United States Patent 9,993,471: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,993,471, titled "Ophthalmic formulations of cetirizine and methods of use," is a significant patent in the field of ophthalmic medications, particularly for the treatment of allergic conjunctivitis. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication Number and Authority
The patent, US9993471B2, was granted by the United States Patent and Trademark Office (USPTO) and is currently active[4].
Inventors and Assignees
While the specific inventors and assignees are not detailed in the provided sources, this information can typically be found in the patent document itself.
Prior Art and Related Patents
The patent builds upon prior art related to ophthalmic formulations, particularly those involving cetirizine and other antihistamines. It distinguishes itself by providing stable formulations without the need for solubilizing compounds like cyclodextrins, which were previously required[4].
Scope of the Patent
Claims
The patent includes several key claims that define its scope:
- Claim 1: A stable ophthalmic formulation of cetirizine as the only active ingredient, with a concentration of 0.01% to 1.0% (w/v), preferably 0.05% to 0.5% (w/v)[4].
- Claim 2: The formulation includes cetirizine in the form of cetirizine hydrochloride or dihydrochloride.
- Claim 3: The formulation is combined with fluticasone, a corticosteroid, to enhance therapeutic efficacy.
- Claim 4: The vehicle for the formulation includes specific concentrations of Polyethylene Glycol 400, Dibasic Sodium Phosphate, Hypromellose, Polysorbate 80, Glycerin, Edetate Disodium, and Benzalkonium Chloride[4].
Methods of Use
The patent also describes methods of treating allergic conjunctivitis and/or allergic rhinoconjunctivitis using these ophthalmic formulations. The methods involve topical application of the formulations to mitigate signs and symptoms of these conditions[4].
Patent Claims Analysis
Independent Claims
The independent claims, such as Claim 1, define the broadest scope of the invention. These claims are crucial as they set the boundaries for what is considered novel and non-obvious.
Dependent Claims
Dependent claims, such as Claims 2 and 3, further specify the invention by adding additional limitations. These claims help to narrow down the scope and provide more detailed descriptions of the preferred embodiments.
Claim Construction
The construction of these claims is critical for determining the patent's validity and enforceability. For instance, the specific concentrations of active and inactive ingredients are key elements that distinguish this patent from prior art[4].
Patent Landscape
Related Patents and Applications
The patent landscape in ophthalmic formulations is dense, with numerous patents and applications related to antihistamines and corticosteroids. For example, other patents may cover different formulations or methods of use for similar therapeutic indications.
Global Dossier and International Patent Offices
To understand the global patent landscape, tools like the Global Dossier provided by the USPTO can be useful. This service allows users to view the patent family for a specific application, including related applications filed at participating IP Offices[1].
Searchable Databases
Databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO) offer comprehensive searches for international patent applications. These resources are essential for identifying prior art and assessing the novelty of the invention[1].
Economic and Market Impact
Market Demand
The demand for effective ophthalmic formulations to treat allergic conjunctivitis is significant, given the prevalence of this condition. Patents like US9993471B2 play a crucial role in driving innovation and ensuring that new treatments are brought to market.
Competitive Landscape
The competitive landscape in the pharmaceutical industry, particularly in ophthalmic medications, is highly competitive. Patents such as this one help companies to differentiate their products and protect their intellectual property.
Legal and Regulatory Considerations
Patent Validity and Enforcement
The validity and enforceability of the patent depend on its claims and the prior art. Ensuring that the patent claims are well-constructed and supported by robust evidence is essential for maintaining its legal standing.
Regulatory Approvals
Ophthalmic formulations must undergo rigorous regulatory approvals before they can be marketed. Patents like US9993471B2 must align with regulatory requirements and guidelines set by bodies such as the FDA.
Conclusion
United States Patent 9,993,471 represents a significant advancement in ophthalmic formulations for treating allergic conjunctivitis. The patent's scope, defined by its claims, highlights the innovation in creating stable formulations without solubilizing compounds. Understanding the broader patent landscape and the economic, market, and legal implications is crucial for both inventors and industry stakeholders.
Key Takeaways
- Stable Ophthalmic Formulations: The patent provides stable ophthalmic formulations of cetirizine without the need for solubilizing compounds.
- Combination Therapies: The formulations can be combined with fluticasone to enhance therapeutic efficacy.
- Specific Concentrations: The vehicle for the formulation includes specific concentrations of various inactive ingredients.
- Global Patent Landscape: Tools like the Global Dossier and international patent databases are essential for understanding the global patent landscape.
- Market and Economic Impact: The patent drives innovation and meets significant market demand for effective ophthalmic treatments.
FAQs
Q: What is the main innovation of United States Patent 9,993,471?
A: The main innovation is the creation of stable ophthalmic formulations of cetirizine without the use of solubilizing compounds like cyclodextrins.
Q: What are the key ingredients in the ophthalmic formulation?
A: The formulation includes cetirizine hydrochloride or dihydrochloride as the active ingredient, combined with specific concentrations of Polyethylene Glycol 400, Dibasic Sodium Phosphate, Hypromellose, Polysorbate 80, Glycerin, Edetate Disodium, and Benzalkonium Chloride.
Q: How does this patent differ from prior art?
A: This patent differs by providing stable ophthalmic formulations of cetirizine without the need for solubilizing compounds, which were previously required.
Q: What is the therapeutic use of this ophthalmic formulation?
A: The formulation is used to treat allergic conjunctivitis and/or allergic rhinoconjunctivitis through topical application.
Q: How can one search for related patents and applications internationally?
A: Tools like the Global Dossier, European Patent Office (EPO) databases, Japan Patent Office (JPO) databases, and the World Intellectual Property Organization (WIPO) PATENTSCOPE ® Search Service can be used to search for related patents and applications internationally.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Unified Patents Portal: https://portal.unifiedpatents.com/patents/patent/US-20160106666-A1
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US9993471B2: https://patents.google.com/patent/US9993471B2/en
