United States Patent 11,097,063: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,097,063, hereafter referred to as the '063 patent, is a significant intellectual property asset that protects the medications OZEMPIC and SAXENDA, which are formulations of the drug semaglutide. This patent is part of a complex patent landscape that involves multiple patents and legal proceedings. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Number and Title
The '063 patent, titled "Syringe Device with a Dose Limiting Mechanism and an Additional Safety Mechanism," was granted on August 24, 2021[4].
Protected Medications
This patent protects OZEMPIC and SAXENDA, which are used for the treatment of type 2 diabetes and obesity, respectively. These medications are formulations of semaglutide, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist[1].
Scope of the Patent
Claims
The '063 patent includes seven claims that describe a syringe device designed to ensure accurate and safe dosing of a medicament. The key claims involve:
- A dose limiting mechanism that interacts with a dose ejecting mechanism to prevent the ejection of a dose exceeding the set dose.
- An additional safety mechanism that prevents the ejection of a dose exceeding the set dose if the dose limiting mechanism fails[4].
International Protection
This patent is part of a larger patent family with fifteen members in thirteen countries, indicating a broad international protection strategy[1].
Patent Claims Analysis
Independent Claims
The patent claims are structured to ensure that the syringe device operates within predefined safety and efficacy parameters. The independent claims focus on the mechanical aspects of the syringe, including the dose limiting and safety mechanisms. These claims are designed to be specific and narrow, which is consistent with the trend of narrower claims being associated with a higher probability of grant and shorter examination processes[3].
Dependent Claims
The dependent claims build upon the independent claims, providing additional details and specifications for the syringe device. These claims help to further define the scope of the invention and ensure that any potential infringers are clearly aware of what is protected[4].
Patent Landscape
Related Patents
The '063 patent is part of a larger portfolio of patents related to semaglutide and its formulations. Other relevant patents include:
- U.S. Patent No. 9,132,239 (Dial-Down Mechanism for Wind-Up Pen)
- U.S. Patent No. 10,335,462 (Use of Long-Acting GLP-1 Peptides)
- U.S. Patent No. 9,457,154
- U.S. Patent No. 9,687,611
- U.S. Patent No. 10,357,616
- Among others[2][5].
These patents collectively protect various aspects of semaglutide formulations, including methods of preparation, therapeutic uses, and device mechanisms.
Litigation and Legal Proceedings
The '063 patent is involved in ongoing litigation, particularly in the context of generic drug approvals. Multiple actions have been filed against companies seeking FDA approval to market generic versions of OZEMPIC. These cases are centralized in the District of Delaware and involve claims of patent infringement against several defendants[5].
ANDA Filings and Generic Challenges
Generic drug manufacturers, such as Mylan, have filed Abbreviated New Drug Applications (ANDAs) seeking approval to market generic versions of OZEMPIC. These filings have led to patent infringement lawsuits, with the '063 patent being one of the asserted patents. The litigation involves complex claim constructions and the determination of whether the generic formulations infringe on the protected claims[2][5].
Foreign Priority and PCT Information
The '063 patent has a foreign priority date of July 27, 2005, based on European Patent Application No. 05016286. This indicates that the initial application was filed in Europe before being pursued in the United States and other countries[1][4].
Estimated Expiration and Supplementary Protection Certificates
The estimated expiration dates for the '063 patent vary by country, and supplementary protection certificates (SPCs) may extend the protection period in some jurisdictions. For example, in Austria, the patent is listed with an estimated expiration date, but specific details require subscription to access[1].
Conclusion
The '063 patent is a critical component of the intellectual property strategy for OZEMPIC and SAXENDA, protecting key aspects of the syringe device used for these medications. The patent's scope is defined by its claims, which focus on ensuring accurate and safe dosing. The broader patent landscape involves multiple related patents and ongoing litigation related to generic drug approvals.
Key Takeaways
- Patent Protection: The '063 patent protects OZEMPIC and SAXENDA, formulations of semaglutide.
- Claims: The patent includes seven claims focusing on a syringe device with dose limiting and safety mechanisms.
- International Protection: The patent is part of a larger patent family with protection in thirteen countries.
- Litigation: The patent is involved in ongoing litigation related to generic drug approvals.
- Related Patents: Part of a portfolio including other patents related to semaglutide formulations and devices.
FAQs
Q: What medications are protected by the '063 patent?
A: The '063 patent protects OZEMPIC and SAXENDA, which are formulations of the drug semaglutide.
Q: What are the key claims of the '063 patent?
A: The key claims involve a dose limiting mechanism and an additional safety mechanism to prevent the ejection of a dose exceeding the set dose.
Q: Is the '063 patent part of an international patent family?
A: Yes, the '063 patent is part of a larger patent family with fifteen members in thirteen countries.
Q: What is the current status of the '063 patent in terms of litigation?
A: The '063 patent is involved in ongoing litigation related to generic drug approvals, particularly in the District of Delaware.
Q: How does the '063 patent fit into the broader patent landscape for semaglutide?
A: The '063 patent is one of several patents protecting various aspects of semaglutide formulations, including methods of preparation, therapeutic uses, and device mechanisms.
Sources
- Drug Patent Watch: "Patent 11,097,063 protects OZEMPIC and SAXENDA and is included in two NDAs."
- RPX Corporation: "OZEMPIC (SEMAGLUTIDE) ) MDL No. 22-MD-3038 (CFC) PATEN"
- Hoover Institution: "Patent Claims and Patent Scope"
- Google Patents: "Patent No. 11,097,063"
- JPML: "OZEMPIC (SEMAGLUTIDE) PATENT LITIGATION MDL No. 3038"
