United States Patent 8,071,073: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 8,071,073, titled "Compositions comprising azelastine and methods of use thereof," is a significant patent in the pharmaceutical industry, particularly in the treatment of allergy-related and vasomotor-related conditions. This patent, assigned to Meda Pharmaceuticals Inc., provides insights into the formulation, components, and methods of use for azelastine-based pharmaceutical compositions.
Background
Azelastine is an antihistamine used to treat allergic rhinitis, allergic conjunctivitis, and other related conditions. The patent focuses on improving the delivery and efficacy of azelastine through various formulations and excipients.
Scope of the Patent
The scope of the patent is broad and encompasses several key aspects:
Pharmaceutical Compositions
The patent describes pharmaceutical compositions that include azelastine or its pharmaceutically acceptable salts or esters. These compositions can be formulated for intranasal, ocular, or oral administration[4].
Excipients and Carriers
The compositions may include various excipients and carriers to enhance the delivery and stability of azelastine. Key excipients mentioned include:
- Sucralose: Used as a taste-masking agent to minimize the bitter taste associated with azelastine[4].
- Hypromellose: Used as a viscosity modifier to adjust the consistency of the formulation[1][4].
- Solvents, Preservatives, Stabilizers: Additional components such as solvents, preservatives, stabilizers, solubility-improving agents, isotonicity agents, and buffers or buffering agents can be included to optimize the formulation[4].
Methods of Use
The patent outlines methods for treating or preventing various allergy-related and vasomotor-related conditions, including allergic rhinitis, vasomotor rhinitis, and allergic conjunctivitis. The methods involve administering the azelastine compositions via the specified routes[4].
Claims of the Patent
The claims of the patent are detailed and specific, ensuring broad protection for the inventions described:
Independent Claims
The patent includes independent claims that define the core inventions:
- Claim 1 typically describes the pharmaceutical composition comprising azelastine or its pharmaceutically acceptable salt or ester, along with specified excipients and carriers[4].
Dependent Claims
Dependent claims further specify the details of the composition, such as the types of excipients, the method of preparation, and the specific conditions treated.
Patent Landscape
The patent landscape surrounding US 8,071,073 is complex and involves several related patents and litigation cases:
Related Patents
Other patents related to azelastine formulations and methods of use are also significant. For example, US 8,758,816 B2 describes similar compositions and methods, emphasizing the use of hypromellose and sucralose to improve the formulation[1].
Litigation and Settlements
Patent litigation in the pharmaceutical industry is common, and cases involving azelastine or similar drugs can provide insights into the enforceability and validity of such patents. For instance, settlements in ANDA (Abbreviated New Drug Application) litigation often involve agreements on the validity and enforceability of the patents-in-suit, as seen in various cases involving different pharmaceutical companies[2][5].
Impact on Innovation and Industry
The patent's scope and claims have a significant impact on innovation and the pharmaceutical industry:
Innovation Incentives
The patent's specificity and breadth can influence innovation by protecting the intellectual property of the inventors, thereby encouraging further research and development in related areas[3].
Licensing and Litigation
The validity and enforceability of the patent claims can affect licensing agreements and litigation outcomes. Narrower claims, as validated during the examination process, are often associated with a higher probability of grant and shorter examination processes, which can reduce licensing and litigation costs[3].
Examples and Illustrations
To illustrate the practical application of this patent, consider the formulation of an intranasal spray containing azelastine. This formulation might include azelastine hydrochloride as the active ingredient, sucralose to mask the bitter taste, and hypromellose to adjust the viscosity of the spray. Such a formulation would be protected under the claims of this patent.
Statistics and Expert Insights
- Patent Scope Metrics: Research indicates that narrower claims, such as those found in this patent, are associated with higher grant probabilities and shorter examination processes. This can be crucial for pharmaceutical companies aiming to bring new products to market efficiently[3].
- Industry Experts: Experts in pharmaceutical formulation emphasize the importance of excipients like sucralose and hypromellose in improving patient compliance and efficacy of the drug[1][4].
Key Takeaways
- Broad Protection: The patent provides broad protection for azelastine-based pharmaceutical compositions, including various excipients and methods of use.
- Innovation: The patent's specificity encourages innovation by protecting intellectual property and reducing licensing and litigation costs.
- Practical Applications: The formulations described are practical and improve the delivery and efficacy of azelastine in treating allergy-related conditions.
- Industry Impact: The patent's validity and enforceability can significantly impact the pharmaceutical industry, influencing licensing agreements and litigation outcomes.
FAQs
Q: What is the primary active ingredient in the pharmaceutical compositions described in US 8,071,073?
A: The primary active ingredient is azelastine or its pharmaceutically acceptable salts or esters.
Q: What is the role of sucralose in the compositions?
A: Sucralose is used as a taste-masking agent to minimize the bitter taste associated with azelastine.
Q: How does hypromellose contribute to the formulation?
A: Hypromellose is used as a viscosity modifier to adjust the consistency of the formulation.
Q: What conditions are treated using the compositions described in the patent?
A: The compositions are used to treat or prevent allergy-related and vasomotor-related conditions, including allergic rhinitis, vasomotor rhinitis, and allergic conjunctivitis.
Q: How does the patent's scope affect innovation in the pharmaceutical industry?
A: The patent's specificity and breadth protect intellectual property, encouraging further research and development while reducing licensing and litigation costs.
Cited Sources
- Fuge et al., Compositions Comprising Azelastine and Methods of Use Thereof, US Patent 8,758,816 B2, June 24, 2014.
- Robins Kaplan LLP, ANDA Litigation Settlements, Generically Speaking, Fall 2019.
- SSRN, Patent Claims and Patent Scope, September 29, 2016.
- US Patent 8,071,073 B2, Compositions Comprising Azelastine and Methods of Use Thereof, Google Patents.
- Robins Kaplan LLP, ANDA Litigation Settlements, Generically Speaking, Q4 2023.
