DCT

2:24-cv-00637

Eagle Pharma Inc v. DR Reddy's Laboratories Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-00637, D.N.J., 02/02/2024
  • Venue Allegations: Venue is alleged to be proper because Defendant Dr. Reddy's Laboratories, Inc. is incorporated in New Jersey, and Defendant Dr. Reddy's Laboratories, Ltd. is a foreign corporation subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiff alleges that Defendants’ submission of a New Drug Application to the FDA for a generic version of Plaintiff's BELRAPZO® injectable drug constitutes an act of infringement of two patents covering stable liquid formulations of bendamustine.
  • Technical Context: The technology concerns pharmaceutical formulations designed to solve the chemical instability of the chemotherapy drug bendamustine, enabling a long-term, storage-stable liquid product that avoids the need for immediate reconstitution before use.
  • Key Procedural History: This is a Hatch-Waxman action initiated under 35 U.S.C. § 271(e)(2) following Defendants' notification to Plaintiff on December 19, 2023, of their submission of New Drug Application (NDA) No. 219014 with a Paragraph IV certification, seeking to market a generic product prior to the expiration of the patents-in-suit.

Case Timeline

Date Event
2010-01-28 Earliest Priority Date for '783 and '214 Patents
2023-12-19 U.S. Patent No. 11,844,783 Issues
2023-12-19 Defendants send Paragraph IV Notice Letter to Plaintiff
2024-01-16 U.S. Patent No. 11,872,214 Issues
2024-02-02 Complaint Filed

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

U.S. Patent No. 11,844,783 - “Formulations of Bendamustine” (Issued Dec. 19, 2023)

The Invention Explained

  • Problem Addressed: The patent’s background section states that bendamustine, the active ingredient in the commercial cancer drug Treanda®, exhibits rapid chemical degradation when its lyophilized (powder) form is reconstituted into a liquid for administration (’783 Patent, col. 2:48-52). This instability makes it unsuitable for long-term storage in a liquid form and renders the reconstitution process clinically inconvenient (’783 Patent, col. 2:58-65).
  • The Patented Solution: The invention is a long-term storage-stable liquid formulation of bendamustine that avoids the need for powder reconstitution. The solution combines bendamustine with a specific non-aqueous, pharmaceutically acceptable fluid—such as one based on polyethylene glycol (PEG)—and adds a “stabilizing amount of an antioxidant” (’783 Patent, Abstract; col. 3:1-6). The patent explains that this specific combination of a less-reactive fluid and an antioxidant unexpectedly and substantially reduces the creation of degradation-related impurities over extended periods, enabling a ready-to-use formulation (’783 Patent, col. 4:58-65).
  • Technical Importance: The invention provided a means to create a ready-to-use or ready-to-dilute liquid version of an important chemotherapy drug, addressing significant stability and convenience challenges present in prior lyophilized powder versions (’783 Patent, col. 2:24-26, 63-65).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and reserves the right to assert other claims (Compl. ¶38).
  • Claim 1 is a method of treatment claim with the following essential elements:
    • A method of treating leukemia in a human, which comprises several steps:
    • Providing a liquid composition containing bendamustine at a concentration of about 20-60 mg/mL.
    • The composition is in a pharmaceutically acceptable fluid "consisting of" polyethylene glycol and optionally other specified components (propylene glycol, ethanol, etc.).
    • The composition includes a "stabilizing amount of an antioxidant."
    • The composition exhibits a specific stability profile: total impurities are less than about 5% after storage for at least 15 months at 5-25 °C.
    • The method includes diluting the composition and then intravenously administering it.

U.S. Patent No. 11,872,214 - “Formulations of Bendamustine” (Issued Jan. 16, 2024)

