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Patent landscape, scope, and claims: |
United States Patent 5,547,957: A Detailed Analysis
Overview of the Patent
United States Patent 5,547,957, titled "Method of treating androgenic alopecia with 5-α reductase inhibitors," was granted to Merck & Co., Inc. and is now expired. This patent revolves around the use of 5-α reductase inhibitors to treat androgenic alopecia (male and female pattern baldness) and other conditions such as acne vulgaris.
Scope of the Patent
The patent's scope is broad, covering various methods and compounds for treating hair loss and acne. Here are the key aspects:
Therapeutic Uses
- The patent describes methods for treating androgenic alopecia and promoting hair growth using 5-α reductase inhibitors[1][4].
- It also includes methods for treating acne vulgaris with the same class of compounds.
Compounds and Structural Formulas
- The patent specifies the structural formulas for the 5-α reductase 2 inhibitor compounds, including finasteride, which is a well-known prescription pharmaceutical[1][4].
- The compounds are defined by their structural formulas, with specific radicals and substituents such as hydrocarbon radicals, alkyl groups, and halogen substituents.
Dosage and Administration
- The dosage regimen is tailored based on factors such as the patient's type, species, age, weight, sex, and medical condition. It also considers the severity of the condition, route of administration, and the patient's renal and hepatic function[1][4].
Claims of the Patent
The patent includes several claims that outline the specific methods, compounds, and delivery mechanisms.
Method Claims
- Claims cover the methods of treating androgenic alopecia and acne vulgaris using 5-α reductase inhibitors.
- These methods involve administering the inhibitors in a dosage amount effective to treat the conditions[1][4].
Compound Claims
- The patent claims cover the specific compounds with the structural formulas described, including finasteride and other related compounds.
- These compounds can be synthesized using well-known procedures in the art[1].
Delivery Mechanisms
- Claims also include various delivery mechanisms such as coupling the compounds with monoclonal antibodies, soluble polymers, or biodegradable polymers for targeted and controlled release[1][4].
Patent Landscape Analysis
To understand the broader context of this patent, a patent landscape analysis is essential.
Defining Scope and Keywords
- The analysis begins by defining the technology field, which in this case is the use of 5-α reductase inhibitors for treating hair loss and acne.
- Relevant keywords include "5-α reductase inhibitors," "androgenic alopecia," "acne vulgaris," and "finasteride"[3].
Searching and Organizing Patents
- Using patent databases, one can retrieve patents related to these keywords.
- Organizing these patents by factors like filing date, assignee, and technology subcategories helps in understanding the evolution and distribution of related patents[3].
Identifying Trends and Key Players
- Analyzing the patent filings reveals trends in the development of 5-α reductase inhibitors.
- Key players in this field include pharmaceutical companies like Merck & Co., Inc., which has been a significant contributor to the development and commercialization of these inhibitors[3].
Analyzing Citations and Evolution
- Studying how patents reference each other provides insights into the impact and development of the technology.
- For example, the patent in question cites earlier patents related to the synthesis and use of 5-α reductase inhibitors, indicating a continuous evolution in the field[1][3].
Key Players and Competitors
- Merck & Co., Inc.: As the assignee of the patent, Merck has been a major player in the development and marketing of finasteride under the brand name Propecia for treating androgenic alopecia.
- Other Pharmaceutical Companies: Companies like Pfizer and GlaxoSmithKline have also been involved in the development of similar treatments, contributing to the competitive landscape in this field.
Technological and Market Impact
- Clinical Impact: The use of 5-α reductase inhibitors has significantly impacted the treatment of androgenic alopecia and acne, offering effective solutions for conditions that were previously difficult to treat.
- Market Impact: The commercial success of finasteride and other related drugs has been substantial, with these medications becoming standard treatments in dermatology and urology.
Legal and Regulatory Aspects
- Patent Expiration: The patent has expired, which means that the exclusive rights to the methods and compounds described are no longer in effect. This has opened up the market for generic versions of finasteride and other 5-α reductase inhibitors.
- Regulatory Approvals: The FDA has played a crucial role in approving these medications for use in the United States, ensuring their safety and efficacy[5].
Future Directions
- Research and Development: Continued research in the field of 5-α reductase inhibitors may lead to new compounds or delivery mechanisms that could further improve treatment outcomes.
- Generic and Biosimilar Market: The expiration of the patent has led to a growing market for generic and biosimilar versions of these drugs, which could increase accessibility and reduce costs.
Key Takeaways
- Effective Treatment: 5-α reductase inhibitors have proven to be effective in treating androgenic alopecia and acne.
- Patent Landscape: The patent landscape analysis reveals a competitive field with significant contributions from major pharmaceutical companies.
- Market Impact: The commercial success of these drugs has been substantial, and their generic versions are expected to further expand the market.
- Future Research: Ongoing research may lead to new and improved treatments.
Frequently Asked Questions (FAQs)
Q: What is the primary use of the patent described in US 5,547,957?
A: The primary use is the treatment of androgenic alopecia and acne vulgaris using 5-α reductase inhibitors.
Q: Who is the assignee of the patent?
A: The assignee is Merck & Co., Inc.
Q: What is the most well-known drug covered by this patent?
A: The most well-known drug is finasteride, marketed under the brand name Propecia.
Q: What are the delivery mechanisms described in the patent?
A: The patent describes delivery mechanisms including monoclonal antibodies, soluble polymers, and biodegradable polymers.
Q: Is the patent still in effect?
A: No, the patent has expired, allowing for the development of generic versions of the drugs described.
Cited Sources
- US5547957A - Method of treating androgenic alopecia with 5-α reductase inhibitors - Google Patents
- Patent Claims Research Dataset - USPTO
- How to Do Patent Landscape Analysis - Goldstein Patent Law
- US6174892B1 - Method of treating acne with 5-α reductase inhibitors - Google Patents
- United States Patent - Regulations.gov
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