United States Patent 8,932,610: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 8,932,610, titled "Aqueous clear solutions of fluocinolone acetonide for treatment of otic inflammation," is a significant patent in the pharmaceutical field, particularly for the treatment of ear inflammation. This patent, issued to a pharmaceutical company, outlines a specific formulation and method for creating an aqueous solution of fluocinolone acetonide, a corticosteroid used to treat various inflammatory conditions.
Background
Fluocinolone acetonide is a synthetic corticosteroid with potent anti-inflammatory and antipruritic properties. It is commonly used in dermatological and otic (ear) treatments. The patent in question addresses the need for a clear, aqueous solution that is both effective and safe for otic use.
Claims Overview
The patent claims revolve around a pharmaceutical composition in the form of a clear aqueous solution containing 0.01-0.10% (w/v) of fluocinolone acetonide. Here are the key aspects of the claims:
Composition
- The solution is aqueous and clear, which is crucial for otic use to ensure visibility and ease of administration[1].
- The concentration of fluocinolone acetonide is specified between 0.01% and 0.10% (w/v), ensuring a potent yet safe therapeutic dose.
Excipients and Additives
- The patent mentions various excipients such as sodium, potassium, and polymers like hydroxyethyl cellulose, hydroxypropyl cellulose, and maltodextrin. These additives help in stabilizing the solution and enhancing its shelf life[1].
Preservative-Free
- The solution is preservative-free, which is important for otic use to avoid potential irritation or allergic reactions that preservatives might cause[1].
Scope of the Patent
The scope of this patent is narrowly defined to ensure that the specific formulation and concentration of fluocinolone acetonide are protected.
Therapeutic Use
- The patent is specifically for the treatment of otic inflammation, which includes conditions such as otitis externa and other inflammatory ear diseases[1].
Formulation
- The clear aqueous solution is designed to be easy to administer and ensure effective delivery of the active ingredient directly to the site of inflammation.
Patent Landscape
The patent landscape surrounding US 8,932,610 involves several key aspects:
Competing Patents
- Other patents may exist for different formulations or concentrations of fluocinolone acetonide, but this patent is unique in its specific aqueous solution formulation for otic use[1].
Regulatory Environment
- The FDA's Orange Book and other regulatory documents play a crucial role in defining the therapeutic equivalence and exclusivity of such pharmaceutical products. This patent would be listed in such databases to ensure compliance and to protect the innovator's rights[4].
Litigation and Enforcement
- Patent infringement cases, similar to those described in other pharmaceutical patent disputes, could arise if other companies attempt to manufacture or market similar products without proper authorization. The legal framework for such cases involves detailed claim construction and comparison with the accused infringing product[2].
Claim Construction and Infringement Analysis
Claim construction is a critical step in determining the scope of the patent. For US 8,932,610, the claims would be construed to ascertain their meaning and scope, and then compared with any accused infringing product to determine infringement.
Independent and Dependent Claims
- Independent claims define the broad scope of the invention, while dependent claims further limit and specify the invention. In this case, the independent claims would focus on the aqueous solution and the concentration of fluocinolone acetonide, while dependent claims might specify additional excipients or manufacturing processes[3].
Process of Making the Product
- For product-by-process claims, the infringement inquiry would focus on the process of making the product as much as the product itself. This ensures that any infringing product must be made using the same process as described in the patent[2].
Impact on the Pharmaceutical Industry
This patent has significant implications for the pharmaceutical industry, particularly in the development and marketing of otic corticosteroid solutions.
Innovation and Competition
- The patent encourages innovation by protecting the specific formulation and concentration of fluocinolone acetonide, allowing the innovator to recoup investment in research and development.
- It also sets a standard for competitors, who must either develop alternative formulations or seek licensing agreements to enter the market[3].
Patient Benefits
- Patients benefit from a safe and effective treatment for otic inflammation, which is specifically designed for ease of use and minimal side effects.
Challenges and Future Directions
The pharmaceutical landscape is constantly evolving, and patents like US 8,932,610 must navigate these changes.
Regulatory Changes
- Changes in FDA regulations or therapeutic equivalence evaluations could impact the patent's exclusivity and market position[4].
Technological Advancements
- Advances in pharmaceutical technology could lead to new formulations or delivery methods that might challenge the existing patent or create opportunities for new patents.
Key Takeaways
- Specific Formulation: The patent protects a clear aqueous solution of fluocinolone acetonide with a concentration between 0.01% and 0.10% (w/v) for otic use.
- Preservative-Free: The solution is preservative-free, enhancing its safety profile for otic administration.
- Regulatory Compliance: The patent is subject to FDA regulations and must be listed in the Orange Book to ensure therapeutic equivalence and exclusivity.
- Innovation and Competition: The patent promotes innovation and sets standards for competitors in the development of otic corticosteroid solutions.
Frequently Asked Questions (FAQs)
What is the primary use of the patent US 8,932,610?
The primary use of this patent is for the treatment of otic inflammation, including conditions such as otitis externa.
What is the concentration of fluocinolone acetonide in the patented solution?
The concentration of fluocinolone acetonide in the patented solution is between 0.01% and 0.10% (w/v).
Why is the solution preservative-free?
The solution is preservative-free to avoid potential irritation or allergic reactions that preservatives might cause in otic use.
How does this patent impact the pharmaceutical industry?
This patent encourages innovation by protecting a specific formulation, allowing the innovator to recoup investment in research and development, and sets standards for competitors.
What regulatory bodies are involved in the oversight of this patent?
The FDA is the primary regulatory body involved, with the patent listed in the FDA's Orange Book to ensure compliance and therapeutic equivalence.
Cited Sources:
- US8932610B2 - Aqueous clear solutions of fluocinolone acetonide for treatment of otic inflammation - Google Patents
- Civil Action No. 20-755-RGA - District of Delaware
- Patent Claims and Patent Scope - Hoover Institution
- Approved Drug Products with Therapeutic Equivalence Evaluations, 36th Edition - DrugPatentWatch
