United States Patent 8,846,650: A Comprehensive Analysis
Introduction
United States Patent 8,846,650, titled "Method of Treating Middle Ear Infections," is a significant patent that addresses the treatment of middle ear infections using a combination of ciprofloxacin and dexamethasone. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
The patent, granted on September 30, 2014, is assigned to Novartis AG and was invented by G. Michael Wall and Peter J. Conroy. It pertains to the use of aqueous suspension formulations containing ciprofloxacin, an antibiotic, and dexamethasone, a corticosteroid, for the topical treatment of middle ear infections in humans[1].
Scope of the Invention
The invention specifically focuses on the topical application of a fixed combination of ciprofloxacin and dexamethasone to treat middle ear infections. This approach is distinct from traditional treatments that often involve oral antibiotics or single-entity topical antibiotics. The formulation is designed to provide both antimicrobial and anti-inflammatory effects, making it a comprehensive treatment for otic infections[1].
Claims of the Patent
The patent includes multiple claims that define the scope of the invention. Here are some key claims:
- Claim 1: A method of treating middle ear infections in humans, comprising administering a topical formulation containing ciprofloxacin and dexamethasone.
- Claim 2: The method of claim 1, where the formulation is an aqueous suspension.
- Claim 3: The method of claim 1, where the ciprofloxacin and dexamethasone are present in specific concentrations.
- Claims 4-12: Various aspects of the formulation, including pH, viscosity, and preservatives.
These claims collectively protect the specific combination, formulation, and method of administration of ciprofloxacin and dexamethasone for treating middle ear infections[1].
Patent Landscape
The patent landscape surrounding US 8,846,650 involves several related patents and regulatory considerations:
Related Patents
The patent is part of a series of continuations and divisions, indicating a complex and evolving intellectual property strategy. It is linked to earlier applications such as Ser. No. 10/946,792 and Ser. No. 10/243,341, which were filed in 2004 and 2002, respectively[1].
Regulatory Aspects
Under the Hatch-Waxman Act, the approval of this patent and its associated drug formulation would require listing in the FDA's "Orange Book." This listing includes patents that the brand-name manufacturer alleges can be reasonably asserted against a generic equivalent. Generic manufacturers must then certify that their products do not infringe these patents or that the patents are invalid or unenforceable[2].
Patent Expiration and Maintenance
The patent has undergone various maintenance fee payments, which are crucial for extending its validity. For instance, the 8th-year maintenance fee for US 8,846,650 was paid in March 2022. However, the patent's critical expiration date is not explicitly mentioned in the provided sources, but related patents have expiration dates ranging from 2023 to 2024[4].
Competitive and Generic Challenges
Generic manufacturers often challenge the validity and enforceability of such patents to enter the market. For example, Sun Pharmaceuticals filed an Abbreviated New Drug Application (ANDA) with certifications that their proposed product did not infringe or that the patents were invalid or unenforceable. This highlights the ongoing legal and regulatory battles surrounding the patent[2].
Patent Analytics and Claim Coverage
To effectively manage and analyze the claims of this patent, companies can 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 future design opportunities. Interactive claim charts can be used to review patent coverage with technical experts, ensuring that the patent landscape is well-understood and optimized[3].
Impact on Treatment of Middle Ear Infections
The invention represented by US 8,846,650 has a significant impact on the treatment of middle ear infections. By providing a topical formulation that combines an antibiotic and a corticosteroid, it offers a more targeted and potentially more effective treatment option compared to traditional methods. This can improve patient outcomes and reduce the risk of systemic side effects associated with oral antibiotics[1].
Key Takeaways
- Invention Scope: The patent covers the use of ciprofloxacin and dexamethasone in an aqueous suspension for treating middle ear infections.
- Claims: The patent includes multiple claims defining the formulation, concentrations, and method of administration.
- Patent Landscape: The patent is part of a complex IP strategy with related patents and regulatory considerations.
- Regulatory Aspects: Listed in the FDA's "Orange Book," with generic manufacturers required to certify non-infringement or invalidity.
- Patent Expiration: Ongoing maintenance fees, with related patents expiring between 2023 and 2024.
- Competitive Challenges: Generic manufacturers challenge the patent's validity to enter the market.
- Patent Analytics: Tools help in managing and analyzing claims to identify coverage gaps and future opportunities.
FAQs
Q: What is the primary focus of United States Patent 8,846,650?
A: The primary focus is on the topical treatment of middle ear infections using a combination of ciprofloxacin and dexamethasone.
Q: Who are the inventors of this patent?
A: The inventors are G. Michael Wall and Peter J. Conroy.
Q: What is the significance of the Hatch-Waxman Act in relation to this patent?
A: The Hatch-Waxman Act simplifies the process for generic manufacturers by allowing them to file an Abbreviated New Drug Application (ANDA) and certifying non-infringement or invalidity of listed patents.
Q: How do patent analytics tools help in managing this patent?
A: Patent analytics tools help in categorizing patents by claims and scope concepts, identifying gaps in coverage, and highlighting future design opportunities.
Q: What is the current status of the patent's expiration?
A: While the exact expiration date of US 8,846,650 is not provided, related patents have expiration dates ranging from 2023 to 2024.
Citations
- Wall et al. United States Patent 8,846,650 B2, Method of Treating Middle Ear Infections, Sep. 30, 2014.
- Gregory D. Miller Gene Y. Kang, Court Document, 25 Main Street, Suite 501, Dec. 20, 2019.
- Schwegman, Patent Analytics, Services.
- Pharsight, Ciprodex patent expiration, Greyb.com.
