DCT

1:23-cv-01459

Novo Nordisk Inc v. Sun Pharmaceutical Industries Ltd

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-01459, D. Del., 12/21/2023
  • Venue Allegations: Venue is based on Defendant Sun Pharmaceutical Industries, Inc. being a Delaware corporation and therefore residing in the district. Jurisdiction over the foreign parent, Sun Pharmaceutical Industries Ltd., is alleged based on its business conduct, revenue derived from Delaware, and previous consent to jurisdiction in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of WEGOVY® (semaglutide) injection infringes five patents related to the semaglutide compound, its pharmaceutical compositions, and its methods of use for weight management.
  • Technical Context: The technology involves semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, which has become a highly significant therapeutic in the large and growing markets for type 2 diabetes and chronic weight management.
  • Key Procedural History: This action was filed under the Hatch-Waxman Act within 45 days of Plaintiff’s receipt of Defendant’s Paragraph IV Certification notice letters, the first of which was dated November 8, 2023. Defendant’s certification asserts that the patents-in-suit are invalid and/or will not be infringed by its proposed generic product.

Case Timeline

Date Event
2005-03-23 ’343 Patent Priority Date
2012-03-06 ’343 Patent Issue Date
2012-08-30 ’003 Patent Priority Date
2017-08-24 ’605 Patent Priority Date
2017-08-24 ’198 Patent Priority Date
2017-09-19 ’003 Patent Issue Date
2020-02-18 ’191 Patent Priority Date
2021-01-12 ’605 Patent Issue Date
2022-05-03 ’191 Patent Issue Date
2023-09-12 ’198 Patent Issue Date
2023-11-08 Sun Pharmaceutical sends initial Paragraph IV Notice Letter
2023-11-10 Sun Pharmaceutical sends Corrected Notice Letter
2023-12-13 Sun Pharmaceutical sends Third Notice Letter regarding ’198 Patent
2023-12-21 Complaint Filing Date

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

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

  • Issued: March 6, 2012

The Invention Explained

  • Problem Addressed: The patent background describes the challenge of patient "needle-phobia" and the clinical need for GLP-1 compounds that can be administered less frequently than once daily to improve patient compliance (’343 Patent, col. 1:49-56).
  • The Patented Solution: The invention is a modified GLP-1 compound, semaglutide, that has been chemically altered through acylation (’343 Patent, col. 2:1-5). This modification allows the compound to bind non-covalently to albumin in the bloodstream, which significantly extends its duration of action and allows for less frequent dosing schedules, such as once weekly (’343 Patent, col. 2:56-62; Abstract).
  • Technical Importance: This approach of using acylation to achieve albumin binding created a long-acting GLP-1 agonist, transforming the therapeutic paradigm from daily to weekly injections for this class of drugs (Compl. ¶¶7, 41).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 3 (Compl. ¶¶75, 77).
  • Claim 1 is a composition of matter claim directed to a compound having a specific chemical structure, which is semaglutide.
  • Claim 3 is a method of treatment claim comprising the elements:
    • A method of treating type 2 diabetes in a subject.
    • Administering to the subject a therapeutically effective amount of a pharmaceutical composition.
    • The composition comprises the compound of claim 1 and a pharmaceutically acceptable excipient.

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

  • Issued: September 19, 2017

The Invention Explained

  • Problem Addressed: The patent is directed to methods for achieving effective weight reduction in patients (’003 Patent, col. 32:29-32).
  • The Patented Solution: The invention claims a specific method for reducing body weight that involves administering semaglutide once a week within a defined dosage range (0.7 mg to 1.6 mg) as a monotherapy, i.e., without another therapeutic agent (’003 Patent, col. 31:4-9; Abstract). The patent thus covers a specific dosing regimen found to be effective for this particular indication.
  • Technical Importance: This patent covers the specific dosing protocol for using semaglutide as a standalone therapy for weight management, which is the core indication for the branded drug WEGOVY® (Compl. ¶44).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶¶95, 103).
  • Claim 1 is a method of use claim comprising the elements:
    • A method for reducing body weight in a subject in need thereof.
    • Comprising administering semaglutide once weekly.
    • The amount administered is at least 0.7 mg and up to 1.6 mg.
    • The semaglutide is administered without another therapeutic agent.

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

  • Issued: January 12, 2021 (Compl. ¶46)

Technology Synopsis

The patent addresses the technical problem of the instability of GLP-1 peptides in liquid solutions (’605 Patent, col. 1:20-24). The patented solution is a liquid pharmaceutical composition of semaglutide that contains no more than 0.01% (w/w) phenol (a preservative) and has a pH between 7.0 and 7.8, a formulation which is described as having improved chemical and/or physical stability (’605 Patent, Abstract; col. 1:38-42).

