DCT

2:25-cv-12347

Eli Lilly & Co v. Qilu Pharmaceutical Co Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-12347, D.N.J., 06/30/2025
  • Venue Allegations: Venue is alleged to be proper as Defendant Qilu Pharmaceutical Co., Ltd. is a foreign corporation that may be sued in any judicial district. Venue is alleged against Defendant Qilu Pharma Inc. based on its regular and established place of business in New Jersey. The complaint also notes that Defendants have previously been sued in the District of New Jersey in other Hatch-Waxman cases and have not contested venue.
  • Core Dispute: Plaintiff alleges that Defendants' Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's REYVOW® (lasmiditan) tablets constitutes an act of infringement of a patent covering a method for the acute treatment of migraine.
  • Technical Context: The technology relates to pharmaceutical compositions for treating migraine, a common and highly disabling neurological disorder.
  • Key Procedural History: This action follows prior litigation between the same parties concerning the same ANDA (No. 219350) but involving different patents. Those earlier cases were consolidated. The patent-in-suit in this action issued after the prior cases were filed and was recently listed in the FDA's Orange Book for the REYVOW® product, prompting this new complaint.

Case Timeline

Date Event
2009-04-02 U.S. Patent No. 12,257,246 Priority Date
2024-03-21 Qilu sends Paragraph IV letter regarding U.S. Patent No. 11,053,214
2024-05-03 Plaintiffs file complaint against Qilu regarding U.S. Patent No. 11,053,214
2024-08-27 U.S. Patent No. 12,071,423 Issues
2024-11-11 Qilu sends Paragraph IV letter regarding U.S. Patent No. 12,071,423
2024-11-27 Plaintiffs file complaint against Qilu regarding U.S. Patent No. 12,071,423
2024-12-17 Parties seek to consolidate prior actions
2025-01-31 REYVOW® New Chemical Entity Exclusivity Expiration Date
2025-03-25 U.S. Patent No. 12,257,246 Issues
2025-04-28 Plaintiffs notify Qilu of issued '246 Patent
2025-05-15 Parties seek to extend deadlines to accommodate '246 Patent
2025-05-29 Plaintiffs receive Paragraph IV letter from Qilu regarding the '246 Patent
2025-06-30 Complaint Filing Date

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

U.S. Patent No. 12,257,246, "Composition of 2,4,6-trifluoro-N-[6-(1-methyl-piperidin-4-carbonyl)-pyridin-2-yl[-benzamide", issued March 25, 2025

The Invention Explained

  • Problem Addressed: The patent addresses the need for anti-migraine treatments that do not rely on vasoconstriction (’246 Patent, col. 1:12-25). Existing effective treatments, known as triptans, work by constricting cranial blood vessels, which carries a risk of coronary vasoconstriction and makes them unsuitable for patients with or at risk for cardiovascular disease (’246 Patent, col. 1:30-41).
  • The Patented Solution: The invention is a method of treating migraine using a pharmaceutical composition containing a specific molecule, 2,4,6-trifluoro-N-[6-(1-methyl-piperidin-4-ylcarbonyl)-pyridin-2-yl]-benzamide, referred to as "Compound I" (’246 Patent, col. 1:56-61). This compound is a selective 5-HT1F receptor agonist that is "neurally active," meaning it can inhibit the trigeminal nerve pathways associated with migraine pain without causing the vascular constriction associated with triptans (’246 Patent, col. 1:45-54). The asserted claims are directed to a specific oral dosage range for this compound for the acute treatment of migraine (’246 Patent, col. 33:21-29).
  • Technical Importance: The development of a "neurally active anti-migraine agent" provided a non-vascular mechanism for acute migraine treatment, which could represent a safer therapeutic option for patients for whom triptans are contraindicated (’246 Patent, col. 2:1-12).

Key Claims at a Glance

  • The complaint focuses its infringement allegations on independent claim 1 (Compl. ¶40).
  • Essential elements of Claim 1:
    • A method for the acute treatment of migraine in a human subject in need thereof
    • consisting of oral administration to said subject a pharmaceutical composition adapted for oral delivery,
    • the composition comprising 50 to 200 mg of 2,4,6-trifluoro-N-[6-(1-methyl-piperidin-4-ylcarbonyl)-pyridin-2-yl]-benzamide, or a pharmaceutically acceptable salt thereof,
    • and a pharmaceutically acceptable diluent or carrier,
    • wherein said composition is administered up to 200 mg daily.
  • The complaint alleges infringement of "at least one claim" of the ’246 patent, including claim 1 (Compl. ¶53, ¶55).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentalities are Defendants' proposed generic 50 mg and 100 mg lasmiditan tablets ("Qilu ANDA Products") for which Defendants seek FDA approval via ANDA No. 219350 (Compl. ¶¶9, 11).
  • Functionality and Market Context: The Qilu ANDA Products are intended as generic equivalents to Plaintiffs' branded REYVOW® product for the acute treatment of migraine (Compl. ¶1). The complaint alleges that Defendants' ANDA relies on the REYVOW® New Drug Application and contains data demonstrating bioequivalence (Compl. ¶50). It is further alleged that the Qilu ANDA Products will have the same method of administration and dosage form as REYVOW®, and that upon approval, Defendants intend to manufacture, market, and sell these generic products in the United States (Compl. ¶¶12, 50). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

