AbbVie Inc v. Alembic Pharma Ltd

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: AbbVie Inc. (Delaware), Allergan, Inc. (Delaware), Allergan Sales, LLC (Delaware), and Johnson & Johnson Vision Care Inc. (Florida)
  • Defendant: Alembic Pharmaceuticals Limited (India) and Alembic Pharmaceuticals, Inc. (Delaware)
  • Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
• Case Identification: 1:24-cv-00405, D. Del., 03/29/2024
• Venue Allegations: Venue is asserted based on Defendant Alembic Pharmaceuticals, Inc. being a Delaware corporation and Defendant Alembic Pharmaceuticals Limited being subject to personal jurisdiction in the district.
• Core Dispute: Plaintiffs allege that Defendants’ filing of an Abbreviated New Drug Application (ANDA) seeking to market a generic version of the ophthalmic solution LASTACAFT® constitutes an act of infringement of two patents covering the drug's formulation and methods of use.
• Technical Context: The technology involves ophthalmic formulations of the compound alcaftadine for the treatment and prevention of symptoms associated with allergic conjunctivitis.
• Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following Plaintiffs' receipt of a notice letter from Alembic regarding its ANDA No. 209290. This ANDA contains a “Paragraph IV Certification” alleging that the patents-in-suit are invalid. The complaint was filed within the 45-day statutory window, triggering an automatic 30-month stay of FDA approval for Alembic’s generic product. The patents are listed in the FDA’s “Orange Book” as covering LASTACAFT®.

Case Timeline

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

U.S. Patent No. 8,664,215, Ocular Allergy Treatments with Alcaftadine, Issued March 4, 2014

The Invention Explained

• Problem Addressed: The patent's background section describes the shortcomings of existing treatments for ocular allergies. It notes that available therapies often cause ocular discomfort, have limited duration requiring multiple daily doses, or possess limited anti-inflammatory effects, failing to address the full range of allergic symptoms. (’215 Patent, col. 2:1-18).
• The Patented Solution: The invention is directed to methods of using alcaftadine to treat or prevent multiple clinical symptoms of ocular allergy, such as itching and redness, with a long duration of action that allows for once-daily administration. The patent describes as a "surprising discovery" that alcaftadine can treat a number of different allergy symptoms, making it particularly useful for this purpose. (’215 Patent, col. 2:30-44).
• Technical Importance: The claimed invention offers a potential clinical advantage over prior therapies by providing a simplified, once-daily dosing regimen for broad-spectrum, long-lasting relief from ocular allergy symptoms. (’215 Patent, col. 2:20-24).

Key Claims at a Glance

• The complaint asserts claims 1-11 (Compl. ¶33). The independent claims are 1, 4, and 11.
• Independent Claim 1: A method of treating a clinical symptom of ocular allergy by administering once daily an ophthalmic composition with alcaftadine.
• Independent Claim 4: A method of preventing ocular itching in a human patient exposed to a conjunctival allergen by administering once daily an ophthalmic composition with alcaftadine, which results in inhibiting ocular itching compared to a non-treated patient.
• Independent Claim 11: A method of preventing conjunctival redness, chemosis, and lid edema for a period exceeding 16 hours in a human patient exposed to a conjunctival allergen by administering once daily an ophthalmic composition with alcaftadine.
• The complaint alleges infringement of claims 1-11.

U.S. Patent No. 10,617,695, Ophthalmic Compositions Containing Alcaftadine, Issued April 14, 2020

The Invention Explained

• Problem Addressed: The patent identifies a need for new ocular allergy therapies that offer improved efficacy and duration of action, allowing for once-daily dosing, while maintaining a favorable safety and tolerability profile. (’695 Patent, col. 2:33-38).
• The Patented Solution: The invention provides specific ophthalmic compositions containing alcaftadine. Unlike the method claims of the ’215 patent, this patent claims the formulation itself, specifying a concentration of "about 0.25% by weight of alcaftadine" in a "pharmaceutically acceptable topical ophthalmic vehicle" with a defined pH range. (’695 Patent, Abstract; col. 5:60-63; Claim 1).
• Technical Importance: The patented composition provides a specific, stable, and effective formulation that can deliver the long-acting, multi-symptom benefits of alcaftadine in a commercially viable product. (’695 Patent, col. 3:55-59).

Key Claims at a Glance

• The complaint asserts claims 1-12 (Compl. ¶¶27, 41). The sole independent claim is Claim 1.
• Independent Claim 1: An ophthalmic composition comprising about 0.25% by weight of alcaftadine or its pharmaceutically acceptable salts.
• The complaint alleges infringement of claims 1-12.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the generic drug product that is the subject of Alembic's ANDA No. 209290 ("Alembic's ANDA Product") (Compl. ¶9).

