Novo Nordisk Inc v. Viatris Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Novo Nordisk Inc. (Delaware) and Novo Nordisk A/S (Denmark)
  • Defendant: Viatris Inc. (Delaware) and Mylan Pharmaceuticals Inc. (West Virginia)
  • Plaintiff's Counsel: Schrader Duff Law & Lowe, PLLC
• Case Identification: 1:26-cv-00100, N.D.W. Va., 08/07/2026
• Venue Allegations: Venue is alleged to be proper in the Northern District of West Virginia because Defendant Mylan Pharmaceuticals Inc. is incorporated in West Virginia and both defendants are alleged to maintain places of business and have committed acts of infringement in the district.
• Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's WEGOVY® (semaglutide) tablets constitutes an act of infringement of four U.S. patents covering the drug's formulation, physical characteristics, and method of use.
• Technical Context: The technology relates to oral formulations of GLP-1 receptor agonists, a significant class of drugs used for treating obesity and type 2 diabetes, by overcoming the challenges of poor absorption and high variability associated with oral peptide delivery.
• Key Procedural History: This is a patent infringement action under the Hatch-Waxman Act, initiated after Plaintiff received a Paragraph IV Notice Letter from Defendants on June 26, 2026, concerning ANDA No. 221156. The complaint was filed within the 45-day statutory window, triggering a potential 30-month stay of FDA approval for the generic product.

Case Timeline

Date	Event
2012-06-21	U.S. Patent No. 11,033,499 Priority Date
2013-05-02	U.S. Patent No. 10,278,923 Priority Date
2018-02-02	U.S. Patent Nos. 11,833,248 & 12,396,953 Priority Date
2019-05-07	U.S. Patent No. 10,278,923 Issued
2021-06-15	U.S. Patent No. 11,033,499 Issued
2023-12-05	U.S. Patent No. 11,833,248 Issued
2025-08-26	U.S. Patent No. 12,396,953 Issued
2026-06-26	Plaintiff Received Defendants' Paragraph IV Notice Letter
2026-08-07	Complaint Filing Date

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 10,278,923

• Patent Identification: U.S. Patent No. 10,278,923 ("Oral Dosing of GLP-1 Compounds"), issued May 7, 2019 Compl. ¶65

The Invention Explained

• Problem Addressed: The patent's background section describes the difficulty of administering peptides like GLP-1 compounds orally due to enzymatic degradation in the gastrointestinal tract and insufficient absorption, which creates a need for an improved method with acceptable variability in plasma concentration '923 Patent, col. 1:18-33
• The Patented Solution: The patent discloses a method of oral administration for long-acting GLP-1 peptides that surprisingly reduces variability in plasma concentration. The invention involves a solid oral dosage form, containing the GLP-1 peptide and an absorption enhancer, that is dosed more frequently (e.g., daily) than might be expected for a drug with a long half-life. This frequent dosing regimen, where the ratio of the peptide's half-life (in days) to the dosing interval (in days) is more than 2:1, is described as providing lower variability in plasma concentration compared to less frequent dosing '923 Patent, abstract '923 Patent, col. 2:34-44 '923 Patent, col. 5:21-39
• Technical Importance: This dosing strategy sought to make oral administration of long-acting GLP-1 agonists more predictable, potentially improving therapeutic efficacy and reducing side effects associated with inconsistent drug levels '923 Patent, col. 3:5-10

Key Claims at a Glance

• The complaint asserts at least claim 14 of the '923 Patent Compl. ¶¶86-87 Compl. ¶91 Claim 14 is an independent method claim.
• The essential elements of independent claim 14 include:
  • A method for treating diabetes and/or obesity in a subject, comprising orally administering a solid oral dosage form composition with a GLP-1 peptide and an enhancer.
  • The GLP-1 peptide is semaglutide and has a plasma half-life in humans of at least 60 hours.
  • The enhancer is sodium N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC).
  • The composition is administered such that the ratio between the peptide's plasma half-life (in days) and the dosing interval (in days) is more than 2:1 '923 Patent, col. 34:39-52

