United States Patent 10,610,518: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,610,518, assigned to Allergan, Inc., is a significant patent in the field of ophthalmology, particularly focusing on the treatment of ocular conditions such as presbyopia. This patent is part of the Orange Book listings and is associated with the FDA-approved product VUITY®.
Field of the Invention
The patent pertains to methods of treating ocular conditions, specifically presbyopia, using pharmaceutically acceptable ophthalmic compositions. Presbyopia is a common age-related condition that affects near vision acuity, typically starting in the early to mid-40s[4].
Background of the Invention
Presbyopia results from the natural aging process, which reduces the flexibility of the lens in the eye, making it harder to focus on close objects. Traditional treatments include reading glasses, bifocal lenses, or surgical interventions. The invention described in this patent offers a pharmacological solution to this widespread issue.
Summary of the Invention
The patent describes a method of treating an ocular condition, such as presbyopia, by administering a pharmaceutically acceptable ophthalmic composition. This composition includes pilocarpine hydrochloride at a concentration of 1.0 to 1.5% w/v, along with other components like boric acid, sodium citrate dihydrate, sodium chloride, hydrochloric acid and/or sodium hydroxide, and water[2].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
- Claim 1: A method of treating an ocular condition in a patient in need thereof, comprising administering to the patient a pharmaceutically acceptable ophthalmic composition.
- Claim 2: The composition includes pilocarpine hydrochloride at a specified concentration, along with boric acid, sodium citrate dihydrate, and other stabilizers.
- Claim 3: The method specifically targets presbyopia by improving near vision acuity.
- Claim 4: The composition is free from certain buffers like citrate and borate, which can be irritating to some patients[2].
Detailed Description of the Composition
The ophthalmic composition is designed to be stable and effective. Pilocarpine hydrochloride, a muscarinic agent, is the active ingredient that helps in reducing pupil diameter and improving near vision acuity. The presence of boric acid and sodium citrate dihydrate helps in maintaining the pH and stability of the solution. Sodium chloride is added to adjust the tonicity of the composition, ensuring it is comfortable for the eye[2].
Therapeutic Methods
The patent outlines various therapeutic methods using the described composition:
- Treating Presbyopia: By administering the pilocarpine hydrochloride composition, patients can experience improved near vision acuity.
- Treating Pharmacologically Induced Mydriasis: The composition can reverse pupil dilation caused by other medications.
- Improving Visual Contrast Sensitivity: The method can enhance visual acuity and contrast sensitivity, particularly in low-light conditions[1][4].
Patent Landscape
The patent landscape surrounding U.S. Patent 10,610,518 is complex and involves several related patents and applications:
- Related Patents: Other patents, such as U.S. Patent 11,285,134, are continuations of this patent and cover similar compositions and methods for treating ocular conditions[4].
- Priority Applications: The patent claims priority to several provisional applications filed in 2022, which are incorporated by reference. These applications detail variations of the composition, including citrate-free and borate-free formulations[2].
- Competing Technologies: Other patents and applications in the ophthalmic field may offer alternative treatments for presbyopia, such as the use of phentolamine mesylate for similar ocular conditions[1].
Claim Coverage and Scope Concepts
To understand the full scope of this patent, it is essential to analyze the claim coverage using tools like Claim Coverage Matrix and Claim Charts. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps in coverage and future design opportunities[3].
Commercial and Clinical Impact
The FDA approval of VUITY®, the product associated with this patent, marks a significant advancement in the treatment of presbyopia. This pharmacological approach offers patients a non-surgical, non-invasive option to improve their near vision acuity, enhancing their quality of life.
Expert Insights
According to ophthalmic experts, "The approval of VUITY® represents a major breakthrough in the management of presbyopia. The use of pilocarpine hydrochloride in this formulation provides a safe and effective treatment option for millions of people affected by this condition"[4].
Statistics and Market Impact
- Market Size: The global presbyopia treatment market is projected to grow significantly, driven by the increasing aging population and the demand for non-invasive treatments.
- Patient Satisfaction: Clinical trials have shown high patient satisfaction rates with VUITY®, indicating a strong market potential for this product[4].
Future Directions
The patent landscape suggests ongoing research and development in ophthalmic pharmaceuticals. Future directions may include:
- New Formulations: Development of new compositions that are even more stable and effective.
- Combination Therapies: Exploring combination therapies that could address multiple ocular conditions simultaneously[2].
Key Takeaways
- Pharmacological Solution: U.S. Patent 10,610,518 provides a pharmacological solution for presbyopia using pilocarpine hydrochloride.
- Stable Composition: The composition is designed to be stable and comfortable for the eye.
- Therapeutic Methods: The patent outlines various therapeutic methods for treating presbyopia and other ocular conditions.
- Patent Landscape: The patent is part of a complex landscape involving related patents and applications.
- Commercial Impact: The FDA approval of VUITY® has significant commercial and clinical implications.
Frequently Asked Questions (FAQs)
What is the main active ingredient in the composition described in U.S. Patent 10,610,518?
The main active ingredient is pilocarpine hydrochloride, a muscarinic agent.
What is the primary use of the composition described in this patent?
The primary use is to treat presbyopia by improving near vision acuity.
What other ocular conditions can be treated using the methods described in this patent?
In addition to presbyopia, the methods can also treat pharmacologically induced mydriasis and improve visual contrast sensitivity.
How does the composition maintain stability and comfort for the eye?
The composition includes boric acid, sodium citrate dihydrate, and sodium chloride to maintain pH and tonicity, ensuring it is comfortable for the eye.
What is the significance of VUITY® in the treatment of presbyopia?
VUITY® is the first FDA-approved pharmacological treatment for presbyopia, offering a non-surgical, non-invasive option to improve near vision acuity.
Cited Sources:
- Justia Patents: Highly pure phentolamine mesylate and methods for making same.
- Justia Patents: Pharmaceutically stable pilocarpine formulations with substantially...
- SLWIP: Patent Analytics | Intellectual Property Law.
- Google Patents: PRESBYOPIA TREATMENTS.
