DCT

3:19-cv-15439

Cubist Pharma LLC v. Amneal Pharma LLC

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:19-cv-15439, D.N.J., 07/16/2019
  • Venue Allegations: Venue is alleged to be proper based on Defendants having regular and established places of business in New Jersey and committing or intending to commit acts of infringement within the district.
  • Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) for a generic version of the CUBICIN RF® drug product constitutes an act of infringement of a patent covering stabilized daptomycin formulations.
  • Technical Context: The technology relates to pharmaceutical formulations of the lipopeptide antibiotic daptomycin, focusing on methods to improve its chemical stability and reduce the time required to reconstitute the solid drug into a liquid for injection.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 212397 and a corresponding Paragraph IV Certification to the FDA. The certification asserts that Plaintiff's patent is invalid, unenforceable, and/or will not be infringed by the proposed generic product.

Case Timeline

Date Event
2009-11-23 ’456 Patent Priority Date
2015-09-22 ’456 Patent Issue Date
c. 2018-11-01 Plaintiff receives Defendants’ ANDA Notice Letter
2019-07-16 Complaint Filing Date

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

U.S. Patent No. 9,138,456 - "Lipopeptide Compositions And Related Methods"

  • Patent Identification: U.S. Patent No. 9,138,456, "Lipopeptide Compositions And Related Methods," issued September 22, 2015 (’456 Patent).

The Invention Explained

  • Problem Addressed: The patent's background section describes challenges with prior daptomycin formulations, which are supplied as a lyophilized (freeze-dried) powder. These challenges include slow reconstitution times (up to 45 minutes) when preparing the drug for injection and chemical instability, leading to degradation of daptomycin into structurally similar but undesirable compounds like anhydro-daptomycin and its β-isomer (’456 Patent, col. 1:43-col. 2:8).
  • The Patented Solution: The invention addresses these problems by creating a solid daptomycin formulation that includes specific sugars, particularly non-reducing sugars like sucrose. The patent teaches that preparing an aqueous solution of daptomycin and a sugar, adjusting its pH, and then lyophilizing it results in a powder that reconstitutes significantly faster and exhibits improved chemical stability, thereby preserving the purity of the active drug (’456 Patent, Abstract; col. 3:5-24).
  • Technical Importance: For healthcare practitioners, reducing drug preparation time is a significant practical benefit, while enhanced chemical stability provides a longer product shelf-life and greater tolerance for varied storage conditions, ensuring drug purity and efficacy (’456 Patent, col. 2:50-62).

Key Claims at a Glance

  • The complaint asserts infringement of at least independent claim 1 and dependent claims 2 and 7-9, among others (Compl. ¶30).
  • Independent Claim 1:
    • A solid pharmaceutical daptomycin composition,
    • wherein said composition is prepared by lyophilizing an aqueous daptomycin solution comprising daptomycin and sucrose.
  • The complaint also asserts claims dependent on claim 1 that add further limitations, such as the molar ratio of daptomycin to sucrose and the pH range of the aqueous solution before lyophilization (Compl. ¶30).

III. The Accused Instrumentality

Product Identification

  • Defendants’ proposed generic version of Plaintiff’s CUBICIN RF® drug product, as described in Abbreviated New Drug Application (“ANDA”) No. 212397 (“Amneal’s Proposed ANDA Product”) (Compl. ¶1).

Functionality and Market Context

  • The accused instrumentality is a proposed generic daptomycin product intended for treating complicated skin and skin structure infections and Staphylococcus aureus bloodstream infections (Compl. ¶6). As an ANDA product, it is intended to be a generic equivalent to Plaintiff's branded CUBICIN RF® (Compl. ¶1). The complaint alleges on information and belief that the product, if commercially manufactured and sold, would possess the composition and characteristics covered by the ’456 Patent (Compl. ¶30). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a detailed claim chart exhibit. The infringement allegations are pleaded generally, stating that discovery and/or testing will show that Amneal’s Proposed ANDA Product infringes. The following chart summarizes the core theory of infringement for the lead independent claim based on the complaint's narrative.

’456 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A solid pharmaceutical daptomycin composition, Amneal's Proposed ANDA Product is alleged to be a solid pharmaceutical composition containing daptomycin, intended as a generic version of CUBICIN RF®. ¶¶1, 30 col. 27:1-4
wherein said composition is prepared by lyophilizing an aqueous daptomycin solution comprising daptomycin and sucrose. The complaint alleges on information and belief that the proposed product will be shown through discovery to contain sucrose and to be manufactured by a lyophilization process falling within the scope of the claim. ¶¶26, 30 col. 27:1-4

Identified Points of Contention

  • Evidentiary Question: The central factual dispute will be the actual composition and manufacturing process of Amneal’s Proposed ANDA Product. The complaint pleads infringement on "information and belief" (Compl. ¶30), placing the evidentiary burden on the Plaintiff to prove through discovery that the accused product contains sucrose and is made by the claimed lyophilization process.
  • Scope Question: A key issue may be whether Amneal’s manufacturing process, as described in its confidential ANDA submission, constitutes “lyophilizing an aqueous daptomycin solution” as that phrase is understood in the context of the patent. If Amneal uses a distinct drying or formulation technique, it may raise a non-infringement argument.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail to identify specific terms already in dispute. However, based on the claim language and technology, the following terms may become central to the infringement analysis.

  • The Term: "prepared by lyophilizing"
  • Context and Importance: Claim 1 is a product-by-process claim. Infringement requires not only that the accused product has the claimed composition but also that it is made by the claimed process. Practitioners may focus on this term because if Amneal's manufacturing method is found to differ materially from the "lyophilizing" process described and claimed in the patent, it could defeat the infringement allegation.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent summary mentions that the solid composition can be prepared by "lyophilization, spray drying or the like" (’456 Patent, col. 2:65-col. 3:1), which a party might argue suggests the inventors did not view the specific method as the only way to achieve the invention, though the claim itself is specific.
    • Evidence for a Narrower Interpretation: The claim explicitly recites "lyophilizing" (’456 Patent, col. 27:3). Furthermore, Example 3 of the patent provides a detailed, multi-step lyophilization protocol, including specific temperatures, times, and vacuum pressures, which could be used to argue for a narrower construction limited to processes with similar parameters (’456 Patent, col. 15:5-col. 16:39).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants will induce and contribute to infringement under 35 U.S.C. § 271(b) and (c) (Compl. ¶30). This allegation is based on the future commercialization of the ANDA product, where Defendants would intend for and provide instructions to healthcare professionals to reconstitute and administer the drug in an allegedly infringing manner.
  • Willful Infringement: While the complaint does not use the word "willful," it alleges facts that could support such a claim. It states that Amneal has had knowledge of the ’456 patent "since at least the date it submitted the Amneal ANDA" (Compl. ¶31). The receipt of Amneal's Paragraph IV Notice Letter further establishes pre-suit knowledge of the patent and the infringement allegations (Compl. ¶25).

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

  • A core issue will be one of compositional identity: does the formulation for Amneal's proposed generic product, as confidentially described in its ANDA, contain sucrose as an excipient? The outcome of this factual question, to be determined through discovery, is fundamental to the infringement analysis of claim 1.
  • A second key issue will be the interpretation of a process limitation: can the plaintiff prove that the manufacturing process for Amneal's product is equivalent to "lyophilizing an aqueous daptomycin solution comprising daptomycin and sucrose" as required by the claim? A finding that Amneal uses a non-infringing manufacturing process, even for a chemically similar end product, could be dispositive.