Detailed Analysis of the Scope and Claims of United States Patent 4,070,462
Introduction
United States Patent 4,070,462, issued on January 24, 1978, is a significant patent in the field of pharmaceuticals, particularly focusing on topical steroid compositions. This patent, titled "Steroid Ointment," introduces innovative formulations and methods for treating skin conditions using steroid anti-inflammatory agents.
Background and Context
The patent was filed in the context of advancing topical treatments for skin conditions such as inflammation, eczema, and other dermatological issues. The invention aimed to improve the efficacy and delivery of steroid anti-inflammatory agents through a specially designed ointment formulation.
Key Components of the Patent
Active Ingredients
The patent centers around the use of steroid anti-inflammatory agents, specifically betamethasone dipropionate, as the active ingredient. Betamethasone dipropionate is a potent corticosteroid used to treat various skin conditions[4].
Vehicle Composition
The ointment vehicle is a critical component of the invention. It includes a mixture of solvents and adjuvants that enhance the consistency, homogeneity, spreadability, texture, and appearance of the ointment. Key components of the vehicle include:
- Glycol Solvent: The steroid is first dissolved in a glycol solvent, which helps in uniform distribution and stability of the active ingredient.
- Petrolatum: This substance is added to improve the texture and spreadability of the ointment.
- Non-essential Pharmaceutical Adjuvants: Up to 10% by weight of these adjuvants can be added to enhance the overall properties of the ointment[4].
Manufacturing Process
The patent describes a conventional manufacturing process involving the thorough mixing of ingredients at ambient or elevated temperatures. The steps include:
- Dissolving the steroid in the glycol solvent.
- Mixing the solvent-steroid mixture with the remaining ingredients.
- Using mechanical agitation as needed to ensure homogeneity and improve texture. Processing equipment such as heat exchangers, propeller mixers, and homogenizers are recommended[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Claim 1: Composition
The first claim describes the composition of the ointment, which includes a steroid anti-inflammatory agent, such as betamethasone dipropionate, dissolved in a glycol solvent and mixed with other ingredients like petrolatum and non-essential adjuvants[4].
Claim 2: Method of Treatment
This claim outlines the method of treating skin conditions using the described ointment composition. It emphasizes the application of the ointment to the affected skin area to reduce inflammation and other symptoms[4].
Claim 3: Vehicle Superiority
The patent claims that the ointment vehicle is unexpectedly superior to previously known vehicles for use with topical steroids. This is evidenced by the greater activity of betamethasone dipropionate in this vehicle compared to standard vehicles at the same concentration[4].
Patent Landscape and Impact
Prior Art
The patent builds upon prior art in the field of topical steroid compositions. For example, U.S. Patent 4,070,462 references earlier work but distinguishes itself through the specific formulation and manufacturing process described[4].
Competing Patents
Other patents, such as those related to penetrating topical pharmaceutical compositions, also exist in the same domain but focus on different active ingredients and formulations. For instance, Canadian Patent 1223819 discusses compositions containing 1-dodecyl-azacycloheptan-2-one, which is distinct from the steroid-based ointment of U.S. Patent 4,070,462[1].
Industry Impact
The invention described in U.S. Patent 4,070,462 has had a significant impact on the treatment of skin conditions. The superior efficacy of the ointment vehicle has made it a preferred choice in dermatological treatments, enhancing patient outcomes and reducing the severity of symptoms.
Patent Analytics and Claim Coverage
To fully understand the protection and coverage provided by this patent, patent analytics tools can be employed. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps or opportunities in intellectual property protection.
- Claim Coverage Matrix: This tool shows which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist. For U.S. Patent 4,070,462, this would involve analyzing the claims related to the composition, method of treatment, and vehicle superiority[3].
- Claim Charts: Interactive claim charts generated by software like ClaimScape® can help technical experts review patent coverage and determine if there are gaps in current coverage or future design opportunities[3].
Expiration and Current Status
The patent has expired, as indicated by its legal status. This means that the specific formulations and methods described in the patent are now in the public domain and can be freely used without infringing on the original patent rights[4].
Key Takeaways
- Innovative Formulation: U.S. Patent 4,070,462 introduced an innovative ointment formulation using betamethasone dipropionate as the active ingredient.
- Superior Vehicle: The patent claims that the ointment vehicle is superior to previously known vehicles, enhancing the efficacy of the steroid.
- Manufacturing Process: The patent describes a detailed manufacturing process to ensure the homogeneity and stability of the ointment.
- Industry Impact: The invention has significantly impacted the treatment of skin conditions, improving patient outcomes.
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for understanding the patent landscape and identifying gaps or opportunities.
FAQs
Q1: What is the main active ingredient in the ointment described in U.S. Patent 4,070,462?
The main active ingredient is betamethasone dipropionate, a potent corticosteroid.
Q2: What is the role of the glycol solvent in the ointment formulation?
The glycol solvent is used to dissolve the steroid, ensuring its uniform distribution and stability in the ointment.
Q3: How does the manufacturing process ensure the homogeneity of the ointment?
The manufacturing process involves thorough mixing of ingredients at ambient or elevated temperatures and may include mechanical agitation to ensure homogeneity and improve texture.
Q4: Why is the ointment vehicle described in the patent considered superior?
The ointment vehicle is considered superior because it enhances the activity of betamethasone dipropionate compared to standard vehicles at the same concentration.
Q5: What is the current status of U.S. Patent 4,070,462?
The patent has expired, and its contents are now in the public domain.
Sources
- Canadian Patents Database - Patent 1223819 Summary
- Google Patents - United States Patent (19) US4489071
- SLWIP - Patent Analytics
- Google Patents - US4070462A - Steroid ointment
- PubChem - Improved betamethasone dipropionate cream - Patent IE-58042-B1
