DCT

1:22-cv-00744

Novartis Pharma Corp v. Accord Healthcare Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-00744, D. Del., 06/06/2022
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendants have committed acts of infringement in the district, have a regular and established place of business there, and have previously litigated Hatch-Waxman cases in the district.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) for a generic version of the cancer drug RYDAPT® constitutes an act of patent infringement.
  • Technical Context: The technology involves a specific staurosporine derivative, midostaurin, used as a targeted therapy for treating acute myeloid leukemia (AML) characterized by a particular genetic mutation.
  • Key Procedural History: This is a Hatch-Waxman action initiated in response to Defendants' notification letter, which stated their intent to market a generic drug before the expiration of the patent-in-suit and included a Paragraph IV certification asserting the patent is invalid, unenforceable, and/or not infringed.

Case Timeline

Date Event
2001-10-30 U.S. Patent No. 7,973,031 Priority Date
2011-07-05 U.S. Patent No. 7,973,031 Issued
2022-04-26 Defendants notify Plaintiffs of ANDA No. 217342 filing
2022-06-06 Complaint Filed

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

U.S. Patent No. 7,973,031 - Staurosporine Derivatives as Inhibitors of FLT3 Receptor Tyrosine Kinase Activity

The Invention Explained

  • Problem Addressed: The patent describes a need for effective treatments for diseases involving "deregulated FLT3 receptor tyrosine kinase activity," specifically certain types of leukemia ('031 Patent, col. 1:12-19). Activating mutations of the FLT3 receptor are found in a significant percentage of patients with acute myeloblastic leukemia (AML) and are associated with a poor prognosis ('031 Patent, col. 26:6-9).
  • The Patented Solution: The invention provides a method of treating these diseases by administering staurosporine derivatives, particularly the compound midostaurin (identified as the "Compound of formula VII"), which was discovered to be a potent inhibitor of the mutated FLT3 kinase ('031 Patent, Abstract; col. 24:35-49). This targeted inhibition is presented as a therapeutic approach for patients whose cancers are driven by this specific mutation ('031 Patent, col. 25:1-8).
  • Technical Importance: The invention represented a shift toward targeted therapy for a genetically-defined subset of AML patients, offering a potential treatment for a group that had a decreased chance of cure with then-current standard chemotherapies ('031 Patent, col. 26:15-19).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims," with a focus on "at least claim 1" (Compl. ¶32, ¶34).
  • Independent Claim 1 requires:
    • A method for treating a mammal suffering from acute myeloid leukemia
    • comprising orally administering to a mammal in need of such treatment
    • a therapeutically effective amount of up to 150 mg per day
    • of the compound N-[(9S,10R,11R,13R)-2,3,10,11,12,13-hexahydro-10-methoxy-9-methyl-1-oxo-9,13-epoxy-1H,9H-diindolo[1,2,3-gh:3',2',1'-lm]pyrrolo[3,4-j][1,7]benzodiazonin-11-yl]-N-methylbenzamide (midostaurin), or a salt thereof.
  • The complaint does not explicitly reserve the right to assert dependent claims, but the assertion of "one or more claims" leaves this possibility open (Compl. ¶32).

III. The Accused Instrumentality

Product Identification

Accord’s ANDA Product No. 217342, a generic version of RYDAPT® (Midostaurin) Capsules, 25 mg (Compl. ¶1, ¶12).

Functionality and Market Context

The complaint alleges that Accord’s ANDA Product, upon approval, will have the same active ingredient (midostaurin), method of administration (oral), dosage form (capsules), and dosage amount as Novartis’s RYDAPT® (Compl. ¶31). The product is intended for the treatment of adult patients with acute myeloid leukemia that is FLT3 mutation-positive (Compl. ¶27). The act of infringement alleged is the submission of the ANDA to the FDA seeking approval to market this generic product prior to the expiration of the ’031 Patent (Compl. ¶32).

IV. Analysis of Infringement Allegations

The infringement theory is based on the statutory act of filing an ANDA under 35 U.S.C. § 271(e)(2). The complaint alleges that the proposed product labeling for Accord's ANDA Product will be "substantially identical" to the RYDAPT® label and will therefore disclose and encourage an infringing use of the product (Compl. ¶34).

