DCT

1:24-cv-00688

Novo Nordisk INC. v. Rio BIOPHARMACEUTICALS, INC.

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-00688, D.N.J., 02/05/2024
  • Venue Allegations: Venue is alleged to be proper based on Defendant's physical presence, business operations, and revenue generation within the District of New Jersey.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's liraglutide injection product, Saxenda®, constitutes an act of infringement of seventeen U.S. patents covering the drug's formulation and its associated injection pen device.
  • Technical Context: The dispute involves both pharmaceutical formulation technology for stabilizing peptides and the mechanical engineering of pen-type injection devices used for self-administration of drugs.
  • Key Procedural History: The lawsuit was initiated under the Hatch-Waxman Act following Defendant's December 22, 2023 notice letter, which included a Paragraph IV Certification asserting that Plaintiff's patents are invalid, unenforceable, and/or will not be infringed by the proposed generic product. The complaint notes this suit was filed within the statutory 45-day window.

Case Timeline

Date Event
2003-11-20 Priority Date for U.S. Patent No. 8,114,833
2004-10-21 Priority Date for U.S. Patent Nos. 8,684,969; 9,687,611; 11,446,443
2005-01-21 Priority Date for U.S. Patent Nos. 9,108,002; 9,616,180; 10,376,652; 11,311,679
2005-01-25 Priority Date for U.S. Patent Nos. 9,457,154; 9,861,757; 10,357,616
2005-07-27 Priority Date for U.S. Patent Nos. 8,920,383; 9,775,953; 10,220,155; 11,097,063
2008-10-24 Priority Date for U.S. Patent Nos. 9,132,239; RE46,363
2012-02-14 U.S. Patent No. 8,114,833 Issues
2014-04-01 U.S. Patent No. 8,684,969 Issues
2014-12-30 U.S. Patent No. 8,920,383 Issues
2015-08-18 U.S. Patent No. 9,108,002 Issues
2015-09-15 U.S. Patent No. 9,132,239 Issues
2016-10-04 U.S. Patent No. 9,457,154 Issues
2017-04-11 U.S. Reissue Patent No. RE46,363 Issues
2017-04-11 U.S. Patent No. 9,616,180 Issues
2017-06-27 U.S. Patent No. 9,687,611 Issues
2017-10-03 U.S. Patent No. 9,775,953 Issues
2018-01-09 U.S. Patent No. 9,861,757 Issues
2019-03-05 U.S. Patent No. 10,220,155 Issues
2019-07-23 U.S. Patent No. 10,357,616 Issues
2019-08-13 U.S. Patent No. 10,376,652 Issues
2021-08-24 U.S. Patent No. 11,097,063 Issues
2022-04-26 U.S. Patent No. 11,311,679 Issues
2022-09-20 U.S. Patent No. 11,446,443 Issues
2023-12-22 Defendant Rio sends Paragraph IV Certification Notice Letter to Plaintiff
2024-02-05 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

The Invention Explained

  • Problem Addressed: The patent's background describes problems arising from the use of mannitol, a common isotonicity agent in peptide drug formulations. Mannitol can crystallize during production, leading to deposits on filling equipment, and can also cause clogging of injection devices when the drug is administered (’833 Patent, col. 1:32-45).
  • The Patented Solution: The invention replaces mannitol with propylene glycol as the isotonicity agent in peptide formulations. This substitution is described as reducing deposits on production equipment and reducing the clogging of injection devices, while maintaining the physical and chemical stability of the peptide drug (’833 Patent, col. 1:52-57; col. 2:56-62). Figures 6 and 7 visually contrast the deposits left by mannitol-based formulations with the cleaner results from propylene glycol-based formulations (’833 Patent, Figs. 6-7).
  • Technical Importance: This approach provided a solution to manufacturing and usability issues that could reduce production yield and compromise the reliable delivery of self-injected peptide therapeutics (’833 Patent, col. 1:37-45).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-31 (Compl. ¶35). Independent claims 1 and 16 are foundational.
  • Independent Claim 1 requires:
    • A pharmaceutical formulation comprising a GLP-1 agonist.
    • Propylene glycol, present in a final concentration of from about 1 mg/ml to about 100 mg/ml.
    • A disodium phosphate dihydrate buffer.
    • A pH of from about 7.0 to about 10.0.
  • Independent Claim 16 requires a method of preparing a GLP-1 agonist formulation, comprising the steps of:
    • Preparing a first solution by dissolving a preservative, propylene glycol, and a disodium phosphate dihydrate buffer in water.
    • Preparing a second solution by dissolving the GLP-1 agonist in water.
    • Mixing the first and second solutions.
    • Adjusting the pH of the mixture to about 7.0 to about 10.0.

