United States Patent 9,925,265: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,925,265, titled "Methods of treating or preventing stent thrombosis," is a significant patent in the field of cardiovascular medicine. This patent, issued to address critical issues related to stent thrombosis, involves the use of specific pharmaceutical compositions to prevent and treat this life-threatening condition.
Background
Stent thrombosis is a serious complication that can occur after the implantation of a stent, a small mesh tube used to keep arteries open. This condition can lead to myocardial infarction (heart attack) and even death. The need for effective treatments and preventive measures is paramount, and this patent addresses this need through innovative pharmaceutical approaches.
Scope of the Patent
The patent encompasses several key methods and compositions aimed at treating or preventing stent thrombosis and related cardiovascular events.
Pharmaceutical Compositions
The patent focuses on pharmaceutical compositions that include cangrelor and bivalirudin, either separately or in combination. Cangrelor is a potent antiplatelet agent, and bivalirudin is an anticoagulant. These drugs are administered to reduce the risk of stent thrombosis and myocardial infarction[1].
Methods of Administration
The patent describes various methods of administering these pharmaceutical compositions. This includes administering cangrelor and bivalirudin either as separate compositions or as a single composition containing both drugs. The administration can be tailored to reduce mortality in subjects undergoing stent implantation or experiencing myocardial infarction[1].
Claims of the Patent
The patent includes multiple claims that define the scope of the invention.
Primary Claims
- The patent claims methods of treating or preventing stent thrombosis using pharmaceutical compositions comprising cangrelor and bivalirudin.
- It also claims methods of reducing mortality in subjects undergoing stent implantation or experiencing myocardial infarction through the administration of these compositions[1].
Specific Embodiments
- The patent includes specific embodiments where cangrelor and bivalirudin are administered separately or together to achieve the desired therapeutic effect.
- It also covers the use of these compositions in combination with pharmaceutically acceptable carriers or diluents[1].
Patent Landscape
The patent landscape surrounding U.S. Patent 9,925,265 is complex and involves several key aspects.
Patent Infringement and Litigation
The patent has been involved in litigation, with cases alleging patent infringement under the patent laws of the United States. For instance, documents related to civil actions for patent infringement mention this patent among others, highlighting the legal battles surrounding its claims[2][5].
Broader Pharmaceutical and Biotechnology Context
The pharmaceutical and biotechnology industries face significant challenges in obtaining and maintaining robust patent protection. The Federal Circuit's stance on genus claims, as outlined in 35 U.S.C. ยง 112(a), has made it difficult for innovators to claim the full scope of their inventions without risking invalidation. This has particular implications for patents like U.S. Patent 9,925,265, which must balance the breadth of claims with the specificity required by current patent laws[3].
Market and Commercial Implications
The market for therapeutic drugs, including those for cardiovascular conditions, is vast and growing. The ability to secure meaningful patent protection is crucial for innovators to recoup their significant investment in research and development. Patents like U.S. Patent 9,925,265 play a critical role in this ecosystem by providing exclusive rights to the inventors, thereby incentivizing further innovation[3].
Impact on Clinical Practice
The methods and compositions described in this patent have the potential to significantly impact clinical practice in the management of stent thrombosis.
Clinical Benefits
- The use of cangrelor and bivalirudin, as outlined in the patent, can reduce the risk of stent thrombosis and myocardial infarction, leading to improved patient outcomes.
- These pharmaceutical compositions can be tailored to individual patient needs, providing a more personalized approach to cardiovascular care[1].
Future Directions
- The patent's focus on combination therapy suggests a direction for future research, where multiple agents are used synergistically to enhance therapeutic efficacy.
- It also highlights the importance of ongoing research into antiplatelet and anticoagulant therapies to address the evolving needs in cardiovascular medicine[1].
Key Takeaways
- Pharmaceutical Compositions: The patent involves the use of cangrelor and bivalirudin, either separately or in combination, to treat or prevent stent thrombosis.
- Methods of Administration: Various methods of administration are described, including separate and combined administration of these drugs.
- Claims and Scope: The patent includes multiple claims defining the methods and compositions, with a focus on reducing mortality and preventing myocardial infarction.
- Patent Landscape: The patent is part of a complex landscape involving litigation and broader industry challenges related to patent protection.
- Clinical Impact: The patent has significant implications for clinical practice, offering improved treatments for stent thrombosis and related cardiovascular conditions.
FAQs
What are the primary pharmaceutical compositions described in U.S. Patent 9,925,265?
The primary pharmaceutical compositions described in the patent include cangrelor and bivalirudin, either used separately or in combination.
How do the methods described in the patent reduce mortality in subjects undergoing stent implantation?
The methods involve administering effective amounts of cangrelor and bivalirudin to reduce the risk of stent thrombosis and myocardial infarction, thereby reducing mortality.
What are the legal implications of this patent in terms of litigation?
The patent has been involved in civil actions for patent infringement, highlighting the legal battles surrounding its claims.
How does the Federal Circuit's stance on genus claims affect this patent?
The Federal Circuit's rigid position on genus claims makes it challenging for innovators to claim the full scope of their inventions without risking invalidation, which has implications for the breadth and validity of the claims in U.S. Patent 9,925,265.
What is the clinical significance of this patent in managing stent thrombosis?
The patent provides methods and compositions that can significantly reduce the risk of stent thrombosis and myocardial infarction, leading to improved patient outcomes in cardiovascular care.
Sources
- US9925265B2 - Methods of treating or preventing stent thrombosis - Google Patents
- Case 2:19-cv-21204 Document 1 Filed 12/09/19 Page 1 of 35 - RPX Insight
- Eviscerating Patent Scope - DigitalCommons@NYLS
- US11559214B2 - Diagnostic and therapeutic device for compromised vascular hemodynamics analysis - Google Patents
- Case 2:19-cv-18565 Document 1 Filed 09/30/19 Page 1 of 13 - RPX Insight
