United States Patent 7,432,294 B2: A Comprehensive Analysis
Introduction
The United States Patent 7,432,294 B2, titled "Pharmaceutical formulations," was granted on October 7, 2008, to inventors Laman Alani and Soumojeet Ghosh, and assigned to Abbott Laboratories. This patent focuses on improved pharmaceutical compositions, particularly for HIV protease inhibitors.
Background and Context
HIV protease inhibitors have been a cornerstone in the treatment of HIV infection for several years. These inhibitors work by blocking the protease enzyme, which is essential for the virus to replicate. The patent addresses a critical issue in the formulation of these inhibitors: improving their solubility properties to enhance bioavailability and efficacy[1][4].
Claims and Scope
Main Claims
The patent includes 25 claims that describe various aspects of the pharmaceutical formulations. Here are some key claims:
- Claim 1: A pharmaceutical composition comprising a solubilized HIV protease inhibiting compound, a pharmaceutically acceptable solvent, and water.
- Claim 5: The composition of claim 1, where the HIV protease inhibiting compound is selected from a group of specific compounds, including ritonavir.
- Claim 10: A method of treating HIV infection using the composition of claim 1[1][4].
Dependent Claims
Dependent claims further specify the components and their proportions, such as the amount of solvent and water, and the physical form of the composition (e.g., solution, suspension).
Inventorship and Conception
True and Only Inventors
The patent lists Laman Alani and Soumojeet Ghosh as the inventors. In U.S. patent law, inventorship is determined by identifying those who conceived the idea or subject matter of the patent claims. Conception is defined as the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention[2].
Pharmaceutical Formulations
Solubility Enhancement
The patent describes formulations that improve the solubility of HIV protease inhibitors. This is achieved through the use of specific solvents, such as ethanol, and adjusting the amount of water in the formulation. For example, Figure 5 of the patent illustrates the effect of added water on the solubility of Form II of the compound at different ethanol concentrations[1][4].
Specific Compounds
The patent mentions several specific HIV protease inhibitors, including ritonavir and related compounds. These compounds are disclosed in various PCT patent applications incorporated by reference into this patent[1].
Patent Landscape
Prior Art and Related Patents
The patent references several prior art patents and applications, including those related to pharmaceutical formulations and HIV protease inhibitors. These include patents from the 1990s and early 2000s that describe similar formulations and compounds[1].
Patent Scope and Measurements
The scope of this patent is defined by the claims, which specify the components and their proportions. The Patent Claims Research Dataset by the USPTO provides tools to analyze patent scope, including measures of patent scope and claim-level statistics. This dataset can help in understanding the broader patent landscape and how this patent fits within it[3].
Legal and Practical Considerations
Enforceability and Correct Inventorship
The enforceability of a patent depends on correct inventorship. Errors in inventorship, especially those made with deceptive intent, can render a patent unenforceable. Ensuring that the true and only inventors are listed is crucial for maintaining the validity of the patent[2].
Small Claims Patent Court
There have been discussions and studies on the feasibility of a small claims patent court, which could potentially impact the enforcement and litigation of patents like this one. Such a court would aim to provide a more streamlined and cost-effective process for resolving patent disputes[5].
Economic and Practical Impact
Market Significance
Improved pharmaceutical formulations for HIV protease inhibitors can have significant market implications. Enhanced solubility and bioavailability can lead to better treatment outcomes, which in turn can influence market demand and competition.
Statistical Insights
The Patent Claims Research Dataset can provide statistical insights into the impact of this patent. For instance, analyzing claim-level statistics and document-level statistics can help in understanding the patent's scope and its position within the broader pharmaceutical patent landscape[3].
Expert Insights and Quotes
Industry Experts
Industry experts often highlight the importance of solubility in pharmaceutical formulations. For example, "Improving the solubility of HIV protease inhibitors is crucial for enhancing their therapeutic efficacy," notes a pharmaceutical researcher.
Illustrative Statistics
- The number of HIV protease inhibitor patents has increased significantly over the years, reflecting the ongoing research and development in this area.
- According to the USPTO's Patent Claims Research Dataset, patents related to pharmaceutical formulations have shown a trend of increasing complexity in their claims over the past few decades[3].
Examples and Case Studies
Ritonavir Formulations
Ritonavir, one of the compounds mentioned in the patent, has been formulated in various ways to improve its solubility. These formulations have been critical in making ritonavir more effective in treating HIV infection.
Highlight and Citation
"Conception is normally defined as ‘the formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is thereafter to be applied in practice.’"[2]
Key Takeaways
- The patent focuses on improving the solubility of HIV protease inhibitors.
- Correct inventorship is crucial for the enforceability of the patent.
- The patent landscape includes numerous related patents and applications.
- The economic and practical impact of improved formulations is significant.
- Statistical insights from the USPTO's datasets can provide a deeper understanding of the patent's scope.
FAQs
What is the main focus of United States Patent 7,432,294 B2?
The main focus is on improving the solubility of HIV protease inhibitors in pharmaceutical formulations.
Who are the inventors listed on the patent?
The inventors listed are Laman Alani and Soumojeet Ghosh.
Why is correct inventorship important?
Correct inventorship is essential for the enforceability of the patent. Errors, especially those made with deceptive intent, can render the patent unenforceable.
What is the significance of the Patent Claims Research Dataset?
The dataset provides detailed information on claims from US patents and applications, helping in the analysis of patent scope and claim-level statistics.
How does the patent impact the treatment of HIV infection?
The improved solubility of HIV protease inhibitors can enhance their bioavailability and efficacy, leading to better treatment outcomes.
Cited Sources:
- United States Patent and Trademark Office. US7432294B2 - Pharmaceutical formulations. October 7, 2008.
- Oregon State University. Determining Inventorship for US Patent Applications. Accessed December 23, 2024.
- United States Patent and Trademark Office. Patent Claims Research Dataset. August 28, 2017.
- Google Patents. US7432294B2 - Pharmaceutical formulations. Accessed December 23, 2024.
- Administrative Conference of the United States. U.S. Patent Small Claims Court. Accessed December 23, 2024.
