DCT
2:24-cv-10802
Eli Lilly & Co v. Qilu Pharmaceutical Co Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Eli Lilly & Company (Indiana)
- Defendant: Qilu Pharmaceutical Co., Ltd. (China) and Qilu Pharma Inc. (Pennsylvania)
- Plaintiff’s Counsel: Walsh Pizzi O'Reilly Falanga LLP
- Case Identification: 2:24-cv-10802, D.N.J., 11/27/2024
- Venue Allegations: Plaintiff alleges venue is proper because Defendant Qilu Pharmaceutical Co., Ltd. is a foreign corporation that may be sued in any district, and Defendant Qilu Pharma Inc. has an established place of business in New Jersey. The complaint also notes that both defendants have previously been sued in the district and have not contested jurisdiction or venue.
- Core Dispute: Plaintiff alleges that Defendants' Abbreviated New Drug Application (ANDA) to market a generic version of the migraine drug REYVOW® constitutes an act of infringement of a patent covering specific tablet formulations.
- Technical Context: The technology relates to pharmaceutical compositions for lasmiditan, a selective 5-HT1F serotonin receptor agonist used for the acute treatment of migraine headaches.
- Key Procedural History: The complaint notes that the patent-in-suit issued on August 27, 2024. A prior lawsuit (2:24-cv-05847) exists between the parties involving the same ANDA but a different patent. This action was initiated after Defendants provided a Paragraph IV certification for the newly issued patent-in-suit, asserting non-infringement and/or invalidity.
Case Timeline
| Date | Event |
|---|---|
| 2019-07-09 | '423 Patent Priority Date |
| 2024-08-27 | U.S. Patent No. 12,071,423 Issued |
| 2024-11-08 | Date of Defendants' Paragraph IV Certification Letter |
| 2024-11-27 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 12,071,423 - Processes and intermediate for the large-scale preparation of 2,4,6-trifluoro-N-[6-(1-methyl-piperidine-4-carbonyl)-pyridin-2-yl]-benzamide hemisuccinate, and preparation of 2,4,6-trifluoro-N-[6-(1-methyl-piperidine-4-carbonyl)-pyridin-2-yl]-benzamide acetate
- Patent Identification: U.S. Patent No. 12,071,423, issued August 27, 2024.
The Invention Explained
- Problem Addressed: The patent specification describes challenges with prior methods for the large-scale synthesis of lasmiditan, noting low overall yields, and states that improvements could provide "substantial and varied benefits, particularly for production at large-scale" (’423 Patent, col. 2:1-4).
- The Patented Solution: While much of the patent discloses improved manufacturing processes, the asserted invention is a specific pharmaceutical composition for an oral tablet. The solution claimed is an immediate-release tablet formulation that combines the active ingredient, lasmiditan hemisuccinate, with a particular set of seven inactive ingredients (excipients) within specified weight ranges (’423 Patent, col. 33:51-68). A detailed example of such a formulation for 50 mg and 100 mg tablets is provided in the patent’s specification (’423 Patent, Table 2, col. 29-30).
- Technical Importance: The invention provides a specific, commercially formulated solid oral dosage form for lasmiditan, which the patent identifies as a selective 5-HT1F receptor agonist approved in the United States for the acute treatment of migraine (’423 Patent, col. 1:21-28).
Key Claims at a Glance
- The complaint asserts independent claim 1 (’423 Patent, col. 33:51-68; Compl. ¶36).
- The essential elements of independent claim 1 are:
- An immediate-release tablet comprising:
- (a) from 50 mg to 100 mg of the active ingredient (lasmiditan hemisuccinate);
- (b) from 30.86 mg to 61.71 mg of microcrystalline cellulose;
- (c) from 7.5 mg to 15.00 mg of pregelatinized starch;
- (d) from 0.56 mg to 1.12 mg of sodium lauryl sulfate;
- (e) from 5.63 mg to 40.53 mg of croscarmellose sodium;
- (f) from 2.25 mg to 4.50 mg of magnesium stearate; and
- (g) from 3.519 mg to 7.035 mg of a film coating.
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are Defendants' proposed 50 mg and 100 mg generic lasmiditan tablets, for which approval is sought in ANDA No. 219350 (the "Qilu ANDA Products") (Compl. ¶¶1, 9).
