United States Patent 6,149,940: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,149,940, titled "Tablet with controlled release of alfuzosin hydrochloride," is a significant patent in the pharmaceutical field, particularly in the area of controlled-release drug delivery systems. This patent, now expired, was granted to address specific challenges in the administration of alfuzosin hydrochloride, a medication used to treat benign prostatic hyperplasia.
Patent Overview
Invention Description
The patent describes a pharmaceutical tablet designed to release alfuzosin hydrochloride in a controlled manner. The tablet consists of two or three layers, each with specific functions:
- Layer 1: Contains the active substance.
- Layer 2: Acts as a barrier to modify the release of the active substance.
- Layer 3: Composed of hydrophilic polymers that gel and/or swell upon contact with gastric juices, further controlling the release rate[4].
Production Process
The tablets are produced using standard tableting processes, including the use of rotary presses capable of producing multi-layer tablets. The layers are formed by mixing powders and/or granulates and compressing them into the desired shape[4].
Patent Claims
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically focus on the structure and composition of the tablet, including the specific layers and their functions. For example:
- Claim 1 might describe the overall structure of the tablet with its multiple layers.
- Claim 2 could detail the composition of each layer, including the types of polymers used[4].
Dependent Claims
Dependent claims further specify the invention by adding additional details to the independent claims. These might include:
- The specific amounts of each layer.
- The method of producing the tablets.
- The shape and size of the tablets[4].
Patent Scope
Metrics for Measuring Patent Scope
The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. These metrics help in understanding the breadth and clarity of the patent claims. For instance, narrower claims are often associated with a higher probability of grant and a shorter examination process[3].
Application to US 6,149,940
In the case of US 6,149,940, the patent claims are relatively specific, focusing on the unique multi-layer structure and the controlled release mechanism. This specificity suggests that the patent scope is well-defined, reducing the likelihood of overly broad claims that could lead to litigation and licensing issues.
Inventorship and Conception
Determining True and Only Inventors
US patent law emphasizes the importance of identifying the true and only inventors, which is crucial for the validity and enforceability of the patent. The conception step, where the idea is formed in the mind of the inventor, is a critical aspect of determining inventorship. For US 6,149,940, the inventors would have had to conceive the idea of the multi-layer tablet with controlled release of alfuzosin hydrochloride and reduce it to practice[2].
Patent Landscape
Global Dossier and International Integration
The patent landscape for pharmaceutical inventions like US 6,149,940 is influenced by global initiatives such as the Global Dossier, which provides access to file histories of related applications from participating IP Offices. This integration helps in understanding the global patent family and citation data, which can be crucial for navigating the complex landscape of pharmaceutical patents[1].
Public Search Facilities and Resources
Resources like the USPTO Public Search Facility and Patent and Trademark Resource Centers (PTRCs) are essential for conducting thorough patent searches. These facilities provide access to patent and trademark information, helping inventors and patent attorneys to ensure that their inventions are novel and non-obvious[1].
Legal and Litigation Aspects
Court Decisions and Patent Validity
The validity of patents can be challenged in court, and decisions from courts like the Court of Appeals for the Federal Circuit are pivotal in shaping patent law. For instance, the court's decisions on inventorship and claim construction can impact the enforceability of patents like US 6,149,940[2][5].
Examples and Illustrations
Production and Administration
The patent includes detailed descriptions of how the tablets are produced and administered. For example, the tablets are designed to increase in volume upon contact with gastric juices, which can be monitored using video microscopy. This detailed description helps in understanding the practical application of the invention[4].
Statistics and Industry Impact
Pharmaceutical Industry Trends
The pharmaceutical industry has seen significant advancements in controlled-release drug delivery systems. Patents like US 6,149,940 contribute to these advancements by providing innovative solutions to drug administration challenges. Statistics on patent filings and grants in this area can indicate the level of innovation and competition within the industry.
Expert Insights
Quotes from Industry Experts
Industry experts often highlight the importance of well-defined patent claims and the need for thorough searches to ensure novelty and non-obviousness. For example:
"The clarity and specificity of patent claims are crucial for avoiding litigation and ensuring the enforceability of the patent"[3].
Key Takeaways
- Specific Claims: The patent includes specific claims that define the structure and composition of the multi-layer tablet.
- Controlled Release: The invention focuses on a controlled release mechanism for alfuzosin hydrochloride.
- Production Process: The tablets are produced using standard tableting processes.
- Global Integration: The patent landscape is influenced by global initiatives like the Global Dossier.
- Legal Considerations: The validity and enforceability of the patent depend on correct inventorship and claim construction.
FAQs
What is the main innovation of US 6,149,940?
The main innovation is the design of a multi-layer tablet that provides controlled release of alfuzosin hydrochloride.
How are the tablets produced?
The tablets are produced using rotary presses and standard tableting processes, involving the compression of powders and/or granulates into the desired shape.
Why is correct inventorship important?
Correct inventorship is crucial for the validity and enforceability of the patent, ensuring that only the true and only inventors are listed.
What resources are available for patent searches?
Resources include the USPTO Public Search Facility, Patent and Trademark Resource Centers (PTRCs), and online tools like the Global Dossier.
How does the patent landscape impact pharmaceutical inventions?
The patent landscape, influenced by global initiatives and court decisions, affects the novelty, non-obviousness, and enforceability of pharmaceutical patents.
Cited Sources
- USPTO: Search for patents - USPTO.
- Oregon State University: Determining Inventorship for US Patent Applications.
- SSRN: Patent Claims and Patent Scope.
- Google Patents: Tablet with controlled release of alfuzosin hydrochloride.
- United States Court of Appeals for the Federal Circuit: DDR Holdings.
