DCT

1:25-cv-01168

Teva Pharma Intl GmbH v. Almaject Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-01168, D. Del., 09/18/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because both Defendants are corporations organized under the laws of Delaware and are subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiffs allege that Defendants' filing of a New Drug Application for a generic version of the cancer treatment drug Bendeka® constitutes an act of infringement of twenty patents related to stable liquid formulations of bendamustine hydrochloride.
  • Technical Context: The technology concerns pharmaceutical formulations designed to keep the active drug bendamustine, a chemotherapy agent, chemically stable in a liquid solution for long-term storage, thereby avoiding reconstitution of a lyophilized powder before administration.
  • Key Procedural History: This infringement action was triggered by Defendants' submission of New Drug Application ("NDA") No. 220186 to the U.S. Food and Drug Administration. The NDA submission included a Paragraph IV Certification asserting that the proposed generic product would not infringe the patents-in-suit or that the patents are invalid. The complaint also notes that Plaintiff Eagle Pharmaceuticals granted an exclusive license to Plaintiff Cephalon for the patents-in-suit, which was later assigned to Plaintiff Teva Pharmaceuticals.

Case Timeline

Date Event
2010-01-28 Earliest Priority Date for ’707, ’831, ’796, ’797, ’887, ’533, ’385, ’783, ’214, ’248, ’257, and ’333 Patents
2012-03-20 Earliest Priority Date for ’908, ’568, ’397, ’398, ’399, ’021, and ’384 Patents
2013-12-17 Issue Date of U.S. Patent No. 8,609,707
2015-02-13 Cephalon executes exclusive license for the patents-in-suit from Eagle
2015-04-07 Issue Date of U.S. Patent No. 9,000,021
2015-05-19 Issue Date of U.S. Patent No. 9,034,908
2015-09-29 Issue Date of U.S. Patent No. 9,144,568
2015-10-14 Cephalon assigns its license rights to Teva Pharmaceuticals
2016-02-23 Issue Date of U.S. Patent No. 9,265,831
2017-02-21 Issue Date of U.S. Patent Nos. 9,572,796, 9,572,797, and 9,572,887
2017-02-28 Issue Date of U.S. Patent No. 9,579,384
2017-03-21 Issue Date of U.S. Patent Nos. 9,597,397, 9,597,398, and 9,597,399
2018-07-03 Issue Date of U.S. Patent No. 10,010,533
2018-08-21 Issue Date of U.S. Patent No. 10,052,385
2023-12-19 Issue Date of U.S. Patent No. 11,844,783
2024-01-16 Issue Date of U.S. Patent No. 11,872,214
2024-11-12 Issue Date of U.S. Patent No. 12,138,248
2025-07-01 Issue Date of U.S. Patent No. 12,343,333
2025-07-08 Issue Date of U.S. Patent No. 12,350,257
2025-08-06 Almaject sends Paragraph IV Notice Letter to Plaintiffs
2025-09-18 Complaint Filing Date

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

U.S. Patent No. 8,609,707 - "Formulations of Bendamustine"

The Invention Explained

  • Problem Addressed: The patent addresses the chemical instability of bendamustine, an anti-cancer drug, when reconstituted from a lyophilized (freeze-dried) powder into a liquid for injection (’707 Patent, col. 1:40-54). The reconstituted drug degrades rapidly in water, making long-term storage in liquid form unsuitable and creating clinical inconvenience (’707 Patent, col. 1:55-62).
  • The Patented Solution: The invention is a long-term, storage-stable liquid formulation of bendamustine that does not require reconstitution. The solution uses a non-aqueous, pharmaceutically acceptable fluid comprising a mixture of polyethylene glycol (PEG) and propylene glycol (PG), along with a "stabilizing amount of an antioxidant," to prevent degradation of the bendamustine active ingredient (’707 Patent, col. 2:60-67).
  • Technical Importance: This solution provides a "ready to use" bendamustine product that enhances stability, eliminates the clinically inconvenient reconstitution step, and reduces the risk of chemical degradation before administration to a patient (’707 Patent, col. 2:16-20).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims of the ’707 Patent (Compl. ¶74). Independent claim 1 is representative:
  • A non-aqueous liquid bendamustine-containing composition, comprising:
    • a) bendamustine or a pharmaceutically acceptable salt thereof;
    • b) a pharmaceutically acceptable fluid comprising i) about 90% polyethylene glycol and about 10% propylene glycol; and
    • ii) a stabilizing amount of an antioxidant.
  • The complaint’s broad allegation of infringing "one or more claims" suggests the right to assert dependent claims is reserved (Compl. ¶74).

