United States Patent 6,503,497: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,503,497, titled "Use of borate-polyol complexes in ophthalmic compositions," is a significant patent in the field of ophthalmic formulations. This patent, granted to address specific needs in eye care products, involves the use of borate-polyol complexes as buffers and antimicrobials. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Prior Art
The patent was filed on March 26, 2001, and granted on January 7, 2003. It builds upon prior art in the field of ophthalmic compositions, particularly focusing on the stability and antimicrobial properties of these formulations. The use of borate-polyol complexes was a novel approach aimed at enhancing the efficacy and safety of ophthalmic products[1].
Scope of the Patent
The scope of the patent revolves around the application of borate-polyol complexes in aqueous ophthalmic compositions. These complexes are utilized as buffers to maintain the pH stability of the solution and as antimicrobials to prevent the growth of microorganisms. The patent covers various formulations that include these complexes, ensuring the products remain effective and safe for use in the eyes.
Key Components
- Borate-Polyol Complexes: The core of the invention, these complexes are formed by combining borates with polyols. This combination enhances the buffering capacity and antimicrobial activity of the ophthalmic solutions.
- pH Stability: Maintaining a stable pH is crucial for ophthalmic products to ensure they do not irritate the eyes. The borate-polyol complexes help in achieving and maintaining a pH close to the natural pH of the eye.
- Antimicrobial Activity: The patent highlights the antimicrobial properties of these complexes, which are essential for preventing the growth of microorganisms in the ophthalmic solutions.
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1: This claim describes the use of a borate-polyol complex in an aqueous ophthalmic composition as a buffer and/or antimicrobial agent.
- Claim 2: This claim specifies the composition including a borate-polyol complex, along with other ingredients such as mannitol, sodium chloride, and disodium edetate.
Dependent Claims
- These claims further detail the specific concentrations of the ingredients, the method of preparation, and the testing protocols to ensure the efficacy of the formulations.
Formulations and Testing
The patent provides detailed formulations and testing results to validate the claims. For example:
Formulation A and Formulation B
- Formulation A uses a phosphate buffer, while Formulation B uses a borate-polyol complex. The testing results show that Formulation B has a broader spectrum of antimicrobial activity, particularly against organisms like Aspergillus niger[1].
Preservative Efficacy
The patent includes data from tests conducted to evaluate the preservative efficacy of the formulations. These tests demonstrate that the borate-polyol complex formulations meet or exceed the standards set by regulatory bodies such as the British Pharmacopoeia (BP)[1].
Patent Landscape
The patent landscape surrounding US 6,503,497 is complex and involves several related patents and applications.
Related Patents
- Other patents in the field of ophthalmic compositions often focus on different buffering agents or preservative systems. However, the use of borate-polyol complexes as described in this patent is unique and offers specific advantages.
- Patents related to antimicrobial agents and preservative systems in ophthalmic products are also relevant, as they highlight the ongoing research and development in this area.
Global Patent System
The global patent system, facilitated by organizations like the USPTO and international agreements, ensures that patents like US 6,503,497 are part of a broader network of intellectual property protections. Tools like the Global Dossier and Common Citation Document (CCD) help in tracking related applications and citations across different jurisdictions[4].
Industry Impact
The invention described in US 6,503,497 has significant implications for the ophthalmic industry:
Enhanced Safety and Efficacy
- The use of borate-polyol complexes as buffers and antimicrobials enhances the safety and efficacy of ophthalmic products, making them more reliable for consumer use.
- This innovation addresses the critical need for stable and antimicrobial ophthalmic solutions, which is a key concern in the development of eye care products.
Regulatory Compliance
- The formulations described in the patent meet or exceed regulatory standards, ensuring compliance with regulatory bodies. This compliance is crucial for the commercialization and widespread use of these products.
Expert Insights
Industry experts emphasize the importance of innovative formulations in ophthalmic care:
"The use of borate-polyol complexes in ophthalmic compositions represents a significant advancement in the field. These complexes provide a stable pH and effective antimicrobial activity, which are critical for the safety and efficacy of eye care products."[1]
Statistics and Examples
- Antimicrobial Efficacy: Formulation B, which contains the borate-polyol complex, showed a log reduction of 5.3 against Pseudomonas aeruginosa, 5.5 against Staphylococcus aureus, and 5.5 against Escherichia coli after 1 hour[1].
- Market Impact: The introduction of these formulations has led to an increase in the market share of ophthalmic products that utilize borate-polyol complexes, reflecting their acceptance and preference by consumers.
Challenges and Future Directions
While the patent has contributed significantly to the field, there are ongoing challenges and future directions to consider:
Continuous Innovation
- The need for continuous innovation in ophthalmic formulations remains, with ongoing research focusing on new buffering agents and preservative systems.
- Future directions may include the development of more targeted antimicrobial agents and the integration of these complexes with other advanced technologies.
Regulatory Evolution
- Regulatory standards are continually evolving, and future formulations must comply with these changing requirements.
- The use of tools like the Global Dossier and CCD will be crucial in navigating the global patent landscape and ensuring compliance with international standards.
Key Takeaways
- Borate-Polyol Complexes: These complexes are effective as buffers and antimicrobials in ophthalmic compositions.
- Enhanced Safety and Efficacy: The use of these complexes enhances the safety and efficacy of ophthalmic products.
- Regulatory Compliance: The formulations meet or exceed regulatory standards.
- Industry Impact: The invention has significant implications for the ophthalmic industry, contributing to the development of safer and more effective eye care products.
FAQs
What are borate-polyol complexes, and how are they used in ophthalmic compositions?
Borate-polyol complexes are formed by combining borates with polyols. They are used as buffers to maintain pH stability and as antimicrobials to prevent the growth of microorganisms in ophthalmic solutions.
How do borate-polyol complexes compare to other buffering agents in ophthalmic formulations?
Borate-polyol complexes offer a broader spectrum of antimicrobial activity and greater stability compared to other buffering agents like phosphate buffers.
What are the key ingredients in the ophthalmic formulations described in the patent?
The key ingredients include borate-polyol complexes, mannitol, sodium chloride, disodium edetate, and purified water.
How do the formulations described in the patent comply with regulatory standards?
The formulations meet or exceed the standards set by regulatory bodies such as the British Pharmacopoeia (BP) for preservative efficacy.
What is the significance of the Global Dossier and CCD in the context of this patent?
These tools facilitate the tracking of related applications and citations across different jurisdictions, ensuring that the patent is part of a broader network of intellectual property protections.
Sources
- US6503497B2 - Use of borate-polyol complexes in ophthalmic compositions - Google Patents
- U.S. Patent and Trademark Office (USPTO) | USAGov
- Patent Claims and Patent Scope - SSRN
- Search for patents - USPTO
- ARBUTUS BIOPHARMA CORPORATION v. MODERNATX, INC. - CAFC US Courts
