Analyzing the Scope and Claims of United States Patent 9,522,191
Introduction
United States Patent 9,522,191, titled "Modified Release Formulations Containing Drug-Ion Exchange Resin Complexes," is a significant patent in the pharmaceutical field, particularly in the area of drug delivery systems. This patent, assigned to Tris Pharma, Inc., outlines innovative methods and compositions for controlled release formulations using drug-ion exchange resin complexes.
Background and Context
The patent is part of a series of continuations and continuations-in-part, indicating a long-standing research and development effort in this area. The earliest application dates back to January 15, 2014, highlighting the evolutionary nature of the technology[1].
Patent Scope
Claims Overview
The patent includes 27 claims that define the scope of the invention. These claims are divided into independent and dependent claims, each detailing specific aspects of the drug-ion exchange resin complexes and their formulations.
- Independent Claims: These claims define the broadest scope of the invention, including the composition of the drug-ion exchange resin complexes, the method of preparation, and the pharmaceutical formulations containing these complexes[1].
- Dependent Claims: These claims narrow down the scope by specifying particular embodiments, such as the type of resin, the drug used, and the specific formulation characteristics.
Key Components
- Drug-Ion Exchange Resin Complexes: The patent focuses on complexes formed between a drug and an ion exchange resin. These complexes are designed to provide controlled release of the drug, which is crucial for maintaining therapeutic levels over an extended period[1].
- Resin Types: The patent specifies various types of ion exchange resins that can be used, including cationic and anionic resins. The choice of resin can affect the release profile of the drug[1].
Claims Analysis
Independent Claim Length and Count
Research on patent scope metrics suggests that independent claim length and count can be indicative of patent breadth and quality. For US Patent 9,522,191, the independent claims are detailed and specific, suggesting a well-defined scope. The number of independent claims is moderate, indicating a balanced approach between breadth and specificity[3].
Claim Language
The language used in the claims is precise and technical, reflecting the complex nature of pharmaceutical formulations. This precision helps in defining the invention clearly and distinguishing it from prior art[1].
Patent Landscape
Prior Art and Related Patents
The patent cites several prior patents and publications, indicating a rich background in the field of drug delivery systems. Patents such as 2,099,402 A and 6,555,136 B2 are referenced, showing the evolutionary path of the technology[1].
Continuations and Family Members
The patent is part of a large family of patents, with multiple continuations and continuations-in-part. This indicates ongoing research and development, with each subsequent patent building upon the previous ones to refine and expand the technology[1].
Legal and Practical Considerations
Patent Classification
The patent is classified under various CPC (Cooperative Patent Classification) categories, including A61K 47/585 and A61K 9/0053, reflecting its relevance to pharmaceutical preparations and drug delivery systems[1].
Global Implications
The use of Global Dossier and Common Citation Document (CCD) tools can help in understanding the global patent landscape related to this invention. These tools provide access to file histories and citation data from participating IP offices, facilitating a comprehensive analysis of the patent's international scope[4].
Industry Impact
Innovation and Licensing
The controlled release formulations described in the patent can significantly impact the pharmaceutical industry by providing more effective and patient-friendly drug delivery systems. This innovation can lead to increased licensing and collaboration opportunities, driving further research and development in the field[3].
Litigation and Patent Quality
The specificity and clarity of the claims in this patent are crucial in avoiding potential litigation issues. Well-defined claims help in establishing clear boundaries of the invention, reducing the likelihood of disputes over patent infringement or validity[3].
Expert Insights
Industry experts and legal practitioners often emphasize the importance of clear and specific patent claims. For instance, Andrei Iancu, former Undersecretary of Commerce for IP and Director of the USPTO, has highlighted the need for high-quality patents that clearly define the invention to promote innovation and reduce litigation costs[2].
Key Takeaways
- Controlled Release Formulations: The patent focuses on drug-ion exchange resin complexes for controlled release formulations.
- Specific Claims: The claims are detailed and specific, defining the scope of the invention clearly.
- Patent Family: The patent is part of a large family of patents, indicating ongoing research and development.
- Global Implications: The use of Global Dossier and CCD tools is essential for understanding the global patent landscape.
- Industry Impact: The innovation can lead to more effective drug delivery systems and increased licensing opportunities.
FAQs
Q: What is the main focus of United States Patent 9,522,191?
A: The main focus is on controlled release formulations using drug-ion exchange resin complexes.
Q: How many claims are included in the patent?
A: The patent includes 27 claims.
Q: What types of resins are specified in the patent?
A: The patent specifies both cationic and anionic ion exchange resins.
Q: How does the patent impact the pharmaceutical industry?
A: It provides more effective and patient-friendly drug delivery systems, potentially increasing licensing and collaboration opportunities.
Q: Why are specific claims important in this patent?
A: Specific claims help in establishing clear boundaries of the invention, reducing the likelihood of disputes over patent infringement or validity.
Sources
- United States Patent and Trademark Office, "MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES," US Patent 9,522,191 B2.
- Administrative Conference of the United States, "U.S. Patent Small Claims Court."
- SSRN, "Patent Claims and Patent Scope."
- United States Patent and Trademark Office, "Search for patents - USPTO."
