DCT
1:23-cv-01195
Novo Nordisk Inc v. Meitheal Pharma Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Novo Nordisk Inc. (Delaware) and Novo Nordisk A/S (Denmark)
- Defendant: Meitheal Pharmaceuticals, Inc. (Delaware) and Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (China)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP; Fenwick & West LLP
- Case Identification: 1:23-cv-01195, D. Del., 10/20/2023
- Venue Allegations: Venue is alleged to be proper in the District of Delaware based on Defendants conducting business, deriving revenue from sales, and engaging in systematic and continuous contacts within the state.
- Core Dispute: Plaintiff alleges that Defendant's submission of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff's Victoza® (liraglutide) product constitutes an act of infringement of two patents covering the drug's formulation and its injection device.
- Technical Context: The dispute involves technology in two distinct areas: pharmaceutical formulations for injectable peptide-based drugs, and the mechanical design of pen-style injection devices used to administer such drugs.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff's receipt of a notice letter dated September 7, 2023, in which Defendant asserted via a Paragraph IV certification that the patents-in-suit are invalid, unenforceable, and/or would not be infringed by its proposed generic product.
Case Timeline
| Date | Event |
|---|---|
| 2003-11-24 | Earliest Priority Date for U.S. Patent 8,114,833 |
| 2007-02-07 | Earliest Priority Date for U.S. Patent 9,265,893 |
| 2012-02-14 | U.S. Patent 8,114,833 Issued |
| 2016-02-23 | U.S. Patent 9,265,893 Issued |
| 2023-09-07 | Date of Defendant's Paragraph IV Notice Letter |
| 2023-10-20 | 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's background section describes problems associated with using mannitol, a common isotonicity agent, in pharmaceutical formulations. Mannitol can crystallize, leading to undesirable deposits on manufacturing equipment and, critically, clogging of needles in injection devices. (Compl. ¶22; ’833 Patent, col. 1:30-46).
- The Patented Solution: The invention replaces mannitol with propylene glycol as the isotonicity agent. The inventors assert that using propylene glycol at specific concentrations results in stable peptide formulations that exhibit reduced deposits during production and reduced clogging of injection devices. (’833 Patent, Abstract; col. 1:50-57).
- Technical Importance: This approach sought to improve the manufacturing efficiency of injectable peptide drugs and enhance the reliability and safety of patient-administered injection pens by preventing needle blockages. (’833 Patent, col. 1:35-46).
Key Claims at a Glance
- The complaint asserts claims 1-31. Independent claim 1 is representative of the composition claims.
- Independent Claim 1:
- 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 said formulation 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 also asserts method claims for preparing the formulation and for reducing deposits and clogging (Compl. ¶22), reserving the right to pursue dependent claims.
U.S. Patent No. 9,265,893 - Injection Button (Issued Feb. 23, 2016)
The Invention Explained
- Problem Addressed: In certain injection pens, the push button and the internal driving mechanism must rotate relative to each other during dose delivery. The patent describes that the friction generated by this relative rotation can contribute to the total force a user must apply, potentially making the device difficult to operate. (Compl. ¶28; ’893 Patent, col. 2:47-52).
- The Patented Solution: The invention is a specific push button connection designed to minimize this rotational friction. It features a "pivot bearing" formed between the push button and a protrusion on the driving part, which is intended to reduce the contact surface area and the resulting friction torque. (’893 Patent, Abstract; col. 2:52-57).
- Technical Importance: The claimed design aims to lower the injection force required from the user, which can improve ease of use and dose accuracy, particularly for patients with limited manual dexterity.
Key Claims at a Glance
- The complaint asserts claims 1-6. Independent claim 1 is representative.
- Independent Claim 1:
- 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 push button further comprises a bore with a bottom surface,
- the bore surrounds a protrusion on the driving part which has a top surface,
- a pivot bearing is formed between the bottom surface and the top surface,
- wherein when a user presses the push button the force is directed toward the driving part, and
- the driving part rotates relative to the push button.
- The complaint reserves the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is "Meitheal's Product," identified as a generic version of liraglutide injection solution, 18 mg/3 ml (6 mg/ml), for which Defendant submitted ANDA No. 218115 to the FDA. (Compl. ¶17).
Functionality and Market Context
- The complaint alleges that Meitheal's ANDA refers to and relies upon the NDA for the branded product, Victoza®, and contains data intended to demonstrate bioequivalence between the two products. (Compl. ¶18). This implies that Meitheal's Product is intended to have the same active ingredient, concentration, and route of administration as Victoza® and to be sold as a lower-cost, substitutable generic alternative. (Compl. ¶1). No probative visual evidence provided in complaint. The complaint does not provide further technical detail on the specific formulation or the design of the injection device for Meitheal's Product.
IV. Analysis of Infringement Allegations
The complaint alleges that the act of submitting the ANDA to seek approval to market Meitheal's Product prior to the expiration of the patents-in-suit constitutes infringement under 35 U.S.C. § 271(e)(2)(A). (Compl. ¶¶ 21, 27). The complaint does not contain a detailed claim chart, but the infringement theory is predicated on the allegation that Meitheal's Product, as described in its ANDA, will possess the features recited in the asserted claims.