U.S. Patent No. 11,033,499

• Patent Identification: U.S. Patent No. 11,033,499 ("Tablet Formulation Comprising a GLP-1 Peptide and a Delivery Agent"), issued June 15, 2021 Compl. ¶68

The Invention Explained

• Problem Addressed: The patent identifies a need for improved oral compositions for delivering peptides, noting the general challenges of transporting such molecules across the gastrointestinal tract '499 Patent, col. 1:36-44
• The Patented Solution: The invention is a specific tablet formulation with defined physical properties intended to improve the oral bioavailability of a GLP-1 peptide. The tablet is made from a granulate containing the peptide and a high concentration (at least 50% w/w) of a delivery agent (a salt of NAC). The final tablet is characterized by a combination of physical parameters, including high bulk density (at least 1.0 g/cm³), low median pore diameter (no more than 1.5 µm), and at least one other feature related to maximum pore diameter, crushing strength, or disintegration time '499 Patent, abstract '499 Patent, col. 1:50-col. 2:9 These properties are described as controlling the tablet's surface erosion and drug release '499 Patent, col. 7:65-col. 8:2
• Technical Importance: This technology provides a specific manufacturing framework that links controllable physical tablet characteristics to the in vivo performance of an oral peptide formulation, addressing a central challenge in the field of oral biologics.

Key Claims at a Glance

• The complaint asserts at least claim 1 of the '499 Patent Compl. ¶¶110-111 Compl. ¶115 Claim 1 is the patent's sole independent claim.
• The essential elements of independent claim 1 include:
  • A tablet comprising a granulate, which in turn comprises: (i) no more than 15% (w/w) GLP-1 peptide and (ii) at least 50% (w/w) salt of NAC.
  • The tablet has a bulk density of at least 1.0 g/cm³.
  • The tablet has a median pore diameter of no more than 1.5 µm.
  • The tablet has a feature selected from the group of: a maximum pore diameter of no more than 4 µm, a crushing strength of 50-400 N, and a disintegration time of 22 minutes or less '499 Patent, col. 39:1-20

Multi-Patent Capsule

• Patent Identification: U.S. Patent No. 11,833,248 ("Solid Compositions Comprising a GLP-1 Agonist and a Salt of N-(8-(2-Hydroxybenzoyl)Amino)Caprylic Acid"), issued December 5, 2023 Compl. ¶71

• Technology Synopsis: This patent claims a specific pharmaceutical composition for oral delivery of a GLP-1 agonist. The invention is defined as a composition "consisting essentially of" semaglutide, magnesium stearate, and SNAC. It further specifies the ratio of magnesium stearate to SNAC and explicitly excludes binders or fillers, suggesting this precise, minimalist formulation is key to its performance '248 Patent, abstract '248 Patent, claim 1

• Asserted Claims: The complaint asserts at least claim 1 Compl. ¶¶132, 137

• Accused Features: The defendants' ANDA product is alleged to have a composition that is "identical or substantially identical" to the claimed formulation Compl. ¶134

• Patent Identification: U.S. Patent No. 12,396,953 ("Solid Compositions Comprising a GLP-1 Agonist and a Salt of N-(8-(2-Hydroxybenzoyl)Amino)Caprylic Acid"), issued August 26, 2025 Compl. ¶74

• Technology Synopsis: This patent, related to the '248 Patent, also claims a specific solid oral composition. It claims a composition comprising semaglutide, SNAC, and magnesium stearate, but defines the invention by different parameters: the amount of semaglutide, the ratio of magnesium stearate to SNAC, and a high purity level for the SNAC component (at least 95% of the excipients) '953 Patent, abstract '953 Patent, claim 1

• Asserted Claims: The complaint asserts at least claim 1 Compl. ¶¶155, 160

• Accused Features: The defendants' ANDA product is alleged to have a composition that is "identical or substantially identical" to the claimed formulation Compl. ¶157

III. The Accused Instrumentality

Product Identification

• The accused instrumentality is Defendants' generic version of WEGOVY® (semaglutide) 9 mg tablets, for which Defendants filed Abbreviated New Drug Application (ANDA) No. 221156 with the FDA Compl. ¶¶22, 32