U.S. Patent No. 8,684,969 - "Injection Device with Torsion Spring and Rotatable Display," Issued April 1, 2014

The Invention Explained

  • Problem Addressed: The patent describes prior art injection pens where the dose-setting scale is limited to less than a single 360-degree revolution. This limits the scale's angular resolution and, consequently, the accuracy with which a user can set a dose (’969 Patent, col. 1:34-42).
  • The Patented Solution: The invention is a pen-style injection device that uses a torsion spring (rather than a linear spring) as the power source. This design enables the use of a "rotatably mounted display member" (like a dose indicator barrel) that can rotate more than one full revolution (’969 Patent, col. 2:16-24). This expanded rotation allows for a dose scale with more numerals, such as one arranged in a helical path, providing higher resolution and improved dose-setting accuracy (’969 Patent, col. 2:48-52; Fig. 1).
  • Technical Importance: This mechanism allows for more precise dose selection in a compact, pen-style format, a critical feature for self-administered drugs where dosing accuracy is paramount.

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-26 (Compl. ¶41). Independent claim 1 is representative.
  • Independent Claim 1 requires:
    • An injection device comprising a torsion spring operatively connected to a dose setting member.
    • The dose setting member is adapted to set a dose to be ejected.
    • A rotatably mounted display member adapted to display the set dose.
    • The display member is rotatable over an angle corresponding to at least one revolution.
    • The display member is a dose indicator barrel.
    • The display member is movable between two end positions defining an operation range associated with a substantially linear working range of the torsion spring.

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

  • Technology Synopsis: This patent describes an "end-of-content" mechanism for an injection device. It prevents a user from setting a dose that is larger than the amount of medicament remaining in the device's reservoir, using an interaction between a threaded piston rod, a limiter, and a driver (’383 Patent, Abstract).
  • Asserted Claims: Claims 1-13 (Compl. ¶47).
  • Accused Features: The end-of-dose limiting mechanism of the device used to deliver Rio's Product is accused of infringement (Compl. ¶47).

U.S. Patent No. 9,108,002 - "Automatic Injection Device with a Top Release Mechanism," Issued August 18, 2015

  • Technology Synopsis: This patent discloses a handheld automatic injection device where the injection is initiated by a release member located at the top of the device (opposite the needle end), which can be actuated by a user's thumb or index finger (’002 Patent, Abstract).
  • Asserted Claims: Claims 1-2 (Compl. ¶53).
  • Accused Features: The release mechanism of the device used to deliver Rio's Product is accused of infringement (Compl. ¶53).

U.S. Patent No. 9,132,239 - "Dial-Down Mechanism for Wind-Up Pen," Issued September 15, 2015

  • Technology Synopsis: This patent describes a mechanism for a torsion spring-assisted "wind-up" injection pen that allows a user to "dial down" or decrease a set dose without expelling medication, a feature improving user safety and convenience (’239 Patent, Abstract).
  • Asserted Claims: Claims 1-3 (Compl. ¶59).
  • Accused Features: The dial-down mechanism of the device used to deliver Rio's Product is accused of infringement (Compl. ¶59).

