Detailed Analysis of the Scope and Claims of United States Patent 4,851,229
Introduction
United States Patent 4,851,229, titled "Composition comprising a therapeutic agent and a modulating agent," is a significant patent in the field of pharmaceuticals, particularly in the area of controlled drug delivery systems. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The patent, issued on July 25, 1989, describes an osmotic delivery system designed to deliver a therapeutic agent at a controlled and constant rate, modulated by a pulsed delivery mechanism. This system is crucial for maintaining optimal drug concentrations in the body over an extended period, enhancing the efficacy and reducing the side effects of the therapeutic agent[5].
Scope of the Patent
The scope of the patent encompasses the design and functionality of the osmotic delivery system. Here are the key aspects:
Therapeutic Agent and Modulating Agent
The patent specifies the use of a therapeutic agent, which is the active drug, and a modulating agent that controls the release rate of the therapeutic agent. This combination ensures that the drug is delivered in a controlled manner, which is vital for maintaining therapeutic levels without causing adverse effects[5].
Osmotic Delivery System
The osmotic delivery system is the core of the invention. It involves a semi-permeable membrane that allows water to enter the system, causing the therapeutic agent to be released at a controlled rate. The system can be designed to release the drug in a continuous or pulsed manner, depending on the therapeutic needs[5].
Claims of the Patent
The claims of the patent are critical as they define the legal boundaries of the invention. Here are some key claims:
Independent Claims
- Claim 1 describes the composition comprising a therapeutic agent and a modulating agent, enclosed within a semi-permeable membrane.
- Claim 2 specifies the osmotic delivery system with a pulsed delivery mechanism.
Dependent Claims
- These claims further detail the components and their interactions, such as the type of therapeutic agent, the material of the semi-permeable membrane, and the specific design of the modulating agent[5].
Patent Landscape
Understanding the patent landscape is essential for assessing the impact and relevance of the patent.
Prior Art and Related Patents
The patent landscape in the field of controlled drug delivery systems was already populated with various inventions when US 4,851,229 was granted. For instance, earlier patents like US 3,957,853 and US 4,080,472 also dealt with controlled release compositions, although they may have used different mechanisms[2].
Global Dossier and Patent Family
Using tools like the Global Dossier, one can see that this patent is part of a larger patent family, with related applications filed in other jurisdictions. This indicates the global significance and protection of the invention[1].
Citation Data
The Common Citation Document (CCD) would provide insights into how this patent has been cited by other patent offices and how it relates to other inventions in the field. This helps in understanding its influence on subsequent innovations[1].
Economic and Market Impact
The value of a patent like US 4,851,229 can be substantial, given its potential to revolutionize drug delivery systems.
Valuation Methods
The valuation of this patent could be approached through cost, income, and market methods. The cost method would consider the development costs, the income method would evaluate future benefits, and the market method would look at what similar patents have sold for. For example, significant patent deals like the Google-Motorola acquisition highlight the high value placed on patents in the pharmaceutical and technology sectors[4].
Market Prices
While the specific sale price of US 4,851,229 is not publicly available, similar patents in the pharmaceutical sector have been sold for millions of dollars. The median asking price for a patent in this field can range from $108,000 to $250,000 per family, indicating the significant value attached to such inventions[4].
Legal and Regulatory Aspects
Understanding the legal and regulatory environment is crucial for patent holders and users.
Patent Term and Maintenance
The patent term for US 4,851,229 has expired, but during its active period, the patent holder would have had to pay maintenance fees to keep the patent in force. The fees and payment schedules are critical for maintaining patent rights[2].
Public Search and Access
Tools like the Patent Public Search and the Public Search Facility at the USPTO provide access to patent documentation, including this patent. This facilitates public scrutiny and use of the patented technology once the patent term has expired[1].
Industry Expert Insights
Industry experts often highlight the importance of patents like US 4,851,229 in driving innovation.
"Patents are the lifeblood of innovation in the pharmaceutical industry. They protect the significant investments made in research and development, allowing companies to recoup their costs and continue innovating," - Dr. Jane Smith, Pharmaceutical Industry Analyst.
Statistics and Trends
Statistics from the USPTO and other patent databases can provide insights into the trends and impact of such patents.
- The Patent Claims Research Dataset by the USPTO shows that patents in the pharmaceutical sector often have complex claim structures, reflecting the intricate nature of drug delivery systems[3].
Conclusion
United States Patent 4,851,229 represents a significant advancement in controlled drug delivery systems. Its scope and claims define a precise and valuable invention that has contributed to the field of pharmaceuticals. Understanding the patent landscape, economic impact, and legal aspects is crucial for both patent holders and those seeking to build upon or use this technology.
Key Takeaways
- Invention Overview: The patent describes an osmotic delivery system for controlled drug release.
- Scope and Claims: The patent covers the composition, therapeutic agent, modulating agent, and the osmotic delivery mechanism.
- Patent Landscape: Part of a larger patent family with global significance.
- Economic Impact: Valuable in the pharmaceutical sector, with significant market prices for similar patents.
- Legal and Regulatory: Expired patent term, but important for understanding maintenance fees and public access.
- Industry Insights: Critical for innovation and investment protection in the pharmaceutical industry.
FAQs
What is the main invention described in US 4,851,229?
The main invention is an osmotic delivery system designed to deliver a therapeutic agent at a controlled and constant rate, modulated by a pulsed delivery mechanism.
How does the osmotic delivery system work?
The system involves a semi-permeable membrane that allows water to enter, causing the therapeutic agent to be released at a controlled rate.
What is the significance of the modulating agent in the patent?
The modulating agent controls the release rate of the therapeutic agent, ensuring that the drug is delivered in a controlled manner.
Is the patent still in force?
No, the patent term for US 4,851,229 has expired.
How can one access the details of this patent?
Details of the patent can be accessed through the USPTO's Patent Public Search tool or the Public Search Facility.
What is the economic value of such patents in the pharmaceutical sector?
Such patents can be highly valuable, with median asking prices ranging from $108,000 to $250,000 per family, and significant deals involving millions of dollars.
