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: Marcus & Shapira LLP
• Case Identification: Novo Nordisk Inc. v. Viatris Inc., 2:26-cv-01667, W.D. Pa., 08/07/2026
• Venue Allegations: Venue is alleged to be proper as Defendants reside in the district, maintain regular and established places of business, and have committed acts of infringement there. Viatris Inc. is alleged to have its principal executive offices in Canonsburg, Pennsylvania.
• Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff's WEGOVY® (semaglutide) tablets constitutes an act of infringement of four U.S. patents related to oral formulations and dosing regimens of GLP-1 compounds.
• Technical Context: The technology relates to oral drug delivery formulations for semaglutide, a GLP-1 receptor agonist used for weight management, a market segment with significant commercial value.
• Key Procedural History: This is a Hatch-Waxman action filed in response to a Paragraph IV certification notice letter dated June 26, 2026, in which Defendants contend that the asserted patents are invalid and/or not infringed by their proposed generic product. The complaint notes that Defendants have previously consented to personal jurisdiction in the Western District of Pennsylvania in other patent litigations.

Case Timeline

Date	Event
2012-06-21	'499 Patent Priority Date
2013-05-02	'923 Patent Priority Date
2018-02-02	'248 and '953 Patents Priority Date
2019-05-07	'923 Patent Issue Date
2020-11-01	Merger creates Viatris Inc.
2021-06-15	'499 Patent Issue Date
2023-12-05	'248 Patent Issue Date
2025-08-26	'953 Patent Issue Date
2026-06-26	Date of 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 - "Oral Dosing of GLP-1 Compounds"

• Patent Identification: U.S. Patent No. 10,278,923, "Oral Dosing of GLP-1 Compounds," issued May 7, 2019. Compl. ¶73

The Invention Explained

• Problem Addressed: The patent addresses the issue of high variability in plasma concentration when administering GLP-1 peptides orally, which can lead to side effects and suboptimal therapeutic effect. '923 Patent, col. 3:5-10 '923 Patent, col. 2:33-38
• The Patented Solution: The patent discloses that for GLP-1 peptides with a long plasma half-life (e.g., at least 60 hours), counterintuitively administering the oral composition more frequently (e.g., once daily) rather than less frequently (e.g., once weekly) leads to a surprising reduction in plasma concentration variability. '923 Patent, abstract '923 Patent, col. 2:46-58 This approach contrasts with typical dosing regimens for long-half-life drugs, which are usually administered less frequently. '923 Patent, col. 2:16-22
• Technical Importance: This method provides a way to improve the safety and efficacy profile of orally administered long-acting GLP-1 peptides, a significant challenge in the field of peptide therapeutics. Compl. ¶74

Key Claims at a Glance

• The complaint asserts at least Claim 14. Compl. ¶94
• Essential elements of independent claim 14 include:
  • A method for treating diabetes and/or obesity.
  • Orally administering a solid oral dosage form composition comprising 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 a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid (SNAC).
  • The composition is administered such that the ratio between the plasma half-life (in days) and the dosing interval (in days) is more than 2:1. Compl. ¶74
• The complaint does not explicitly reserve the right to assert other claims but infringement is alleged for "one or more claims." Compl. ¶39

U.S. Patent No. 11,033,499 - "Tablet Formulation Comprising a GLP-1 Peptide and a Delivery Agent"

• 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. ¶76

The Invention Explained

• Problem Addressed: The patent background notes the general difficulty of oral delivery for peptides and proteins due to poor bioavailability. '499 Patent, col. 1:20-27 The invention aims to improve the bioavailability of GLP-1 peptides when co-formulated with a delivery agent like SNAC. '499 Patent, col. 3:1-5
• The Patented Solution: The invention is a tablet with specific, tightly controlled physical properties. It comprises a granulate of the GLP-1 peptide and the delivery agent (NAC, or SNAC), and the final tablet is manufactured to have a high bulk density (at least 1.0 g/cm³), a small median and maximum pore diameter, and a defined crushing strength or disintegration time. '499 Patent, abstract '499 Patent, col. 2:1-12 These characteristics, achieved through processes like roller compaction, are disclosed to improve bioavailability. '499 Patent, col. 5:6-9 '499 Patent, col. 5:61-64
• Technical Importance: The invention provides a specific manufacturing blueprint for creating a physically robust oral tablet that enhances the absorption of a GLP-1 peptide, a key step in making such drugs orally viable. Compl. ¶77

