DCT
1:24-cv-01013
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: 1:24-cv-01013, D. Del., 09/05/2024
- Venue Allegations: Plaintiff alleges venue is proper because Defendant has agreed not to contest venue in the District of Delaware and maintains systematic and continuous business contacts within the state.
- Core Dispute: Plaintiff alleges that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for a generic version of the weight-loss drug Wegovy® constitutes an act of patent infringement, and that the future sale of such a product would infringe a patent covering a specific method-of-use for the active ingredient, semaglutide.
- Technical Context: The technology involves a specific dosing regimen for semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, a highly prominent class of pharmaceuticals used for treating type 2 diabetes and obesity.
- Key Procedural History: This is a Hatch-Waxman action filed in response to Defendant’s ANDA submission seeking FDA approval for a generic drug product. The asserted patent is listed in the FDA’s “Orange Book” as covering Plaintiff’s branded product, Wegovy®.
Case Timeline
| Date | Event |
|---|---|
| 2017-10-12 | U.S. Patent No. 12,029,779 Priority Date |
| 2024-07-09 | U.S. Patent No. 12,029,779 Issue Date |
| 2024-09-05 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 12,029,779 - "Semaglutide in Medical Therapy"
- Patent Identification: U.S. Patent No. 12,029,779, “Semaglutide in Medical Therapy,” issued July 9, 2024. (Compl. ¶32).
The Invention Explained
- Problem Addressed: The patent’s background section states that while medical therapies for weight management exist, they are often challenging, and existing GLP-1 receptor agonists can cause significant gastrointestinal adverse events. The patent identifies a desire for "improved medical therapies for weight management." (’779 Patent, col. 1:17-27).
- The Patented Solution: The invention is based on the "surprisingly" discovered beneficial ratio between efficacy and side effects when administering semaglutide at high dosages. The patent describes that administering semaglutide in a once-weekly regimen of 2.0-4.0 mg results in improved body weight reduction while the increase in adverse events, such as nausea, is lower than might be expected from such a high dose. (’779 Patent, col. 2:41-58). This specific dosing schedule is presented as the solution.
- Technical Importance: This dosing regimen provides a method to achieve a high degree of weight loss while maintaining a manageable safety profile, potentially expanding the therapeutic window for semaglutide in treating obesity. (’779 Patent, col. 9:30-58).
Key Claims at a Glance
- The complaint asserts infringement of at least claims 2 and 7, which implicates independent claims 1 and 7. (Compl. ¶43).
- Independent Claim 1:
- A method for reducing body weight of a subject in need thereof,
- comprising administering semaglutide subcutaneously to the subject
- in an amount of about 2.4 mg weekly.
- Independent Claim 7:
- A method for reducing body weight of a subject in need thereof,
- comprising administering semaglutide subcutaneously to the subject
- in an amount of 2.4 mg once weekly.
- The complaint’s use of "at least" suggests Plaintiff reserves the right to assert additional claims. (Compl. ¶43).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is "Defendant's ANDA Product," a generic version of semaglutide injection intended for subcutaneous use. (Compl. ¶16).
Functionality and Market Context
- The product is designed to be a bioequivalent generic version of Plaintiff’s Wegovy® drug product. (Compl. ¶18). The complaint alleges that the proposed label for the ANDA Product will instruct its use for weight management, including a maintenance dosage of 2.4 mg administered once weekly, mirroring the label for Wegovy®. (Compl. ¶11, ¶40, ¶46). The product is indicated for reducing and maintaining body weight, as well as for reducing the risk of major adverse cardiovascular events in certain adults with obesity or overweight. (Compl. ¶9).
IV. Analysis of Infringement Allegations
Claim Chart Summary
The complaint’s infringement theory is that use of the Defendant’s ANDA Product in accordance with its proposed label will directly infringe the asserted method claims. The complaint provides a chemical structure diagram of the active ingredient, semaglutide. (Compl. p. 4, Figure 1). The structural formula in Figure 1 illustrates the specific molecule that the complaint alleges is administered in the infringing method.
