DCT

2:25-cv-02020

Eli Lilly & Co v. Humanwell Pharmaceutical US Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-02020, D.N.J., 03/21/2025
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey based on Defendant Epic Pharma, LLC having an active business registration and a regular and established place of business in the state, as well as both Defendants' alleged engagement in activities within the district related to the preparation and submission of the Abbreviated New Drug Application (ANDA) at issue.
  • Core Dispute: This is a Hatch-Waxman action in which Plaintiffs allege that Defendants’ submission of an ANDA to the FDA for approval to market a generic version of the migraine drug REYVOW® constitutes an act of infringement of a patent covering a specific crystalline form of the drug's active ingredient.
  • Technical Context: The technology concerns pharmaceutical polymorphism, specifically distinct crystalline hydrate forms of the compound lasmiditan, which can affect a drug's stability, solubility, and manufacturing consistency.
  • Key Procedural History: The lawsuit was triggered by Defendants' notice letter, containing a Paragraph IV certification, which advised Plaintiffs of the submission of ANDA No. 219669 and asserted that the patent-in-suit is invalid or will not be infringed by the proposed generic product. The complaint also notes a related, pending patent infringement action against a different ANDA filer, Qilu Pharmaceutical Co., Ltd., concerning its own generic lasmiditan product.

Case Timeline

Date Event
2016-12-06 U.S. Patent No. 11,053,214 Priority Date
2021-07-06 U.S. Patent No. 11,053,214 Issue Date
2025-01-31 REYVOW® New Chemical Entity Exclusivity Expiration Date
2025-02-05 Date of Defendants' Paragraph IV Notice Letter
2025-02-10 Plaintiffs' receipt of Paragraph IV Notice Letter
2025-03-03 Defendants produce Humanwell ANDA and portions of DMF to Plaintiffs
2025-03-21 Complaint Filing Date

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

  • Patent Identification: U.S. Patent No. 11,053,214 (“’214 Patent”), issued July 6, 2021.

U.S. Patent No. 11,053,214 - Compositions and methods related to pyridinoylpiperidine 5-HT1F agonists

The Invention Explained

  • Problem Addressed: The patent's background describes a need for new anti-migraine therapies that do not cause vasoconstriction, a risk associated with the "triptan" class of drugs (’214 Patent, col. 1:41-51). Further, it highlights the general need in pharmaceutical development to identify, characterize, and control specific crystalline forms (polymorphs and pseudo-polymorphs) of an active pharmaceutical ingredient (API), because these different forms can possess distinct physical properties that affect a drug's manufacturing, stability, and therapeutic utility (’214 Patent, col. 2:13-19, col. 2:57-65).
  • The Patented Solution: The patent claims to have discovered and characterized new "pseudo-polymorphic forms" of the hemisuccinate salt of lasmiditan, the API in REYVOW® (’214 Patent, Abstract; col. 3:10-18). The invention is not the compound itself, but a specific hydrated crystalline structure of the compound, designated "Form D di-hydrate," which is defined by a characteristic X-ray powder diffraction (XRPD) pattern (’214 Patent, col. 4:27-34).
  • Technical Importance: The ability to consistently produce a specific, stable crystalline form of a drug is critical for ensuring product quality, predictable performance, and compliance with strict regulatory requirements for pharmaceutical products (’214 Patent, col. 2:57-65).

Key Claims at a Glance

  • The complaint asserts infringement of the ’214 Patent, providing Claim 1 as an exemplary claim (Compl. ¶37).
  • Independent Claim 1 is broken down into its essential elements below:
    • A crystalline Form D di-hydrate of the hemisuccinate salt of 2,4,6-trifluoro-N-[6-(1-methyl-piperidine-4-carbonyl)-pyridin-2-yl]-benzamide
    • characterized by an X-ray diffraction pattern when measured using Cu-Kα radiation
    • having at least peaks at about 18.7+/-0.2 degrees 2θ, 26.5+/-0.2 degrees 2θ, 27.0+/-0.2 degrees 2θ, 27.5+/-0.2 degrees 2θ and 27.8+/-0.2 degrees 2θ.
  • The complaint alleges infringement of "at least one claim" of the patent, suggesting its allegations are not limited to Claim 1 (Compl. ¶45).

III. The Accused Instrumentality

Product Identification

  • The products are the proposed 50 mg and 100 mg generic lasmiditan hemisuccinate tablets for which Defendants seek FDA approval via Humanwell ANDA No. 219669 (the “Humanwell ANDA Products”) (Compl. ¶¶ 10, 12).

Functionality and Market Context

  • The Humanwell ANDA Products are intended to be generic equivalents of Plaintiffs’ branded migraine treatment, REYVOW® (Compl. ¶1). The ANDA submission necessarily contains data purporting to show that the proposed generic is bioequivalent to REYVOW® (Compl. ¶30). The core technical aspect at issue is the solid-state form of the API. Plaintiffs allege, based on their review of confidential ANDA and Drug Master File documents, that the API in Defendants’ product is the specific crystalline form protected by the ’214 Patent (Compl. ¶¶ 38, 41).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

Claim Chart Summary

The following table summarizes the infringement allegations for the exemplary asserted claim.

