DCT
1:24-cv-00067
Novo Nordisk Inc v. Mylan Pharma Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Novo Nordisk Inc. (Delaware) and Novo Nordisk A/S (Denmark)
- Defendant: Mylan Pharmaceuticals Inc. (West Virginia)
- Plaintiff’s Counsel: Schrader Companion Duff & Law, PLLC; Fenwick & West LLP (Of Counsel)
- Case Identification: 1:24-cv-00067, N.D. W. Va., 07/02/2024
- Venue Allegations: Venue is alleged to be proper in the Northern District of West Virginia as Defendant Mylan Pharmaceuticals Inc. is a West Virginia corporation with its principal place of business located within the district.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of the diabetes drug Ozempic® constitutes an act of infringement of two patents covering the drug's active ingredient, semaglutide, and its method of use.
- Technical Context: The technology involves long-acting GLP-1 receptor agonists, a class of drugs that has become a standard of care and a highly significant commercial market for the treatment of type 2 diabetes.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following a notice letter, dated May 22, 2024, in which Mylan informed Novo Nordisk of its ANDA filing and its certification (a "Paragraph IV certification") that the patents-in-suit are invalid, unenforceable, or will not be infringed. Novo Nordisk filed this complaint within the statutory 45-day period, which triggers an automatic 30-month stay of FDA approval for Mylan’s generic product.
Case Timeline
| Date | Event |
|---|---|
| 2005-03-18 | Earliest Priority Date for ’343 Patent |
| 2012-03-06 | Issue Date for ’343 Patent |
| 2012-07-01 | Earliest Priority Date for ’462 Patent |
| 2019-07-02 | Issue Date for ’462 Patent |
| 2024-05-22 | Mylan sends Paragraph IV Notice Letter |
| 2024-07-02 | 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’s background section notes that while GLP-1 compounds are effective for treating diabetes, their widespread use is hindered by the need for frequent injections due to their short in-vivo half-life, which is a challenge for patients with "needle-phobia" (’343 Patent, col. 1:47-54).
- The Patented Solution: The invention is a modified GLP-1 analog that is acylated—meaning a fatty acid-based side chain is attached—at a specific lysine residue. This side chain allows the drug to bind reversibly to albumin in the bloodstream, creating a circulating reservoir that dramatically extends the drug's half-life and allows for less frequent dosing (’343 Patent, Abstract; col. 2:1-5). The specific compound claimed is semaglutide.
- Technical Importance: This albumin-binding strategy was a key technological advancement that enabled the development of once-weekly injectable diabetes therapies, representing a significant improvement in patient convenience and compliance over previous daily or twice-daily treatments (’343 Patent, col. 1:47-54).
Key Claims at a Glance
- The complaint asserts infringement of claims 1-6 (Compl. ¶19). Independent claims are 1 and 3.
- Independent Claim 1 (as corrected): This is a composition of matter claim directed to a specific chemical structure:
- A compound of the structure N-epsilon26-[2-(2-[2-(2-[2-(2-[4-(17-Carboxyheptadecanoylamino)-4(S)-carboxybutyrylamino]ethoxy)ethoxy]acetylamino)ethoxy]ethoxy)acetyl]][Aib8,Arg34]GLP-1-(7-37)peptide.
- Independent Claim 3 (as corrected): This is a method of use claim:
- A method for treating type 2 diabetes in a subject,
- comprising administering to a subject in need of such treatment an effective amount of a pharmaceutical composition,
- comprising a compound of the structure from claim 1 and a pharmaceutically acceptable excipient.
- The complaint also asserts dependent claims 2, 4, 5, and 6.
U.S. Patent No. 10,335,462 - "Use of Long-Acting GLP-1 Peptides," issued July 2, 2019
The Invention Explained
- Problem Addressed: Even with the availability of long-acting GLP-1 agonists, there remains a need for treatment regimens that can provide an improved reduction in key clinical markers like HbA1c (a measure of long-term blood sugar control) and body weight compared to existing therapies (’462 Patent, col. 2:51-62).
- The Patented Solution: The patent claims a specific method of treating type 2 diabetes by administering semaglutide once weekly in a particular dose (1.0 mg). The specification presents clinical trial data suggesting that this specific regimen provides a surprisingly improved reduction in both HbA1c and body weight compared to other treatments, including the GLP-1 agonist liraglutide (’462 Patent, col. 2:56-62; Fig. 1; Fig. 5).
- Technical Importance: This patent aims to protect a specific, clinically optimized dosing regimen for a known compound, moving beyond the molecule itself to its particular method of use that allegedly provides superior efficacy.
Key Claims at a Glance
- The complaint asserts infringement of claims 1-10 (Compl. ¶26). Independent claim 1 is representative.
- Independent Claim 1: This is a method of use claim broken down as follows:
- 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 reserves the right to assert dependent claims 2-10.
III. The Accused Instrumentality
- Product Identification: The accused instrumentality is "Mylan’s Product," a generic semaglutide injection at a concentration of 2 mg/3 mL (0.68 mg/mL), for which Mylan has filed ANDA No. 219255 seeking FDA approval (Compl. ¶14).
- Functionality and Market Context: Mylan's Product is a subcutaneous injectable solution intended to be a generic equivalent to Novo Nordisk's brand-name drug, Ozempic® (Compl. ¶¶1, 11). The complaint alleges that Mylan's ANDA relies on the safety and efficacy data of Ozempic® and contains data intended to demonstrate the bioequivalence between Mylan's Product and Ozempic® (Compl. ¶15). No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The infringement allegations are made under 35 U.S.C. § 271(e)(2)(A), where the submission of an ANDA for a drug claimed in a patent is a statutory act of infringement to create federal court jurisdiction.