Functionality and Market Context

• The complaint alleges that the Defendants' ANDA Product is a solid oral tablet intended as a generic substitute for Novo Nordisk's WEGOVY® tablets (Compl. ¶32, Compl. ¶34). Its proposed label is alleged to copy the WEGOVY® label, instructing once-daily oral administration for weight reduction in adults with obesity or overweight Compl. ¶¶82, 88 The complaint alleges the product contains the active ingredient semaglutide and inactive ingredients including SNAC and magnesium stearate Compl. ¶81 The complaint includes a diagram showing the structural formula of semaglutide, identifying the active pharmaceutical ingredient at the core of the dispute Compl. ¶29, Fig. 1 The product's approval is sought for the 9 mg dosage strength, and the ANDA is said to contain data demonstrating its bioequivalence to the corresponding WEGOVY® tablet Compl. ¶34

IV. Analysis of Infringement Allegations

U.S. Patent No. 10,278,923 Infringement Allegations

Claim Element (from Independent Claim 14)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A method for treating diabetes and/or obesity in a subject in need of such treatment, comprising: orally administering to said subject a therapeutically effective amount of a solid oral dosage form composition comprising a glucagon-like peptide-1 (GLP-1) peptide and an enhancer,	The Defendants' ANDA Product is a solid oral tablet intended for treating obesity, containing the GLP-1 peptide semaglutide and the enhancer SNAC. The proposed label allegedly instructs this use.	¶¶32, 81, 83	col. 34:39-44
wherein the GLP-1 peptide is . . . semaglutide . . . and has a plasma half-life in humans of at least 60 hours;	The active ingredient is semaglutide. The WEGOVY® label, which the ANDA label allegedly copies, states the half-life is approximately one week (168 hours).	¶¶81, 85	col. 34:45-48
wherein the enhancer is sodium N-(8-(2-hydroxybenzoyl)amino)caprylate (SNAC); and	The product allegedly contains SNAC as an inactive ingredient.	¶81	col. 34:49-50
wherein said composition is administered such that the ratio between the plasma half-life in days in humans of said peptide and the dosing interval in days of said composition is more than 2:1.	The proposed label allegedly instructs once-daily dosing (1 day interval). With a half-life of 7 days, the alleged ratio is 7:1, which is greater than 2:1.	¶¶82, 85	col. 34:50-52

Identified Points of Contention

• Scope Questions: Infringement of method-of-use claim 14 hinges on the specific instructions in the Defendants' proposed product label. A potential dispute is whether the label's language will be found to actively induce physicians and patients to practice every step of the claimed method.
• Technical Questions: The complaint's allegation regarding the peptide's half-life relies on the WEGOVY® label. A factual question may arise as to whether the half-life of semaglutide in Defendants' specific formulation is indeed at least 60 hours, as required by the claim.

U.S. Patent No. 11,033,499 Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A tablet comprising a granulate, wherein said granulate comprises: i) no more than 15% (w/w) GLP-1 peptide, wherein the GLP-1 peptide is a peptide; and ii) at least 50% (w/w) salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (NAC);	The ANDA product is a tablet alleged to be a generic copy of WEGOVY® tablets. It contains the peptide semaglutide and the NAC salt SNAC, and is alleged to have a composition that is "identical or substantially identical" to the branded product, which is covered by the claim.	¶¶108, 110, 112	col. 39:1-9
wherein said tablet has a) a bulk density of at least 1.0 g/cm³;	The ANDA product is alleged to be "identical or substantially identical" to WEGOVY® tablets, which are alleged to meet this physical parameter.	¶¶110, 112	col. 39:10-14
b) a median pore diameter of no more than 1.5 µm; and	The ANDA product is alleged to be "identical or substantially identical" to WEGOVY® tablets, which are alleged to meet this physical parameter.	¶¶110, 112	col. 39:10-14
c) a feature selected from the group consisting of a maximum pore diameter of no more than 4 µm, a crushing strength of 50-400 N, and a disintegration time of 22 minutes or less.	The ANDA product is alleged to be "identical or substantially identical" to WEGOVY® tablets, which are alleged to meet at least one of these physical parameters.	¶¶110, 112	col. 39:15-20

Identified Points of Contention

• Technical Questions: The infringement analysis for the '499 patent will depend entirely on factual evidence from testing the Defendants' actual ANDA product. The complaint alleges identity but provides no test data. The central dispute will be whether Defendants' tablets, as manufactured, actually exhibit the specific, quantitative physical properties (bulk density, pore diameter, etc.) recited in claim 1.

