DCT

1:21-cv-00186

Bial Portela & Ca SA v. Alkem Laboratories Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:21-cv-00186, D. Del., 02/10/2021
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant S&B Pharma is incorporated in Delaware, and Defendant Alkem Laboratories may be sued in any district where it is subject to personal jurisdiction.
  • Core Dispute: Plaintiffs allege that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the epilepsy drug APTIOM® constitutes an act of infringement of a patent covering a specific pharmaceutical formulation of the drug.
  • Technical Context: The technology relates to pharmaceutical formulations for oral solid dosage forms (tablets) of the anticonvulsant drug eslicarbazepine acetate.
  • Key Procedural History: This lawsuit was filed under the Hatch-Waxman Act in response to Defendants’ ANDA submission. The complaint notes that this is the third lawsuit between the parties concerning generic versions of APTIOM®, with two prior suits involving different sets of patents covering the same drug product.

Case Timeline

Date Event
2007-10-26 '781 Patent Priority Date
2013-11-08 FDA approves APTIOM® (NDA 022416) for adjunctive therapy
2015-08-27 FDA approves APTIOM® for monotherapy
2017-09-13 FDA approves APTIOM® for pediatric use
Before 2018-01-08 Alkem files ANDA No. 211199 for generic Eslicarbazepine Acetate
2018-01-08 Alkem sends First Notice Letter regarding other patents
2018-02-22 Plaintiffs file "First Suit" against Alkem
2020-06-09 Plaintiffs file "Second Suit" against Alkem
2020-11-25 Alkem sends Second Notice Letter regarding other patents
2021-02-09 U.S. Patent No. 10,912,781 Issues
2021-02-10 Complaint Filed

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

U.S. Patent No. 10,912,781 - "Pharmaceutical Composition Comprising Licarbazepine Acetate"

  • Patent Identification: U.S. Patent No. 10,912,781, "Pharmaceutical Composition Comprising Licarbazepine Acetate," issued February 9, 2021.

The Invention Explained

  • Problem Addressed: The patent's background describes the active pharmaceutical ingredient (API), eslicarbazepine acetate, as having an "extremely low bulk density," which leads to "poor flowability" and makes the compound "difficult to compress" into tablets (ʼ781 Patent, col. 6:16-24). These properties can result in very large tablets and poor dissolution of the drug once ingested, hindering its therapeutic effectiveness (ʼ781 Patent, col. 6:21-24).
  • The Patented Solution: The invention is a specific pharmaceutical formulation and a wet granulation process designed to overcome these manufacturing challenges. The process involves granulating the API with specific types of excipients, a binder and a disintegrant, to significantly increase the bulk density of the powder mixture (ʼ781 Patent, col. 2:27-33). A key aspect of the described process is the split addition of the disintegrant, with part being mixed with the API before granulation (intragranular) and the remainder being added to the dried granules (extragranular), which is stated to improve the final product's dissolution profile (ʼ781 Patent, col. 6:40-47).
  • Technical Importance: This formulation technology addresses fundamental challenges in pharmaceutical manufacturing, enabling the reliable, large-scale production of a consistent oral dosage form for an otherwise difficult-to-handle drug compound (ʼ781 Patent, col. 5:16-24).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" without specifying them (Compl. ¶13). Independent claim 1 is representative:
  • Independent Claim 1:
    • A pharmaceutical composition consisting essentially of eslicarbazepine acetate in combination with a binder and a disintegrant,
    • wherein eslicarbazepine acetate is present in an amount of from 80 to 90 wt %,
    • the binder is present in an amount of from 3 to 10 wt %,
    • the disintegrant is present in an amount of from 3 to 10 wt %, and
    • wherein the pharmaceutical composition exhibits a dissolution of at least 60% at about 30 minutes at a specified temperature and pH using a paddle apparatus.
  • The complaint reserves the right to assert other claims, including dependent claims (Compl. ¶54).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendants' Eslicarbazepine Acetate Tablets in 200, 400, 600, and 800 mg dosage forms, for which Alkem filed Abbreviated New Drug Application (ANDA) No. 211199 with the FDA (Compl. ¶11, ¶44).

Functionality and Market Context

  • The accused product is a proposed generic version of Plaintiffs' branded drug, APTIOM® (Compl. ¶44). The complaint alleges that in its ANDA, Alkem represented to the FDA that its generic product is "pharmaceutically and therapeutically equivalent" to APTIOM® tablets, which are used for the treatment of partial-onset seizures (Compl. ¶39, ¶52).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that the act of filing ANDA No. 211199 constitutes infringement under 35 U.S.C. § 271(e)(2)(A), but does not provide a detailed element-by-element comparison of the accused product to the patent claims (Compl. ¶53). The infringement theory is premised on the allegation that Alkem's product is a generic equivalent of APTIOM®, for which the '781 Patent is listed in the FDA's Orange Book (Compl. ¶42, ¶52). The following chart summarizes the implied allegations for a representative claim.

