DCT

1:25-cv-06986

Allergan Inc v. Alembic Pharma Ltd

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-06986, E.D.N.Y., 12/19/2025
  • Venue Allegations: Venue is asserted on the basis that the defendant is a foreign corporation and may therefore be sued in any judicial district.
  • Core Dispute: Plaintiffs allege that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of the glaucoma drug LUMIGAN® 0.01% constitutes an act of infringement of a patent covering the drug's formulation.
  • Technical Context: The technology concerns an ophthalmic solution for treating glaucoma and ocular hypertension, a condition affecting millions and representing a significant pharmaceutical market.
  • Key Procedural History: The complaint notes that the patent-in-suit has been the subject of multiple prior ANDA litigations. In one case, the patent was found valid and infringed after a bench trial, a decision affirmed by the U.S. Court of Appeals for the Federal Circuit. In another, the defendant stipulated to not contest validity. A third case, filed in the same district as the present action, involved a dispute over the patent's term adjustment that was dismissed after the court found the issue too fact-intensive for early resolution.

Case Timeline

Date Event
2005-03-16 ’504 Patent Priority Date
2010-08-31 FDA Approval of LUMIGAN® 0.01%
2010-12-14 ’504 Patent Issue Date
2014-01-13 E.D. Tex. finds ’504 Patent valid and infringed in Sandoz litigation
2015-08-01 Federal Circuit affirms E.D. Tex. decision in Sandoz litigation
2024-10-01 Stipulated dismissal in Mankind Pharma litigation
2025-08-13 E.D.N.Y. denies motion for reconsideration in Amneal litigation
2025-09-01 Stipulated dismissal in Amneal litigation
2025-11-07 Alembic sends Paragraph IV Notice Letter to Plaintiffs
2025-12-19 Complaint Filing Date
2027-06-13 ’504 Patent Expiration Date

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

U.S. Patent No. 7,851,504 - “Enhanced bimatoprost ophthalmic solution”

The Invention Explained

  • Problem Addressed: The patent addresses the need for effective ophthalmic compositions for treating glaucoma and ocular hypertension. The background acknowledges the use of bimatoprost as a treatment and benzalkonium chloride (BAK) as a preservative in commercial eye drops (’504 Patent, col. 1:11-23). The implicit challenge is to optimize the formulation to enhance therapeutic efficacy while maintaining safety and stability.
  • The Patented Solution: The invention is a specific aqueous ophthalmic solution combining a low concentration of the active ingredient, bimatoprost, with a relatively high concentration of the preservative BAK (’504 Patent, Abstract). The specification discloses that increasing the concentration of BAK can result in higher permeability of bimatoprost, suggesting that a higher preservative level can enhance the delivery and absorption of the active drug (’504 Patent, col. 5:57-62). This allows the formulation to achieve its therapeutic effect with a lower amount of bimatoprost.
  • Technical Importance: This formulation strategy suggests a method to improve drug delivery not by altering the active ingredient itself, but by manipulating an excipient (the preservative) to increase the bioavailability of the drug in the eye.

Key Claims at a Glance

  • The complaint asserts infringement of claims 1, 2, and 3 (Compl. ¶42). Claim 1 is the sole independent claim asserted.
  • Independent Claim 1 requires:
    • A composition having a pH of about 7.3
    • which consists essentially of
    • about 0.01% bimatoprost,
    • about 200 ppm benzalkonium chloride,
    • a phosphate buffer,
    • NaCl,
    • and water,
    • wherein the composition is an aqueous liquid formulated for ophthalmic administration.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendant Alembic’s generic version of LUMIGAN® 0.01%, for which it seeks FDA approval via ANDA No. 210144 (Compl. ¶1-2).

Functionality and Market Context

The product is an ophthalmic solution designed to reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension (Compl. ¶3-4). As an ANDA product, it is intended to be a bioequivalent and lower-cost generic alternative to Plaintiffs’ brand-name LUMIGAN® 0.01% (Compl. ¶1, ¶28). The complaint alleges that Alembic intends to market and sell this product throughout the United States, including in New York, upon receiving FDA approval (Compl. ¶19, ¶27).

