DCT

1:23-cv-00101

Novo Nordisk Inc. v. Mylan Pharma Inc.

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-00101, D. Del., 01/27/2023
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Viatris Inc. is a Delaware corporation, and Defendant Mylan Pharmaceuticals Inc. is alleged to be an agent and alter ego of Viatris that distributes products in the district.
  • Core Dispute: Plaintiff alleges that Defendants’ filing of an Abbreviated New Drug Application (ANDA) for a generic version of the weight-management drug Wegovy® (semaglutide) infringes five patents covering the active pharmaceutical ingredient, specific formulations, and methods of use.
  • Technical Context: The technology relates to long-acting glucagon-like peptide-1 (GLP-1) receptor agonists, a class of drugs that has become highly significant in the treatment of type 2 diabetes and chronic weight management.
  • Key Procedural History: This is a Hatch-Waxman patent infringement action initiated under 35 U.S.C. § 271(e)(2) following Defendants’ submission of ANDA No. 217705 with a Paragraph IV certification. Plaintiff received a Notice Letter from Defendants on December 16, 2022, asserting that the patents-in-suit are invalid. The complaint also includes extensive allegations that Mylan Pharmaceuticals Inc. operates as an alter ego of Viatris Inc.

Case Timeline

Date Event
2005-03-23 U.S. Patent 8,129,343 Priority Date
2005-03-23 U.S. Patent 8,536,122 Priority Date
2012-03-06 U.S. Patent 8,129,343 Issued
2012-10-01 U.S. Patent 9,764,003 Priority Date
2013-09-17 U.S. Patent 8,536,122 Issued
2017-08-24 U.S. Patent 10,888,605 Priority Date
2017-09-19 U.S. Patent 9,764,003 Issued
2020-02-18 U.S. Patent 11,318,191 Priority Date
2021-01-12 U.S. Patent 10,888,605 Issued
2022-05-03 U.S. Patent 11,318,191 Issued
2022-12-16 Plaintiff receives Defendants' Notice Letter
2023-01-27 Complaint Filing Date

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 GLP-1 peptides have a very short biological half-life, which limits their therapeutic utility by requiring frequent injections (U.S. Patent 8,129,343, Abstract).
  • The Patented Solution: The patent discloses acylated GLP-1 compounds, such as semaglutide, which are modified with a fatty acid side chain (Compl. ¶75). This modification allows the compound to bind to albumin in the bloodstream, thereby extending its duration of action and enabling less frequent administration (U.S. Patent 8,129,343, Abstract; Compl. ¶¶30, 32). The complaint includes a structural formula of the claimed compound (Compl. ¶75, Figure 1).
  • Technical Importance: Acylation is a key chemical strategy for protracting the therapeutic effect of peptide-based drugs, allowing for more convenient dosing regimens such as once-weekly injections (Compl. ¶30).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 and method claim 3 (Compl. ¶103).
  • Claim 1 is directed to a compound with the specific chemical structure of semaglutide (Compl. ¶75).
  • Claim 3 is directed to a method of treatment comprising administering a pharmaceutical composition containing the claimed compound (Compl. ¶76, ¶102).
  • The complaint does not explicitly reserve the right to assert dependent claims for the ’343 Patent.

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

The Invention Explained

  • Problem Addressed: As with the related ’343 Patent, the technology addresses the short half-life of native GLP-1 peptides, which makes them unsuitable for convenient therapeutic administration (U.S. Patent 8,536,122, Abstract).
  • The Patented Solution: The patent claims GLP-1 analogs, including semaglutide, and pharmaceutical compositions containing them (Compl. ¶79). It also claims methods of treatment by administering a GLP-1 analog, including semaglutide (Compl. ¶80). This patent appears to provide further coverage for the semaglutide molecule and its therapeutic applications.
  • Technical Importance: This patent family provides foundational coverage for semaglutide, a compound that has become a commercially significant therapy for weight management and diabetes due to its long-acting profile (Compl. ¶29).

Key Claims at a Glance

  • The complaint asserts claims 1–2, 4–11, 13, and 15 (Compl. ¶125).
  • The asserted claims include those directed to compounds, pharmaceutical compositions, and methods of treatment comprising semaglutide (Compl. ¶¶79-80, 129, 131). The complaint does not specify which of the asserted claims are independent.
  • The complaint does not explicitly reserve the right to assert dependent claims for the ’122 Patent.

