DCT

1:22-cv-01270

Bial Portela & Ca SA v. Aurobindo Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-01270, D. Del., 09/27/2022
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Aurobindo Pharma USA, Inc. is a Delaware corporation.
  • Core Dispute: Plaintiffs allege that Defendants’ filing of an Abbreviated New Drug Application (ANDA) for a generic version of the epilepsy drug APTIOM® (eslicarbazepine acetate) constitutes an act of infringement of a patent covering methods for its once-daily administration.
  • Technical Context: The technology relates to pharmaceutical methods for treating epilepsy, specifically focusing on dosing regimens that optimize the drug's efficacy and a patient's total exposure to the active compound.
  • Key Procedural History: Plaintiffs previously filed a separate lawsuit (the "First Suit," C.A. No. 21-1682-CFC) against Aurobindo on November 29, 2021, asserting a different set of patents also related to APTIOM®. This complaint initiates a new action based on a more recently issued patent and Aurobindo’s subsequent "Second Notice Letter" certifying its ANDA against this new patent.

Case Timeline

Date Event
2005-05-06 Earliest Patent Priority Date ('247 Patent)
2013-11-08 FDA approves NDA for APTIOM® as adjunctive therapy
2015-08-27 FDA approves NDA for APTIOM® as monotherapy
2017-09-13 FDA approves NDA for APTIOM® for pediatric patients
2021-11-29 Plaintiffs file "First Suit" against Aurobindo on other patents
2022-06-21 U.S. Patent No. 11,364,247 Issues
2022-08-17 Date of Aurobindo's "Second Notice Letter" regarding the '247 Patent
2022-09-27 Complaint Filing Date

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

U.S. Patent No. 11,364,247 - "Methods of Treatment of Partial Onset Seizures Using Eslicarbazepine Acetate," issued June 21, 2022

The Invention Explained

  • Problem Addressed: The patent’s background section describes that while the drug carbamazepine is effective for treating epilepsy, it can produce toxic metabolites leading to serious side effects. A related compound, oxcarbazepine, has fewer side effects but also suffers from "greatly reduced potency." (’247 Patent, col. 1:21-39). The stated problem is the need for a treatment that retains high potency while avoiding the side effects associated with existing therapies.
  • The Patented Solution: The patent discloses methods of treatment using eslicarbazepine acetate. The central discovery presented is that administering the drug in a single once-daily dose provides an unexpectedly enhanced clinical efficacy compared to administering the same total daily dosage in a twice-daily regimen (’247 Patent, col. 15:1-9). This improved efficacy is attributed to a higher total systemic drug exposure (measured as AUC, or area under the curve) in patients on the once-daily schedule, a surprising result for a drug with a relatively short biological half-life (’247 Patent, col. 15:26-34).
  • Technical Importance: The invention claims to provide a more effective and convenient dosing regimen for epilepsy patients, potentially improving treatment outcomes and patient compliance over multi-dose daily schedules. (Compl. ¶41-42).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" without specifying which ones (Compl. ¶13). Independent Claim 1 is representative of the core invention.
  • Independent Claim 1:
    • A method for treating epilepsy in a patient in need thereof,
    • comprising administering once-daily
    • from about 400 mg to about 2400 mg of eslicarbazepine acetate
    • to the patient, wherein the patient is a human.
  • The complaint implicitly reserves the right to assert other claims, including dependent claims and other independent claims such as Claim 11, which is directed to treating "refractory epilepsy."

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Aurobindo's Generic Product," which is the subject of Abbreviated New Drug Application ("ANDA") No. 216481 (Compl. ¶11).

Functionality and Market Context

  • The complaint alleges that Aurobindo's product consists of Eslicarbazepine Acetate Tablets in 200, 400, 600, and 800 mg dosage forms (Compl. ¶43).
  • The product is described as a generic version of Plaintiffs' APTIOM® tablets and is intended for the same therapeutic use: the treatment of partial-onset seizures (Compl. ¶12, ¶37). As an ANDA product, it must be pharmaceutically and therapeutically equivalent to the branded drug it references (Compl. ¶51). The complaint alleges that upon approval, Aurobindo will market this product as a direct substitute for APTIOM® (Compl. ¶11, ¶43).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

This action is brought under the Hatch-Waxman Act, where the filing of an ANDA is a statutory act of infringement if the proposed generic product would infringe a valid patent upon commercialization (35 U.S.C. § 271(e)(2)). The complaint does not contain a detailed element-by-element infringement analysis. The following chart summarizes the infringement theory as inferred from the complaint's allegations regarding the nature of the ANDA filing.