IV. Analysis of Infringement Allegations

The complaint does not provide a detailed element-by-element breakdown of its infringement allegations or attach the underlying notice letter and its accompanying claim chart. Instead, it alleges on information and belief that Alembic's ANDA Product meets every limitation of claims 1–3 of the '504 Patent, stating that Alembic's Notice Letter "does not dispute" this point (Compl. ¶42). The infringement theory is characteristic of ANDA litigation: because Alembic's product is a generic version of LUMIGAN® 0.01% and must be bioequivalent, its formulation will necessarily fall within the scope of the patent claims covering that product.

No probative visual evidence provided in complaint.

  • Identified Points of Contention: Given the complaint’s limited technical detail, the infringement analysis may raise several questions for the court.
    • Scope Questions: The use of the transitional phrase "consists essentially of" in Claim 1 raises the question of whether Alembic's ANDA product contains any unlisted ingredients that materially affect the basic and novel properties of the claimed formulation. The complaint does not identify the full composition of the accused product.
    • Technical Questions: A potential issue concerns the claim's numerical limitations, such as "about 0.01% bimatoprost" and "about 200 ppm benzalkonium chloride." The dispute may turn on whether the precise concentrations in Alembic's formulation fall within the scope of the term "about" as interpreted by the court.

V. Key Claim Terms for Construction

  • The Term: "consists essentially of"

    • Context and Importance: This term defines the scope of the claimed composition. It is broader than "consisting of" but narrower than "comprising," permitting the inclusion of unlisted ingredients only if they do not materially affect the invention's basic and novel properties. The infringement analysis will depend on what those properties are and whether any excipients in Alembic's product materially affect them.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent specification describes other conventional excipients that may be used in ophthalmic solutions, such as chelating agents, viscosity enhancers, and other tonicity agents, suggesting the inventors contemplated their potential inclusion (’504 Patent, col. 2:14-49).
      • Evidence for a Narrower Interpretation: The patent's examples and description focus on the enhanced permeability and absorption of bimatoprost resulting from a specific, higher concentration of BAK (’504 Patent, col. 5:51-62). A party could argue that this enhanced permeability is a "basic and novel property," meaning any unlisted ingredient that significantly impacts bimatoprost absorption would be excluded from the claim's scope.

  • The Term: "about 200 ppm benzalkonium chloride"

    • Context and Importance: The definition of "about" will determine the permissible range of BAK concentration in an infringing product. Since Alembic’s ANDA formulation may not contain exactly 200 ppm of BAK, the case could turn on whether its actual concentration is close enough to be considered "about 200 ppm."
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification discloses broader ranges for BAK concentration, such as "from 100 ppm to 250 ppm" and "from 150 ppm to 200 ppm," which may suggest that the inventors did not consider 200 ppm to be a precise, critical threshold (’504 Patent, col. 1:60-61, col. 2:12-14).
      • Evidence for a Narrower Interpretation: The patent's experimental data specifically compares a 200 ppm BAK formulation to a 50 ppm control, demonstrating a statistically significant increase in drug concentration in the aqueous humor at 200 ppm (’504 Patent, Table 2). This data could support an argument that "about 200 ppm" should be construed narrowly around the specific value shown to produce the superior result.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that should Alembic engage in the commercial manufacture and sale of its ANDA product, it would induce and contribute to the infringement of the ’504 Patent (Compl. ¶30, ¶41). These allegations are based on the premise that Alembic's product is intended for use by patients and medical professionals in a manner that directly infringes the patent's claims.
  • Willful Infringement: The complaint asserts that Alembic had "actual and constructive notice of the ’504 patent prior to filing Alembic’s ANDA" and was aware its actions would constitute infringement (Compl. ¶43). While the term "willful" is not used, the factual predicate for such a claim is laid. The complaint's emphasis on the patent's extensive and successful prior litigation history against other generic challengers may be used to support this allegation and a request for enhanced damages or attorney's fees (Compl. ¶9-11; Prayer for Relief ¶(h)).

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

  • A primary issue will be one of patent validity: In light of the ’504 Patent’s history of surviving challenges, can the defendant advance a successful invalidity argument, possibly focusing on issues like the patent term adjustment that were raised but not resolved on the merits in prior litigation?
  • A second central question will be one of claim scope: How will the court construe the phrase "consists essentially of"? The answer will determine whether any unlisted excipients in the defendant's formulation are sufficient to place the product outside the bounds of the asserted claims.
  • A final key question will be one of numerical precision: Does the concentration of benzalkonium chloride in the accused generic product fall within the scope of the term "about 200 ppm" as used in Claim 1, an issue that will depend on both the court's construction of "about" and the specific composition of the defendant's formulation?