DCT
2:23-cv-04027
Novo Nordisk INC. v. Lupin LTD. DO NOT File IN This Case
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Novo Nordisk Inc. (Delaware) and Novo Nordisk A/S (Denmark)
- Defendant: Lupin Ltd. (India)
- Plaintiff’s Counsel: Fenwick & West LLP
- Case Identification: 2:23-cv-04027, D.N.J., 07/27/2023
- Venue Allegations: Venue is asserted on the basis that Defendant is a foreign corporation subject to personal jurisdiction in the District of New Jersey, where it allegedly conducts business and has previously availed itself of the court’s jurisdiction by litigating other patent disputes.
- Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's Victoza® (liraglutide) product infringes patents covering the drug's pharmaceutical formulation and the mechanical design of its injection device.
- Technical Context: The case involves injectable GLP-1 receptor agonists, a class of drugs used to treat type 2 diabetes, where formulation stability and ease of administration via pen-like devices are critical for commercial success and patient adherence.
- Key Procedural History: The action was initiated under the Hatch-Waxman Act following Defendant’s submission of an ANDA containing a Paragraph IV certification, asserting that the patents-in-suit are invalid, unenforceable, or will not be infringed. The patents are listed in the FDA's "Orange Book" for Victoza®.
Case Timeline
| Date | Event |
|---|---|
| 2003-11-20 | U.S. Patent 8,114,833 Priority Date |
| 2007-02-05 | U.S. Patent 9,265,893 Priority Date |
| 2012-02-14 | U.S. Patent 8,114,833 Issued |
| 2016-02-23 | U.S. Patent 9,265,893 Issued |
| 2023-06-12 | Defendant sends Paragraph IV Notice Letter to Plaintiff |
| 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
The Invention Explained
- Problem Addressed: The patent’s background section identifies a problem with using mannitol, a common isotonicity agent, in peptide formulations. Mannitol can crystallize during production, causing deposits on manufacturing equipment and in the final drug product, and can also lead to the clogging of fine-gauge needles on injection devices (’833 Patent, col. 1:30-45).
- The Patented Solution: The invention proposes a pharmaceutical formulation that replaces mannitol with propylene glycol as the isotonicity agent. This substitution is described as reducing the formation of deposits during production and minimizing the clogging of injection devices, thereby improving manufacturing efficiency and the reliability of drug delivery (’833 Patent, Abstract; col. 2:50-58). Figure 7 of the patent visually contrasts the deposits on a needle from a mannitol-based formulation with the lack of deposits from a propylene glycol-based formulation (’833 Patent, Fig. 7).
- Technical Importance: The solution addresses key challenges in the large-scale manufacturing and patient use of self-administered injectable peptide therapies, where formulation stability and reliable device function are essential (’833 Patent, col. 1:35-45).
Key Claims at a Glance
- The complaint asserts claims 1-31 (Compl. ¶22). Independent claim 1 is representative of the composition claims.
- 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 about 1 mg/ml to about 100 mg/ml,
- and the formulation has a pH of about 7.0 to about 10.0.
- The complaint notes that claims 16-31 are directed to methods of preparation and methods for reducing deposits or clogging (Compl. ¶22).
U.S. Patent No. 9,265,893 - Injection Button
The Invention Explained
- Problem Addressed: In some pen-style injection devices, the push button and an internal driving part must rotate relative to each other during injection. The patent states that the friction generated by this relative rotation contributes to the total force a user must apply, which is undesirable (’893 Patent, col. 1:28-34).
- The Patented Solution: The invention is a specific mechanical connection between the push button and the driving part that minimizes actuation force. It achieves this by creating a "pivot bearing" between the two components, which minimizes the surface area of interaction, and by incorporating radial bearings that stabilize the components against off-center forces from a user's thumb, preventing tilting that would otherwise increase friction (’893 Patent, Abstract; col. 1:52-66).
- Technical Importance: By reducing the injection force, the invention improves the usability of self-injection pens, a critical factor for patients, particularly those with reduced hand strength or dexterity (’893 Patent, col. 1:40-44).
Key Claims at a Glance
- The complaint asserts claims 1-6 (Compl. ¶28). Independent claim 1 is the primary apparatus claim.
