DCT

1:22-cv-00294

Novo Nordisk Inc v. Rio Biopharma Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-00294, D. Del., 03/04/2022
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware primarily because Defendant Rio Biopharmaceuticals, Inc. is a Delaware corporation.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application ("ANDA") to market a generic version of the diabetes drug Ozempic® constitutes an act of infringement of five U.S. patents covering the active pharmaceutical ingredient, its methods of use, and the associated injection device.
  • Technical Context: The technology at issue relates to GLP-1 receptor agonists, a class of drugs for the treatment of type 2 diabetes, and the mechanical devices used for their subcutaneous injection.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' notification to Plaintiff, via a Paragraph IV Certification letter dated January 21, 2022, of their intent to market a generic semaglutide product prior to the expiration of the patents-in-suit.

Case Timeline

Date Event
2004-11-09 Priority Date for U.S. Patent No. 9,687,611
2005-01-27 Priority Date for U.S. Patent No. 9,457,154
2005-03-23 Priority Date for U.S. Patent No. 8,129,343
2008-10-24 Priority Date for U.S. Patent No. 9,132,239
2012-03-06 U.S. Patent No. 8,129,343 Issues
2012-08-30 Priority Date for U.S. Patent No. 10,335,462
2015-09-15 U.S. Patent No. 9,132,239 Issues
2016-10-04 U.S. Patent No. 9,457,154 Issues
2017-06-27 U.S. Patent No. 9,687,611 Issues
2019-07-02 U.S. Patent No. 10,335,462 Issues
2022-01-21 Defendants Send Paragraph IV Notice Letter
2022-03-04 Complaint Filed

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

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

  • Patent Identification: U.S. Patent No. 8,129,343, entitled “Acylated GLP-1 Compounds,” issued on March 6, 2012 (Compl. ¶15).

The Invention Explained

  • Problem Addressed: The therapeutic utility of native glucagon-like peptide-1 (GLP-1) compounds is limited by their very short in-vivo half-life, which necessitates frequent injections for patients (8,129,343 Patent, Abstract).
  • The Patented Solution: The invention describes modifying GLP-1 analog peptides through acylation, which involves attaching a specialized side chain to a lysine residue in the peptide. This side chain includes at least two acidic groups and is designed to enable the compound to bind non-covalently to albumin in the bloodstream, thereby significantly extending its duration of action (’343 Patent, Abstract; col. 5:20-33).
  • Technical Importance: This chemical modification strategy enables the development of long-acting GLP-1 therapies that can be administered less frequently, such as once weekly, improving patient adherence and quality of life ('343 Patent, col. 2:48-55).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-6 (Compl. ¶28). Independent claims 1 and 3 are representative.
  • Claim 1 (Composition of Matter):
    • A GLP-1 analog
    • Comprising a modification of at least one non-proteogenic amino acid residue
    • Which is acylated with a specific moiety on the lysine residue at position 26
    • Wherein the moiety comprises at least two acidic groups, with one attached terminally
  • Claim 3 (Method of Use):
    • A method for treating type 2 diabetes
    • Comprising administering to a patient in need thereof an effective amount of a compound of claim 1

U.S. Patent No. 9,132,239 - Dial-Down Mechanism For Wind-Up Pen

  • Patent Identification: U.S. Patent No. 9,132,239, entitled “Dial-Down Mechanism For Wind-Up Pen,” issued on September 15, 2015 (Compl. ¶16).

The Invention Explained

  • Problem Addressed: The patent describes a problem with certain spring-driven "wind-up" injection pens where, if a user selects a dose that is too large, it is not possible to reduce the set dose without expelling the entire dose, leading to medication waste (’239 Patent, col. 1:36-41).
  • The Patented Solution: The invention provides a mechanical dial-down mechanism. It includes a ratchet arm that engages teeth on a fixed element to hold a strained torsion spring in place during dose setting. To reduce the dose, the user rotates the dose setting member in the opposite direction, which causes a reset element to move the ratchet arm out of engagement with the teeth, allowing the spring to partially unwind and the dose to be decreased without expelling the drug ('239 Patent, Abstract; col. 3:42-col. 4:1).
  • Technical Importance: This mechanism provides users with the ability to easily and safely correct a dose that has been set too high, which reduces medication waste and improves the usability and safety of the injection device ('239 Patent, col. 2:40-47).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-3 (Compl. ¶35). Claim 1 is the sole independent claim.
  • Claim 1 (Apparatus):
    • A dial-down mechanism for an injection device comprising a torsion spring
    • A dose setting member rotatable relative to a housing in a first direction (to set a dose) and a second direction (to dial down)
    • A fixation element coupled to the housing with inwardly pointing teeth
    • At least one ratchet arm coupled to the dose setting member that engages the teeth to prevent rotation in the second direction
    • A reset member that acts on the ratchet arm to move it out of engagement with the teeth when the dose setting member is rotated in the second direction

