United States Patent 9,034,867: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,034,867, issued on May 19, 2015, is a significant patent in the field of pharmaceutical compositions, particularly for the delivery of antipsychotic drugs. This patent, assigned to Alkermes Pharma Ireland Limited, introduces innovative formulations that enhance the stability and delivery of these critical medications.
Background
Antipsychotic drugs are crucial for treating a range of neurological and psychiatric disorders, including schizophrenia, bipolar disorder, anxiety disorders, and insomnia. However, these drugs often face challenges related to stability and delivery, which can impact their efficacy and patient compliance.
Inventors and Assignees
The patent was invented by Jason M. Perry, Daniel R. Deaver, Magali B. Hickey, Julius F. Remenar, and Jennifer Vandiver, and is assigned to Alkermes Pharma Ireland Limited[5].
Scope of the Patent
Pharmaceutical Compositions
The patent focuses on pharmaceutical compositions comprising sorbitan esters of carboxylic acids. These compositions are designed to improve the delivery of antipsychotic drugs, particularly those that are hydrolytically labile. The use of sorbitan esters enhances the stability and solubility of these drugs, making them more effective and easier to administer[5].
Claims
The patent includes several key claims:
- Composition Claims: The patent claims pharmaceutical compositions that include a therapeutically effective amount of an antipsychotic agent and a sorbitan ester of a carboxylic acid.
- Method Claims: It also claims methods for preparing these compositions and methods for treating neurological and psychiatric disorders using these compositions.
- Formulation Claims: Specific formulations are claimed, including those with improved storage stability and enhanced injection speeds[5].
Key Components
Sorbitan Esters
Sorbitan esters play a critical role in these compositions. They act as stabilizers and solubilizers, ensuring that the antipsychotic agents remain effective over a longer period. The patent specifies various types of sorbitan esters that can be used, such as sorbitan monooleate and sorbitan monolaurate[5].
Antipsychotic Agents
The patent covers a range of antipsychotic agents, including but not limited to aripiprazole. These agents are often hydrolytically labile, meaning they can degrade when exposed to water, which the sorbitan esters help mitigate[1][5].
Patent Landscape
Related Patents
Several related patents further expand on the innovations introduced in US 9,034,867:
- Patent 9,452,131: This patent, also assigned to Alkermes Pharma Ireland Limited, focuses on aripiprazole formulations with increased injection speeds, enhancing the delivery of antipsychotic drugs[1].
- Patent 9,193,685: This patent addresses pharmaceutical compositions with improved storage stability for hydrolytically labile antipsychotic agents[5].
- Patent 10,226,458: This patent covers pharmaceutical compositions comprising sorbitan esters, similar to US 9,034,867, but with additional formulations and methods[5].
Expiration Dates
The patent expires on November 7, 2032, which is significant for generic drug manufacturers and other stakeholders in the pharmaceutical industry[5].
Impact on Pharmaceutical Industry
Enhanced Stability and Delivery
The compositions described in this patent offer improved stability and delivery mechanisms for antipsychotic drugs. This enhances patient compliance and the overall efficacy of the treatment.
Competitive Advantage
For Alkermes Pharma Ireland Limited, this patent provides a competitive advantage in the market for antipsychotic medications. It allows the company to offer unique and effective formulations that other companies cannot replicate until the patent expires.
Regulatory and Legal Considerations
Patent Scope and Claims
The scope and claims of this patent are carefully defined to ensure that the innovations are protected while allowing for future development in related areas. The patent's claims are validated through various legal and regulatory processes to ensure their enforceability[3].
Litigation and Licensing
The patent's validity and scope can be subject to litigation and licensing agreements. Companies may need to navigate these legal complexities to develop or use similar formulations.
Future Developments
Generic Availability
As the patent approaches its expiration date, generic versions of these formulations may become available, potentially changing the market dynamics for antipsychotic medications.
Continued Innovation
The innovations introduced by this patent are likely to spur further research and development in pharmaceutical compositions and delivery systems. This could lead to even more effective treatments for neurological and psychiatric disorders.
Key Takeaways
- Innovative Formulations: The patent introduces novel pharmaceutical compositions using sorbitan esters to enhance the stability and delivery of antipsychotic drugs.
- Improved Efficacy: These formulations improve the efficacy and patient compliance of antipsychotic treatments.
- Competitive Advantage: The patent provides a competitive edge for Alkermes Pharma Ireland Limited in the pharmaceutical market.
- Regulatory Considerations: The patent's scope and claims are carefully defined and subject to regulatory and legal scrutiny.
- Future Impact: The patent's expiration and potential generic availability could significantly impact the market for antipsychotic medications.
FAQs
What is the main focus of United States Patent 9,034,867?
The main focus of this patent is on pharmaceutical compositions comprising sorbitan esters of carboxylic acids for the delivery of antipsychotic drugs.
Who are the inventors of this patent?
The inventors are Jason M. Perry, Daniel R. Deaver, Magali B. Hickey, Julius F. Remenar, and Jennifer Vandiver.
What is the role of sorbitan esters in these compositions?
Sorbitan esters act as stabilizers and solubilizers, enhancing the stability and solubility of the antipsychotic agents.
When does the patent expire?
The patent expires on November 7, 2032.
How does this patent impact the pharmaceutical industry?
It provides a competitive advantage to Alkermes Pharma Ireland Limited and enhances the efficacy and patient compliance of antipsychotic treatments.
Cited Sources
- United States Patent - googleapis.com: "ARIPIPRAZOLE FORMULATIONS HAVING INCREASED INJECTION SPEEDS"[1].
- Google Patents: "Pharmaceutical compositions having improved storage stability"[2].
- SSRN: "Patent Claims and Patent Scope"[3].
- Googleapis.com: "United States Patent - googleapis.com"[4].
- Drugs.com: "Generic Aristada Availability - Drugs.com"[5].
