United States Patent 10,357,535: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,357,535, titled "Daptomycin formulations and uses thereof," is a significant patent in the pharmaceutical industry, particularly in the development and formulation of the antibiotic daptomycin. This patent, assigned to Hospira, addresses critical aspects of daptomycin formulations, including stability, reconstitution times, and the use of additives.
Background of Daptomycin
Daptomycin is a cyclic lipopeptide antibiotic used primarily to treat systemic and life-threatening infections caused by Gram-positive bacteria. Its effectiveness and the need for stable formulations have driven extensive research and development in this area.
Scope of the Patent
The patent US10,357,535 focuses on lyophilized daptomycin formulations that incorporate various additives to enhance the stability and reconstitution characteristics of the drug.
Additives and Formulation Components
The patent describes the use of pharmaceutically acceptable additives such as antioxidants and organic acids. These additives are crucial for maintaining the stability of daptomycin during storage and reconstitution. For instance, the formulation may include sugars like sucrose, which are non-reducing and added in specific concentrations (about 2.5% w/v to about 25% w/v) to improve reconstitution times and stability profiles[1][4].
pH Range
The formulations are designed to have a pH range of about 6.5 to about 7.5, which is optimal for the stability of daptomycin[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- The patent claims lyophilized daptomycin formulations that include specific additives such as antioxidants and organic acids.
- It also claims the method of preparing these formulations, emphasizing the importance of the lyophilization process and the role of additives in enhancing stability and reconstitution times[1].
Dependent Claims
- Dependent claims provide additional details on the types and concentrations of additives, such as the use of sucrose and phosphate buffers, and the specific pH range of the formulations[1].
Patent Landscape
The patent landscape surrounding daptomycin formulations is complex and involves multiple players.
Patent Expiry and Generic Versions
The patent US10,357,535 is set to expire on September 11, 2033. This expiry date is crucial for generic manufacturers, as it allows them to develop and market their own versions of daptomycin. Companies like Fresenius Kabi USA LLC, Xellia Pharmaceuticals, Hainan Poly Pharmaceutical Co Ltd, and Hisun Pharmaceutical Hangzhou Co Ltd have already filed for generic versions of daptomycin[2].
Recent Legal Activities
Recent legal activities on daptomycin patents include various notifications and grant processes. For example, patent US11,759,497, also related to daptomycin formulations, has seen several recent legal activities such as email notifications, patent grant notifications, and issue date calculations[2].
Competing Patents
Other patents, such as US9,135,456B2, also focus on daptomycin formulations with improved chemical stability and faster reconstitution times. These patents often overlap in their claims but may differ in specific formulation components or methods of preparation[4].
Impact on the Pharmaceutical Industry
The patent US10,357,535 has significant implications for the pharmaceutical industry:
Stability and Reconstitution
The formulations described in this patent offer improved stability and faster reconstitution times, which are critical for clinical use. This enhances the usability and effectiveness of daptomycin in treating infections[1][4].
Generic Competition
The impending expiry of this patent and the development of generic versions will increase competition in the market, potentially reducing costs and making daptomycin more accessible to patients[2].
Measuring Patent Scope
The scope of a patent, such as US10,357,535, can be measured by analyzing the breadth of its claims. The first independent claim typically provides the best indication of a patent’s scope. Longer claims with more conditions imply a narrower scope, while broader claims offer more protection against infringers[3].
Conclusion
United States Patent 10,357,535 is a pivotal patent in the field of daptomycin formulations, addressing key issues of stability and reconstitution. The patent's scope and claims are carefully defined to protect the invention while allowing for future developments and generic competition.
Key Takeaways
- Improved Formulations: The patent describes lyophilized daptomycin formulations with additives to enhance stability and reconstitution times.
- Additives and pH Range: Specific additives like sucrose and organic acids are used, and the formulations have a pH range of about 6.5 to about 7.5.
- Patent Expiry: The patent is set to expire on September 11, 2033, opening the door for generic versions.
- Competing Patents: Other patents also focus on improving daptomycin formulations, highlighting the competitive landscape.
- Industry Impact: The patent enhances the usability and effectiveness of daptomycin and will influence the market with the introduction of generic versions.
Frequently Asked Questions (FAQs)
What is the main focus of United States Patent 10,357,535?
The main focus is on lyophilized daptomycin formulations that include specific additives to enhance stability and reconstitution times.
What additives are used in the formulations described in the patent?
The formulations include pharmaceutically acceptable additives such as antioxidants, organic acids, and sugars like sucrose.
What is the pH range of the formulations described in the patent?
The pH range is about 6.5 to about 7.5.
When is the patent set to expire?
The patent is set to expire on September 11, 2033.
How does the patent impact the pharmaceutical industry?
The patent enhances the stability and usability of daptomycin and will influence the market with the introduction of generic versions upon its expiry.
Cited Sources:
- US10357535B2 - Daptomycin formulations and uses thereof - Google Patents
- Drug Patents containing Daptomycin - Pharsight
- The Ways We've been Measuring Patent Scope are Wrong - Boston University Law
- US9138456B2 - Lipopeptide compositions and related methods - Google Patents
