United States Patent 8,680,052: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,680,052, titled "Methods of treating, reducing the incidence of, and/or preventing an ischemic event in a patient undergoing percutaneous coronary intervention (PCI)," is a significant patent in the field of cardiovascular medicine. This patent, granted to its inventors, outlines innovative methods and pharmaceutical compositions aimed at mitigating ischemic events during and after PCI procedures.
Background and Context
Percutaneous coronary intervention (PCI) is a common procedure used to open narrowed coronary arteries due to coronary artery disease. However, this procedure can sometimes lead to ischemic events, which are a major concern for patient safety and outcomes. The patent addresses this critical issue by introducing specific therapeutic strategies.
Scope of the Patent
The patent's scope is broad and encompasses several key aspects:
Methods of Treatment
The patent describes methods for treating, reducing the incidence of, and/or preventing ischemic events in patients undergoing PCI. These methods involve the administration of a pharmaceutical composition containing cangrelor, a potent P2Y12 receptor inhibitor[1].
Pharmaceutical Compositions
The patent details pharmaceutical compositions that include cangrelor, which can be administered intravenously, either as a bolus or infusion. These compositions may also include other pharmaceutically acceptable excipients to enhance stability and efficacy[1].
Additional Therapeutic Agents
The methods may further involve the administration of additional therapeutic agents, such as other P2Y12 inhibitors (e.g., clopidogrel, prasugrel, or ticagrelor), bivalirudin, or heparin. These agents can be administered separately or concurrently with cangrelor, either in the same pharmaceutical composition or as separate doses[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Primary Claims
- The primary claims focus on the methods of administering cangrelor to patients undergoing PCI to prevent or reduce ischemic events.
- These claims specify the dosage forms (e.g., bolus, infusion) and the potential inclusion of other therapeutic agents[1].
Dependent Claims
- Dependent claims elaborate on the primary claims by specifying additional details such as the types of additional therapeutic agents that can be used, the timing of administration, and the formulation of the pharmaceutical composition[1].
Patent Landscape
Understanding the patent landscape around US 8,680,052 involves analyzing related patents, competitors, and the broader intellectual property environment.
Related Patents
- Other patents in the same field, such as those related to P2Y12 inhibitors (e.g., clopidogrel, prasugrel, ticagrelor), are relevant. These patents may overlap in terms of therapeutic targets or methods of administration[1].
Competitors and Market Impact
- Companies involved in cardiovascular medicine, such as pharmaceutical manufacturers and medical device companies, are key players in this patent landscape. The patent's exclusivity period and the potential for generic competition are crucial factors[5].
Intellectual Property Strategy
- Effective patent analytics, such as those provided by tools like ClaimScape®, can help in understanding the coverage and gaps in patent claims. This is essential for strategic decision-making, including determining the value of patent claims and identifying future design opportunities[3].
Clinical Significance
The clinical significance of this patent lies in its potential to improve patient outcomes during and after PCI procedures.
Reducing Ischemic Events
- By administering cangrelor and potentially other therapeutic agents, the methods described in the patent aim to reduce the incidence of ischemic events, thereby enhancing patient safety and reducing the risk of complications[1].
Bleeding Risks
- An important aspect of the patent is that the methods may not significantly increase severe bleeding or the need for transfusions, which is a common concern with anticoagulant and antiplatelet therapies[1].
Economic and Regulatory Implications
The economic and regulatory implications of this patent are substantial.
Market Exclusivity
- The patent grants exclusivity to the inventors or assignees, allowing them to market and sell the pharmaceutical compositions without competition for a specified period. This can have significant economic benefits[5].
Regulatory Approvals
- The patent's validity and enforcement are subject to regulatory approvals and compliance with FDA guidelines. Any changes in regulatory policies can impact the patent's value and the market landscape[4].
Litigation and Enforcement
Patent litigation is a critical aspect of protecting intellectual property rights.
Infringement Cases
- The patent has been involved in litigation, as seen in cases where companies have been accused of patent infringement. These cases highlight the importance of enforcing patent rights to protect innovation[5].
Defending Patent Claims
- The patent holders must defend their claims against challenges and ensure that the patent remains valid and enforceable throughout its term[5].
Future Directions and Opportunities
The patent opens up several future directions and opportunities:
Research and Development
- Further research can focus on optimizing the dosage and administration protocols of cangrelor and other therapeutic agents to enhance efficacy and safety.
- New formulations and delivery systems could also be explored to improve patient compliance and outcomes[1].
Market Expansion
- The patent's exclusivity period provides a window for market expansion and establishing a strong market presence before generic competition arises.
- Strategic partnerships and licensing agreements can also be pursued to leverage the patent's value globally[3].
Key Takeaways
- Innovative Treatment Methods: The patent introduces novel methods for preventing ischemic events during PCI using cangrelor and other therapeutic agents.
- Pharmaceutical Compositions: The patent details various pharmaceutical compositions and administration methods.
- Clinical Significance: The methods aim to reduce ischemic events without significantly increasing bleeding risks.
- Economic and Regulatory Implications: The patent has significant economic and regulatory implications, including market exclusivity and regulatory compliance.
- Litigation and Enforcement: Protecting the patent through litigation is crucial for maintaining its value.
Frequently Asked Questions (FAQs)
What is the primary therapeutic agent described in US Patent 8,680,052?
The primary therapeutic agent is cangrelor, a P2Y12 receptor inhibitor.
How is the pharmaceutical composition administered according to the patent?
The pharmaceutical composition can be administered intravenously, either as a bolus or infusion.
Can other therapeutic agents be used in conjunction with cangrelor?
Yes, other therapeutic agents such as clopidogrel, prasugrel, ticagrelor, bivalirudin, or heparin can be used concurrently or sequentially.
What is the clinical significance of this patent?
The patent aims to reduce the incidence of ischemic events during and after PCI procedures, thereby improving patient safety and outcomes.
How does the patent impact the market and regulatory environment?
The patent grants market exclusivity and requires compliance with regulatory guidelines, which can have significant economic and regulatory implications.
Cited Sources
- US8680052B1 - Methods of treating, reducing the incidence of, and/or preventing an ischemic event in a patient undergoing percutaneous coronary intervention (PCI).
- Patent Claims Research Dataset - USPTO.
- Patent Analytics | Intellectual Property Law.
- Search for patents - USPTO.
- Robert C. Brady Charles H. Chevalier GIBBONS P.C. One Gateway ....
