United States Patent 10,888,570: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,888,570, titled "Spironolactone aqueous compositions," is a significant patent that protects a stable, ready-to-use liquid formulation of spironolactone. This patent is crucial for pharmaceutical companies, particularly those involved in the development and marketing of spironolactone products. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Title and Abstract
The patent, titled "Spironolactone aqueous compositions," discloses a stable, ready-to-use liquid formulation comprising spironolactone and its method of use. This formulation is designed to improve the stability and efficacy of spironolactone, a medication commonly used to treat conditions such as heart failure, high blood pressure, and edema[1][2].
Inventors and Assignee
The inventors of this patent are Anthony Pipho and Michael Paul DeHart, both from Winterville, North Carolina. The assignee is CMP Development LLC, based in Farmville, North Carolina[1].
Patent Claims
Composition and Formulation Claims
The patent claims cover the composition and formulation of the spironolactone aqueous solution. These claims are specific to the stability and ready-to-use nature of the formulation, which is a critical aspect for pharmaceutical applications. The claims ensure that the formulation maintains its efficacy and stability over time, making it a reliable option for patients[1][2].
Method of Use Claims
In addition to the composition claims, the patent also includes method of use claims. These claims outline the specific ways in which the spironolactone aqueous composition can be used, ensuring that the invention is not only a novel formulation but also has practical applications in medical treatment[1].
Patent Family and International Protection
Global Patent Family Members
The patent has four patent family members in four different countries: Canada, the European Patent Office, Morocco, and the World Intellectual Property Organization (WIPO). This global protection ensures that the invention is safeguarded across multiple jurisdictions, preventing unauthorized use and replication[1].
Estimated Expiration Dates
Understanding the estimated expiration dates of these patents is crucial for both the patent holder and potential competitors. While the exact expiration dates are not publicly disclosed without subscription, knowing the patent family members helps in planning future strategies related to the invention[1].
New Drug Application (NDA) and Approval
NDA and Approval Details
The patent is included in one New Drug Application (NDA) with the approval date of August 4, 2017. The tradename for this product is CAROSPIR, and it is classified as an oral suspension. This approval indicates that the formulation has met the regulatory standards for safety and efficacy set by the FDA[1].
Patent Landscape and Competitors
Related Patents
The patent landscape for spironolactone formulations includes other related patents such as U.S. Patents Nos. 10,624,906 and 10,660,907, which also pertain to spironolactone compositions. These patents collectively form a robust intellectual property portfolio for CMP Development LLC, protecting various aspects of spironolactone formulations[5].
Litigation and Disputes
Patents in the pharmaceutical sector are often subject to litigation, especially when generic versions of drugs are involved. For instance, CMP Development LLC has been involved in legal disputes with companies like Amneal Pharmaceuticals LLC regarding the validity and infringement of their spironolactone patents[5].
Impact on Pharmaceutical Industry
Stability and Efficacy
The stable, ready-to-use liquid formulation of spironolactone protected by this patent enhances the drug's stability and efficacy. This is particularly important for patients who require consistent and reliable medication, as it ensures that the drug maintains its therapeutic effect over its shelf life[1].
Market Competition
The protection offered by this patent gives CMP Development LLC a competitive edge in the market. It prevents generic manufacturers from producing identical formulations, thereby safeguarding the company's market share and revenue streams[1].
Regulatory and Legal Considerations
Patent Eligibility Criteria
The USPTO's guidance on patent eligibility, especially in the context of pharmaceutical inventions, emphasizes the importance of practical applications and concrete technological improvements. This patent, by specifying a stable and ready-to-use formulation, meets these criteria by providing a tangible benefit over existing formulations[4].
Recent Case Law and Guidance
Recent updates and case law, such as those integrated into the 2024 USPTO guidance, highlight the need for claims to integrate judicial exceptions into practical applications. This patent, by detailing the method of use and the specific formulation, aligns with these legal standards, ensuring its validity and enforceability[4].
Conclusion
United States Patent 10,888,570 is a pivotal patent in the pharmaceutical industry, particularly for spironolactone formulations. It protects a stable, ready-to-use liquid formulation that enhances the drug's efficacy and stability. The global protection through patent family members and the inclusion in an NDA further solidify its importance. Understanding the scope, claims, and the broader patent landscape is essential for both the patent holder and competitors in navigating the complex world of pharmaceutical intellectual property.
Key Takeaways
- Stable Formulation: The patent protects a stable, ready-to-use liquid formulation of spironolactone.
- Global Protection: The patent has family members in Canada, the European Patent Office, Morocco, and WIPO.
- NDA Approval: The formulation is approved under the tradename CAROSPIR with an NDA approval date of August 4, 2017.
- Competitive Edge: The patent gives CMP Development LLC a competitive edge in the market by preventing generic versions.
- Regulatory Compliance: The patent aligns with USPTO guidance on patent eligibility by providing a practical application and technological improvement.
FAQs
What is the main subject of United States Patent 10,888,570?
The main subject of United States Patent 10,888,570 is a stable, ready-to-use liquid formulation of spironolactone.
Who are the inventors of this patent?
The inventors of this patent are Anthony Pipho and Michael Paul DeHart.
What is the tradename of the product protected by this patent?
The tradename of the product protected by this patent is CAROSPIR.
In which countries does this patent have family members?
This patent has family members in Canada, the European Patent Office, Morocco, and the World Intellectual Property Organization (WIPO).
What is the significance of the NDA approval for this patent?
The NDA approval indicates that the formulation has met the regulatory standards for safety and efficacy set by the FDA, allowing it to be marketed and used clinically.
How does this patent impact the pharmaceutical industry?
This patent enhances the stability and efficacy of spironolactone, providing a reliable medication option for patients and giving CMP Development LLC a competitive edge in the market.
What are the key considerations for patent eligibility in this context?
The key considerations include integrating judicial exceptions into practical applications and demonstrating concrete technological improvements, as outlined in the 2024 USPTO guidance.
Are there any recent legal or regulatory updates relevant to this patent?
Yes, the 2024 USPTO guidance update on AI and patent eligibility provides relevant insights, although this patent specifically pertains to pharmaceutical formulations rather than AI technology.
What is the estimated expiration date of this patent?
The exact expiration date is not publicly disclosed without subscription, but it can be estimated based on the patent's filing and approval dates.
Sources
- DrugPatentWatch - Patent 10,888,570 protects CAROSPIR and is included in one NDA.
- Unified Patents Portal - US-10888570-B2 - Spironolactone aqueous compositions.
- USPTO - Patent Claims Research Dataset.
- Mintz - Understanding the 2024 USPTO Guidance Update on AI Patent.
- Robins Kaplan - CMP Development, LLC v. Amneal Pharms. LLC.
