United States Patent 8,604,072: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,604,072, titled "Treatment using dantrolene," is a significant patent related to the formulation and use of dantrolene, a drug used in the treatment of various medical conditions, including malignant hyperthermia. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Publication Number and Authority
The patent in question is US8604072B2, issued by the United States Patent and Trademark Office (USPTO)[4].
Prior Art and Background
The patent builds on prior art related to dantrolene formulations, particularly focusing on low-volume, safe-for-injection formulations. Dantrolene is known for its use in treating malignant hyperthermia, a life-threatening medical emergency triggered by certain drugs used in general anesthesia[4].
Legal Status
As of the current date, the patent has expired. The legal status indicates that the patent's lifetime has ended, and it no longer provides exclusive rights to the patent holder[4].
Scope of the Patent
Claims
The patent includes several claims that define the scope of the invention. Here are some key aspects:
- Formulation: The patent describes low-volume formulations of dantrolene that are safe for injection. These formulations are designed to improve the prevention and treatment of conditions such as malignant hyperthermia[4].
- Components: The claims specify the use of dantrolene sodium, water, and other substances like mannitol to create a stable and effective formulation[4].
- Indications: The patent covers the use of these formulations for various medical indications, including malignant hyperthermia and other conditions where dantrolene is beneficial[4].
Detailed Description
The patent provides a detailed description of the formulation process, including the preparation of the dantrolene solution, the use of specific excipients, and the stability testing of the final product. It also discusses the pharmacological effects and the mechanism of action of dantrolene in treating the specified conditions[4].
Claims Analysis
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding additional limitations.
- Independent Claims: These claims define the core invention, such as the low-volume formulation of dantrolene and its use in treating malignant hyperthermia.
- Dependent Claims: These claims build upon the independent claims by specifying additional details, such as the concentration of dantrolene, the presence of specific excipients, and the method of administration[4].
Claim Charts and Scope Concepts
To analyze the claims effectively, tools like Claim Charts and scope concepts can be used. These tools help in categorizing patents by claims and overarching scope concepts, making it easier to identify gaps in coverage and future design opportunities[3].
Patent Landscape
Family Patents
The patent US8604072B2 is part of a larger family of patents related to dantrolene. Understanding the family patents is crucial for strategizing market entry and identifying potential generic entry points. The family patents include various other patents with similar claims and scope, such as US7758890, US8685460, and US9884044, which have different expiration dates and statuses[1].
Global Patent Protection
While the patent in question is specific to the United States, dantrolene formulations are protected by patents in multiple countries. Analyzing the global patent landscape using tools like the Global Dossier can provide insights into the patent family and related applications filed at participating IP Offices[2].
Exclusivities and Generic Launch
In addition to patent protection, Ryanodex (the brand name for dantrolene formulations) has been granted exclusivities, such as Orphan Drug Exclusivity, which can delay the launch of generic versions even after the patent has expired. However, as of 2021, these exclusivities have expired, potentially paving the way for generic competition[1].
Patent Search and Analytics
Tools for Patent Search
To conduct a thorough analysis of the patent landscape, various tools are available:
- Patent Public Search: This tool provides enhanced access to prior art and allows users to search and analyze patent applications and granted patents[2].
- Global Dossier: This service provides access to the file histories of related applications from participating IP Offices, helping users to identify office actions and other relevant data[2].
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts help in analyzing the scope and claims of patents, identifying gaps, and highlighting future design opportunities[3].
Impact on Market and Generic Competition
Generic Entry Points
The expiration of the patent and exclusivities opens up opportunities for generic manufacturers to enter the market. Identifying markets with weaker patent protection can be crucial for strategizing generic launch[1].
Market Competition
With the patent expired, the market for dantrolene formulations is expected to become more competitive. Generic versions can offer cost-effective alternatives, potentially changing the market dynamics and pricing strategies of the original patent holder[1].
Key Takeaways
- Patent Expiration: The patent US8604072B2 has expired, ending the exclusive rights of the patent holder.
- Formulation and Claims: The patent covers low-volume, safe-for-injection formulations of dantrolene and specifies various components and indications.
- Global Protection: Dantrolene formulations are protected by patents in multiple countries, and understanding the global patent landscape is crucial.
- Exclusivities: Exclusivities like Orphan Drug Exclusivity have expired, allowing for potential generic competition.
- Market Impact: The expiration of the patent and exclusivities opens up the market for generic competition, which can change market dynamics.
FAQs
What is the current status of United States Patent 8,604,072?
The patent has expired, and it no longer provides exclusive rights to the patent holder.
What are the key claims of the patent?
The key claims include the low-volume formulation of dantrolene, its components, and its use in treating conditions like malignant hyperthermia.
How does the patent fit into the broader patent landscape for dantrolene?
The patent is part of a larger family of patents related to dantrolene formulations, with protection in multiple countries and various other related patents.
What impact does the expiration of the patent have on the market?
The expiration opens up opportunities for generic manufacturers to enter the market, potentially increasing competition and changing market dynamics.
What tools can be used to analyze the claims and scope of the patent?
Tools like Claim Charts, scope concepts, and patent analytics software can be used to analyze the claims and identify gaps or opportunities in coverage.
Sources
- Pharsight: Ryanodex patent expiration - Pharsight
- USPTO: Search for patents - USPTO
- SLWIP: Patent Analytics | Intellectual Property Law
- Google Patents: US8604072B2 - Treatment using dantrolene - Google Patents
- PubChem: Treatment using dantrolene - Patent US-2012121662-A1 - PubChem
