DCT

1:23-cv-00013

Novo Nordisk Inc v. Viatris Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-00013, N.D. W. Va., 01/27/2023
  • 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 therefore resides in the judicial district.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) for a generic version of Wegovy® (semaglutide) injection infringes five U.S. patents covering the drug compound, its pharmaceutical formulations, and methods of use.
  • Technical Context: The patents relate to GLP-1 receptor agonists, a class of therapeutics used for treating type 2 diabetes and, with the introduction of Wegovy®, for chronic weight management.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff's receipt of a Notice Letter dated December 16, 2022, in which Defendants provided a Paragraph IV certification against the asserted patents. The complaint alleges that Defendants' accompanying Detailed Statement asserts invalidity as the basis for non-infringement without providing separate factual arguments for why the ANDA product itself would not infringe.

Case Timeline

Date Event
2005-03-23 Priority Date for ’343 and ’122 Patents
2012-03-06 U.S. Patent No. 8,129,343 Issues
2012-07-02 Priority Date for ’003 Patent
2013-09-17 U.S. Patent No. 8,536,122 Issues
2017-08-24 Priority Date for ’605 Patent
2017-09-19 U.S. Patent No. 9,764,003 Issues
2020-02-18 Priority Date for ’191 Patent
2021-01-12 U.S. Patent No. 10,888,605 Issues
2022-05-03 U.S. Patent No. 11,318,191 Issues
2022-12-16 Date of Defendants' Paragraph IV Notice Letter
2023-01-27 Complaint Filed

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

U.S. Patent No. 8,129,343 - "Acylated GLP-1 Compounds"

The Invention Explained

  • Problem Addressed: Native glucagon-like peptide 1 (GLP-1) compounds have therapeutic potential but are limited by a very short duration of action in vivo, requiring frequent injections that can impact patient compliance (’343 Patent, col. 2:40-50).
  • The Patented Solution: The invention describes modifying GLP-1 analog peptides by attaching a side chain (acylating) to a lysine residue. This side chain includes a lipophilic portion and a hydrophilic linker containing at least two acidic groups, a structure designed to enable non-covalent binding to circulating albumin, thereby extending the compound's half-life in the body and allowing for less frequent administration (’343 Patent, Abstract; col. 4:5-24). The chemical structure depicted in the complaint is an embodiment of this solution (Compl. ¶75).
  • Technical Importance: This albumin-binding strategy was a key technical approach for transforming GLP-1 therapies from daily injections into long-acting injectables suitable for once-weekly dosing, a significant development in the treatment of type 2 diabetes and related metabolic conditions (’343 Patent, col. 2:48-53).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and method claim 3 (Compl. ¶103).
  • Independent Claim 1: A compound claim defining a specific chemical structure comprising:
    • A GLP-1 analog peptide backbone with specified amino acid substitutions.
    • An acylated side chain attached to a lysine residue, the side chain comprising a linker and a terminal diacid group.
  • Method Claim 3: A method of treatment claim comprising:
    • A method for treating type 2 diabetes in a subject.
    • By administering a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable excipient.

U.S. Patent No. 8,536,122 - "Acylated GLP-1 Compounds"

The Invention Explained

  • Problem Addressed: Like its parent ’343 Patent, the ’122 Patent addresses the need to develop GLP-1 compounds with a longer duration of action to reduce the burden of frequent injections on patients with conditions like type 2 diabetes (’122 Patent, col. 2:42-53).
  • The Patented Solution: The patent discloses a class of acylated GLP-1 analogs with specific modifications designed to prolong their therapeutic effect. Critically, the patent explicitly claims the specific compound known as semaglutide, which is the active ingredient in Wegovy® (’122 Patent, col. 28:5-30, Claim 4). This solution provides a concrete chemical entity intended for less frequent administration.
  • Technical Importance: The invention of the specific semaglutide molecule provided a potent, long-acting GLP-1 analog that proved effective for once-weekly administration, forming the basis for commercially significant therapies for both diabetes and weight management (’122 Patent, col. 4:5-12).

Key Claims at a Glance

  • The complaint asserts claims 1-2, 4-11, 13, and 15 (Compl. ¶132). The lead asserted independent claims appear to be claim 4 (a compound claim) and claim 15 (a method claim).
  • Independent Claim 4: A compound claim for a specific molecule:
    • The compound which is Nε26-{2-(2-{2-[[2-(2-{2-[[(4S)-4-carboxy-4-(17-carboxyheptadecanoylamino)butanoyl]amino]ethoxy}ethoxy)acetyl]amino}ethoxy)ethoxy]acetyl}[Aib8,Arg34]GLP-1-(7-37)-peptide (semaglutide).
  • Method Claim 15: A method of treatment claim comprising:
    • A method for treating type 2 diabetes in a subject.
    • By administering a pharmaceutical composition comprising the compound of claim 4 (semaglutide) and a pharmaceutically acceptable excipient.

