DCT
3:23-cv-04027
Novo Nordisk Inc v. Lupin Ltd D
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: 3:23-cv-04027, D.N.J., 07/27/2023
- Venue Allegations: Venue is alleged to be proper because Defendant is a foreign corporation, has a presence in and derives revenue from New Jersey, and has previously litigated and filed counterclaims in the district, thereby availing itself of the jurisdiction.
- Core Dispute: Plaintiff alleges that Defendant's proposed generic version of the diabetes drug Victoza®, for which it filed an Abbreviated New Drug Application (ANDA), will infringe two Novo Nordisk patents covering the drug's liquid formulation and the mechanical push-button of its injection device.
- Technical Context: The case concerns liraglutide (a GLP-1 agonist), a widely used injectable treatment for type 2 diabetes, where formulation stability and the usability of the patient-administered injection pen are critical technical and commercial factors.
- Key Procedural History: This action was filed under the Hatch-Waxman Act following a notice letter from Lupin, which included a Paragraph IV certification asserting that the patents-in-suit are invalid, unenforceable, or will not be infringed by its proposed generic product. The patents are listed in the FDA’s "Orange Book" as covering Victoza®.
Case Timeline
| Date | Event |
|---|---|
| 2003-11-24 | ’833 Patent Priority Date |
| 2007-02-07 | ’893 Patent Priority Date |
| 2012-02-14 | ’833 Patent Issue Date |
| 2016-02-23 | ’893 Patent Issue Date |
| 2023-06-12 | Lupin sends Paragraph IV Notice Letter |
| 2023-07-27 | 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 identifies a problem with mannitol, a common isotonicity agent used in injectable peptide formulations. Mannitol can crystallize during production, leading to deposits on filling equipment, and can also cause clogging of the fine-gauge needles used in injection devices. (’833 Patent, col. 1:30-45).
- The Patented Solution: The invention replaces mannitol with propylene glycol as the isotonicity agent. The specification asserts that this substitution reduces both deposits on production equipment and the clogging of injection needles, while maintaining the formulation's physical and chemical stability. (’833 Patent, col. 1:52-58). The patent presents experimental data, such as simulated filling and needle clogging tests, to demonstrate the superior performance of propylene glycol compared to mannitol and other agents. (’833 Patent, col. 17:9-col. 18:20).
- Technical Importance: The described solution addresses key manufacturing and usability challenges for peptide drugs, potentially increasing production yield and improving the reliability and safety of patient-administered injection therapies. (’833 Patent, col. 1:36-40).
Key Claims at a Glance
- The complaint asserts independent claims 1, 16, 23, 26, and 29. Claim 1 is representative of the formulation itself.
- Independent Claim 1 requires:
- 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 reserves the right to assert claims 1-31. (Compl. ¶22).
U.S. Patent No. 9,265,893 - "Injection Button," Issued Feb. 23, 2016
The Invention Explained
- Problem Addressed: In dose-setting injection pens, the user pushes a button that does not rotate, but this action causes an internal dose-setting component to rotate. The friction between these relatively rotating parts increases the force the user must apply to deliver an injection, which can be difficult for some patients. (’893 Patent, col. 1:22-34).
- The Patented Solution: The invention is a specific mechanical connection between the stationary push button and the rotating internal driving part. It uses a "pivot bearing" to minimize the contact surface area and radius of the friction force between the two parts. (’893 Patent, col. 1:52-57). The design also incorporates radial bearings to stabilize the connection against off-center forces applied by the user, ensuring smooth operation. (’893 Patent, col. 2:2-8).
- Technical Importance: This mechanical design aims to reduce the injection force required from the user, thereby improving ease of use, patient comfort, and potentially the accuracy of dose delivery. (’893 Patent, col. 1:47-49).
Key Claims at a Glance
- The complaint asserts independent claim 1.
- Independent Claim 1 requires:
- A push button connection for an injection device
- comprising a push button mountable on a driving part
- the driving part being rotatable relatively to the push button
- the push button further comprises a bore with a bottom surface which surrounds a protrusion on the driving part
- the protrusion has a top surface
- wherein a pivot bearing is formed between the bottom surface and the top surface
- wherein when a user presses on 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 claims 1-6. (Compl. ¶28).
III. The Accused Instrumentality
Product Identification
Lupin's proposed generic version of liraglutide injection solution, 18 mg/3 ml (6 mg/ml), as described in 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® and contains data intended to demonstrate its bioequivalence. (Compl. ¶¶17-18). As this is an ANDA case based on a pre-market filing, the complaint does not provide specific technical details on the final composition of Lupin’s formulation or the precise mechanical structure of its injection device. The core allegation is that to be a generic equivalent of Victoza®, the product must necessarily practice the patented inventions. (Compl. ¶¶15, 22, 28).
IV. Analysis of Infringement Allegations
The complaint provides a conclusory allegation of infringement without detailed claim charts. The analysis below is based on the infringement theory implicit in a Hatch-Waxman case: that the proposed generic product, by seeking to be a bioequivalent copy of the branded drug Victoza®, will necessarily have the features covered by the patents listed in the Orange Book for that drug.
No probative visual evidence provided in complaint.
