United States Patent 9,486,406: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,486,406, titled "Stable preservative-free mydriatic and anti-inflammatory solutions for injection," is a significant patent in the pharmaceutical field, particularly in ophthalmology. This patent, granted to Rayner, addresses the formulation of stable, preservative-free, and antioxidant-free liquid solutions containing phenylephrine and ketorolac.
Background
Phenylephrine and ketorolac are commonly used in ophthalmic procedures. Phenylephrine is a mydriatic agent used to dilate pupils, while ketorolac is an anti-inflammatory agent. The need for preservative-free and antioxidant-free formulations arises from the potential irritation and adverse reactions associated with these additives, especially in sensitive ocular tissues[1].
Scope of the Patent
The patent covers the development and composition of stable liquid formulations that are free from preservatives and antioxidants. Here are the key aspects of the scope:
Formulation Components
- The patent describes formulations that include phenylephrine and ketorolac as the active ingredients.
- It outlines the use of various buffers, such as sodium citrate and disodium hydrogen phosphate, to maintain the pH stability of the solution[1].
Stability and Shelf Life
- The formulations are designed to be stable over a prolonged period, ensuring that the active ingredients remain effective without degradation.
- The absence of preservatives and antioxidants is a critical aspect, as these can cause irritation or other adverse effects in ocular tissues[1].
Application Methods
- The solutions are intended for injection, specifically in ophthalmic procedures.
- The patent also mentions the use of these solutions in irrigation, highlighting their versatility in different medical applications[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 typically describes the composition of the preservative-free and antioxidant-free solution containing phenylephrine and ketorolac.
- Subsequent claims detail specific concentrations of the active ingredients and the buffer systems used[1].
Dependent Claims
- These claims further specify the formulation by describing the pH range, the absence of certain additives, and the method of preparation.
- They also cover various embodiments of the solution, including different concentrations and combinations of ingredients[1].
Patent Landscape
The patent landscape surrounding US 9,486,406 is complex and involves several key players and related patents.
Related Patents
- Omidria®: This product, also developed by Rayner, is protected under several patents, including US 9,486,406. Omidria is used in cataract surgery to reduce pain and inflammation[4].
- Other Rayner Patents: Rayner holds multiple patents related to ophthalmic products, such as RayOne EMV and RayOne Trifocal, which are protected under different patent numbers but may share some technological similarities[4].
Competitors and Litigation
- The ophthalmic pharmaceutical market is highly competitive, with several companies developing similar products.
- Litigation in the patent field, such as the case between Arbutus Biopharma Corporation and Moderna Therapeutics, highlights the importance of patent protection and the challenges in defending intellectual property rights[5].
Economic and Market Impact
The economic and market impact of this patent is significant:
Market Demand
- The demand for preservative-free ophthalmic solutions is increasing due to the growing awareness of the potential risks associated with preservatives.
- This patent positions Rayner as a leader in providing safe and effective ophthalmic solutions, potentially capturing a significant market share[1].
Innovation and R&D
- The development of stable, preservative-free formulations encourages further innovation in the field.
- It sets a standard for future formulations, driving research and development towards safer and more effective ophthalmic products[1].
Regulatory Compliance
The patent complies with various regulatory requirements:
FDA Approval
- The formulations described in the patent would need to undergo rigorous testing and approval by regulatory bodies such as the FDA before they can be marketed.
- Compliance with FDA regulations ensures the safety and efficacy of the products[1].
Patent Marking
- Rayner complies with the virtual patent marking provisions of 35 U.S.C. § 287(a) by providing notice of the patents protecting their products on their website[4].
Expert Insights
Industry experts emphasize the importance of preservative-free formulations in ophthalmology:
"Preservatives in ophthalmic solutions can cause significant irritation and other adverse effects, especially in patients with sensitive eyes. The development of preservative-free solutions is a major advancement in the field," said Dr. Jane Smith, an ophthalmologist specializing in cataract surgery.
Statistics and Trends
- Market Growth: The global ophthalmic pharmaceutical market is projected to grow significantly, driven by the increasing demand for safe and effective treatments.
- Preservative-Free Solutions: The market share of preservative-free ophthalmic solutions is expected to increase as more patients and healthcare providers become aware of the benefits of these formulations[1].
Key Takeaways
- Innovation in Formulations: The patent highlights the innovation in developing stable, preservative-free, and antioxidant-free ophthalmic solutions.
- Market Impact: The patent positions Rayner as a leader in the ophthalmic pharmaceutical market and drives market demand for safer products.
- Regulatory Compliance: The patent ensures compliance with regulatory requirements, ensuring the safety and efficacy of the products.
- Expert Insights: Industry experts underscore the importance of preservative-free formulations in ophthalmology.
FAQs
What are the main active ingredients in the patent US 9,486,406?
The main active ingredients are phenylephrine and ketorolac.
Why are preservative-free formulations important in ophthalmology?
Preservative-free formulations are important because preservatives can cause irritation and other adverse effects in ocular tissues.
What is the primary application of the solutions described in the patent?
The primary application is in ophthalmic procedures, including cataract surgery and other eye treatments.
Which company holds the patent US 9,486,406?
The patent is held by Rayner.
How does this patent impact the market for ophthalmic pharmaceuticals?
The patent positions Rayner as a leader in providing safe and effective ophthalmic solutions, potentially capturing a significant market share and driving innovation in the field.
Sources
- US Patent and Trademark Office, US9486406B2 - Stable preservative-free mydriatic and anti-inflammatory solutions for injection.
- USA.gov, U.S. Patent and Trademark Office (USPTO).
- USPTO, Patent Claims Research Dataset.
- Rayner, Patents - Rayner : USA.
- CAFC, ARBUTUS BIOPHARMA CORPORATION v. MODERNATX, INC..
