DCT
1:24-cv-00050
Novo Nordisk Inc v. Mylan Pharma Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Novo Nordisk Inc. (Delaware) and Novo Nordisk A/S (Denmark)
- Defendant: Mylan Pharmaceuticals Inc. (West Virginia)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: Novo Nordisk Inc. v. Mylan Pharmaceuticals Inc., 1:24-cv-00050, D. Del., 01/12/2024
- Venue Allegations: Plaintiff alleges venue is proper because Defendant has agreed not to contest venue in this District, has purposefully availed itself of the forum by conducting business in Delaware, and is registered to do business in the state.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of the weight-management drug WEGOVY® infringes a patent directed to a stable, phenol-free formulation of the active ingredient semaglutide.
- Technical Context: The case concerns injectable formulations of GLP-1 receptor agonists, a highly successful class of drugs for chronic weight management, for which long-term chemical and physical stability is a critical attribute for commercial products.
- Key Procedural History: This is a Hatch-Waxman action filed under 35 U.S.C. § 271(e)(2), triggered by Defendant’s ANDA filing containing a Paragraph IV certification that asserts the patent-in-suit is invalid and/or not infringed. The patent-in-suit is listed in the FDA’s Orange Book in connection with Plaintiff’s WEGOVY® product.
Case Timeline
| Date | Event |
|---|---|
| 2017-08-24 | ’198 Patent Priority Date |
| 2023-09-12 | ’198 Patent Issue Date |
| 2023-12-01 | Plaintiff receives Defendant's Paragraph IV Notice Letter |
| 2024-01-12 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,752,198 - "GLP-1 Compositions and Uses Thereof"
The Invention Explained
- Problem Addressed: The patent's background section identifies the technical challenge that liquid pharmaceutical compositions containing GLP-1 peptides, the class of drug to which semaglutide belongs, are often prone to physical and chemical instability, which can compromise their efficacy and shelf-life (ʼ198 Patent, col. 1:20-27).
- The Patented Solution: The invention addresses this stability problem with a specific liquid formulation of semaglutide that, among other features, does not contain phenol, a common preservative. The patent asserts that omitting phenol results in a formulation with "improved chemical and/or physical stability as compared to a liquid pharmaceutical composition that contains phenol," an outcome described as surprising given that removing phenol from a related drug, liraglutide, decreases its stability (ʼ198 Patent, col. 2:9-14, col. 9:40-46). The patent presents data in its examples purporting to demonstrate this improved stability in phenol-free compositions (ʼ198 Patent, col. 9:9-39, Tables 2 & 3).
- Technical Importance: Achieving a stable, ready-to-use liquid formulation is significant for patient-administered injectable drugs, as it can extend product shelf-life and ensure consistent dosing and safety without requiring complex storage conditions or reconstitution by the user (ʼ198 Patent, col. 1:20-27).
Key Claims at a Glance
- The complaint asserts infringement of at least independent claims 1 and 8 (Compl. ¶59).
- Independent Claim 1 (Composition Claim): Its essential elements are:
- A liquid pharmaceutical composition comprising semaglutide;
- The composition does not contain phenol;
- It is for parenteral administration;
- It is an aqueous solution with at least 60% (w/w) water;
- It comprises a buffer or an isotonic agent;
- The semaglutide concentration is between 0.01 mg/mL and 10.0 mg/mL;
- The pH is between 7.0 and 7.8; and
- The composition "exhibits improved chemical and/or physical stability as compared to a liquid pharmaceutical composition that contains phenol."
- Independent Claim 8 (Method Claim): Its essential elements are:
- A method of treating obesity;
- Comprising administering a therapeutically effective amount of the composition of claim 1 to a subject in need thereof.
- The complaint alleges infringement of "one or more claims," reserving the right to assert additional claims (Compl. ¶59).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is "Defendant's ANDA Product," a proposed generic version of semaglutide injection intended for subcutaneous use (Compl. ¶15).
Functionality and Market Context
- The product is a liquid pharmaceutical composition for chronic weight management (Compl. ¶¶ 9, 15). The complaint alleges that, to secure FDA approval, the Defendant's ANDA Product must be bioequivalent to Plaintiff's WEGOVY® product and that its formulation is "identical to that in WEGOVY®" (Compl. ¶¶ 17, 54). The complaint provides the structural formula for semaglutide, the active ingredient in both WEGOVY® and the proposed generic product (Compl. ¶12, Figure 1). Figure 1 from the complaint depicts the chemical structure of semaglutide, identifying the active pharmaceutical ingredient at the heart of the dispute (Compl. p. 3).
