United States Patent 9,399,040: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,399,040, titled "Ophthalmologic Irrigation Solutions and Method," is a significant patent in the field of ophthalmology, particularly related to the product Omidria® developed by Omeros Corporation. This patent, along with several others, protects the unique formulation and method of use of Omidria®, which is an ophthalmologic irrigation solution used during surgical procedures.
Background of Omidria®
Omidria® is the first and only FDA-approved product of its kind, commercially launched in 2015. It is designed for use in cataract surgery and other intraocular lens replacement procedures to reduce post-operative pain and inflammation, and to prevent miosis (pupil constriction) during and after surgery[5].
Patent Overview
Publication and Issuance
The '040 Patent was issued by the United States Patent and Trademark Office (USPTO) on July 26, 2016. It is part of a series of patents that cover various aspects of ophthalmologic irrigation solutions and methods[2][4].
Claims and Scope
The patent includes multiple claims that describe the composition and method of use of the ophthalmologic irrigation solution. Key components of the solution include:
- Mydriatic agents: To dilate the pupils.
- Anti-inflammatory agents: To reduce inflammation.
- Local anesthetic agents: To alleviate pain.
- Receptor agonists and antagonists: To manage various physiological responses during surgery[1].
The claims specify the concentrations of these agents, the method of preparation, and the conditions under which the solution is administered during ophthalmologic procedures. The solution is designed for continuous irrigation during surgery to maintain optimal conditions for the procedure.
Expiry and Current Status
The '040 Patent, along with several related patents (US8,173,707, US8,586,633, US9,066,856, US9,278,101, and US9,486,406), has expired as of July 2023. However, the generic launch of equivalent products is delayed due to FDA-granted exclusivities that remain active until 2033[4][5].
Patent Landscape
Related Patents
The '040 Patent is part of a broader patent portfolio that includes several other patents related to Omidria®. These patents cover various aspects such as:
- Stable preservative-free mydriatic and anti-inflammatory solutions: Protected by patents like US9,066,856 and US9,486,406[2][4].
- Ophthalmologic irrigation solutions and methods: Covered by patents like US8,173,707 and US9,278,101[2][4].
Litigation and Challenges
The patents protecting Omidria® have been subject to litigation, particularly with respect to generic versions. Companies like Sandoz have filed Abbreviated New Drug Applications (ANDAs) for generic versions, which led to patent infringement lawsuits by Omeros. Sandoz has since converted to a Paragraph III certification, meaning the FDA cannot approve the ANDA until after the expiry of all relevant patents in 2033[5].
Impact on Generic Launch
The expiry of the '040 Patent and other related patents does not immediately allow for the launch of generic versions due to the FDA-granted exclusivities. These exclusivities are crucial in delaying the generic launch, ensuring that Omeros maintains market exclusivity for Omidria® until 2033[4][5].
Technical Aspects
Composition
The patent describes a solution that includes a combination of mydriatic agents (e.g., phenylephrine), anti-inflammatory agents (e.g., ketorolac), and local anesthetic agents. The solution is formulated to be preservative-free, which is critical for ophthalmologic use to avoid adverse reactions[1].
Method of Use
The method involves continuous irrigation during ophthalmologic procedures. The solution is administered to maintain pupil dilation, reduce inflammation, and alleviate pain, thereby improving the surgical environment and post-operative outcomes[1].
Economic and Market Implications
Market Exclusivity
The combination of patent protection and FDA-granted exclusivities ensures that Omeros maintains market exclusivity for Omidria® until 2033. This exclusivity is vital for the company's revenue stream, as it prevents generic competition during this period[4][5].
Generic Competition
Once the patents and exclusivities expire, the market is expected to see the entry of generic versions, which could significantly impact the pricing and market share of Omidria®. Companies like Sandoz are already positioning themselves for this eventuality by filing ANDAs with Paragraph III certifications[5].
Regulatory Considerations
FDA Approvals and Exclusivities
The FDA has granted several exclusivities to Omidria®, including pediatric exclusivity, which extends the market exclusivity period. These exclusivities are critical in delaying the generic launch and are closely monitored by regulatory bodies and industry stakeholders[4].
Patent Litigation
The patent landscape around Omidria® is complex, with multiple patents and ongoing litigation. This complexity highlights the importance of robust patent protection strategies in the pharmaceutical industry to safeguard intellectual property and market position[2][5].
Key Takeaways
- Patent Expiry: The '040 Patent and related patents have expired as of July 2023.
- FDA Exclusivities: Market exclusivity for Omidria® extends until 2033 due to FDA-granted exclusivities.
- Generic Launch: Generic versions cannot be approved until after the expiry of all relevant patents and exclusivities in 2033.
- Litigation: Ongoing patent litigation has been a significant factor in protecting Omidria® from generic competition.
- Market Impact: The entry of generic versions in 2033 is expected to impact the market share and pricing of Omidria®.
FAQs
What is the main purpose of United States Patent 9,399,040?
The main purpose of this patent is to protect the composition and method of use of ophthalmologic irrigation solutions, specifically Omidria®, used during cataract surgery and other intraocular lens replacement procedures.
What are the key components of the ophthalmologic irrigation solution described in the patent?
The solution includes mydriatic agents, anti-inflammatory agents, and local anesthetic agents, formulated to be preservative-free.
Why is the patent landscape around Omidria® complex?
The patent landscape is complex due to multiple related patents, ongoing litigation, and FDA-granted exclusivities that delay the generic launch.
What is the current status of the '040 Patent?
The '040 Patent has expired as of July 2023, but generic versions cannot be launched until after the expiry of all relevant patents and exclusivities in 2033.
How do FDA exclusivities impact the market for Omidria®?
FDA exclusivities extend the market exclusivity period for Omidria®, preventing generic competition until 2033 and ensuring Omeros maintains market exclusivity during this period.
Sources
- US9399040B2 - Ophthalmologic irrigation solutions and method - Google Patents
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - Insight.RPXCorp
- Patent Claims and Patent Scope - SSRN
- Omidria patent expiration - Pharsight
- Sandoz Amends ANDA to Not Seek Approval for Generic Version of OMIDRIA - BusinessWire
