Understanding the Scope and Claims of United States Patent 3,906,108
Introduction
United States Patent 3,906,108, titled "Stabilized Tretinoin Cream Emulsion," was granted to Lanny G. Felty and assigned to Johnson & Johnson. This patent is significant in the field of dermatology and cosmetic formulations, particularly for its innovative approach to stabilizing tretinoin, a derivative of vitamin A, in a cream emulsion.
Background and Context
Tretinoin is a widely used retinoid in dermatological treatments, especially for conditions like acne, fine lines, and skin discoloration. However, its instability and sensitivity to light and oxygen have posed significant challenges in formulation and storage.
Key Claims and Innovations
Stabilization of Tretinoin
The patent's primary claim revolves around the stabilization of tretinoin in a cream emulsion. This is achieved through the use of xanthan gum as the stabilizer, which allows the cream to be stored without refrigeration for extended periods without losing its therapeutic effectiveness[1][4].
Composition and Ingredients
The stabilized cream emulsion includes tretinoin, xanthan gum, and various other ingredients such as emulsifiers, fatty acids, and preservatives like methylparaben and propylparaben. The specific composition ensures the uniformity and stability of the cream[1][4].
Storage and Shelf Life
A critical aspect of this patent is the ability of the stabilized cream emulsion to be stored at room temperature without refrigeration. This enhances its shelf life and makes it more convenient for use and distribution[1][4].
Patent Scope and Claims
Claim Structure
The patent claims are structured to cover the specific formulation and method of stabilizing tretinoin. The claims include:
- Composition Claims: These claims define the specific ingredients and their proportions in the stabilized cream emulsion.
- Method Claims: These claims describe the process of preparing the stabilized cream emulsion.
- Use Claims: These claims outline the therapeutic uses of the stabilized tretinoin cream emulsion[1].
Breadth of Protection
The scope of the patent claims is designed to protect the innovative use of xanthan gum as a stabilizer in tretinoin cream emulsions. The claims are broad enough to cover various formulations that use this stabilizer but narrow enough to ensure that the invention is clearly defined and distinguishable from prior art[1].
Patent Landscape Analysis
Technological Domain
The patent falls within the technological domain of cosmetic and pharmaceutical formulations, particularly in the area of dermatological treatments. This domain is highly competitive, with numerous patents and ongoing research in stabilizing active ingredients like tretinoin[5].
Competitor Activity
Patent landscape analysis reveals that several other patents and applications exist in this domain, focusing on different methods of stabilizing retinoids. For example, patents like EP0408370A2 also discuss stable tretinoin emulsified cream formulations, indicating a robust competitive landscape[4].
Market Developments
The market for dermatological treatments is expanding, with a significant focus on innovative formulations that enhance stability and efficacy. Patent landscape studies show trends in mergers and acquisitions, in/out-licensing, and litigation activities within this industry, highlighting the importance of robust patent protection[5].
Legal Status and Expiry
The patent US3906108A has expired, which means that the specific formulation and method described in the patent are now in the public domain. However, understanding the legal status and expiry dates of related patents is crucial for companies looking to develop similar products without infringing existing patents[5].
Impact on Industry
Innovation and Competition
The stabilization of tretinoin using xanthan gum has set a precedent for future formulations. This innovation has driven competition in the industry, with other companies developing their own stabilized retinoid products. The patent landscape analysis helps companies navigate this competitive environment by identifying key patents, trends, and potential risks[5].
Regulatory and Legal Considerations
The patent's expiration has opened up opportunities for generic and similar products. However, companies must still comply with regulatory requirements and ensure that their products do not infringe on other existing patents in the domain. A thorough patent landscape analysis is essential for making informed decisions in this regard[5].
Key Takeaways
- Stabilization Method: The use of xanthan gum as a stabilizer in tretinoin cream emulsions is a key innovation.
- Patent Scope: The patent claims cover the composition, method of preparation, and therapeutic use of the stabilized cream emulsion.
- Competitive Landscape: The technological domain is highly competitive, with numerous patents and ongoing research.
- Market Trends: The market for dermatological treatments is expanding, with a focus on innovative formulations.
- Legal Considerations: Understanding the legal status and expiry dates of related patents is crucial for developing new products.
FAQs
Q: What is the main innovation of United States Patent 3,906,108?
A: The main innovation is the stabilization of tretinoin in a cream emulsion using xanthan gum, allowing for storage without refrigeration.
Q: What are the key ingredients in the stabilized cream emulsion?
A: The key ingredients include tretinoin, xanthan gum, emulsifiers, fatty acids, and preservatives like methylparaben and propylparaben.
Q: Why is the stabilization of tretinoin important?
A: Stabilization ensures that the tretinoin retains its therapeutic effectiveness over a longer period, enhancing its shelf life and convenience.
Q: What is the current legal status of the patent?
A: The patent has expired, meaning the specific formulation and method are now in the public domain.
Q: How does patent landscape analysis help in this domain?
A: It helps in understanding the competitive landscape, identifying key patents, trends, and potential risks, and making informed decisions for product development.
Sources
- US3906108A - Stabilized tretinoin cream emulsion - Google Patents
- Cosmetic material containing triple-encapsulated retinol - PubChem
- Eviscerating Patent Scope - DigitalCommons@NYLS
- EP0408370A2 - Stable tretinoin emulsified cream formulations - Google Patents
- Navigating Technological Domains with Patent Landscape Analysis - Sagacious Research
