United States Patent 8,759,351: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,759,351, titled "Methods for administering aripiprazole," is a significant patent in the pharmaceutical industry, particularly for the drug Abilify Maintena Kit. This patent, owned by Otsuka Pharmaceutical Co Ltd., pertains to the administration methods of aripiprazole, an antipsychotic medication. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of Aripiprazole and Abilify Maintena Kit
Aripiprazole is an atypical antipsychotic used primarily for the treatment of schizophrenia and bipolar disorder. Abilify Maintena Kit is an extended-release injectable formulation of aripiprazole, designed to provide sustained therapeutic effects over a prolonged period.
Scope of the Patent
The patent US8759351B2 focuses on methods for administering aripiprazole in an extended-release injectable composition. Here are the key aspects of its scope:
Extended Release Formulation
The patent describes methods for formulating aripiprazole in a way that avoids sustained release matrices, ensuring a controlled and extended release of the active pharmaceutical ingredient (API)[1].
Pharmaceutical Composition
The composition includes aripiprazole as the active substance, along with various excipients and vehicles to facilitate the extended release. This includes substances like methyl cellulose, polyethylene glycol, and polyoxyethylene sorbitan monooleate[1].
Administration Methods
The patent details subcutaneous administration methods, emphasizing the importance of the formulation in achieving the desired pharmacologic effect without the need for sustained release matrices[1].
Claims of the Patent
The claims of US8759351B2 are crucial in defining the boundaries of the patent's protection. Here are some key claims:
Independent Claims
The patent includes independent claims that describe the specific methods and compositions for administering aripiprazole. These claims are designed to be broad enough to cover various aspects of the formulation and administration but narrow enough to be enforceable[1].
Dependent Claims
Dependent claims further specify the details of the independent claims, such as the types of excipients used, the method of preparation, and the mode of administration. These claims help in narrowing down the scope to specific embodiments of the invention[1].
Patent Landscape
Understanding the patent landscape is essential for navigating the intellectual property rights surrounding Abilify Maintena Kit.
Patent Expiration
The patent US8759351B2 has expired as of August 2023. This expiration means that the specific methods and compositions described in this patent are no longer protected by patent law, potentially allowing generic versions to enter the market[4].
Related Patents
There are several other patents related to Abilify Maintena Kit that are still active. For example, patents like US8399469, which protects the low hygroscopic aripiprazole drug substance and its preparation processes, are set to expire in June 2025[2][4].
Litigations and Legal Proceedings
The Abilify Maintena Kit has been subject to various legal proceedings, including patent litigations. These litigations often challenge the validity of the patents or seek to revoke them. For instance, patent US10525057 was challenged in June 2017, and the decision was made in March 2019[2].
Exclusivities
Besides patent protection, Abilify Maintena Kit benefits from FDA-granted exclusivities. These exclusivities prevent other companies from marketing generic or bioequivalent versions of the drug, even if the patents have expired. This adds another layer of protection and delays the generic launch[2].
Impact on Generic Launch
The expiration of US8759351B2 and other related patents, along with the status of ongoing legal activities, significantly impacts the potential launch of generic versions of Abilify Maintena Kit.
Generic Entry Points
The expiration of key patents like US8759351B2 opens up opportunities for generic manufacturers to develop and market their own versions of the drug. However, they must ensure that their products do not infringe on any remaining active patents or exclusivities[4].
Global Patent Landscape
Understanding the global patent landscape is crucial. Patents protecting Abilify Maintena Kit vary by country, and identifying markets with weaker patent protection can be strategic for generic entry[4].
Metrics for Patent Scope
The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. Narrower claims, as seen in the examination process, are often associated with a higher probability of grant and a shorter examination process[3].
Conclusion
The United States Patent 8,759,351 is a critical component of the intellectual property portfolio for Abilify Maintena Kit. Understanding its scope, claims, and the broader patent landscape is essential for both the original patent holder and potential generic manufacturers.
Key Takeaways
- Patent Expiration: US8759351B2 has expired, allowing for potential generic entries.
- Related Patents: Other patents related to Abilify Maintena Kit are still active, protecting various aspects of the drug.
- Litigations and Exclusivities: Ongoing legal proceedings and FDA-granted exclusivities continue to protect the drug.
- Global Landscape: The global patent landscape varies, offering strategic opportunities for generic entry in certain markets.
- Patent Metrics: Narrower claims are associated with a higher probability of grant and shorter examination processes.
Frequently Asked Questions
1. What is the current status of US Patent 8,759,351?
US Patent 8,759,351 has expired as of August 2023.
2. What does the patent protect?
The patent protects methods for administering aripiprazole in an extended-release injectable composition without sustained release matrices.
3. Are there other active patents related to Abilify Maintena Kit?
Yes, several other patents related to Abilify Maintena Kit are still active, including those protecting the low hygroscopic aripiprazole drug substance and its preparation processes.
4. How do FDA-granted exclusivities affect the generic launch of Abilify Maintena Kit?
FDA-granted exclusivities prevent other companies from marketing generic or bioequivalent versions of the drug, even if the patents have expired, thereby delaying the generic launch.
5. What metrics can be used to measure the scope of a patent?
Metrics such as independent claim length and independent claim count can be used to measure the scope of a patent, with narrower claims often associated with a higher probability of grant and shorter examination processes[3].
Cited Sources:
- US8759351B2 - Methods for administering aripiprazole - Google Patents
- Abilify Maintena Kit patent expiration - Pharsight
- Patent Claims and Patent Scope - Hoover Institution
- Abilify Asimtufii patent expiration - Pharsight