Functionality and Market Context
The Qilu ANDA Products are designed as immediate-release tablets intended for the acute treatment of migraine (Compl. ¶1). The complaint alleges that Defendants' ANDA relies on the FDA's findings of safety and efficacy for Plaintiff's REYVOW® product and contains data purporting to demonstrate bioequivalence to REYVOW® (Compl. ¶43). Upon approval, the products would compete as lower-cost generic alternatives to the branded drug. No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
’423 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An immediate-release tablet, wherein the tablet comprises: | The Qilu ANDA Products are alleged to be immediate-release tablets that are bioequivalent to Plaintiff's REYVOW® tablets. | ¶¶36, 43 | col. 33:51 |
| (a) from 50 mg to 100 mg free base equivalent of 2,4,6-trifluoro-N-[6-(1-methyl-piperidine-4-carbonyl)-pyridin-2-yl]-benzamide hemisuccinate; | The complaint alleges on information and belief that the Qilu ANDA Products contain the active ingredient within the claimed range. | ¶37 | col. 30:65-67 |
| (b) from 30.86 mg to 61.71 mg of microcrystalline cellulose; | The complaint alleges on information and belief that the Qilu ANDA Products contain this excipient within the claimed range. | ¶37 | col. 30:2-3 |
| (c) from 7.5 mg to 15.00 mg of pregelatinized starch; | The complaint alleges on information and belief that the Qilu ANDA Products contain this excipient within the claimed range. | ¶37 | col. 30:4 |
| (d) from 0.56 mg to 1.12 mg of sodium lauryl sulfate; | The complaint alleges on information and belief that the Qilu ANDA Products contain this excipient within the claimed range. | ¶37 | col. 30:6 |
| (e) from 5.63 mg to 40.53 mg of croscarmellose sodium; | The complaint alleges on information and belief that the Qilu ANDA Products contain this excipient within the claimed range. | ¶37 | col. 30:5, 10 |
| (f) from 2.25 mg to 4.50 mg of magnesium stearate; and | The complaint alleges on information and belief that the Qilu ANDA Products contain this excipient within the claimed range. | ¶37 | col. 30:11 |
| (g) from 3.519 mg to 7.035 mg of the film coating. | The complaint alleges on information and belief that the Qilu ANDA Products contain this component within the claimed range. | ¶37 | col. 30:14-15 |
Note: The complaint alleges infringement on "information and belief," with the specific factual support for each component's quantity being redacted in the public filing. The infringement theory appears to be based on the regulatory requirement that a generic product be bioequivalent to the branded product, which Plaintiff alleges is embodied by the patent's claims (Compl. ¶¶37, 43).
Identified Points of Contention
- Technical Question: A central factual question for the court will be whether the specific formulation detailed in Defendants' confidential ANDA contains each of the seven recited components in amounts that fall within the specific numerical ranges of claim 1. The dispute will likely focus on a direct comparison of the claimed "recipe" against the accused product's actual composition.
- Scope Questions: The complaint does not raise obvious disputes over claim term meaning, as the claimed components are standard pharmaceutical excipients. The primary contention is expected to be one of literal infringement based on quantitative amounts, rather than one of claim scope ambiguity.
V. Key Claim Terms for Construction
The terms of claim 1 are largely standard in the pharmaceutical arts and define specific chemical entities and quantitative ranges. As such, the dispute may focus less on claim construction and more on a direct factual comparison between the accused product and the claim limitations. However, one term is foundational to the scope of all claims.
- The Term: "comprises"
- Context and Importance: This transitional phrase defines whether the claim is "open" or "closed." Its construction determines whether a tablet containing additional, unlisted ingredients could still infringe the claim. Practitioners may focus on this term because if Defendants' formulation includes an excipient not listed in claim 1, the product could still be found to infringe because "comprising" is inclusive.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term "comprising" is used consistently in the patent's claims, which under established patent law principles, creates a strong presumption that the claims are open-ended and do not exclude additional, unrecited elements (’423 Patent, col. 33-34).
- Evidence for a Narrower Interpretation: The patent does not appear to provide explicit evidence to rebut the standard, broad interpretation of "comprising." A party seeking a narrower scope would need to argue that the specification as a whole limits the composition to only the listed elements, which is a difficult argument to sustain without explicit limiting language.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendants will induce and contribute to infringement by third parties (e.g., patients) (Compl. ¶52). The stated basis for this is that Defendants know the Qilu ANDA Products are "especially made or adapted for use in infringing" the '423 patent and are not staple articles of commerce suitable for substantial non-infringing use (Compl. ¶52).
- Willful Infringement: The complaint does not include a specific count for willful infringement. However, it does allege that the case is "exceptional" under 35 U.S.C. § 285 and requests an award of attorneys' fees (Compl. ¶54; Prayer for Relief ¶b). The factual basis for this allegation is not detailed.
VII. Analyst’s Conclusion: Key Questions for the Case
- A central question will be one of factual correspondence: Does the specific formulation disclosed in Defendants' confidential ANDA literally meet every quantitative range recited in claim 1 of the ’423 patent? The resolution of the infringement claim will likely depend on discovery into the precise composition of the Qilu ANDA Products.
- An equally important question will be one of validity: As indicated by their Paragraph IV certification, Defendants will likely challenge the patent's validity (Compl. ¶44). A key issue for the court will be whether the specific combination and ranges of excipients in claim 1 would have been obvious to a person of ordinary skill in the art of pharmaceutical formulation at the time of the invention.