DCT
1:24-cv-00330
Novo Nordisk Inc v. Rio Biopharma Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Novo Nordisk Inc. (DE) and Novo Nordisk A/S (Denmark)
- Defendant: Rio Biopharmaceuticals, Inc. (DE)
- Plaintiff’s Counsel: Saul Ewing LLP; Fenwick & West LLP
- Case Identification: 1:24-cv-00330, D.N.J., 01/19/2024
- Venue Allegations: Venue is asserted based on Defendant’s alleged physical presence, business activities, and revenue generation within the District of New Jersey.
- Core Dispute: In this Hatch-Waxman action, Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) to market a generic version of the diabetes drug Victoza® infringes patents covering the drug's formulation and its associated injection device.
- Technical Context: The dispute involves pharmaceutical formulation science, specifically agents used to ensure stability and usability in injectable peptide drugs, and the mechanical engineering of injection pen components to improve user experience.
- Key Procedural History: The lawsuit was triggered by a December 8, 2023 notice letter from the Defendant, which included a Paragraph IV certification asserting that Plaintiff's patents are invalid, unenforceable, or will not be infringed. The complaint notes this suit was filed within the 45-day statutory window. Plaintiff also certifies that this case is related to other pending litigation against different generic manufacturers (Lupin, ScinoPharm, Dr. Reddy's, Biocon, and Orbicular) concerning some of the same patents and pharmaceutical products.
Case Timeline
| Date | Event |
|---|---|
| 2003-11-24 | U.S. Patent No. 8,114,833 Earliest Priority Date |
| 2007-02-07 | U.S. Patent No. 9,265,893 Earliest Priority Date |
| 2012-02-14 | U.S. Patent No. 8,114,833 Issue Date |
| 2016-02-23 | U.S. Patent No. 9,265,893 Issue Date |
| 2023-12-08 | Defendant Rio sends Paragraph IV Notice Letter |
| 2024-01-19 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,114,833
- Patent Identification: 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 "'833 Patent").
The Invention Explained
- Problem Addressed: The patent describes that mannitol, a common agent used to maintain proper tonicity in injectable peptide formulations, has a tendency to crystallize. This crystallization can cause deposits on manufacturing equipment, reducing production efficiency, and can clog the fine needles of injection devices, compromising drug delivery ('833 Patent, col. 2:30-45).
- The Patented Solution: The invention replaces mannitol with propylene glycol as the isotonicity agent in the peptide formulation. This solution is described as reducing deposits during production and, critically, preventing the clogging of injection devices, making the formulation "optimal for production and for use" ('833 Patent, col. 2:50-64). Figure 7 of the patent visually depicts deposits on a needle from a mannitol-based formulation (top panel) versus the absence of such deposits with the propylene glycol formulation (bottom panel) ('833 Patent, Fig. 7).
- Technical Importance: The invention provides a more physically stable and reliable formulation for peptide drugs like GLP-1 agonists, which are often self-administered daily using pen injectors for chronic conditions ('833 Patent, col. 2:36-45, col. 22:1-4).
Key Claims at a Glance
- The complaint asserts claims 1-31 ('833 Patent, Compl. ¶20).
- Independent Claim 1 requires:
- 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
- wherein 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 broad allegation covering claims 1-31 serves this purpose.
U.S. Patent No. 9,265,893
- Patent Identification: U.S. Patent No. 9,265,893, “Injection Button,” issued February 23, 2016 (the "'893 Patent").
The Invention Explained
- Problem Addressed: In injection pens, the user pushes a button to deliver a dose. This action often causes a driving part within the pen to rotate. The patent states that friction between the non-rotating button and the rotating internal part requires the user to apply significant force, making the injection difficult ('893 Patent, col. 1:49-54).
- The Patented Solution: The invention is a specific mechanical connection between the push button and the driving part that minimizes friction. It uses a "pivot bearing" to reduce the surface area of contact and one or more radial bearings to manage off-center forces, thereby reducing the force a user must apply to perform an injection ('893 Patent, col. 1:55-61; col. 2:1-14). Figure 1 shows a cross-section of the push button (10) mounted on a protrusion of the driving part (20), illustrating the key bearing surfaces ('893 Patent, Fig. 1).
- Technical Importance: This mechanical design improves the ergonomics and ease of use of injection pens, which can enhance patient compliance for self-administered therapies ('893 Patent, col. 1:42-44).
Key Claims at a Glance
- The complaint asserts claims 1-6 ('893 Patent, Compl. ¶26).
- Independent Claim 1 requires:
- A push button connection for an injection device,
- comprising a push button mountable on a driving part, with the parts being "rotatable relatively" to each other,
- the button having a bore that surrounds a protrusion on the driving part,
- wherein a "pivot bearing" is formed between a bottom surface of the bore and a top surface of the protrusion,
- whereby a user's press directs force to the driving part, which rotates relative to the button.
- The complaint does not explicitly reserve the right to assert dependent claims, but the allegation covering claims 1-6 serves this purpose.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is Defendant’s proposed "generic version of liraglutide injection solution, 18 mg/3 ml (6 mg/ml)," referred to as "Rio's Product" (Compl. ¶9, ¶15).
Functionality and Market Context
- The complaint alleges that Rio's Product is a generic version of Plaintiff's Victoza® product and that Rio's ANDA relies on the Victoza® New Drug Application (NDA) and contains data to demonstrate bioequivalence (Compl. ¶1, ¶16). Victoza® is a GLP-1 receptor agonist used for the treatment of type 2 diabetes (see '833 Patent, col. 3:25-27).
- The complaint does not provide specific details about the formulation of Rio's Product beyond its identification as a generic version of Victoza® (Compl. ¶15). Similarly, while infringement of the '893 device patent is alleged, the complaint does not describe the specific injection device with which Rio's Product is intended to be used (Compl. ¶26).