’779 Patent Infringement Allegations
| Claim Element (from Independent Claim 7) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for reducing body weight of a subject in need thereof, | Defendant's ANDA Product, as a generic of Wegovy®, is indicated for reducing excess body weight and maintaining weight reduction long term. | ¶9, ¶38 | col. 1:17-18 |
| comprising administering semaglutide subcutaneously to the subject | The ANDA Product is a semaglutide injection for subcutaneous use, and its proposed label instructs administration via subcutaneous injection. | ¶16, ¶42 | col. 2:50-53 |
| in an amount of 2.4 mg once weekly. | The ANDA Product will be offered in a dosage strength that allows for a 2.4 mg dose, and the proposed label instructs a maintenance dosage of 2.4 mg once weekly. | ¶11, ¶16, ¶40 | col. 5:58-61 |
Identified Points of Contention
- Scope Questions: A central question for the court will be whether the acts described in the proposed label of Defendant's ANDA Product fall squarely within the scope of the asserted claims. In ANDA litigation, this is often less contentious than validity, but disputes could arise over the precise meaning of claim terms.
- Technical Questions: The primary technical questions in an ANDA case relate to patent validity, which will be raised in the defendant's answer, not the complaint. Based on the complaint, a key evidentiary issue will be establishing that the Defendant’s proposed label "essentially copies" the Wegovy® label, thereby inducing infringement by physicians and patients as alleged. (Compl. ¶46). Another question is whether the product has substantial non-infringing uses, which the complaint alleges it does not. (Compl. ¶48).
V. Key Claim Terms for Construction
- The Term: "about 2.4 mg" (from Claim 1)
- Context and Importance: The distinction between "about 2.4 mg" in Claim 1 and "2.4 mg" in Claim 7 is significant. The doctrine of claim differentiation suggests these terms must have different scopes. Practitioners may focus on this term because its construction will define the boundary of infringement for Claim 1 and could be pivotal if Defendant’s product specifications show any variation from an exact 2.4 mg dosage.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discloses the invention in terms of ranges, such as "2.0-4.0 mg once weekly" (’779 Patent, col. 2:32-33), and uses the word "about" when listing specific dose amounts, such as "about 2.4 mg" (’779 Patent, col. 3:21-22). This language may support an interpretation that "about" encompasses a range of values consistent with the disclosed invention.
- Evidence for a Narrower Interpretation: The patent includes Claim 7, which recites "2.4 mg" without the modifier "about." A party could argue that to preserve the validity and distinct scope of Claim 7, the term "about" in Claim 1 must be interpreted narrowly. Furthermore, the specification includes an embodiment listing "2.4 mg" as a specific option from a group, which could be argued to represent a precise, intended amount. (’779 Patent, col. 5:58-61, Embodiment 8).
VI. Other Allegations
Indirect Infringement
- The complaint alleges that if Defendant’s ANDA is approved, it will induce and contribute to infringement. The inducement allegation is based on the claim that Defendant's proposed product label will instruct and encourage medical professionals and patients to administer the drug in a manner that directly infringes the patent. (Compl. ¶46). The contributory infringement allegation is based on the assertion that the ANDA product is not a staple article of commerce and lacks substantial non-infringing uses. (Compl. ¶48).
Willful Infringement
- The complaint does not explicitly allege "willful infringement." However, it does allege that Defendant has "actual knowledge of the '779 Patent" (Compl. ¶37) and characterizes the case as "exceptional" in its request for attorneys' fees under 35 U.S.C. § 285 (Compl. ¶56). These allegations could form the basis for a future claim of enhanced damages for any post-suit infringement.
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue, as is typical in ANDA litigation, will be one of patent validity: although not yet at issue, Defendant will likely argue that the claimed 2.4 mg once-weekly dosing regimen was obvious to a person of ordinary skill in the art based on prior knowledge of semaglutide and related compounds.
- A key infringement question will be one of inducement by labeling: does the language in the proposed label for Defendant's generic product direct, encourage, and instruct users to perform all steps of the patented method, thereby making future commercialization an act of induced infringement?
- A dispositive claim construction question may arise regarding definitional scope: how should the court construe "about 2.4 mg" in Claim 1 in light of the parallel claim (Claim 7) that omits the word "about"? The answer will determine the precise boundary of infringement for one of the two asserted independent claims.