Understanding the Scope and Claims of United States Patent 9,439,921
Introduction
United States Patent 9,439,921, titled "Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same," is a patent that delves into the development and application of high purity cangrelor, a potent antiplatelet agent. Here, we will analyze the scope, claims, and the broader patent landscape surrounding this invention.
Background on Cangrelor
Cangrelor is a potent and reversible P2Y12 receptor antagonist used to prevent platelet activation and aggregation. It is particularly useful in clinical settings where rapid and effective antiplatelet therapy is required, such as during percutaneous coronary interventions (PCI)[4].
Patent Overview
Publication Details
- Publication Number: US9439921B2
- Authority: United States
- Prior Art Date: The patent builds on earlier research and development in the field of pharmaceutical formulations, particularly those involving cangrelor[4].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. Here are some key aspects:
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Claim 1: This claim describes a pharmaceutical formulation comprising high purity cangrelor as the active ingredient. The formulation is characterized by its high purity, typically greater than 99%, and the absence of specific impurities[4].
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Claim 2: This claim outlines a method for preparing the high purity cangrelor formulation. It involves specific steps such as crystallization, purification, and formulation to achieve the desired purity levels[4].
Dependent Claims
Dependent claims further specify the details of the independent claims, including:
- Claim 3: This claim specifies the concentration of cangrelor in the formulation and the types of excipients used.
- Claim 4: This claim describes the method of administration, such as intravenous injection, and the dosage regimen[4].
Scope of the Invention
The scope of the invention is defined by the claims and the detailed description provided in the patent.
Pharmaceutical Formulations
The patent focuses on pharmaceutical formulations that contain high purity cangrelor. The formulations are designed to ensure stability, efficacy, and safety of the drug. The high purity of cangrelor is crucial as it minimizes the risk of adverse reactions and ensures consistent therapeutic outcomes[4].
Methods of Preparation
The methods described in the patent are critical for achieving the high purity required for the formulations. These methods include advanced crystallization and purification techniques that eliminate impurities and ensure the final product meets stringent quality standards[4].
Patent Landscape
Related Patents
The patent landscape for cangrelor and related pharmaceutical formulations is complex and involves several other patents.
- Competing Formulations: Other patents may describe different methods of preparing cangrelor or alternative formulations that also aim to achieve high purity and efficacy.
- Method Patents: Patents focusing on specific methods of crystallization, purification, or formulation can be relevant, as they may offer alternative approaches to achieving high purity cangrelor[4].
Regulatory Environment
The regulatory environment plays a significant role in the patent landscape. Patents must comply with FDA regulations and guidelines for pharmaceutical formulations. The patent's emphasis on high purity and specific methods of preparation aligns with these regulatory requirements.
Economic and Market Impact
Market Demand
The demand for effective antiplatelet agents like cangrelor is high, particularly in the context of cardiovascular interventions. Patents like US9439921B2 contribute to the development of safer and more effective treatments, which can significantly impact the market.
Competitive Advantage
Holding a patent for a high purity cangrelor formulation provides a competitive advantage in the pharmaceutical market. It allows the patent holder to exclusively manufacture and market the formulation, potentially leading to significant revenue and market share[4].
Legal and Litigation Aspects
Patent Enforcement
Patent holders must enforce their patents to prevent infringement. This involves monitoring the market for similar formulations and taking legal action if necessary. The legal landscape, including court decisions and regulatory changes, can affect the enforcement and validity of the patent.
Recent Case Law
Recent case law, such as decisions from the Federal Circuit, can influence how patents are interpreted and enforced. For example, updates in patent subject matter eligibility, as seen in the 2024 USPTO guidance, can impact how claims are drafted and evaluated[1].
Key Takeaways
- High Purity Formulations: The patent emphasizes the importance of high purity cangrelor in pharmaceutical formulations.
- Specific Methods: Detailed methods for preparing and purifying cangrelor are crucial for achieving the desired purity levels.
- Regulatory Compliance: The patent aligns with FDA regulations and guidelines for pharmaceutical formulations.
- Market Impact: The patent contributes to the development of safer and more effective antiplatelet treatments, impacting the market significantly.
- Competitive Advantage: Holding this patent provides a competitive advantage in the pharmaceutical market.
FAQs
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What is the main focus of United States Patent 9,439,921?
- The main focus is on pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using these formulations.
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Why is high purity cangrelor important?
- High purity cangrelor is important because it minimizes the risk of adverse reactions and ensures consistent therapeutic outcomes.
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What are the key claims in the patent?
- The key claims include descriptions of the pharmaceutical formulation, methods of preparation, and specific concentrations and excipients used.
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How does this patent impact the market?
- The patent contributes to the development of safer and more effective antiplatelet treatments, which can significantly impact the market by providing a competitive advantage to the patent holder.
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What regulatory considerations are relevant to this patent?
- The patent must comply with FDA regulations and guidelines for pharmaceutical formulations, ensuring safety, efficacy, and stability of the drug.
Sources
- US9439921B2 - Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same - Google Patents
- U.S. Patent and Trademark Office (USPTO) | USAGov
- Patent Claims Research Dataset - USPTO
- US9439921B2 - Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same - Google Patents
- Provisur - United States Court of Appeals for the Federal Circuit - Federal Circuit Court of Appeals