IV. Analysis of Infringement Allegations
'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, | Rio's Product is a generic liraglutide solution; liraglutide is a GLP-1 agonist. | ¶15 | col. 3:25-34 |
| a disodium phosphate dihydrate buffer | As a generic version of Victoza®, Rio's Product is alleged to contain the claimed formulation components, which are Orange Book listed for Victoza®. | ¶14, ¶20 | col. 22:1-4 |
| and propylene glycol, | As a generic version of Victoza®, Rio's Product is alleged to contain the claimed formulation components, which are Orange Book listed for Victoza®. | ¶14, ¶20 | col. 22:1-4 |
| 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 that the manufacture, use, or sale of Rio's Product would infringe, implying its concentration falls within the claimed range. | ¶20 | col. 22:1-4 |
| and wherein said formulation has a pH of from about 7.0 to about 10.0. | The complaint alleges that the manufacture, use, or sale of Rio's Product would infringe, implying its pH falls within the claimed range. | ¶20 | col. 22:1-4 |
- Identified Points of Contention:
- Factual Questions: The primary question is factual: does the formulation described in Rio's confidential ANDA meet every limitation of the asserted claims? The dispute will center on the precise composition, including the concentration of propylene glycol and the final pH of Rio's Product, as compared to the ranges defined in the 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 being rotatable relatively to the push button... | The complaint alleges that the sale of Rio's Product would infringe the '893 Patent, which implies the product is intended for use with an injection device that contains the claimed connection. | ¶26 | col. 1:45-54 |
| ...which bore surrounds a protrusion on the driving part... | The complaint does not describe the specific structure of the accused device. Infringement is alleged based on Rio's ANDA submission for a product covered by the patent. | ¶26 | col. 4:1-5 |
| and wherein a pivot bearing is formed between the bottom surface and the top surface, | The complaint does not describe the specific structure of the accused device. The allegation suggests Rio's ANDA specifies a device with this feature. | ¶26 | col. 4:15-18 |
| 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 complaint does not describe the specific operation of the accused device. The allegation suggests Rio's ANDA specifies a device that operates in this manner. | ¶26 | col. 1:45-54 |
- Identified Points of Contention:
- Scope Questions: What constitutes a "pivot bearing" under the patent's claims? The construction of this term will be critical to determining infringement.
- Technical Questions: A key evidentiary question is what specific injection device, if any, is identified in Rio's ANDA. Does that device's push button mechanism contain a "pivot bearing" and "radial bearing" structure that corresponds to the claims, or is there a fundamental design difference? The complaint's silence on the accused device makes this a central point of future discovery.
V. Key Claim Terms for Construction
For the '833 Patent
- The Term: "propylene glycol" (Claim 1)
- Context and Importance: This term is the core of the invention, identified as the solution to the problems caused by mannitol. Its construction is important because infringement hinges on the presence of this specific agent in the accused formulation within the claimed concentration and pH ranges.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims themselves and the summary of the invention define the invention broadly as using "propylene glycol" to replace a prior art isotonicity agent, without limiting it to a specific grade or source ('833 Patent, col. 2:50-54).
- Evidence for a Narrower Interpretation: The specification repeatedly frames the utility of propylene glycol in its ability to solve specific problems: reducing deposits on production equipment and preventing needle clogging ('833 Patent, col. 22:1-4; col. 30:56-62). A party could argue that the term should be interpreted in light of this stated purpose and the performance characteristics demonstrated in the examples.
For the '893 Patent
- The Term: "pivot bearing" (Claim 1)
- Context and Importance: This is the central structural element of the claimed invention for reducing friction. Whether the accused device contains a "pivot bearing" as defined by the patent will likely be a dispositive issue for infringement of the '893 Patent. Practitioners may focus on this term because it is a specific mechanical feature that distinguishes the invention from prior art.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the function of the pivot bearing as minimizing the surface area of interaction to reduce friction ('893 Patent, col. 1:55-61). This functional description could support an interpretation that covers any structure achieving that specific purpose.
- Evidence for a Narrower Interpretation: The detailed description identifies the pivot bearing (18, 22) as being formed specifically "between the bottom surface of the bore and the top surface of the protrusion" ('893 Patent, col. 4:15-18). The embodiment shown includes a "raised pointer forming a pivot 18" ('893 Patent, col. 3:62-63), which could be used to argue for a more structurally limited definition tied to the disclosed embodiment.
VI. Other Allegations
- Indirect Infringement: The complaint does not contain a separate count for indirect infringement. However, the allegation that Rio's "sale of Rio's Product" infringes the '893 device patent suggests a potential theory of induced infringement, as Rio would be selling the drug with instructions or intent for it to be used in an infringing injection device (Compl. ¶26).
- Willful Infringement: Willfulness is alleged based on Rio's awareness of the patents-in-suit at the time it submitted its ANDA (Compl. ¶23, ¶29). This knowledge is premised on the patents' listing in the FDA's Orange Book for Victoza® and Rio's service of a Paragraph IV certification notice letter (Compl. ¶14, ¶17).
VII. Analyst’s Conclusion: Key Questions for the Case
- A key factual question will be one of compositional identity: does Rio's formulation, as detailed in its confidential ANDA, fall squarely within the claimed ranges for propylene glycol concentration and pH required by the '833 patent, or has Rio designed a non-infringing alternative?
- A central evidentiary question will be one of device structure: what does Rio’s ANDA specify as the delivery device for its generic drug? Does that device incorporate the specific "pivot bearing" architecture of the '893 patent, or does it utilize a different mechanical design to manage rotational friction in the push button? The resolution of the '893 patent infringement claim may depend entirely on the contents of the ANDA regarding the delivery device.