DCT

1:23-cv-04031

Novo Nordisk INC. v. Lupin LTD.

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-04031, D.N.J., 07/27/2023
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant is a foreign corporation subject to personal jurisdiction in the district, has conducted business in New Jersey, and has previously litigated patent disputes and consented to venue in this district.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff’s Saxenda® pharmaceutical product constitutes infringement of sixteen U.S. patents covering the drug formulation and its injection device technology.
  • Technical Context: The dispute centers on liraglutide, a GLP-1 receptor agonist used for weight management, and the pen-style injection devices used for its administration, a significant area of the pharmaceutical market.
  • Key Procedural History: The action is a Hatch-Waxman suit initiated in response to Defendant’s Notice Letter, which included a Paragraph IV Certification asserting that Plaintiff’s patents are invalid, unenforceable, or will not be infringed by Defendant’s proposed generic product.

Case Timeline

Date Event
2003-11-24 ’833 Patent Priority Date
2004-10-21 ’969 and ’611 Patents Priority Date
2005-01-21 ’002, ’180, ’652, and ’679 Patents Priority Date
2005-01-25 ’154, ’757, and ’616 Patents Priority Date
2005-07-27 ’383, ’953, ’155, and ’063 Patents Priority Date
2008-10-24 ’239 and RE46,363 Patents Priority Date
2012-02-14 U.S. Patent No. 8,114,833 Issued
2014-04-01 U.S. Patent No. 8,684,969 Issued
2014-12-30 U.S. Patent No. 8,920,383 Issued
2015-08-18 U.S. Patent No. 9,108,002 Issued
2015-09-15 U.S. Patent No. 9,132,239 Issued
2016-10-04 U.S. Patent No. 9,457,154 Issued
2017-04-11 U.S. Patent No. 9,616,180 Issued
2017-04-11 U.S. Patent No. RE46,363 Issued
2017-06-27 U.S. Patent No. 9,687,611 Issued
2017-10-03 U.S. Patent No. 9,775,953 Issued
2018-01-09 U.S. Patent No. 9,861,757 Issued
2019-03-05 U.S. Patent No. 10,220,155 Issued
2019-07-23 U.S. Patent No. 10,357,616 Issued
2019-08-13 U.S. Patent No. 10,376,652 Issued
2021-08-24 U.S. Patent No. 11,097,063 Issued
2022-04-26 U.S. Patent No. 11,311,679 Issued
2023-06-12 Defendant's ANDA Notice Letter Sent
2023-07-27 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 (Compl. ¶12).

The Invention Explained

  • Problem Addressed: The patent describes how mannitol, a common agent used to ensure proper isotonicity in injectable peptide drugs, causes problems by crystallizing during production. This crystallization leads to deposits on filling equipment, reducing production capacity, and can also clog the fine needles of injection devices during administration by the patient (’833 Patent, col. 1:31-44).
  • The Patented Solution: The invention replaces mannitol with propylene glycol as the isotonicity agent. The specification asserts that formulations with propylene glycol exhibit reduced deposits on production equipment and reduced clogging of injection devices, while remaining physically and chemically stable for administration (’833 Patent, col. 1:50-65).
  • Technical Importance: This approach addresses both manufacturing efficiency and end-user safety/reliability for injectable peptide therapeutics (’833 Patent, col. 1:36-49).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-31 (Compl. ¶36). Independent claim 1 covers the formulation, and independent claim 16 covers a method of preparation.
  • 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 said propylene glycol is present 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 does not explicitly reserve the right to assert dependent claims, but the assertion of a range of claims implies this possibility.

U.S. Patent No. 8,684,969 - "Injection Device with Torsion Spring and Rotatable Display"

Issued April 1, 2014 (Compl. ¶13).

