DCT

1:23-cv-20935

Novo Nordisk INC. v. ScinoPharm Taiwan LTD.

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-20935, D.N.J., 10/05/2023
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant is a foreign corporation, subject to personal jurisdiction in the District of New Jersey, and has previously availed itself of the jurisdiction by litigating in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) to market a generic version of the diabetes drug Victoza® constitutes an act of infringement of two patents covering the drug's formulation and its injection device.
  • Technical Context: The dispute involves technologies for stabilizing injectable peptide formulations and for improving the mechanical usability of pen-style injection devices.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following a notice letter dated August 22, 2023, in which Defendant certified that the patents-in-suit are invalid, unenforceable, and/or will not be infringed by its proposed generic product. The complaint also references other litigation involving the same plaintiff and some of the same patents to support its jurisdictional arguments.

Case Timeline

Date Event
2003-11-20 Earliest Priority Date for ’833 Patent
2007-02-05 Earliest Priority Date for ’893 Patent
2012-02-14 ’833 Patent Issued
2016-02-23 ’893 Patent Issued
2023-08-22 Defendant’s Paragraph IV Certification Notice Letter Sent
2023-10-05 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," issued February 14, 2012

The Invention Explained

  • Problem Addressed: The patent’s background section identifies a problem with using mannitol, a common agent for maintaining proper tonicity in injectable drug formulations. Mannitol can crystallize during the manufacturing process, leading to deposits on filling equipment and in the final drug product, and can also cause clogging of the fine-gauge needles used in injection devices (’833 Patent, col. 2:32-45).
  • The Patented Solution: The invention proposes replacing mannitol with propylene glycol as the isotonicity agent in peptide formulations. This substitution is described as a solution that reduces both production line deposits and needle clogging, thereby improving manufacturing efficiency and the reliability of the final product for patient use (’833 Patent, Abstract; col. 2:51-58). The specification includes visual evidence comparing the significant deposits on a needle from a mannitol-based formulation with the lack of deposits from a propylene glycol-based formulation, as depicted in the patent’s Figure 7 (Compl., Ex. A, p. 21).
  • Technical Importance: The invention addresses practical challenges in the large-scale manufacturing and end-use administration of injectable peptide drugs, aiming to increase production yield and enhance patient safety and convenience (’833 Patent, col. 2:37-45).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-31, with independent claim 1 being the primary composition claim (Compl. ¶22).
  • Essential elements of independent claim 1 include:
    • A pharmaceutical formulation comprising at least one GLP-1 agonist,
    • a disodium phosphate dihydrate buffer and
    • propylene glycol,
    • wherein the propylene glycol is present in a final concentration of from about 1 mg/ml to about 100 mg/ml, and
    • the formulation has a pH of from about 7.0 to about 10.0.
  • The complaint reserves the right to pursue infringement of all dependent claims.

U.S. Patent No. 9,265,893 - "Injection Button," issued February 23, 2016

The Invention Explained

  • Problem Addressed: In pen-style injection devices where the push button and an internal driving part must rotate relative to each other, the resulting friction increases the force a user needs to apply to administer a dose (’893 Patent, col. 1:29-34).
  • The Patented Solution: The invention is a specific mechanical connection between the push button and the driving part that incorporates a "pivot bearing." This design is intended to minimize the surface area of interaction and the radius of friction, thereby reducing the actuation force required from the user (’893 Patent, Abstract; col. 1:52-57). The patent's Figure 1 shows a cross-sectional view of this connection, illustrating the relationship between the button (10), the driving part (20), and the pivot bearing (18, 22) (Compl., Ex. B, p. 38).
  • Technical Importance: The technology aims to make self-administration of injectable drugs easier and more accessible, particularly for patients who may have diminished hand strength or dexterity (’893 Patent, col. 1:47-49).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-6, with claim 1 being the sole independent claim (Compl. ¶28).
  • Essential elements of independent claim 1 include:
    • A push button connection for an injection device comprising a push button and a driving part,
    • the button is mountable on the driving part and is rotatable relative to it,
    • the button has a bore with a bottom surface that surrounds a protrusion on the driving part,
    • a pivot bearing is formed between the button's bottom surface and the protrusion's top surface, and
    • when pressed, the button directs force to the driving part, which rotates relative to the button.
  • The complaint asserts infringement of dependent claims 2-6.

III. The Accused Instrumentality

Product Identification

  • Defendant’s proposed generic version of liraglutide injection solution, 18 mg/3 ml (6 mg/ml), identified in connection with ANDA No. 217612 (“ScinoPharm’s Product”) (Compl. ¶10).