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

  • Technology Synopsis: The patent claims a method for reducing body weight. The method comprises administering semaglutide once weekly in a specific dose range of at least 0.7 mg and up to 1.6 mg, where the semaglutide is not administered with another therapeutic agent (Compl. ¶83).
  • Asserted Claims: At least claim 1 (Compl. ¶168).
  • Accused Features: The proposed label for Defendants’ ANDA product is accused of inducing infringement by instructing administration of semaglutide once weekly for weight management in a dose escalation schedule that includes the claimed amounts (Compl. ¶¶159, 165).

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

  • Technology Synopsis: GLP-1 peptides are prone to instability in liquid solutions (’605 Patent, col. 1:20-22). The patent claims a specific liquid pharmaceutical composition for parenteral administration that improves stability, comprising 0.5 to 5 mg/mL semaglutide, no more than 0.1 mg/mL phenol, at least 60% (w/w) water, a buffer or isotonic agent, and a pH between 7.0 and 7.8 (Compl. ¶86). The patent also claims a method of treatment using this composition (Compl. ¶87).
  • Asserted Claims: At least claims 1 and 14 (Compl. ¶197).
  • Accused Features: The specific formulation of Defendants’ proposed generic product, which the complaint alleges is identical to the formulation of Wegovy® and is therefore covered by the claims (Compl. ¶192).

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

  • Technology Synopsis: The invention relates to improving properties of GLP-1 compositions, such as reducing injection pain (’191 Patent, col. 1:60-63). The patent claims a liquid pharmaceutical composition with specific concentrations of semaglutide (0.5 to 10 mg/mL), phenol (0.0% to 0.1% w/w), and sodium chloride (8.2 to 8.9 mg/mL) (Compl. ¶90). The patent also claims a method of administering this composition (Compl. ¶91).
  • Asserted Claims: At least claims 1 and 15 (Compl. ¶226).
  • Accused Features: The specific formulation of Defendants’ proposed generic product, which is alleged to contain the same components in the same concentrations as the claimed composition (Compl. ¶¶214-216, 221).

III. The Accused Instrumentality

Product Identification

  • Defendants' generic semaglutide injection product, for which Defendants submitted Abbreviated New Drug Application (ANDA) No. 217705 to the U.S. Food and Drug Administration (FDA) (Compl. ¶25).

Functionality and Market Context

  • The accused instrumentality is a generic version of Plaintiff’s Wegovy® product, which is an aqueous solution of the active ingredient semaglutide for subcutaneous injection (Compl. ¶¶25, 33-34). It is indicated for chronic weight management in adults and is administered once weekly via a pre-filled, single-dose pen (Compl. ¶¶27, 29-30). The complaint alleges that Defendants' ANDA product will have the same formulation and label instructions as Wegovy® (Compl. ¶105, ¶134). The complaint also alleges that Viatris is claiming first-to-file status for a generic version of Wegovy, signaling its significant commercial interest in this product category (Compl. ¶50). The complaint includes a visual representation of the chemical structure of semaglutide, the active ingredient in both Wegovy® and the accused product (Compl. ¶33, Figure 1).

IV. Analysis of Infringement Allegations

U.S. Patent 8,129,343 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound of the structure: [structure of semaglutide] The active ingredient in Defendants' ANDA Product is semaglutide, which the complaint alleges has the claimed chemical structure. ¶98; ¶99 Claim 1
[Method Claim 3] A method of treating type 2 diabetes in a subject, said method comprising administering to a subject in need of such treatment an effective amount of a pharmaceutical composition comprising a compound of the structure [of semaglutide]... The complaint alleges infringement of method claims for weight management based on the proposed label for the ANDA product, which allegedly instructs administration for chronic weight management. ¶101; ¶102; ¶107 Claim 3

U.S. Patent 8,536,122 Infringement Allegations

Claim Element (from Asserted Claims 1-15) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound of GLP-1 analogs and pharmaceutical compositions comprising a GLP-1 analog, including semaglutide. The Defendants' ANDA Product is a pharmaceutical composition that contains semaglutide as its active ingredient. The complaint provides the structural formula for semaglutide. ¶127; ¶128 Claims 1-13
A method of treatment by administering a GLP-1 analog, including semaglutide... for chronic weight management. The proposed label for Defendants' ANDA product allegedly instructs physicians and patients to administer the product for chronic weight management in adults with an initial body mass index of 30 kg/m² or greater, or 27 kg/m² or greater with a weight-related comorbid condition. ¶130; ¶136 Claim 15

