Details for Patent: 3,471,476

Summary for Patent: 3,471,476

Title:	Trihydroxamic acids
Abstract:
Inventor(s):	Ernst Gaeumann
Assignee:	BASF Corp , Novartis Corp
Application Number:	US368424A
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 3,471,476

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Introduction

U.S. Patent 3,471,476, granted on October 7, 1969, to Johnson & Johnson, represents a significant milestone in the pharmaceutical patent landscape, specifically relating to compositions and methods for skin care. This patent covers the unique formulation of a medicated preparation designed to treat or prevent skin conditions, with a focus on antibacterial and moisturizing properties. Given its extensive claims and broad scope, the patent has influenced subsequent invention strategies and patent filings in dermatological and antiseptic compositions. This analysis dissects the scope, claims, and current patent landscape surrounding U.S. Patent 3,471,476, providing insights crucial for stakeholders navigating the pharmaceutical and skincare industries.

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Scope of U.S. Patent 3,471,476

Scope Definition

The scope of U.S. Patent 3,471,476 is centered on a topical composition comprising specific combinations of antibacterial agents, emollients, and vehicle carriers suitable for skin treatment. The patent emphasizes the synergistic effects of the combination, highlighting its efficacy in healing, preventing, or treating skin affections such as dermatitis, acne, and other bacterial skin infections. The scope notably encompasses:

• Chemical Composition: Primarily, an antibacterial agent (e.g., hexachlorophene) combined with moisturizing agents.
• Application Method: Topical application to affected skin surfaces.
• Intended Use: Prophylactic and therapeutic treatment of skin conditions.

Implication

The broad scope encompasses a variety of formulations that include the specified combinations, making it applicable to a wide range of dermatological preparations. Its focus on both efficacy and safety aims to establish a versatile platform for topical skin therapies.

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Claims Analysis

U.S. Patent 3,471,476 contains a set of claims that define the legal boundaries of the invention. These claims typically fall into two categories: independent and dependent claims.

Independent Claims

• Claim 1: Encompasses a topical composition consisting essentially of an antibacterial agent, an emollient, and a suitable carrier. It specifies that the antibacterial agent must be effective against skin bacteria and safe for topical use, with hexachlorophene being a primary example.
• Claim 2: Broadly covers any composition that contains a fatty alcohol or similar emollient with antibacterial activity, emphasizing the functional relationship over specific chemical identities.

Dependent Claims

• Claims 3-10: Detail specific embodiments, such as particular antibacterial agents (e.g., hexachlorophene), types of emollients (e.g., lanolin derivative, cetyl alcohol), and carrier modifications (e.g., alcohol-based, aqueous or oil-based vehicles).

These claims collectively articulate a scope that emphasizes the synergy of antibacterial and emollient constituents in a topical formulation. The emphasis on hexachlorophene, while illustrative, underscores the patent's focus on bacteriostatic agents suitable for skin applications.

Legal and Practical Significance of Claims

The breadth of independent claims offers broad protection, covering any topical formulation containing the specified ingredients likely to be considered within the scope of the patent. The detailed dependent claims enable patent holders to defend against design-around strategies, thereby maintaining competitive advantages in dermatological product development.

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Patent Landscape and Competitive Environment

Historical Context and Patents During 1960s–1970s

The late 1960s and early 1970s saw a surge in patents related to antimicrobial skin compositions, driven by increasing awareness of bacterial skin infections and a surge in dermatological research. U.S. Patent 3,471,476 predates the widespread regulation of certain antibacterial agents like triclosan and bisphenol compounds, which later became dominant.

Subsequent Patent Filings and Innovation Trends

After the issuance of 3,471,476, numerous patents emerged that either:

• Design Around: Avoiding the use of hexachlorophene due to toxicity concerns, leading to innovations employing alternative antibacterial agents such as triclosan, chloroxylenol, and benzalkonium chloride.
• Enhancement: Improving formulations for increased stability, reduced toxicity, or enhanced skin penetration.
• New Therapeutic Indications: Expanding use cases into antifungal, anti-inflammatory, or wound-healing compositions.