U.S. Patent No. 9,265,831 - "Formulations of Bendamustine"

The Invention Explained

  • Problem Addressed: Like its parent ’707 Patent, the ’831 Patent addresses the rapid degradation of bendamustine in aqueous solutions, which prevents long-term storage in a ready-to-use liquid form (’831 Patent, col. 1:43-57).
  • The Patented Solution: The invention claims a stable, non-aqueous liquid formulation that includes bendamustine, a fluid containing a mixture of polyethylene glycol and propylene glycol, and a stabilizing amount of an antioxidant. The claims of the ’831 Patent further quantify the stability by specifying low levels of certain impurities, known as PG esters, after extended storage periods at refrigerated temperatures (’831 Patent, col. 10:35-42; Abstract).
  • Technical Importance: This formulation provides a clinically convenient, ready-to-use liquid bendamustine product with proven long-term chemical stability, evidenced by specific, low impurity thresholds after storage (’831 Patent, col. 2:10-15).

Key Claims at a Glance

  • The complaint asserts infringement of one or more claims of the ’831 Patent (Compl. ¶84). Independent claim 1 is representative:
  • A liquid bendamustine-containing composition, comprising:
    • a) bendamustine or a pharmaceutically acceptable salt thereof; and
    • b) a pharmaceutically acceptable fluid comprising about 5% to about 10% propylene glycol, polyethylene glycol and a stabilizing amount of an antioxidant...
    • the bendamustine-containing composition having less than or equal to 0.11% total PG esters at about 1 month of storage at a temperature of about 5° C.
  • The complaint’s broad allegation of infringing "one or more claims" suggests the right to assert dependent claims is reserved (Compl. ¶84).

Multi-Patent Capsule: U.S. Patent No. 9,572,796

  • Patent Identification: U.S. Patent No. 9,572,796, "Formulations of Bendamustine," issued February 21, 2017 (’796 Patent).
  • Technology Synopsis: This patent, related to the ’707 and ’831 patents, claims a liquid bendamustine formulation comprising polyethylene glycol, propylene glycol, and an antioxidant. The claims focus on achieving stability as defined by having less than or equal to specific low percentages of total PG esters after storage for various time periods at about 25° C. (’796 Patent, Abstract; col. 10:1-43).
  • Asserted Claims: One or more claims are asserted (Compl. ¶94). Representative independent claims include 1 and 16.
  • Accused Features: The accused product is alleged to be a liquid formulation containing bendamustine, polyethylene glycol, propylene glycol, and an antioxidant, which is stable over time (Compl. ¶¶54-57, 61).

Due to the large number of asserted patents, which appear to cover overlapping subject matter related to bendamustine formulations and methods of use, capsule summaries for the 17 additional patents are omitted for conciseness. Each follows a similar pattern of alleging infringement based on the composition and stability of the Defendants' NDA product.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is the generic bendamustine hydrochloride injection, 100 mg/4 mL (25 mg/mL), for which Almaject, Inc. and Alvogen, Inc. submitted New Drug Application No. 220186 to the FDA for approval (Compl. ¶1).

Functionality and Market Context

  • The complaint alleges, upon information and belief, that the Defendants' product is a liquid formulation containing bendamustine hydrochloride as the active ingredient (Compl. ¶51).
  • The formulation is alleged to contain a combination of solvents including polyethylene glycol and propylene glycol, along with a stabilizing amount of an antioxidant such as monothioglycerol (Compl. ¶¶54-57).
  • The complaint further alleges that the product exhibits long-term stability, with less than about 5% total impurities after 15 months of storage at temperatures from about 5°C to 25°C (Compl. ¶¶62-64). The proposed labeling for the product allegedly recommends its use for treating chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma (Compl. ¶¶58, 60).
  • The product is intended to be a generic competitor to the branded drug Bendeka®, and its filing via an NDA seeks to establish it as a bioequivalent alternative for the same medical indications (Compl. ¶¶1, 69).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

8,609,707 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A non-aqueous liquid bendamustine-containing composition, comprising: The accused product is alleged to be a liquid formulation supplied in a sterile vial. ¶¶1, 68 col. 4:11-13
a) bendamustine or a pharmaceutically acceptable salt thereof; The accused product contains bendamustine hydrochloride at a concentration of 25 mg/mL. ¶¶51, 52 col. 2:61-63
b) a pharmaceutically acceptable fluid comprising i) about 90% polyethylene glycol and about 10% propylene glycol; The accused product is alleged to contain polyethylene glycol and propylene glycol. ¶¶54, 55, 56 col. 3:36-44
and ii) a stabilizing amount of an antioxidant. The accused product is alleged to contain a stabilizing amount of an antioxidant, such as monothioglycerol. ¶¶54, 57 col. 3:58-62
  • Identified Points of Contention:
    • Scope Questions: The analysis may turn on the construction of "about 90% polyethylene glycol and about 10% propylene glycol." A key question will be whether the specific ratio of these solvents in the Defendants' product, once determined through discovery, falls within the scope of the term "about" as used in the patent.
    • Technical Questions: A factual question will be whether the amount of antioxidant in the accused product constitutes a "stabilizing amount" as defined by the patent. This raises the question of what evidence the complaint provides to show that the antioxidant performs the claimed stabilizing function to the degree required by the claim.