’343 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A compound of the structure N-epsilon26-[2-(2-[2-(2-[2-(2-[4-(17-Carboxyheptadecanoylamino)-4(S)-carboxybutyrylamino]ethoxy)ethoxy]acetylamino)ethoxy]ethoxy)acetyl]][Aib8,Arg34]GLP-1-(7-37)peptide | Mylan's ANDA seeks approval for a generic version of semaglutide injection. The complaint alleges that this specific compound, semaglutide, is encompassed by the claims of the ’343 patent. | ¶14, ¶19 | col. 129:1-col. 130:17 |
| A method for treating type 2 diabetes in a subject, said method comprising administering to a subject in need of such treatment an effective amount of a pharmaceutical composition comprising a compound [of the structure from claim 1]... | Mylan's Product, being a generic version of Ozempic®, is intended for the treatment of type 2 diabetes. The complaint alleges that Mylan's marketing and sale of the product would induce infringement of the method claims. | ¶19, ¶20 | col. 131:2-10 |
- Identified Points of Contention:
- Scope Questions: Given that corrected Claim 1 recites a specific chemical structure for semaglutide, the primary infringement question may be one of direct comparison. A potential dispute could arise if Mylan's proposed product contains a different salt form, stereoisomer, or polymorph, raising the question: "Does Mylan's active pharmaceutical ingredient fall within the literal scope of the claimed chemical structure, or are there legally significant structural differences?"
’462 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for treating type 2 diabetes | Mylan's Product is a generic version of Ozempic®, which is indicated for the treatment of type 2 diabetes. It is alleged Mylan's product will be marketed and prescribed for this same use. | ¶15, ¶26 | col. 3:4-5 |
| comprising administering semaglutide once weekly in an amount of 1.0 mg... | The complaint alleges that Mylan's manufacture, use, or sale of its product would infringe claims covering various dosages, including 1.0 mg once weekly. This implies an allegation that Mylan's product labeling will instruct or encourage such administration. | ¶26, ¶27 | col. 17:1-3 |
- Identified Points of Contention:
- Technical Questions: Infringement of this method-of-use patent will depend entirely on the content of Mylan's proposed product labeling. The central question is evidentiary: "What will Mylan's final, FDA-approved label instruct or suggest regarding the dosage and frequency of its semaglutide product for the treatment of type 2 diabetes?"
V. Key Claim Terms for Construction
In this pharmaceutical case, particularly given the specific structural claim of the ’343 patent, the dispute may focus more on validity than claim construction. However, the interpretation of certain terms could become relevant.
- The Term: "semaglutide" (from ’462 Patent, Claim 1)
- Context and Importance: While the chemical identity of semaglutide is well-established, its use in a patent claim ties it to the patent's disclosure. Practitioners may focus on this term because a defendant could attempt to create a non-infringement defense by arguing its generic product, while bioequivalent, is a different polymorph, salt, or has other subtle structural distinctions that place it outside the definition of "semaglutide" as contemplated and enabled by the patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification provides the specific chemical name for semaglutide: N-epsilon26-[2-(2-[2-(2-[2-(2-[4-(17-Carboxyheptadecanoylamino)-4(S)-carboxybutyrylamino]ethoxy)ethoxy]acetylamino)ethoxy]ethoxy)acetyl]][Aib8,Arg34]GLP-1-(7-37) (’462 Patent, col. 17:63-65). This supports an interpretation where "semaglutide" means any compound meeting that precise chemical formula, regardless of its crystalline form or salt.
- Evidence for a Narrower Interpretation: The patent's claims rely on clinical data showing improved results. The specification details the exact formulation used in those trials, including specific excipients like phosphate buffer, propylene glycol, and phenol (’462 Patent, col. 21:7-14). A defendant might argue that the term "semaglutide" as used in the claims is limited to the specific form and formulation that was tested and proven to be superior, and that other forms are not covered.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Mylan's future commercial marketing and product labeling will intentionally induce medical professionals and patients to use its product in a manner that infringes the asserted method claims of both patents (’343 Patent, Compl. ¶20; ’462 Patent, Compl. ¶27).
- Willful Infringement: Willfulness is alleged based on Mylan's knowledge of the patents-in-suit, evidenced by its Paragraph IV certification letter that explicitly identified the ’343 and ’462 patents (Compl. ¶¶ 16, 23, 30). Novo Nordisk seeks a finding that the case is "exceptional," which would support an award of attorneys' fees (Compl. ¶¶ 23, 30; Prayer for Relief F).
VII. Analyst’s Conclusion: Key Questions for the Case
This case appears to be a quintessential Hatch-Waxman dispute where the primary conflict will likely occur over patent validity rather than infringement, although infringement of the method-of-use claims remains a key issue dependent on future evidence. The central questions for the court are:
A core issue will be one of patent validity: will Mylan be able to prove by clear and convincing evidence that the asserted claims of the ’343 patent (covering the semaglutide molecule) and the ’462 patent (covering its specific dosing regimen) are invalid for reasons such as obviousness or lack of enablement, as it certified to the FDA?
A key evidentiary question will be one of induced infringement: will the language of Mylan's proposed product label, once disclosed in litigation, be found to actively instruct or encourage physicians to prescribe, and patients to use, the generic product in a manner that directly infringes the specific treatment methods claimed in the asserted patents?