Key Claims at a Glance

• The complaint asserts at least Claim 1. Compl. ¶118
• Essential elements of independent claim 1 include:
  • A tablet comprising a granulate.
  • The granulate comprises no more than 15% (w/w) GLP-1 peptide and 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: 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. Compl. ¶77
• The complaint alleges infringement of "one or more claims." Compl. ¶112

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. '248 Patent Compl. ¶79

• Technology Synopsis: The patent addresses the need for stable and effective oral GLP-1 formulations. It claims a very specific composition "consisting essentially of" semaglutide, magnesium stearate, and SNAC within defined ratios, and which notably "does not comprise a binder or filler," suggesting an invention focused on minimizing excipients to improve performance. Compl. ¶80 '248 Patent, abstract

• Asserted Claims: At least Claim 1. Compl. ¶140

• Accused Features: The composition of the Defendants' ANDA Product is alleged to be identical or substantially identical to that of WEGOVY® tablets (9 mg) and thereby covered by the claims. Compl. ¶142

• 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. '953 Patent Compl. ¶82

• Technology Synopsis: Similar to the '248 Patent, this invention concerns a specific solid composition for oral delivery of a GLP-1 agonist. It claims a pharmaceutical composition "comprising" semaglutide, SNAC, and magnesium stearate, with specific quantitative limitations on the amount of semaglutide and the ratio of magnesium stearate to SNAC, as well as a high purity level for SNAC. Compl. ¶83 '953 Patent, abstract

• Asserted Claims: At least Claim 1. Compl. ¶163

• Accused Features: The composition of the Defendants' ANDA Product is alleged to be identical or substantially identical to that of WEGOVY® tablets (9 mg) and thus to contain the claimed combination of ingredients in the specified amounts. Compl. ¶165

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendants' ANDA Product, a proposed generic version of WEGOVY® (semaglutide) 9 mg tablets, submitted to the FDA under ANDA No. 221156. Compl. ¶22 Compl. ¶32

Functionality and Market Context

• The complaint alleges that the Defendants' ANDA Product is a generic pharmaceutical tablet designed for oral administration. Compl. ¶32 It is intended to be bioequivalent to Novo Nordisk's WEGOVY® tablets (9 mg). Compl. ¶34 The complaint alleges the product contains the active ingredient semaglutide and inactive ingredients including SNAC and magnesium stearate. Compl. ¶89 The proposed product label is alleged to be an essential copy of the WEGOVY® label, instructing patients on a dose escalation schedule for the treatment of obesity and related conditions. Compl. ¶92 Compl. ¶93 The complaint includes Figure 1, a diagram showing the structural formula of the active ingredient, semaglutide. Compl. ¶29, Figure 1
• The complaint cites a report indicating Viatris is claiming first-to-file status for a generic version of Wegovy, suggesting a significant commercial motivation to be the first generic to market. Compl. ¶7

IV. Analysis of Infringement Allegations

'923 Patent Infringement Allegations

Claim Element (from Independent Claim 14)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A method for treating diabetes and/or obesity...comprising orally administering...a solid oral dosage form composition	Defendants' proposed label for its ANDA product allegedly instructs physicians and patients to orally administer the tablets to treat obesity.	¶91; ¶96	col. 4:54-65
comprising a...GLP-1 peptide...[which] is semaglutide and has a plasma half-life in humans of at least 60 hours	The ANDA product's active ingredient is semaglutide. The WEGOVY® label, which the ANDA label allegedly copies, states the half-life is approximately one week (168 hours).	¶89; ¶93	col. 11:1-12
an enhancer that is a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid	The ANDA product contains the enhancer SNAC, which is a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid.	¶89	col. 11:21-25
wherein the composition is administered such that the ratio between the plasma half-life in days...and the dosing interval in days...is more than 2:1	The WEGOVY® label, allegedly copied by the ANDA label, instructs once-daily dosing. With a half-life of ~7 days, the ratio is ~7:1, which is greater than 2:1.	¶90; ¶93	col. 5:27-40

'499 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
A tablet comprising a granulate comprising no more than 15% (w/w) GLP-1 peptide...and at least 50% (w/w) salt of NAC	The complaint alleges Defendants' ANDA product is a tablet whose composition is identical or substantially identical to the WEGOVY® 9 mg tablet, which is alleged to meet these compositional requirements.	¶120	col. 4:1-5
wherein said tablet has a bulk density of at least 1.0 g/cm³	The complaint alleges the ANDA product is covered by at least claim 1 of the '499 Patent, which implies that it meets the claimed physical parameters.	¶118-119	col. 7:38-44
a median pore diameter of no more than 1.5 µm	The complaint alleges the ANDA product is covered by at least claim 1, implying it has this property.	¶118-119	col. 8:1-3
and 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 complaint alleges the ANDA product is covered by at least claim 1, implying it has at least one of these features.	¶118-119	col. 8:35-52

