DCT

1:24-cv-00775

Novo Nordisk Inc v. Mylan Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-00775, D. Del., 07/01/2024
  • Venue Allegations: Defendant Mylan Pharmaceuticals Inc. has agreed not to contest personal jurisdiction or venue in the District of Delaware for this action.
  • Core Dispute: Plaintiff alleges that Defendant’s Abbreviated New Drug Application (ANDA) for a generic version of the diabetes drug Ozempic® (semaglutide) infringes two patents covering the semaglutide compound itself and specific methods of its use.
  • Technical Context: The technology is in the field of long-acting glucagon-like peptide-1 (GLP-1) receptor agonists, a major class of injectable pharmaceutical products for the treatment of type 2 diabetes and obesity.
  • Key Procedural History: This is a Hatch-Waxman action initiated after Defendant provided Plaintiff with a Paragraph IV certification notice on May 22, 2024, asserting that the patents-in-suit are invalid, unenforceable, and/or not infringed by its proposed generic product. The complaint was filed within the 45-day statutory window, triggering an automatic 30-month stay on the FDA’s approval of the Defendant’s ANDA.

Case Timeline

Date Event
2005-03-18 U.S. Patent No. 8,129,343 Priority Date
2012-03-06 U.S. Patent No. 8,129,343 Issue Date
2012-07-01 U.S. Patent No. 10,335,462 Priority Date
2019-07-02 U.S. Patent No. 10,335,462 Issue Date
2024-05-22 Mylan sends Paragraph IV Notice Letter to Novo Nordisk
2024-07-01 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 addresses the "substantial fear of injecting themselves" ("needle-phobia") among diabetes patients and the need to develop GLP-1 compounds that can be administered less frequently than once a day (’343 Patent, col. 1:41-55). Native GLP-1 has a very short in vivo half-life, requiring frequent administration.
  • The Patented Solution: The invention is a modified GLP-1 analog that is acylated with a specific chemical moiety containing both a lipophilic part (a fatty acid) and a hydrophilic linker containing acidic groups (’343 Patent, Abstract). This structure is designed to bind non-covalently to albumin in the bloodstream, which acts as a reservoir and significantly extends the compound's duration of action, allowing for less frequent dosing (’343 Patent, col. 2:56-66).
  • Technical Importance: This albumin-binding strategy represents a key method for protracting the half-life of therapeutic peptides, transforming them from drugs requiring daily or more frequent injections into candidates for once-weekly administration (’343 Patent, col. 2:56-66).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-6, including independent claims 1 and 3 (Compl. ¶20).
  • Independent Claim 1 recites a compound of a specific chemical structure, which comprises:
    • A GLP-1 peptide analog with the amino acid sequence of SEQ ID NO: 7.
    • A specific acylated moiety, N-ε26-[2-(2-[2-(2-[2-(2-[4-(17-Carboxyheptadecanoylamino)-4(S)-carboxybutyrylamino]ethoxy)ethoxy]acetylamino)ethoxy]ethoxy)acetyl], attached to the lysine residue at position 26.
  • Independent Claim 3 recites a method of treating type 2 diabetes by administering an effective amount of the compound of claim 1.
  • The complaint also asserts infringement of dependent claims 2 and 4-6 (Compl. ¶20).

U.S. Patent No. 10,335,462 - "Use of Long-Acting GLP-1 Peptides," issued July 2, 2019

The Invention Explained

  • Problem Addressed: The patent aims to provide an improved therapeutic method for treating type 2 diabetes that results in superior glycemic control and body weight reduction compared to existing therapies (’462 Patent, col. 2:50-59).
  • The Patented Solution: The invention is a specific method of using the long-acting GLP-1 peptide semaglutide. The patent discloses that administering semaglutide in specific once-weekly dosage regimens provides surprisingly improved reductions in HbA1c and body weight, as demonstrated by clinical trial data presented in the specification (’462 Patent, Abstract; col. 2:5-14; Figs. 1, 5).
  • Technical Importance: The patent defines a specific, clinically-validated dosage regimen for a long-acting GLP-1 agonist, which may provide a basis for distinguishing its use and efficacy from prior art treatments (’462 Patent, col. 2:50-59).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-10, including independent claim 1 (Compl. ¶27).
  • Independent Claim 1 recites a method with the following essential elements:
    • A method for treating type 2 diabetes,
    • comprising administering semaglutide,
    • once weekly,
    • in an amount of 1.0 mg,
    • to a subject in need thereof.
  • The complaint also asserts infringement of dependent claims 2-10 (Compl. ¶27).

III. The Accused Instrumentality

Product Identification

  • Defendant's proposed generic version of semaglutide injection, 2 mg/3 mL (0.68 mg/mL), identified in ANDA No. 219255 ("Mylan's Product") (Compl. ¶15).

