United States Patent 5,800,807: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,800,807, assigned to Bausch & Lomb Incorporated, is a significant patent in the field of ophthalmic compositions, particularly those designed to moisturize and lubricate the eyes. This patent, filed on January 29, 1997, and granted on September 1, 1998, addresses the formulation of ophthalmic solutions with high water-binding properties.
Background and Context
The patent is part of a broader landscape of ophthalmic solutions aimed at treating dry eye and other ocular irritations. Previous patents, such as U.S. Pat. No. 5,591,426 and U.S. Pat. No. 5,106,615, have also focused on similar formulations, highlighting the ongoing research and development in this area[1][2].
Inventors and Assignee
The patent was invented by Zhenze Hu and John Denick, both from Pittsford, NY, and assigned to Bausch & Lomb Incorporated, a well-known company in the ophthalmic industry.
Patent Claims
Primary Claims
The patent claims revolve around ophthalmic compositions that include a combination of humectants, such as glycerin and propylene glycol, along with other demulcents like polyvinyl pyrrolidone and cellulose derivatives. These compositions are designed to be isotonic, buffered, and may include preservatives like benzalkonium chloride[1].
Detailed Claim Structure
- Claim 1: Describes the ophthalmic composition comprising glycerin, propylene glycol, and a cellulose derivative.
- Claim 2: Specifies the composition as a buffered, aqueous solution.
- Claim 3: Includes the option for the composition to be unpreserved or preserved with specific preservatives.
- Claims 4-12: Provide various embodiments of the composition, including different concentrations of the ingredients and the presence of additional demulcents like polyvinyl pyrrolidone[1].
Key Components of the Patent
Humectants
The patent emphasizes the use of glycerin and propylene glycol as primary humectants, which are crucial for their water-binding properties. These components help in maintaining the moisture level in the eyes, thereby alleviating dryness and irritation[1].
Demulcents
In addition to humectants, the patent includes demulcents such as polyvinyl pyrrolidone and cellulose derivatives (e.g., hydroxypropyl methyl cellulose). These components enhance the lubricating properties of the ophthalmic solution[1].
Buffering and Preservatives
The composition is buffered to maintain the pH level of the eye, and it may include preservatives to extend the shelf life of the solution. Common preservatives mentioned include benzalkonium chloride and polyhexamethylene biguanide (PHMB)[1].
Patent Landscape
Related Patents
- U.S. Pat. No. 5,591,426: This patent, also related to ophthalmic solutions, includes a borate-buffered, preserved aqueous solution with glycerin, polyvinyl pyrrolidone, and a cellulose derivative[2].
- U.S. Pat. No. 5,106,615: This patent describes isotonic humectant eyedrops with glycerin, polyethylene glycol, or propylene glycol, along with an anionic polymer such as Carbomer 941[1].
Industry Impact
The patent contributes to the development of more effective ophthalmic solutions, addressing the growing need for treatments for dry eye and other ocular conditions. Companies like Bausch & Lomb Incorporated have been at the forefront of this research, ensuring that their products meet the highest standards of efficacy and safety.
Legal and Regulatory Aspects
Patent Scope and Quality
The scope of this patent is well-defined, with clear claims that specify the composition and its components. This clarity is crucial in the context of patent quality debates, where overly broad or unclear claims can lead to licensing and litigation issues[3].
Expiration and Current Status
The patent has expired, which means that the formulation and methods described are now in the public domain. This expiration can lead to further innovation and competition in the ophthalmic solutions market.
Technical and Scientific Significance
Viscosity and Surface Tension
The patent includes data on the viscosity and surface tension of the ophthalmic solutions, which are critical parameters for ensuring the comfort and effectiveness of the product. For instance, the viscosity of the solution should be such that it provides adequate lubrication without causing discomfort[2].
Clinical Relevance
The composition described in the patent is clinically relevant as it addresses the need for effective moisturizing and lubricating agents for the eyes. The use of glycerin and propylene glycol, along with other demulcents, has been validated through various studies and clinical trials.
Conclusion
United States Patent 5,800,807 is a significant contribution to the field of ophthalmic compositions, providing a detailed formulation for effective moisturizing and lubricating ophthalmic solutions. The patent's clear claims and well-defined scope make it a valuable resource for researchers and manufacturers in the industry.
Key Takeaways
- The patent describes ophthalmic compositions with high water-binding properties.
- Key components include glycerin, propylene glycol, and cellulose derivatives.
- The composition can be buffered and preserved.
- The patent has expired, making the formulation public domain.
- The technical and scientific significance lies in its clinical relevance and detailed specification of viscosity and surface tension.
Frequently Asked Questions (FAQs)
What are the primary humectants used in the ophthalmic composition described in the patent?
The primary humectants are glycerin and propylene glycol.
What is the role of demulcents in the ophthalmic solution?
Demulcents, such as polyvinyl pyrrolidone and cellulose derivatives, enhance the lubricating properties of the solution.
Can the ophthalmic composition be preserved? If so, what preservatives are mentioned?
Yes, the composition can be preserved. Common preservatives mentioned include benzalkonium chloride and polyhexamethylene biguanide (PHMB).
What is the current status of the patent?
The patent has expired, making the formulation and methods described in the public domain.
How does the patent contribute to the ophthalmic industry?
The patent contributes by providing a detailed formulation for effective moisturizing and lubricating ophthalmic solutions, addressing the need for treatments for dry eye and other ocular conditions.
Cited Sources
- U.S. Pat. No. 5,800,807 - Ophthalmic compositions including glycerin and propylene glycol.
- U.S. Pat. No. 5,591,426 - Ophthalmic solution for artificial tears.
- Patent Claims and Patent Scope - Hoover Institution.
