United States Patent 8,980,839: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,980,839, titled "Topical aqueous nanomicellar, ophthalmic solutions and uses thereof," is a significant patent in the field of ophthalmic formulations. This patent, issued on March 17, 2015, to inventors Ashim K. Mitra and Sidney L. Weiss, and assigned to Ocular Technologies SARL, covers innovative formulations and methods for treating ocular diseases.
Patent Overview
Inventors and Assignees
The patent was invented by Ashim K. Mitra and Sidney L. Weiss, both renowned experts in pharmaceutical formulations. The assignee is Ocular Technologies SARL, a company focused on ophthalmic solutions[5].
Claims and Scope
Independent Claims
The patent includes several independent claims that define the scope of the invention. Key claims involve:
- Formulations for topical administration, specifically ophthalmic solutions.
- The use of polyoxyl lipids or fatty acids and polyalkoxylated alcohols.
- The inclusion of nanomicelles in these formulations[2][5].
Dependent Claims
Dependent claims further specify the components and methods of the formulations, including:
- Specific concentrations of active ingredients.
- Methods of preparing the nanomicellar solutions.
- Applications for treating or preventing ocular diseases such as dry eye syndrome (keratoconjunctivitis sicca)[5].
Formulation Components
Polyoxyl Lipids and Fatty Acids
The patent specifies the use of polyoxyl lipids, such as HCO-40 (polyoxyl castor oil), which are crucial for stabilizing the nanomicelles[2][4].
Polyalkoxylated Alcohols
Octoxynol-40 is cited as an example of a polyalkoxylated alcohol used in these formulations. These components help in the formation and stability of the nanomicelles[2][4].
Nanomicelles
Definition and Role
Nanomicelles are microscopic structures formed by the self-assembly of amphiphilic molecules. In this patent, they are used to enhance the solubility and delivery of active ingredients to the eye[5].
Benefits
The use of nanomicelles improves the bioavailability and stability of the active ingredients, making the ophthalmic solutions more effective for treating ocular conditions[5].
Methods of Use
Topical Administration
The formulations are designed for topical administration to the eye, providing a targeted and efficient delivery system for treating ocular diseases[5].
Therapeutic Applications
The patent covers methods for treating or preventing various ocular diseases, including dry eye syndrome, by increasing tear production and reducing inflammation[5].
Patent Landscape
Related Patents
Several related patents expand on the concepts introduced in US 8,980,839:
- US 10,918,694: Also deals with cyclosporine-containing formulations and uses similar components like polyoxyl lipids and polyalkoxylated alcohols[4].
- US 10,441,630: Covers broader aspects of topical formulations, including methods of treating ocular diseases using nanomicelles[5].
Patent Expiration Dates
The patent is set to expire on August 23, 2033, which is 20 years from the filing date of the original application[5].
Impact on Ophthalmic Treatments
Innovation in Ophthalmic Solutions
This patent has contributed significantly to the development of advanced ophthalmic solutions, particularly in the treatment of dry eye syndrome and other ocular conditions. The use of nanomicelles has enhanced the efficacy and stability of these solutions.
Clinical Significance
The formulations described in this patent have been clinically significant, providing relief to patients with ocular diseases by improving tear production and reducing symptoms associated with dry eye syndrome.
Regulatory and Legal Aspects
Patent Scope and Quality
The scope of this patent is well-defined, with clear claims that specify the components and methods of the formulations. This clarity is crucial for maintaining patent quality and avoiding potential litigation issues[3].
Exclusivity and Market Rights
The patent holder has exclusive rights to the proprietary chemical formulation, which may run concurrently with FDA-granted exclusivity periods. This ensures that the patent holder can protect their invention and maintain market exclusivity for a specified period[5].
Conclusion
The United States Patent 8,980,839 is a pivotal patent in the field of ophthalmic formulations, offering innovative solutions for treating ocular diseases. The use of nanomicelles, polyoxyl lipids, and polyalkoxylated alcohols has significantly improved the efficacy and stability of ophthalmic solutions. Understanding the scope, claims, and patent landscape of this invention is essential for both researchers and industry professionals looking to advance ophthalmic treatments.
Key Takeaways
- The patent covers topical aqueous nanomicellar ophthalmic solutions.
- Key components include polyoxyl lipids, polyalkoxylated alcohols, and nanomicelles.
- The formulations are used to treat ocular diseases such as dry eye syndrome.
- The patent is set to expire on August 23, 2033.
- Related patents expand on similar formulations and therapeutic applications.
Frequently Asked Questions (FAQs)
What are the main components of the formulations described in US 8,980,839?
The main components include polyoxyl lipids (e.g., HCO-40), polyalkoxylated alcohols (e.g., Octoxynol-40), and nanomicelles.
What is the therapeutic application of these formulations?
These formulations are used to treat or prevent ocular diseases, particularly dry eye syndrome (keratoconjunctivitis sicca), by increasing tear production.
Who are the inventors and assignees of this patent?
The inventors are Ashim K. Mitra and Sidney L. Weiss, and the assignee is Ocular Technologies SARL.
What is the significance of nanomicelles in these formulations?
Nanomicelles enhance the solubility and delivery of active ingredients to the eye, improving the bioavailability and stability of the formulations.
When is the patent set to expire?
The patent is set to expire on August 23, 2033.
Cited Sources:
- US8980839B2 - Topical aqueous nanomicellar, ophthalmic solutions and uses thereof - Google Patents
- US10918694B2 - Topical cyclosporine-containing formulations and uses thereof - Google Patents
- Patent Claims and Patent Scope - Hoover Institution
- United States Patent - googleapis.com
- Generic Cequa Availability - Drugs.com