Functionality and Market Context

  • The complaint alleges that Mylan's Product is a generic version of Novo Nordisk's Ozempic® product and contains semaglutide as its active pharmaceutical ingredient (Compl. ¶15). The complaint further alleges that Mylan's ANDA relies on the Ozempic® New Drug Application and contains data to demonstrate bioequivalence (Compl. ¶16). Ozempic® is indicated for the treatment of type 2 diabetes, and the complaint alleges Mylan's Product is intended for the same use (Compl. ¶1, ¶27). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The infringement allegations are based on 35 U.S.C. § 271(e)(2)(A), which defines the submission of an ANDA seeking approval to market a generic drug prior to patent expiration as an act of infringement. The analysis considers whether the product, if marketed as described in the ANDA, would infringe the asserted claims.

U.S. Patent No. 8,129,343 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A compound of the structure N-ε26-[2-(2-[2-(2-[2-(2-[4-(17-Carboxyheptadecanoylamino)-4(S)-carboxybutyrylamino]ethoxy)ethoxy]acetylamino)ethoxy]ethoxy)acetyl][Aib8,Arg34]GLP-1-(7-37) Mylan's Product contains semaglutide, which the complaint alleges is the compound of claim 1. ¶15, ¶20 col. 61:5-62:38

U.S. Patent No. 10,335,462 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating type 2 diabetes, The proposed labeling for Mylan's Product will instruct its use for treating type 2 diabetes. ¶27 col. 3:4-6
comprising administering semaglutide Mylan's Product is a semaglutide injection. ¶15 col. 17:1-3
once weekly The proposed labeling for Mylan's Product will instruct for once-weekly administration. ¶27 col. 17:1-3
in an amount of 1.0 mg The proposed labeling for Mylan's Product will include instructions for administering a 1.0 mg dose, consistent with the approved dosing for Ozempic®. ¶12, ¶27 col. 17:1-3
to a subject in need thereof. The product is indicated for subjects with type 2 diabetes. ¶27 col. 3:1-3

Identified Points of Contention

  • Scope Questions: The complaint does not detail the bases for non-infringement or invalidity asserted in Mylan's Paragraph IV letter (Compl. ¶17). However, in ANDA litigation, a primary defense is patent invalidity. For the ’462 Patent, a dispute may arise over whether the claimed dosage is obvious. A central question for the court will be whether selecting a "1.0 mg once weekly" dose constitutes an inventive step or was merely the result of routine, predictable dose-finding experiments known in the art.
  • Technical Questions: A technical question for the ’462 Patent may concern the evidentiary support for the "1.0 mg" limitation in claim 1. The patent's specification details clinical trial data for 0.8 mg and 1.6 mg doses but does not appear to present data for a 1.0 mg dose specifically (e.g., ’462 Patent, Table 1, col. 21). This may raise questions regarding whether the specification provides adequate written description and enablement for the precise claimed amount.

V. Key Claim Terms for Construction

Term: "an amount of 1.0 mg" (from ’462 Patent, claim 1)

  • Context and Importance: The patentability of this method claim likely rests on the specificity and non-obviousness of this exact dosage amount. The construction of this term will be critical to both infringement and validity analyses. Practitioners may focus on this term because Mylan will likely argue it is either not literally met or, more likely, that a claim to this specific dose is invalid as obvious over a known range of effective doses for GLP-1 agonists.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification discusses the invention in broader terms, such as a method comprising administration "in an amount of at least 0.7 mg per week" (’462 Patent, col. 2:40-44). This language could be used to argue that "1.0 mg" is an exemplary embodiment of a broader inventive concept of using a higher-dose weekly regimen.
    • Evidence for a Narrower Interpretation: The claim language is precise: "1.0 mg." The patent consistently treats different dosages as distinct, presenting separate clinical trial results for doses like 0.8 mg and 1.6 mg (’462 Patent, Fig. 1). This suggests that each dosage amount is a discrete and specific variable, supporting a narrow construction limited to exactly 1.0 mg.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Mylan will intentionally induce infringement of the method claims of both patents. This is based on the allegation that Mylan's commercial marketing and product labeling will actively encourage and instruct physicians and patients to administer Mylan's Product in the patented manner (Compl. ¶21, ¶28).
  • Willful Infringement: The complaint alleges Mylan was aware of the patents-in-suit when it filed its ANDA, citing the Paragraph IV notice letter as evidence of pre-suit knowledge (Compl. ¶24, ¶31). This forms the basis for a request for a finding that the case is "exceptional" under 35 U.S.C. § 285, which could permit an award of attorney's fees.

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

  • A core issue will be one of validity: can Novo Nordisk defend the patentability of the asserted claims against an obviousness challenge? Specifically for the ’462 patent, the key question is whether the claimed "1.0 mg once weekly" dosage regimen was a non-obvious invention with unexpected results, or a product of routine and predictable clinical dose-finding that is unpatentable over the prior art.
  • A related evidentiary question will be one of patent support: does the ’462 patent’s specification, which presents clinical data for dosages such as 0.8 mg and 1.6 mg but not explicitly for 1.0 mg, provide sufficient written description and enablement to support a claim limited to the precise "1.0 mg" amount, as required by patent law?
  • Finally, for the ’343 patent, the dispute will likely focus on chemical obviousness: does the specific acylated semaglutide compound claimed in the patent represent a non-obvious structural modification over the landscape of known GLP-1 analogs and protraction techniques at the time of the invention?