United States Patent 6,022,562: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,022,562, titled "Medicinal and/or nutritional microcapsules for oral administration," is a significant patent in the field of pharmaceuticals and nutrition. This patent, assigned to Flamel Technologies, addresses the development of microcapsules designed to enhance the absorption and residence time of medicinal and nutritional active principles (APs) in the gastrointestinal tract.
Background and Context
The patent focuses on sustained-release systems, which are crucial for ensuring that medicinal and nutritional compounds are absorbed effectively over a prolonged period. This is particularly important for medications and nutrients that need to be released in a controlled manner to maintain therapeutic levels in the body[1].
Scope of the Patent
Key Characteristics
The patent describes microcapsules that have several key characteristics:
- Residence Time: These microcapsules are designed to have a longer residence time in the small intestine than the natural transit time, enhancing the effective in vivo absorption of the APs.
- Composition: The microcapsules contain at least one AP, excluding acetylsalicylic acid, and are formulated to ensure sustained or controlled release in the small intestine.
- Size and Form: The microcapsules are multiparticulate forms, typically smaller than 2 mm, allowing them to cross the stomach quickly and uniformly, independent of the pylorus opening[1].
Technological Innovations
The patent introduces several technological innovations:
- Density Adjustment: The microcapsules can include densifying agents to increase their density, which significantly prolongs their transit time in the gastrointestinal tract. This approach is highlighted in other related patents, such as EP 0,080,341 and 0,173,210[1].
- Bioadhesive Properties: The invention also involves bioadhesive particulate systems where the sustained-release form of the AP is overcoated with an adhesive composition based on polymers like Carbopol®, Polycarbophil®, alginates, gelatin, or pectin. This separates the functions of release control and bioadhesion[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention:
- Microcapsule Composition: Claims specify the composition of the microcapsules, including the type of APs, the presence of nitrogen-containing polymers, and the use of densifying agents.
- Preparation Process: The patent also claims a process for preparing these microcapsules, which involves specific steps to ensure the desired characteristics are achieved[1].
Dependent Claims
Dependent claims further detail the specifics of the microcapsules and the preparation process, including the percentage of nitrogen-containing polymers and the preferred types of polymers used in the coating composition[1].
Patent Landscape
Related Patents
The patent landscape surrounding US 6,022,562 includes several related patents and applications:
- EP 396,425: This patent discloses a system for the administration of APs like nitrates, ephedrines, and potassium chloride in a single daily dose.
- FR 2,395,026: This patent claims a process for preparing sustained-release microparticles containing densifying agents to prolong transit time[1].
Litigation and Enforcement
Flamel Technologies has been involved in litigation to protect this patent. For instance, they filed a lawsuit against Lupin Limited in the U.S. District Court for the District of Columbia for infringement of US Patent No. 6,022,562[2].
Valuation and Economic Impact
Valuation Methods
The value of a patent like US 6,022,562 can be determined using various methods:
- Cost Approach: This involves the costs incurred in developing the patent.
- Income Approach: This method considers the future benefits provided by the patent, such as income or savings.
- Market Approach: This determines the value based on what a willing buyer would pay for a similar asset[4].
Given the innovative nature and the potential market impact of this patent, its value could be substantial, likely falling within the median to high range of patent valuations.
Challenges and Criticisms
Patent Scope and Quality
The scope and quality of patents, including US 6,022,562, are subject to scrutiny. There are concerns about the breadth and clarity of patent claims, which can affect innovation and litigation costs. Studies have shown that narrower claims tend to have a higher probability of grant and shorter examination processes[3].
Industry Impact
Enhanced Absorption
The microcapsules described in this patent have the potential to significantly enhance the absorption of medicinal and nutritional compounds, leading to better therapeutic outcomes and improved patient compliance.
Market Domination
Companies holding such patents can gain a competitive edge in the market by offering products with superior absorption profiles, which can lead to market domination in the pharmaceutical and nutritional sectors.
Key Takeaways
- Innovative Microcapsules: The patent introduces microcapsules with prolonged residence time in the small intestine, enhancing absorption.
- Technological Advancements: The use of densifying agents and bioadhesive properties are key technological innovations.
- Litigation and Enforcement: The patent has been subject to litigation to protect its claims.
- Valuation: The patent's value can be substantial, determined through cost, income, and market approaches.
- Industry Impact: The patent has the potential to enhance therapeutic outcomes and lead to market dominance.
FAQs
What is the main innovation of US Patent 6,022,562?
The main innovation is the development of microcapsules with a longer residence time in the small intestine, enhancing the absorption of medicinal and nutritional active principles.
How do the microcapsules achieve prolonged transit time?
The microcapsules achieve prolonged transit time through the use of densifying agents, which increase their density and slow down their transit through the gastrointestinal tract.
What are the potential benefits of these microcapsules?
The potential benefits include enhanced absorption of medicinal and nutritional compounds, leading to better therapeutic outcomes and improved patient compliance.
Has this patent been involved in any litigation?
Yes, Flamel Technologies has filed a lawsuit against Lupin Limited for infringement of this patent.
How is the value of this patent determined?
The value can be determined using the cost, income, and market approaches, considering the costs incurred, future benefits, and market demand.
Sources
- US6022562A - Medicinal and/or nutritional microcapsules for oral administration - Google Patents
- Flamel Technologies Announces Filing of Lawsuit - BioSpace
- Patent Claims and Patent Scope - Hoover Institution
- The value of a patent - Perpetual Motion Patents
