DCT
1:25-cv-00276
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: 1:25-cv-00276, D. Del., 03/07/2025
- Venue Allegations: Venue is asserted as proper in the District of Delaware on the grounds that Defendant Mylan Pharmaceuticals Inc. has agreed not to contest venue in the district.
- Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's Wegovy® (semaglutide) injection product constitutes an act of infringement of a patent covering stable, low-phenol or phenol-free formulations of the drug.
- Technical Context: The technology concerns liquid pharmaceutical formulations for GLP-1 receptor agonists, a class of drugs used for weight management and to reduce cardiovascular risk in certain patient populations.
- Key Procedural History: This action was filed under the Hatch-Waxman Act, triggered by Defendant's submission of ANDA No. 217705 to the U.S. Food and Drug Administration. The complaint notes other co-pending litigation involving the same Defendant and the same ANDA.
Case Timeline
| Date | Event |
|---|---|
| 2017-08-24 | ’017 Patent Priority Date |
| 2025-02-04 | ’017 Patent Issue Date |
| 2025-03-07 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
- Patent Identification: U.S. Patent No. 12,214,017, "GLP-1 Compositions and Uses Thereof," issued February 4, 2025.
The Invention Explained
- Problem Addressed: The patent's background section identifies a need for improved stability in liquid solutions of GLP-1 peptides, which are described as being "prone to develop lack of stability" (’017 Patent, col. 1:26-29).
- The Patented Solution: The patent discloses that, surprisingly, liquid compositions of the GLP-1 peptide semaglutide achieve "improved chemical and/or physical stability" when formulated with "no more than 0.01% (w/w) phenol" or, in some embodiments, no phenol at all (’017 Patent, Abstract; col. 1:45-51). This approach is counterintuitive because phenol is a common antimicrobial preservative in parenteral drug products.
- Technical Importance: Achieving a stable liquid formulation allows the drug to be supplied in a ready-to-use format, such as in pre-filled single-dose pens, which can improve patient convenience and dosing accuracy compared to drugs that require reconstitution before use (’017 Patent, col. 4:10-17).
Key Claims at a Glance
- The complaint asserts infringement of at least claim 1 of the ’017 Patent (Compl. ¶41).
- Independent Claim 1 requires:
- A liquid pharmaceutical composition comprising semaglutide;
- The composition does not contain phenol;
- The composition is administered parenterally;
- The composition is an aqueous solution with at least 60% water OR contains a buffer or an isotonic agent;
- The concentration of semaglutide is between 0.01 mg/ml and 10.0 mg/ml; and
- The pH of the composition is between 7.0 and 7.8.
- The complaint notes that Plaintiff may assert infringement of additional claims of the ’017 Patent (Compl. ¶19).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is Defendant Mylan's proposed generic semaglutide injection, identified as ANDA Product No. 217705 (Compl. ¶¶5, 16).
Functionality and Market Context
- The ANDA Product is described as a generic version of Novo Nordisk's Wegovy®, an injectable drug for subcutaneous use intended to reduce body weight and cardiovascular risk (Compl. ¶¶5, 9, 16). The complaint alleges that to gain FDA approval, Mylan's ANDA refers to Wegovy®'s New Drug Application and contains data to demonstrate bioequivalence (Compl. ¶18). The complaint includes a visual representation of the semaglutide chemical structure, identifying it as the active ingredient in Wegovy®. This visual is described as "Figure 1. Structural Formula of semaglutide." (Compl. p. 4, ¶13).
- The complaint alleges that the ANDA Product will be commercially manufactured, sold, and imported upon FDA approval, positioning it as a direct generic competitor to the brand-name Wegovy® product (Compl. ¶¶17, 44).