'246 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for the acute treatment of migraine in a human subject in need thereof Defendants' ANDA seeks approval for the human use of the Qilu ANDA Products, and the proposed product labeling will instruct for the acute treatment of migraine. ¶43, ¶47 col. 33:21-23
consisting of oral administration to said subject a pharmaceutical composition adapted for oral delivery, The Qilu ANDA Products are tablets intended for oral administration, which Defendants have allegedly represented will have the same method of administration as REYVOW®. ¶11, ¶50 col. 33:23-25
the composition comprising 50 to 200 mg of 2,4,6-trifluoro-N-[6-(1-methyl-piperidin-4-ylcarbonyl)-pyridin-2-yl]-benzamide, or a pharmaceutically acceptable salt thereof, The Qilu ANDA Products are alleged to comprise 50 to 200 mg of the active pharmaceutical ingredient, specifically in 50 mg and 100 mg tablet forms. ¶11, ¶41 col. 33:25-29
and a pharmaceutically acceptable diluent or carrier, The Qilu ANDA Products are alleged to comprise a pharmaceutically acceptable diluent or carrier as part of their tablet formulation. ¶41 col. 33:28-29
wherein said composition is administered up to 200 mg daily. The proposed labeling for the Qilu ANDA Products will allegedly instruct a daily dosage that falls within the claimed limit. ¶40, ¶47 col. 33:28-29
  • Identified Points of Contention:
    • Validity Question: As this is a Hatch-Waxman case initiated in response to a Paragraph IV certification, the central dispute will likely concern the validity of the asserted claims, which Qilu's certification states are "either invalid or will not be infringed" (Compl. ¶51). A likely defense will be that the claimed dosage range of 50-200 mg was obvious in light of the clinical data and other art available at the time of the invention.
    • Scope Question: A potential, though likely secondary, issue for infringement revolves around the claim term "consisting of." This term strictly limits the invention to the recited elements. The question for the court would be whether Defendants' proposed method includes any additional active steps or ingredients that would place it outside the scope of the claim.

V. Key Claim Terms for Construction

  • The Term: "consisting of"

    • Context and Importance: This transitional phrase is a term of art in patent law that creates a strong presumption that the claim is "closed" and does not read on compositions or methods that include unrecited elements. Practitioners may focus on this term because it provides a potential, albeit narrow, path to arguing non-infringement, even in an ANDA case.
    • Intrinsic Evidence for Interpretation: The patent's use of the more open-ended term "comprising" elsewhere in the specification (e.g., ’246 Patent, col. 2:30-31) suggests the patentees deliberately chose the more restrictive "consisting of" for Claim 1. This contrast between claim terms may support a narrow, closed-ended construction.

  • The Term: "acute treatment of migraine"

    • Context and Importance: The definition of this term distinguishes the claimed method from prophylactic or preventative treatments. While infringement seems straightforward as the ANDA label for a generic must mirror the branded drug's indication for acute treatment, the scope of this term may be relevant to validity challenges based on prior art.
    • Intrinsic Evidence for Interpretation: The patent specification explicitly provides context for this term. For instance, Example 2 is titled "A Double Blind Randomized Placebo-Controlled Parallel Group Dose-Ranging Study of Oral Compound I in the Acute Treatment of Migraine" (’246 Patent, col. 19:46-50). The specification also distinguishes this from "prophylaxis treatment" or "prevention" (’246 Patent, col. 9:52-60), supporting a construction limited to treating a migraine attack that is already underway.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b). The factual basis is that Defendants' submission of the ANDA with proposed product labeling allegedly "encourage and instruct a healthcare provider" and patients to use the generic product in a manner that directly infringes the method claimed in the ’246 Patent (Compl. ¶¶47, 60).
  • Willful Infringement: The complaint does not use the term "willful," but it alleges that Defendants had knowledge of the ’246 patent, at least as of the date Plaintiffs received Defendants' Paragraph IV certification letter (Compl. ¶¶51, 59). The complaint further alleges that the case is "exceptional" under 35 U.S.C. § 285, which is the statutory basis for awarding enhanced damages and attorney's fees, often predicated on a finding of willfulness (Compl. ¶63).

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

  • A central question for the court will be one of validity, specifically obviousness: Given the state of the art and the clinical trial data disclosed in the patent's own specification, did selecting the oral dosage range of "50 to 200 mg" for the acute treatment of migraine represent a non-obvious inventive step, or would this specific range have been obvious to a person of ordinary skill in the art seeking to optimize a known compound for a known purpose?
  • A key question regarding infringement will be one of statutory interpretation in the ANDA context: Because an ANDA filer's proposed product and label must correspond to the approved branded drug, an allegation of infringement is often straightforward. The case will therefore likely turn on whether Defendants can mount a successful invalidity challenge to the patent claims, as their own ANDA filing provides the primary evidence that their product, if approved, would be used in a manner that practices the claimed method.