DCT
2:23-cv-22112
Novo Nordisk Inc v. DR Reddy's Laboratories Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Novo Nordisk Inc. (Delaware) and Novo Nordisk A/S (Denmark)
- Defendant: Dr. Reddy's Laboratories, Ltd. (India) and Dr. Reddy's Laboratories, Inc. (New Jersey)
- Plaintiff’s Counsel: Saul Ewing LLP; Fenwick & West LLP
- Case Identification: 2:23-cv-22112, D.N.J., 11/08/2023
- Venue Allegations: Venue is alleged based on Defendant Dr. Reddy’s Laboratories, Inc. having a principal place of business in New Jersey, and Defendant Dr. Reddy’s Laboratories, Ltd. having previously consented to jurisdiction and availed itself of the district by litigating prior patent cases.
- Core Dispute: Plaintiff alleges that Defendant’s submission 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 injection device.
- Technical Context: The case concerns injectable GLP-1 receptor agonists, a major class of drugs for treating type 2 diabetes and obesity, and the technology used to formulate these drugs and deliver them via pen-style injection devices.
- Key Procedural History: This is a Hatch-Waxman action filed in response to a Paragraph IV certification notice letter from Dr. Reddy's dated September 25, 2023, which asserted that the patents-in-suit are invalid, unenforceable, or will not be infringed. The complaint notes several other pending litigations initiated by Novo Nordisk against other generic manufacturers concerning some of the same patents and the same branded drug product.
Case Timeline
| Date | Event |
|---|---|
| 2003-11-20 | ’833 Patent Priority Date |
| 2007-02-05 | ’893 Patent Priority Date |
| 2012-02-14 | ’833 Patent Issue Date |
| 2016-02-23 | ’893 Patent Issue Date |
| 2023-09-25 | Dr. Reddy's sends Paragraph IV Notice Letter |
| 2023-11-08 | 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 Feb. 14, 2012
The Invention Explained
- Problem Addressed: The patent describes a problem with using mannitol, a common agent for ensuring proper tonicity in pharmaceutical formulations. The inventors observed that mannitol can crystallize during the manufacturing process, leading to deposits on production equipment and, in the final product, clogging of the fine needles used in injection pens (’833 Patent, col. 2:30-45).
- The Patented Solution: The invention replaces mannitol with propylene glycol as the isotonicity agent in peptide formulations. This solution is described as reducing deposits during production and minimizing the clogging of injection devices, while maintaining the physical and chemical stability of the peptide drug (’833 Patent, col. 2:51-64).
- Technical Importance: This approach aimed to improve the manufacturing efficiency, yield, and end-user reliability of self-administered injectable peptide drugs, a growing and critical class of therapeutics (’833 Patent, col. 2:35-45).
Key Claims at a Glance
- The complaint asserts infringement of claims 1-31 (Compl. ¶26). Independent claim 1 is a composition claim covering the formulation itself.
- Independent Claim 1 recites:
- 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
- the 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 claims 1-31 inherently includes all dependent claims.
U.S. Patent No. 9,265,893 - Injection Button, Issued Feb. 23, 2016
The Invention Explained
- Problem Addressed: In pen-style injection devices where setting a dose involves rotation, the push button used for injection often rotates relative to an internal driving part. This relative motion creates friction, which increases the force a patient must apply to perform the injection, potentially making it more difficult to use (’893 Patent, col. 1:49-54).
- The Patented Solution: The invention is a two-part push button connection designed to minimize this friction. It creates a "pivot bearing" between the button and the driving part, which reduces the surface area of interaction and the radius of the resulting friction force. This design makes the injection process smoother and requires less force from the user (’893 Patent, col. 1:55-61; Abstract).
- Technical Importance: This mechanical improvement enhances the ease-of-use and user experience for self-administered injection pens, which is a critical factor for patient compliance with chronic-use medications (’893 Patent, col. 1:41-44).
Key Claims at a Glance
- The complaint asserts infringement of claims 1-6 (Compl. ¶32). Independent claim 1 covers the core mechanical connection.
