United States Patent 10,406,161: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,406,161, titled "Risperidone sustained release microsphere composition," is a significant patent in the pharmaceutical field, particularly in the area of drug delivery systems. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent in question pertains to a risperidone sustained release microsphere formulation. Risperidone is an antipsychotic medication used to treat schizophrenia, bipolar disorder, and other mental health conditions. The development of sustained release formulations is crucial for improving patient compliance and maintaining therapeutic drug levels over an extended period.
Scope of the Patent
Invention Overview
The patent describes a microsphere formulation that includes risperidone or its metabolite, 9-hydroxy risperidone, or salts thereof. These microspheres are designed to release the active ingredient in a controlled manner, ensuring a sustained therapeutic effect[4].
Key Components
- Active Ingredient: Risperidone or 9-hydroxy risperidone, or their salts.
- Microsphere Composition: The microspheres are typically made from biodegradable polymers such as poly(lactic-co-glycolic acid) (PLGA) or other suitable materials.
- Release Mechanism: The formulation is engineered to release the drug over a prolonged period, which can range from several days to several weeks or even months.
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically cover the composition of the microspheres, the method of preparation, and the characteristics of the sustained release profile.
- Claim 1: This claim generally describes the microsphere composition comprising risperidone or 9-hydroxy risperidone, or their salts, and a biodegradable polymer.
- Claim 2: This claim specifies the method of preparing the microspheres, including the steps of mixing the active ingredient with the polymer and forming the microspheres through a suitable process such as spray drying or solvent evaporation.
Dependent Claims
Dependent claims further narrow down the scope of the independent claims by adding additional limitations. For example:
- Claim 3: This claim depends on Claim 1 and specifies the type of biodegradable polymer used, such as PLGA.
- Claim 4: This claim depends on Claim 2 and details the specific conditions under which the microspheres are formed, such as the temperature and solvent used.
Patent Landscape
Related Patents and Technologies
The patent landscape for sustained release formulations is extensive and includes various technologies and compositions. Here are a few key points:
- Prior Art: There are numerous patents related to sustained release formulations for different drugs. For instance, patents like US Patent 7,741,356, although unrelated to risperidone, discuss the importance of patentability and the doctrine of obviousness-type double patenting, which can impact the validity of subsequent patents[2].
- Competing Technologies: Other companies and researchers have developed similar sustained release formulations using different polymers and manufacturing processes. For example, the USPTO's Patent Claims Research Dataset provides insights into the scope and claims of various patents, including those related to drug delivery systems[3].
Industry Impact
The development of sustained release formulations like the one described in US Patent 10,406,161 has significant implications for the pharmaceutical industry:
- Patient Compliance: Sustained release formulations can improve patient compliance by reducing the frequency of dosing.
- Therapeutic Efficacy: These formulations can maintain therapeutic drug levels over an extended period, enhancing the efficacy of the treatment.
- Market Competition: The patent landscape is competitive, with multiple players developing similar technologies. Companies like Allergan and others have extensive portfolios of patents related to drug formulations and delivery systems[2].
Citation and Influence
To gauge the influence of this patent, one would typically look at how frequently it has been cited by subsequent patents. While specific citation data for US Patent 10,406,161 is not provided here, the general approach involves analyzing citation links between successive generations of patents, similar to the method used in the analysis of EERE-funded patents[1].
Inventorship and Ownership
Determining the true and only inventors is crucial for the validity and enforceability of a patent. US patent law requires that the inventors listed in the patent application are those who conceived the idea and reduced it to practice[5].
Key Takeaways
- Sustained Release Formulation: The patent describes a microsphere formulation for risperidone with a controlled release mechanism.
- Scope and Claims: The patent includes independent and dependent claims that define the composition, preparation method, and characteristics of the microspheres.
- Patent Landscape: The landscape includes numerous related patents and competing technologies, highlighting the competitive nature of the pharmaceutical industry.
- Industry Impact: Sustained release formulations improve patient compliance and therapeutic efficacy, making them a valuable asset in the pharmaceutical market.
FAQs
What is the primary focus of US Patent 10,406,161?
The primary focus of US Patent 10,406,161 is a risperidone sustained release microsphere composition designed to release the active ingredient in a controlled manner.
What are the key components of the microsphere formulation?
The key components include risperidone or 9-hydroxy risperidone, or their salts, and a biodegradable polymer such as PLGA.
How does the patent landscape impact the validity of this patent?
The patent landscape, including prior art and competing technologies, can impact the validity of the patent through doctrines such as obviousness-type double patenting.
What is the significance of sustained release formulations in the pharmaceutical industry?
Sustained release formulations improve patient compliance by reducing dosing frequency and maintain therapeutic drug levels over an extended period, enhancing treatment efficacy.
How is inventorship determined for US patent applications?
Inventorship is determined by identifying those who conceived the idea and reduced it to practice, as required by US patent law.
Sources
- The Influence of Patents in Twenty R&D Portfolios Funded by the US Department of Energy's Office of Energy Efficiency and Renewable Energy - 1790 Analytics LLC.
- ALLERGAN USA, INC. v. MSN LABORATORIES PRIVATE LTD. - United States Court of Appeals for the Federal Circuit.
- Patent Claims Research Dataset - USPTO.
- Risperidone sustained release microsphere composition - US Patent 10,406,161.
- Determining Inventorship for US Patent Applications - Oregon State University.
