United States Patent 10,413,543: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,413,543, titled "Stable multiparticulate pharmaceutical composition of rosuvastatin," is a significant patent in the pharmaceutical industry, particularly in the field of cardiovascular health. This patent, granted to its inventors, outlines a novel formulation of rosuvastatin, a widely used statin for lowering cholesterol. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Rosuvastatin
Rosuvastatin is a statin medication used to treat high cholesterol and reduce the risk of cardiovascular disease. It works by inhibiting the enzyme HMG-CoA reductase, which is crucial for cholesterol production in the liver. The effectiveness of rosuvastatin has made it a cornerstone in the management of hyperlipidemia, but its formulation can significantly impact its stability, efficacy, and patient compliance.
Scope of the Patent
The patent 10,413,543 focuses on a stable multiparticulate pharmaceutical composition of rosuvastatin. This composition is designed to improve the stability and bioavailability of rosuvastatin, addressing issues such as degradation and variability in absorption. Here are the key aspects of the scope:
Stable Multiparticulate Composition
The patent describes a multiparticulate formulation, which consists of multiple small particles, each containing rosuvastatin. This design enhances the stability of the drug by reducing the risk of degradation and improving its dissolution profile[4].
Improved Bioavailability
The multiparticulate composition is engineered to enhance the bioavailability of rosuvastatin. This is crucial because improved bioavailability can lead to better therapeutic outcomes and reduced dosages, which in turn can improve patient compliance.
Manufacturing Process
The patent also details the manufacturing process for this composition, which involves specific steps to ensure the stability and uniformity of the multiparticulate particles. This includes the use of particular excipients and a controlled release mechanism.
Claims of the Patent
The claims of a patent are the most critical part as they define the legal boundaries of the invention. Here are some key claims of patent 10,413,543:
Composition Claims
The patent claims a stable multiparticulate pharmaceutical composition comprising rosuvastatin and specific excipients that enhance its stability and bioavailability. These claims are broad enough to cover various formulations but specific enough to distinguish the invention from prior art[4].
Method of Manufacture Claims
The patent also claims the method of manufacturing the multiparticulate composition, including the steps and materials used. This ensures that any similar manufacturing process would infringe on the patent.
Use Claims
Claims related to the use of the composition for treating hyperlipidemia and reducing the risk of cardiovascular disease are also included. These claims are essential for protecting the therapeutic applications of the invention.
Patent Landscape
Understanding the patent landscape is crucial for assessing the competitive environment and potential infringement risks.
Prior Art and Related Patents
The patent landscape for rosuvastatin formulations is complex, with numerous patents covering various aspects of statin formulations. Patent 10,413,543 must be distinguished from prior art, such as other multiparticulate or controlled-release formulations of rosuvastatin. The use of specific excipients and the manufacturing process detailed in this patent help differentiate it from existing patents[4].
Competitor Patents
Other pharmaceutical companies have patents related to statin formulations, including those for rosuvastatin. For example, patents covering different formulations, delivery systems, or manufacturing processes could be considered competitors in the market.
International Patent Protection
Given the global nature of the pharmaceutical industry, international patent protection is essential. The inventors may have filed or plan to file patent applications in other jurisdictions to protect their invention worldwide. This could involve PCT applications or national stage entries in various countries[2].
Economic and Commercial Impact
The economic and commercial impact of this patent is significant.
Market Demand
The demand for effective and stable rosuvastatin formulations is high due to the prevalence of hyperlipidemia and cardiovascular diseases. A stable multiparticulate composition can capture a substantial market share, especially if it offers improved efficacy and patient compliance.
Cost and Licensing
The cost of developing and commercializing a new pharmaceutical formulation is substantial. The patent holder may seek licensing agreements with other pharmaceutical companies to recoup these costs and expand market reach. Licensing fees can be a significant revenue stream, especially if the formulation becomes a standard treatment option[2].
Legal and Regulatory Considerations
The patenting process and subsequent legal and regulatory considerations are critical.
Patent Prosecution
The patent prosecution process for 10,413,543 would have involved detailed examinations by the USPTO to ensure the invention meets the criteria of novelty, non-obviousness, and enablement. Any challenges or rejections during this process would have been addressed through arguments and amended claims[2].
Infringement and Litigation
Protecting the patent from infringement is essential. The patent holder must monitor the market for any potential infringers and take legal action if necessary. Litigation, such as the case in DDR Holdings, can be complex and costly but is crucial for maintaining patent rights[5].
Conclusion and Future Directions
The stable multiparticulate pharmaceutical composition of rosuvastatin described in patent 10,413,543 represents a significant advancement in the treatment of hyperlipidemia. The detailed analysis of its scope, claims, and the broader patent landscape highlights its potential impact on the pharmaceutical industry.
Key Takeaways
- Stable Formulation: The patent describes a stable multiparticulate composition that enhances the bioavailability and stability of rosuvastatin.
- Manufacturing Process: The specific manufacturing process detailed in the patent ensures uniformity and stability of the formulation.
- Market Impact: The patent has significant economic and commercial implications due to the high demand for effective rosuvastatin formulations.
- Legal Considerations: Protecting the patent from infringement and navigating the complex legal landscape are crucial for maintaining its value.
FAQs
What is the main innovation of patent 10,413,543?
The main innovation is a stable multiparticulate pharmaceutical composition of rosuvastatin that enhances its bioavailability and stability.
How does the multiparticulate composition improve rosuvastatin?
The composition improves rosuvastatin by reducing degradation, enhancing bioavailability, and providing a more consistent therapeutic effect.
What are the key claims of the patent?
The key claims include the composition itself, the method of manufacture, and the use of the composition for treating hyperlipidemia.
Why is international patent protection important for this invention?
International patent protection is essential to safeguard the invention in global markets and prevent unauthorized use or manufacture.
What are the potential economic benefits of this patent?
The potential economic benefits include capturing a significant market share, generating revenue through licensing agreements, and reducing costs associated with developing and commercializing the formulation.
Cited Sources
- National Science Foundation. Invention, Knowledge Transfer, and Innovation. 2022.
- University of Kansas. Intellectual Property Protection - KU Office of Research.
- United States Patent and Trademark Office. Patent Claims Research Dataset.
- PubChem. Stable multiparticulate pharmaceutical composition of rosuvastatin.
- United States Court of Appeals for the Federal Circuit. DDR Holdings. 2014.
