United States Patent 9,169,238: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 9,169,238, titled "Solid pharmaceutical composition," is a significant patent in the pharmaceutical industry, particularly in the realm of solid dosage forms. This patent, assigned to Takeda Pharmaceutical Company Limited, addresses the stabilization and formulation of specific compounds and diuretics in solid preparations.
Background
The patent was granted to Takeda Pharmaceutical Company Limited and is part of a broader portfolio of patents related to pharmaceutical formulations. Understanding the scope and claims of this patent is crucial for both innovator companies and generic manufacturers.
Scope of the Patent
Overview
The patent 9,169,238 focuses on the stabilization of a compound represented by the formula (I) or a salt thereof, along with a diuretic, in a solid pharmaceutical preparation. The invention aims to improve the dissolution properties of the compound, which is critical for its bioavailability and efficacy.
Key Components
- Compound (I): The patent specifies a compound with a monocyclic nitrogen-containing heterocyclic group (R1), an esterified carboxyl group (R2), and an optionally substituted lower alkyl group (R3)[1].
- Diuretic: The patent includes a diuretic component, which is granulated separately from the compound (I) to enhance the stability and dissolution properties of the final preparation.
- pH Control Agent: The inclusion of a pH control agent is also mentioned to further stabilize the compound and diuretic in the solid preparation.
Claims
Independent Claims
The patent includes several independent claims that define the scope of the invention. Here are some key claims:
- Claim 1: This claim describes a solid pharmaceutical composition comprising a first part containing the compound (I) or a salt thereof and a pH control agent, and a second part containing a diuretic, where both parts are granulated separately[1].
- Claim 2: This claim specifies the method of preparing the solid pharmaceutical composition, emphasizing the separate granulation of the compound (I) and the diuretic[1].
Dependent Claims
Dependent claims further elaborate on the independent claims by adding additional limitations or specifications. For example:
- Claim 3: This claim details the specific types of pH control agents that can be used to stabilize the compound (I)[1].
Patent Landscape
Related Patents
The patent 9,169,238 is part of a larger family of patents related to pharmaceutical formulations. Other patents, such as those listed for Edarbi® and Edarbyclor®, also owned by Takeda Pharmaceutical Company Limited, share similar technological backgrounds and may intersect with this patent in terms of claims and scope[4].
Litigation and Settlements
Patents in the pharmaceutical sector are often subject to litigation, particularly in the context of generic drug approvals under the Hatch-Waxman Act. While the specific patent 9,169,238 is not mentioned in recent litigation updates, understanding the broader litigation landscape is crucial for navigating patent disputes and settlements[2][5].
Impact on Pharmaceutical Formulations
Improved Dissolution Properties
The separate granulation of the compound (I) and the diuretic, as described in the patent, results in a solid preparation with superior dissolution properties compared to conventional granulation methods. This improvement is critical for ensuring the bioavailability and efficacy of the drug[1].
Stabilization
The inclusion of a pH control agent further stabilizes the compound and diuretic, enhancing the overall stability of the solid pharmaceutical composition. This is particularly important for compounds that are sensitive to pH changes.
Industry Relevance
Generic Drug Manufacturers
For generic drug manufacturers, understanding the scope and claims of this patent is essential to avoid infringement. Generic manufacturers must ensure that their formulations do not infringe on the patented methods and compositions described in 9,169,238.
Innovator Companies
Innovator companies can leverage this patent to protect their intellectual property and maintain market exclusivity. The patent's focus on specific formulation techniques and stabilization methods provides a competitive edge in the development of solid dosage forms.
Key Takeaways
- Compound Stabilization: The patent emphasizes the stabilization of a specific compound and a diuretic in a solid pharmaceutical preparation.
- Separate Granulation: The method of separately granulating the compound and the diuretic is a key aspect of the invention.
- pH Control Agent: The inclusion of a pH control agent is crucial for further stabilizing the composition.
- Improved Dissolution: The patent results in a solid preparation with improved dissolution properties.
- Industry Relevance: Understanding this patent is vital for both generic and innovator companies in the pharmaceutical industry.
FAQs
Q: What is the main focus of United States Patent 9,169,238?
A: The main focus is on the stabilization and formulation of a specific compound and a diuretic in a solid pharmaceutical preparation.
Q: How does the patent improve the dissolution properties of the compound?
A: The patent improves dissolution properties by separately granulating the compound and the diuretic.
Q: What is the role of the pH control agent in the patent?
A: The pH control agent further stabilizes the compound and diuretic in the solid preparation.
Q: Why is this patent important for generic drug manufacturers?
A: It is important for generic drug manufacturers to avoid infringement by ensuring their formulations do not replicate the patented methods and compositions.
Q: How does this patent benefit innovator companies?
A: It provides innovator companies with intellectual property protection and a competitive edge in the development of solid dosage forms.
Sources
- US9169238B2 - Solid pharmaceutical composition - Google Patents
- ANDA Litigation Settlements | Hatch-Waxman - Robins Kaplan LLP
- Patent Claims and Patent Scope - Hoover Institution
- PATENTS - Azurity Pharmaceuticals
- ANDA Litigation Settlements | Hatch-Waxman - Robins Kaplan LLP