Identified Points of Contention

  • Validity Questions: The complaint states that Defendants’ Paragraph IV certification and Notice Letter assert that the patents-in-suit are invalid (Compl. ¶38, ¶97). This suggests the primary legal dispute will concern the validity of the asserted claims over the prior art, rather than non-infringement. The complaint does not detail the factual or legal bases for Defendants’ invalidity contentions.
  • Technical Questions: The infringement theory for all five patents rests on the allegation that Defendants’ ANDA product and its proposed label are essentially copies of the Wegovy® product and label (Compl. ¶105, ¶134, ¶163, ¶192, ¶221). A central factual question will therefore be whether the chemical composition and instructions for use of the proposed generic product fall squarely within the scope of the asserted claims.

V. Key Claim Terms for Construction

The Term: "no more than 0.1 mg/mL phenol" (from ’605 Patent, claim 1)

  • Context and Importance: This quantitative limitation is central to the infringement analysis for the ’605 Patent. The complaint's infringement theory depends on Defendants' formulation containing phenol within this specified upper limit. Practitioners may focus on this term because any deviation in Defendants' formulation could create a non-infringement argument, potentially requiring Plaintiff to assert infringement under the doctrine of equivalents.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification discusses compositions with "substantially no phenol" and "no more than 0.01% (w/w) phenol," which may suggest that the primary inventive concept is the reduction or elimination of phenol for improved stability, rather than adherence to a specific numerical ceiling (’605 Patent, col. 2:50-52).
    • Evidence for a Narrower Interpretation: The claim language provides a precise numerical boundary ("no more than 0.1 mg/mL"). The patent's abstract highlights compositions with "no more than 0.01% (w/w) phenol," emphasizing the importance of a low phenol concentration, which could support a strict reading of the claimed limit (’605 Patent, Abstract).

The Term: "8.2 to 8.9 mg/mL sodium chloride" (from ’191 Patent, claim 1)

  • Context and Importance: This term defines the concentration range of the isotonic agent in the claimed formulation of the ’191 Patent. Infringement requires the accused product to meet this specific range. This term will be critical as it sets a precise boundary for literal infringement of the composition claims.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes various concentration ranges for sodium chloride, such as "above 6.4 mg/ml" and "7-12 mg/ml," which could be used to argue that the claimed range is one example of a broader inventive concept related to using higher salt concentrations to, for example, reduce injection pain (’191 Patent, col. 2:5-24).
    • Evidence for a Narrower Interpretation: Claim 1 recites a specific and narrow range ("8.2 to 8.9 mg/mL"). The prosecution history (not provided) may reveal that this specific range was added to distinguish the invention from prior art, which would support a narrower construction limited to the recited values.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges induced infringement for all five patents. The basis for this allegation is that Defendants' proposed product label will instruct and encourage physicians, prescribers, and patients to administer the generic product in a manner that directly infringes the asserted method-of-use claims (e.g., Compl. ¶107, ¶136, ¶165).

Willful Infringement

  • The complaint alleges that Defendants had actual, pre-suit knowledge of the asserted patents, citing their Paragraph IV certification and the associated Notice Letter (e.g., Compl. ¶95, ¶123). The complaint further alleges that Defendants' invalidity positions are "devoid of an objective good faith basis," which forms the basis for a claim of willfulness and a request for enhanced damages and attorneys' fees (e.g., Compl. ¶118, ¶147).

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

  • A core issue will be one of validity: As the complaint indicates that Defendants’ primary defense is invalidity, the case will likely center on whether the claims covering the semaglutide compound, its specific formulations, and its use for weight management are patentable over the prior art.
  • A key evidentiary question will be one of formulation identity: Does the Defendants’ proposed generic product, including its active and inactive ingredients, concentrations, and pH, fall literally within the precise ranges defined by the composition claims of the ’605 and ’191 patents, or will the dispute hinge on the doctrine of equivalents?
  • A significant procedural question raised is the corporate relationship between the defendants: The case may involve early motion practice regarding whether Plaintiff’s extensive allegations are sufficient to establish that Mylan Pharmaceuticals Inc. is an alter ego of Viatris Inc., which could affect personal jurisdiction, venue, and the scope of liability.