Detailed Analysis of the Scope and Claims of United States Patent 10,881,605
Introduction
United States Patent 10,881,605, titled "Methods for the Preparation of Injectable Depot Compositions," is a significant patent in the pharmaceutical field, particularly in the development of long-acting injectable formulations. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent, assigned to Laboratorios Farmaceuticos Rovi SA, was granted on December 29, 2020, with a priority date of May 31, 2010. This indicates a long development and approval process, highlighting the complexity and innovation involved in the invention[2].
Scope of the Invention
The patent focuses on methods for preparing injectable depot compositions, which are designed to release the active pharmaceutical ingredient over an extended period. This is crucial for treatments that require sustained drug delivery, such as antipsychotic medications.
Key Components
- Active Pharmaceutical Ingredient: The patent involves the use of various drugs, including antipsychotics, which are formulated to provide a prolonged therapeutic effect.
- Excipients and Polymers: The composition includes solvents and polymers, such as RIGA copolymer, which play a critical role in the sustained release mechanism.
- Preparation Methods: The patent details specific methods for mixing, sieving, and stabilizing the formulation to ensure consistent and effective drug delivery[2][5].
Claims
The patent includes several claims that define the scope of the invention. Here are some key claims:
Independent Claims
- Claim 1 typically describes the method for preparing the injectable depot composition, including the steps of mixing the active ingredient with a solvent and a polymer, followed by sieving and stabilizing the mixture.
- Claim 2 may specify the type of polymer used, such as RIGA copolymer, and the particle size of the formulation.
Dependent Claims
- These claims further detail the specific conditions and parameters for the preparation method, such as the ratio of the active ingredient to the polymer, the solvent used, and the temperature and pressure conditions during the process.
Patent Landscape
Prior Art and Related Patents
The patent landscape for injectable depot compositions is rich with prior art and related patents. For instance, other patents like EP4404913A1 and AU2022351480A1 also describe similar formulations and preparation methods, indicating a competitive and innovative field[4][5].
Global Dossier and International Patent Offices
To understand the global reach of this patent, one can use resources like the Global Dossier provided by the USPTO, which allows access to file histories of related applications from participating IP Offices. This helps in identifying similar patents filed in other countries and understanding the international patent family[1].
Common Citation Document (CCD)
The Common Citation Document (CCD) application is useful for consolidating prior art cited by multiple patent offices, providing a comprehensive view of the prior art landscape for this invention[1].
Economic and Statistical Analysis
The USPTO's Patent Claims Research Dataset can provide insights into the scope and trends of patent claims, including those related to pharmaceutical formulations. This dataset, which includes detailed information on claims from US patents granted between 1976 and 2014, can help in understanding the broader trends in patent scope and the competitive landscape[3].
Practical Implications
Clinical Applications
The injectable depot compositions described in this patent have significant clinical implications, particularly for patients requiring long-term treatment with antipsychotic medications. These formulations can improve patient compliance and reduce the frequency of injections, thereby enhancing the overall therapeutic outcome.
Manufacturing and Quality Control
The detailed preparation methods outlined in the patent are crucial for ensuring the quality and consistency of the final product. Manufacturers must adhere strictly to these methods to maintain the efficacy and safety of the injectable depot compositions.
Challenges and Future Directions
Regulatory Compliance
Compliance with regulatory requirements is a significant challenge. Patent holders must ensure that their manufacturing processes meet the standards set by regulatory bodies such as the FDA.
Innovation and Competition
The field of injectable depot compositions is highly competitive, with numerous patents and ongoing research. Continuous innovation and improvement in formulation and preparation methods are essential to stay ahead in this competitive landscape.
Key Takeaways
- Innovative Formulation: The patent describes a novel method for preparing injectable depot compositions with sustained release properties.
- Clinical Significance: These formulations are particularly useful for long-term treatments, improving patient compliance and therapeutic outcomes.
- Regulatory and Manufacturing Considerations: Strict adherence to the preparation methods and regulatory standards is crucial.
- Competitive Landscape: The patent landscape is rich with prior art and ongoing innovations, necessitating continuous improvement and innovation.
FAQs
Q: What is the main focus of United States Patent 10,881,605?
A: The patent focuses on methods for preparing injectable depot compositions, particularly for antipsychotic medications.
Q: What are the key components of the injectable depot composition described in the patent?
A: The composition includes an active pharmaceutical ingredient, a solvent, and a polymer such as RIGA copolymer.
Q: How can one access related international patents for this invention?
A: Using resources like the Global Dossier and searching databases of international patent offices such as the European Patent Office (EPO) and the World Intellectual Property Organization (WIPO)[1].
Q: What is the significance of the Common Citation Document (CCD) in patent searching?
A: The CCD consolidates prior art cited by multiple patent offices, providing a comprehensive view of the prior art landscape for a specific invention[1].
Q: How can the USPTO's Patent Claims Research Dataset be useful in analyzing this patent?
A: The dataset provides detailed information on claims from US patents, helping to understand trends in patent scope and the competitive landscape[3].
Sources
- USPTO - Search for Patents: https://www.uspto.gov/patents/search
- Unified Patents Portal - US-20180318208-A1: https://portal.unifiedpatents.com/patents/patent/US-20180318208-A1
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - EP4404913A1: https://patents.google.com/patent/EP4404913A1/en
- Google Patents - AU2022351480A1: https://patents.google.com/patent/AU2022351480A1/en
