United States Patent 9,387,182: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,387,182, titled "Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders," is a significant patent in the pharmaceutical industry, particularly in the treatment of various mood and psychiatric disorders. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Title and Number
The patent in question is U.S. Patent 9,387,182, focusing on carbostyril derivatives and their application as serotonin reuptake inhibitors for treating mood disorders.
Publication and Priority Dates
The patent was published on December 6, 2016, with a priority date that traces back to earlier filings related to the development of aripiprazole and other carbostyril derivatives[4].
Scope of the Patent
Claims
The patent includes multiple claims that define the scope of protection. Here are some key aspects:
- Active Ingredients: The patent claims cover specific carbostyril derivatives, including aripiprazole, which is known for its 5-HT1A receptor agonist activity. These compounds are useful in treating various mood disorders such as depression, bipolar disorder, and other psychiatric conditions[4].
- Therapeutic Uses: The claims extend to the therapeutic applications of these compounds, including the treatment of depressive symptoms, bipolar disease, and other mood disorders. The patent also mentions potential uses in treating dementia, Parkinson's disease, and other neurological conditions[4].
Method of Use Claims
The patent includes method-of-use claims that specify the indications for which the carbostyril derivatives are approved. These include acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder[2].
Patent Claims Analysis
Independent Claims
The independent claims are crucial as they define the broadest scope of protection. For U.S. Patent 9,387,182, these claims focus on the chemical structure of the carbostyril derivatives and their therapeutic applications. The independent claims are typically more general and set the foundation for the dependent claims[3].
Dependent Claims
Dependent claims build upon the independent claims and provide more specific details. For example, they might specify particular dosages, modes of administration, or specific patient populations. These claims help to narrow down the scope and provide additional layers of protection[3].
Patent Landscape
Related Patents
The patent landscape surrounding U.S. Patent 9,387,182 includes several other patents related to aripiprazole and carbostyril derivatives. These patents cover various aspects such as low hygroscopic forms of aripiprazole, different strengths and formulations, and other therapeutic uses[1][2].
- Patent Expiration: Several patents related to aripiprazole have expired, including those covering the low hygroscopic forms of the drug substance, which expired in September 2022. This has paved the way for generic versions of the drug[1].
- Litigation History: There have been several litigation cases involving patents related to aripiprazole, including U.S. Patent 9,387,182. These cases have been filed in the United States District Court for the District of New Jersey and have involved generic manufacturers like Zydus Pharmaceuticals[2][5].
Legal Activities and Status
Maintenance Fees and Expiration
The patent's legal status is critical for understanding its current validity. For U.S. Patent 9,387,182, the payment of maintenance fees has been documented. However, the patent's expiration date is set for December 25, 2023, which includes pediatric exclusivity[2].
Litigation and Infringement
Litigation activities surrounding this patent have been significant. Generic manufacturers have filed ANDAs (Abbreviated New Drug Applications) with paragraph IV certifications, challenging the validity or enforceability of the patents. These cases have been dismissed, but they highlight the ongoing legal battles in the pharmaceutical patent landscape[2].
Impact on Generic Launch
Generic Availability
The expiration of key patents, including U.S. Patent 9,387,182, has significant implications for the availability of generic versions of aripiprazole. Generic manufacturers can now produce and market their versions of the drug, which can lead to increased competition and potentially lower prices for patients[1][2].
Market Dynamics
The entry of generic versions into the market can disrupt the dominance of the original branded drug. This shift can lead to changes in market share, pricing strategies, and overall market dynamics. It is crucial for pharmaceutical companies to monitor these developments closely to adjust their strategies accordingly.
Key Takeaways
- Patent Scope: U.S. Patent 9,387,182 covers carbostyril derivatives, including aripiprazole, for treating mood disorders.
- Claims Analysis: The patent includes independent and dependent claims that define the scope of protection.
- Patent Landscape: The patent is part of a broader landscape involving multiple related patents and ongoing litigation.
- Legal Status: The patent is set to expire on December 25, 2023, with significant implications for generic launch.
- Market Impact: The expiration and subsequent generic launch can significantly affect market dynamics and pricing.
FAQs
What is the main focus of U.S. Patent 9,387,182?
The main focus of U.S. Patent 9,387,182 is on carbostyril derivatives, specifically aripiprazole, and their use as serotonin reuptake inhibitors for treating mood disorders.
When is U.S. Patent 9,387,182 set to expire?
U.S. Patent 9,387,182 is set to expire on December 25, 2023, including pediatric exclusivity.
What are the implications of the patent's expiration for generic manufacturers?
The expiration of the patent allows generic manufacturers to produce and market their versions of aripiprazole, increasing competition and potentially lowering prices.
Have there been any significant litigation cases involving this patent?
Yes, there have been several litigation cases involving U.S. Patent 9,387,182, particularly with generic manufacturers challenging the patent's validity or enforceability.
How does the patent landscape affect the market dynamics of aripiprazole?
The patent landscape, including the expiration of key patents, can lead to increased competition, changes in market share, and adjustments in pricing strategies for aripiprazole.
Cited Sources
- Pharsight: "Abilify patent expiration - Pharsight"
- FDA: "ANDA 090165 ANDA APPROVAL Zydus Pharmaceuticals (USA ... - FDA"
- Hoover Institution: "Patent Claims and Patent Scope - Hoover Institution"
- Google Patents: "US9387182B2 - Carbostyril derivatives and serotonin reuptake ... - Google Patents"
- Insight.RPXCorp: "UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY ... - Insight.RPXCorp"