’247 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating epilepsy in a patient in need thereof... Aurobindo's ANDA seeks FDA approval to market a generic version of APTIOM®, a drug indicated for the treatment of partial-onset seizures, which is a form of epilepsy. ¶12, ¶37, ¶43 col. 16:48-52
comprising administering once-daily... The prescribing information for the branded drug APTIOM® instructs once-daily administration. Aurobindo's proposed label for its therapeutically equivalent generic product will allegedly instruct for the same once-daily use. ¶41, ¶56 col. 16:1-3
from about 400 mg to about 2400 mg of eslicarbazepine acetate... Aurobindo's ANDA covers tablets in 200, 400, 600, and 800 mg strengths, and the intended prescribed daily dose for treating epilepsy falls within the claimed range. ¶11, ¶43 col. 16:1-3
to the patient, wherein the patient is a human. The ANDA seeks approval for a prescription drug for use in human patients. ¶3, ¶43 col. 16:50-52

Identified Points of Contention

  • Scope Questions: The primary dispute may center on the scope of the claims. A question for the court is whether the term "epilepsy" as used in the claims is limited to the "refractory partial epilepsy" that was the subject of the clinical trials described in the patent (’247 Patent, col. 7:40-44), or if it has a broader meaning. The scope of the term "about" in relation to the dosage range could also become a point of contention.
  • Technical Questions: A key technical underpinning of the patent is the assertion that once-daily dosing provides a superior pharmacokinetic profile (i.e., higher total drug exposure) compared to twice-daily dosing (’247 Patent, col. 15:26-34). An evidentiary question may be whether the instructions in Aurobindo's proposed product label will inevitably lead physicians and patients to practice the claimed method that produces this specific, advantageous technical result.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for a definitive analysis of claim construction disputes. However, based on the patent's focus, the following terms may be central.

  • The Term: "once-daily"

  • Context and Importance: This term is the central feature of the claimed invention, distinguishing it from prior art multi-dose regimens. Its definition is critical to determining whether the instructions on the accused product's label will induce infringement.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: Parties may argue the term should be given its plain and ordinary meaning: administering a total daily dose at a single time during a 24-hour period.
    • Evidence for a Narrower Interpretation: The patent specification repeatedly contrasts "once-daily" administration with "twice-daily" administration in the context of clinical trial results showing unexpectedly superior efficacy and drug exposure (’247 Patent, col. 15:1-9, col. 15:26-34). A party could argue that "once-daily" should be construed not merely as a timing instruction, but as a method that necessarily achieves the superior pharmacokinetic profile described in the patent.

  • The Term: "about [a dosage]"

  • Context and Importance: This term defines the boundaries of the claimed dosage range. Practitioners may focus on this term because its breadth determines whether slightly different dosages prescribed in practice could fall inside or outside the scope of the claims.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification does not provide an explicit definition, suggesting the term should be interpreted according to its ordinary meaning of "approximately" or "nearly."
    • Evidence for a Narrower Interpretation: The patent’s clinical data relies on specific dose cohorts (e.g., 400 mg, 800 mg, 1200 mg) (’247 Patent, Tables 1, 4, 5). A party could argue that the term "about" should be interpreted narrowly in light of these specific embodiments and the pharmacokinetic data they generated, rather than as a broad approximation.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges that Aurobindo will induce infringement under § 271(b) (Compl. ¶53). The factual basis for this allegation is that Aurobindo has knowledge of the ’247 patent, as evidenced by its notice letter, and that it intends to cause infringement by creating a product with a proposed package insert that will instruct healthcare professionals and patients to administer the drug in a manner that directly infringes the patent's claims (e.g., once-daily for epilepsy) (Compl. ¶55-57).

Willful Infringement

  • The complaint does not use the term "willful infringement" but does request a finding that the case is "exceptional" and an award of attorney fees under 35 U.S.C. § 285 (Compl., p. 13, ¶F). The alleged basis for this is Aurobindo's knowledge of the patent, established by its notice letter, and its subsequent actions to market an allegedly infringing product (Compl. ¶57).

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

  • A core issue will be one of claim scope and construction: How broadly will the court define the key terms "once-daily" and "about"? The patentability of the claims hinges on the unexpected technical result of the "once-daily" method, raising the question of whether the term itself implicitly includes achieving that specific pharmacokinetic outcome.
  • A central question of infringement under Hatch-Waxman will be: Does Aurobindo’s ANDA, including its proposed product label, describe a product and method of use that would inevitably lead a patient or physician to practice every element of the asserted claims? The dispute will likely focus on whether the instructions for use on the generic label are sufficient to prove inducement of the patented method.