United States Patent 8,420,056: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,420,056, titled "Abuse-proofed dosage form," is a significant patent in the pharmaceutical industry, particularly in the area of drug abuse prevention. This patent, assigned to Grünenthal GmbH, addresses a critical issue in pharmaceuticals by designing dosage forms that are resistant to abuse.
Background
The patent was granted on April 16, 2013, and is part of a series of patents focused on developing abuse-deterrent formulations. The need for such formulations arises from the increasing problem of prescription drug abuse, which has become a public health concern.
Claims Overview
Independent Claims
The patent includes several independent claims that define the scope of the invention. Here are some key claims:
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Claim 1: This claim describes an abuse-proofed dosage form that is thermoshaped without being extruded, comprising at least one synthetic or natural polymer and at least one active ingredient. The dosage form is designed to be resistant to crushing and grinding, which are common methods used to abuse drugs[4].
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Claim 19: This claim specifies the dosage form as being safeguarded from abuse by incorporating a gelling agent that prevents the active ingredient from being released rapidly when the dosage form is tampered with[4].
Dependent Claims
Dependent claims further elaborate on the independent claims by adding specific details or limitations. For example:
- Claims 20-22: These claims describe the types of polymers and gelling agents that can be used, such as polyethylene oxide or polyvinyl acetate, and the methods of preparing the dosage form[4].
Scope of the Invention
The scope of the invention is broad yet specific, focusing on the design and composition of abuse-proofed dosage forms.
Key Components
- Polymer Matrix: The dosage form is composed of a polymer matrix that provides the structural integrity and abuse resistance.
- Active Ingredient: The active ingredient is embedded within the polymer matrix to prevent rapid release when the dosage form is tampered with.
- Gelling Agent: The inclusion of a gelling agent ensures that even if the dosage form is crushed or ground, it will form a gel that prevents the rapid release of the active ingredient[4].
Methods of Preparation
The patent describes various methods for preparing the abuse-proofed dosage form, including thermoshaping and the use of specific solvents and processing conditions[4].
Patent Landscape
Related Patents
The patent is part of a larger family of patents related to abuse-deterrent formulations. Other patents in this family include:
- U.S. Patent No. 8,114,383: This patent also deals with abuse-proofed dosage forms but focuses on different formulations and methods of preparation[1].
- U.S. Patent No. 8,075,872: This patent describes additional compositions and methods for creating abuse-resistant dosage forms[1].
Litigation and Appeals
The patent has been involved in various legal proceedings, including appeals related to obviousness and nonstatutory double patenting. For instance, in one appeal, the Examiner's rejections on the grounds of obviousness-type double patenting were reversed[1].
Economic and Market Impact
The development of abuse-proofed dosage forms has significant economic and market implications. These formulations can reduce the risk of prescription drug abuse, which in turn can lower healthcare costs associated with abuse and overdose.
Market Demand
There is a growing demand for abuse-deterrent formulations due to increasing regulatory pressures and public health concerns. This demand drives innovation and investment in this area, making patents like U.S. Patent 8,420,056 highly valuable.
Competitive Landscape
The competitive landscape in this field is intense, with several pharmaceutical companies and research institutions working on similar technologies. Patents like this one provide a competitive edge by protecting the intellectual property and allowing the patent holder to market and sell the invention exclusively.
Technical and Scientific Significance
Innovative Aspects
The patent introduces innovative aspects in the design and preparation of dosage forms, particularly the use of thermoshaping and gelling agents to prevent abuse.
Scientific Contributions
The scientific contributions of this patent include the development of new materials and methods that enhance the safety and efficacy of pharmaceutical products. This work contributes to the broader field of pharmaceutical science by providing solutions to a critical public health issue.
Challenges and Limitations
Manufacturing Complexity
One of the challenges associated with this patent is the complexity of manufacturing the abuse-proofed dosage forms. The process requires precise control over the composition and processing conditions to ensure the desired properties.
Regulatory Compliance
Another challenge is ensuring regulatory compliance. The development and approval of new pharmaceutical formulations are heavily regulated, and compliance with these regulations can be time-consuming and costly.
Future Directions
Research and Development
Future research and development in this area may focus on improving the manufacturing processes, exploring new materials, and enhancing the efficacy of the abuse-deterrent mechanisms.
Market Expansion
As the demand for abuse-deterrent formulations continues to grow, there is potential for market expansion both domestically and internationally. This could involve collaborations with other pharmaceutical companies and regulatory bodies to bring these products to a wider audience.
Key Takeaways
- Innovative Design: The patent introduces an innovative design for abuse-proofed dosage forms using thermoshaping and gelling agents.
- Broad Scope: The scope of the invention is broad, covering various compositions and methods of preparation.
- Economic Impact: The patent has significant economic and market implications by reducing the risk of prescription drug abuse.
- Competitive Edge: The patent provides a competitive edge in the pharmaceutical market by protecting the intellectual property.
- Future Directions: Future research and development will focus on improving manufacturing processes and expanding market reach.
FAQs
What is the main purpose of U.S. Patent 8,420,056?
The main purpose of U.S. Patent 8,420,056 is to describe and protect an abuse-proofed dosage form designed to prevent the misuse of pharmaceuticals.
What are the key components of the abuse-proofed dosage form?
The key components include a polymer matrix, an active ingredient, and a gelling agent that prevents rapid release of the active ingredient when the dosage form is tampered with.
How does the patent impact the pharmaceutical industry?
The patent impacts the industry by providing a solution to the problem of prescription drug abuse, reducing healthcare costs, and driving innovation in abuse-deterrent formulations.
What are some of the challenges associated with this patent?
Challenges include the complexity of manufacturing the dosage forms and ensuring regulatory compliance.
What are the future directions for research and development in this area?
Future directions include improving manufacturing processes, exploring new materials, and enhancing the efficacy of the abuse-deterrent mechanisms.
Cited Sources
- GRÜNENTHAL GMBH, Casetext.
- AI VISUALIZE, INC. v. NUANCE COMMUNICATIONS, INC., CAFC.
- Patent Claims Research Dataset, USPTO.
- US8420056B2 - Abuse-proofed dosage form, Google Patents.
