United States Patent 9,259,428: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,259,428, titled "Combination of Azelastine and Fluticasone for Nasal Administration," is a significant patent in the pharmaceutical industry, particularly in the treatment of allergic rhinitis. This patent, issued on February 16, 2016, covers a specific formulation and method of administering two active pharmaceutical ingredients: azelastine, an antihistamine, and fluticasone, a corticosteroid.
Background and Context
Allergic rhinitis is a common condition that affects millions of people worldwide. The combination of azelastine and fluticasone has been found to be highly effective in managing its symptoms. The patent in question protects the intellectual property related to this specific combination and its method of administration[2][5].
Scope of the Patent
The patent covers a pharmaceutical product or formulation that includes azelastine or a pharmaceutically acceptable salt, solvate, or physiologically functional derivative, combined with fluticasone or a pharmaceutically acceptable salt, solvate, or physiologically functional derivative. This combination is specifically designed for nasal administration, targeting conditions such as allergic rhinitis[1].
Active Ingredients
- Azelastine: An antihistamine that helps to alleviate symptoms such as itching, sneezing, and runny nose.
- Fluticasone: A corticosteroid that reduces inflammation and swelling in the nasal passages.
Formulation
The patent describes various formulations, including aqueous suspensions, which may include additional components such as preservatives (e.g., benzalkonium chloride), stabilizers, solubility-improving agents, isotonicity agents, buffers, and bioadhesives. The formulation is designed to ensure stability and efficacy of the active ingredients when administered nasally[1][4].
Claims of the Patent
The patent includes multiple claims that define the scope of protection. Here are some key claims:
Claim Construction
The court has construed the term "conditions" in the claims to mean "disease(s) or illness(es)"[2]. This interpretation is crucial for understanding the applicability of the patent to various medical conditions.
Specific Claims
- Claims 1-4, 7, 8, 10-18, and 20-28 of the '723 patent and claims 16, 17, and 24 of the '620 patent are relevant, but the '428 patent specifically focuses on the combination of azelastine and fluticasone for nasal administration[2][5].
Patent Landscape
The patent landscape surrounding U.S. Patent 9,259,428 is complex and involves several related patents.
Related Patents
- U.S. Patent Nos. 8,163,723 and 8,168,620: These patents also cover combinations of azelastine and steroids, with similar claims and scope. They are part of the same patent family and have overlapping protection[2][5].
- Expiration Dates: The '723 patent expires on August 29, 2023, the '620 patent on February 24, 2026, and the '428 patent expired on June 13, 2023[5].
Litigation and Infringement
The patent has been involved in litigation, particularly with generic drug manufacturers like Apotex. Meda Pharmaceuticals and Cipla Ltd. have alleged infringement by Apotex, which sought FDA approval for a generic version of the product. The litigation highlights the importance of this patent in protecting the intellectual property of the innovator companies[2][5].
Impact on Generic Drug Approval
The Hatch-Waxman Act allows generic drug companies to file Abbreviated New Drug Applications (ANDAs) by referencing the studies performed by the innovator. However, generic companies must certify that the listed patents are invalid, unenforceable, or will not be infringed. Apotex's Paragraph IV certification for the '723, '620, and '428 patents is a prime example of this process[5].
Patent Analytics and Claim Coverage
To manage the complex patent landscape, companies use patent analytics tools. These tools help in categorizing patents by claims and scope concepts, identifying gaps in coverage, and determining the value of patent claims. This is particularly important for companies holding multiple patents related to the same technology[3].
Future Directions and Opportunities
The expiration of the '428 patent and other related patents opens up opportunities for generic manufacturers. However, innovator companies can continue to protect their intellectual property through other patents and formulations. The use of patent analytics can help in identifying future design opportunities and ensuring comprehensive coverage of their intellectual property[3].
Key Components and Additional Agents
The formulations covered by the patent may include various additional components such as:
- Preservatives: To extend the shelf life of the product.
- Stabilizers: To maintain the stability of the active ingredients.
- Solubility-improving agents: To enhance the solubility of azelastine and fluticasone.
- Isotonicity agents: To ensure the formulation is isotonic with the nasal mucosa.
- Buffers: To maintain the pH of the formulation.
- Bioadhesives: To improve the retention of the formulation in the nasal cavity[1][4].
Administration Modes
While the '428 patent specifically covers nasal administration, other patents and formulations may include different modes of administration, such as ocular, oral, buccal, sublingual, or pulmonary[4].
Conclusion
The United States Patent 9,259,428 is a critical patent in the pharmaceutical industry, protecting the combination of azelastine and fluticasone for nasal administration. Understanding the scope, claims, and patent landscape is essential for both innovator companies and generic manufacturers. As the patent landscape evolves, the use of patent analytics and strategic management of intellectual property will remain vital.
Key Takeaways
- The patent covers a specific combination of azelastine and fluticasone for nasal administration.
- It is part of a family of patents that protect similar formulations.
- The patent has been involved in significant litigation regarding generic drug approval.
- The expiration of related patents opens up opportunities for generic manufacturers.
- Patent analytics is crucial for managing the complex patent landscape.
Frequently Asked Questions
What are the active ingredients covered by U.S. Patent 9,259,428?
The active ingredients are azelastine, an antihistamine, and fluticasone, a corticosteroid.
What is the primary mode of administration for the formulation covered by this patent?
The primary mode of administration is nasal.
What other patents are related to U.S. Patent 9,259,428?
Related patents include U.S. Patent Nos. 8,163,723 and 8,168,620, which also cover combinations of azelastine and steroids.
Why is patent analytics important in managing this patent?
Patent analytics helps in categorizing patents by claims and scope concepts, identifying gaps in coverage, and determining the value of patent claims, which is essential for managing a complex patent landscape.
What happens when the patent expires?
When the patent expires, generic manufacturers can produce and market generic versions of the product without infringing on the original patent, provided they comply with regulatory requirements.