The Invention Explained

  • Problem Addressed: The patent notes that many prior art injection pens use dose indicator barrels that are limited to less than one full rotation for setting a dose. This limits the scale length and, consequently, the accuracy and resolution of the dose setting procedure. Some prior devices also use linear springs, which can be mechanically inefficient and non-linear in their force delivery (’969 Patent, col. 1:32-62).
  • The Patented Solution: The invention uses a torsion spring, which provides a more linear and efficient force, operatively connected to a dose setting member. Critically, it employs a rotatably mounted display member, such as a dose indicator barrel, that is capable of rotating more than one full revolution. This allows the dose numerals to be arranged along a helical path, creating an expanded, high-resolution dose scale (’969 Patent, Abstract; col. 2:10-23).
  • Technical Importance: The invention aims to provide a more user-friendly and accurate dose setting mechanism for automatic, pen-style injection devices (’969 Patent, col. 2:5-9).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-26 (Compl. ¶42). Independent claim 1 is the lead apparatus claim.
  • Essential elements of independent claim 1 include:
    • An injection device comprising a torsion spring operatively connected to a dose setting member adapted to set a dose;
    • A rotatably mounted display member adapted to display the dose;
    • The display member being rotatable over an angle corresponding to at least one revolution;
    • The display member comprising a dose indicator barrel; and
    • The display member being movable between two end positions defining an operation range associated with a substantially linear working range of the torsion spring.
  • The complaint does not explicitly reserve the right to assert dependent claims.

Multi-Patent Capsules

  • U.S. Patent No. 8,920,383: "Dose Mechanism for an Injection Device for Limiting a Dose Setting Corresponding to the Amount of Medicament Left," issued December 30, 2014 (Compl. ¶14).

    • Technology Synopsis: The patent addresses preventing a user from setting a dose that exceeds the amount of medicament remaining in the device. It discloses a mechanism with a limiter that moves toward a stop position during dose setting, physically preventing an overdose or an incomplete dose setting (’383 Patent, Abstract).
    • Asserted Claims: Claims 1-13 (Compl. ¶48).
    • Accused Features: The complaint alleges Lupin's generic liraglutide injection device will infringe (Compl. ¶48).

  • U.S. Patent No. 9,108,002: "Automatic Injection Device with a Top Release Mechanism," issued August 18, 2015 (Compl. ¶15).

    • Technology Synopsis: The patent describes a handheld automatic injection device where the injection is initiated by a release member located at the top (proximal end) of the device, opposite the needle end. This design is intended to be ergonomic and similar to conventional manual injection pens (’002 Patent, Abstract; col. 2:10-21).
    • Asserted Claims: Claims 1-2 (Compl. ¶54).
    • Accused Features: The complaint alleges Lupin's generic liraglutide injection device will infringe (Compl. ¶54).

  • U.S. Patent No. 9,132,239: "Dial-Down Mechanism for Wind-Up Pen," issued September 15, 2015 (Compl. ¶16).

    • Technology Synopsis: The technology relates to a mechanism that allows a user to "dial down" or decrease a previously set dose in a torsion spring-assisted injection pen without expelling medication. It involves a ratchet arm that can be disengaged from a ring element to permit the dose to be reduced (’239 Patent, Abstract).
    • Asserted Claims: Claims 1-3 (Compl. ¶60).
    • Accused Features: The complaint alleges Lupin's generic liraglutide injection device will infringe (Compl. ¶60).

  • U.S. Patent Nos. 9,457,154; 9,861,757; 10,357,616: "Injection Device with an End of Dose Feedback Mechanism," issued October 4, 2016; January 9, 2018; and July 23, 2019, respectively (Compl. ¶¶17, 21, 23).

    • Technology Synopsis: These related patents describe an injection device that provides a non-visual (e.g., audible or tactile) feedback signal to the user only at the end of the injection. This is achieved by the relative rotational movement of two parts of the device causing an abutment or engagement that generates the feedback signal, confirming full dose delivery (’154 Patent, Abstract).
    • Asserted Claims: Claims 1-17 of the ’154 patent, 1-12 of the ’757 patent, and 1-9 of the ’616 patent (Compl. ¶¶66, 90, 102).
    • Accused Features: The complaint alleges Lupin's generic liraglutide injection device will infringe (Compl. ¶¶66, 90, 102).

  • U.S. Patent Nos. 9,616,180; 10,376,652; 11,311,679: "Automatic Injection Device with a Top Release Mechanism," issued April 11, 2017; August 13, 2019; and April 26, 2022, respectively (Compl. ¶¶18, 24, 26).

    • Technology Synopsis: These related patents build on the technology of the ’002 patent, further detailing a handheld automatic injection device initiated by a release member at the top (proximal end) of the pen. The claims focus on the combination of a release member, a display member, and other mechanical components (’180 Patent, Abstract).
    • Asserted Claims: Claims 1-14 of the ’180 patent, 1-15 of the ’652 patent, and 1-6 of the ’679 patent (Compl. ¶¶72, 108, 120).
    • Accused Features: The complaint alleges Lupin's generic liraglutide injection device will infringe (Compl. ¶¶72, 108, 120).

