United States Patent 8,685,460: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,685,460, granted to Eagle Pharmaceuticals' exclusive licensor, is a significant patent in the pharmaceutical industry, particularly for the treatment of heat stroke and other related conditions. This article delves into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Title and Description
The patent titled "Treatment using dantrolene" was granted by the United States Patent and Trademark Office (USPTO) for the use of dantrolene sodium in treating heat stroke. Dantrolene sodium is the active ingredient in Ryanodex, a drug developed by Eagle Pharmaceuticals[2][5].
Scope of the Patent
Claims
The patent includes several claims that define the scope of protection. These claims typically cover the method of treatment, the dosage form, and the specific conditions under which dantrolene sodium is administered. For instance, the patent claims the use of dantrolene for treating heat stroke, which is a critical expansion of its traditional use in treating malignant hyperthermia[2][5].
Independent Claim Length and Count
The scope of a patent can also be measured by the length and count of its independent claims. Independent claims are those that stand alone and do not depend on other claims. A higher number of independent claims and longer claim lengths can indicate a broader scope of protection. However, this also raises concerns about patent quality, as overly broad claims can be unclear and potentially diminish innovation incentives[3].
Patent Claims and Exclusivities
Active and Expired Patents
The patent landscape for Ryanodex, which includes US Patent 8,685,460, involves multiple patents filed between 2014 and 2018. As of the current date, one patent (US7758890) remains active, while others have expired. The active patent is set to expire in June 2025, which will significantly impact the generic launch of Ryanodex[1].
Exclusivities
In addition to patent protection, Ryanodex has been granted exclusivities by the FDA, including Orphan Drug Exclusivity (ODE). These exclusivities, which expired in July 2021, prevented other companies from marketing generic or bioequivalent versions of Ryanodex, regardless of the patent status. These exclusivities play a crucial role in delaying the generic launch of the drug[1].
Patent Landscape
Family Patents
The protection of Ryanodex is not limited to the United States. It is protected by a family of patents in multiple countries. Understanding this broader patent landscape is essential for strategizing market entry, as it helps identify markets with weaker patent protection that could be ideal for generic entry[1].
Recent Legal Activities
Tracking recent legal activities on the patents, such as maintenance fee payments, patent expirations, and any amendments or term extensions, is crucial. These activities can affect the patent's expiry date and, consequently, the generic launch date. For example, the payment of maintenance fees and the expiration of certain patents have been critical in shaping the current patent landscape for Ryanodex[1].
Impact on Generic Launch
Estimated Generic Launch Date
The generic launch of Ryanodex is estimated to be June 30, 2025, based on the current patent and exclusivity status. This date can be influenced by any changes in the patent landscape, such as term extensions or the abandonment of patents[1].
Market Entry Strategies
Companies planning to enter the market with generic versions of Ryanodex need to closely monitor the patent landscape. Identifying markets with weaker patent protection can provide early entry points. Additionally, understanding the exclusivities and their expiration dates is vital for strategic planning[1].
Clinical Use and Dosage
Treatment Indications
Ryanodex, using dantrolene sodium, is approved for the treatment and prevention of malignant hyperthermia in patients at risk. The patent's extension to include heat stroke treatment broadens its clinical utility[4].
Dosage Form
The drug is available in a suspension form for intravenous use, with a specific dosage of 250MG/VIAL. This formulation is critical for rapid administration in emergency situations[4].
Conclusion
The United States Patent 8,685,460 is a pivotal patent in the pharmaceutical industry, particularly for the treatment of heat stroke and malignant hyperthermia. Understanding its scope, claims, and the broader patent landscape is essential for both the innovator company and potential generic entrants.
Key Takeaways
- Patent Scope: The patent covers the use of dantrolene sodium for treating heat stroke and malignant hyperthermia.
- Claims: The patent includes specific claims defining the method of treatment and dosage form.
- Exclusivities: Orphan Drug Exclusivity has played a role in delaying generic launch.
- Patent Landscape: The protection extends beyond the U.S. with a family of patents in multiple countries.
- Generic Launch: Estimated to be June 30, 2025, based on current patent and exclusivity status.
- Clinical Use: Approved for treating and preventing malignant hyperthermia and heat stroke.
FAQs
1. What is the active ingredient in Ryanodex?
The active ingredient in Ryanodex is dantrolene sodium.
2. What conditions is Ryanodex approved to treat?
Ryanodex is approved for the treatment and prevention of malignant hyperthermia and heat stroke.
3. When is the generic launch of Ryanodex estimated?
The generic launch of Ryanodex is estimated to be June 30, 2025.
4. What type of exclusivities has Ryanodex been granted?
Ryanodex has been granted Orphan Drug Exclusivity (ODE), which expired in July 2021.
5. How does the patent landscape affect the generic launch of Ryanodex?
The patent landscape, including the expiration of patents and exclusivities, directly affects the generic launch date. Monitoring these changes is crucial for strategic planning.
Cited Sources
- Pharsight: Ryanodex patent expiration.
- Eagle Pharmaceuticals: Exclusive Licensor Granted US Patent for Dantrolene in the Treatment of Heat Stroke.
- Hoover Institution: Patent Claims and Patent Scope.
- All for Drugs: FDA Approves Ryanodex for the Treatment of Malignant Hyperthermia.
- Eagle Pharmaceuticals Investor Relations: Exclusive Licensor Granted U.S. Patent for Dantrolene in the Treatment of Heat Stroke.