U.S. Patent No. 9,764,003 - "Use of Long-Acting GLP-1 Peptides"

  • Patent Identification: U.S. Patent No. 9,764,003, entitled “Use of Long-Acting GLP-1 Peptides,” issued September 19, 2017 (’003 Patent) (Compl. ¶82).
  • Technology Synopsis: The patent addresses the use of semaglutide for weight reduction. It claims a method of reducing body weight by administering semaglutide once weekly within a specific dosage range (Compl. ¶83).
  • Asserted Claims: At least claim 1 (Compl. ¶¶160, 168).
  • Accused Features: The proposed label for the Defendants' ANDA Product allegedly instructs the administration of semaglutide once weekly for chronic weight management, which Plaintiff alleges falls within the scope of the claimed method (Compl. ¶¶156, 165).

U.S. Patent No. 10,888,605 - "GLP-1 Compositions and Uses Thereof"

  • Patent Identification: U.S. Patent No. 10,888,605, entitled “GLP-1 Compositions and Uses Thereof,” issued January 12, 2021 (’605 Patent) (Compl. ¶85).
  • Technology Synopsis: The patent claims a specific liquid pharmaceutical formulation for parenteral administration containing semaglutide. The claims recite specific concentration ranges for semaglutide, a low level of phenol, a minimum water content, an excipient (buffer or isotonic agent), and a specific pH range (Compl. ¶86).
  • Asserted Claims: At least claims 1 and 14 (Compl. ¶¶190, 197).
  • Accused Features: Plaintiff alleges that Defendants' ANDA product is a liquid formulation that is identical to Novo Nordisk's Wegovy® product and therefore meets the limitations of the claimed composition (Compl. ¶¶187, 192).

U.S. Patent No. 11,318,191 - "GLP-1 Compositions and Uses Thereof"

  • Patent Identification: U.S. Patent No. 11,318,191, entitled “GLP-1 Compositions and Uses Thereof,” issued May 3, 2022 (’191 Patent) (Compl. ¶89).
  • Technology Synopsis: This patent, like the ’605 Patent, is directed to a specific liquid pharmaceutical composition of semaglutide. The claims recite particular concentrations of semaglutide, phenol, and sodium chloride (Compl. ¶90).
  • Asserted Claims: At least claims 1 and 15 (Compl. ¶¶219, 226).
  • Accused Features: The complaint alleges that the formulation of Defendants' ANDA product is identical to that of Wegovy® and is therefore covered by the patent's composition claims (Compl. ¶¶216, 221).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendants' ANDA No. 217705 product, a generic version of Plaintiff's Wegovy® (semaglutide) injection ("ANDA Product") (Compl. ¶25).

Functionality and Market Context

  • The ANDA Product is described as an injectable drug containing semaglutide as its active ingredient, intended for subcutaneous use (Compl. ¶¶33, 98). The complaint alleges the ANDA Product is bioequivalent to Wegovy® and that its formulation and proposed label are essentially copies of the brand-name product (Compl. ¶¶37, 105). Wegovy® is indicated as an adjunct to diet and exercise for chronic weight management in adults with obesity or who are overweight with at least one weight-related comorbidity, such as type 2 diabetes (Compl. ¶29). It is administered once weekly via pre-filled, single-dose pens (Compl. ¶¶27, 30). Defendants' ANDA filing is part of a stated strategy to pursue complex generic injectables (Compl. ¶7).

IV. Analysis of Infringement Allegations

’343 Patent Infringement Allegations

Claim Element (from Independent Claim 1 and Method Claim 3) Alleged Infringing Functionality Complaint Citation Patent Citation
Claim 1: A compound of the structure [depicting an acylated GLP-1 analog] The active ingredient in the ANDA Product is semaglutide, which the complaint alleges is a compound covered by the claimed structure. The complaint provides a structural formula for semaglutide. (Figure 1, Compl. ¶99). ¶¶98, 99, 100, 103 col. 27:35-67
Claim 3: A method for treating type 2 diabetes in a subject, said method comprising administering a pharmaceutical composition according to claim 2 The ANDA Product's proposed label allegedly instructs its use for chronic weight management in adults who may have type 2 diabetes as a comorbidity, thereby instructing the claimed method of treatment. ¶¶101, 102, 107 col. 28:1-4
  • Identified Points of Contention:
    • Scope Questions: The complaint alleges Defendants' primary defense is invalidity rather than non-infringement (Compl. ¶97). A central issue for the court will therefore be the validity of the claims. A potential infringement question is whether the semaglutide molecule falls within the literal scope of the Markush group structure defined in claim 1.
    • Technical Questions: What evidence demonstrates that the specific semaglutide molecule in the ANDA Product embodies every structural element recited in claim 1 of the ’343 Patent?

