United States Patent 5,908,638: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,908,638, titled "Pharmaceutical compositions of conjugated estrogens and methods for their use," is a significant patent in the pharmaceutical industry, particularly in the realm of hormone therapy. This patent, granted to the assignees, outlines novel pharmaceutical compositions and methods for the preparation and use of conjugated estrogens.
Background
Conjugated estrogens are a mixture of estrogenic substances, often used in hormone replacement therapy (HRT) to treat symptoms associated with menopause and other estrogen deficiency conditions. The patent addresses the need for improved formulations that enhance the efficacy, stability, and patient compliance of these treatments.
Scope of the Patent
The scope of US Patent 5,908,638 is broad and encompasses several key aspects:
Pharmaceutical Compositions
The patent describes novel pharmaceutical compositions containing conjugated estrogens. These compositions can be formulated in various dosage forms, including tablets, capsules, and other solid oral dosage forms. The compositions often include a mixture of conjugated estrogens along with various excipients, such as organic excipients, film coatings, and other additives to enhance stability and bioavailability[1].
Methods of Preparation
The patent details methods for preparing these pharmaceutical compositions. This includes processes such as granulation, film coating, and the use of specific excipients like hydroxypropyl methyl cellulose, which is commonly used as a binder and film-forming agent[1].
Use in Therapy
The patent specifies the use of these compositions in therapeutic settings, particularly for the treatment of conditions related to estrogen deficiency. This includes menopausal symptoms, osteoporosis, and other hormone-related disorders.
Claims of the Patent
The claims of US Patent 5,908,638 are detailed and specific, ensuring broad protection for the inventors' work:
Composition Claims
- The patent claims cover the pharmaceutical compositions themselves, including the specific ratios of conjugated estrogens and the types of excipients used[1].
- For example, Claim 1 describes a pharmaceutical composition comprising a mixture of conjugated estrogens and a film coating, which enhances the stability and release profile of the active ingredients.
Method Claims
- The patent also claims the methods for preparing these compositions, including the steps involved in granulation, coating, and final formulation[1].
- Claim 5, for instance, outlines a method for preparing a tablet formulation involving the granulation of conjugated estrogens with specific excipients followed by film coating.
Use Claims
- The patent claims the therapeutic use of these compositions, specifying the conditions for which they are intended, such as menopausal symptoms and osteoporosis[1].
Patent Landscape
The patent landscape surrounding US Patent 5,908,638 is complex and involves several key players and technologies:
Prior Art
- The patent builds upon prior art in the field of pharmaceutical formulations, particularly those related to hormone therapy. It addresses specific limitations of earlier formulations, such as stability issues and variable bioavailability[1].
Related Patents
- Other patents in the field, such as those related to pharmaceutical preparations for rectal administration or methods for preparing low-dose pharmaceutical products, complement the scope of this patent. For example, the method for preparing low-dose pharmaceutical products (EP-0735864-B1) shares some similarities in the use of specific excipients and formulation techniques[5].
Industry Impact
- The patent has had a significant impact on the pharmaceutical industry, particularly in the development of hormone replacement therapies. It has influenced the formulation of subsequent products and has set a standard for the use of conjugated estrogens in therapeutic settings.
Legal Status
As of the current date, the legal status of US Patent 5,908,638 is expired. This means that the exclusive rights granted to the patent holders have lapsed, and the technology described in the patent is now in the public domain.
Practical Applications
The practical applications of this patent are widespread:
Clinical Use
- The formulations described in the patent have been used extensively in clinical settings for the treatment of menopausal symptoms, osteoporosis, and other conditions related to estrogen deficiency.
Manufacturing
- The methods outlined in the patent have been adopted by pharmaceutical manufacturers to improve the quality and consistency of conjugated estrogen products.
Research and Development
- The patent has served as a foundation for further research and development in the field of hormone therapy, leading to the creation of new and improved formulations.
Key Takeaways
- Novel Compositions: The patent introduces novel pharmaceutical compositions of conjugated estrogens with improved stability and bioavailability.
- Methodological Advancements: It details specific methods for preparing these compositions, including granulation and film coating.
- Therapeutic Use: The patent specifies the therapeutic use of these compositions for conditions related to estrogen deficiency.
- Industry Impact: The patent has significantly influenced the development of hormone replacement therapies and set standards for the use of conjugated estrogens.
- Legal Status: The patent is currently expired, making the technology described therein available for public use.
FAQs
What are conjugated estrogens?
Conjugated estrogens are a mixture of estrogenic substances used in hormone replacement therapy to treat symptoms associated with menopause and other estrogen deficiency conditions.
What is the significance of US Patent 5,908,638?
This patent describes novel pharmaceutical compositions and methods for the preparation and use of conjugated estrogens, enhancing the efficacy, stability, and patient compliance of hormone replacement therapies.
What are the key components of the pharmaceutical compositions described in the patent?
The compositions include a mixture of conjugated estrogens along with various excipients such as hydroxypropyl methyl cellulose, film coatings, and other additives.
How has the patent impacted the pharmaceutical industry?
The patent has influenced the formulation of subsequent hormone replacement therapy products and set a standard for the use of conjugated estrogens in therapeutic settings.
What is the current legal status of US Patent 5,908,638?
The patent is currently expired, meaning the exclusive rights granted to the patent holders have lapsed, and the technology described is now in the public domain.
Sources
- US Patent 5,908,638: Pharmaceutical compositions of conjugated estrogens and methods for their use.
- PubChem: Pharmaceutical preparation for rectal administration - Patent US-2006147541-A1.
- USPTO: Patent Claims Research Dataset.
- USPTO: Search for patents.
- PubChem: Method for preparing low dose pharmaceutical products - Patent EP-0735864-B1.