’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 a formulation of liraglutide, which is a GLP-1 agonist. | ¶¶17, 22 | col. 4:26-34 |
| a disodium phosphate dihydrate buffer | As a bioequivalent of Victoza®, Lupin's Product is alleged to contain the same buffer system. | ¶¶18, 22 | col. 31:50-54 |
| 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 | Lupin's Product is alleged to contain propylene glycol as an isotonicity agent within the claimed concentration range to match the formulation of Victoza®. | ¶¶18, 22 | col. 10:17-20 |
| and wherein said formulation has a pH of from about 7.0 to about 10.0. | Lupin's Product is alleged to have a pH within the claimed range to ensure stability and bioequivalence. | ¶¶18, 22 | col. 10:31-35 |
- Identified Points of Contention:
- Factual Questions: A central question is whether the precise concentration of propylene glycol and the exact pH of Lupin's formulation, as specified in its confidential ANDA, fall within the ranges defined by the claim.
- Scope Questions: The interpretation of the term "about" will be critical in determining whether Lupin's specific formulation values literally meet 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 being rotatable relatively to the push button | The injection device for Lupin's Product is alleged to feature a push button and internal driving part that rotate relative to each other during injection, as it is a generic version of the Victoza® device. | ¶¶18, 28 | col. 3:49-52 |
| ...a bore...surrounds a protrusion on the driving part... | The internal geometry of Lupin's push button mechanism is alleged to have a bore that fits over a protrusion on the driving part. | ¶¶18, 28 | col. 3:55-63 |
| wherein a pivot bearing is formed between the bottom surface [of the bore] and the top surface [of the protrusion] | Lupin's device is alleged to incorporate a friction-reducing pivot bearing at the interface between the button and the driving part to achieve the same functional characteristics as the Victoza® pen. | ¶¶18, 28 | col. 3:53-57 |
- Identified Points of Contention:
- Technical Questions: Does the specific mechanical interface in Lupin's injection device meet the structural requirements of a "pivot bearing" as described in the patent, or does it achieve friction reduction through a different, non-infringing mechanism?
- Scope Questions: How broadly will the term "pivot bearing" be construed? Will it cover any structure that performs the same function, or will it be limited to structures highly similar to the "raised pointer" embodiment shown in the patent's figures?
V. Key Claim Terms for Construction
Term from the ’833 Patent: "about"
- Context and Importance: This term appears in the claimed ranges for both propylene glycol concentration and pH. The infringement analysis for Claim 1 will depend entirely on whether the specific values in Lupin's ANDA are considered to be "about" the claimed values. Practitioners may focus on this term because its breadth can determine the outcome of a literal infringement analysis for a chemical formulation.
- Intrinsic Evidence for a Broader Interpretation: The patent uses the term "about" consistently when defining the claimed ranges, suggesting it was intended to have its ordinary meaning of "approximately," providing some tolerance beyond the precise numerical endpoints. (e.g., ’833 Patent, col. 31:54-58).
- Intrinsic Evidence for a Narrower Interpretation: The patent provides numerous examples with highly specific concentration and pH values (e.g., "Propylene glycol: 14.0 or 14.3 mg/ml"; "pH: 7.40, 7.70, 7.90 or 8.15"). (’833 Patent, col. 20:15-18). A party may argue that this level of precision in the specification limits the permissible scope of "about".
Term from the ’893 Patent: "pivot bearing"
- Context and Importance: This term describes the core structural element of the invention for reducing injection force. Proving that Lupin's device contains a "pivot bearing" is essential to Novo Nordisk's infringement case for the ’893 Patent.
- Intrinsic Evidence for a Broader Interpretation: The specification describes the "pivot bearing" functionally, stating that by forming it, "the surface area of interaction between the two objects can be minimized and the radius of the resulting friction force can be kept at a minimum." (’893 Patent, col. 1:53-57). This may support a construction based on the structure's friction-reducing function.
- Intrinsic Evidence for a Narrower Interpretation: The patent describes a specific embodiment where the "most proximal bottom surface 17 of the bore 12 is formed with a raised pointer forming a pivot 18." (’893 Patent, col. 3:64-67). This explicit structural detail in the description of the figures could be used to argue for a narrower definition limited to a "pointer"-like structure.
VI. Other Allegations
- Indirect Infringement: The infringement action is brought under 35 U.S.C. § 271(e)(2), which defines the submission of an ANDA seeking approval to market a generic version of a patented drug as a statutory act of infringement. The complaint alleges Lupin infringed by submitting its ANDA for a product that, if approved and marketed, would infringe the patents. (Compl. ¶¶21, 27).
- Willful Infringement: The complaint alleges that "Lupin was aware" of the ’833 and ’893 patents when it submitted its ANDA. (Compl. ¶¶25, 31). This alleged knowledge, established at the latest by the research required to prepare its Paragraph IV certification, forms the basis for the request for a finding of an exceptional case and attorneys' fees.
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary issue will be one of factual proof and discovery: What are the exact technical specifications of Lupin's proposed product as detailed in its confidential ANDA? The case will turn on a direct comparison of Lupin’s formulation (propylene glycol concentration, pH) and device mechanics against the limitations of the asserted claims.
- A second core issue will be one of claim construction and scope: Can Novo Nordisk successfully argue for a construction of "about" ('833 patent) that is broad enough to encompass Lupin's formulation values, and a construction of "pivot bearing" ('893 patent) that reads on the specific mechanical linkage in Lupin's device? The resolution of these terms could be dispositive.
- A key strategic question will be one of infringement theory: Given the lack of detail in the complaint, it remains to be seen whether Novo Nordisk will be able to prove literal infringement for every claim element or if it will need to rely on the doctrine of equivalents for either the chemical formulation or the mechanical device, which presents a higher evidentiary hurdle.