U.S. Patent No. 9,457,154 - Injection Device With An End of Dose Feedback Mechanism

  • Patent Identification: U.S. Patent No. 9,457,154, entitled “Injection Device With An End of Dose Feedback Mechanism,” issued on October 4, 2016 (Compl. ¶17).
  • Technology Synopsis: The patent addresses the need for a clear, non-visual signal to inform a user that a full dose has been successfully injected. The invention discloses a mechanism where the relative rotational movement between two parts of the injection device, occurring only at the end of the injection process, generates a distinct audible and/or tactile feedback signal (9,457,154 Patent, Abstract).
  • Asserted Claims: Claims 1-17 (Compl. ¶41).
  • Accused Features: The complaint alleges that Rio's product, an injection device, includes a dose delivering mechanism that provides an audible feedback signal to a user at the end of injection of a set dose (Compl. ¶41).

U.S. Patent No. 9,687,611 - Injection Device With Torsion Spring and Rotatable Display

  • Patent Identification: U.S. Patent No. 9,687,611, entitled “Injection Device With Torsion Spring and Rotatable Display,” issued on June 27, 2017 (Compl. ¶18).
  • Technology Synopsis: The patent addresses the limited dose-setting accuracy of injection pens whose display scales are confined to a single revolution. The invention provides a dose display member, such as a dose indicator barrel, that is capable of rotating more than 360 degrees, allowing for numerals to be arranged along a helical path, which provides an expanded scale and higher resolution for dose setting (9,687,611 Patent, Abstract).
  • Asserted Claims: Claims 1-15 (Compl. ¶47).
  • Accused Features: The complaint accuses Rio's product, an injection pen, of infringing claims directed to a device with a torsion spring operatively connected to a dose setting member and a rotatably mounted display member, such as a dose indicator barrel with a helical scale (Compl. ¶47).

U.S. Patent No. 10,335,462 - Use of Long-Acting GLP-1 Peptides

  • Patent Identification: U.S. Patent No. 10,335,462, entitled “Use of Long-Acting GLP-1 Peptides,” issued on July 2, 2019 (Compl. ¶19).
  • Technology Synopsis: The patent addresses the need for effective, long-acting treatment regimens for type 2 diabetes. The invention is a method of treatment comprising the administration of a GLP-1 agonist with a half-life of at least 72 hours (such as semaglutide) in an amount of at least 0.7 mg per week, administered once weekly or less often, to achieve outcomes like reduction of HbA1c (10,335,462 Patent, Summary of Invention).
  • Asserted Claims: Claims 1-10 (Compl. ¶53).
  • Accused Features: The complaint alleges that the intended use of Rio's semaglutide product for treating type 2 diabetes will infringe the patented method of administration (Compl. ¶53).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Rio's Product," identified as a generic version of Ozempic® (semaglutide) subcutaneous solution in two concentrations: 2 mg/1.5 ml (1.34 mg/ml) and 4 mg/3 ml (1.34 mg/ml) (Compl. ¶8, ¶23). This encompasses both the drug product and the injection device used for its administration.

Functionality and Market Context

  • The complaint alleges that Rio's ANDA seeks approval for a product that is a generic version of, and bioequivalent to, Novo Nordisk's Ozempic® product (Compl. ¶1, ¶24). The functionality is therefore that of a long-acting GLP-1 receptor agonist for subcutaneous injection via a pen-type device for the treatment of type 2 diabetes. The filing of the ANDA signifies Defendants' intent to enter the market and compete with the branded Ozempic® product upon FDA approval (Compl. ¶13, ¶23).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint provides conclusory allegations of infringement for each patent, which is common in initial ANDA litigation filings. The infringement theory is predicated on the act of submitting an ANDA for a drug product whose commercial manufacture, use, or sale would infringe the patents-in-suit. The following tables summarize the core allegations for the lead patents based on this theory.