  • U.S. Patent No. 9,687,611: "Injection Device with Torsion Spring and Rotatable Display," issued June 27, 2017 (Compl. ¶19).

    • Technology Synopsis: This patent is related to the ’969 patent and further describes an injection device using a torsion spring connected to a dose setting member and a rotatable display member, such as a dose indicator barrel with a helical scale, for enhanced dose setting accuracy (’611 Patent, Abstract).
    • Asserted Claims: Claims 1-15 (Compl. ¶78).
    • Accused Features: The complaint alleges Lupin's generic liraglutide injection device will infringe (Compl. ¶78).

  • U.S. Patent No. 9,775,953: "Dose Mechanism for an Injection Device for Limiting a Dose Setting Corresponding to the Amount of Medicament Left," issued October 3, 2017 (Compl. ¶20).

    • Technology Synopsis: This patent is related to the ’383 patent and discloses a mechanism for preventing a user from setting a dose that is larger than the remaining amount of drug in the reservoir. It uses a limiter coupled to a driver and a threaded piston rod to create a stop (’953 Patent, Abstract).
    • Asserted Claims: Claims 1-25 (Compl. ¶84).
    • Accused Features: The complaint alleges Lupin's generic liraglutide injection device will infringe (Compl. ¶84).

  • U.S. Patent Nos. 10,220,155; 11,097,063: "Syringe Device with a Dose Limiting Mechanism and an Additional Safety Mechanism," issued March 5, 2019 and August 24, 2021, respectively (Compl. ¶¶22, 25).

    • Technology Synopsis: These related patents concern a syringe device featuring both a primary dose limiting mechanism and a redundant, additional safety mechanism. This structure is intended to prevent the ejection of a dose exceeding the set dose even if the primary mechanism fails (’155 Patent, Abstract).
    • Asserted Claims: Claims 1-8 of the ’155 patent and 1-7 of the ’063 patent (Compl. ¶¶96, 114).
    • Accused Features: The complaint alleges Lupin's generic liraglutide injection device will infringe (Compl. ¶¶96, 114).

  • U.S. Patent No. RE46,363: "Dial-Down Mechanism for Wind-Up Pen," issued April 11, 2017 (Compl. ¶27).

    • Technology Synopsis: This patent, a reissue of a related patent, covers a mechanism that allows a user to reduce or "dial down" a dose that has been set in a torsion-spring powered ("wind-up") injection pen without first expelling the medication (’363 Patent, Abstract).
    • Asserted Claims: Claims 1-11 (Compl. ¶126).
    • Accused Features: The complaint alleges Lupin's generic liraglutide injection device will infringe (Compl. ¶126).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Lupin's Product," a generic version of liraglutide injection solution, 18 mg/3 ml (6 mg/ml), for which Lupin submitted ANDA No. 218382 to the FDA (Compl. ¶¶10, 31).

Functionality and Market Context

  • The complaint alleges that Lupin's product is a generic version of Novo Nordisk's Saxenda®, a pharmaceutical product for weight management (Compl. ¶¶1, 28). The complaint further states that Lupin's ANDA relies on the Saxenda® New Drug Application and contains data demonstrating bioequivalence (Compl. ¶32). The infringement allegations encompass both the chemical formulation of the drug solution and the mechanical injection device intended for its delivery (Compl. ¶¶36, 42). The complaint does not provide specific technical details about the formulation or the device beyond alleging they will infringe the patents-in-suit.
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a claim chart analysis. The infringement allegations are pleaded generally for each patent, stating that the manufacture, use, offer for sale, or sale of Lupin’s Product would infringe the asserted claims (e.g., Compl. ¶¶36, 42).

The narrative infringement theory for the ’833 Patent is that Lupin's proposed generic product, being a bioequivalent version of Saxenda®, is a GLP-1 formulation that will necessarily meet the claimed composition limitations regarding the use of propylene glycol as an isotonicity agent, its concentration, and the formulation's pH (Compl. ¶¶31, 36).

The narrative infringement theory for the ’969 Patent and the other fourteen device patents is that the injection device Lupin intends to market with its generic drug will contain the mechanical structures and operate according to the methods claimed in those patents, such as using a torsion spring and a multi-revolution display barrel (Compl. ¶42).