U.S. Patent No. 9,457,154 - "Injection Device with an End of Dose Feedback Mechanism," Issued October 4, 2016

  • Technology Synopsis: This patent relates to a mechanism in an injection device that provides a non-visual (e.g., audible or tactile) feedback signal to the user only at the end of an injection, confirming that the full set dose has been delivered (’154 Patent, Abstract).
  • Asserted Claims: Claims 1-17 (Compl. ¶65).
  • Accused Features: The end-of-dose feedback mechanism of the device used to deliver Rio's Product is accused of infringement (Compl. ¶65).

U.S. Patent No. 9,616,180 - "Automatic Injection Device with a Top Release Mechanism," Issued April 11, 2017

  • Technology Synopsis: This patent, related to the '002 Patent, describes an automatic injection device with a push-button-like release member located at the top end of the device, opposite where the needle is mounted (’180 Patent, Abstract; Compl. ¶71).
  • Asserted Claims: Claims 1-14 (Compl. ¶71).
  • Accused Features: The release mechanism of the device used to deliver Rio's Product is accused of infringement (Compl. ¶71).

U.S. Patent No. 9,687,611 - "Injection Device with Torsion Spring and Rotatable Display," Issued June 27, 2017

  • Technology Synopsis: This patent, related to the '969 Patent, covers an injection device with a torsion spring connected to a dose setting member and a rotatably mounted display member, such as a dose indicator barrel with a helical scale (’611 Patent, Abstract; Compl. ¶77).
  • Asserted Claims: Claims 1-15 (Compl. ¶77).
  • Accused Features: The dose setting and display mechanism of the device used to deliver Rio's Product is accused of infringement (Compl. ¶77).

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

  • Technology Synopsis: This patent, related to the '383 patent, covers a mechanism that prevents the setting of a dose that exceeds the amount of medicament left in the device's reservoir (’953 Patent, Abstract; Compl. ¶83).
  • Asserted Claims: Claims 1-25 (Compl. ¶83).
  • Accused Features: The end-of-dose limiting mechanism of the device used to deliver Rio's Product is accused of infringement (Compl. ¶83).

U.S. Patent No. 9,861,757 - "Injection Device with an End of Dose Feedback Mechanism," Issued January 9, 2018

  • Technology Synopsis: This patent, related to the '154 patent, covers a mechanism in an injection device that provides a tactile feedback signal to a user at the end of the injection of a set dose (’757 Patent, Abstract; Compl. ¶89).
  • Asserted Claims: Claims 1-12 (Compl. ¶89).
  • Accused Features: The end-of-dose tactile feedback mechanism of the device used to deliver Rio's Product is accused of infringement (Compl. ¶89).

U.S. Patent No. 10,220,155 - "Syringe Device with a Dose Limiting Mechanism and an Additional Safety Mechanism," Issued March 5, 2019

  • Technology Synopsis: This patent covers a syringe device that includes both a dose limiting mechanism and a separate safety mechanism structure to prevent the injection of a dose exceeding the set amount (’155 Patent, Abstract; Compl. ¶95).
  • Asserted Claims: Claims 1-8 (Compl. ¶95).
  • Accused Features: The dose limiting and safety mechanisms of the device used to deliver Rio's Product are accused of infringement (Compl. ¶95).

U.S. Patent No. 10,357,616 - "Injection Device with an End of Dose Feedback Mechanism," Issued July 23, 2019

  • Technology Synopsis: This patent, related to the '154 and '757 patents, covers a mechanism that provides an audible feedback signal to the user at the end of an injection of a set dose (’616 Patent, Abstract; Compl. ¶101).
  • Asserted Claims: Claims 1-9 (Compl. ¶101).
  • Accused Features: The end-of-dose audible feedback mechanism of the device used to deliver Rio's Product is accused of infringement (Compl. ¶101).