’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... | Meitheal’s Product is alleged to be a liraglutide injection solution, and liraglutide is a GLP-1 agonist. | ¶¶17, 22 | col. 4:26-28 |
| a disodium phosphate dihydrate buffer... | The complaint alleges Meitheal's Product will infringe the claim, which implies the ANDA specifies a formulation containing the claimed buffer. | ¶22 | col. 10:45-55 |
| and propylene glycol, wherein said propylene glycol is present...in a final concentration of from about 1 mg/ml to about 100 mg/ml... | The complaint's allegation implies that Meitheal's Product, as defined in its ANDA, will contain propylene glycol as an isotonicity agent within the claimed concentration range. | ¶¶17, 22 | col. 10:20-25 |
| and wherein said formulation has a pH of from about 7.0 to about 10.0. | The infringement allegation implies that Meitheal's Product will be formulated to a pH level that falls within the claimed range. | ¶22 | col. 10:32-35 |
- Identified Points of Contention:
- Compositional Questions: The central factual dispute will be whether Meitheal's proposed generic formulation, as specified in its confidential ANDA, actually contains propylene glycol and a disodium phosphate dihydrate buffer, and if so, whether their respective concentrations and the formulation's pH fall within the ranges of the asserted claims.
- Scope Questions: The construction of the term "about" will be important in defining the precise boundaries of the claimed concentration and pH ranges.
’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 infringement allegation implies that the injection device intended for use with Meitheal's Product will include a push button mounted on a driving part. | ¶28 | col. 3:40-44 |
| being rotatable relatively to the push button... | The allegation implies that the device's driving part is designed to rotate relative to the push button during operation. | ¶28 | col. 3:48-51 |
| a pivot bearing is formed between the bottom surface [of the button's bore] and the top surface [of the driving part's protrusion]... | This is the core of the infringement allegation for the ’893 patent. The complaint's theory necessarily assumes that Meitheal's proposed injection device incorporates this specific "pivot bearing" structure. | ¶28 | col. 4:16-19 |
- Identified Points of Contention:
- Technical Questions: A primary question is whether the mechanical interface between the push button and driving part in Meitheal's proposed device actually creates what can be defined as a "pivot bearing."
- Scope Questions: The dispute will likely focus on the proper construction of "pivot bearing." The patent describes a specific geometry, raising the question of whether other friction-reducing interfaces would fall within the claim's scope.
V. Key Claim Terms for Construction
’833 Patent
- The Term: "about"
- Context and Importance: This term appears in the limitations defining the concentration of propylene glycol and the pH range. Its construction will determine the literal scope of the claims. A broader interpretation of "about" would make it more difficult for Defendant to design a non-infringing formulation by making slight modifications to concentration or pH.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The use of the term itself suggests the patentee did not intend to be limited to the exact numerical values stated. The specification discusses the invention in general terms, not always tied to precise values. (’833 Patent, col. 2:50-53).
- Evidence for a Narrower Interpretation: The patent provides specific examples with precise values (e.g., "Propylene glycol...: 13.7" mg/ml, pH 7.90), which a party could argue should limit the scope of "about" to a narrow range of equivalents around those embodiments. (’833 Patent, col. 19:14-20).
’893 Patent
- The Term: "pivot bearing"
- Context and Importance: This term defines the central novel feature of the claimed injection button. Whether Meitheal's device infringes will likely depend entirely on whether its push button connection includes a structure that meets the definition of a "pivot bearing."
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party might argue the term should be given a functional definition, covering any structure that provides a pivot point to reduce rotational friction between the two components, not just the specific one pictured. The term itself is a functional one. (’893 Patent, col. 2:52-57).
- Evidence for a Narrower Interpretation: The specification describes a very specific structure corresponding to the term: "the pivot 18 formed in the most proximal bottom surface 17 of the bore 12 bears on the top surface 22 of the protrusion 21 thus forming a pivot bearing 22, 18." (’893 Patent, col. 4:16-19, Fig. 1). This explicit definition tying the term to specific numbered elements in the figures could support a narrow construction limited to the disclosed embodiment or its close structural equivalents.
VI. Other Allegations
- Indirect Infringement: The complaint's counts are for direct infringement under the statutory provisions of 35 U.S.C. § 271(e)(2)(A), which defines the submission of an ANDA as an act of infringement. (Compl. ¶¶ 21, 27). For the method claims of the ’833 Patent, an underlying theory of induced infringement would be based on the proposed product labeling in the ANDA, which would instruct medical professionals and patients on how to prepare and use the infringing formulation.
- Willful Infringement: The complaint alleges that Defendant was "aware" of the ’833 and ’893 patents at the time it submitted its ANDA, which forms the basis for a request for a finding of an exceptional case and an award of attorneys' fees under 35 U.S.C. § 285. (Compl. ¶¶ 25, 31).
VII. Analyst’s Conclusion: Key Questions for the Case
This Hatch-Waxman litigation presents two distinct infringement inquiries. The resolution of the case will likely depend on the answers to the following questions:
A central issue will be one of compositional identity: does the drug formulation described in Defendant's confidential ANDA contain propylene glycol as an isotonicity agent and a disodium phosphate dihydrate buffer, with the concentration and pH falling within the scope of the ’833 patent's claims, particularly as defined by the term "about"?
A key evidentiary question will be one of structural correspondence: does the injection pen mechanism proposed for use with the generic product incorporate the specific "pivot bearing" structure taught by the ’893 patent, or does it employ a mechanically distinct, non-infringing interface between its push button and driving part?