Asserted Claims

Independent claims 1 (composition) and 14 (method of treating obesity) are asserted (Compl. ¶¶131, 133).

Accused Features

The accused feature is Sun’s ANDA product formulation, which is alleged to be a liquid aqueous solution comprising semaglutide at a concentration of 0.5 mg/mL to 5.0 mg/mL, a phenol concentration of no more than 0.1 mg/mL, and a pH between 7.0 and 7.8 (Compl. ¶¶47, 118-121, 126).

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

  • Issued: May 3, 2022 (Compl. ¶50)

Technology Synopsis

This patent addresses the technical challenge of creating a stable, single-use liquid formulation of semaglutide that minimizes injection site pain (’191 Patent, col. 13:21-30). The solution is a specific liquid pharmaceutical composition comprising semaglutide (0.5 to 10 mg/mL), a very low amount of phenol (0.0% to 0.1% w/w), and a narrow, specific concentration of sodium chloride (8.2 to 8.9 mg/mL) (’191 Patent, col. 25:50-54; Abstract).

Asserted Claims

Independent claims 1 (composition) and 15 (method of treatment) are asserted (Compl. ¶¶159, 161).

Accused Features

The accused feature is Sun’s ANDA product formulation, which is alleged to contain the claimed concentrations of semaglutide, phenol (or lack thereof), and sodium chloride (Compl. ¶¶51, 147-149, 154).

U.S. Patent No. 11,752,198 - "GLP-1 Compositions and Uses Thereof"

  • Issued: September 12, 2023 (Compl. ¶54)

Technology Synopsis

The patent claims a liquid pharmaceutical composition of semaglutide that explicitly does not contain the preservative phenol (’198 Patent, col. 12:49-50). The invention is based on the discovery that such a phenol-free formulation exhibits improved chemical and/or physical stability when compared to an equivalent composition that does contain phenol, addressing the stability problem for liquid GLP-1 peptides without a traditional preservative (’198 Patent, col. 12:56-59; Abstract).

Asserted Claims

Independent claims 1 (composition) and 8 (method of treating obesity) are asserted (Compl. ¶¶188, 190).

Accused Features

The accused feature is Sun's ANDA product, which is alleged to be a liquid pharmaceutical composition that does not contain phenol and meets the other claimed parameters such as semaglutide concentration and pH range (Compl. ¶¶55, 175-178, 183).

III. The Accused Instrumentality

Product Identification

Sun’s ANDA Product, a generic semaglutide injection intended for subcutaneous use (Compl. ¶18).

Functionality and Market Context

The product is an aqueous solution of semaglutide intended for chronic weight management, to be sold in various dosages identical to those of Novo Nordisk's WEGOVY® product (Compl. ¶18). The complaint alleges that, as required by FDA regulations for generic drugs, Sun’s ANDA product will have the same active ingredient, dosage form, strength, and route of administration as WEGOVY®, and its proposed label will be essentially a copy of the WEGOVY® label (Compl. ¶¶70, 98, 126, 154, 183). The complaint includes Figure 1, a diagram showing the structural formula of semaglutide, which it alleges is the active ingredient in both WEGOVY® and Sun's ANDA Product (Compl. ¶15, ¶64). As a generic version of a highly successful brand-name drug, the accused product targets the significant commercial market for pharmaceutical weight management therapies.

IV. Analysis of Infringement Allegations

’343 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound of the [specified chemical structure] The active ingredient in Sun’s ANDA Product is semaglutide, which the complaint alleges has the chemical structure claimed by the patent. ¶62, ¶64, ¶70 col. 29:1-67
a pharmaceutically acceptable excipient Sun's ANDA Product is a liquid pharmaceutical composition that contains inactive ingredients, or excipients, along with the active ingredient semaglutide. ¶70, ¶17 col. 43:6-12

Identified Points of Contention

  • Validity Questions: The complaint states that Sun's Paragraph IV notification does not allege non-infringement of the ’343 Patent, but rather asserts that the patent is invalid (Compl. ¶62). This suggests the primary legal dispute will not be over whether Sun's product has the claimed chemical structure, but whether the patent on that structure is valid in light of prior art or other legal requirements.
  • Scope Questions: For the method claim (Claim 3), infringement hinges on whether the act of submitting an ANDA with a label that proposes a use covered by the patent (treating type 2 diabetes, which is an indicated comorbidity for WEGOVY®) constitutes infringement under 35 U.S.C. § 271(e)(2).

