DCT

1:25-cv-00767

Novo Nordisk Inc v. Sun Pharmaceutical Industries Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00767, D. Del., 06/20/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Sun Pharmaceutical Industries, Inc. is a Delaware corporation and thus resides in the district. It is also alleged that both defendants have conducted business in the district and have previously consented to personal jurisdiction in the court through prior litigation.
  • 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) injection constitutes an act of patent infringement.
  • Technical Context: The technology concerns stable, liquid pharmaceutical formulations of semaglutide, a GLP-1 receptor agonist used for weight management and cardiovascular risk reduction in a highly significant commercial market.
  • Key Procedural History: This lawsuit was initiated under the Hatch-Waxman Act, filed within the 45-day statutory window after Plaintiff received a Paragraph IV Notice Letter from Defendants. The complaint notes prior litigation between the parties as a basis for establishing personal jurisdiction.

Case Timeline

Date Event
2017-08-24 ’017 Patent Priority Date
2025-02-04 ’017 Patent Issue Date
2025-05-07 Plaintiff Received Defendant's Paragraph IV Notice Letter
2025-06-20 Complaint Filing Date

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

U.S. Patent No. 12,214,017 - "GLP-1 Compositions and Uses Thereof"

The Invention Explained

  • Problem Addressed: The patent's background section identifies that GLP-1 peptides like semaglutide are "prone to develop lack of stability in liquid solutions," which can compromise their therapeutic utility and shelf-life (’017 Patent, col. 1:25-28).
  • The Patented Solution: The patent describes a liquid pharmaceutical formulation of semaglutide that achieves improved chemical and/or physical stability without requiring the use of phenol, a common preservative (’017 Patent, col. 1:45-50). The solution involves specific ranges for semaglutide concentration and pH, and the use of particular excipients, to create a stable, ready-to-use parenteral formulation (’017 Patent, col. 1:45-58).
  • Technical Importance: Creating stable, liquid, ready-to-use formulations for biologic drugs is a significant challenge in pharmaceutical development, and overcoming it allows for more convenient patient administration devices like pre-filled pens.

Key Claims at a Glance

  • The complaint asserts infringement of at least Claim 1 of the ’017 Patent (Compl. ¶44).
  • The essential elements of independent claim 1 are:
    • A liquid pharmaceutical composition comprising: semaglutide;
    • wherein said composition (a) does not contain phenol; and
    • (b) is administered parenterally; and
    • (c)(i) is an aqueous solution comprising at least 60% (w/w) water or (ii) further comprises one or more pharmaceutically acceptable excipients selected from the group consisting of a buffer or an isotonic agent; and
    • wherein the semaglutide is in the range of 0.01 mg/ml-10.0 mg/ml; and
    • wherein the pH of the composition is in between 7.0 and 7.8.
  • The complaint alleges infringement of "one or more claims," which may imply an intent to assert dependent claims later in the litigation (Compl. ¶27).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Sun's ANDA Product," a generic version of semaglutide injection for which Defendants have sought FDA approval via ANDA No. 217962 (Compl. ¶¶ 7, 18).

Functionality and Market Context

  • The complaint alleges that Sun's ANDA Product is a liquid formulation of semaglutide intended for subcutaneous injection, designed to be bioequivalent to Plaintiff's WEGOVY® product (Compl. ¶¶ 18, 21).
  • The complaint alleges on information and belief that Sun's ANDA Product will have the same concentrations as WEGOVY® and that, as required by FDA regulations, its formulation is "identical to that in WEGOVY®" (Compl. ¶¶ 18, 50).
  • The complaint provides the structural formula of semaglutide as Figure 1 to identify the active ingredient in WEGOVY® and, by extension, the accused generic product (Compl. ¶15). The complaint's Figure 1 shows the chemical structure of the semaglutide molecule (Compl. ¶15).