The Invention Explained

  • Problem Addressed: The '214 Patent addresses the same technical problem as the ’783 Patent: the rapid degradation of bendamustine in liquid solutions and the clinical inconvenience of reconstituting a lyophilized powder before use (’214 Patent, col. 2:45-65).
  • The Patented Solution: The patented solution is identical in concept to that of the ’783 Patent. It describes a storage-stable liquid formulation of bendamustine using a pharmaceutically acceptable fluid (e.g., PEG-based) and a stabilizing antioxidant to limit the formation of impurities over time, thereby creating a ready-to-use product (’214 Patent, Abstract; col. 3:1-6). The primary distinction from the ’783 Patent lies in the claim format.
  • Technical Importance: As with the ’783 patent, this invention provides a stable, ready-to-use liquid formulation of a known chemotherapy drug, enhancing clinical convenience and sidestepping the problems of reconstitution (’214 Patent, col. 2:24-26, 63-65).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and reserves the right to assert other claims (Compl. ¶46).
  • Claim 1 is a product claim with the following essential elements:
    • A sterile vial that contains a liquid bendamustine composition.
    • The composition contains about 100 mg of bendamustine at a concentration of about 25 mg/mL.
    • The composition is in a pharmaceutically acceptable fluid "consisting of" polyethylene glycol and optionally other specified components.
    • The composition includes a "stabilizing amount of antioxidant."
    • The composition meets a specific stability threshold: total impurities are less than about 5% after storage for at least 15 months at 5-25 °C.

III. The Accused Instrumentality

Product Identification

  • The accused product is Defendants' generic version of BELRAPZO® (bendamustine hydrochloride) Injection, 100 mg/4 mL (25 mg/mL), identified in connection with NDA No. 219014 (Compl. ¶1).

Functionality and Market Context

  • The accused product is a liquid injectable formulation of bendamustine hydrochloride intended for the treatment of chronic lymphocytic leukemia and non-Hodgkin's lymphoma (Compl. ¶32). The complaint alleges, upon information and belief, that the product is a liquid formulation containing bendamustine at a concentration of 25 mg/mL, uses polyethylene glycol as a fluid, includes an antioxidant, and possesses a stability profile that meets the requirements of the asserted claims (Compl. ¶¶31, 34, 35).
  • As a generic drug, the product seeks to be a lower-cost, bioequivalent alternative to Plaintiff’s branded BELRAPZO® product and is seeking FDA approval to enter the market before the expiration of the patents-in-suit (Compl. ¶¶1, 28).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

'783 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating leukemia in a human in need thereof comprising Defendants' proposed labeling for the NDA Product will direct its use for the treatment of leukemia. ¶32, ¶40 col. 14:49
providing a liquid bendamustine-containing composition comprising bendamustine... wherein the bendamustine concentration in the composition is from about 20 mg/mL to about 60 mg/mL; The NDA Product is a liquid composition containing 100 mg/4 mL (25 mg/mL) of bendamustine hydrochloride, which is within the claimed range. ¶31 col. 14:58-61
a pharmaceutically acceptable fluid consisting of polyethylene glycol and optionally one or more of propylene glycol, ethanol, benzyl alcohol and glycofurol; and The NDA Product is alleged to contain polyethylene glycol. ¶34 col. 14:62-65
a stabilizing amount of an antioxidant; The NDA Product is alleged to contain a stabilizing amount of an antioxidant. ¶34 col. 15:1-2
wherein the total impurities... is less than about 5% peak area response... after at least about 15 months at a temperature of about 5 °C to about 25 °C; The NDA Product is alleged to have the same or substantially similar stability as recited in the claims. ¶29, ¶35 col. 15:3-9
diluting the liquid bendamustine containing composition; and Defendants' proposed labeling will direct the dilution of the NDA Product before administration. ¶40 col. 15:10-11
intravenously administering the diluted composition to the human. Defendants' proposed labeling will direct the intravenous administration of the diluted NDA Product. ¶40 col. 15:12-13

'214 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A sterile vial containing a liquid bendamustine-containing composition comprising Defendants seek approval to manufacture and sell their NDA Product, which is a liquid bendamustine composition supplied in a vial. ¶38, ¶46 col. 14:1-3
about 100 mg of bendamustine... wherein the bendamustine concentration in the composition is about 25 mg/mL; The NDA Product contains 100 mg/4 mL, which is equivalent to a concentration of 25 mg/mL. ¶31 col. 14:4-7
a pharmaceutically acceptable fluid consisting of polyethylene glycol and optionally one or more of propylene glycol, ethanol, benzyl alcohol and glycofurol; and The NDA Product is alleged to contain polyethylene glycol. ¶34 col. 14:8-11
a stabilizing amount of antioxidant, The NDA Product is alleged to contain a stabilizing amount of an antioxidant. ¶34 col. 14:12-12
wherein the total impurities... is less than about 5% peak area response... after at least about 15 months at a temperature of about 5 °C to about 25 °C. The NDA Product is alleged to meet the claimed stability requirements. ¶29, ¶35 col. 14:13-19
  • Identified Points of Contention:
    • Factual Questions: The complaint's allegations regarding the precise composition of the accused product are made "upon information and belief," noting that Defendants "did not disclose the composition" (Compl. ¶33, ¶34). A primary point of contention will be factual: will discovery confirm that the accused product's formulation and stability profile match the elements required by the claims?
    • Scope Questions: The term "consisting of" in the "pharmaceutically acceptable fluid" limitation is highly restrictive. A key legal and technical question will be whether the accused product's fluid base contains any unrecited excipients. If it does, it raises the question of whether the product can fall within the scope of this limitation.

