Detailed Analysis of the Scope and Claims of United States Patent 9,295,687
Introduction
United States Patent 9,295,687, titled "Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same," is a crucial patent in the pharmaceutical industry, particularly for the drug Kengreal (cangrelor). This patent, issued on March 29, 2016, is assigned to The Medicines Company, which has since assigned the rights to Chiesi Farmaceutici S.p.A.[2].
Patent Overview
Inventors and Assignees
The patent was invented by Panna Dutta, Adel Rafai Far, Min Ding, and Rajeshwar Motheram, and it was originally assigned to The Medicines Company before being transferred to Chiesi Farmaceutici S.p.A.[2].
Patent Expiration
The patent is set to expire on July 10, 2035, which is one of the later expiration dates among the patents protecting Kengreal[2][5].
Scope of the Patent
Pharmaceutical Formulations
The patent covers pharmaceutical formulations that include high purity cangrelor as the active ingredient. Cangrelor is an antiplatelet drug used to reduce the risk of periprocedural myocardial infarction, stent thrombosis, and other ischemic events in patients undergoing percutaneous coronary intervention (PCI)[1][5].
Methods of Preparation
The patent details methods for preparing these pharmaceutical formulations. This includes processes for synthesizing high purity cangrelor and formulating it into a drug product suitable for intravenous administration. The methods ensure the stability and efficacy of the drug, which is critical for its therapeutic use[5].
Methods of Use
The patent also describes methods for using these pharmaceutical formulations. Specifically, it outlines the dosing regimen for administering cangrelor, which typically involves an initial bolus dose followed by a continuous infusion during the PCI procedure. This regimen is designed to inhibit platelet activation and aggregation effectively[1][5].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover:
- The pharmaceutical formulations themselves, emphasizing the high purity of cangrelor.
- The methods for preparing these formulations, including specific steps and reagents.
- The methods for using these formulations, including the dosing regimen and administration protocol[5].
Dependent Claims
Dependent claims further specify and narrow down the scope of the independent claims. These may include details such as specific concentrations of cangrelor, additional excipients, and specific conditions for the preparation and use of the formulations[5].
Patent Landscape
Related Patents
Kengreal is protected by a portfolio of patents, including several other U.S. patents such as 8,680,052, 9,427,448, 9,439,921, and 9,700,575. These patents collectively cover various aspects of cangrelor, including different formulations, methods of use, and combinations with other antiplatelet drugs[2].
Patent Litigation
The patent landscape for Kengreal includes ongoing litigation to protect the intellectual property rights. For instance, Chiesi USA Inc. has filed lawsuits against generic manufacturers to prevent infringement of these patents[2].
Generic Availability
As of now, there is no therapeutically equivalent generic version of Kengreal available in the United States due to the robust patent protection[5].
Impact on the Pharmaceutical Industry
Innovation and Competition
The patent protects innovative formulations and methods, ensuring that the original developer, Chiesi Farmaceutici S.p.A., maintains a competitive edge in the market. This encourages continued innovation in the field of antiplatelet therapy[2].
Patient Access
The patent expiration date of July 10, 2035, means that patients will continue to rely on the branded version of Kengreal until generic alternatives become available. This can impact healthcare costs and access to this critical medication[5].
Conclusion
United States Patent 9,295,687 is a significant patent that safeguards the intellectual property related to high purity cangrelor formulations and their use. Understanding the scope and claims of this patent is essential for pharmaceutical companies, researchers, and healthcare providers involved in the development and use of antiplatelet therapies.
Key Takeaways
- Patent Overview: Issued on March 29, 2016, and set to expire on July 10, 2035.
- Scope: Covers pharmaceutical formulations of high purity cangrelor, methods for preparation, and methods for use.
- Claims: Includes independent and dependent claims defining the invention's scope.
- Patent Landscape: Part of a broader portfolio protecting Kengreal, with ongoing litigation to prevent infringement.
- Impact: Protects innovation, affects competition, and influences patient access to the medication.
FAQs
Q: Who are the inventors of United States Patent 9,295,687?
A: The inventors are Panna Dutta, Adel Rafai Far, Min Ding, and Rajeshwar Motheram.
Q: What is the expiration date of United States Patent 9,295,687?
A: The patent is set to expire on July 10, 2035.
Q: What is the primary use of the pharmaceutical formulations covered by this patent?
A: The primary use is to reduce the risk of periprocedural myocardial infarction, stent thrombosis, and other ischemic events in patients undergoing PCI.
Q: Is there a generic version of Kengreal available?
A: No, there is currently no therapeutically equivalent generic version of Kengreal available in the United States.
Q: Who is the current assignee of this patent?
A: The current assignee is Chiesi Farmaceutici S.p.A., having been transferred from The Medicines Company.
Sources
- DrugPatentWatch: Summary for KENGREAL.
- RPX Corporation: Complaint against MSN Pharmaceuticals, MSN Laboratories Private Ltd., MSN Life Sciences Private Limited, and Endo Procurement Operations Limited.
- Hoover Institution: Patent Claims and Patent Scope.
- ACS Publications: Synthetic Approaches to the New Drugs Approved During 2015.
- Drugs.com: Generic Kengreal Availability.
