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Patent landscape, scope, and claims: |
Analyzing the Scope and Claims of United States Patent 7,163,931
Introduction
United States Patent 7,163,931, titled "Stable Pharmaceutical Composition Comprising an Estrogen," is a significant patent in the pharmaceutical industry, particularly in the field of hormonal therapies. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, granted on January 16, 2007, addresses a critical issue in pharmaceutical formulations: the stability of estrogenic compounds. Estrogens, such as ethinyl estradiol, are commonly used in hormonal contraceptives and hormone replacement therapies but are prone to degradation, affecting their efficacy and shelf life[4].
Scope of the Patent
The patent describes a stable pharmaceutical composition that includes an estrogen, specifically ethinyl estradiol, complexed with a cyclodextrin derivative. Here are the key components of the scope:
Active Ingredients
- The composition includes an estrogen, such as ethinyl estradiol, which is complexed with a cyclodextrin derivative to enhance stability[4].
Excipients and Stabilizers
- The formulation includes diluents like lactose, sucrose, corn starch, and microcrystalline cellulose.
- Stabilizers such as sucrose fatty acid esters are used.
- Water-soluble polymers like polyethylene glycol, methacrylate copolymers, and copovidone are incorporated.
- Antioxidants like vitamin E, vitamin E acetate, butylated hydroxyanisole, and butylated hydroxytoluene are added to prevent oxidative degradation.
- Surfactants such as poloxamer, sodium lauryl sulfate, and polysorbate are included to improve the formulation's properties[4].
Preparation Methods
The patent outlines various methods for preparing the pharmaceutical composition, including melt extrusion, solid dispersion, solid solution, coprecipitation, wet granulation, melt granulation, dry granulation, and direct compression[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the stable pharmaceutical composition comprising an estrogen complexed with a cyclodextrin derivative, along with specified excipients and stabilizers.
- Claim 2 specifies the method of preparing the composition using various techniques like melt extrusion and wet granulation[4].
Dependent Claims
- These claims further detail the specific components and their proportions, as well as additional features of the composition, such as the stability requirements and the absence of certain ingredients like polyvinylpyrrolidone[4].
Patent Landscape
To understand the significance and positioning of this patent, it is essential to examine the broader patent landscape in the field of pharmaceutical formulations.
Prior Art
- Previous patents, such as US Patent No. 5,134,127 and US Patent No. 5,382,434, addressed similar issues of stability and formulation but used different approaches, such as clathrate complexes and dry granulation methods[4].
International Context
- The European Patent Office (EPO) and other international intellectual property offices have similar patents and applications related to stable pharmaceutical compositions. For example, the EPO's esp@cenet database provides access to European patents that may overlap or complement the claims of US Patent 7,163,931[1].
Current Trends and Innovations
- The field of pharmaceutical formulations is continuously evolving, with new technologies and materials being developed to improve stability, bioavailability, and patient compliance. Recent patents and research focus on advanced delivery systems, such as nanoparticles and liposomes, which could potentially replace or enhance the formulations described in US Patent 7,163,931.
Legal and Regulatory Aspects
The validity and enforcement of US Patent 7,163,931 are subject to various legal and regulatory frameworks.
Patent Search and Examination
- The USPTO's Patent Public Search tool and other resources, such as the Patent Examination Data System (PEDS), are crucial for conducting thorough searches and examinations to ensure the novelty and non-obviousness of the invention[1].
Litigation and Dispute Resolution
- In the event of disputes or infringement claims, the patent holder may need to navigate the legal system, potentially involving small claims patent courts, as proposed in recent studies by the Administrative Conference of the United States (ACUS)[5].
Economic and Market Impact
The economic and market impact of US Patent 7,163,931 can be significant, given the widespread use of estrogenic compounds in pharmaceuticals.
Market Dominance
- A stable pharmaceutical composition can provide a competitive edge in the market, as it ensures consistent efficacy and longer shelf life, which are critical factors for both manufacturers and consumers.
Licensing and Collaboration
- The patent can be a valuable asset for licensing agreements or collaborative research, enabling the development of new products and formulations that build upon the patented technology.
Key Takeaways
- Stability Enhancement: The patent provides a method to enhance the stability of estrogenic compounds, which is crucial for maintaining the efficacy of hormonal therapies.
- Comprehensive Formulation: The composition includes a range of excipients and stabilizers that contribute to its stability and bioavailability.
- Versatile Preparation Methods: The patent outlines multiple methods for preparing the pharmaceutical composition, offering flexibility in manufacturing.
- Legal and Regulatory Compliance: The patent's validity and enforcement are subject to thorough searches, examinations, and legal frameworks.
- Market Impact: The stable pharmaceutical composition can have a significant market impact by ensuring consistent efficacy and longer shelf life.
FAQs
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What is the main issue addressed by US Patent 7,163,931?
- The main issue is the stability of estrogenic compounds in pharmaceutical formulations.
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What are the key components of the stable pharmaceutical composition described in the patent?
- The composition includes an estrogen complexed with a cyclodextrin derivative, along with specified excipients and stabilizers.
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How is the stability of the composition ensured?
- The stability is ensured through the use of cyclodextrin derivatives, antioxidants, and specific excipients.
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What are the various methods for preparing the pharmaceutical composition?
- Methods include melt extrusion, solid dispersion, solid solution, coprecipitation, wet granulation, melt granulation, dry granulation, and direct compression.
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How does this patent impact the pharmaceutical market?
- It provides a competitive edge by ensuring consistent efficacy and longer shelf life of estrogenic compounds.
Sources
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USPTO - Search for patents
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USA.gov - U.S. Patent and Trademark Office (USPTO)
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USPTO - Patent Claims Research Dataset
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Google Patents - WO2012120365A1
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ACUS - U.S. Patent Small Claims Court
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