IV. Analysis of Infringement Allegations
’198 Patent Infringement Allegations (Claim 1)
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A liquid pharmaceutical composition comprising: semaglutide | Defendant's ANDA Product is a liquid semaglutide injection. | ¶¶12, 15 | col. 3:45-54 |
| wherein said composition does not contain phenol | The WEGOVY® label, which the ANDA is alleged to copy, lists inactive ingredients that do not include phenol. | ¶¶47, 54 | col. 2:9-14 |
| is for parenteral administration | The product is for subcutaneous injection. | ¶¶10, 48 | col. 4:56-58 |
| is an aqueous solution comprising at least 60% (w/w) water | The product is described as an aqueous solution containing water for injection. | ¶¶13, 47 | col. 3:35-38 |
| further comprises one or more pharmaceutically acceptable excipients selected from the group consisting of a buffer or an isotonic agent | The formulation contains disodium phosphate dihydrate (a buffer) and sodium chloride. | ¶¶14, 47 | col. 2:15-18 |
| wherein the semaglutide is in the range of 0.01 mg/ml-10.0 mg/ml | The proposed product will be available in concentrations, such as 0.5 mg/mL and 3.2 mg/mL, that fall within the claimed range. | ¶¶13, 46 | col. 2:2-11 |
| wherein the pH of the composition is in between 7.0 and 7.8 | The WEGOVY® label states the product has a pH of approximately 7.4. | ¶¶14, 47 | col. 2:48-50 |
| wherein the liquid pharmaceutical composition exhibits improved chemical and/or physical stability as compared to a liquid pharmaceutical composition that contains phenol | The complaint alleges the WEGOVY® formulation, and therefore the identical ANDA product, is covered by the claim, implying this condition is met. | ¶49 | col. 2:9-14 |
’198 Patent Infringement Allegations (Claim 8)
| Claim Element (from Independent Claim 8) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating obesity | The ANDA product's proposed label will be indicated for chronic weight management in adults with obesity (BMI ≥ 30 kg/m²). | ¶¶9, 50, 56 | col. 4:50-54 |
| comprising administering ... a therapeutically effective amount of the pharmaceutical composition according to claim 1 | The proposed label will instruct physicians and patients to administer the formulation, which is alleged to meet all limitations of claim 1. | ¶¶56, 57 | col. 4:45-47 |
Identified Points of Contention
- Evidentiary Question: The complaint's infringement theory for the functional limitation "exhibits improved chemical and/or physical stability" rests on the allegation that the ANDA product is identical to WEGOVY®, which is asserted to be covered by the claims (Compl. ¶¶49, 54). This raises the question of what evidence Plaintiff will need to produce to prove that the defendant's specific product meets this comparative, functional requirement, or if arguing identity to the branded product is sufficient.
- Scope Question: A potential dispute may arise over the scope of the phrase "as compared to a liquid pharmaceutical composition that contains phenol." The parties may contest what specific phenol-containing formulation serves as the proper baseline for this comparison.
V. Key Claim Terms for Construction
The Term: "does not contain phenol"
Context and Importance: This negative limitation is central to distinguishing the invention. Practitioners may focus on this term because its interpretation—whether it means an absolute absence or falls below a certain de minimis or functional threshold—will define a primary boundary of the claim scope.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plain language of claim 1, "does not contain phenol," suggests a complete absence of the substance (ʼ198 Patent, col. 13:45).
- Evidence for a Narrower Interpretation: The patent abstract describes compositions with "no more than 0.01% (w/w) phenol," and embodiment 2 refers to a composition with "substantially no phenol" (ʼ198 Patent, Abstract; col. 15:2). A party could argue these passages suggest the term should be construed to mean not intentionally added as a preservative or present below a certain trace amount, rather than a strict zero.
The Term: "improved chemical and/or physical stability as compared to a liquid pharmaceutical composition that contains phenol"
Context and Importance: This is a functional, comparative limitation that is a cornerstone of the patent's asserted contribution. Its construction is critical because it sets the performance standard that an accused product must meet to infringe.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party could argue that the patent's own examples, which compare a phenol-free formulation to one containing 5.5 mg/ml phenol and find improved stability, provide a sufficient and enabling example of the required comparison (ʼ198 Patent, col. 10:5-15, Table 5; col. 9:9-20, Table 2). This suggests any formulation showing improvement over a reasonable phenol-containing baseline would infringe.
- Evidence for a Narrower Interpretation: A party could argue the term is indefinite unless the baseline for comparison (e.g., the specific composition and concentration of phenol) is clearly defined. They may argue the comparison must be made to a specific prior art formulation under specific conditions, and that the "improvement" must meet a particular quantitative or statistical threshold not explicitly stated in the claim.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement, stating that Defendant’s ANDA Product will have a label that "instructs, recommends, encourages, promotes, and/or suggests" that physicians and patients use the product for the claimed method of treating obesity (Compl. ¶56). It further alleges contributory infringement on the basis that the accused product is not a staple article of commerce and has no substantial non-infringing uses (Compl. ¶58).
- Willful Infringement: The complaint alleges Defendant had actual, pre-suit knowledge of the ’198 Patent via its Paragraph IV Notice Letter, received December 1, 2023 (Compl. ¶¶19, 43). The complaint seeks attorneys' fees under 35 U.S.C. § 285, alleging that Defendant's invalidity and non-infringement positions are "devoid of an objective good faith basis" (Compl. ¶67).
VII. Analyst’s Conclusion: Key Questions for the Case
- A key evidentiary question will be one of functional performance: can the plaintiff prove that the defendant's proposed generic product meets the claim limitation of exhibiting "improved chemical and/or physical stability" as compared to a phenol-containing formulation? The case may hinge on whether alleging formulation identity to WEGOVY® is sufficient, or if direct comparative testing of the ANDA product is required.
- The case will also likely involve a core issue of claim construction: how will the court define the comparative baseline for the "improved... stability" limitation? The resolution of what specific phenol-containing formulation must be used for comparison, and what quantum of "improvement" is necessary, will be critical to determining the ultimate scope of the asserted claims.