DCT

1:23-cv-04027

Novo Nordisk INC. v. Lupin LTD.

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-04027, D.N.J., 07/27/2023
  • Venue Allegations: Venue is asserted based on Defendant’s business contacts within New Jersey and its prior litigation conduct in the district, which is alleged to constitute consent to jurisdiction.
  • Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the diabetes drug Victoza® constitutes an act of infringement of two U.S. patents covering the drug's formulation and its associated injection device.
  • Technical Context: The dispute involves pharmaceutical formulation science for injectable peptides and the mechanical engineering of drug delivery devices, specifically pen injectors.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant's submission of a Paragraph IV certification, asserting that Plaintiff's patents are invalid, unenforceable, or will not be infringed. The complaint was filed within the 45-day statutory window, triggering an automatic 30-month stay on the FDA’s approval of Defendant's generic product.

Case Timeline

Date Event
2003-11-20 U.S. Patent 8,114,833 - Earliest Priority Date
2007-02-05 U.S. Patent 9,265,893 - Earliest Priority Date
2012-02-14 U.S. Patent 8,114,833 - Issue Date
2016-02-23 U.S. Patent 9,265,893 - Issue Date
2023-06-12 Defendant sends Paragraph IV Notice Letter
2023-07-27 Complaint Filing Date

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”

  • Patent Identification: U.S. Patent No. 8114833, "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 mannitol, a common isotonicity agent used in injectable peptide formulations. Mannitol has a tendency to crystallize, which causes deposits to form on manufacturing equipment and can lead to the clogging of fine-gauge injection needles used by patients (’833 Patent, col. 1:30-45).
  • The Patented Solution: The invention replaces mannitol with propylene glycol as the isotonicity agent. The specification asserts that this substitution results in a physically and chemically stable formulation that significantly reduces the formation of deposits during production and minimizes the clogging of injection devices, as illustrated in comparative studies (’833 Patent, col. 1:50-65; Fig. 7).
  • Technical Importance: The solution provides a more reliable and efficient method for both manufacturing and administering injectable peptide drugs, which are a critical class of therapeutics.

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-31 (Compl. ¶22). Independent claim 1 is a composition claim.
  • Independent Claim 1:
    • 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
    • wherein the formulation has a pH of from about 7.0 to about 10.0.
  • The complaint reserves the right to assert all claims, including dependent claims and method claims 16-31 (Compl. ¶22).

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

  • Patent Identification: U.S. Patent No. 9265893, "Injection Button," issued February 23, 2016.

The Invention Explained

  • Problem Addressed: In certain injection pen designs, the push button and an internal driving part must rotate relative to each other during injection. The friction created by this relative rotation contributes to the total force a user must apply, which can be a challenge for some patients (’893 Patent, col. 1:22-34).
  • The Patented Solution: The patent describes a specific two-part push button connection that is engineered to minimize this rotational friction. The design features a "pivot bearing" formed between the top surface of a protrusion on the driving part and the bottom surface of a bore in the push button, which reduces the surface area of interaction and the resulting friction force (’893 Patent, col. 1:50-55; Fig. 1).
  • Technical Importance: By reducing the required injection force, the invention makes the device easier to use, potentially improving patient compliance and the overall user experience.

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-6 (Compl. ¶28). Claim 1 is the sole independent claim.
  • Independent Claim 1:
    • 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 comprising a bore with a bottom surface;
    • the bore surrounds a protrusion on the driving part, which has a top surface;
    • wherein a pivot bearing is formed between the bottom surface and the top surface;
    • wherein force from a user pressing the button is directed to the driving part; and
    • wherein the driving part rotates relative to the push button.
  • The complaint reserves the right to assert dependent claims 2-6 (Compl. ¶28).

III. The Accused Instrumentality

Product Identification

  • Defendant's generic liraglutide injection solution, 18 mg/3 ml (6 mg/ml), and the associated injection device for which Defendant submitted ANDA No. 215421 to the FDA (Compl. ¶¶10, 17).

Functionality and Market Context

  • The complaint alleges that Defendant's product is a generic version of Plaintiff's Victoza® product and relies on the Victoza® New Drug Application to demonstrate bioequivalence (Compl. ¶¶17-18). This implies the accused product contains the same active pharmaceutical ingredient (liraglutide, a GLP-1 agonist) at the same concentration and is intended for the same therapeutic indications as Victoza® (Compl. ¶14, 17). The infringement allegations suggest the accused product's formulation and delivery device embody the patented technologies.

IV. Analysis of Infringement Allegations

The complaint does not contain a detailed claim chart or specific factual allegations mapping the accused product’s features to the claim elements. It provides a narrative infringement theory by identifying the patents-in-suit and the accused product.