Functionality and Market Context

  • The complaint alleges that ScinoPharm’s Product is a generic version of Plaintiff's Victoza® product and relies on the Victoza® New Drug Application (NDA) to establish its safety and efficacy (Compl. ¶¶1, 17). The complaint further alleges that data within the ANDA demonstrates the bioequivalence of ScinoPharm’s Product to Victoza® (Compl. ¶18). The complaint does not provide specific technical details regarding the formulation or the delivery device of the proposed generic product beyond these allegations.

IV. Analysis of Infringement Allegations

The complaint does not provide detailed, element-by-element infringement allegations or reference any claim chart exhibits. Instead, it makes a statutory infringement allegation under 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 an act of infringement (Compl. ¶¶21, 27). The narrative theory is that because ScinoPharm’s Product is a generic version of Victoza®, and Victoza® and/or its use are covered by the patents-in-suit, the future commercial manufacture, use, or sale of ScinoPharm's Product would infringe claims of the ’833 and ’893 patents (Compl. ¶¶15, 22, 28).

  • Identified Points of Contention:
    • ’833 Patent: The core dispute for the formulation patent will likely center on validity, as asserted in ScinoPharm’s Paragraph IV certification (Compl. ¶19). A key question for the court may be whether substituting propylene glycol for mannitol as an isotonicity agent would have been obvious to a person of ordinary skill in the art at the time of the invention. For infringement, the question is whether ScinoPharm’s proposed formulation contains a GLP-1 agonist, propylene glycol, and a buffer within the specific concentrations and pH ranges recited in the asserted claims.
    • ’893 Patent: The dispute for the device patent will likely focus on claim construction and non-infringement. Generic manufacturers often attempt to design around device patents. The analysis will raise the question of whether the injection device ScinoPharm plans to market with its drug incorporates the specific "push button connection" recited in claim 1, particularly the "pivot bearing" element, or if it utilizes a different mechanical design.

V. Key Claim Terms for Construction

  • ’833 Patent, Claim 1

    • The Term: "GLP-1 agonist"
    • Context and Importance: The definition of this term is critical for establishing that the patent covers the active ingredient in both Victoza® and the accused generic product, which is liraglutide.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification provides a broad, functional definition: "any peptide which fully or partially activates the human GLP-1 receptor" (’833 Patent, col. 3:32-34). This supports a construction covering a wide range of molecules with the specified activity.
      • Evidence for a Narrower Interpretation: While a defendant might argue for a narrower scope based on the specific examples listed, the patent explicitly includes the specific chemical name for liraglutide in dependent claim 14, which may foreclose a non-infringement argument based on the scope of this term (’833 Patent, col. 23:22-26).

  • ’893 Patent, Claim 1

    • The Term: "pivot bearing"
    • Context and Importance: This term is central to the mechanical novelty of the claimed injection button. The infringement analysis will depend entirely on whether the structure in ScinoPharm’s device meets the court's construction of this term. Practitioners may focus on this term because design-around efforts for mechanical patents often hinge on avoiding such structurally defined elements.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification describes the function of the pivot bearing as minimizing the surface area of interaction to reduce friction (’893 Patent, col. 1:52-57). A plaintiff could argue the term should cover any structure that performs this function in the manner described.
      • Evidence for a Narrower Interpretation: The detailed description discloses a specific embodiment where the pivot bearing is formed by a "raised pointer" on the bottom of the button's bore that makes contact with the top surface of the driving part's protrusion (’893 Patent, col. 3:62-64, Fig. 1). A defendant could argue the term should be limited to this point-contact structure or similar specific geometries.

VI. Other Allegations

  • Indirect Infringement: The complaint does not plead separate counts for indirect or contributory infringement. The primary basis for the suit is the statutory act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶¶21, 27).
  • Willful Infringement: The complaint alleges that ScinoPharm was aware of the ’833 and ’893 patents at the time it submitted its ANDA, citing the Paragraph IV certification letter as evidence of pre-suit knowledge (Compl. ¶¶25, 31). This forms the basis for the willfulness allegation and the corresponding request for attorneys' fees under 35 U.S.C. § 285.

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

  • A central issue for the ’833 formulation patent will likely be one of validity: Did the state of the art regarding pharmaceutical excipients make the substitution of propylene glycol for mannitol in a peptide formulation an obvious step for a person of ordinary skill, or does the substitution represent a non-obvious solution to the recited problems of production deposits and needle clogging?
  • A key question for the ’893 device patent will be one of claim scope and non-infringement: Can the term "pivot bearing" be construed broadly to cover a range of low-friction rotational contacts, or is it limited to the specific point-contact structure disclosed in the patent's embodiment? The answer will determine whether ScinoPharm's competing device design falls within or outside the scope of the claims.