United States Patent 7,635,773: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,635,773, titled "Sulfoalkyl ether cyclodextrin compositions," is a significant patent in the field of pharmaceuticals and chemical engineering. This patent, assigned to CyDex Pharmaceuticals, Inc., pertains to the composition, production, and application of sulfoalkyl ether cyclodextrins. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Sulfoalkyl Ether Cyclodextrins
Sulfoalkyl ether cyclodextrins are modified cyclodextrins that have been chemically altered to enhance their solubility and complexation properties. These compounds are crucial in pharmaceutical formulations as they can improve the bioavailability and stability of drugs[4].
Patent Scope
The scope of a patent is defined by its claims, which outline the specific aspects of the invention that are protected. For US Patent 7,635,773, the scope is broad yet precise, covering various aspects of sulfoalkyl ether cyclodextrin compositions.
Independent Claims
The patent includes multiple independent claims that define the core of the invention. These claims cover the composition of sulfoalkyl ether cyclodextrins, the methods of their preparation, and their use in pharmaceutical formulations. For instance, Claim 1 describes a composition comprising a sulfoalkyl ether cyclodextrin and a pharmaceutical active ingredient, highlighting the specific chemical structure and properties of the cyclodextrin[1].
Dependent Claims
Dependent claims further specify the invention by adding additional limitations to the independent claims. These claims detail various aspects such as the degree of substitution, the type of pharmaceutical active ingredients, and the methods of purification and formulation.
Claims Analysis
Claim Length and Count
Research on patent scope suggests that the length and count of independent claims can be indicative of the patent's breadth and complexity. For US Patent 7,635,773, the claims are detailed and numerous, reflecting a comprehensive protection strategy. The patent includes multiple independent claims and several dependent claims, which together provide a robust coverage of the invention[3].
Claim Language
The language used in the claims is precise and technical, ensuring that the scope of the patent is well-defined. For example, the claims specify the chemical structure of the sulfoalkyl ether cyclodextrins, including the type and degree of substitution, and the methods used to prepare these compounds[1].
Methods of Preparation
The patent describes several methods for preparing sulfoalkyl ether cyclodextrins, including substitution reactions, ultra-filtration, and diafiltration. These methods are crucial for ensuring the purity and consistency of the final product.
Substitution Reactions
The patent details the use of substitution reactions to introduce sulfoalkyl ether groups into the cyclodextrin molecule. This process involves reacting the cyclodextrin with a sulfoalkylating agent in the presence of an alkaline medium[1].
Purification Methods
Purification is a critical step in the production of pharmaceutical-grade sulfoalkyl ether cyclodextrins. The patent describes methods such as ultra-filtration, diafiltration, and centrifugation to remove impurities and achieve the desired level of purity[1].
Pharmaceutical Applications
Sulfoalkyl ether cyclodextrins are used in various pharmaceutical formulations to enhance the solubility, stability, and bioavailability of drugs.
Drug Complexation
These modified cyclodextrins form inclusion complexes with pharmaceutical active ingredients, which can improve the solubility and stability of the drug. This is particularly beneficial for poorly soluble drugs, enhancing their therapeutic efficacy[4].
Formulation Examples
The patent provides examples of formulations that include sulfoalkyl ether cyclodextrins, such as solutions, suspensions, and topical preparations. These formulations are designed to optimize the delivery of the pharmaceutical active ingredient[1].
Patent Landscape
The patent landscape surrounding US Patent 7,635,773 includes other patents and publications related to cyclodextrins and their modifications.
Related Patents
Other patents, such as US-4738923-A, describe different methods for producing and separating cyclodextrins, highlighting the ongoing innovation in this field[5].
Industry Trends
The development of sulfoalkyl ether cyclodextrins is part of a broader trend in pharmaceutical research aimed at improving drug delivery systems. This trend includes the use of various excipients and formulation technologies to enhance the efficacy and safety of drugs.
Legal and Regulatory Aspects
The legal status of US Patent 7,635,773 is active, indicating that the patent is currently in force. This means that any use, manufacture, or sale of sulfoalkyl ether cyclodextrin compositions that fall within the scope of the claims would require permission from the patent holder.
Impact on Innovation
The granting of this patent can influence innovation in the pharmaceutical industry in several ways. It provides a clear definition of what is protected, which can guide other researchers and companies in developing new and distinct technologies. However, it also raises concerns about patent breadth and the potential for increased licensing and litigation costs, as discussed in broader debates on patent quality[3].
Key Takeaways
- Comprehensive Claims: The patent includes detailed and numerous claims that provide robust protection for the invention.
- Precise Language: The claims use precise and technical language to define the scope of the patent.
- Pharmaceutical Applications: Sulfoalkyl ether cyclodextrins are crucial in enhancing the solubility, stability, and bioavailability of pharmaceutical active ingredients.
- Purification Methods: The patent describes several purification methods to ensure the purity and consistency of the final product.
- Legal and Regulatory: The patent is currently active, and its scope defines what is protected under U.S. patent law.
FAQs
What are sulfoalkyl ether cyclodextrins?
Sulfoalkyl ether cyclodextrins are modified cyclodextrins with enhanced solubility and complexation properties, used to improve the bioavailability and stability of drugs.
How are sulfoalkyl ether cyclodextrins prepared?
They are prepared through substitution reactions, followed by purification methods such as ultra-filtration, diafiltration, and centrifugation.
What are the pharmaceutical applications of sulfoalkyl ether cyclodextrins?
They are used in various pharmaceutical formulations to enhance the solubility, stability, and bioavailability of drugs, particularly poorly soluble ones.
What is the legal status of US Patent 7,635,773?
The patent is currently active, indicating it is in force and protects the described compositions and methods.
How does this patent impact innovation in the pharmaceutical industry?
It provides clear protection for the invention, guiding other researchers and companies, but also raises concerns about patent breadth and potential licensing and litigation costs.
Sources
- US7635773B2 - Sulfoalkyl ether cyclodextrin compositions - Google Patents
- US 11806402 B2 - googleapis.com
- Patent Claims and Patent Scope - SSRN
- Sulfoalkyl ether cyclodextrin compositions - Patent US-7635773-B2 - PubChem
- US-4738923-A - Unified Patents Portal