For the ’833 Patent, the infringement theory is that to be a bioequivalent generic version of Victoza®, Defendant's product must necessarily have a formulation that meets the limitations of the asserted claims, including the use of propylene glycol as an isotonicity agent within the claimed concentration and pH ranges (Compl. ¶¶18, 22). Plaintiff's patent includes Figure 7, a set of photographs comparing needle deposits from a mannitol-based formulation (top) with a propylene glycol-based formulation (bottom), to visually substantiate the invention's technical advantages ('833 Patent, Fig. 7).

For the ’893 Patent, the infringement theory is that the injection device distributed with Defendant's generic drug will contain a push button mechanism that infringes the asserted claims (Compl. ¶28). The patent provides a cross-sectional diagram in Figure 1 that illustrates the claimed connection, including the push button (10), driving part (20), and the pivot bearing (18, 22) between them ('893 Patent, Fig. 1).

  • Identified Points of Contention:
    • Scope and Factual Questions (’833 Patent): A primary issue will be factual: does Defendant's formulation fall within the literal scope of the claims? Defendant’s Paragraph IV certification suggests it may argue for non-infringement by using a different isotonicity agent or a concentration of propylene glycol outside the claimed range, or it may challenge the patent's validity (Compl. ¶19). The construction of the term "about" may be critical in determining the boundaries of the claimed concentration and pH ranges.
    • Structural and Functional Questions (’893 Patent): The analysis will likely focus on whether the mechanism in Defendant's device includes a "pivot bearing" and other structural elements as defined in the claims. The dispute will concern the precise structure and operation of the accused device compared to the specific limitations of the claims.

V. Key Claim Terms for Construction

  • The Term: "about" (from '833 Patent, Claim 1)

    • Context and Importance: This term appears in Claim 1 of the ’833 Patent, defining the permissible ranges for both propylene glycol concentration ("about 1 mg/ml to about 100 mg/ml") and pH ("about 7.0 to about 10.0"). The scope of "about" is critical, as it will determine whether a formulation that is close but not identical to the recited endpoints infringes. Practitioners may focus on this term because even a small deviation in Defendant's formulation could form the basis of a non-infringement defense.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The repeated use of "about" throughout the claims and specification may suggest the patentee did not intend to be limited to the precise numerical values recited and that some degree of variability is contemplated (’833 Patent, col. 31:47-66).
      • Evidence for a Narrower Interpretation: The specification provides numerous examples with highly specific values (e.g., "Propylene glycol: 14.0 ... mg.ml," "pH: 7.40, 7.70, 7.90 or 8.15") which a defendant might use to argue that "about" should be interpreted narrowly and does not encompass significant deviation from the stated values (’833 Patent, col. 20:15-18).

  • The Term: "pivot bearing" (from '893 Patent, Claim 1)

    • Context and Importance: This is the central structural element of Claim 1 of the ’893 Patent, described as being "formed between the bottom surface [of the push button bore] and the top surface [of the driving part protrusion]." The definition of this term will dictate whether Defendant's push button mechanism infringes.
    • 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. 1:50-55). A plaintiff might argue that any structure that achieves this function in the claimed manner constitutes a "pivot bearing."
      • Evidence for a Narrower Interpretation: The detailed description and figures disclose a specific embodiment where the pivot is a "raised pointer" (18) on the push button bearing on the top surface (22) of the protrusion (’893 Patent, col. 3:63-65; Fig. 1). A defendant could argue that the term should be limited to this specific point-on-surface structure or a close equivalent.

VI. Other Allegations

  • Indirect Infringement: While not explicitly detailed, a claim for induced infringement is inherent in an ANDA case. The complaint alleges infringement through "use" of the product, which would be carried out by patients and healthcare providers (Compl. ¶22, 28). The basis for inducement would likely be Defendant’s proposed drug label and instructions for use, which would allegedly direct users to use the infringing formulation and device in an infringing manner.
  • Willful Infringement: The complaint alleges that Defendant was aware of the patents-in-suit when it submitted its ANDA, citing Defendant's Paragraph IV Notice Letter as evidence of pre-suit knowledge (Compl. ¶¶19, 25, 31). This alleged knowledge forms the basis of the request for a finding of exceptional case and attorneys' fees.

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

  • A core issue will be one of factual infringement and claim construction: Does Defendant's generic formulation contain propylene glycol within the specific concentration and pH ranges required by the '833 patent claims? The resolution may depend on the court's construction of the term "about" and its application to the precise composition of the accused product.
  • A second central question will be one of structural infringement: Does the push button mechanism in Defendant's injection device incorporate a "pivot bearing" as that term is construed in light of the '893 patent's specification and figures, or has Defendant engineered a functionally similar but structurally distinct, non-infringing design?