it alleges that Defendant had actual and/or constructive knowledge of the '164 Patent prior to the lawsuit, based on the patent's listing in the FDA's Orange Book and Defendant's own Paragraph IV certification notice. (Compl. ¶¶70, 76, 87).

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

  • A core issue will be one of induced infringement scope: does the proposed label for Defendant's generic product specifically instruct or encourage use in a patient population that is coextensive with the closed list of mutations recited in the '164 patent's claims? The case will likely turn on a comparison of the precise language of the product labels against the patent's claims.
  • A key evidentiary question will be one of inevitable infringement: does following the instructions on the proposed generic label necessarily result in direct infringement by physicians and patients, or does the label allow for substantial non-infringing uses that would negate a finding of inducement?