Detailed Analysis of the Scope and Claims of United States Patent 6,958,319
Introduction
United States Patent 6,958,319, titled "Formulation of Boronic Acid Compounds," is a significant patent in the field of pharmaceuticals, particularly involving boronic acid derivatives. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, issued to the inventors, describes stable compounds prepared from boronic acid and their lyophilized forms. These compounds are crucial in pharmaceutical applications, especially in the formulation of drugs that require specific stability and bioavailability characteristics[4].
Scope of the Patent
The scope of the patent is defined by the claims, which outline the specific aspects of the invention that are protected.
Claims Overview
The patent includes multiple claims that cover various aspects of the formulation, including:
- Compound Claims: These claims describe the specific chemical structures of the boronic acid compounds, including the formula and the substituents (Z1 and Z2)[4].
- Method Claims: These claims cover the methods of preparing these compounds, including the lyophilization process[4].
- Use Claims: These claims specify the pharmaceutical uses of the formulated compounds, such as their application in treating various diseases[4].
Key Components
- Boronic Acid Derivatives: The patent focuses on boronic acid compounds, which are known for their therapeutic potential. The claims detail the specific derivatives and their chemical structures[4].
- Lyophilization: The process of lyophilization is critical in stabilizing these compounds. The claims cover the methods and conditions under which this process is carried out[4].
- Pharmaceutical Applications: The patent highlights the pharmaceutical applications of these compounds, including their use in drug formulations and their stability in various environments[4].
Claim Analysis
Independent Claims
Independent claims are the broadest claims in a patent and define the core invention. For US 6,958,319, these claims typically include:
- The chemical structure of the boronic acid compounds.
- The method of preparing these compounds.
- The lyophilized form of the compounds.
Dependent Claims
Dependent claims narrow down the scope of the independent claims by adding additional limitations. These claims might include:
- Specific substituents (Z1 and Z2) in the chemical structure.
- Detailed conditions for the lyophilization process.
- Particular pharmaceutical uses or formulations[4].
Patent Landscape
Prior Art
The patent landscape includes prior art that was considered during the examination process. This includes other patents and publications related to boronic acid compounds and their formulations. The Common Citation Document (CCD) application, for instance, consolidates prior art cited by multiple patent offices, which would have been relevant during the examination of this patent[1].
Related Patents
Other patents related to boronic acid compounds and their pharmaceutical applications are part of the broader patent landscape. For example, patents covering similar chemical structures or methods of preparation would be relevant. The European Patent Office (EPO) and other international patent databases provide access to such related patents[1].
International Patent Family
The Global Dossier service provided by the USPTO allows users to see the patent family for a specific application, including related applications filed at participating IP Offices. This helps in understanding the global protection and related filings for the same invention[1].
Economic and Research Implications
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides detailed information on claims from US patents, including those related to pharmaceutical formulations. This dataset can be used to analyze trends and scope measurements of patents like US 6,958,319, offering insights into the patent scope and its economic implications[3].
Industry Impact
The formulation of boronic acid compounds has significant implications for the pharmaceutical industry. Patents like US 6,958,319 protect innovative formulations that can lead to new drugs or improved versions of existing ones. This can impact the market by introducing new treatments and influencing competition among pharmaceutical companies.
Practical Applications and Examples
Pharmaceutical Formulations
The stable compounds formulated under this patent can be used in various pharmaceutical applications. For example, the drug VELCADE, which is a boronic acid derivative, is used in the treatment of certain cancers. The stability and bioavailability ensured by the formulations described in US 6,958,319 are crucial for such drugs[5].
Research and Development
Researchers and pharmaceutical companies can use the information from this patent to develop new formulations or improve existing ones. The detailed methods and chemical structures provided can serve as a starting point for further research and development.
Challenges and Limitations
Patent Expiration
The patent has expired, which means that the protected formulations and methods are now in the public domain. This can lead to generic versions of the drugs being developed, potentially reducing the market share of the original patent holder.
Regulatory Compliance
Any new formulations or methods derived from this patent must comply with current regulatory standards. This includes ensuring the safety, efficacy, and stability of the compounds, which can be a challenging and costly process.
Key Takeaways
- Scope and Claims: The patent covers specific boronic acid compounds, their lyophilized forms, and the methods of preparation.
- Patent Landscape: The patent is part of a broader landscape that includes prior art, related patents, and international filings.
- Economic Implications: The patent has significant economic implications for the pharmaceutical industry, influencing the development of new drugs and treatments.
- Practical Applications: The formulations described are crucial for pharmaceutical applications, ensuring stability and bioavailability.
- Challenges and Limitations: The patent's expiration and regulatory compliance are key considerations for any further development or use of the protected formulations.
FAQs
Q: What is the main subject of United States Patent 6,958,319?
A: The main subject is the formulation of stable compounds prepared from boronic acid and their lyophilized forms.
Q: What are the key components protected by the patent?
A: The key components include the specific chemical structures of the boronic acid compounds, the method of preparing these compounds, and their lyophilized forms.
Q: How does the patent impact the pharmaceutical industry?
A: The patent protects innovative formulations that can lead to new drugs or improved versions of existing ones, influencing competition and market dynamics.
Q: What happens now that the patent has expired?
A: With the patent expired, the protected formulations and methods are now in the public domain, allowing for the development of generic versions of the drugs.
Q: Where can one find more information about related patents and prior art?
A: Information about related patents and prior art can be found through resources such as the USPTO's Patent Public Search, Global Dossier, and international patent databases like the EPO's esp@cenet[1].
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Unified Patents - US-6958319-B2: https://portal.unifiedpatents.com/patents/patent/US-6958319-B2
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US6958319B2: https://patents.google.com/patent/US6958319B2/en
- Patent Docs - in the united states district court: https://www.patentdocs.org/files/u_ks_v_us.pdf
