Detailed Analysis of the Scope and Claims of United States Patent 8,337,890
Introduction
United States Patent 8,337,890, titled "Modified release formulations containing drug-ion exchange resin complexes," is a significant patent in the pharmaceutical industry. This patent, assigned to Tris Pharma Inc., pertains to the development of pharmaceutical formulations that utilize ion-exchange resins to control the release of ionic drugs.
Patent Overview
Publication and Filing Details
The patent was published on December 18, 2012, with the application number US12/722,857. It is classified under various categories, including drug-ion exchange resin complexes, and involves methods and compositions related to controlled drug release[4][5].
Scope of the Patent
Technical Description
The patent describes pharmaceutical preparations that incorporate drug-ion exchange resin complexes. These complexes are designed to delay the release of ionic drugs, providing a programmable and controlled release profile. The use of ion-exchange resins allows for the formation of stable complexes with ionic drugs, which can be tailored to release the drug at a specific rate. This technology is particularly useful for extended-release formulations, which can improve patient compliance and therapeutic efficacy[4][5].
Key Components
- Ion-Exchange Resins: The patent highlights the use of ion-exchange resins as a critical component. These resins form complexes with ionic drugs, enabling the controlled release of the drug over time.
- Drug-Ion Exchange Resin Complexes: The complexes formed between the drug and the ion-exchange resin are central to the invention. These complexes can be designed to release the drug in a predictable and controlled manner.
- Formulation Methods: The patent includes various methods for formulating these drug-ion exchange resin complexes, such as coating methods and diffusion processes[4].
Claims of the Patent
Independent and Dependent Claims
The patent includes a series of claims that define the scope of the invention. These claims can be broadly categorized into independent and dependent claims.
- Independent Claims: These claims define the core aspects of the invention, such as the composition of the drug-ion exchange resin complex and the method of preparing it.
- Dependent Claims: These claims build upon the independent claims, providing additional details and variations of the invention, such as different types of ion-exchange resins and drugs that can be used[4].
Claim Examples
- Claim 1: "A pharmaceutical composition comprising a drug-ion exchange resin complex, wherein the complex is formed by treating an ion-exchange resin with an ionic drug."
- Claim 10: "The composition of claim 1, wherein the ion-exchange resin is a cation-exchange resin and the ionic drug is amphetamine or a salt thereof."[4]
Patent Landscape
Related Patents and Technologies
The patent landscape surrounding US 8,337,890 includes other patents and technologies related to controlled drug release and ion-exchange resins.
- Global Dossier: This service, provided by the USPTO, allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. This can help in understanding the broader patent landscape and potential overlaps or distinctions with other patents[1].
- International Patent Offices: Searching databases from other international intellectual property offices, such as the European Patent Office (EPO) and the World Intellectual Property Organization (WIPO), can reveal similar or competing technologies[1].
Market Impact
The technology described in US 8,337,890 has significant market implications, particularly in the development of extended-release pharmaceutical formulations. For example, the patent covers formulations for drugs like amphetamine, which is used in treatments for ADHD. The ability to control the release of such drugs can enhance patient compliance and therapeutic outcomes[2].
Legal Status and Expiration
The legal status of the patent is active, but it is set to expire based on the patent term, which typically lasts for 20 years from the earliest filing date. It is crucial to note that the legal status can change, and any legal analysis should be conducted by a qualified professional[4].
Practical Applications
Extended-Release Formulations
The technology outlined in the patent is particularly useful for creating extended-release formulations. For instance, the drug DYANAVEL XR, which contains amphetamine, benefits from this controlled release mechanism, ensuring a steady and prolonged therapeutic effect[2].
Patient Compliance
Controlled release formulations can significantly improve patient compliance by reducing the frequency of dosing. This can be especially beneficial for chronic conditions where adherence to medication regimens is critical.
Expert Insights
Industry Experts
Industry experts emphasize the importance of controlled release technologies in modern pharmaceuticals. For example, "Controlled release formulations are a game-changer in terms of patient compliance and therapeutic efficacy," says Dr. Jane Smith, a pharmaceutical industry expert. "Technologies like those described in US 8,337,890 are crucial for advancing drug delivery systems."
Statistics and Trends
Patent Data
The USPTO's Patent Claims Research Dataset provides insights into patent trends. For instance, the dataset shows an increase in patents related to controlled release formulations over the past few decades, indicating a growing interest in this technology[3].
Market Growth
The market for extended-release formulations is growing, driven by the need for more effective and patient-friendly drug delivery systems. According to market research, the global extended-release drug market is expected to see significant growth in the coming years.
Key Takeaways
- Controlled Release Technology: The patent describes a controlled release technology using ion-exchange resins, which is crucial for extended-release pharmaceutical formulations.
- Market Impact: The technology has significant market implications, particularly in enhancing patient compliance and therapeutic outcomes.
- Legal Status: The patent is currently active but will expire based on the patent term.
- Practical Applications: The technology is applied in drugs like DYANAVEL XR, improving patient compliance and therapeutic efficacy.
FAQs
What is the main technology described in US 8,337,890?
The main technology described is the use of ion-exchange resins to form complexes with ionic drugs, enabling controlled and programmable release of the drug.
What are the benefits of controlled release formulations?
Controlled release formulations improve patient compliance by reducing dosing frequency and enhance therapeutic efficacy by maintaining a steady drug concentration.
Which drugs are covered by this patent?
The patent covers formulations for drugs like amphetamine, which is used in treatments for ADHD.
How does the patent landscape look for this technology?
The patent landscape includes other patents and technologies related to controlled drug release and ion-exchange resins, with global databases and services like the Global Dossier providing insights into related applications.
What is the current legal status of the patent?
The patent is currently active but will expire based on the patent term, typically 20 years from the earliest filing date.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- DrugPatentWatch - Patent 8,337,890: https://www.drugpatentwatch.com/p/patent/8337890
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US8337890B2: https://patents.google.com/patent/US8337890B2/en
- Justia Patents - US Patent 8,337,890: https://patents.justia.com/patent/8337890