- Independent Claim 1 recites:
- A push button connection for an injection device comprising:
- a push button mountable on a driving part being rotatable relatively to the push button,
- which push button further comprises a bore with a bottom surface and which bore surrounds a protrusion on the driving part,
- which protrusion has a top surface,
- wherein a pivot bearing is formed between the bottom surface and the top surface,
- whereby force from a user pressing the button is directed to the driving part while the driving part rotates relative to the push button.
- The complaint’s assertion of claims 1-6 includes the dependent claims, which add further structural limitations.
III. The Accused Instrumentality
- Product Identification: The accused instrumentality is Defendant’s proposed generic version of liraglutide injection, 18 mg/3 ml (6 mg/ml), which is the subject of ANDA No. 214411 submitted to the FDA (Compl. ¶¶1, 8, 21).
- Functionality and Market Context: The complaint alleges that the accused product is a generic version of Novo Nordisk's Victoza®, a pharmaceutical solution for injection (Compl. ¶21). The ANDA is alleged to rely on the Victoza® New Drug Application and contain data to demonstrate bioequivalence (Compl. ¶22). The product is intended for the same therapeutic uses as Victoza® and seeks to enter the market prior to the expiration of the patents-in-suit (Compl. ¶1). The complaint further alleges that the claims of the patents-in-suit cover Victoza® and its use (Compl. ¶19), and that the '833 and '893 patents are listed in the FDA's Orange Book with respect to Victoza® (Compl. ¶20).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
'833 Patent Infringement Allegations
The complaint alleges that the manufacture, use, or sale of Dr. Reddy's Product would infringe claims 1-31 of the ’833 Patent (Compl. ¶26). The following chart summarizes the infringement theory for representative claim 1, based on the allegation that the accused product is a generic version of Victoza®, which is covered by the patent (Compl. ¶¶19, 21-22).
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A pharmaceutical formulation comprising at least one GLP-1 agonist... | The complaint alleges the accused product is a liraglutide injection, and liraglutide is a GLP-1 agonist. | ¶¶1, 21 | col. 4:26-34 |
| ...a disodium phosphate dihydrate buffer... | The complaint's allegation that the accused product is a generic version of Victoza® implies it will contain the same buffer system. | ¶¶19, 22, 26 | col. 10:46-54 |
| ...and propylene glycol... | The complaint's allegation that the accused product is a generic version of Victoza® implies it will contain propylene glycol. | ¶¶19, 22, 26 | col. 2:51-57 |
| ...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 alleges the accused product is a generic copy, implying its formulation will meet the claimed concentration range. | ¶¶22, 26 | col. 10:20-22 |
| ...and wherein said formulation has a pH of from about 7.0 to about 10.0. | The complaint alleges the accused product is a generic copy, implying its formulation will meet the claimed pH range. | ¶¶22, 26 | col. 10:31-35 |
- Identified Points of Contention:
- Scope Questions: The complaint does not provide the specific formulation of the accused product. A central question for the court will be whether discovery confirms that Dr. Reddy's proposed formulation literally contains each recited ingredient within the claimed concentration and pH ranges.
- Technical Questions: A potential dispute may arise over the function of propylene glycol. Claims 23, 26, and 29 are method claims for reducing deposits or clogging by replacing a prior isotonicity agent with propylene glycol. This raises the question of whether Dr. Reddy's product must be shown to use propylene glycol for the purpose of isotonicity to infringe these method claims.
'893 Patent Infringement Allegations
The complaint alleges that the manufacture, use, or sale of Dr. Reddy's Product, which is a drug solution, would infringe claims 1-6 of the ’893 Patent, which are directed to a mechanical injection button (Compl. ¶32). This implies a theory of indirect infringement.
| 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 being rotatable relatively to the push button... | The complaint alleges that the sale of the accused drug product infringes, implying it will be administered via an injection device containing the claimed features. | ¶¶20, 32 | col. 3:45-51 |
| ...which push button further comprises a bore... which bore surrounds a protrusion on the driving part... | The infringement allegation implies the intended device will have this internal structure. | ¶¶20, 32 | col. 4:1-2 |
| ...wherein a pivot bearing is formed between the bottom surface [of the bore] and the top surface [of the protrusion]... | The infringement allegation implies the intended device will contain the claimed friction-reducing pivot bearing. | ¶¶20, 32 | col. 4:11-15 |
| ...wherein when a user presses on the push button the force is directed toward the driving part and wherein the driving part rotates relative to the push button. | The infringement allegation implies the intended device will operate in the claimed manner. | ¶¶20, 32 | col. 3:40-51 |
- Identified Points of Contention:
- Legal Questions: A primary issue is one of indirect infringement. The complaint does not specify facts showing how Dr. Reddy's induces or contributes to infringement of device claims by selling a drug. The court will need to determine if Novo Nordisk can prove the requisite acts and intent for inducement, for example, through Dr. Reddy's proposed product labeling and instructions for use.
