United States Patent 9,855,246: A Detailed Analysis
Overview of the Patent
The United States Patent 9,855,246, titled "Stable preservative-free mydriatic and anti-inflammatory solutions for injection," is a significant innovation in the field of ophthalmology. This patent, granted to Omeros Corporation, pertains to the development of stable, preservative-free, and antioxidant-free liquid formulations of phenylephrine and ketorolac for injection.
Background and Context
The patent builds upon previous research and developments in ophthalmological compositions, particularly those involving ketorolac and phenylephrine. These compounds are widely used for their anti-inflammatory and mydriatic properties, respectively. The need for preservative-free and antioxidant-free formulations arises from the potential irritant effects of preservatives and antioxidants on the eye, making this invention crucial for patient comfort and safety[4].
Scope of the Invention
Key Components
- Phenylephrine: A mydriatic agent used to dilate the pupils.
- Ketorolac: An anti-inflammatory agent used to reduce pain and inflammation.
- Preservative-Free and Antioxidant-Free: The formulations are designed to avoid the use of preservatives and antioxidants, which can be irritating to the eyes[4].
Formulation Details
The patent describes specific concentrations and formulations of phenylephrine and ketorolac that are stable and effective. For instance, the solution can include a concentration of phenylephrine between 0.5% and 2.0% and ketorolac between 0.1% and 0.5%. The solution is buffered to maintain a pH that is compatible with the eye, typically between 6.0 and 7.5[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Composition Claims
- Claims related to the specific concentrations of phenylephrine and ketorolac in the solution.
- Claims regarding the absence of preservatives and antioxidants.
- Claims about the pH range and buffering agents used in the formulation[4].
Method Claims
- Claims related to the methods of preparing these stable, preservative-free solutions.
- Claims about the use of these solutions for ophthalmic procedures, such as cataract surgery and other intraocular surgeries[4].
Patent Landscape Analysis
Related Patents and Prior Art
The patent landscape in this area is rich with previous inventions and disclosures related to ophthalmological compositions. Patents such as U.S. Patent Nos. 9,066,856, 9,486,406, and others have laid the groundwork for the development of stable formulations of ketorolac and phenylephrine. These prior patents often involved buffered formulations and various methods of stabilizing the compounds[1][2].
Competitive Environment
The competitive environment in the ophthalmic drug market is intense, with several companies and research institutions actively involved in developing new formulations and methods. The patent landscape report on AI-driven drug discovery highlights the increasing trend in patent filings in the pharmaceutical sector, including ophthalmology, indicating a highly competitive and innovative field[3].
Litigation and Enforcement
The patent is currently involved in a litigation case where Somerset is seeking to market a generic version of the product OMIDRIA® (phenylephrine and ketorolac injection) before the expiration of the patents-in-suit, including U.S. Patent No. 9,855,246. This litigation underscores the importance of patent protection in the pharmaceutical industry and the efforts to enforce these patents against potential infringers[2].
Technological and Market Impact
Technological Advancements
The invention represents a significant technological advancement in ophthalmic drug formulations by providing stable, preservative-free, and antioxidant-free solutions. This innovation addresses the need for safer and more comfortable treatments for patients undergoing ophthalmic procedures.
Market Impact
The market for ophthalmic drugs is substantial, and innovations like this patent can significantly impact market dynamics. The absence of preservatives and antioxidants can make the product more appealing to both healthcare providers and patients, potentially increasing market share and driving growth in the sector.
Key Takeaways
- Innovation in Formulations: The patent introduces stable, preservative-free, and antioxidant-free formulations of phenylephrine and ketorolac.
- Clinical Significance: These formulations are crucial for reducing eye irritation and improving patient comfort during ophthalmic procedures.
- Competitive Landscape: The patent is part of a highly competitive environment in ophthalmic drug development.
- Litigation and Enforcement: The patent is involved in ongoing litigation to protect against generic versions.
Frequently Asked Questions (FAQs)
1. What are the key components of the patent 9,855,246?
The key components are phenylephrine and ketorolac, formulated in a preservative-free and antioxidant-free solution.
2. Why are preservative-free and antioxidant-free formulations important?
These formulations are important because preservatives and antioxidants can be irritating to the eyes, making the treatment more comfortable and safer for patients.
3. What is the significance of the pH range in the formulation?
The pH range, typically between 6.0 and 7.5, is crucial for maintaining compatibility with the eye and ensuring the stability of the solution.
4. Is this patent involved in any litigation?
Yes, the patent is involved in a litigation case where Somerset is seeking to market a generic version of the product before the expiration of the patents-in-suit.
5. How does this patent impact the ophthalmic drug market?
The patent can significantly impact the market by providing a safer and more comfortable treatment option, potentially increasing market share and driving growth in the sector.
Cited Sources:
- US Patent Application for CHELATED, STABLE ... - Justia Patents
- Case 2:24-cv-09017-EP-JSA Document 1 Filed 09/06/24 Page 1 of ...
- AI Driven Drug Discovery Patent Landscape Report 2024 - Business Wire
- US9855246B2 - Stable preservative-free mydriatic and anti-inflammatory solutions for injection - Google Patents
