United States Patent 10,322,085: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 10,322,085, titled "Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof," is a significant patent in the field of pharmaceutical and cosmetic formulations. This patent, granted to innovators in the field, outlines a novel composition and its applications, which are crucial for understanding the patent's scope, claims, and its position within the broader patent landscape.
Background and Invention Overview
The patent describes a foamable pharmaceutical carrier that includes a benefit agent selected from the group consisting of a dicarboxylic acid and a dicarboxylic acid ester. This composition is designed to be substantially resistant to aging and phase separation, and it can stabilize other active ingredients within the formulation[1].
Key Components of the Composition
Benefit Agent
The benefit agent in this composition is either a dicarboxylic acid or a dicarboxylic acid ester. These agents are chosen for their emollient, pharmaceutical, or cosmetic properties. Specific examples of dicarboxylic acids include oxalic acid, malonic acid, succinic acid, glutaric acid, adipic acid, and others[1].
Polymeric Agent
The composition also includes a polymeric agent, which can be a bioadhesive agent, a gelling agent, a film-forming agent, or a phase change agent. This polymeric agent is present in a concentration of about 0.01% to about 5% by weight of the total composition[1].
Propellant
If the composition is contained in a pressurized container, it further includes a liquefied hydrocarbon gas propellant at a concentration of about 3% to about 25% by weight of the total composition. This propellant makes the composition substantially flowable and capable of forming a foam upon release[1].
Claims and Scope
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover the composition itself, the method of preparing the composition, and the use of the composition as a vehicle for various active ingredients. For example, Claim 1 might describe the composition comprising a dicarboxylic acid or its ester, a polymeric agent, and optionally a liquefied hydrocarbon gas propellant[1].
Dependent Claims
Dependent claims further narrow down the scope by specifying particular aspects of the composition, such as the concentration of the polymeric agent, the type of dicarboxylic acid used, or the presence of additional active agents. These claims provide a detailed description of the various embodiments of the invention[1].
Patent Landscape and Prior Art
Related Patents and Technologies
The patent landscape in the field of pharmaceutical and cosmetic formulations is highly competitive and densely populated. Patents like US10,322,085 must differentiate themselves through novel compositions and unique properties. For instance, the use of dicarboxylic acids and their esters as benefit agents sets this patent apart from other foamable vehicle compositions[1].
Prior Art Considerations
When drafting the claims for this patent, it was crucial to ensure that the scope was not overly broad, which could lead to invalidation due to prior art or abstract idea exceptions. The claims must be anchored to the specific embodiments disclosed in the specification to avoid such risks[3].
Practical Applications and Benefits
Stability and Resistance to Aging
The composition described in the patent is substantially resistant to aging and phase separation, which is a significant advantage in pharmaceutical and cosmetic formulations. This stability ensures that the active ingredients remain effective over a longer period[1].
Foamable Properties
The inclusion of a liquefied hydrocarbon gas propellant allows the composition to form a foam upon release, which is beneficial for topical applications. This foamable property enhances user experience and can improve the delivery of active ingredients to the skin[1].
Regulatory and Legal Considerations
Patent Term and Expiration
Understanding the patent term and any adjustments due to prosecution delays is crucial. The patent term for US10,322,085 would be subject to the standard 20-year term from the filing date, with any potential adjustments for Patent Term Adjustment (PTA) if delays occurred during prosecution[2].
Infringement and Litigation
In the event of infringement, the patent holder would need to assert their rights through legal channels. The scope and claims of the patent would be critical in determining the validity of any infringement claims and the potential outcomes in litigation[2].
Industry Impact and Future Directions
Market Dominance
A patent like US10,322,085 can provide a competitive edge in the market by offering unique and stable foamable compositions. Companies holding such patents can leverage this innovation to dominate market segments related to pharmaceutical and cosmetic products[4].
Innovation and R&D
The patent encourages further innovation in the field by setting a new standard for foamable vehicle compositions. Researchers and developers can build upon this invention to create even more advanced formulations, driving the industry forward[4].
Key Takeaways
- Novel Composition: The patent introduces a novel foamable vehicle composition using dicarboxylic acids and their esters.
- Stability and Foamable Properties: The composition is resistant to aging and phase separation and forms a foam upon release.
- Polymeric Agents: The inclusion of polymeric agents enhances the properties of the composition.
- Regulatory Considerations: Understanding the patent term and potential adjustments is crucial.
- Industry Impact: The patent can provide a competitive edge and drive further innovation in the industry.
FAQs
What is the primary benefit agent in the composition described in US10,322,085?
The primary benefit agent is either a dicarboxylic acid or a dicarboxylic acid ester.
How does the composition achieve its foamable properties?
The composition includes a liquefied hydrocarbon gas propellant at a concentration of about 3% to about 25% by weight.
What are the advantages of using dicarboxylic acids in the composition?
Dicarboxylic acids provide stability against aging and phase separation and can stabilize other active ingredients.
Can the claims of US10,322,085 be broadened without risking invalidation?
No, broadening the claims without anchoring them to the specific embodiments disclosed in the specification can risk invalidation due to prior art or abstract idea exceptions.
How does the patent impact the pharmaceutical and cosmetic industries?
The patent provides a competitive edge by offering unique and stable foamable compositions, driving innovation and market dominance.
Sources
- US10322085B2 - Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof - Google Patents
- In re Cellect - United States Court of Appeals for the Federal Circuit
- The Importance of Getting the Claim Scope Right in a US Patent Application - Rimon Law
- Invention: U.S. and Comparative Global Trends - National Science Foundation