• Identified Points of Contention:
  • Scope and Evidentiary Questions ('923 Patent): The infringement allegation for the '923 Patent is for inducement, based on the ANDA product's proposed label instructing a method of use. A central question will be whether following these instructions necessarily results in infringement of all claim limitations. This may raise an evidentiary question regarding how "plasma half-life in humans" is to be proven for the specific patient population, and whether the "more than 2:1" ratio is met in all prescribed uses.
  • Technical and Evidentiary Questions ('499 Patent): The infringement analysis for the '499 Patent will hinge on whether Defendants' proposed generic product, if manufactured, will actually possess the specific physical properties recited in the claims (e.g., bulk density, median pore diameter, maximum pore diameter). This raises a key evidentiary question that will likely require testing of product samples and competing expert testimony on the measurement and interpretation of these technical parameters.

V. Key Claim Terms for Construction

• The Term: "plasma half-life in humans of at least 60 hours" ('923 Patent)

• Context and Importance: This term is a cornerstone of the '923 Patent's method claim. Its definition is critical because infringement depends on the drug having this long half-life while being dosed frequently. Practitioners may focus on this term because its measurement methodology-whether it is based on intravenous or oral administration, and across what patient population-could be a point of dispute.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The patent defines "plasma half-life" as the time it takes to halve the plasma concentration after administration (i.v. or p.o.) following the initial distribution phase, suggesting flexibility in the measurement method. '923 Patent, col. 3:38-42
  • Evidence for a Narrower Interpretation: The patent repeatedly provides specific examples where the half-life is determined after intravenous (i.v.) administration. '923 Patent, col. 5:59 '923 Patent, col. 6:2 A party could argue that this is the required or preferred method for establishing the claimed half-life.

• The Term: "bulk density" ('499 Patent)

• Context and Importance: This physical parameter is central to Claim 1 of the '499 Patent, which requires a density of "at least 1.0 g/cm³." The method of measuring this property will be critical to the infringement analysis. Practitioners may focus on this term because different measurement techniques can yield different results, and the patent specifies a particular method.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The term itself is a standard one in pharmaceutics. A party might argue for its plain and ordinary meaning.
  • Evidence for a Narrower Interpretation: The specification explicitly describes how to determine bulk density, stating it can be calculated from tablet dimensions or "determined by submerging the tablet into a non-wetting liquid at atmospheric pressure, like mercury, and determining the displaced volume." '499 Patent, col. 7:31-40 A party could argue that this specific methodology, detailed in the patent's "Assay (I)," is controlling for claim construction.

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement for the '923 method patent. The basis for this allegation is that Defendants' ANDA, by essentially copying the WEGOVY® label, will instruct, recommend, and encourage physicians and patients to administer the generic product in a manner that directly infringes the claimed method. (Compl. ¶96; Compl. ¶97).
• Willful Infringement: The complaint alleges that Defendants have actual knowledge of the asserted patents. Compl. ¶88 Compl. ¶114 Compl. ¶136 Compl. ¶159 It further alleges that Defendants' Detailed Statement accompanying their Paragraph IV certification "is devoid of an objective good faith basis," which forms the basis for a claim that the case is "exceptional" and warrants an award of attorneys' fees under 35 U.S.C. § 285. Compl. ¶106 Compl. ¶130 Compl. ¶152 Compl. ¶176

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

1. A central issue will be one of evidentiary proof for the composition claims: For the '499, '248, and '953 patents, can Plaintiff demonstrate that the Defendants' proposed ANDA product, if manufactured, will necessarily meet the specific and restrictive compositional and physical parameters of the claims, such as the precise bulk density and pore diameter ('499 Patent) or the "consisting essentially of" formulation '248 Patent?
2. A key question for the '923 method patent will be one of inducement: Assuming the Defendants' product label mirrors the WEGOVY® label, does this instruction for once-daily dosing, when combined with evidence of semaglutide's half-life, constitute sufficient proof of specific intent to encourage infringement of a claim requiring a specific half-life-to-dosing-interval ratio?
3. A significant legal and technical question will be one of claim construction: How will the court define the measurement protocols for critical claim terms like "bulk density" and "median pore diameter" in the '499 patent? The outcome will likely depend on whether the court adopts the specific assays detailed in the patent specification or allows for a broader, plain and ordinary meaning.