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A crystalline Form D di-hydrate of the hemisuccinate salt of 2,4,6-trifluoro-N-[6-(1-methyl-piperidine-4-carbonyl)-pyridin-2-yl]-benzamide... The complaint alleges that the Humanwell ANDA Products comprise this specific crystalline hydrate form of the lasmiditan hemisuccinate salt. ¶38 col. 4:27-34
...characterized by an X-ray diffraction pattern when measured using Cu-Kα radiation having at least peaks at about 18.7+/-0.2 degrees 2θ, 26.5+/-0.2 degrees 2θ, 27.0+/-0.2 degrees 2θ, 27.5+/-0.2 degrees 2θ and 27.8+/-0.2 degrees 2θ. The complaint alleges that the API in the Humanwell ANDA Products is characterized by an X-ray diffraction pattern that includes these five specific peaks. ¶38 col. 20:41-44

Identified Points of Contention

  • Scope Questions: The claim recites peaks at "about" specific values, which are themselves given a tolerance of "+/-0.2 degrees." The litigation may focus on the proper interpretation of this language. A question for the court will be whether the term "about" broadens the claimed ranges beyond the explicit "+/-0.2 degrees" tolerance, and if so, by how much.
  • Technical Questions: The primary technical dispute will be a factual one: does the API in the Humanwell ANDA Products actually exist as the claimed "crystalline Form D di-hydrate" exhibiting the required XRPD peaks? The complaint makes this allegation "on information and belief" (Compl. ¶38), and the definitive answer will depend on expert testing and analysis of the generic product samples obtained during discovery.

V. Key Claim Terms for Construction

  • The Term: "about"

    • Context and Importance: This term directly qualifies the five numerical 2θ peak values that define the patented crystalline form. Its construction is critical because it determines the literal boundary of the claim. Practitioners may focus on this term because its interpretation will dictate how much deviation is permitted between the XRPD pattern of the accused product and the values recited in the claim.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent specification frequently uses "about" when discussing analytical measurements and acknowledges that XRPD peak assignments can vary due to instrumental factors, stating they "can vary by plus or minus about 0.1, 0.2, 0.3, or 0.4 degrees" (’214 Patent, col. 7:25-29). This language may support an interpretation that "about" is intended to capture a degree of variability beyond the explicit "+/-0.2" range.
      • Evidence for a Narrower Interpretation: A party could argue that the explicit inclusion of a "+/-0.2 degrees" tolerance in the claim itself represents the full extent of intended variability. Under this view, the term "about" might be construed as redundant or as encompassing an extremely small, insignificant variance, so as not to render the explicit tolerance meaningless.

  • The Term: "crystalline Form D di-hydrate"

    • Context and Importance: This term defines the identity of the material being claimed. The dispute will turn on whether the accused product comprises this specific physical form. The construction of this term will determine what characteristics, beyond the five listed XRPD peaks, are required for a substance to qualify as the claimed invention.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim language itself defines the form primarily by its characteristic XRPD peaks. A party may argue that any crystalline material meeting the chemical definition (lasmiditan hemisuccinate di-hydrate) and exhibiting those five peaks is, by definition, "crystalline Form D di-hydrate."
      • Evidence for a Narrower Interpretation: The specification provides a more detailed "fingerprint" for Form D, including a full list of XRPD peaks in Table 2 and thermal analysis data (TGA/DSC) in FIG. 2 (’214 Patent, col. 19:8-20:41; Fig. 2). A party may argue that to be "crystalline Form D di-hydrate," a substance must substantially match this more complete characterization, not just the five selected peaks in Claim 1.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants' future commercial activities would constitute induced and contributory infringement under 35 U.S.C. §§ 271(b) and (c) (Compl. ¶45). The factual basis alleged is that Defendants know their product is "especially made or adapted for use in infringing" the patent and is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶47).
  • Willful Infringement: The complaint does not contain a formal allegation of "willful infringement." It does, however, allege that this is an "exceptional case" within the meaning of 35 U.S.C. § 285, which, if proven, would warrant an award of attorneys' fees to Plaintiffs (Compl. ¶49).

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

  • A central issue will be one of factual proof: Will expert characterization of the Humanwell ANDA Products, once produced in discovery, confirm that the API exists as the specific "crystalline Form D di-hydrate" and exhibits an XRPD pattern falling within the scope of the asserted claims?
  • A key legal question will be one of claim scope: How will the court construe the term "about" in the context of a claim that already provides an explicit numerical tolerance ("+/-0.2 degrees") for its XRPD peak values? The resolution of this issue will directly impact the literal infringement analysis.
  • An underlying strategic question, prompted by the Defendants' Paragraph IV certification, will be one of validity: Can Defendants meet their burden of proving by clear and convincing evidence that the asserted claims of the ’214 Patent are invalid, likely by arguing that the claimed crystalline form was anticipated or rendered obvious by the prior art?