V. Key Claim Terms for Construction

  • The Term: "consisting of"

  • Context and Importance: This transitional phrase appears in the "pharmaceutically acceptable fluid" limitation in both asserted independent claims (’783 Patent, cl. 1; ’214 Patent, cl. 1). Its construction is critical because, unlike the more open term "comprising," "consisting of" typically excludes any element not specified in the claim. If Defendants' fluid contains an unrecited substance, the non-infringement argument may be straightforward, making the definition of this term central to the dispute.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: A party seeking a broader scope might argue that the phrase allows for unrecited components that are impurities or are otherwise unrelated to the "fluid" itself. However, the patent specification provides little direct support for an interpretation beyond the standard, restrictive legal meaning.
    • Evidence for a Narrower Interpretation: The use of "consisting of" is strong intrinsic evidence for a narrow, closed-ended interpretation. A party arguing for this scope will assert that the plain meaning excludes any unrecited ingredients from the fluid base. The patent drafters used "comprising" elsewhere in the claims (e.g., "composition comprising"), suggesting the choice of "consisting of" for the fluid was a deliberate and limiting one (’783 Patent, cl. 1).

  • The Term: "stabilizing amount of an antioxidant"

  • Context and Importance: This functional language appears in both asserted claims and is a core component of the inventive solution. Infringement requires not just the presence of an antioxidant, but that it is present in a "stabilizing amount." Practitioners may focus on this term because the dispute will likely involve what technical evidence is required to prove that a given quantity of an antioxidant is "stabilizing" in the context of the claims.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification provides a broad definition, stating that a "stabilizing amount" shall be understood to include "those amounts which increase or enhance the stability of the bendamustine in the compositions" (’783 Patent, col. 4:2-5). This supports an argument that any amount shown to reduce degradation relative to a control formulation meets the limitation.
    • Evidence for a Narrower Interpretation: The claims themselves link the formulation to a specific outcome: "less than about 5% total impurities... after at least about 15 months" (’783 Patent, cl. 1). A party could argue that a "stabilizing amount" must be construed as an amount sufficient to achieve this claimed stability outcome. Furthermore, a defendant could point to the specific concentrations used in the patent’s examples (e.g., 2.5 mg/mL or 5 mg/mL of an antioxidant) as context for what the inventors contemplated as a "stabilizing amount" (’783 Patent, Tables 3, 7).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants will actively induce infringement of the ’783 method patent. This allegation is based on the assertion that Defendants' proposed product labeling will instruct and encourage healthcare professionals to perform the claimed method steps of diluting and intravenously administering the drug for its approved indications (Compl. ¶¶41, 48). Knowledge is alleged based on Defendants' awareness of the patent and its underlying application (Compl. ¶¶54, 66).
  • Willful Infringement: The complaint alleges that Defendants have "acted without a reasonable basis for believing" they would not be liable for infringement (Compl. ¶¶61, 73). These allegations, combined with claims that Defendants knew of the patents-in-suit and/or their pending applications, form the basis for a potential claim of willful infringement (Compl. ¶¶54, 66).

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

  • A central issue will be one of factual proof: will discovery validate the complaint’s "information and belief" allegations that the precise chemical composition and long-term stability profile of Defendants’ generic product fall within the specific parameters required by the asserted claims?
  • The case may also turn on a question of definitional scope: can the restrictive claim term "consisting of," as applied to the pharmaceutically acceptable fluid, be interpreted to permit the presence of any unlisted excipients, or does it create a strict boundary that Defendants’ formulation may not cross?
  • For the method of treatment claims, a key question will be one of induced infringement: does the evidence, particularly Defendants’ proposed product label, demonstrate the requisite intent and affirmative acts to encourage and instruct medical professionals to perform each step of the patented method?