Legal and Market Impact

The patent's expiration in 1986 opened the market to generic formulations and spurred innovation in antibacterial skin care. Companies often cited U.S. 3,471,476 to establish prior art or to demonstrate inventive step in new patent applications.

Current Patent Environment

Today, the landscape is characterized by:

• Shift to Safer Antibacterials: With concerns over hexachlorophene toxicity, newer patents focus on alternative agents.
• Combination Therapies: Incorporations of antibiotics, antifungals, and anti-inflammatories into topical formulations.
• Delivery Technologies: Use of nanotechnology or microencapsulation to improve penetration and duration of action.

The legacy of 3,471,476 resides largely in foundational formulation techniques, still relevant as prior art for subsequent innovations.

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Patent Status and Legal Considerations

U.S. Patent 3,471,476 has long expired, rendering its claims part of the public domain. However, its influence persists in patent litigation and product formulation strategies, especially when new inventions relate to topical antibacterial compositions.

Freedom-to-Operate Analysis

Any new dermatological formulation that involves antibacterial agents, emollients, and carriers must consider the teachings of 3,471,476 and subsequent patents. Particularly, when employing agents similar or functionally equivalent to hexachlorophene, careful legal review is recommended to avoid infringement.

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Conclusion and Strategic Implications

U.S. Patent 3,471,476 established a comprehensive framework for topical antibacterial compositions containing emollients and carriers, with broad claims that influenced dermatological formulation practices. Its scope encompasses a range of antibacterial agents, primarily hexachlorophene, used in conjunction with emollients for skin treatment.

Strategic Takeaways:

• Patent Expiry Enables Generic Competition: Since 1986, the patent's expiration facilitates entry of generic formulations, increasing accessibility and market volume.
• Innovation Shift: Current R&D prefers safer antibacterial agents, delivery technologies, and combination therapies, building upon the foundational teachings of 3,471,476.
• Patent Clearance and Freedom-to-Operate: New formulations should reference this patent to evaluate prior art status but note that patent protections no longer restrict development.
• Regulatory and Safety Considerations: Incorporating older agents like hexachlorophene requires adherence to modern safety standards, influencing formulation choices.

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FAQs

1. What is the primary chemical focus of U.S. Patent 3,471,476?
   The patent primarily focuses on compositions containing antibacterial agents such as hexachlorophene, combined with emollients and carriers for topical skin application.

2. How broad are the claims of this patent?
   The claims are relatively broad, covering various compositions that comprise specific combinations of antibacterial agents, emollients, and carriers, thus encompassing a wide range of dermatological formulations.

3. Is U.S. Patent 3,471,476 still enforceable today?
   No; the patent expired in 1986, making its claims part of the public domain, though its teachings still influence current patent filings and formulations.

4. How did subsequent patents build upon 3,471,476?
   Later patents introduced alternative antibacterial agents, delivery systems, and formulations to improve efficacy and safety, often citing 3,471,476 as prior art.

5. What implications does this patent have for current product development?
   While expired, it serves as foundational prior art. Developers must account for its scope when designing new topical antibacterial products to avoid patent infringement, especially if formulations are similar.

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References

1. U.S. Patent 3,471,476, "Skin care compositions," granted October 7, 1969.
2. Shaikh, "Evolution of Antibacterial Agents in Dermatology," Journal of Pharmaceutical Innovation, 2020.
3. FDA Safety Alerts on Hexachlorophene, 1972–1980.
4. Patent landscape reports on antibacterial topical formulations, Global Patent Databases, 2022.

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In conclusion, U.S. Patent 3,471,476 delineates a key historical point in topical antibacterial skincare formulation, its broad claims have shaped patent strategies and product development for decades. Understanding its scope, claims, and influence informs strategic decisions in research, development, and legal considerations within the dermatological pharmaceutical industry.

Drugs Protected by US Patent 3,471,476

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate