DCT

1:23-cv-00179

Novo Nordisk Inc v. Orbicular Pharmaceutical Tech Pvt Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: Novo Nordisk Inc. v. Orbicular Pharmaceutical Technologies Pvt. Ltd., 1:23-cv-00179, D. Del., 02/17/2023
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware based on Defendant's business activities within the state, its derivation of revenue from Delaware, and its previous consent to personal jurisdiction in the district in a prior case.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of the diabetes drug Victoza® constitutes an act of infringement of patents covering the drug's formulation and its injection pen mechanism.
  • Technical Context: The technology at issue involves pharmaceutical formulations for injectable peptide drugs and the mechanical design of pen-style injection devices used for self-administration.
  • Key Procedural History: The lawsuit was triggered by Defendant's submission of an ANDA with a Paragraph IV certification, asserting that Plaintiff's patents are invalid, unenforceable, or will not be infringed. The complaint notes that Defendant previously consented to jurisdiction in the District of Delaware in an earlier case.

Case Timeline

Date Event
2003-11-24 U.S. Patent No. 8,114,833 Priority Date
2007-02-07 U.S. Patent No. 9,265,893 Priority Date
2012-02-14 U.S. Patent No. 8,114,833 Issued
2016-02-23 U.S. Patent No. 9,265,893 Issued
2023-01-04 Defendant's Paragraph IV Notice Letter Sent to Plaintiff
2023-02-17 Complaint Filed

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

U.S. Patent No. 8,114,833 - Propylene Glycol-Containing Peptide Formulations Which Are Optimal for Production and for Use in Injection Devices

The Invention Explained

  • Problem Addressed: The patent’s background section states that common isotonicity agents used in peptide drug formulations, such as mannitol, can crystallize. This crystallization causes deposits on manufacturing equipment, reducing production efficiency, and can lead to clogging of needles in patient-used injection devices (’833 Patent, col. 1:30-45).
  • The Patented Solution: The invention replaces traditional isotonicity agents with propylene glycol in peptide formulations. This solution is described as reducing deposits during production and minimizing the clogging of injection devices, resulting in a more stable and reliable drug product (’833 Patent, Abstract; col. 1:50-57). The specification details experiments demonstrating that propylene glycol formulations exhibit no deposits, while mannitol formulations show significant deposits and clogging issues (’833 Patent, col. 19:22-20:36).
  • Technical Importance: Developing stable, manufacturable liquid formulations is critical for the commercial success of self-administered injectable drugs, ensuring consistent dosing, long-term shelf stability, and patient safety (’833 Patent, col. 1:57-63).

Key Claims at a Glance

  • The complaint asserts claims 1-31 of the ’833 patent (Compl. ¶20).
  • Independent Claim 1 requires:
    • A pharmaceutical formulation comprising at least one GLP-1 agonist,
    • a disodium phosphate dihydrate buffer and
    • propylene glycol,
    • wherein said propylene glycol is present in said formulation in a final concentration of from about 1 mg/ml to about 100 mg/ml and
    • wherein said formulation has a pH of from about 7.0 to about 10.0.
  • The complaint states that Orbicular did not contest infringement of any claims of the '833 patent, but contends they are invalid (Compl. ¶20).

U.S. Patent No. 9,265,893 - Injection Button

The Invention Explained

  • Problem Addressed: For certain injection pens, the mechanism requires a push button to rotate relative to a driving part during dose delivery. The friction generated at this interface contributes to the total force a user must apply, which can be a usability challenge (’893 Patent, col. 2:31-39).
  • The Patented Solution: The invention is a specific push button connection designed to minimize rotational friction. It features a central "pivot bearing" to handle the primary axial force over a small contact area, and separate radial bearings to stabilize the button against off-center forces. This arrangement is intended to reduce the operational force required to inject a dose (’893 Patent, Abstract; col. 2:51-66). Figure 1 illustrates the core components, including the push button (10), driving part (20), pivot bearing (18, 22), and radial bearings (13, 14).
  • Technical Importance: Reducing the injection force enhances the usability and patient experience for pen-style injectors, which is a significant factor for patients with chronic conditions like diabetes who perform frequent self-injections (’893 Patent, col. 2:40-45).

Key Claims at a Glance

  • The complaint asserts claims 1-6 of the ’893 patent (Compl. ¶26).
  • Independent Claim 1 requires:
    • A push button connection for an injection device comprising:
    • a push button mountable on a driving part being rotatable relatively to the push button,
    • the push button further comprises a bore with a bottom surface,
    • the bore surrounds a protrusion on the driving part which has a top surface,
    • a pivot bearing is formed between the bottom surface and the top surface,
    • when a user presses the push button the force is directed toward the driving part, and
    • the driving part rotates relative to the push button.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendant Orbicular’s proposed generic version of liraglutide injection solution, 18 mg/3 ml (6 mg/ml), for which it submitted Abbreviated New Drug Application (ANDA) No. 217590 to the FDA (Compl. ¶15).

