DCT
1:22-cv-00296
Novo Nordisk As v. Sun Pharmaceutical Industries Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Novo Nordisk Inc. (Delaware) and Novo Nordisk A/S (Denmark)
- Defendant: Sun Pharmaceutical Industries Ltd. (India) and Sun Pharmaceutical Industries, Inc. (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP; Fenwick & West LLP
- Case Identification: 1:22-cv-00296, D. Del., 03/04/2022
- Venue Allegations: Venue is alleged to be proper based on Defendant Sun Pharmaceutical Industries, Inc.'s incorporation in Delaware and both defendants' business conduct in the district.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of Plaintiff’s Ozempic® (semaglutide) product constitutes an act of infringement of two U.S. patents covering the drug's method of use and its injection pen device.
- Technical Context: The case involves semaglutide, a GLP-1 receptor agonist used for treating type 2 diabetes, and the mechanical technology of pen-type injection devices used for its administration.
- Key Procedural History: This action was filed under the Hatch-Waxman Act, triggered by a Paragraph IV Certification in Sun's ANDA No. 216478, which asserted that Novo Nordisk's patents are invalid, unenforceable, and/or will not be infringed. The complaint was filed within the 45-day statutory window following receipt of Sun's notice letter, which may trigger an automatic 30-month stay of FDA approval for the generic product.
Case Timeline
| Date | Event |
|---|---|
| 2008-10-29 | ’239 Patent Priority Date |
| 2012-08-30 | ’462 Patent Priority Date |
| 2015-09-15 | ’239 Patent Issue Date |
| 2019-07-02 | ’462 Patent Issue Date |
| 2022-01-27 | Date of Defendant's Notice Letter |
| 2022-03-04 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,132,239 - "Dial-down mechanism for wind-up pen" (Issued Sep. 15, 2015)
The Invention Explained
- Problem Addressed: The patent describes a problem with prior art spring-loaded injection pens where, if a user sets a dose that is too large, it is not possible to decrease the set dose without expelling the entire dose and starting over ( ’239 Patent, col. 1:33-38).
- The Patented Solution: The invention is a "dial-down" mechanism that allows a user to both increase and decrease a set dose before injection ( ’239 Patent, col. 2:38-44). It uses a rotatable dose setting tube with a flexible "ratchet arm" that engages teeth on a fixed ring to hold the set dose. A separate "reset tube" can be rotated in the opposite direction to act on the ratchet arm, moving it out of engagement with the teeth and allowing the dose to be dialed down without expelling the drug ( ’239 Patent, col. 4:56-65; Fig. 2).
- Technical Importance: This mechanism provides a more user-friendly and less wasteful dose-setting process for patients who self-administer medication with pen injectors.
Key Claims at a Glance
- The complaint asserts claims 1-3 (Compl. ¶24). Independent claim 1 is asserted.
- Independent Claim 1: The essential elements are a dial-down mechanism for an injection device containing:
- A torsion spring for storing energy.
- A fixation element coupled to the housing with inwardly pointing teeth.
- At least one ratchet arm coupled to a dose setting member, which engages the teeth to prevent rotation in one direction.
- A reset member that can be rotated to disengage the ratchet arm from the teeth, allowing the dose setting member to rotate in the second direction to "dial down" the set dose.
- The complaint reserves the right to assert dependent claims 2-3 (Compl. ¶24).
U.S. Patent No. 10,335,462 - "Use of long-acting GLP-1 peptides" (Issued Jul. 2, 2019)
The Invention Explained
- Problem Addressed: The patent is directed at providing improved therapeutic regimens for long-acting GLP-1 agonists to treat conditions like type 2 diabetes and obesity ( ’462 Patent, col. 2:51-56).
- The Patented Solution: The patent claims specific methods of use for long-acting GLP-1 peptides, such as semaglutide, focusing on defined weekly dosage amounts that are shown to provide an improved reduction in HbA1c (a measure of blood sugar control) and body weight compared to other treatments ( ’462 Patent, Abstract; col. 2:56-62). The core of the invention is the identification of a specific, effective weekly dosage regimen for a long-acting GLP-1 agonist ( ’462 Patent, col. 18:1-22).
- Technical Importance: This invention provides a specific, clinically evaluated dosing schedule that improves patient outcomes in managing type 2 diabetes.
Key Claims at a Glance
- The complaint asserts claims 1-10 (Compl. ¶30). Independent claim 1 is asserted.
- Independent Claim 1: The essential elements are a method for treating type 2 diabetes comprising:
- Administering semaglutide.
- The administration occurs once weekly.
- The administration is in an amount of 1.0 mg.
- The administration is to a subject in need thereof.
- The complaint reserves the right to assert dependent claims 2-10 (Compl. ¶30).
III. The Accused Instrumentality
- Product Identification: "Sun's Product," which is a generic version of Ozempic® (semaglutide) injection for subcutaneous use, in dosages of 2 mg/1.5 ml (1.34 mg/ml) and 4 mg/3 ml (1.34 mg/ml) (Compl. ¶1, p.3). The infringement is predicated on Sun's filing of ANDA No. 216478 with the FDA (Compl. ¶19).
- Functionality and Market Context: The complaint alleges that Sun's ANDA seeks approval to market a generic version of Novo Nordisk's Ozempic® product before the expiration of the patents-in-suit (Compl. ¶1). The ANDA relies upon the Ozempic® NDA and contains data to demonstrate the bioequivalence of Sun's Product to Ozempic® (Compl. ¶20). The intended use of Sun's Product is therefore for the treatment of type 2 diabetes, the same as Ozempic®. No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint does not contain a claim chart. The following tables summarize the infringement theory based on the complaint's narrative allegations.
