DCT

2:23-cv-20935

Novo Nordisk Inc v. ScinoPharm Taiwan Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:23-cv-20935, D.N.J., 10/05/2023
  • Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant, a foreign corporation, conducts business and derives revenue in the state, has engaged in systematic and continuous contacts with the state, and has previously litigated in the district, thereby availing itself of the jurisdiction.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of the diabetes drug Victoza® constitutes an act of infringement of patents related to the drug's liquid formulation and its injection device mechanism.
  • Technical Context: The technology at issue addresses challenges in formulating and administering injectable peptide-based drugs, focusing on chemical stability, manufacturing efficiency, and the usability of pen-style injection devices.
  • Key Procedural History: The action was triggered by a Paragraph IV certification notice letter sent by Defendant to Plaintiff on August 22, 2023, asserting that the patents-in-suit are invalid, unenforceable, or will not be infringed. The complaint also notes related litigation involving the same plaintiff and similar patents against other generic drug manufacturers.

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 Issue Date
2016-02-23 ’893 Patent Issue Date
2023-08-22 Defendant Sends Paragraph IV Notice Letter
2023-10-05 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," issued February 14, 2012 (’833 Patent)

The Invention Explained

  • Problem Addressed: The patent’s background section identifies problems with using mannitol, a common isotonicity agent, in liquid peptide formulations. The inventors observed that mannitol can crystallize, causing deposits on manufacturing equipment—which reduces production capability—and in the final drug product, which can lead to the clogging of needles in injection devices. (’833 Patent, col. 1:29-49).
  • The Patented Solution: The invention replaces mannitol with propylene glycol as the isotonicity agent in the peptide formulation. This substitution is described as a solution that reduces deposits during production and minimizes clogging of injection devices, while also providing a physically and chemically stable formulation suitable for administration. (’833 Patent, col. 2:35-58, Abstract).
  • Technical Importance: For chronic-use injectable drugs, ensuring formulation stability and efficient, high-yield manufacturing is critical for providing a safe, reliable, and cost-effective product. (’833 Patent, col. 1:35-49).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-31 (Compl. ¶22). Independent claims 1, 16, 23, 26, and 29 are asserted.
  • Independent Claim 1 (Composition): A pharmaceutical formulation comprising:
    • At least one GLP-1 agonist
    • A disodium phosphate dihydrate buffer
    • Propylene glycol, present in a final concentration of from about 1 mg/ml to about 100 mg/ml
    • A pH of from about 7.0 to about 10.0
  • Independent Claim 16 (Method of Preparation): A method of preparing a GLP-1 agonist formulation by mixing a first solution (preservative, propylene glycol, buffer) with a second solution (GLP-1 agonist).
  • Independent Claim 23 (Method of Reducing Deposits): A method for reducing deposits on production equipment by replacing a previously used isotonicity agent with propylene glycol.
  • The complaint asserts all claims in the patent, which includes numerous dependent claims specifying particular peptides, concentrations, and pH ranges.

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

The Invention Explained

  • Problem Addressed: In pen-style injection devices, a user pushes a button that must rotate relative to an internal driving part to dispense the medicine. The patent notes that friction between these relatively rotating components increases the force a user must apply, making the injection process difficult. (’893 Patent, col. 1:49-56).
  • The Patented Solution: The invention is a specific mechanical design for the push button connection that minimizes this friction. It creates a "pivot bearing" between the button and a protrusion on the driving part. This design minimizes the surface area of interaction and the radius of the resulting friction force, which in turn reduces the force the user must apply to actuate the device. (’893 Patent, col. 1:57-62; Abstract). The patent's Figure 1 depicts this pivot bearing arrangement.
  • Technical Importance: Reducing the force required for injection enhances the usability of self-administered therapies, improving patient compliance and accessibility, particularly for individuals with impaired dexterity. (’893 Patent, col. 1:49-56).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-6 (Compl. ¶28).
  • Independent Claim 1 (Apparatus): A push button connection for an injection device, comprising:
    • A push button mountable on a driving part and rotatable relative to it.
    • The push button has a bore with a bottom surface that surrounds a protrusion on the driving part.
    • The protrusion has a top surface.
    • A pivot bearing is formed between the button's bore bottom surface and the protrusion's top surface.
    • When pressed, the force is directed to the driving part, which rotates relative to the button.
  • The complaint also asserts dependent claims 2-6, which add limitations such as radial bearings and specify materials.

III. The Accused Instrumentality

Product Identification

The accused instrumentality is ScinoPharm's proposed generic version of Victoza®, identified as "liraglutide injection solution, 18 mg/3 ml (6 mg/ml)," for which ScinoPharm filed ANDA No. 217612 with the FDA (Compl. ¶10, 17).

Functionality and Market Context

The complaint alleges that ScinoPharm's product is a generic version of and is bioequivalent to Novo Nordisk's Victoza® product (Compl. ¶1, 18). The infringement action is based on the filing of the ANDA itself, which constitutes a statutory act of infringement under 35 U.S.C. § 271(e)(2) if the product, once approved, would infringe. The complaint alleges the patents-in-suit are listed in the FDA's Orange Book for Victoza® (Compl. ¶16).

IV. Analysis of Infringement Allegations

The complaint, structured as a notice pleading, does not contain detailed infringement contentions or claim charts that map features of the accused product to specific claim limitations. The following is a prose summary of the infringement theories as alleged.

No probative visual evidence provided in complaint.