U.S. Patent No. 10,376,652 - "Automatic Injection Device with a Top Release Mechanism," Issued August 13, 2019

  • Technology Synopsis: This patent, related to the '002 and '180 patents, covers an injection device with a release member at the top end and a display member (’652 Patent, Abstract; Compl. ¶107).
  • Asserted Claims: Claims 1-15 (Compl. ¶107).
  • Accused Features: The release and display mechanisms of the device used to deliver Rio's Product is accused of infringement (Compl. ¶107).

U.S. Patent No. 11,097,063 - "Syringe Device with a Dose Limiting Mechanism and an Additional Safety Mechanism," Issued August 24, 2021

  • Technology Synopsis: This patent, related to the '155 patent, covers a syringe device with both a dose limiting mechanism and a safety mechanism structure to prevent ejection of a dose exceeding a set dose (’063 Patent, Abstract; Compl. ¶113).
  • Asserted Claims: Claims 1-7 (Compl. ¶113).
  • Accused Features: The dose limiting and safety mechanisms of the device used to deliver Rio's Product are accused of infringement (Compl. ¶113).

U.S. Patent No. 11,311,679 - "Automatic Injection Device with a Top Release Mechanism," Issued April 26, 2022

  • Technology Synopsis: This patent, related to the '002, '180, and '652 patents, covers an injection device with a release member on the end opposite the injection needle (’679 Patent, Abstract; Compl. ¶119).
  • Asserted Claims: Claims 1-6 (Compl. ¶119).
  • Accused Features: The release mechanism of the device used to deliver Rio's Product is accused of infringement (Compl. ¶119).

U.S. Patent No. 11,446,443 - "Injection Device with Torsion Spring and Rotatable Display," Issued September 20, 2022

  • Technology Synopsis: This patent, related to the '969 and '611 patents, covers an injection device with a torsion spring connected to a dose setting member and a rotatably mounted display member (’443 Patent, Abstract; Compl. ¶125).
  • Asserted Claims: Claims 1-19 (Compl. ¶125).
  • Accused Features: The dose setting and display mechanism of the device used to deliver Rio's Product is accused of infringement (Compl. ¶125).

U.S. Reissue Patent No. RE46,363 - "Dial-Down Mechanism for Wind-Up Pen," Issued April 11, 2017

  • Technology Synopsis: This patent, a reissue of a patent related to the '239 patent, covers a dial-down mechanism for a wind-up injection pen, as well as a method for its use (’363 Patent, Abstract; Compl. ¶131).
  • Asserted Claims: Claims 1-11 (Compl. ¶131).
  • Accused Features: The dial-down mechanism and method of use for the device used to deliver Rio's Product are accused of infringement (Compl. ¶131).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is "Rio's Product," identified as a generic version of liraglutide injection solution, 18 mg/3 ml (6 mg/ml), for which Rio submitted ANDA No. 218240 to the FDA (Compl. ¶9, ¶30).

Functionality and Market Context

  • The complaint alleges that Rio's Product is a generic version of Plaintiff's Saxenda® product and that Rio's ANDA relies on the Saxenda® New Drug Application to demonstrate bioequivalence (Compl. ¶30-31). The infringement allegations cover not only the drug formulation itself but also the device intended for its delivery, which is implicitly alleged to be functionally identical or equivalent to the pen device used for Saxenda® (Compl. ¶41, ¶47, et seq.).
  • The complaint frames the infringement as an artificial act under 35 U.S.C. § 271(e)(2)(A), arising from the submission of the ANDA, which seeks FDA approval to manufacture and sell Rio's Product before the expiration of the patents-in-suit (Compl. ¶34, ¶40, et seq.).

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a claim-chart analysis. The infringement counts are pleaded generally, stating that the manufacture, use, or sale of Rio's Product would infringe the specified claims of each patent-in-suit (e.g., Compl. ¶35, ¶41). The narrative theory of infringement is that by seeking approval for a generic version of Saxenda®, Rio's Product will necessarily contain the formulation claimed by the '833 patent and will be administered by a device embodying the technology claimed by the sixteen device patents.