’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... a fixation element (10)... | The complaint alleges that Sun's manufacture, use, or sale of its product during the patent term would infringe, implying the associated injection device contains a dial-down mechanism. | ¶24 | col. 5:67-6:2 |
| at least one ratchet arm (21) coupled to the dose setting member (20)... | The complaint does not provide specific factual allegations about the structure of the accused device's dose setting member or ratchet arm. | ¶24 | col. 6:3-7 |
| the dial-down mechanism further comprises a reset member (30) configured for movement... to activate[] the ratchet arm (21) to disengage the fixation element (10)... | The complaint does not provide specific factual allegations about the structure or function of the accused device's reset mechanism. | ¶24 | col. 6:4-16 |
- Identified Points of Contention:
- Technical Questions: A primary question will be whether the injection pen device described in Sun's ANDA actually contains the specific mechanical components recited in claim 1. The complaint does not plead facts about the specific structure of the accused device, such as the presence of a "ratchet arm" and a "reset member" that function in the claimed manner. Discovery into the design of Sun's proposed device will be central.
’462 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for treating type 2 diabetes, | Sun seeks approval to market a generic version of Ozempic®, which is indicated for the treatment of type 2 diabetes. Sun's product label will allegedly instruct for this use. | ¶1, ¶29-31 | col. 15:56-61 |
| comprising administering semaglutide | Sun's Product is a "semaglutide injection" that is allegedly bioequivalent to Ozempic®. | ¶19, ¶30 | col. 17:1-3 |
| once weekly in an amount of 1.0 mg | The complaint alleges that Sun's product would infringe claims directed to administering a semaglutide solution. The infringement theory suggests Sun's proposed label will instruct for a dosing regimen that meets this limitation. | ¶30-31 | col. 17:1-3 |
| to a subject in need thereof. | Sun is seeking approval for a product to treat type 2 diabetes, which would be administered to patients ("subjects") in need of such treatment. | ¶1, ¶30-31 | col. 15:58-61 |
- Identified Points of Contention:
- Scope Questions: The complaint identifies Sun's product concentrations as 1.34 mg/ml (Compl. p.3), while claim 1 of the '462 patent recites a specific dose of "1.0 mg." A key question will be whether Sun's proposed product labeling, as submitted in its ANDA, instructs or encourages administration of a 1.0 mg weekly dose, thereby inducing infringement of this claim limitation.
V. Key Claim Terms for Construction
For the ’239 Patent:
- The Term: "reset member (30) ... which acts on at least one part (25) of the ratchet arm to move the ratchet arm (21) out of engagement"
- Context and Importance: The specific interaction between the "reset member" and the "ratchet arm" is the core of the dial-down functionality. Practitioners may focus on this term because the infringement analysis will depend on whether Sun's device, if it has a dial-down feature, achieves it through the specific mechanism of one component acting on another as claimed, or through an alternative design.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language is functional, stating the reset member "activates the ratchet arm (21) to disengage." This could support an interpretation covering any mechanism where rotation of the reset member causes the disengagement, regardless of the precise contact geometry.
- Evidence for a Narrower Interpretation: The specification describes a specific embodiment where a "reset surface (36)" on the reset member is "pressed against the sloped surface (26) of the protrusion (25) which pulls the steep surface (24) out of engagement" ( ’239 Patent, col. 4:60-65). This detailed description of a "pulling" action based on sloped surfaces may support a narrower construction limited to this specific type of interaction.
For the ’462 Patent:
- The Term: "administering semaglutide ... in an amount of 1.0 mg"
- Context and Importance: This term is critical because it defines the precise dosage that constitutes the patented method. The infringement case against Sun will require proof that its product label will induce physicians and patients to administer this exact amount.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The complaint does not provide a basis for a broad interpretation. The patent consistently refers to specific dosages tested in clinical trials as the basis for the invention, suggesting the numbers are not arbitrary ( ’462 Patent, Table 1, Fig. 1).
- Evidence for a Narrower Interpretation: Claim 1 recites the specific amount "1.0 mg" without any qualifying language like "about" or "approximately." The patent's detailed description and clinical data are tied to specific dose levels (e.g., 0.8 mg, 1.6 mg), and the claim singles out the 1.0 mg dose, suggesting the number is a precise limitation ( ’462 Patent, col. 17:1-3).
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement for the ’462 patent. The basis is that Sun's sale, marketing, and product labeling for its generic semaglutide would, with knowledge of the '462 patent, intentionally encourage and instruct physicians and patients to administer the drug in a manner that directly infringes the claimed methods (Compl. ¶31).
- Willful Infringement: The complaint alleges that Sun was aware of both the ’239 and ’462 patents when it submitted its ANDA, as evidenced by its Paragraph IV certification (Compl. ¶27, ¶34). This alleged pre-suit knowledge forms the basis for seeking enhanced damages and a finding that the case is exceptional.
VII. Analyst’s Conclusion: Key Questions for the Case
- A critical evidentiary question of structure: For the ’239 device patent, the central issue is factual: does the injection pen described in Sun’s confidential ANDA filing incorporate the specific mechanical structures of a "ratchet arm" and "reset member" that function as recited in the claims, or does it utilize a non-infringing design?
- A pivotal question of inducement: For the ’462 method-of-use patent, the case will likely turn on the content of Sun’s proposed product label. The key question is whether the label will explicitly or implicitly instruct prescribing physicians and patients to administer a "1.0 mg" weekly dose of semaglutide for treating type 2 diabetes, thereby inducing infringement of claim 1.
- A question of claim scope: The construction of the specific dosage limitation "1.0 mg" in the '462 patent will be significant. The court will need to determine if this term is limited to the exact value or if it can encompass a range, a question that will be informed by the patent's specification and prosecution history.