Analyzing the Scope and Claims of United States Patent 9,446,135: Risperidone Sustained Release Microsphere Composition
Introduction
United States Patent 9,446,135, issued on September 20, 2016, pertains to a risperidone sustained release microsphere composition. This patent, assigned to Shandong Luye Pharmaceutical Co., Ltd., is crucial for understanding the formulation, application, and legal protection of this specific pharmaceutical composition.
Patent Overview
Publication and Filing Details
- Publication Number: US9446135B2
- Filing Date: The patent was filed as part of the application US14/113,738[4].
Inventors and Assignees
- Inventors: Sun Kaoxiang, Liang Rongcai, Wang Qilin, Wang Wenyan, Liu Wanhui, and Li Youxin.
- Assignee: Shandong Luye Pharmaceutical Co., Ltd.[2].
Scope of the Patent
Pharmaceutical Composition
The patent describes a sustained release microsphere formulation that includes risperidone or its metabolite, 9-hydroxy risperidone, or salts thereof. This formulation is designed to provide a controlled release of the active ingredient over an extended period, which is beneficial for treating psychotic diseases such as schizophrenia and bipolar disorder[4].
Key Components
- Microspheres: The microspheres are composed of biodegradable polymers, such as polylactide and polyglycolide, which encapsulate the risperidone or its derivatives.
- Excipients: The formulation may include various excipients like glycerine, mannitol, and solvents to enhance the stability and release characteristics of the microspheres[4].
Claims of the Patent
Method of Preparation
The patent includes claims related to the method of preparing the microsphere formulation. This involves steps such as:
- Encapsulation: Encapsulating risperidone or its derivatives within the biodegradable polymer matrix.
- Formulation: Formulating the microspheres into a pharmaceutical composition suitable for injection[4].
Pharmaceutical Uses
The claims also cover the use of the risperidone microspheres in the preparation of antipsychotic drugs. Specifically, it mentions the treatment of psychotic diseases, including acute and chronic conditions[1].
Specific Chemicals and Processes
The patent details the use of specific chemicals and processes, such as:
- Polylactide and Polyglycolide: These biodegradable polymers are used to form the microspheres.
- Inorganic Acid Salts: These may be included in the formulation to adjust the release profile.
- Solvents and Dispersion Agents: Glycerine and other solvents are used in the preparation process[4].
Patent Landscape
Exclusivity and Patent Term
- Patent Expiration: The patent is set to expire on April 10, 2032, assuming no extensions or adjustments[2].
- Exclusivity: The patent holder, Shandong Luye Pharmaceutical Co., Ltd., has exclusive rights to the proprietary chemical formulation and manufacturing process described in the patent.
Generic Availability
As of the current date, there is no therapeutically equivalent generic version of the risperidone sustained release microsphere formulation available in the United States. This is due to the patent protection and exclusivity granted to the original patent holder[2].
Impact on Innovation and Competition
Patent Scope and Quality
The scope of this patent is defined by its claims, which are specific to the formulation and method of preparation of the risperidone microspheres. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process, which can encourage innovation by providing clear boundaries for competitors[3].
Licensing and Litigation
The patent's exclusivity period and the specificity of its claims can influence licensing and litigation strategies. Companies seeking to develop similar formulations must either obtain a license from the patent holder or develop distinct formulations that do not infringe on the existing patent claims.
Clinical and Therapeutic Implications
Treatment of Psychotic Diseases
The sustained release microsphere formulation of risperidone offers significant clinical benefits, including improved patient compliance due to reduced dosing frequency and more consistent therapeutic levels of the drug. This can lead to better management of psychotic diseases and improved patient outcomes[4].
Patient Compliance
The controlled release profile of the microspheres helps in maintaining therapeutic drug levels over an extended period, which can enhance patient compliance and reduce the risk of medication non-adherence.
Regulatory Considerations
FDA Approval and Exclusivity
The FDA grants exclusivity periods to manufacturers upon the approval of new drugs, which can run concurrently with patent protection. This ensures that the manufacturer has sole marketing rights for a specified period, further protecting the intellectual property and investment in the drug development process[2].
Conclusion
United States Patent 9,446,135 provides comprehensive protection for the risperidone sustained release microsphere composition, ensuring exclusivity for Shandong Luye Pharmaceutical Co., Ltd. until its expiration in 2032. The patent's specific claims and detailed formulation process underscore its significance in the treatment of psychotic diseases and highlight the importance of patent protection in pharmaceutical innovation.
Key Takeaways
- Patent Protection: The patent provides exclusive rights to the proprietary formulation and manufacturing process.
- Formulation Details: The microspheres are composed of biodegradable polymers and include risperidone or its derivatives.
- Clinical Benefits: The sustained release formulation enhances patient compliance and therapeutic outcomes.
- Regulatory Exclusivity: The patent holder enjoys sole marketing rights during the exclusivity period.
- Innovation Impact: The patent encourages innovation by setting clear boundaries for competitors.
FAQs
Q: What is the primary active ingredient in the patent 9,446,135?
A: The primary active ingredient is risperidone or its metabolite, 9-hydroxy risperidone, or salts thereof.
Q: Who is the assignee of the patent 9,446,135?
A: The assignee is Shandong Luye Pharmaceutical Co., Ltd.
Q: What is the expected expiration date of the patent?
A: The patent is set to expire on April 10, 2032.
Q: Are there any generic versions of this formulation available in the United States?
A: As of the current date, there are no therapeutically equivalent generic versions available.
Q: What are the clinical benefits of the sustained release microsphere formulation?
A: The formulation improves patient compliance and maintains consistent therapeutic drug levels, leading to better management of psychotic diseases.
Sources
- US9446135B2 - Risperidone sustained release microsphere composition - Google Patents
- Generic Rykindo Availability - Drugs.com
- Patent Claims and Patent Scope - SSRN
- Risperidone sustained release microsphere composition - Google Patents
- Drug patent 9446135 - DrugPatentWatch