IV. Analysis of Infringement Allegations
U.S. Patent No. 12,214,017 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A liquid pharmaceutical composition comprising: semaglutide; | The ANDA Product is a "generic version of semaglutide injection," with semaglutide as its active ingredient. | ¶16 | col. 22:21-22 |
| wherein said composition (a) does not contain phenol; | The complaint alleges the ANDA Product is identical to Wegovy®, whose listed ingredients do not include phenol. | ¶33, ¶39, ¶43 | col. 22:23 |
| and (b) is administered parenterally; | The ANDA seeks approval for "subcutaneous use," which is a form of parenteral administration. | ¶16, ¶40 | col. 22:24 |
| and (c)(i) is an aqueous solution comprising at least 60% (w/w) water or (ii) further comprises one or more pharmaceutically acceptable excipients selected from the group consisting of a buffer or an isotonic agent; | The Wegovy® label, which the ANDA Product label is expected to copy, lists "water for injection," "disodium phosphate dihydrate" (a buffer), and "sodium chloride" (an isotonic agent). | ¶15, ¶39, ¶43 | col. 22:25-30 |
| and wherein the semaglutide is in the range of 0.01 mg/ml-10.0 mg/ml; | The Wegovy® dosages, which the ANDA seeks to market, correspond to concentrations (e.g., 0.5 mg/mL, 3.2 mg/mL) that fall within the claimed range. | ¶14, ¶38 | col. 22:31-32 |
| and 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." | ¶15, ¶39 | col. 22:33-34 |
Identified Points of Contention
- Scope Questions: The infringement analysis hinges on the allegation that Mylan's ANDA Product will be identical in formulation to Wegovy® (Compl. ¶43). A potential point of dispute could arise if Mylan's actual formulation as specified in its ANDA differs from Wegovy® in a way that avoids a claim limitation.
- Technical Questions: The central infringement allegation for the "does not contain phenol" limitation appears to be based on an inference from the listed ingredients on the Wegovy® label (Compl. ¶39). This raises the question of what evidence the ANDA file contains regarding the presence or absence of phenol in the proposed generic product.
V. Key Claim Terms for Construction
- The Term: "does not contain phenol"
- Context and Importance: This negative limitation is central to the patent's asserted novelty and the infringement case. Practitioners may focus on this term because its construction will determine the standard of proof for infringement. Whether it requires absolute absence (zero molecules) or merely the absence of phenol as a formulated ingredient could be a decisive issue.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent’s abstract and summary of the invention describe the composition as comprising "no more than 0.01% (w/w) phenol" (’017 Patent, Abstract; col. 1:36-37). A plaintiff could argue this language informs the meaning of "does not contain" in the claim, suggesting it covers formulations with functionally insignificant or trace amounts of phenol below this threshold.
- Evidence for a Narrower Interpretation: The claim language itself is an absolute, unqualified statement: "does not contain phenol" (’017 Patent, col. 22:23). A defendant would likely argue that this phrase should be given its plain and ordinary meaning, requiring complete and total absence, and that the different wording in the specification ("no more than 0.01%") was a deliberate choice not carried into the claim.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that the ANDA Product "is not a staple article of commerce and has no substantial approved uses that do not infringe at least claim 1" (Compl. ¶45). This allegation, combined with the assertion that Mylan's product label will instruct users on an infringing use, lays the groundwork for a claim of induced infringement upon commercialization.
- Willful Infringement: The complaint alleges that Mylan has "actual knowledge of the ’017 Patent" (Compl. ¶37) and characterizes the case as "exceptional," seeking attorneys' fees under 35 U.S.C. § 285 (Compl. ¶53). This suggests an intent to pursue a finding of willful infringement based on Mylan's knowledge of the patent, likely obtained through its listing in the FDA's Orange Book.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim construction: How will the court interpret the negative limitation "does not contain phenol"? Will the specification's disclosure of "no more than 0.01%" be read into the claim, or will the claim's absolute language require proof of total absence?
- A key evidentiary question will be one of infringement under § 271(e)(2): Does the chemical composition specified in Mylan's confidential ANDA filing for its proposed generic product meet every limitation of the asserted claim, thereby making the submission of the ANDA itself an act of infringement? The outcome will depend on what Mylan has told the FDA it intends to market.