United States Patent 5,955,109: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 5,955,109, titled "Methods and compositions for topical delivery of retinoic acid," is a significant patent in the field of dermatology and cosmetic formulations. This patent, issued to address the challenges of delivering retinoic acid topically, introduces novel formulations and methods that enhance the stability and efficacy of retinoic acid in skincare products.
Background and Context
Retinoic acid, a derivative of vitamin A, is widely used in skincare for its anti-aging and therapeutic properties. However, its instability and potential for irritation have posed challenges in its topical application. The patent aims to overcome these issues through innovative formulations and delivery methods[1].
Scope of the Patent
Novel Formulations
The patent describes novel formulations where retinoic acid is retained as impregnants inside solid particles. These particles can be porous, allowing for controlled release of the retinoic acid. This approach helps in stabilizing the retinoic acid, reducing its degradation, and minimizing skin irritation[1].
Composition Characteristics
The compositions include solid particles with pores that can be interconnected and open to the particle surface. This design facilitates the full diffusion of the retained retinoic acid outward from the particles, ensuring effective delivery to the skin[1][4].
Active Ingredients and Excipients
The patent specifies the use of various excipients and active ingredients, such as organic macromolecular compounds, polyvinyl pyrrolidone, and poly(meth)acrylates. These components help in maintaining the stability and efficacy of the retinoic acid[1].
Claims of the Patent
Method Claims
The patent includes method claims that outline the process of preparing these novel formulations. This involves the polymerization of monomers and the use of porogens to form the pores within the solid particles. The method ensures that the retinoic acid is evenly distributed and retained within these particles[1][2].
Composition Claims
The composition claims detail the specific ingredients and their proportions used in the formulations. These claims cover a range of compositions, including those with different types of solid particles, pore structures, and excipients[1].
Use Claims
The patent also includes use claims, which specify the applications of these formulations in skincare products. These claims cover anti-aging preparations, treatments for skin conditions, and general skincare routines[1].
Patent Landscape
Classification and Categories
The patent is classified under various categories in the International Patent Classification (IPC) system, including A61K8/00 for cosmetics or similar toiletry preparations, and A61K8/67 for vitamins, specifically vitamin A and its derivatives[1].
Related Patents and Technologies
Other patents, such as those related to microparticles and porous materials, are relevant to this technology. For example, the European Patent EP2317989A2 also discusses microparticles with similar characteristics, highlighting the broader landscape of research in this area[4].
Legal and Regulatory Aspects
Patent Disclosure and Enablement
The patent's validity and scope are subject to the disclosure and enablement requirements under 35 U.S.C. § 112(a). This section mandates that the patent specification must be written in "such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use the same." The Federal Circuit's recent jurisprudence on genus claims and the written description requirement can impact the patent's scope and validity[3].
Genus Claims and Written Description
The patent's claims, particularly those that attempt to capture a genus of compounds, must comply with the written description and enablement requirements. The Federal Circuit's rigid position on these matters can make it challenging to obtain broad patent protection for such formulations[3].
Impact on the Industry
Innovation and Commercialization
The patent's innovations in topical retinoic acid delivery have significant implications for the skincare and pharmaceutical industries. Companies can develop more stable and effective skincare products, enhancing their commercialization strategies and market competitiveness.
Market Expansion
The growing market for skincare and anti-aging products, coupled with the advancements in retinoic acid delivery, positions this patent at the forefront of industry innovation. The market for therapeutic skincare products is expanding, and such patents play a crucial role in driving this growth.
Key Takeaways
- Novel Formulations: The patent introduces novel formulations where retinoic acid is retained in solid particles, enhancing stability and efficacy.
- Composition and Method Claims: The patent includes detailed claims on the composition and preparation methods of these formulations.
- Legal and Regulatory Compliance: The patent must comply with disclosure and enablement requirements, particularly in the context of genus claims.
- Industry Impact: The patent has significant implications for the skincare and pharmaceutical industries, driving innovation and market growth.
FAQs
Q: What is the main innovation of United States Patent 5,955,109?
A: The main innovation is the development of novel formulations where retinoic acid is retained as impregnants inside solid particles, enhancing its stability and efficacy in topical applications.
Q: What are the key components of the formulations described in the patent?
A: The formulations include solid particles with pores, organic macromolecular compounds, and other excipients like polyvinyl pyrrolidone and poly(meth)acrylates.
Q: How does the patent comply with the disclosure and enablement requirements?
A: The patent must provide a written description in "such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use the same," as per 35 U.S.C. § 112(a).
Q: What is the impact of the Federal Circuit’s jurisprudence on genus claims for this patent?
A: The Federal Circuit’s rigid position on genus claims can make it challenging to obtain broad patent protection, as the claims must be narrowly defined to avoid invalidation.
Q: How does this patent influence the skincare and pharmaceutical industries?
A: The patent drives innovation by providing more stable and effective skincare products, enhancing commercialization strategies and contributing to market growth in the skincare and anti-aging sectors.
Sources
- US5955109A - Methods and compositions for topical delivery of retinoic acid - Google Patents
- WO2010023689A2 - Microparticles - Google Patents
- Eviscerating Patent Scope - DigitalCommons@NYLS
- EP2317989A2 - Microparticles - Google Patents