’003 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for reducing body weight, comprising administering semaglutide once weekly... Sun’s proposed label for its ANDA Product allegedly instructs physicians and patients to use the product for chronic weight management, which involves reducing body weight, and to administer it once weekly. ¶91, ¶100 col. 31:4-6
...in an amount of at least 0.7 mg and up to 1.6 mg... The proposed label allegedly instructs a dose escalation schedule that includes administration of 1 mg for four weeks, which falls within the claimed dosage range. ¶94 col. 31:6-7
...wherein the said semaglutide is administered without another therapeutic agent. The proposed label allegedly instructs that the product should not be used in combination with other semaglutide-containing products or any other GLP-1 receptor agonist. ¶92 col. 31:8-9

Identified Points of Contention

  • Technical Questions: A factual question will be whether the instructions on Sun's final, FDA-approved label will indeed direct users to perform all steps of the claimed method, thereby inducing infringement. The complaint proceeds on the belief that the label will "essentially copy" the WEGOVY® label (Compl. ¶98).
  • Scope Questions: The interpretation of the negative limitation "without another therapeutic agent" may be a point of contention. The dispute could center on whether this phrase precludes co-administration with any other drug, or more narrowly, other drugs for weight management or diabetes, which would be more directly supported by the alleged label instructions.

V. Key Claim Terms for Construction

’343 Patent

The complaint does not provide sufficient detail for analysis of claim construction issues. The infringement allegation rests on the identity of a chemical compound, and the primary dispute, as framed by the complaint, appears to be one of patent validity rather than the meaning of claim terms (Compl. ¶62).

’003 Patent

  • The Term: "without another therapeutic agent" (Claim 1)
  • Context and Importance: The scope of this term is critical for determining infringement of the method claim. A broad construction could make infringement difficult to prove, while a narrower construction focused on related therapies would strengthen the plaintiff's position. Practitioners may focus on this term because it represents a potential non-infringement argument based on how patients might use the generic drug in combination with other medications for unrelated conditions.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The plain meaning of the words "another therapeutic agent" could support a construction that encompasses any other drug, regardless of its purpose. The claims do not explicitly limit the term to a particular class of agent.
    • Evidence for a Narrower Interpretation: The patent's specification describes the invention in the context of treating obesity and diabetes (’003 Patent, Abstract). The complaint alleges the accused product's label will specifically caution against use with "other semaglutide-containing products or any other GLP-1 receptor agonist," suggesting the relevant context is limited to similar therapeutic agents (Compl. ¶92). Parties may argue the term should be construed in light of the patent's overall focus on weight management.

VI. Other Allegations

Indirect Infringement

The complaint alleges that Sun will induce infringement of the asserted method claims (’003, ’605, ’191, and ’198 Patents) by seeking FDA approval for a product with a proposed label that instructs physicians and patients to use the product in an infringing manner (e.g., Compl. ¶¶100, 128, 156, 185). The complaint also asserts that the semaglutide injection is not a staple article of commerce and has no substantial non-infringing uses, supporting a claim of contributory infringement (e.g., Compl. ¶¶102, 130, 158, 187).

Willful Infringement

The complaint does not contain an explicit allegation of willful infringement. However, for each patent, it alleges that Sun's infringement assertions in its Paragraph IV notice are "devoid of an objective good faith basis," states the case is "exceptional," and requests attorneys' fees under 35 U.S.C. § 285 (e.g., Compl. ¶¶83, 110, 139, 167, 196). These allegations are based on Sun's alleged pre-suit knowledge of the patents, evidenced by its Paragraph IV certification letters (e.g., Compl. ¶¶88, 115, 144, 172).

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

  • A central issue will be one of validity versus infringement: For the ’343 patent covering the semaglutide compound, the dispute is framed not around whether Sun's product is structurally the same, but whether Novo Nordisk's patent on that compound is valid. The case will likely focus on arguments of obviousness or anticipation based on the prior art.
  • A key question for the multiple formulation patents (’605, ’191, ’198) will be one of compositional identity: Does Sun's ANDA, by seeking approval for a bioequivalent generic, necessarily describe a product that meets the specific and often narrow ranges of excipient concentrations (e.g., sodium chloride) and properties (e.g., pH, absence of phenol) required by the composition claims?
  • A key evidentiary question for the method-of-use patents (’003, ’605, ’191, ’198) will be one of induced infringement: Will the contents of Sun's final approved label provide sufficient evidence that Sun actively encourages and instructs physicians and patients to perform the patented methods of administration, including specific dosing regimens and limitations on co-administration?