Detailed Analysis of the Scope and Claims of United States Patent 9,200,088
Introduction
United States Patent 9,200,088, titled "Sulfoalkyl Ether Cyclodextrin Compositions," is a significant patent in the field of pharmaceuticals, particularly in the development and use of cyclodextrin derivatives. This patent, owned by CyDex Pharmaceuticals, Inc., is crucial for understanding the intellectual property landscape surrounding sulfoalkyl ether cyclodextrin (SAE-CD) compositions.
Background of the Invention
The patent relates to compositions comprising sulfoalkyl ether cyclodextrin, which are used in various pharmaceutical applications. Cyclodextrins are cyclic oligosaccharides known for their ability to form inclusion complexes with a wide range of guest molecules, enhancing the solubility, stability, and bioavailability of drugs[4].
Scope of the Patent
Composition
The patent covers compositions that include sulfoalkyl ether cyclodextrin, which is a modified form of cyclodextrin. These compositions are designed to improve the solubility and stability of active pharmaceutical ingredients (APIs). The SAE-CDs are characterized by their ability to form stable complexes with APIs, thereby enhancing their pharmacokinetic properties[4].
Methods of Preparation
The patent also includes methods for preparing these SAE-CD compositions. These methods involve the chemical modification of cyclodextrins to introduce sulfoalkyl ether groups, which enhance the solubility and complexation properties of the cyclodextrins[4].
Uses of the Compositions
The SAE-CD compositions are intended for use in various pharmaceutical formulations, including injectable solutions, oral formulations, and topical applications. They are particularly useful in improving the solubility and stability of poorly soluble drugs, thereby enhancing their bioavailability and therapeutic efficacy[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover the SAE-CD compositions, methods of preparing these compositions, and their use in pharmaceutical formulations. For example, Claim 1 describes a composition comprising a sulfoalkyl ether cyclodextrin having specific structural characteristics[4].
Dependent Claims
Dependent claims further specify the scope of the invention by detailing various aspects of the SAE-CD compositions, such as the degree of substitution, the type of sulfoalkyl ether groups, and the methods of preparation. These claims provide a detailed description of the invention and help in distinguishing it from prior art[4].
Patent Landscape
Related Patents
The patent landscape surrounding US 9,200,088 includes several related patents owned by CyDex Pharmaceuticals. These include patents such as US 8,410,077 and US 9,493,582, which also relate to cyclodextrin compositions and their preparation and use. These patents collectively form a robust intellectual property portfolio that protects the company's innovations in the field of cyclodextrin-based pharmaceuticals[2][5].
Litigation and Enforcement
The patent has been involved in several litigation cases, where CyDex Pharmaceuticals has alleged infringement by other pharmaceutical companies. For instance, CyDex has sued Alembic Pharmaceuticals and Lupin for allegedly infringing the '088 patent by seeking FDA approval for generic versions of drugs that use SAE-CD compositions[2][5].
Patent Analytics and Claim Coverage
To manage and analyze the patent landscape effectively, companies like CyDex can use patent analytics tools. These tools help in tracking patents by claims and scope concepts, identifying gaps in coverage, and highlighting future design opportunities. Claim charts generated by these tools can be reviewed by technical experts to determine the applicability of specific scope concepts to target products or methods[3].
Exclusivity and Expiration
The '088 patent is active and has a defined expiration date. Any commercial manufacture, use, sale, or importation of products that infringe this patent before its expiration date could result in legal action. The patent's exclusivity period is crucial for CyDex to maintain its market position and protect its intellectual property[4].
Industry Impact
The '088 patent has significant implications for the pharmaceutical industry, particularly in the development of formulations for poorly soluble drugs. The use of SAE-CD compositions can enhance the bioavailability and therapeutic efficacy of these drugs, making them more effective and safer for patients.
Key Takeaways
- Composition and Preparation: The patent covers compositions and methods for preparing sulfoalkyl ether cyclodextrin.
- Pharmaceutical Applications: These compositions are used to enhance the solubility and stability of APIs.
- Patent Landscape: The patent is part of a broader intellectual property portfolio related to cyclodextrin compositions.
- Litigation: The patent has been involved in several infringement cases.
- Patent Analytics: Tools like claim charts and scope concepts help in managing and analyzing the patent landscape.
Frequently Asked Questions (FAQs)
What is the main subject of US Patent 9,200,088?
The main subject of US Patent 9,200,088 is sulfoalkyl ether cyclodextrin compositions, including their preparation and use in pharmaceutical formulations.
Who owns the '088 patent?
The '088 patent is owned by CyDex Pharmaceuticals, Inc.
What are the key applications of SAE-CD compositions?
SAE-CD compositions are used to enhance the solubility and stability of active pharmaceutical ingredients, particularly in injectable solutions, oral formulations, and topical applications.
How does the patent impact the pharmaceutical industry?
The patent impacts the industry by providing a method to improve the bioavailability and therapeutic efficacy of poorly soluble drugs through the use of SAE-CD compositions.
What are the implications of infringing the '088 patent?
Infringing the '088 patent can result in legal action, including claims for damages and other relief, as seen in the litigation cases involving CyDex Pharmaceuticals.
Cited Sources:
- United States Patent and Trademark Office. US9200088B2 - Sulfoalkyl ether cyclodextrin compositions. December 1, 2015.
- RPX Insight. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE CYDEX PHARMACEUTICALS, INC., Plaintiff, v. ALEMBIC GLOBAL HOLDING SA, ALEMBIC PHARMACEUTICALS, LTD. and ALEMBIC PHARMACEUTICALS, INC., Defendants. February 7, 2020.
- Schwegman, Lundberg & Woessner, P.A. Patent Analytics. Retrieved from https://www.slwip.com/services/patent-analytics/
- Google Patents. US9200088B2 - Sulfoalkyl ether cyclodextrin compositions. December 1, 2015.
- RPX Insight. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE CYDEX PHARMACEUTICALS, INC., Plaintiff, v. LUPIN LIMITED and LUPIN PHARMACEUTICALS, INC., Defendants. October 29, 2019.
