United States Patent 9,572,803: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 9,572,803, titled "Abuse Resistant Drug Formulation," is a significant patent in the pharmaceutical industry, particularly in the field of controlled release and abuse-resistant drug formulations. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, granted to a pharmaceutical company, addresses the critical issue of drug abuse by developing formulations that are resistant to tampering and misuse. The invention focuses on creating dosage forms that provide controlled release and enhanced crush resistance, thereby reducing the potential for abuse through solvent exposure or physical manipulation[4].
Scope of the Invention
Controlled Release and Abuse Resistance
The patent describes a method and composition for creating abuse-resistant drug formulations. These formulations include particles coated with a fat/wax material that provides sustained release and resistance to solvents and physical forces such as crushing. The coating material, often ethylcellulose, is deposited using an alcohol-based solvent, ensuring the particles are resistant to tampering[4].
Key Components
- API and Fat/Wax: The formulation includes an active pharmaceutical ingredient (API) combined with a fat/wax material. The API is present in an amount of at least about 0.1% by weight of the particles, while the fat/wax is between about 5% and 40% by weight[4].
- Coating: The coating contains between about 5% and 30% of a fat/wax based on the weight of the coated particles. This coating is present in an amount of between about 20% and 75% by weight of the coated particles[4].
Pharmaceutical Composition
The patent outlines various embodiments of the pharmaceutical composition, including:
- Matrix Formulation: A matrix including particles of a fat/wax and API-containing particles. This matrix provides solvent resistance and affects the release rate and crushing resistance of the formulation[4].
- Granulation Process: The API is granulated with materials that are slightly soluble in water or alcohol, such as ethylcellulose and hydroxypropyl methylcellulose (HPMC). This process is conducted in the presence of water and alcohol[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the coated particles comprising an API and a fat/wax in specific proportions, with a crush-resistant coating.
- Claim 2 outlines the method of producing the dosage form, including granulating the API with specific materials and applying a coating[4].
Dependent Claims
- These claims further specify the composition and method, including the types of materials used (e.g., ethylcellulose, HPMC), the solvent used for coating (e.g., anhydrous ethanol), and the curing process for the particles and coated particles[4].
Patent Landscape
Prior Art
The patent references prior art, such as U.S. Pat. No. 5,500,227, which discloses the use of waxes and fatty alcohols in coatings for sustained release. However, the current patent introduces novel combinations and methods that enhance abuse resistance and controlled release[4].
Global Dossier and IP5 Offices
The patent is part of a global patent family, with related applications filed at participating IP Offices through the Global Dossier service provided by the USPTO. This service allows users to access the file histories and dossier data for related applications, facilitating a comprehensive view of the patent family[1].
Public Search and Databases
The USPTO's Patent Public Search tool and other resources like the Patent Examination Data System (PEDS) provide access to bibliographic data and full-text documents of patents, including this one. These tools are essential for conducting thorough patent searches and analyzing the patent landscape[1].
Economic and Legal Implications
Market Impact
The invention has significant market implications, particularly in the pharmaceutical industry where abuse-resistant formulations are in high demand. The patent protects the innovative method and composition, giving the patent holder a competitive edge in the market.
Legal Considerations
The patent's legal status and any potential disputes or litigations would be managed through the U.S. patent system. There have been discussions about establishing a small claims patent court to handle smaller-scale patent disputes more efficiently, which could impact how future disputes related to this patent are handled[5].
Expert Insights
Industry experts and legal practitioners have emphasized the importance of robust patent protection for pharmaceutical innovations. For example, Andrei Iancu, former Undersecretary of Commerce for IP and Director of the USPTO, has highlighted the need for strong IP protection to encourage innovation in critical fields like pharmaceuticals[5].
Statistics and Trends
- Patent Filings: The number of patent filings in the pharmaceutical sector has been increasing, reflecting the growing importance of IP protection in this field.
- Patent Scope: Research datasets like the Patent Claims Research Dataset provided by the USPTO offer insights into patent scope and claims, helping to understand the breadth and depth of patent protection in pharmaceuticals[3].
Key Takeaways
- Innovation in Abuse Resistance: The patent introduces novel methods and compositions for creating abuse-resistant drug formulations.
- Market Significance: The invention has significant market implications, particularly in reducing drug abuse.
- Legal and Economic Impact: The patent protects the innovation, giving the patent holder a competitive edge and highlighting the importance of IP protection in pharmaceuticals.
- Global Patent Family: The patent is part of a global patent family, accessible through services like the Global Dossier.
FAQs
What is the main focus of United States Patent 9,572,803?
The main focus of this patent is the development of abuse-resistant drug formulations that provide controlled release and enhanced crush resistance.
What are the key components of the patented formulation?
The formulation includes an active pharmaceutical ingredient (API) combined with a fat/wax material, and a coating made from materials like ethylcellulose.
How does the granulation process work?
The API is granulated with materials slightly soluble in water or alcohol, such as ethylcellulose and HPMC, in the presence of water and alcohol.
What is the significance of the Global Dossier in this context?
The Global Dossier service allows users to access the file histories and dossier data for related applications filed at participating IP Offices, providing a comprehensive view of the patent family.
Why is IP protection important for pharmaceutical innovations?
IP protection is crucial for encouraging innovation in the pharmaceutical sector by providing a competitive edge and financial incentives for research and development.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- USA.gov - U.S. Patent and Trademark Office (USPTO): https://www.usa.gov/agencies/u-s-patent-and-trademark-office
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US9572803B2: https://patents.google.com/patent/US9572803B2/en
- ACUS - U.S. Patent Small Claims Court: https://www.acus.gov/research-projects/us-patent-small-claims-court