  • Identified Points of Contention:
    • Scope Questions: For the ’833 Patent, a central dispute may concern the scope of the term "about" as applied to the claimed concentration of propylene glycol and the pH range. The analysis will question whether Lupin's formulation, while bioequivalent, is formulated to fall literally outside the numerical ranges recited in the claims and whether the term "about" is broad enough to cover any minor deviations.
    • Technical Questions: For the ’969 Patent and the other device patents, the primary questions will be technical and evidentiary. Once the design of Lupin's proposed device is produced in discovery, the analysis will focus on whether its components and their interactions meet every limitation of the asserted claims. For example, does the accused device's spring function as the claimed "torsion spring," and is it "operatively connected" to the dose setting member in the manner required by the claims? The complaint provides no evidence to answer these questions at this stage.

V. Key Claim Terms for Construction

  • The Term: "about" (from claim 1 of the ’833 Patent)

    • Context and Importance: This term appears in the claimed ranges for both propylene glycol concentration ("from about 1 mg/ml to about 100 mg/ml") and pH ("from about 7.0 to about 10.0"). Its construction is critical because it defines the boundaries of literal infringement. Practitioners may focus on this term because generic manufacturers often formulate products to be just outside the literal numerical ranges of a patent, making the scope of "about" a dispositive issue.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent uses the term "about" consistently in the claims, suggesting the patentee did not intend to be limited to the exact numerical endpoints recited (’833 Patent, col. 21:60-67, col. 22:1-2).
      • Evidence for a Narrower Interpretation: The specification provides numerous examples with precise values, such as a formulation with 14.0 mg/ml propylene glycol and a pH of 8.15 (’833 Patent, col. 19:54-62). A party could argue that these specific examples define the core of the invention and that "about" should not extend the scope significantly beyond what is necessary to account for minor experimental variability.

  • The Term: "torsion spring operatively connected to a dose setting member" (from claim 1 of the ’969 Patent)

    • Context and Importance: This phrase describes the core power and control mechanism of the claimed injection device. The definition of "torsion spring" and the nature of the "operative connection" will be central to determining whether an accused device with a different spring type (e.g., a clock spring) or a different mechanical linkage infringes.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The summary of the invention describes the connection in general functional terms, stating the spring is "operatively connected to a dose setting member" without limiting the specific structure (’969 Patent, col. 2:10-12).
      • Evidence for a Narrower Interpretation: The detailed description and figures depict a specific embodiment where the torsion spring is a "helical spring which extends coaxially with the piston rod, and which interconnects the housing and the dose setting member" (’969 Patent, col. 3:55-61). A defendant may argue that the claim term should be construed consistently with this disclosed embodiment, thereby narrowing its scope.

VI. Other Allegations

  • Indirect Infringement: The complaint does not plead separate counts for indirect infringement. The central allegation is the act of infringement under 35 U.S.C. § 271(e)(2)(A), which is the submission of the ANDA itself (Compl. ¶35).
  • Willful Infringement: For each of the sixteen asserted patents, the complaint alleges that "Lupin was aware of the [asserted] patent when it submitted its ANDA" (e.g., Compl. ¶¶39, 45, 51). This allegation of pre-suit knowledge forms the basis for Plaintiff's request for a finding of an "exceptional case" and an award of attorneys' fees pursuant to 35 U.S.C. § 285 (Compl. ¶T, p. 23).

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

  • A core issue will be one of bioequivalence versus infringement: For the ’833 formulation patent, can Novo Nordisk establish that Lupin’s proposed generic product, by virtue of being bioequivalent to Saxenda®, must necessarily fall within the scope of the asserted claims, especially concerning the ranges defined by the term "about"?
  • A key evidentiary question will be one of technical comparison: For the fifteen device patents, does the specific mechanical design of Lupin’s yet-to-be-disclosed injection device incorporate each element of the asserted claims, or are there sufficient technical differences in its components (e.g., the type of spring, the display mechanism, the dose-limiting feature) to support a non-infringement defense?
  • A central question for damages and fees will be the nature of willfulness: Given the large number of patents asserted, can Novo Nordisk demonstrate that Lupin's Paragraph IV certification for each patent was objectively baseless, or that Lupin proceeded with subjective recklessness, sufficient to render the case exceptional under 35 U.S.C. § 285?