'781 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition consisting essentially of eslicarbazepine acetate in combination with a binder and a disintegrant, The complaint alleges Alkem's ANDA describes a generic drug product that is pharmaceutically equivalent to APTIOM®, which is covered by the patent-in-suit. ¶52, ¶53 col. 16:62-64
wherein eslicarbazepine acetate is present in an amount of from 80 to 90 wt %, The ANDA product is alleged to contain the active ingredient within the claimed weight percentage range. ¶52, ¶53 col. 16:64-65
the binder is present in an amount of from 3 to 10 wt %, The ANDA product is alleged to contain a binder within the claimed weight percentage range. ¶52, ¶53 col. 16:65-66
the disintegrant is present in an amount of from 3 to 10 wt %, The ANDA product is alleged to contain a disintegrant within the claimed weight percentage range. ¶52, ¶53 col. 16:66-67
and wherein the pharmaceutical composition exhibits a dissolution of at least 60% at about 30 minutes... The ANDA product, being allegedly therapeutically equivalent, is alleged to meet the claimed dissolution profile. ¶52, ¶53 col. 16:67-17:4
  • Identified Points of Contention:
    • Technical Questions: The primary question is evidentiary and will depend on the contents of the confidential ANDA. Does the formulation described in ANDA No. 211199 actually contain eslicarbazepine acetate, a binder, and a disintegrant within the specific weight percentage ranges recited in Claim 1? What evidence does the ANDA provide that the proposed generic product achieves the dissolution rate of "at least 60% at about 30 minutes" required by the claim?
    • Scope Questions: A central dispute may concern the claim term "consisting essentially of." Does Alkem's formulation contain other excipients not recited in the claim, and if so, do those components "materially affect the basic and novel characteristics" of the claimed invention, which the patent identifies as improved bulk density and dissolution ('781 Patent, col. 2:27-33)?

V. Key Claim Terms for Construction

  • The Term: "consisting essentially of"
  • Context and Importance: This transitional phrase is critical in formulation patents. Its construction defines how many, and what types of, unlisted ingredients can be included in the accused product without avoiding infringement. Practitioners may focus on this term because the inclusion of common, unlisted excipients (e.g., fillers, glidants, lubricants) in Alkem's ANDA product could form the basis of a non-infringement defense.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party may argue the term only excludes ingredients that would defeat the stated purpose of the invention—achieving the claimed dissolution rate and improved manufacturability. The patent's extensive lists of potential excipients could be cited to support flexibility in the formulation (ʼ781 Patent, col. 6:9-8:65).
    • Evidence for a Narrower Interpretation: A party may point to statements in the patent that the invention "does not contain any filler" or "does not include a wetting agent" as evidence that the inventors intended to claim a simple, specific formulation (ʼ781 Patent, col. 2:19-26). Furthermore, claim 19 explicitly excludes various calcium salts, suggesting a specific intent to exclude particular unlisted components (ʼ781 Patent, col. 17:28-33).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that upon approval, Alkem will actively induce infringement under § 271(b) and contribute to infringement under § 271(c) (Compl. ¶54). The allegations are based on Alkem's knowledge of the patent and the assertion that its generic product is "especially adapted for a use that infringes the '781 patent" and has "no substantial non-infringing use" (Compl. ¶56, ¶57).
  • Willful Infringement: The complaint does not use the term "willful," but it does allege that Alkem has knowledge of the patent and its infringement (Compl. ¶64, ¶68). It further requests a declaration that the case is "exceptional" and seeks an award of attorney fees pursuant to 35 U.S.C. § 285, which is the statutory remedy for findings of willful infringement or other litigation misconduct (Compl. p. 14, ¶G).

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

  • A central issue will be one of factual correspondence: Does the specific formulation detailed in Alkem's confidential ANDA—including the identity and weight percentages of all excipients—fall squarely within the boundaries of the asserted patent claims? The case's trajectory will be heavily influenced by the contents of this undisclosed document.
  • The case will also turn on a question of definitional scope: How will the court construe the term "consisting essentially of"? The decision on whether unlisted excipients in Alkem's product materially alter the invention's properties will be critical to the infringement analysis.
  • Finally, a key question for the court, though not yet raised by a defendant, will likely concern patent validity: In the context of pharmaceutical formulation arts, was the combination of known excipients (a binder and a disintegrant) with a known API, within specified ranges to achieve improved dissolution, an inventive step or an obvious solution that a skilled formulator would have been motivated to pursue?