United States Patent 8,765,153: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,765,153, titled "Levalbuterol salt," is a significant patent in the pharmaceutical industry, particularly in the development of inhaler formulations. This patent, granted to address specific needs in aerosol formulations, is crucial for understanding the intellectual property landscape surrounding levalbuterol, a key component in respiratory treatments.
Background of Levalbuterol
Levalbuterol is a medication used to treat asthma and other respiratory conditions. It is the R-enantiomer of the drug albuterol, known for its bronchodilatory properties. The development of levalbuterol salts, such as levalbuterol L-tartrate, has been a focus area for improving the efficacy and stability of inhaler formulations[5].
Patent Overview
Publication Details
- Publication Number: US8765153B2
- Prior Art Date: This patent builds on earlier research and development in the field of aerosol formulations and pharmaceutical salts.
- Legal Status: The patent has expired, but its impact on the field remains significant[1].
Scope of the Patent
Levalbuterol L-Tartrate
The patent specifically deals with levalbuterol L-tartrate, a salt form of levalbuterol that offers desirable properties for use in metered dose inhalers (MDIs). The crystals formed by this salt have improved stability and aerosol performance, making them ideal for respiratory treatments[1][5].
Aerosol Formulation
The patent describes methods for formulating aerosols using levalbuterol L-tartrate. This includes the use of propellants and other excipients to create a stable and effective inhaler product. The formulation is designed to ensure consistent delivery of the medication, which is critical for patient compliance and treatment efficacy[1].
Claims of the Patent
Key Claims
- The patent includes claims related to the composition of levalbuterol L-tartrate crystals, their method of preparation, and their use in aerosol formulations.
- Specific claims cover the particle size and distribution of the crystals, which are crucial for optimal aerosol performance.
- The patent also claims the use of ethanol in the crystallization process, which enhances the stability and purity of the levalbuterol L-tartrate crystals[1].
Claim Coverage
The claims are structured to protect the intellectual property related to the unique properties and applications of levalbuterol L-tartrate. This includes:
- Composition Claims: These cover the specific chemical composition of levalbuterol L-tartrate and its crystals.
- Method Claims: These describe the processes for preparing the crystals and formulating the aerosol.
- Use Claims: These specify the use of levalbuterol L-tartrate in MDIs and other inhaler devices[1].
Patent Landscape
Competing Patents
The patent landscape surrounding levalbuterol and its salts is complex, with multiple patents covering various aspects of formulation, delivery, and use. Competing patents may focus on different salt forms, alternative formulations, or innovative delivery systems. Understanding this landscape is crucial for navigating potential infringement issues and identifying opportunities for innovation[3].
Patent Analytics
To fully comprehend the patent landscape, companies often use patent analytics tools. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps in coverage and potential future directions. For example, Claim Coverage Matrix and Claim Charts can be used to review patent coverage and determine the applicability of specific scope concepts to target products or methods[3].
Impact on the Pharmaceutical Industry
Improved Efficacy
The development of levalbuterol L-tartrate has significantly improved the efficacy of inhaler treatments. The stable and consistent delivery of medication ensured by this formulation enhances patient outcomes and compliance.
Market Competition
The expiration of this patent opens up the market for generic versions of levalbuterol L-tartrate inhalers. This can lead to increased competition, potentially driving down costs and making the medication more accessible to a wider population.
Future Innovations
The knowledge and techniques developed through this patent can serve as a foundation for future innovations in respiratory treatments. Researchers can build upon the understanding of levalbuterol salts and aerosol formulations to develop new and improved therapies.
Regulatory and Legal Considerations
USPTO Role
The U.S. Patent and Trademark Office (USPTO) plays a critical role in granting and managing patents, including those related to pharmaceuticals. Understanding the USPTO's processes and guidelines is essential for navigating the patent landscape[2].
Patent Expiration
The expiration of a patent like US8765153B2 means that the protected intellectual property is now in the public domain. This allows other companies to manufacture and market similar products without infringing on the original patent.
Conclusion
United States Patent 8,765,153 has been instrumental in advancing the development of levalbuterol inhaler formulations. The patent's focus on levalbuterol L-tartrate crystals and their use in aerosol formulations has improved the efficacy and stability of respiratory treatments.
Key Takeaways
- Levalbuterol L-Tartrate: This salt form of levalbuterol offers desirable properties for use in MDIs.
- Aerosol Formulation: The patent describes methods for formulating aerosols using levalbuterol L-tartrate.
- Claim Coverage: The patent includes claims related to composition, method, and use.
- Patent Landscape: Understanding competing patents and using patent analytics tools is crucial for navigating the intellectual property landscape.
- Impact on Industry: The patent has improved treatment efficacy and will influence future innovations in respiratory treatments.
FAQs
Q: What is the primary focus of United States Patent 8,765,153?
A: The primary focus is on levalbuterol L-tartrate and its use in aerosol formulations for metered dose inhalers.
Q: Why is levalbuterol L-tartrate important in inhaler formulations?
A: It offers improved stability and aerosol performance, making it ideal for consistent medication delivery.
Q: What happens now that the patent has expired?
A: The protected intellectual property is now in the public domain, allowing other companies to manufacture and market similar products.
Q: How does the USPTO play a role in this patent?
A: The USPTO is responsible for granting and managing patents, including this one, and ensures that intellectual property rights are protected.
Q: What tools can be used to analyze the patent landscape?
A: Tools such as Claim Coverage Matrix and Claim Charts can be used to review patent coverage and identify gaps or opportunities[3].