9,265,831 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A liquid bendamustine-containing composition, comprising: a) bendamustine or a pharmaceutically acceptable salt thereof; and The accused product is a liquid formulation containing bendamustine hydrochloride. ¶¶1, 51 col. 2:54-56
b) a pharmaceutically acceptable fluid comprising about 5% to about 10% propylene glycol, polyethylene glycol and a stabilizing amount of an antioxidant... The accused product is alleged to contain propylene glycol, polyethylene glycol, and a stabilizing amount of an antioxidant. ¶¶54-57 col. 3:28-35
the bendamustine-containing composition having less than or equal to 0.11% total PG esters at about 1 month of storage at a temperature of about 5° C. The complaint alleges on information and belief that the accused product meets this precise stability and impurity profile. ¶61 col. 10:35-42
  • Identified Points of Contention:
    • Scope Questions: The dispute may focus on the term "a stabilizing amount of an antioxidant." The court will need to determine if this requires a specific functional outcome or merely the presence of a substance known to be an antioxidant in an amount typical for such function.
    • Technical Questions: A critical evidentiary question will be whether the Defendants' product actually has "less than or equal to 0.11% total PG esters at about 1 month of storage at a temperature of about 5° C." The complaint alleges this on "information and belief," suggesting that confirming this fact will be a key goal of discovery and a central point of the technical dispute.

V. Key Claim Terms for Construction

The Term: "a stabilizing amount of an antioxidant" (’707 Patent, Claim 1; ’831 Patent, Claim 1)

  • Context and Importance: This term is central because it defines a required functional property of a key ingredient. The dispute will likely involve whether the mere presence of an antioxidant (e.g., monothioglycerol) suffices, or if Plaintiffs must prove that the specific amount used in the accused product actively enhances the stability of bendamustine to meet the claim. Practitioners may focus on this term because it links a compositional element to a functional outcome, creating a potential area for non-infringement arguments if the alleged antioxidant does not perform the claimed function in the accused product.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification states that "stabilizing amount" should be understood to "include those amounts which increase or enhance the stability of the bendamustine" (’707 Patent, col. 3:60-63). This could support an interpretation where any amount that provides some measurable increase in stability is sufficient.
    • Evidence for a Narrower Interpretation: The patent provides specific examples with antioxidant concentrations such as 2.5 mg/mL and 5 mg/mL that achieve stability, characterized by low levels of impurities after long-term storage (’707 Patent, col. 5:2-6; col. 7-8, Tables 3-4). This could support a narrower construction requiring an amount sufficient to achieve the specific long-term stability profiles demonstrated in the patent's examples.

The Term: "about" (e.g., "about 90% polyethylene glycol," "about 5° C.") (’707 Patent, Claim 1; ’831 Patent, Claim 1)

  • Context and Importance: The definition of "about" is critical for determining the literal scope of the numerical limitations in the claims regarding composition and storage conditions. The infringement analysis will depend on how much variance from the stated numbers (e.g., 90%, 5°C) is permissible. Practitioners may focus on this term because even a small deviation in the accused product's formulation from the claimed percentages could support a non-infringement defense if "about" is construed narrowly.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The repeated use of "about" throughout the claims and specification suggests the patentee did not intend to be limited to the exact numerical values, but rather to a functional range around those values that would be understood by a person of ordinary skill in the art.
    • Evidence for a Narrower Interpretation: The patent provides detailed examples with specific percentages and stability data tied to those percentages (e.g., "90% PEG 400 and 10% propylene glycol" in Example 4) (’707 Patent, col. 7:48-54). This could be used to argue that "about" should be interpreted narrowly in light of the specific embodiments that demonstrate the invention's success at those precise values.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges induced infringement against both Defendants, stating they "plan and intend to, and will, actively induce infringement" upon NDA approval (Compl. ¶¶77, 87). The basis for inducement appears to be the proposed product labeling, which would instruct medical professionals and patients to use the generic product in a manner that allegedly infringes the patents (Compl. ¶¶76, 86). The complaint also alleges contributory infringement, stating the product and its labeling are "especially made or adapted for use in infringing" and are "not suitable for substantial non-infringing use" (Compl. ¶¶78, 88).

Willful Infringement

  • Willfulness is alleged based on Defendants having "acted with full knowledge" of the patents-in-suit and "without a reasonable basis for believing that they would not be liable for infringing" (Compl. ¶¶80, 90). These allegations are made for each of the twenty asserted patents.

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

  • A core issue will be one of evidentiary proof: can Plaintiffs, through discovery, prove that the precise chemical composition and stability profile of the Defendants' generic product, currently pleaded only on "information and belief," actually meet the specific quantitative limitations recited in the claims, such as solvent ratios and impurity percentages after long-term storage?
  • A central question will be one of claim scope: how broadly will the court construe the term "a stabilizing amount of an antioxidant"? Will the mere presence of an ingredient classified as an antioxidant suffice, or must that ingredient be shown to provide a specific, quantifiable level of stability in the accused formulation to meet the claim limitation?
  • A key legal and factual question will be one of infringement under the Hatch-Waxman Act: does the act of filing the NDA for a product that, if approved and marketed, would have the formulation and stability profile alleged in the complaint constitute an act of infringement of claims directed to a composition with specific stability characteristics that are only measurable after extended periods of time?