’031 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating a mammal suffering from acute myeloid leukemia... The proposed labeling for Accord's ANDA Product will allegedly relate to the treatment of acute myeloid leukemia. ¶34 col. 42:50-51
...comprising orally administering to a mammal in need of such treatment... Accord’s ANDA Product is a capsule for oral administration, and its proposed labeling will allegedly direct this method of administration. ¶1, ¶31 col. 42:51-52
...a therapeutically effective amount of up to 150 mg per day... Accord's ANDA Product will allegedly have the same dosage amount as RYDAPT®, and the proposed labeling will direct a dosage regimen that meets this limitation. ¶31 col. 42:66-43:1
...of N-[(9S,10R,11R,13R)-2,3,10,11,12,13-hexahydro-10-methoxy-9-methyl-1-oxo-9,13-epoxy-1H,9H-diindolo[1,2,3-gh:3',2',1'-lm]pyrrolo[3,4-j][1,7]benzodiazonin-11-yl]-N-methylbenzamide of the formula (VII): [chemical structure] or a salt thereof. Accord's ANDA seeks approval for a product containing midostaurin, which is the same active ingredient as RYDAPT® and the compound recited in the claim. ¶31 col. 42:54-43:11

No probative visual evidence provided in complaint.

Identified Points of Contention

  • Scope Questions: Claim 1 is directed to treating "acute myeloid leukemia" generally. The complaint states that RYDAPT® (and thus the likely proposed generic label) is indicated for a specific subtype: FLT3 mutation-positive AML (Compl. ¶27). This raises the question of whether the specific labeled indication falls within the scope of the broader claim language, or if a potential mismatch exists that could be argued at trial.
  • Technical Questions: The complaint does not provide the proposed label or specify the exact dosage regimen that will be recommended. A key question will be whether the dosage instructions on Accord’s proposed label direct an administration of "up to 150 mg per day" as required by Claim 1. Any recommended daily dose exceeding this amount would place the use outside the claim's literal scope.

V. Key Claim Terms for Construction

  • The Term: "acute myeloid leukemia"

    • Context and Importance: The construction of this term is central to the infringement analysis. Practitioners may focus on this term because the branded drug's label is for a specific genetic subtype (FLT3 mutation-positive AML), while the asserted independent claim is broader. The outcome of this construction could determine whether the specific labeled use infringes the general method claim.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The plain language of Claim 1 does not contain any limitation to a specific subtype of AML ('031 Patent, col. 42:50-51).
      • Evidence for a Narrower Interpretation: The patent specification repeatedly emphasizes that the invention addresses the problem of deregulated FLT3 kinase activity ('031 Patent, col. 25:1-3; col. 26:6-9). A defendant could argue that the claims should be interpreted in light of the stated purpose of the invention, potentially limiting their scope to the FLT3-mutated form of the disease. Dependent Claim 2 explicitly adds this limitation ('031 Patent, col. 44:1-4), which could be used to argue that the independent claim should be read more broadly under the doctrine of claim differentiation.

  • The Term: "therapeutically effective amount"

    • Context and Importance: This term, coupled with the "up to 150 mg per day" limitation, defines the dosage element of the claim. Its definition will be critical for determining whether the dosage regimen on the accused product's label meets the claim limitation.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent does not provide an explicit definition, suggesting the term could be given its plain and ordinary meaning as understood by a person of ordinary skill in the art.
      • Evidence for a Narrower Interpretation: The specification discusses various dosages and administration schedules, such as a total dose of 225 mg/day (e.g., 75 mg three times a day) ('031 Patent, col. 30:48-50). A party might argue the term should be understood in the context of the specific examples provided, although the claim language of "up to 150 mg per day" appears to be a clear cap that is distinct from the 225 mg/day example.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Accord will actively induce infringement by providing a product label that directs and encourages medical professionals and patients to administer the ANDA product in a manner that infringes one or more claims of the ’031 Patent (Compl. ¶36).
  • Willful Infringement: The willfulness allegation is based on Accord's filing of a Paragraph IV certification, which Plaintiffs assert was done "without a reasonable basis for believing that it would not be liable for infringing the '031 Patent" (Compl. ¶37).

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

  • A core issue will be one of claim scope versus labeled use: Can the method of treating "acute myeloid leukemia" as recited in Claim 1 be proven to be infringed by a product label that directs treatment for the specific subtype of FLT3 mutation-positive AML? The relationship between the general language of the independent claim and the specific indication on the proposed label will be a central point of dispute.
  • A key evidentiary question will be one of dosage limitation: Does the dosage regimen that will be instructed on Accord’s proposed product label fall within the "up to 150 mg per day" limitation of Claim 1? The ultimate infringement determination will depend on the precise text of the proposed label, which is not yet in the record.
  • A final question will be validity and enforceability: The case was triggered by Accord's Paragraph IV certification, which asserts that the '031 patent is invalid, unenforceable, and/or not infringed (Compl. ¶13). While the complaint focuses on infringement, Accord's eventual counterclaims will likely challenge the patent's validity on grounds such as obviousness or lack of written description.