Detailed Analysis of the Scope and Claims of United States Patent 9,066,856
Introduction
United States Patent 9,066,856, titled "Stable preservative-free mydriatic and anti-inflammatory solutions for injection," is a crucial patent held by Omeros Corporation. This patent protects the formulation and use of OMIDRIA®, a pharmaceutical product containing phenylephrine and ketorolac. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
The patent US 9,066,856 was granted to Omeros Corporation and is set to expire in October 2033, unless there are any changes due to legal activities such as patent term extensions or amendments[1][4].
Scope of the Patent
This patent pertains to stable, preservative-free, and antioxidant-free liquid formulations of phenylephrine and ketorolac for injection. These formulations are designed for ophthalmic use, specifically for mydriasis (pupil dilation) and anti-inflammatory purposes during eye surgeries[4].
Claims of the Patent
The patent includes several claims that define the scope of protection:
- Composition Claims: These claims specify the formulation of the solution, including the concentrations of phenylephrine and ketorolac, and the absence of preservatives and antioxidants[4].
- Method Claims: These claims cover the methods of preparing and using the solution, including the process of irrigation during ophthalmic procedures[4].
- Use Claims: These claims define the intended use of the formulation, such as for mydriasis and anti-inflammatory purposes in ophthalmic surgeries[4].
Key Components of the Formulation
The patent describes a pharmaceutical composition that includes:
- Phenylephrine, a mydriatic agent
- Ketorolac, an anti-inflammatory agent
- A buffer system to maintain the stability of the solution
- The absence of preservatives and antioxidants, which is a critical aspect of the invention[4].
Patent Landscape
The patent landscape surrounding US 9,066,856 is complex and involves multiple related patents.
- Related Patents: Other patents such as US 9,486,406 and US 9,855,246 also protect various aspects of the OMIDRIA® formulation and its use. These patents are set to expire around the same time as US 9,066,856[1].
- Expired Patents: Some related patents, such as US 8,173,707, US 8,586,633, and US 9,278,101, have already expired, which could potentially open up opportunities for generic versions or alternative formulations[1].
Legal Activities and Challenges
The patent is currently involved in several legal activities:
- Paragraph IV Certifications: Companies like Somerset have filed Abbreviated New Drug Applications (ANDAs) with the FDA, challenging the validity, enforceability, or infringement of the patents, including US 9,066,856. This process allows generic manufacturers to seek approval before the patent expires[2].
- Litigation: Omeros Corporation has filed lawsuits against companies like Somerset under the Hatch-Waxman Act, alleging infringement of their patents, including US 9,066,856. These lawsuits aim to prevent the early launch of generic versions of OMIDRIA®[2][5].
Impact on Generic Launch
The legal battles and the status of the patent can significantly impact the timing of generic launches. If a generic manufacturer successfully challenges the patent through a Paragraph IV certification, they may be able to launch their product before the patent expires. However, if the patent holder prevails in litigation, the generic launch could be delayed until the patent expires[1][2].
Patent Analytics and Claim Coverage
To navigate the complex patent landscape, companies often use patent analytics tools. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps in coverage and potential opportunities for innovation. For example, Claim Coverage Matrices and Claim Charts can be used to review patent coverage and determine the applicability of scope concepts to target products or methods[3].
Future Directions and Opportunities
The expiration of patents like US 9,066,856 presents both challenges and opportunities. For Omeros Corporation, it is crucial to monitor legal activities and protect their intellectual property. For generic manufacturers, understanding the patent landscape and leveraging tools like patent analytics can help in identifying opportunities for launching generic versions or developing new formulations.
Conclusion
The United States Patent 9,066,856 is a pivotal patent in the ophthalmic pharmaceutical sector, protecting the unique formulation and use of OMIDRIA®. Understanding its scope, claims, and the surrounding patent landscape is essential for both the patent holder and potential generic manufacturers. The ongoing legal activities and the use of patent analytics tools will continue to shape the future of this product and the broader market.
Key Takeaways
- Patent Scope: US 9,066,856 protects stable, preservative-free mydriatic and anti-inflammatory solutions for injection.
- Claims: The patent includes composition, method, and use claims related to the formulation and application of OMIDRIA®.
- Patent Landscape: The patent is part of a complex landscape involving multiple related patents and ongoing legal activities.
- Legal Challenges: Generic manufacturers can challenge the patent through Paragraph IV certifications, while the patent holder can litigate to protect their rights.
- Future Opportunities: The expiration of the patent and the use of patent analytics tools present opportunities for innovation and generic launches.
Frequently Asked Questions
Q: What is the primary focus of United States Patent 9,066,856?
A: The primary focus is on stable, preservative-free mydriatic and anti-inflammatory solutions for injection, specifically the formulation and use of OMIDRIA®.
Q: When is the patent set to expire?
A: The patent is set to expire in October 2033, unless there are any changes due to legal activities.
Q: How can generic manufacturers launch their products before the patent expires?
A: Generic manufacturers can launch their products before the patent expires by filing an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification, challenging the validity, enforceability, or infringement of the patent.
Q: What tools can companies use to navigate the complex patent landscape?
A: Companies can use patent analytics tools, such as Claim Coverage Matrices and Claim Charts, to categorize patents by claims and scope concepts and identify gaps in coverage.
Q: What are the implications of the patent's expiration for Omeros Corporation and generic manufacturers?
A: The expiration of the patent presents challenges for Omeros Corporation in protecting their intellectual property and opportunities for generic manufacturers to launch their products, potentially changing the market dynamics.
