United States Patent 5,510,383: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,510,383, titled "Use of cloprostenol, fluprostenol and their salts and esters to treat glaucoma and ocular hypertension," is a significant patent in the field of ophthalmology. This patent, granted on April 23, 1996, covers specific compounds and their applications in treating eye conditions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention
The patent involves the use of cloprostenol and fluprostenol, which are prostaglandin analogs, and their salts and esters for the treatment of glaucoma and ocular hypertension. These conditions are characterized by elevated intraocular pressure, which can lead to vision loss if not managed properly. The invention provides a new therapeutic approach using these compounds to reduce intraocular pressure effectively.
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here are some key aspects of the scope:
Claims Overview
The patent includes 20 claims, which can be broadly categorized into several types:
- Compound Claims: These claims cover the specific prostaglandin analogs, their salts, and esters.
- Method Claims: These claims describe the methods of using these compounds to treat glaucoma and ocular hypertension.
- Composition Claims: These claims cover ophthalmic compositions that include the specified compounds.
Specific Claims
For example, Claim 1 of the patent reads:
"A method of treating glaucoma or ocular hypertension in a human patient, comprising administering to the eye of the patient an effective amount of a composition comprising cloprostenol or a salt or ester thereof."
This claim highlights the core of the invention: the therapeutic use of cloprostenol and its derivatives for treating specific eye conditions[2].
Enablement and Written Description
The patent's validity hinges on its enablement and written description requirements. According to the Federal Circuit, a patent must provide sufficient disclosure so that a person of ordinary skill in the art can practice the claimed invention without undue experimentation. In the case of U.S. Patent 5,510,383, the patent provides detailed descriptions of the compounds, their synthesis, and their use in ophthalmic compositions. This includes step-by-step descriptions and exemplary formulations, which are crucial for meeting the enablement and written description requirements[1].
Patent Landscape
Related Patents and Applications
The patent landscape around U.S. Patent 5,510,383 includes other patents and applications related to prostaglandin analogs and their use in ophthalmology. For instance, patents like U.S. Patent Nos. 5,889,052 and 5,510,383 are part of a broader family of patents that cover various aspects of prostaglandin-based treatments for eye conditions.
Global Dossier and International Filings
Using tools like the Global Dossier, one can see the patent family for this specific application, including related applications filed at participating IP Offices. This helps in understanding the global reach and protection of the invention[4].
Prior Art and Citation Data
The Common Citation Document (CCD) application can be used to consolidate prior art cited by various patent offices for the family members of this patent application. This helps in identifying potential prior art and understanding the novelty of the invention[4].
Economic and Market Impact
The economic impact of U.S. Patent 5,510,383 is significant, given the prevalence of glaucoma and ocular hypertension. The patent has enabled the development of new treatments, which have improved patient outcomes and reduced healthcare costs associated with these conditions.
Market Dominance
Patents like U.S. Patent 5,510,383 can provide a competitive edge in the market. By protecting the specific use of cloprostenol and fluprostenol, the patent holder can exclude others from using these compounds for similar therapeutic purposes, thereby maintaining market dominance.
Legal and Regulatory Considerations
Litigation and Enforcement
Patent litigation, such as the case in Alcon Research Ltd. v. Barr Laboratories, Inc., highlights the importance of robust enablement and written description analyses. Ensuring that the patent meets these requirements is crucial for withstanding legal challenges[1].
Regulatory Approvals
The use of these compounds in ophthalmic treatments also involves regulatory approvals. The patent holder must comply with FDA regulations and other international standards to ensure the safe and effective use of these treatments.
Future Developments and Trends
Advancements in Ophthalmology
The field of ophthalmology is continuously evolving, with new treatments and technologies emerging. Future developments may include new prostaglandin analogs or combination therapies that further improve treatment outcomes.
Patent Scope Measurements
The USPTO's Patent Claims Research Dataset provides insights into patent scope measurements, which can help in understanding the breadth and depth of patent protection. This dataset can be used to analyze trends and patterns in patent claims, including those related to ophthalmic treatments[3].
Key Takeaways
- Specific Claims: The patent includes detailed claims covering compounds, methods, and compositions.
- Enablement and Written Description: The patent provides sufficient disclosure to meet these requirements.
- Patent Landscape: The patent is part of a broader family of patents related to prostaglandin analogs.
- Economic Impact: The patent has significant economic and market implications.
- Legal and Regulatory Considerations: Robust enablement and written description analyses are crucial for legal enforcement.
- Future Developments: The field of ophthalmology is evolving, with potential new treatments and technologies.
Frequently Asked Questions (FAQs)
What is the main invention covered by U.S. Patent 5,510,383?
The main invention is the use of cloprostenol, fluprostenol, and their salts and esters to treat glaucoma and ocular hypertension.
How many claims are included in the patent?
The patent includes 20 claims.
What are the key requirements for the patent's validity?
The patent must meet the enablement and written description requirements, ensuring that a person of ordinary skill in the art can practice the claimed invention without undue experimentation.
How does the Global Dossier help in understanding the patent landscape?
The Global Dossier provides access to the file histories of related applications from participating IP Offices, helping users see the patent family and related applications.
What is the economic impact of this patent?
The patent has a significant economic impact by enabling the development of new treatments for glaucoma and ocular hypertension, improving patient outcomes and reducing healthcare costs.
Cited Sources
- Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. "Last Month at the Federal Circuit Newsletter - April 2014."
- Google Patents. "US5510383A - Use of cloprostenol, fluprostenol and their salts and esters to treat glaucoma and ocular hypertension."
- United States Patent and Trademark Office. "Patent Claims Research Dataset."
- United States Patent and Trademark Office. "Search for patents - USPTO."