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Scope Questions: A primary question for the sixteen device patents will be whether the specific mechanical structures and functions recited in the claims (e.g., "torsion spring operatively connected to a dose setting member" from the '969 patent) read on the actual design of the injection device Rio intends to market. The complaint does not describe the specific structure of Rio's proposed device.
    • Technical Questions: For the '833 patent, a central factual question will be whether Rio's Product formulation contains propylene glycol within the claimed concentration range and meets the other specific limitations of the asserted claims. For the device patents, the dispute will turn on evidence of how Rio's proposed device operates, such as whether its display member rotates more than one revolution or whether its end-of-dose mechanism provides the specific type of tactile or audible feedback claimed.

V. Key Claim Terms for Construction

  • From the ’833 Patent:

    • The Term: "propylene glycol is present in a final concentration of from about 1 mg/ml to about 100 mg/ml" (Claim 1).
    • Context and Importance: The case may turn on how this concentration range is defined and measured, especially the scope of "about." Defendant may argue that its formulation falls outside this range, or that the term is indefinite. Practitioners may focus on this term because it is a precise numerical limitation central to the infringement analysis.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The use of the word "about" suggests the patentee did not intend the range to be strictly limited to 1-100 mg/ml. The specification provides numerous examples with specific concentrations (e.g., 14.0 mg/ml, 13.7 mg/ml) that fall well within the range, which may be used to argue the term encompasses normal manufacturing variances (’833 Patent, col. 15:47-50; col. 19:15-16).
      • Evidence for a Narrower Interpretation: The specification also defines propylene glycol's role as an "isotonicity agent," and a defendant might argue that the claimed range should be construed as limited to only those concentrations that achieve isotonicity, potentially narrowing the scope of "about" (’833 Patent, col. 1:46-51).

  • From the ’969 Patent:

    • The Term: "rotatable over an angle corresponding to at least one revolution" (Claim 1).
    • Context and Importance: This term is critical for distinguishing the invention from prior art single-revolution dose dials. Infringement will depend on whether Rio's device has a display member that is physically capable of and designed to rotate more than 360 degrees during dose setting. Practitioners may focus on this term as it defines a key structural and functional departure from the prior art described in the patent.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification repeatedly emphasizes the advantage of exceeding one revolution to increase scale resolution, stating the dose setting scale may contain "at least 50, 60, 70, 80, 90, 100 units," which implies multi-revolution capability (’969 Patent, col. 5:5-8). This supports a broad functional interpretation.
      • Evidence for a Narrower Interpretation: Embodiments describing a "helical path" for the numerals on a dose indicator barrel could be used to argue that the term requires this specific structure, potentially limiting the claim's scope to exclude other multi-revolution display mechanisms that do not use a helical arrangement (’969 Patent, col. 2:48-52).

VI. Other Allegations

  • Indirect Infringement: The complaint does not contain specific allegations of fact to support indirect infringement.
  • Willful Infringement: The complaint alleges for each patent-in-suit that "Rio was aware of the [...] patent when it submitted its ANDA" (e.g., Compl. ¶38, ¶44). This allegation of pre-suit knowledge, established through the Paragraph IV certification process, forms the basis for the willfulness claim and the request for attorneys' fees under 35 U.S.C. § 285.

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

  • A central issue will be one of factual comparison: Does the formulation detailed in Rio's ANDA fall within the specific compositional and pH limitations of the asserted claims of the '833 patent?
  • A key evidentiary question will be one of mechanical identity: What is the specific design and mechanism of action of the injection device Rio plans to market with its generic drug? The resolution of the infringement allegations for the sixteen asserted device patents will depend entirely on a comparison of that device's structure and function against the detailed mechanical limitations recited in the claims.
  • A third core issue, raised by Defendant's Paragraph IV certification but not detailed in the complaint, will be one of patent validity: Even if Rio's product reads on the claims, the case will turn on whether Rio can prove by clear and convincing evidence that the asserted claims of Novo Nordisk's seventeen patents are invalid for reasons such as anticipation or obviousness.