8,129,343 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A GLP-1 analog...which is acylated with a moiety...on the lysine residue in position 26... Rio's Product is a "generic version of semaglutide solution," which is an acylated GLP-1 compound. ¶23, ¶28 col. 25:56-col. 28:67
wherein said moiety comprises at least two acidic groups, wherein one acidic group is attached terminally. The semaglutide molecule in Rio's Product allegedly contains the specific acylation moiety required by the claim. ¶28 col. 5:28-33

9,132,239 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A dial-down mechanism for an injection device comprising a torsion spring which is strained when setting a dose... The injection device for Rio's Product is alleged to be a spring-assisted "wind-up" pen. ¶35 col. 1:26-30
at least one ratchet arm...coupled to the dose setting member... The device for Rio's Product allegedly contains a ratchet arm mechanism. ¶35 col. 2:60-65
a reset member...which acts on...the ratchet arm to move the ratchet arm out of engagement with the teeth...thereby dialing down the set dose. The device for Rio's Product allegedly contains a mechanism allowing the user to reduce a set dose without expelling medication. ¶35 col. 2:4-15
  • Identified Points of Contention:
    • Scope Questions: For the '343 and ’462 patents, a question may arise as to whether the specific formulation of semaglutide in Rio's Product, including any excipients or impurities, falls within the scope of the asserted claims. For the device patents ('239, ’154, and ’611), the central question is one of definitional scope: Do the mechanical components of Rio's proposed injection device meet the specific structural and functional definitions of terms like "ratchet arm," "reset element," and "rotatably mounted display member" as used in the patent claims?
    • Technical Questions: A key technical question for the device patents will be whether Rio's device operates in the precise manner claimed. For the '239 patent, for example, what is the specific mechanical interaction between the reset element and the ratchet arm in Rio's device, and does it function as required by the claim? For the '154 patent, what is the evidence that Rio's device produces a feedback signal that is generated only at the end of the dose, as opposed to throughout the injection?

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail to identify specific claim construction disputes. However, based on the technology and the asserted claims, practitioners may focus on the following terms:

  • The Term: "moiety" ('343 Patent, Claim 1)

  • Context and Importance: The definition of this term is critical to determining the scope of chemical structures that fall under the composition of matter claims. The infringement and validity analyses for the '343 patent will depend on how broadly or narrowly this term is construed.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent provides a general chemical formula for the side chain ("B-U'-") and defines its constituent parts ("B" and "U'") with some structural variability, which may support a construction covering more than just the specific examples ('343 Patent, col. 9:1-col. 13:23).
    • Evidence for a Narrower Interpretation: The patent provides numerous specific chemical structures as examples of the acylated side chain. A defendant might argue that the term "moiety" should be limited by these specific embodiments ('343 Patent, col. 7-8; col. 59-92).

  • The Term: "reset element" ('239 Patent, Claim 1)

  • Context and Importance: The specific structure and function of the "reset element" are central to the novelty of the dial-down mechanism. The infringement analysis will turn on whether the corresponding component in the accused device operates in the manner defined by this term.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes the function of the reset element in general terms as acting on the ratchet arm "to move the ratchet arm out of engagement," which could encompass a variety of mechanical solutions ('239 Patent, col. 2:7-15).
    • Evidence for a Narrower Interpretation: The figures and detailed description show a specific embodiment where the reset element is a "prolongation on the reset tube" with a "reset surface" that physically contacts and displaces a "protrusion" on the ratchet arm ('239 Patent, col. 4:29-48; Fig. 5). This detailed depiction could be used to argue for a narrower construction limited to this specific type of interaction.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement of the method-of-use claims of the '343 and '462 patents. The basis for this allegation is that Defendants' commercial marketing, sale, and product labeling for Rio's Product will intentionally encourage and instruct patients and physicians to use the product in the patented manner for treating type 2 diabetes (Compl. ¶29, ¶54).
  • Willful Infringement: The complaint alleges that Rio's infringement is willful and exceptional for all five patents-in-suit. This allegation is based on Defendants' awareness of the patents at the time of their ANDA submission, as demonstrated by their sending of the Paragraph IV Certification letter (Compl. ¶32, ¶38, ¶44, ¶50, ¶57).

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

Based on the complaint, the litigation will likely revolve around the following central issues for the court's determination:

  • A core issue will be one of validity: Although not detailed in the complaint, Defendants' Paragraph IV certification asserts that the patents-in-suit are invalid or unenforceable (Compl. ¶25). This suggests that a significant portion of the case will focus on challenges to the patents' novelty, non-obviousness, and written description, particularly for the foundational '343 and '462 patents covering the semaglutide compound and its weekly dosage regimen.
  • A key evidentiary question will be one of mechanical infringement: For the three device patents ('239, '154, '611), the dispute will center on a detailed, element-by-element comparison of Rio's proposed generic injection pen to the patent claims. The case may turn on subtle differences in the structure and operation of the device's internal mechanisms, such as the dial-down feature, the end-of-dose click, and the helical dose display.