Functionality and Market Context

Alembic's ANDA Product is an alcaftadine ophthalmic solution at a 0.25% concentration, intended as a generic equivalent to Plaintiffs' branded product, LASTACAFT® (Compl. ¶¶21, 28). The complaint alleges that Alembic's product is intended for the prevention of itching associated with allergic conjunctivitis and that its marketing will rely on a product label that is a copy of the FDA-approved label for LASTACAFT® (Compl. ¶¶21, 28). The alleged act of infringement is the submission of the ANDA to the FDA for the purpose of obtaining approval to market this generic product prior to the expiration of the patents-in-suit (Compl. ¶10).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

'215 Patent Infringement Allegations

'695 Patent Infringement Allegations

Identified Points of Contention

• Scope Questions: For the '215 patent's method claims, a central question will be whether Alembic's proposed product label will be found to actively induce infringement. The analysis will focus on whether the label's language specifically encourages or instructs users to perform every step of the claimed methods, including the "once daily" administration and achieving prevention for "a period exceeding 16 hours" (as required by claim 11).
• Technical Questions: For the '695 patent, infringement appears factually straightforward if Alembic's product contains 0.25% alcaftadine as alleged. The primary dispute is therefore expected to shift from infringement to the validity of the patent claims, which Alembic challenged in its Paragraph IV certification (Compl. ¶26).

V. Key Claim Terms for Construction

The Term: "a period exceeding 16 hours" (’215 Patent, Claim 11)

• Context and Importance: This term defines the duration of efficacy, which is a core element of the asserted novelty of the '215 patent. Practitioners may focus on this term because proving that Alembic's label induces a method that meets this specific durational requirement will be critical to Plaintiffs' infringement case for this claim.
• Evidence for a Broader Interpretation: The specification discusses a general desire for a "longer duration of action," which could suggest that "exceeding 16 hours" is an exemplary, rather than a strict, limitation. (’215 Patent, col. 2:20-22).
• Evidence for a Narrower Interpretation: Claim 11 uses the precise phrase "exceeding 16 hours." Furthermore, the specification’s Example 4 describes clinical trials specifically assessing patient response at a 16-hour interval, providing strong intrinsic support for this specific time frame. (’215 Patent, col. 8:30-41).

The Term: "about 0.25% by weight" (’695 Patent, Claim 1)

• Context and Importance: This term defines the concentration of the active ingredient. In the context of an ANDA, where the generic product must be bioequivalent to the branded drug, the definition of "about" is important for determining the claim's scope, which could be relevant for both infringement and validity analyses.
• Evidence for a Broader Interpretation: The specification discloses a wide possible range of concentrations, from "about 0.005% by weight to about 10.0% by weight," which may support a more flexible reading of "about." (’695 Patent, col. 7:41-43).
• Evidence for a Narrower Interpretation: The patent consistently highlights 0.25% as a particularly preferred concentration. Example 1 explicitly provides a formulation with 2.5 mg/mL (equivalent to 0.25% w/v), and independent claim 1 specifically recites "about 0.25%," suggesting the term may be intended to cover only minor manufacturing tolerances around that precise value. (’695 Patent, col. 7:47-49; Table 1).

VI. Other Allegations

Indirect Infringement

The complaint alleges induced infringement, asserting that Alembic's proposed product label will "encourage, recommend, and promote" infringement by instructing physicians and patients to use the product in a manner that directly infringes the method claims of the '215 patent (Compl. ¶28). The complaint also pleads contributory infringement, alleging the product is "especially made or adapted for use in infringing" the patents and is "not suitable for substantial noninfringing use" (Compl. ¶¶36, 44).

Willful Infringement

The complaint alleges that Alembic acted with "full knowledge" of the patents-in-suit (Compl. ¶¶34, 42). This allegation is based on Alembic's submission of a Paragraph IV certification, which demonstrates pre-suit awareness of the patents and their listing in the FDA Orange Book.

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

• A core issue will be one of induced infringement: Can Plaintiffs demonstrate that the specific language on Alembic’s proposed product label will actively encourage medical professionals and patients to administer the generic drug in a way that meets every limitation of the asserted method claims in the '215 patent, including the "once daily" and "exceeding 16 hours" requirements?
• A second central question will be one of patent validity: Since Alembic’s product is formulated to be a bioequivalent copy of LASTACAFT®, direct infringement of the '695 patent's composition claim appears to be a significant possibility. The case may therefore turn on the strength of Alembic’s defense, asserted in its Paragraph IV certification, that the claims of the patents-in-suit are invalid as anticipated or obvious in light of the prior art.
• An underlying evidentiary question will be the interpretation of the prior art: The ultimate outcome will likely depend on how the court construes the scope and content of prior art related to alcaftadine formulations and their use for ocular allergies. This will determine whether the claimed inventions represented a patentable advance over what was already known.