’122 Patent Infringement Allegations

Claim Element (from Independent Claim 4 and Method Claim 15) Alleged Infringing Functionality Complaint Citation Patent Citation
Claim 4: The compound which is ... (semaglutide). The active ingredient of the ANDA Product is alleged to be semaglutide, the compound explicitly recited in the claim. The complaint provides a visual of the semaglutide structure. (Figure 1, Compl. ¶128). ¶¶127, 128, 129 col. 28:5-30
Claim 15: A method for treating type 2 diabetes ... comprising administering a pharmaceutical composition comprising the compound of claim 4... The ANDA Product's proposed label allegedly instructs its use for chronic weight management, including in patients with type 2 diabetes, thereby instructing the administration of a composition containing semaglutide for a claimed indication. ¶¶130, 131, 136 col. 28:60-64
  • Identified Points of Contention:
    • Scope Questions: The complaint notes that Defendants' Detailed Statement alleges claim 12 does not disclose semaglutide (Compl. ¶125). This may suggest a potential dispute over how broadly the patent's specification supports the full scope of the asserted claims, including claim 4 which explicitly names semaglutide.
    • Technical Questions: Does the active pharmaceutical ingredient in the ANDA Product meet the precise structural and chemical identity of "semaglutide" as claimed in the patent?

V. Key Claim Terms for Construction

  • The Term: "semaglutide" (from claim 4 of the ’122 Patent)
  • Context and Importance: This term is dispositive for infringement of claim 4 of the ’122 Patent. Plaintiff alleges the ANDA Product's active ingredient is semaglutide (Compl. ¶127). The dispute will likely center not on the definition of the term itself, which is a specific chemical entity, but on the validity of the claim that recites it. Practitioners may focus on this term because its precise definition underpins the core of the infringement allegation for this patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification describes a family of acylated GLP-1 compounds, which could provide context for understanding the invention, but is unlikely to broaden the definition of a term that names a specific compound (’122 Patent, col. 4:5-24).
    • Evidence for a Narrower Interpretation: Claim 4 itself provides the full, unambiguous chemical name for semaglutide (’122 Patent, col. 28:5-30). The patent also incorporates by reference a prior patent (WO 2006/097537, Example 4) that details the preparation of this exact compound, providing an explicit and limiting definition (’122 Patent, col. 3:45-47).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement on the basis that Defendants' proposed product label will instruct and encourage physicians and patients to administer the ANDA Product in a manner that infringes the asserted method of use claims (Compl. ¶¶107, 136, 165, 194, 223). The complaint also pleads contributory infringement, alleging the ANDA product is not a staple article of commerce and has no substantial non-infringing uses (Compl. ¶¶109, 138, 167, 196, 225).
  • Willful Infringement: Willfulness is alleged based on Defendants' actual knowledge of the asserted patents, evidenced by their Paragraph IV certification and Notice Letter (Compl. ¶¶95, 123, 152, 180, 210). Plaintiff further alleges that Defendants' invalidity arguments are "devoid of an objective good faith basis," supporting a claim that the case is exceptional under 35 U.S.C. § 285 (Compl. ¶¶118, 147, 175, 205, 234).

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

  • A central issue will be one of patent validity: as the complaint anticipates, the case will likely turn on whether Defendants can prove by clear and convincing evidence that the asserted claims covering the semaglutide compound, its specific pharmaceutical formulations, and its methods of use are invalid over the prior art.
  • A key evidentiary question will concern induced infringement: does the text of Defendants' proposed product label instruct medical professionals and patients to perform all steps of the asserted method claims, particularly those in the ’003 Patent directed to specific dosages for weight reduction?
  • Finally, a core issue for the formulation patents will be claim scope: can Plaintiff establish that the specific combination of ingredients, concentrations, and pH recited in the claims of the ’605 and ’191 Patents were non-obvious, and does the Defendants' ANDA product, which allegedly copies the commercial embodiment, fall within that scope?