- Technical Questions: Does the injection device intended for use with Dr. Reddy's generic product actually contain a "pivot bearing" as that term is construed? The analysis will depend on the specific mechanics of the proposed generic delivery device.
V. Key Claim Terms for Construction
For the '833 Patent
- The Term: "propylene glycol" (in the context of method claims 23, 26, and 29)
- Context and Importance: The patent's core innovation is using propylene glycol as a superior isotonicity agent. The method claims require "replacing the isotonicity agent... with propylene glycol." Infringement of these claims may depend on whether propylene glycol in the accused product functions as the isotonicity agent, or for some other purpose (e.g., as a preservative or solvent). Practitioners may focus on this term because if another substance in the formulation is the primary isotonicity agent, it could create a non-infringement argument for these method claims.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Claim 1, a composition claim, merely requires the presence of propylene glycol without specifying its function.
- Evidence for a Narrower Interpretation: The Background section explicitly frames the problem as needing an "alternative isotonic agent to mannitol" ('833 Patent, col. 2:46-49). The Summary of the Invention states the invention relates to methods for reducing deposits and clogging by "replacing the isotonicity agent previously utilized... with propylene glycol" ('833 Patent, col. 2:37-40, col. 2:58-61). This language suggests the term's context is tied to its function as an isotonicity agent.
For the '893 Patent
- The Term: "pivot bearing"
- Context and Importance: This term describes the central friction-reducing element of the invention. Its construction will be critical to the infringement analysis, as it defines the specific mechanical interaction required between the push button and the driving part.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term itself could be argued to cover any interface that allows for pivoting motion between two parts under an axial load.
- Evidence for a Narrower Interpretation: The detailed description discloses a specific embodiment where the "pivot bearing" is formed by a "raised pointer" on the push button that bears on the top surface of the driving part's protrusion ('893 Patent, col. 3:62-64). A defendant may argue the term is limited to this or a structurally equivalent point-contact configuration, as opposed to a broader flat-surface-on-flat-surface interaction.
VI. Other Allegations
- Indirect Infringement: For the ’893 patent, infringement is premised on the sale of the drug product for use in an injection device (Compl. ¶32). This constitutes an allegation of indirect infringement (inducement or contributory), as the defendant is not alleged to be making or selling the device itself. The basis for this allegation is the Orange Book listing of the device patent for the Victoza® drug product (Compl. ¶20).
- Willful Infringement: The complaint alleges that "Dr. Reddy's was aware of the '833 patent when it submitted its ANDA" and "was aware of the '893 patent when it submitted its ANDA" (Compl. ¶¶29, 35). This allegation of pre-suit knowledge, evidenced by the submission of a Paragraph IV certification, forms the basis for the request for a finding of an exceptional case and an award of attorneys' fees (Compl. ¶¶29, 35; Prayer for Relief ¶F).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central legal question will be one of indirect infringement: For the ’893 patent, can Novo Nordisk establish that Dr. Reddy's, by filing an ANDA for a drug formulation, will actively induce infringement of claims directed to the mechanical structure of a separate injection device, and what level of evidence regarding the specific generic device is required at the pleading stage?
- A key evidentiary question for the '833 patent will be one of literal infringement: As the complaint lacks specific details of the accused formulation, the case will depend on whether discovery confirms that Dr. Reddy's proposed generic product falls squarely within the claimed ranges for pH and propylene glycol concentration, and contains the specific buffer recited in the claims.
- The overarching issue, inherent to any ANDA litigation, will be patent validity: While the complaint focuses on infringement, the core of the defense, as foreshadowed by the Paragraph IV certification, will be an attempt to prove by clear and convincing evidence that the asserted claims of the ’833 and ’893 patents are invalid for reasons such as obviousness or lack of enablement (Compl. ¶23).