IV. Analysis of Infringement Allegations

'017 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A liquid pharmaceutical composition comprising: semaglutide Sun’s ANDA Product is a liquid pharmaceutical composition that contains semaglutide as its active ingredient. ¶18, ¶50 col. 2:45-50
wherein said composition (a) does not contain phenol The WEGOVY® label does not list phenol as an ingredient, and the complaint alleges Sun's ANDA Product has an identical formulation. ¶17, ¶50 col. 1:47-48
(b) is administered parenterally The product is an injection for subcutaneous administration, which is a form of parenteral administration. ¶18, ¶47 col. 2:1-2
(c)(i) is an aqueous solution...or (ii) further comprises one or more...excipients selected from...a buffer or an isotonic agent WEGOVY® is an aqueous solution containing excipients including disodium phosphate dihydrate (a buffer) and sodium chloride (an isotonic agent). ¶16, ¶17, ¶50 col. 3:27-31
wherein the semaglutide is in the range of 0.01 mg/ml-10.0 mg/ml The alleged concentrations of semaglutide in Sun's ANDA Product (e.g., 0.5 mg/mL, 3.2 mg/mL) fall within the claimed range. ¶16, ¶18 col. 1:50-51
wherein the pH of the composition is in between 7.0 and 7.8 WEGOVY® has a pH of approximately 7.4, and Sun's ANDA Product is alleged to have the same pH. ¶17, ¶50 col. 1:52-53

Identified Points of Contention

  • Scope Questions: The complaint asserts that Sun's Paragraph IV certification relies on invalidity arguments rather than non-infringement (Compl. ¶25). This suggests the primary legal dispute may center on whether the claimed formulation is obvious over the prior art, rather than whether Sun's product meets the claim limitations.
  • Technical Questions: A central factual question is whether Sun's ANDA Product formulation is identical to the WEGOVY® formulation, as the complaint alleges on information and belief (Compl. ¶50). Discovery will be needed to determine if Sun's product contains any different excipients or preservatives that could distinguish it from the claimed composition.

V. Key Claim Terms for Construction

The Term: "does not contain phenol"

Context and Importance

This negative limitation appears to be central to the patent's asserted novelty. Its construction will be critical for determining the scope of the claim. Practitioners may focus on this term because its interpretation could either broadly exclude products with only trace amounts of phenol or narrowly apply only to products with absolute zero phenol content.

Intrinsic Evidence for Interpretation

  • Evidence for a Broader Interpretation: The specification discloses embodiments with "no more than 0.01% (w/w) phenol" and "substantially no phenol" (’017 Patent, col. 1:47-48, col. 2:58-59). A party could argue this language implies that the term "does not contain" should not be read as requiring absolute absence, but rather the absence of a functionally significant or intentionally added amount.
  • Evidence for a Narrower Interpretation: The plain language of the claim itself is absolute. A party could argue that "does not contain" must be given its plain and ordinary meaning of complete absence. This is reinforced by a separate claim embodiment which recites, "The composition according to claim 1 or 2, wherein said composition does not comprise phenol" (’017 Patent, col. 5:45-47), suggesting the patentee intended the strict meaning.

VI. Other Allegations

Indirect Infringement

The complaint's primary infringement count is under 35 U.S.C. § 271(e)(2)(A), which defines the submission of an ANDA as a statutory act of infringement (Compl. ¶27). The complaint also asserts that the future commercialization of Sun's ANDA Product would constitute direct infringement, as the product label, allegedly copied from WEGOVY®, would instruct for parenteral administration of the claimed composition (Compl. ¶¶ 29, 50, 54).

Willful Infringement

The complaint alleges that Sun had pre-suit, actual knowledge of the ’017 Patent via the Paragraph IV notice letter (Compl. ¶42). It further claims that Sun's invalidity and non-infringement positions lack an "objective good faith basis," which forms the foundation for a request for enhanced damages and attorneys' fees (Compl. ¶¶ 60-61).

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

  • A core issue will be one of validity: Can Plaintiff defend the non-obviousness of the claimed formulation—a stable, parenteral semaglutide solution specifically lacking phenol—against Defendants' assertions that it represents a straightforward application of known pharmaceutical formulation principles?
  • A key evidentiary question will be one of compositional identity: Will discovery confirm the complaint's allegation, made on information and belief, that Sun's ANDA product is compositionally identical to WEGOVY®, or will Sun's actual formulation reveal a difference that places it outside the scope of Claim 1?
  • A central legal question will be one of claim construction: How will the court interpret the negative limitation "does not contain phenol"? Whether this term is construed to mean absolute absence or merely the absence of an effective amount could be dispositive for infringement.