United States Patent 9,662,342: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 9,662,342, titled "Formulations of cyclophosphamide liquid concentrate," is a significant patent in the pharmaceutical industry, particularly in the field of oncology. This patent, granted in 2017, pertains to novel formulations of cyclophosphamide, a widely used chemotherapeutic agent. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background on Cyclophosphamide
Cyclophosphamide is a chemotherapy drug used to treat various types of cancer and some autoimmune disorders. It is an alkylating agent that interferes with the DNA replication process, thereby inhibiting cancer cell growth. However, its formulation and stability have been ongoing challenges in pharmaceutical development[1][4].
Scope of the Patent
The patent US 9,662,342 focuses on formulations of cyclophosphamide in liquid concentrate form, which are designed to enhance stability and ease of use. Here are the key aspects of the patent's scope:
Formulation Components
The patented formulations contain cyclophosphamide as the active ingredient, combined with ethanol and an ethanol-soluble acidifying agent, such as citric acid. These components are crucial for maintaining the stability of the cyclophosphamide in liquid form[1][4].
Stability Enhancements
The inclusion of ethanol and citric acid helps in stabilizing the cyclophosphamide, preventing its degradation and ensuring that the formulation remains effective over a longer period. This is particularly important for chemotherapy agents, where potency and stability are critical[1].
Ready-to-Use and Ready-to-Dilute Formulations
The patent covers both ready-to-use and ready-to-dilute formulations. This flexibility allows healthcare providers to prepare the drug according to specific patient needs, enhancing the convenience and safety of administration[1][4].
Claims of the Patent
The claims of the patent are detailed and specific, ensuring that the invention is well-defined and protected. Here are some key claims:
Independent Claims
The patent includes independent claims that describe the composition of the cyclophosphamide liquid concentrate. These claims specify the presence of cyclophosphamide, ethanol, and an acidifying agent like citric acid[1][4].
Dependent Claims
Dependent claims further elaborate on the independent claims by specifying the concentrations of the components, the pH range of the formulation, and other specific characteristics that ensure the stability and efficacy of the drug[1].
Method Claims
The patent also includes method claims that describe the process of preparing the cyclophosphamide liquid concentrate. These methods ensure that the formulation is consistent and reliable[1].
Patent Landscape
Understanding the patent landscape is crucial for assessing the impact and uniqueness of the US 9,662,342 patent.
Prior Art
Prior to this patent, formulations of cyclophosphamide often faced stability issues, particularly in liquid forms. The use of ethanol and citric acid as stabilizers represents a significant advancement over previous formulations[1].
Related Patents
Other patents related to cyclophosphamide formulations exist, but they often focus on different aspects such as solid formulations or different stabilizing agents. The unique combination of ethanol and citric acid in US 9,662,342 sets it apart from these other patents[5].
Patent Scope Metrics
Research on patent scope metrics, such as independent claim length and independent claim count, suggests that narrower claims with clear definitions are more likely to be granted and have a shorter examination process. The claims in US 9,662,342 are well-defined and specific, aligning with these metrics[3].
Impact on the Pharmaceutical Industry
The US 9,662,342 patent has several implications for the pharmaceutical industry:
Enhanced Stability
The stabilized liquid concentrate formulations of cyclophosphamide improve the drug's shelf life and reduce the risk of degradation, making it more reliable for clinical use[1].
Improved Patient Care
The ready-to-use and ready-to-dilute formulations enhance the convenience and safety of drug administration, which is critical in chemotherapy where precise dosing is essential[1].
Innovation and Competition
This patent encourages innovation by setting a new standard for cyclophosphamide formulations. It also creates a competitive landscape where other pharmaceutical companies may strive to develop similar or improved formulations[3].
Legal and Regulatory Considerations
The patent's legal status and regulatory compliance are important aspects:
Patent Validity
The patent is currently active, but its validity can be challenged through various legal and administrative processes. The clarity and specificity of the claims reduce the likelihood of successful challenges[1].
Regulatory Approvals
The formulations described in the patent must comply with regulatory standards set by agencies such as the FDA. The stability and efficacy data provided in the patent support regulatory approvals[1].
Conclusion
The United States Patent 9,662,342 represents a significant advancement in the formulation of cyclophosphamide, a critical chemotherapy agent. The patent's scope and claims are well-defined, ensuring the stability and efficacy of the drug. This innovation has a positive impact on patient care and sets a new standard in the pharmaceutical industry.
Key Takeaways
- Stabilized Formulations: The patent introduces stabilized liquid concentrate formulations of cyclophosphamide using ethanol and citric acid.
- Ready-to-Use and Ready-to-Dilute: The formulations are available in both ready-to-use and ready-to-dilute forms, enhancing convenience and safety.
- Improved Stability: The inclusion of ethanol and citric acid ensures the stability of cyclophosphamide, reducing degradation risks.
- Impact on Industry: The patent sets a new standard for cyclophosphamide formulations, encouraging innovation and competition.
- Regulatory Compliance: The formulations must comply with regulatory standards, and the patent provides necessary data to support regulatory approvals.
FAQs
What is the main innovation of the US 9,662,342 patent?
The main innovation is the development of stabilized liquid concentrate formulations of cyclophosphamide using ethanol and citric acid.
What are the key components of the patented formulations?
The key components are cyclophosphamide, ethanol, and an ethanol-soluble acidifying agent like citric acid.
How do the formulations improve patient care?
The ready-to-use and ready-to-dilute formulations enhance the convenience and safety of drug administration, which is critical in chemotherapy.
What is the current legal status of the patent?
The patent is currently active, but its validity can be challenged through legal and administrative processes.
How does the patent impact the pharmaceutical industry?
The patent sets a new standard for cyclophosphamide formulations, encouraging innovation and competition among pharmaceutical companies.
Sources
- US9662342B2 - Formulations of cyclophosphamide liquid concentrate - Google Patents
- US-9662342-B2 - Unified Patents Portal
- Patent Claims and Patent Scope - Hoover Institution
- US9662342B2 - Formulations of cyclophosphamide liquid concentrate - Google Patents
- US-4879286-A - Cyclophosphamide - Unified Patents Portal