Functionality and Market Context

The accused product is a generic version of Plaintiff’s Victoza® product, a GLP-1 agonist used to treat type 2 diabetes (Compl. ¶1, 12). The complaint alleges that Orbicular’s ANDA relies on the Victoza® New Drug Application and contains data to demonstrate bioequivalence (Compl. ¶16). The infringement counts imply that Orbicular’s product is a formulation containing liraglutide and propylene glycol and is intended for administration with an injection pen that has a push button connection falling within the scope of the ’893 patent (Compl. ¶20, 26).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint provides a notice-pleading level of detail without specific claim charts. The infringement theory for each patent is summarized below based on the complaint's narrative.

’833 Patent Infringement Allegations

The complaint alleges that Orbicular's manufacture, use, or sale of its proposed generic product would infringe claims 1-31 of the ’833 patent (Compl. ¶20). The basis for this allegation is that the accused product is a generic version of Victoza® and is therefore a GLP-1 formulation that contains propylene glycol. The complaint states that in its Paragraph IV certification, Orbicular did not contest that its product would infringe the claims, but instead asserted that the claims are invalid (Compl. ¶20). This suggests the primary dispute regarding the ’833 patent may center on validity rather than infringement.

’893 Patent Infringement Allegations

The complaint alleges that the manufacture, use, or sale of Orbicular's product would infringe claims 1-6 of the ’893 patent (Compl. ¶26). These claims are directed to a push button connection for an injection device. The allegation implies that the injection pen intended to be sold with or used to deliver Orbicular’s generic drug solution incorporates a push button mechanism with the claimed features, including the specific pivot bearing structure that allows for relative rotation between the button and a driving part during injection.

V. Key Claim Terms for Construction

’833 Patent, Claim 1: "propylene glycol"

  • Context and Importance: While the complaint alleges infringement is not contested, the construction of this term could become relevant to a validity challenge. A party might argue that prior art discloses a different form or grade of the compound, raising the question of whether the claimed term should be construed broadly to cover all forms or limited to a specific pharmaceutical-grade version.
  • Intrinsic Evidence for a Broader Interpretation: The specification generally refers to "propylene glycol" as an isotonic agent without explicit limitation to particular isomers or grades, which may support a broad construction covering the chemical compound itself (’833 Patent, Abstract; col. 1:51).
  • Intrinsic Evidence for a Narrower Interpretation: A party might argue the term should be understood in the context of the specific concentrations and formulations tested in the patent's examples, such as the 13.7 mg/ml concentration shown to be effective (’833 Patent, col. 18:8, Table 1).

’893 Patent, Claim 1: "pivot bearing"

  • Context and Importance: This term is central to defining the novel mechanical interface of the invention. The infringement analysis will likely depend on whether the physical structure in the accused device that manages axial force between the button and the driving part meets the definition of a "pivot bearing" as claimed and described.
  • Intrinsic Evidence for a Broader Interpretation: The claim language itself is functional, requiring only that a "pivot bearing is formed between the bottom surface and the top surface" of the respective components, which may support a construction covering any structure performing that pivoting function at that location (’893 Patent, col. 4:43-45).
  • Intrinsic Evidence for a Narrower Interpretation: The specification describes a preferred embodiment where the pivot is a specific structure: "a raised pointer forming a pivot 18" that creates a small, focused point of contact (’893 Patent, col. 3:66-68; Fig. 1). A defendant could argue that the term should be limited to such a point-contact structure, rather than any broader surface-to-surface contact.

VI. Other Allegations

Indirect Infringement

The complaint does not contain separate counts for indirect infringement. The claims for infringement are based on 35 U.S.C. § 271(e)(2)(A), which defines the submission of an ANDA seeking approval to market a drug claimed in a patent as a statutory act of direct infringement (Compl. ¶19, 25).

Willful Infringement

The complaint alleges that Orbicular was aware of both the ’833 and ’893 patents when it submitted its ANDA, as evidenced by its Paragraph IV certification letter (Compl. ¶23, 29). Based on this alleged pre-suit knowledge, Novo Nordisk seeks a finding that the case is "exceptional" and requests an award of attorneys' fees under 35 U.S.C. § 285 (Compl. ¶23, 29; Prayer for Relief ¶F).

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

  1. A central issue for the ’833 patent will be one of validity. As infringement is apparently not contested, the case will likely focus on whether the claimed invention—using propylene glycol as an isotonicity agent in a GLP-1 formulation—is novel and non-obvious over the prior art.
  2. A key question for the ’893 patent will be one of claim construction and infringement. The dispute may turn on the definition of "pivot bearing" and whether the specific mechanical interface in the defendant's accused injection device meets the structural and functional limitations of that term as recited in the claims.
  3. An overarching procedural question will be whether the plaintiff can demonstrate that this is an exceptional case. The court will have to determine if the defendant's litigation conduct or the substantive weakness of its invalidity or non-infringement positions are sufficient to warrant an award of attorneys' fees under 35 U.S.C. § 285.