  • ’833 Patent Infringement Allegations: The complaint alleges that ScinoPharm's proposed generic liraglutide solution, as described in its ANDA, will have a formulation that infringes claims 1-31 of the ’833 Patent (Compl. ¶22). The infringement theory posits that to be a bioequivalent generic of Victoza®, ScinoPharm's product will necessarily be a pharmaceutical formulation containing a GLP-1 agonist at a specific pH and will use propylene glycol as an isotonicity agent in the claimed concentration ranges. The allegations also cover the methods of preparing such a formulation and using it to reduce clogging, which would be infringed by ScinoPharm’s manufacturing processes and the product’s intended use (Compl. ¶22).

  • ’893 Patent Infringement Allegations: The complaint alleges that the injection device intended for use with ScinoPharm's product will infringe claims 1-6 of the ’893 Patent (Compl. ¶28). The theory is that the commercial manufacture, use, or sale of ScinoPharm's product, presumably supplied with or for use in a pen-style injector, would embody the claimed push button connection. This suggests a potential theory of direct infringement (if ScinoPharm supplies the device) or indirect infringement (if it instructs or encourages use of an infringing device).

  • Identified Points of Contention:

    • Scope Questions: For the ’833 Patent, a potential dispute may arise over the term "about" as it applies to the claimed concentration and pH ranges. The case may turn on whether the specific values in ScinoPharm's ANDA fall within a legally acceptable interpretation of these ranges. For the ’893 Patent, a key question is whether the term "pivot bearing" can be read to cover the specific mechanical interface in the device associated with the ANDA, or if that device uses a functionally or structurally distinct connection.
    • Technical Questions: A primary technical question for the ’833 Patent is whether the formulation detailed in the confidential ANDA filing in fact contains propylene glycol, a disodium phosphate dihydrate buffer, and a GLP-1 agonist within the claimed parameters. For the ’893 Patent, the question is whether the injector device for the generic product actually has the claimed structure, specifically the combination of a pivot bearing and the relative rotational movement between the button and driving part.

V. Key Claim Terms for Construction

  • Term from ’833 Patent: "from about 1 mg/ml to about 100 mg/ml" (Claim 1)

    • Context and Importance: This concentration range for propylene glycol is a central limitation of the core composition claim. The infringement analysis will depend heavily on whether the concentration in ScinoPharm's ANDA product falls within this range, making the construction of "about" critical.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification uses the term "about" in relation to other ranges, such as "from about 13 to about 15 mg/ml" (’833 Patent, col. 10:31-32), suggesting the inventors intended a degree of flexibility and not strict numerical boundaries.
      • Evidence for a Narrower Interpretation: The patent discloses multiple working examples with highly specific concentrations, such as "13.7" mg/ml and "14.0" mg/ml (’833 Patent, col. 15:8, col. 19:15). A party could argue that these specific embodiments inform and limit the scope of "about" to values very close to those explicitly recited.

  • Term from ’893 Patent: "a pivot bearing" (Claim 1)

    • Context and Importance: This term describes the core friction-reducing mechanism of the invention. Whether the connection in the accused device constitutes a "pivot bearing" will likely be a central point of the infringement dispute.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification describes the functional purpose of the feature: to "minimize the surface area of interaction" and keep the "radius of the resulting friction force... at a minimum" (’893 Patent, col. 1:57-62). A party could argue that any structure achieving this specific function meets the definition.
      • Evidence for a Narrower Interpretation: The preferred embodiment discloses a specific structure: "a raised pointer forming a pivot 18" that makes contact with the opposing surface (’893 Patent, col. 3:63-65). A party may argue that the term "pivot bearing" is limited to this point-contact geometry and does not read on other types of interfaces, such as a small, flat-on-flat surface.

VI. Other Allegations

  • Indirect Infringement: While the complaint's primary focus is the statutory infringement under 35 U.S.C. § 271(e)(2)(A), the assertion of method claims in the ’833 Patent (e.g., methods of reducing clogging) and device claims in the ’893 Patent implies potential claims for induced infringement. The complaint alleges that ScinoPharm's "manufacture, use, offer to sell, or sale" would infringe, which could be supported by evidence from the proposed product's labeling and instructions for use, though no such evidence is detailed in the complaint itself (Compl. ¶22, 28).
  • Willful Infringement: The complaint alleges that ScinoPharm "was aware of the '833 patent when it submitted its ANDA" and "was aware of the '893 patent when it submitted its ANDA" (Compl. ¶25, 31). This allegation of pre-suit knowledge, supported by the ANDA filer's obligation to review the Orange Book, forms the basis for a claim of willful infringement and a request for enhanced damages and attorneys' fees.

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

  • A central issue for the ’833 Patent will be one of compositional identity: does the confidential formulation in ScinoPharm's ANDA fall within the metes and bounds of the asserted composition claims? This will require a factual comparison of the formulations and a potential judicial construction of the scope of the term "about."

  • A core question for the ’893 Patent will be one of structural equivalence: does the injection device intended for use with the generic product incorporate the specific "pivot bearing" claimed in the patent, or does it utilize a different mechanical connection to manage friction that places it outside the claim's scope?

  • Ultimately, the overarching question for the court is one of statutory infringement: would the drug product and its associated delivery device that ScinoPharm seeks to market, as defined by its ANDA, infringe any valid and enforceable claim of the patents-in-suit if it were commercially manufactured and sold?