United States Patent 11,103,492 B2: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,103,492 B2, titled "Compositions and kits for omeprazole suspension," was granted to Azurity Pharmaceuticals, Inc. on August 31, 2021. This patent is significant in the pharmaceutical industry, particularly for the formulation and preparation of omeprazole suspensions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Omeprazole
Omeprazole is a proton pump inhibitor (PPI) widely used to treat acid-related gastrointestinal disorders. Its formulation, especially in suspension form, is crucial for patients who have difficulty swallowing capsules or tablets.
Scope of the Patent
The patent covers compositions and kits for preparing reconstituted suspensions of omeprazole. Here are the key aspects of the scope:
Liquid Diluents and Formulations
The patent describes specific liquid diluents and formulations that enhance the stability and bioavailability of omeprazole in suspension form. These include the use of sodium carboxymethyl cellulose (CMC) and poloxamer 188, which are critical components in maintaining the suspension's stability and ensuring consistent drug delivery[4].
Kits for Reconstitution
The invention also includes kits that facilitate the reconstitution of omeprazole suspensions. These kits typically contain a powder or granule form of omeprazole and a liquid diluent, along with instructions for reconstitution. The design of these kits simplifies the preparation process, making it more user-friendly for healthcare providers and patients[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the composition of the liquid diluent, which includes sodium CMC and poloxamer 188.
- Claim 2 outlines the kit for preparing the reconstituted suspension, including the powder or granule form of omeprazole and the liquid diluent[4].
Dependent Claims
- These claims further specify the concentrations of the components, such as the percentage of sodium CMC and poloxamer 188, and the pH range of the diluent.
- They also detail the method of reconstitution and the storage conditions for the suspension[4].
Patent Landscape
Understanding the patent landscape is crucial for navigating the intellectual property rights surrounding omeprazole formulations.
Prior Art and Related Patents
The patent cites several prior art documents, including earlier patents related to omeprazole formulations. For example, patents such as US6780882 and others mentioned in the prior art section of the patent document, highlight the evolution of omeprazole formulations over the years[4].
Litigation and Enforcement
Historically, omeprazole patents have been the subject of significant litigation. For instance, AstraZeneca, the original patent holder of omeprazole, engaged in extensive legal battles with generic manufacturers like Apotex and Impax Laboratories. These cases involved challenges to the validity and infringement of AstraZeneca's patents, highlighting the complexities and stakes involved in pharmaceutical patent litigation[2].
Market Exclusivity
The patent landscape also involves considerations of market exclusivity. Even after the expiration of the original patents, companies like AstraZeneca have benefited from six-month market exclusivity periods granted by the FDA, which can significantly impact the timing of generic drug approvals[2].
Patent Analytics and Claim Coverage
To fully understand the protection and gaps in the patent landscape, patent analytics play a vital role. Here’s how:
Claim Coverage Matrix
A Claim Coverage Matrix can help identify which patents and claims are actively protecting the intellectual property related to omeprazole suspensions. This matrix categorizes patents by claims and scope concepts, providing a clear picture of the patent landscape and highlighting any gaps or opportunities[3].
Interactive Claim Charts
Tools like ClaimScape® software generate interactive claim charts that help technical experts and management review the patent coverage. These charts are particularly useful in determining whether a particular scope concept is applicable to a target product or method, and they can be updated as new patents are filed or as development avenues are explored[3].
Key Components and Stability
The patent emphasizes the importance of specific components in maintaining the stability of the omeprazole suspension:
Poloxamer 188 and Sodium CMC
Poloxamer 188 and sodium CMC are critical for stabilizing the suspension and ensuring consistent drug delivery. The patent provides detailed data on the dissolution profiles of these formulations, demonstrating their efficacy in maintaining the stability of omeprazole over time[4].
Regulatory Considerations
The approval process for generic versions of omeprazole suspensions involves regulatory considerations, particularly under the Abbreviated New Drug Application (ANDA) process. The FDA requires specific certifications regarding each patent that covers the application's drug, and the patent holder can file suit under section 271(e)(2)(A) if a Paragraph IV certification is made, potentially delaying the approval of the generic version[2].
Conclusion
The United States Patent 11,103,492 B2 is a significant development in the formulation of omeprazole suspensions, offering improved stability and bioavailability. Understanding the scope, claims, and broader patent landscape is essential for pharmaceutical companies navigating the complex world of intellectual property and regulatory approvals.
Key Takeaways
- Improved Formulations: The patent introduces specific liquid diluents and formulations that enhance the stability and bioavailability of omeprazole in suspension form.
- Kits for Reconstitution: The invention includes kits that simplify the preparation of omeprazole suspensions.
- Patent Landscape: The patent landscape involves extensive prior art, litigation history, and regulatory considerations.
- Patent Analytics: Tools like Claim Coverage Matrix and interactive claim charts are crucial for understanding and managing the patent landscape.
- Regulatory Considerations: The approval process for generic versions involves specific certifications and potential legal actions under the ANDA process.
FAQs
What is the main focus of the United States Patent 11,103,492 B2?
The main focus is on compositions and kits for preparing reconstituted suspensions of omeprazole.
What are the key components in the liquid diluents described in the patent?
The key components include sodium carboxymethyl cellulose (CMC) and poloxamer 188.
Why is the stability of omeprazole suspension important?
Stability is crucial for ensuring consistent drug delivery and maintaining the efficacy of the medication over time.
How does the patent impact generic drug manufacturers?
The patent can delay the approval of generic versions through the ANDA process and potential legal actions under section 271(e)(2)(A).
What role do patent analytics play in managing intellectual property related to omeprazole suspensions?
Patent analytics help in identifying which patents and claims are actively protecting the intellectual property, highlighting gaps or opportunities, and providing tools like Claim Coverage Matrix and interactive claim charts.
Sources
- United States Patent and Trademark Office - US11103492B2 - Compositions and kits for omeprazole suspension.
- Casetext - Omeprazole Patent v. Apotex, 536 F.3d 1361.
- SLWIP - Patent Analytics | Intellectual Property Law.
- Google Patents - US11103492B2 - Compositions and kits for omeprazole suspension.