- Essential elements of Independent Claim 1 include:
- A push button connection for an injection device comprising a push button mountable on a driving part.
- The push button and driving part are relatively rotatable.
- The push button has a bore surrounding a protrusion on the driving part.
- A pivot bearing is formed between the bottom surface of the bore and the top surface of the protrusion.
- When a user presses the button, force is directed to the driving part, and the driving part rotates relative to the push button.
III. The Accused Instrumentality
Product Identification
- Defendant’s proposed generic liraglutide injection solution, 18 mg/3 ml (6 mg/ml), for which it submitted ANDA No. 215421 (“Lupin’s Product”) (Compl. ¶10, 17).
Functionality and Market Context
- The complaint alleges that Lupin’s Product is a generic version of Novo Nordisk's Victoza® product and that its ANDA relies on the Victoza® New Drug Application (NDA) to demonstrate bioequivalence (Compl. ¶17, 18).
- Based on these allegations, Lupin's Product is an injectable drug containing the GLP-1 agonist liraglutide, intended for the treatment of type 2 diabetes. The complaint alleges that Lupin intends to manufacture, sell, and import this product into the United States upon receiving FDA approval (Compl. ¶10). The complaint does not provide specific details regarding the formulation excipients or injection device design of Lupin’s Product. No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint provides a high-level notice of infringement without detailed factual allegations or claim charts. The infringement theory appears to be that for Lupin's Product to be a bioequivalent generic version of Victoza®, it must necessarily practice the inventions claimed in the patents-in-suit.
’833 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical formulation comprising at least one GLP-1 agonist, | Lupin’s Product is alleged to be a formulation containing liraglutide, which is a GLP-1 agonist, to establish bioequivalence with Victoza® (Compl. ¶14, 17). | ¶17, 22 | col. 4:26-34 |
| a disodium phosphate dihydrate buffer | The complaint does not specify the buffer in Lupin's Product. However, the infringement allegation implies that to be a bioequivalent generic of Victoza®, Lupin’s Product must contain the same buffer system as claimed (Compl. ¶15, 22). | ¶22 | col. 19:10-11 |
| and propylene glycol, | The infringement allegation implies that Lupin's Product contains propylene glycol as an isotonicity agent, consistent with the Victoza® formulation covered by the patent (Compl. ¶15, 22). | ¶22 | col. 19:12 |
| wherein said propylene glycol is present in said formulation in a final concentration of from about 1 mg/ml to about 100 mg/ml | The complaint does not provide the concentration of propylene glycol in Lupin's Product but alleges that the product infringes claims requiring this concentration range (Compl. ¶22). | ¶22 | col. 2:65-67 |
| and wherein said formulation has a pH of from about 7.0 to about 10.0. | The complaint does not state the pH of Lupin's Product but alleges infringement of claims requiring this pH range, which is necessary for a stable and effective liraglutide formulation (Compl. ¶22). | ¶22 | col. 2:67-col. 3:1 |
Identified Points of Contention:
- Scope Questions: Will the court determine that to be "bioequivalent," Lupin's Product must necessarily contain every excipient recited in claim 1, including the specific "disodium phosphate dihydrate buffer," or could a different buffer be used while maintaining bioequivalence?
- Technical Questions: What evidence will establish the precise composition of Lupin's Product as detailed in its confidential ANDA filing? The case will depend on whether that composition reads on the asserted claims.
’893 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A push button connection for an injection device comprising: a push button mountable on a driving part | The complaint alleges that Lupin's Product, being a generic version of the Victoza® pen-delivered drug, is administered using an injection device that infringes the asserted claims (Compl. ¶28). | ¶28 | col. 3:36-39 |
| being rotatable relatively to the push button | The infringement allegation implies that the driving part of Lupin's device rotates relative to the push button during dose delivery, as is required for the device to function like the one used for Victoza® (Compl. ¶28). | ¶28 | col. 3:45-51 |
| a pivot bearing is formed between the bottom surface [of a bore in the button] and the top surface [of a protrusion on the driving part] | The complaint alleges that Lupin’s device infringes claims requiring a "pivot bearing." This implies the device incorporates a similar friction-reducing mechanism between the push button and driving part to ensure proper and user-friendly operation (Compl. ¶28). | ¶28 | col. 4:13-17 |
Identified Points of Contention:
- Scope Questions: How will the term "pivot bearing" be construed? Will it be limited to the specific point-contact geometry shown in the patent's figures, or can it be read more broadly to cover other types of mechanical interfaces that allow for pivotal motion between the two components?