V. Key Claim Terms for Construction

For the '923 Patent:

• The Term: "ratio between the plasma half-life in days in humans of said peptide and the dosing interval in days of said composition is more than 2:1"
• Context and Importance: This ratio is the central limitation of the asserted method claim, defining the core of the patented dosing regimen. Proving that the Defendants' proposed label instructs a use that meets this ratio is essential for the Plaintiff's infringement case.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The patent defines "plasma half-life" generally as the time it takes for plasma concentration to halve after the initial distribution phase, which could be measured after either intravenous or oral administration '923 Patent, col. 4:37-41 This may support flexibility in how the value is determined.
  • Evidence for a Narrower Interpretation: The patent provides detailed examples of pharmacokinetic studies and calculations '923 Patent, col. 31:12-col. 33:50 A party could argue that these examples define the specific context and methodology required to properly calculate the ratio, potentially limiting it to the methods disclosed.

For the '248 and '953 Patents:

• The Term: "consisting essentially of"
• Context and Importance: This transitional phrase appears in the independent claims of both the '248 and '953 patents (e.g.,'248 Patent, claim 1). Its construction is critical because it determines whether the presence of any unlisted ingredients in the Defendants' product would remove it from the scope of the claims. The '248 patent, for example, claims a composition "consisting essentially of" semaglutide, magnesium stearate, and SNAC, and explicitly excludes binders or fillers.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The plain meaning of "consisting essentially of" allows for the presence of unlisted ingredients that do not materially affect the basic and novel properties of the invention. A party might argue that minor impurities or processing aids do not materially affect the composition's function.
  • Evidence for a Narrower Interpretation: The '248 patent's explicit exclusion of "a binder or filler" in claim 1 provides strong evidence for a narrow interpretation '248 Patent, col. 20:20-22 This suggests that the patentee intended to strictly limit the composition to only the listed components and those that are not binders or fillers, making the presence of any such additional substance in the accused product a strong non-infringement argument.

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement of the '923 method patent, asserting that Defendants' product label will instruct and encourage physicians and patients to administer the drug in a manner that directly infringes claim 14 Compl. ¶88 The complaint also alleges contributory infringement on the basis that the ANDA product is not a staple article of commerce and lacks substantial non-infringing uses Compl. ¶90
• Willful Infringement: The complaint alleges that Defendants had actual knowledge of the asserted patents prior to the lawsuit, based on their listing in the FDA's Orange Book and Defendants' Paragraph IV certification letter Compl. ¶¶80, 106, 128, 151 Plaintiff asserts that Defendants' infringement is, or will be, willful and requests enhanced damages and attorneys' fees, alleging the case is "exceptional" Compl. ¶¶99, 100, 122, 123, 145, 146, 168, 169

VII. Analyst's Conclusion: Key Questions for the Case

• A core issue for the '499, '248, and '953 patents will be one of evidentiary proof: can Novo Nordisk demonstrate through empirical testing that Viatris's generic tablets meet the specific, quantitative compositional and physical parameters recited in the claims, such as bulk density, pore diameter, and component ratios? The case may turn on a "battle of the experts" analyzing the respective products.
• A key question for the '923 patent will be one of induced infringement: does the language of Viatris's proposed product label go beyond merely describing the drug's properties and instead actively instruct or encourage practitioners and patients to follow the specific dosing regimen that satisfies the patent's claimed half-life-to-dosing-interval ratio?
• A central legal question for the '248 and '953 patents will be the scope of the claims: how will the court construe the term "consisting essentially of"? The outcome will determine whether any unlisted substances in Viatris's formulation, even in small amounts, are sufficient to place the product outside the bounds of the patent claims, particularly for the '248 patent which explicitly excludes binders and fillers.