- Technical Questions: What is the actual mechanical design of the injection device that Lupin intends to market with its generic product? Does its push-button mechanism function in a way that meets the structural and relational limitations of claim 1?
V. Key Claim Terms for Construction
- The Term: "a disodium phosphate dihydrate buffer" (’833 Patent, claim 1)
- Context and Importance: This term is critical because it defines a specific chemical component of the claimed formulation. Infringement of claim 1 hinges on whether Lupin's Product contains this exact buffer. Practitioners may focus on this term because if Lupin's ANDA specifies a different buffer (e.g., citrate or histidine), it could form the basis of a straightforward non-infringement defense, whereas a finding of equivalence would be required for Plaintiff to prevail on that theory.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification lists numerous alternative buffers, including sodium acetate, citrate, and glycine, stating that "Each one of these specific buffers constitutes an alternative embodiment of the invention" (’833 Patent, col. 10:46-54). A party could argue this shows the specific buffer choice was not essential to the invention, supporting a broader reading or application of the doctrine of equivalents.
- Evidence for a Narrower Interpretation: Claim 1 explicitly recites "a disodium phosphate dihydrate buffer," not a generic "buffer." The doctrine of claim differentiation suggests that because broader claims could have been pursued, the choice to recite a specific buffer in this claim was a deliberate limitation of its scope.
- The Term: "pivot bearing" (’893 Patent, claim 1)
- Context and Importance: This term is at the core of the ’893 patent's proposed solution for reducing injection force. The definition of "pivot bearing" will determine whether only specific friction-minimizing structures are covered or if any point of relative rotation falls within the claim's scope. Practitioners may focus on this term because the infringement analysis will turn on whether the mechanical interface in Lupin's accused device meets the structural and functional characteristics of the claimed "pivot bearing."
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term itself is a functional one, and a party could argue it should be construed to mean any structure that serves as a pivot point between the push button and driving part, regardless of its specific geometry.
- Evidence for a Narrower Interpretation: The specification repeatedly links the "pivot bearing" to the objective of minimizing friction by minimizing the surface area of interaction (’893 Patent, col. 1:55-58). The detailed description explains that the pivot bearing is formed by a "raised pointer" (18) on the push button contacting the top surface (22) of the protrusion, suggesting a specific point-contact structure rather than a simple flat-surface-on-flat-surface contact (’893 Patent, col. 4:29-33). This may support a narrower construction requiring a structure specifically designed to reduce contact area.
VI. Other Allegations
- Indirect Infringement: The complaint does not contain specific counts for indirect infringement. However, by filing an ANDA, Lupin is seeking approval to market a drug product whose label will instruct medical professionals and patients on its use. This act inherently lays the groundwork for a future claim of induced infringement of any asserted method claims, such as the method of preparation and use claims of the ’833 patent.
- Willful Infringement: The complaint alleges that Lupin was aware of both the ’833 patent and the ’893 patent at the time it submitted its ANDA (Compl. ¶25, 31). This allegation of pre-suit knowledge forms the basis for the claim of willful infringement and the associated request for enhanced damages and attorneys' fees.
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this ANDA litigation will likely depend on the answers to two central questions that bridge claim construction and factual proof:
- A primary issue will be one of compositional identity: Does Lupin’s generic formulation, as confidentially described in its ANDA, contain the precise combination of a GLP-1 agonist, propylene glycol, and the specifically claimed “disodium phosphate dihydrate buffer” required by claim 1 of the ’833 patent, or does it utilize an alternative that would necessitate an equivalence analysis?
- A key question for the device patent will be one of mechanical and functional scope: Can the term “pivot bearing” in the ’893 patent be construed to cover the specific push-button mechanism in Lupin’s proposed injection device, or is there a fundamental difference in the design and operation of the components that manage actuation force and relative rotation?